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| Name | Class |
|---|---|
| University of the Western Cape | OTHER |
| TB HIV Care | OTHER |
| University of Toronto | OTHER |
| University of California, San Francisco |
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The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment <50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.
RATIONALE: Approximately 60% of the estimated 121,000 - 167,000 female sex workers (FSW) in South Africa are living with HIV. Research suggests only 39% of these women are currently on antiretroviral therapy (ART) and face individual, network and structural level barriers to ART initiation, retention and adherence. To prevent clinical treatment outcome disparities and reduce onward HIV transmission, understanding how best to adapt and implement, scalable and effective interventions to promote viral suppression among marginalized women is paramount. The overall goal of the Siyaphambili study is to inform South African HIV service delivery and scale up determining the most cost-effective package needed to achieve viral suppression among FSW and by characterizing the FSW most in need of these intensive HIV treatment interventions.
HYPOTHESIS: DTP and ICM will be equally effective at achieving viral suppression and will have a synergistic effect when combined and targeted at those who remain non-responsive to either isolated intervention. Additionally, an adaptive, graduated multicomponent intervention to achieve viral suppression would be preferred under standard thresholds for cost-effectiveness over single-intensity interventions or intensive multicomponent interventions for all FSW.
INTERVENTION: The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among FSW living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.
STUDY DESIGN: A sequential multistage adaptive randomized study, embedded within the TB/HIV Care program in Durban, South Africa, will enroll 800 viremic FSW into the 18-month trial. Women will be randomized to either DTP or ICM at enrolment and rerandomized 6 months after enrolment based on their response to the initial intervention.
PRIMARY OBJECTIVE: To compare the effectiveness and durability of nurse-led DTP and ICM in isolation or in combination to achieve viral suppression.
SECONDARY OBJECTIVE: To estimate the incremental impact and cost-effectiveness associated with study interventions and combination of interventions.
OUTCOMES: The primary outcome of the study is retention and viral suppression among those initially randomized to the DTP verse ICM intervention. The secondary outcomes are retention and viral suppression of non-responders, retention and viral suppression among month 6 non-responders, retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention verse combined DTP+ICM, risk stratification tool, durability of retention and viral suppression of responders, to assess adherence, to assess viral suppression of retained, loss-to-follow-up, intervention acceptability, switching to 2nd/3rd line ART, and ART resistance.
ANALYTIC PLAN:
Primary analysis for primary outcome:
Retention in ART care and viral suppression will be a combined outcome in an intention to treat (ITT) analysis at 18 months to compare participants initially randomized to the DTP verse ICM intervention. Viral suppression is defined as a viral load assessment <50 RNA copies/mL and participants lost to follow up or who experience death during the trial duration will be grouped with non-virally suppressed participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTP, Continue DTP if Responsive | Active Comparator | DTP:
Continues with DTP intervention if virally suppressed at 6 months. |
|
| DTP, Standard of Care (SoC) if Responsive | Active Comparator | DTP:
SoC:
Returns to SoC if virally suppressed at 6 months. |
|
| DTP, Continue DTP if Non-Responsive | Active Comparator | DTP:
Continues with DTP intervention if not virally suppressed at 6 months. |
|
| DTP, DTP+ICM if Non-Responsive | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTP | Behavioral | Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms | Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM. Participants are considered to be retained in care if they attended their 18-month final study visit and were engaged in care at 18-months. Viral suppression is defined as having less than 50 viral copies per milliliter. | 18 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Retention and Viral Suppression of Non-Responders | Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM | 18 months after enrollment |
| Risk Factors of Loss to Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Decentralized Treatment Provision (DTP) Pick-Ups | Number and percentage of DTP pick-ups attended among participants randomized to received DTP. | Up to 18 months after enrollment |
| ICM Phone-Based Contacts |
Inclusion Criteria:
Exclusion Criteria:
Only cisgender women will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Baral, MD, MPH | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Harry Hausler, MD, MPH | TB HIV Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TB HIV Care | Durban | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40810449 | Derived | Comins CA, Genberg B, Mcingana M, Bandeen-Roche K, Phetlhu DR, Steingo J, Mishra S, Wang L, Baral S, Hausler H, Schwartz S. Longitudinal Trajectories of Engagement With HIV Treatment Support Strategies Among Female Sex Workers Living With HIV in South Africa. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):323-330. doi: 10.1097/QAI.0000000000003738. | |
| 38776334 | Derived | Comins CA, Baral S, Mcingana M, Shipp L, Phetlhu DR, Young K, Guddera V, Hausler H, Schwartz S. ART coverage and viral suppression among female sex workers living with HIV in eThekwini, South Africa: Baseline findings from the Siyaphambili study. PLOS Glob Public Health. 2024 May 22;4(5):e0002783. doi: 10.1371/journal.pgph.0002783. eCollection 2024. |
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Of the 1391 participants enrolled, 777 met randomization criteria (non-virally suppressed) and were randomized to one of the two tested strategies. Participants who were virally suppressed at baseline OR lost to follow up prior to baseline randomization (n=614) continued with standard of care and were not randomized.
Recruitment took place at sex work venues and the TB HIV Care drop-in center in Durban, South Africa from June 2018 to March 2020. The first participant was enrolled on June 22, 2018 and the last participant was enrolled on March 23, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTP, Continue DTP if Responsive | DTP:
Continues with DTP intervention if virally suppressed at 6 months. DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
| FG001 | DTP, Standard of Care (SoC) if Responsive | DTP:
SoC:
Returns to SoC if virally suppressed at 6 months. DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
| FG002 | DTP, Continue DTP if Non-Responsive | DTP:
Continues with DTP intervention if not virally suppressed at 6 months. DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
| FG003 | DTP, DTP+ICM if Non-Responsive | DTP:
Receives both interventions at 6 months if non-virally suppressed. DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
| FG004 | ICM, Continue ICM if Responsive | ICM:
Continues with ICM intervention at 6 months if virally suppressed. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
| FG005 | ICM, SoC if Responsive | ICM:
SoC:
Returns to SoC if virally suppressed at 6 months. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
| FG006 | ICM, Continue ICM if Non-Responsive | ICM:
Continues with ICM intervention at 6 months if non-virally suppressed. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
| FG007 | ICM, ICM+DTP if Non-Responsive | ICM:
DTP:
Receives both interventions at 6 months if non-virally suppressed. DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
| FG008 | Standard of Care (SoC) | SoC (virally suppressed at baseline OR lost to follow up prior to baseline randomization):
|
| FG009 | Baseline Randomization: ICM | ICM:
|
| FG010 | Baseline Randomization: DTP | DTP:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Baseline Randomization |
|
| ||||||||||||||||||
| Period 2: Re-Randomization |
|
Non-virally suppressed participants who not lost to follow up prior to baseline randomization were randomized into two arms at baseline, DTP or ICM, presented here. Virally suppressed at baseline participants and non-virally suppressed participants who were lost to follow up prior to baseline randomization received standard of care.
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| ID | Title | Description |
|---|---|---|
| BG000 | Individualized Case Management (ICM) at Baseline | ICM:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms | Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM. Participants are considered to be retained in care if they attended their 18-month final study visit and were engaged in care at 18-months. Viral suppression is defined as having less than 50 viral copies per milliliter. | This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM). All 777 participants randomized at baseline are included here. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months after enrollment |
|
Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety & monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement.
AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
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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 | Decentralize Treatment Provision (DTP) at Baseline | DTP:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Imprisoned while enrolled in study | Social circumstances | Systematic Assessment |
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A limitation to this study has been determining engagement in care and viral load status for those who were lost to follow up (LTFU) in the trial in order to inform the primary outcome. Given the high rates of LTFU, participants may have been seeking care elsewhere and achieved viral suppression during the follow up period without our knowledge. This has implications for our primary outcome which uses an intention to treat (ITT) analysis of engagement in care and viral suppression.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefan Baral | Johns Hopkins Bloomberg School of Public Health | 4105028975 | sbaral@jhu.edu |
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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 | Apr 9, 2018 | Nov 18, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2018 | May 30, 2023 | ICF_004.pdf |
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| OTHER |
| National Institute for Communicable Diseases, South Africa | OTHER |
This sequential multistage adaptive randomized trial (SMART) assesses two interventions to address treatment barriers: (1) nurse-led mobile decentralized treatment programs (DTP) and (2) peer-led, individualized case management (ICM).
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DTP:
ICM:
Receives both interventions at 6 months if non-virally suppressed. |
|
| ICM, Continue ICM if Responsive | Active Comparator | ICM:
Continues with ICM intervention at 6 months if virally suppressed. |
|
| ICM, SoC if Responsive | Active Comparator | ICM:
SoC:
Returns to SoC if virally suppressed at 6 months. |
|
| ICM, Continue ICM if Non-Responsive | Active Comparator | ICM:
Continues with ICM intervention at 6 months if non-virally suppressed. |
|
| ICM, ICM+DTP if Non-Responsive | Active Comparator | ICM:
DTP:
Receives both interventions at 6 months if non-virally suppressed. |
|
| Standard of Care (SoC) | No Intervention | Standard of Care (SoC):
|
| ICM | Behavioral | Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
|
Risk stratification to identify FSW at highest risk for loss to follow-up. |
| Up to 18 months after enrollment |
| Durability of Retention and Viral Suppression of Responders | Durability of retention and viral suppression among 6 month responders continuing on DTP or ICM vs. those randomized to revert to standard of care (SoC) | Up to 18 months after enrollment |
| Adherence Assessment | Self-reported adherence to assess adherence across arms | 18 months |
| Viral Suppression of Retained | Among those retained, comparison of viral suppression across arms | Up to 18 months after enrollment |
| Loss-to-Follow-Up | Loss-to-follow-up across arms (DTP vs. ICM). This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM). All 777 participants randomized at baseline are included here. Loss to follow-up is defined as having missed the 18-month final study visit. | 18 months after study enrollment |
| Intervention Acceptability | Participant reported intervention acceptability | Acceptability of each intervention at 6 month timepoint |
| 2nd/3rd Line ART | Number of participants who were tested and identified as resistant to first line therapy and were referred to a Department of Health facility for second line therapy across arms | Up to 18 months after enrollment |
| ART Resistance | Report and compare resistance across arms | Up to 18 months after enrollment |
| Participants' Costs South in African Rand (ZAR) | Participants' cost data were collected by opportunity cost questionnaire for the intervention arms in the trial and are summarized descriptively to support potential future modeling. Participants' costs are defined as costs associated with attending each visit for HIV care (transportation, food, child-care and other; and money that would have been earned from clients (opportunity cost). Follow-up costs were for attending each DTP/ICM and HIV care clinic visit. | Baseline, Follow-up up to 5 months |
Number of ICM phone-based contacts
| Up to 18 months after enrollment |
| ICM In-Person Meetings | Percentage of face-to-face case manager sessions attended | Up to 18 months after enrollment |
| 37147708 | Derived | Bhardwaj A, Comins CA, Guddera V, Mcingana M, Young K, Phetlhu R, Mulumba N, Mishra S, Hausler H, Baral S, Schwartz S. Prevalence of depression, syndemic factors and their impact on viral suppression among female sex workers living with HIV in eThekwini, South Africa. BMC Womens Health. 2023 May 5;23(1):232. doi: 10.1186/s12905-023-02392-2. |
| 36474210 | Derived | Chen C, Baral S, Comins CA, Mcingana M, Wang L, Phetlhu DR, Mulumba N, Guddera V, Young K, Mishra S, Hausler H, Schwartz SR. HIV- and sex work-related stigmas and quality of life of female sex workers living with HIV in South Africa: a cross-sectional study. BMC Infect Dis. 2022 Dec 6;22(1):910. doi: 10.1186/s12879-022-07892-4. |
| 35212470 | Derived | Wang L, Dowdy DW, Comins CA, Young K, Mcingana M, Mulumba N, Mhlophe H, Chen C, Hausler H, Schwartz SR, Baral S, Mishra S; Siyaphambili Study team. Health-related quality of life of female sex workers living with HIV in South Africa: a cross-sectional study. J Int AIDS Soc. 2022 Feb;25(2):e25884. doi: 10.1002/jia2.25884. |
| Protocol Violation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Decentralized Treatment Provision (DTP) at Baseline | DTP:
|
| BG002 | Standard of Care (Virally Suppressed at Baseline OR Lost to Follow up Before Baseline Randomization) | SoC (virally suppressed at baseline OR lost to follow up prior to baseline randomization):
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nationality | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Currently enrolled in school | Count of Participants | Participants |
|
| Can read and/or write in Zulu or English | Count of Participants | Participants |
|
| Current employment other than sex work | Count of Participants | Participants |
|
| Relationship status | Count of Participants | Participants |
|
| Median age at first sex | Median | Inter-Quartile Range | years |
|
| Median age at first exchange of sex acts for goods | Median | Inter-Quartile Range | years |
|
| Median age at first exchange of sex acts for money | Median | Inter-Quartile Range | years |
|
| Advertises service online | Count of Participants | Participants |
|
| Always carries condoms while working | Count of Participants | Participants |
|
| Consistent condom use with new clients (last 30 days) | Count of Participants | Participants |
|
| Consistent condom use with regular clients (last 30 days) | Count of Participants | Participants |
|
| Consistent condom use with non-paying partners (last 30 days) | Count of Participants | Participants |
|
| Hormonal contraception | Count of Participants | Participants |
|
| Non-hormonal contraception | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Tested for tuberculosis in last 6 months | Count of Participants | Participants |
|
| Hospitalized in last 6 months | Count of Participants | Participants |
|
| Antiretroviral therapy experience | Count of Participants | Participants |
|
| Ever experienced physical abuse | Count of Participants | Participants |
|
| Ever experienced sexual abuse | Count of Participants | Participants |
|
| Median self-reported health state | This measure uses a Median Self-reported Health Scale which ranges from 0 to 100. Participants were asked to respond to the following prompt: "To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your health is today, in your opinion." | Median | Inter-Quartile Range | units on a scale |
|
| Depression | Count of Participants | Participants |
|
| Drinks alcohol two or more times a week | Count of Participants | Participants |
|
| Ever injected drugs | Count of Participants | Participants |
|
| Baseline viral load | Count of Participants | Participants |
|
| OG001 | Individualized Case Management (ICM) at Baseline | ICM:
|
|
|
|
| Secondary | Retention and Viral Suppression of Non-Responders | Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM | This outcome was specified as a comparison of two subgroups rather than overall sample. This is why only two groups are included in this outcome and the number of participants is smaller than the total sample. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months after enrollment |
|
|
|
|
| Secondary | Risk Factors of Loss to Follow-up | Risk stratification to identify FSW at highest risk for loss to follow-up. | Risk factors for loss to follow up were analyzed across the sample, not by randomization assignment. Groups here reflect this approach. | Posted | Count of Participants | Participants | Up to 18 months after enrollment |
|
|
|
|
| Secondary | Durability of Retention and Viral Suppression of Responders | Durability of retention and viral suppression among 6 month responders continuing on DTP or ICM vs. those randomized to revert to standard of care (SoC) | This is a subgroup analysis of two of the month 6 re-randomization arms rather than the entire sample. Groups listed here and sample sizes reflect this approach. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 18 months after enrollment |
|
|
|
|
| Secondary | Adherence Assessment | Self-reported adherence to assess adherence across arms | This outcome was analyzed by baseline randomization status rather than month 6 re-randomization status. Groups included here reflect this. Numbers analyzed are smaller due to the fact that there was loss to follow up and not all participants answered questions on self-reported adherence. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
|
|
|
|
| Secondary | Viral Suppression of Retained | Among those retained, comparison of viral suppression across arms | This outcome was analyzed by baseline randomization status (DTP vs. ICM). Number of participants included reflects the total number retained in care across the two arms, which is less than the original sample size due to loss to follow up. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 18 months after enrollment |
|
|
|
|
| Secondary | Loss-to-Follow-Up | Loss-to-follow-up across arms (DTP vs. ICM). This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM). All 777 participants randomized at baseline are included here. Loss to follow-up is defined as having missed the 18-month final study visit. | This outcome was analyzed by baseline randomization assignment (DTP vs. ICM). Groups included here reflect this. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months after study enrollment |
|
|
|
|
| Secondary | Intervention Acceptability | Participant reported intervention acceptability | This outcome was analyzed by baseline randomization status (DTP vs. ICM) which is reflected in the two groups included here. The number for analysis is smaller than the overall sample due to not all participants responding to acceptability questions either due to refusal or loss to follow up. | Posted | Count of Participants | Participants | Acceptability of each intervention at 6 month timepoint |
|
|
|
| Secondary | 2nd/3rd Line ART | Number of participants who were tested and identified as resistant to first line therapy and were referred to a Department of Health facility for second line therapy across arms | This outcome was analyzed by baseline randomization as reflected in the two groups included. The number analyzed reflects the number of individuals who were tested for drug resistance which was a subset of the sample in line with protocol guidelines. | Posted | Count of Participants | Participants | Up to 18 months after enrollment |
|
|
|
| Secondary | ART Resistance | Report and compare resistance across arms | This outcome was analyzed by baseline randomization assignment as shown in the two groups included here. The number of participants analyzed represents those tested for drug resistance in line with protocol guidelines. | Posted | Count of Participants | Participants | Up to 18 months after enrollment |
|
|
|
|
| Secondary | Participants' Costs South in African Rand (ZAR) | Participants' cost data were collected by opportunity cost questionnaire for the intervention arms in the trial and are summarized descriptively to support potential future modeling. Participants' costs are defined as costs associated with attending each visit for HIV care (transportation, food, child-care and other; and money that would have been earned from clients (opportunity cost). Follow-up costs were for attending each DTP/ICM and HIV care clinic visit. | Participants with cost questionnaire data collected were included in analyses. | Posted | Mean | Inter-Quartile Range | ZAR | Baseline, Follow-up up to 5 months |
|
|
|
| Other Pre-specified | Decentralized Treatment Provision (DTP) Pick-Ups | Number and percentage of DTP pick-ups attended among participants randomized to received DTP. | Only a subset of participants received the DTP intervention either from baseline or at 6 months (550 total). The number of units represents the total expected number of DTP pickups per protocol. | Posted | Count of Units | Total DTP pickups | Up to 18 months after enrollment | Total DTP pickups | Total DTP pickups |
|
|
|
| Other Pre-specified | ICM Phone-Based Contacts | Number of ICM phone-based contacts | Only a subset of participants received the ICM intervention, either from baseline or at 6 months (552 total). The units analyzed represent the total number of expected phone calls per protocol. | Posted | Count of Units | Planned phone-based contacts | Up to 18 months after enrollment | Planned phone-based contacts | Planned phone-based contacts |
|
|
|
| Other Pre-specified | ICM In-Person Meetings | Percentage of face-to-face case manager sessions attended | Only a subset of participants received the ICM intervention, either from baseline or at month 6 (552 total). The units analyzed represent the number of expected in person sessions per protocol. | Posted | Count of Units | Number of planned in-person ICM sessions | Up to 18 months after enrollment | Number of planned in-person ICM sessions | Number of planned in-person ICM sessions |
|
|
|
| 4 |
| 387 |
| 8 |
| 387 |
| 0 |
| 387 |
| EG001 | Individualized Case Management (ICM) at Baseline | ICM:
| 12 | 390 | 16 | 390 | 0 | 390 |
| EG002 | Standard of Care (SoC) at Baseline | SoC:
Returns to SoC if virally suppressed at 6 months. ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. | 1 | 523 | 1 | 523 | 0 | 523 |
| EG003 | Enrolled But Not Randomized | A subset of participants were enrolled in the study but not randomized for the following reasons:
| 0 | 91 | 0 | 91 | 0 | 91 |
| Physical violence | Social circumstances | Systematic Assessment | Experienced physical violence while enrolled in study (unrelated to study participation) |
|
| Hospitalization | Social circumstances | Systematic Assessment | Hospitalization during enrollment unrelated to study participation |
|
| Motor vehicle accident | Social circumstances | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment | Not related to study participation |
|
| Gallstones and swollen feet | Gastrointestinal disorders | Systematic Assessment | Not related to study participation |
|
| Sexual violence | Social circumstances | Systematic Assessment | Not related to study participation |
|
Not provided
Not provided
| Marijuana use in the past 30 days |
|
| Experienced physical violence in the pasts 6 months |
|
| Experienced sexual violence in the past 6 months |
|
| Viral load of 50-1000 copies/mL at baseline |
|
| Viral load greater than 1000 copies/mL at baseline |
|
Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.
| Regression, Cox |
| <0.05 |
Threshold for statistical significance: 0.05 |
| Hazard Ratio (HR) |
| 1.60 |
| 2-Sided |
| 95 |
| 1.02 |
| 2.51 |
| Superiority |
| Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days | Regression, Cox | <0.05 | Threshold for statistical significance: 0.05 | Hazard Ratio (HR) | 1.31 | 2-Sided | 95 | 1.09 | 1.57 | Superiority |
| Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months. | Regression, Cox | <0.05 | Threshold for statistical significance: 0.05 | Hazard Ratio (HR) | 1.24 | 2-Sided | 95 | 1.01 | 1.52 | Superiority |
| Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not | Regression, Cox | <0.05 | Threshold for statistical significance: 0.05 | Hazard Ratio (HR) | 1.62 | 2-Sided | 95 | 1.31 | 2.00 | Superiority |
| Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. <50 copies/mL. | Regression, Cox | <0.05 | Threshold for statistical significance: 0.05 | Hazard Ratio (HR) | 2.33 | 2-Sided | 95 | 1.65 | 3.29 | Superiority |
| Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL. | Regression, Cox | <0.05 | Threshold for significance: 0.05 | Hazard Ratio (HR) | 2.47 | 2-Sided | 95 | 1.82 | 3.36 | Superiority |
| Follow-up up to 5 months |
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