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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Emory University | OTHER |
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The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP My Way intervention | Experimental | PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. |
|
| Control | No Intervention | These participants will continue to receive PrEP at the clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP My Way | Other | Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests). This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence | PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported PrEP Adherence in the Past 30 Days | PrEP adherence as measured by questionnaires at kit delivery. | Months 1, 3, 6 (intervention arm) |
| Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Use | The PrEP My Way intervention will be considered feasible if >70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) have a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at >66% (2/3) of visits. The outcome indicates the number of participants at each time point who received a kit and were able to 1) read their HIV test (if testing was desired), 2) provide a vaginal swab that could be assessed for gonorrhea/chlamydia (if testing was desired), and 3) inject medroxyprogesterone (if the product was desired). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Kisumu | Kenya |
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| ID | Title | Description |
|---|---|---|
| FG000 | PrEP My Way Intervention | PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests). This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP. |
| FG001 | Control | These participants will continue to receive PrEP at the clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PrEP My Way Intervention | PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests). This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Adherence | PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots | TFV-DP detection at 6 months per dried blood spots | Posted | Count of Participants | Participants | Six months |
|
Adverse event data was monitored/assessed from July 2021 - September 2022 (from the first enrollment through study completion for a total of 14 months, averaging 6 months per participant).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PrEP My Way Intervention | PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests). This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Haberer, MD, MS | Massachusetts General Hospital | 617-724-0351 | jhaberer@mgb.org |
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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 | Jan 20, 2021 | Feb 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months
| At 6 months |
| Rates of STI Testing | Testing for gonorrhea and chlamydia | Months 1, 3, and 6 |
| Rates of Hormonal Contraception | Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices) | Months 1, 3, and 6 |
| Prevention-effective Adherence at 6 Months | Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) >1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV) | Measured at 6 months |
| Six months |
| Acceptability of Intervention | The PrEP My Way intervention will be considered acceptable if >70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale (SUS) as "very good" or higher. The scores on the SUS are normalized on a scale 0-100 (higher scores indicate higher usability). | Six months |
| BG001 | Control | These participants will continue to receive PrEP at the clinic. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | These participants will continue to receive PrEP at the clinic. |
|
|
| Secondary | Self-reported PrEP Adherence in the Past 30 Days | PrEP adherence as measured by questionnaires at kit delivery. | Intervention participants reporting PrEP use at each kit delivery. Up to 75 participants could have taken PrEP at each time point; the number of participants analyzed at each time point is a subset of the 75, because not all participants chose to receive kits. | Posted | Mean | Full Range | percentage of doses taken | Months 1, 3, 6 (intervention arm) |
|
|
|
| Secondary | Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) | PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months | Study participants | Posted | Count of Participants | Participants | At 6 months |
|
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| Secondary | Rates of STI Testing | Testing for gonorrhea and chlamydia | Participants who had STI testing done | Posted | Count of Participants | Participants | Months 1, 3, and 6 |
|
|
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| Secondary | Rates of Hormonal Contraception | Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices) | participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices) | Posted | Count of Participants | Participants | Months 1, 3, and 6 |
|
|
|
| Secondary | Prevention-effective Adherence at 6 Months | Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) >1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV) | Women with ongoing HIV prevention needs, defined as meeting one of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) >1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV) | Posted | Count of Participants | Participants | Measured at 6 months |
|
|
|
| Other Pre-specified | Feasibility of Intervention Use | The PrEP My Way intervention will be considered feasible if >70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) have a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at >66% (2/3) of visits. The outcome indicates the number of participants at each time point who received a kit and were able to 1) read their HIV test (if testing was desired), 2) provide a vaginal swab that could be assessed for gonorrhea/chlamydia (if testing was desired), and 3) inject medroxyprogesterone (if the product was desired). | Intervention participants | Posted | Count of Participants | Participants | Six months |
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|
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| Other Pre-specified | Acceptability of Intervention | The PrEP My Way intervention will be considered acceptable if >70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale (SUS) as "very good" or higher. The scores on the SUS are normalized on a scale 0-100 (higher scores indicate higher usability). | Intervention participants completing the SUS at Month 6 | Posted | Median | Inter-Quartile Range | units on a scale | Six months |
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|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Control | These participants will continue to receive PrEP at the clinic. | 0 | 75 | 0 | 75 | 0 | 75 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Month 3 |
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| Month 6 |
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| Month 6 |
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| Title | Measurements |
|---|
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