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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH121161 | U.S. NIH Grant/Contract | View source | |
| IRB00012628 | Other Identifier | JHSPH IRB |
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| Name | Class |
|---|---|
| TB HIV Care | OTHER |
| Unity Health Toronto | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.
The overall aim of this trial is to investigate which PrEP support strategies most effectively and efficiently optimize(s) PrEP persistence among female sex workers (FSW) and adolescent girls and youth women (AGYW) in South Africa. The trial will be implemented by TB HIV Care, a South African non-profit organization that provides direct HIV service delivery to FSW and AGYW across 10 districts in South Africa. The investigators plan to individually randomize 304 FSW and AGYW at the TB HIV Care site in uMgungundlovu, KwaZulu-Natal, to a fractional factorial trial, randomizing combinations of four separate strategies to support PrEP continuation. As fthe strategies are being tested, this results in 16 different intervention/study conditions, with one condition serving as a control where FSW and AGYW will receive the standard of care and no additional PrEP support. The other 15 conditions will be a combination of the standard of care alongside different PrEP delivery and support strategies implemented by TB HIV Care: case management, food vouchers, peer support buddies, and PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use and persistence, so that these services can be scaled up to other TB HIV Care sites. By utilizing the fractional factorial design in alignment the multiphase optimization strategy framework (MOST) the trial is feasible to conduct even with 16 arms, as the design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. | |
| Case management | Experimental | Participants will receive case management layered on existing standard of care. |
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| Food vouchers | Experimental | Participants will receive food vouchers layered on existing standard of care. |
|
| PrEP support buddy | Experimental | Participants will receive the PrEP support buddy intervention layered on existing standard of care. |
|
| Community-based PrEP pickup points | Experimental | Participants will receive the community-based PrEP pickup point intervention layered on existing standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case management | Behavioral | Participants will receive case management delivered by a peer with PrEP experience/success for seven months, with the goal of improving self-efficacy to take PrEP. The intention of this intervention is to help participants to develop individualized strategies to address and overcome barriers to PrEP use, as well as develop disclosure strategies. This strategy includes weekly face-to-face support with the case manager for the first month of the trial, followed by monthly face-to-face support for the remainder of the trial follow up period. The strategy will also include client-initiated on-demand phone consultation with the case manager and mental health/substance use screening and referrals. Participants randomized to this strategy may also opt into daily timed PrEP pill-taking reminders via short message service (SMS). |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Persistence at 7 Months After PrEP Initiation | Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Month 7 |
| PrEP Adherence at 7 Months After PrEP Initiation | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will not be included in this outcome. | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Persistence at 1 Month After PrEP Initiation | Participants who had PrEP in their possession 1-month after initiation, or returned for their 1-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
Identifies as a cisgender woman (assigned female sex at birth and currently identifies as a woman).
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| Name | Affiliation | Role |
|---|---|---|
| Sheree Schwartz, PhD, MPH | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Harry Hausler, MD, PhD, MPH | TB HIV Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TB HIV Care | Pietermaritzburg | KwaZulu-Natal | 3200 | South Africa |
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Recruitment took place at the TB HIV Care drop-in center in uMgungundlovu, KwaZulu-Natal from April to September 2024. The first participant was enrolled on April 16, 2024 and the last participant was enrolled September 6th, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2023 |
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This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.
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| PrEP support buddy + Community-based PrEP pickup points | Experimental | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. |
|
| Food vouchers + Community-based PrEP pickup points | Experimental | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. |
|
| Food vouchers + PrEP support buddy | Experimental | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. |
|
| Case management + Community-based PrEP pickup points | Experimental | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. |
|
| Case management + PrEP support buddy | Experimental | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. |
|
| Case management + Food vouchers | Experimental | Participants in this arm will receive both the case management and food voucher interventions in combination. |
|
| Food voucher + PrEP support buddy + Community-based PrEP pickup points | Experimental | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. |
|
| Case management + PrEP support buddy + Community-based PrEP pickup points | Experimental | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. |
|
| Case management + Food vouchers + Community-based PrEP pickup points | Experimental | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. |
|
| Case management + Food vouchers + PrEP support buddy | Experimental | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. |
|
| Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points | Experimental | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. |
|
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| Food vouchers | Behavioral | Participants will be given food vouchers with a value of 200 South African Rand at the time of PrEP initiation and at 1- and 4-month standard of care visits at which clinical checkups and PrEP refills are provided. The goal of these vouchers is to improve participants' capacity to persist on PrEP. While PrEP can be taken without food, some experience increased side effects or prefer to take pills with food, making adherence difficult if they cannot afford food at times. |
|
| PrEP support buddy | Behavioral | Participants will identify a person in their network (such as a friend, partner, parent) that they wish to support them in their PrEP usage, with the goal of improving participants' motivation and self-efficacy to persist on PrEP and providing social support to facilitate ongoing PrEP use. Support buddies selected by FSW and AGYW randomized to this intervention will receive a one-time training session on PrEP and support strategies as well as informational materials and text reminders to assist them in providing ongoing PrEP support. |
|
| Community-based PrEP pickup points | Behavioral | Participants will be able to pick up PrEP from alternative pick-up points within the community that are convenient for them, with the goal of making PrEP more accessible to participants. Ten pickup points will be established at existing Hubs of Hope throughout the subdistricts served by the TB HIV Care programme. Hubs of Hope are based in the War Rooms within subdistricts, where the TB HIV Care programme operates, and serve as meeting places for service users to receive support searching for jobs, completing online courses, and other personal development activities to support a multi-sectoral approach to health. A TB HIV Care ambassador is based at each Hub of Hope to coordinate activities and provide support to service users. Participants who choose to use pick-up points will have the option of either completing an HIV self-test or testing with the on-site TB HIV Care staff to confirm HIV-negative status prior to receipt of PrEP refills. |
|
| PrEP Persistence at 4 Months After PrEP Initiation |
Participants who had PrEP in their possession 4-months after initiation, or returned for their 4-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. |
| Month 4 |
| PrEP Persistence at 13 Months After PrEP Initiation | Participants who had PrEP in their possession 13-months after initiation, or returned for their 13-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Month 13 |
| PrEP Adherence at 7 Months After PrEP Initiation Among Trial Participants Who Provided Dried Blood Spot Samples | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Those who do not return at 7-months or do not provide a DBS sample will be excluded from this analysis. | Month 7 |
| FG001 | Case Management | Participants will receive case management layered on existing standard of care. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. |
| FG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| FG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| FG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| FG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| FG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| FG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| FG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| FG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. |
| BG001 | Case Management | Participants will receive case management layered on existing standard of care. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. |
| BG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| BG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| BG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| BG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| BG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| BG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| BG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| BG016 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Population | Count of Participants | Participants |
| ||||||||||||||||
| Education | Highest level of education completed, or currently studying. | Count of Participants | Participants |
| |||||||||||||||
| Living situation | Count of Participants | Participants |
| ||||||||||||||||
| Ever pregnant | Count of Participants | Participants |
| ||||||||||||||||
| Homeless in the past 6 months | Count of Participants | Participants |
| ||||||||||||||||
| Prior PrEP use | History of PrEP use prior to current PrEP initiation at study enrollment | Count of Participants | Participants |
| |||||||||||||||
| Perceived HIV risk | Count of Participants | Participants |
| ||||||||||||||||
| History of forced sex | Participant reported ever being forced to have sex when they did not want to. | Count of Participants | Participants |
| |||||||||||||||
| History of physical violence | Participant reported ever being physically hurt by another person. | Count of Participants | Participants |
| |||||||||||||||
| Alcohol use in the past year | Self-reported frequency of consuming drinks containing alcohol during the past 12 months. | Count of Participants | Participants |
| |||||||||||||||
| Depression | Participants scored 3 or higher on the 2-item Patient Health Questionnaire (PHQ-2). Score range 0-6, score of 3 or higher indicating a likely major depressive disorder. | Count of Participants | Participants |
| |||||||||||||||
| Anxiety | Participants scored 3 or higher on the 2-item Generalized Anxiety Disorder scale (GAD-2). Score range 0-6, score of 3 or higher suggests possible generalized anxiety disorder. | Count of Participants | Participants |
| |||||||||||||||
| Food insecurity | Participants reported going to sleep hungry at least once during the past 4 weeks. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PrEP Persistence at 7 Months After PrEP Initiation | Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Participants with data collected | Posted | Count of Participants | Participants | Month 7 |
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| Primary | PrEP Adherence at 7 Months After PrEP Initiation | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will not be included in this outcome. | Participants with data collected | Posted | Count of Participants | Participants | Month 7 |
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| Secondary | PrEP Persistence at 1 Month After PrEP Initiation | Participants who had PrEP in their possession 1-month after initiation, or returned for their 1-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Participants with data collected | Posted | Count of Participants | Participants | Month 1 |
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| Secondary | PrEP Persistence at 4 Months After PrEP Initiation | Participants who had PrEP in their possession 4-months after initiation, or returned for their 4-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Participants with data collected | Posted | Count of Participants | Participants | Month 4 |
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| Secondary | PrEP Persistence at 13 Months After PrEP Initiation | Participants who had PrEP in their possession 13-months after initiation, or returned for their 13-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records. | Participants with data collected | Posted | Count of Participants | Participants | Month 13 |
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| Secondary | PrEP Adherence at 7 Months After PrEP Initiation Among Trial Participants Who Provided Dried Blood Spot Samples | The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Those who do not return at 7-months or do not provide a DBS sample will be excluded from this analysis. | Those who did not return at 7-months or did not provide a DBS sample were excluded from this analysis. | Posted | Count of Participants | Participants | Month 7 |
|
During the trial period from April 2024-May 2025, approximately 13 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG001 | Case Management | Participants will receive case management layered on existing standard of care. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 1 | 19 | 0 | 19 |
| EG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. | 0 | 20 | 1 | 20 | 0 | 20 |
| EG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. | 1 | 19 | 0 | 19 | 0 | 19 |
| EG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. | 0 | 19 | 1 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV Seroconversion | Infections and infestations | Systematic Assessment | HIV seroconversion detected during study follow-up through routine HIV testing administered at PrEP pick-up visits. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheree Schwartz | Johns Hopkins Bloomberg School of Public Health | 443-983-2564 | sschwartz@jhu.edu |
| May 19, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019090 | Case Management |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
| 18-24 |
|
| 25-29 |
|
| 30-34 |
|
| 35-39 |
|
| 40+ |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Adolescent girls and young women |
|
| Grade 10-11 |
|
| Grade 12 (Matric) |
|
| Post-secondary |
|
| Currently studying |
|
| Renting own place |
|
| Partner's place |
|
| Other |
|
| A little |
|
| Somewhat |
|
| A lot |
|
| Prefer not to answer |
|
| Monthly or less |
|
| Two or more times per month |
|
| OG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
|
|
| OG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
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| OG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
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| OG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
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| OG002 | Food Vouchers | Participants will receive food vouchers layered on existing standard of care. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG003 | PrEP Support Buddy | Participants will receive the PrEP support buddies layered on existing standard of care. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG004 | Community-based PrEP Pickup Points | Participants will receive the community-based PrEP pickup points layered on existing standard of care. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG005 | PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG006 | Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG007 | Food Vouchers + PrEP Support Buddy | Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG008 | Case Management + Community-based PrEP Pickup Points | Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG009 | Case Management + PrEP Support Buddy | Participants in this arm will receive both the case management and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG010 | Case Management + Food Vouchers | Participants in this arm will receive both the case management and food voucher interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. |
| OG011 | Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG012 | Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG013 | Case Management + Food Vouchers + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
| OG014 | Case Management + Food Vouchers + PrEP Support Buddy | Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. |
| OG015 | Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points | Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination. Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders. Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided. PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support. Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP. |
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