HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
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ClinicalTrials.gov Identifier: NCT03500172 |
Recruitment Status :
Completed
First Posted : April 17, 2018
Last Update Posted : November 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Virologic Response | Behavioral: DTP Behavioral: ICM | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1391 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 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). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa |
Actual Study Start Date : | June 22, 2018 |
Actual Primary Completion Date : | November 24, 2021 |
Actual Study Completion Date : | January 5, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: DTP, Continue DTP if Responsive
DTP:
Continues with DTP intervention if virally suppressed at 6 months. |
Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
Active Comparator: DTP, Standard of Care (SoC) if Responsive
DTP:
SoC:
Returns to SoC if virally suppressed at 6 months. |
Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
Active Comparator: DTP, Continue DTP if Non-Responsive
DTP:
Continues with DTP intervention if not virally suppressed at 6 months. |
Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. |
Active Comparator: DTP, DTP+ICM if Non-Responsive
DTP:
Receives both interventions at 6 months if non-virally suppressed. |
Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. Behavioral: ICM Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
Active Comparator: ICM, Continue ICM if Responsive
ICM:
Continues with ICM intervention at 6 months if virally suppressed. |
Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
Active Comparator: ICM, SoC if Responsive
ICM:
SoC:
Returns to SoC if virally suppressed at 6 months. |
Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
Active Comparator: ICM, Continue ICM if Non-Responsive
ICM:
Continues with ICM intervention at 6 months if non-virally suppressed. |
Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
Active Comparator: ICM, ICM+DTP if Non-Responsive
ICM:
DTP:
Receives both interventions at 6 months if non-virally suppressed. |
Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. Behavioral: ICM Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. |
- Retention and Viral Suppression of DTP verse ICM [ Time Frame: 18 months after enrollment ]Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM
- Retention and Viral Suppression of Non-Responders [ Time Frame: 18 months after enrollment ]Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM
- Risk factors of uncontrolled viremia and/or lost to follow-up [ Time Frame: Up to 18 months after enrollment ]Risk stratification tool to identify FSW at highest risk for uncontrolled viremia and/or lost to follow-up.
- Durability of Retention and Viral Suppression of Responders [ Time Frame: Up to 18 months after enrollment ]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)
- Adherence Assessment [ Time Frame: 6, 12 and 18 months ]Self-reported adherence and refill pick-up data to assess adherence across arms
- Viral Suppression of Retained [ Time Frame: Up to 18 months after enrollment ]Among those retained, comparison of viral suppression across arms
- Loss-to-Follow-Up [ Time Frame: 18 months after study enrollment ]Loss-to-follow-up across arms
- Intervention Acceptability [ Time Frame: Up to 18 months after enrollment ]Participant reported intervention acceptability
- 2nd/3rd Line ART [ Time Frame: Up to 18 months after enrollment ]Numbers switching to 2nd/3rd Line ART across arms
- ART Resistance [ Time Frame: Up to 18 months after enrollment ]Report and compare resistance across arms
- Comparative cost-effectiveness of intervention [ Time Frame: Up to 18 months after enrollment ]Comparison of intervention cost-effectiveness according to order of intervention and duration of intervention received
- DTP Pick-Ups [ Time Frame: Up to 18 months after enrollment ]Number and proportion of DTP pick-ups attended within 7-days of scheduled visit
- ICM Phone-Based Contacts [ Time Frame: Up to 18 months after enrollment ]Number of ICM phone-based contacts; proportion of participant initiating phone-based contacts at 6, 12 and 18 months
- ICM In-Person Meetings [ Time Frame: Up to 18 months after enrollment ]Proportion of face-to-face case manager sessions attended

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Only cisgender women will be enrolled into the study. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Sells sex for goods or money as their main source of income
- Assigned female sex at birth
- ≥ 18 years of age
- Living with HIV; diagnosed ≥ 6 months prior
- Currently living in Durban
- If on ART, initiated ≥2 months prior
Exclusion Criteria:
- Engagement in an ongoing HIV treatment research study
- Planning on leaving Durban for more than 3 months in the following 12 months
- Pregnant at time of enrollment
- On a second line or third ART regimen
- Participating in an adherence club

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500172
South Africa | |
TB HIV Care | |
Durban, South Africa |
Principal Investigator: | Stefan Baral, MD, MPH | Johns Hopkins Bloomberg School of Public Health | |
Principal Investigator: | Harry Hausler, MD, MPH | TB/HIV Care |
Documents provided by Johns Hopkins Bloomberg School of Public Health:
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT03500172 |
Other Study ID Numbers: |
R01NR016650 ( U.S. NIH Grant/Contract ) |
First Posted: | April 17, 2018 Key Record Dates |
Last Update Posted: | November 23, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Female Sex Workers Viral Suppression South Africa |
Decentralized care Antiretroviral therapy Differentiated care |