HIV-1 Virologic ResponseNCT03500172
HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
A study testing DTP and ICM in people with HIV-1 Virologic Response, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Virologic Response
- What is being tested?
- DTP and ICM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,391 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Jun 2018to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
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.
Read the detailed description
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.
- Conditions
- HIV-1 Virologic Response
- Being tested
- DTP, ICM
- Keywords
- HIV, Female Sex Workers, Viral Suppression, South Africa, Decentralized care, Antiretroviral therapy, Differentiated care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPBehavioural
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
ICMBehavioural
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
| Study group | Role | What they receive |
|---|---|---|
| DTP, Continue DTP if Responsive | Active comparator | DTP:
* Standard of care (SoC), minus clinic referrals for antiretroviral therapy (ART) treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if virally suppressed at 6 months. Receives: Behavioral: DTP |
| DTP, Standard of Care (SoC) if Responsive | Active comparator | DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
SoC:
* HIV counseling and testing (HTC)
* Sexually transmitted infection (STI) screening and treatment
* Tuberculosis (TB) screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months. Receives: Behavioral: DTP |
| DTP, Continue DTP if Non-Responsive | Active comparator | DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if not virally suppressed at 6 months. Receives: Behavioral: DTP |
| DTP, DTP+ICM if Non-Responsive | Active comparator | DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through female sex worker (FSW) initiated interaction
Receives both interventions at 6 months if non-virally suppressed. Receives: Behavioral: DTP; Behavioral: ICM |
| ICM, Continue ICM if Responsive | Active comparator | ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if virally suppressed. Receives: Behavioral: ICM |
| ICM, SoC if Responsive | Active comparator | ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months. Receives: Behavioral: ICM |
| ICM, Continue ICM if Non-Responsive | Active comparator | ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if non-virally suppressed. Receives: Behavioral: ICM |
| ICM, ICM+DTP if Non-Responsive | Active comparator | ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed. Receives: Behavioral: DTP; Behavioral: ICM |
| Standard of Care (SoC) | No intervention | Standard of Care (SoC): * HIV counseling and testing (HTC) * Sexually transmitted infection (STI) screening and treatment * Tuberculosis (TB) screening and referral * Health education through peer educators and peer supported follow-up related to linkages to care * Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months after enrollment
Secondary outcomes (10)
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
Measured: 18 months after enrollment
Risk Factors of Loss to Follow-up
Risk stratification to identify FSW at highest risk for loss to follow-up.
Measured: 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)
Measured: Up to 18 months after enrollment
Adherence Assessment
Self-reported adherence to assess adherence across arms
Measured: 18 months
Viral Suppression of Retained
Among those retained, comparison of viral suppression across arms
Measured: 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.
Measured: 18 months after study enrollment
Intervention Acceptability
Participant reported intervention acceptability
Measured: 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
Measured: Up to 18 months after enrollment
ART Resistance
Report and compare resistance across arms
Measured: 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.
Measured: Baseline, Follow-up up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start22 Jun 2018
- Primary completion24 Nov 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1 Virologic ResponseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 1,391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Western Cape, TB HIV Care, University of Toronto, University of California, San Francisco, National Institute for Communicable Diseases, South Africa
- Responsible party
- Sponsor
- Investigators
- Stefan Baral, MD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthHarry Hausler, MD, MPH, Principal investigator, TB HIV Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500172
- Sponsor's protocol ID
- R01NR016650
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2018
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40810449Comins 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.
PubMed 38776334Bhardwaj 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.
PubMed 37147708Chen 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.
PubMed 36474210Wang 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.
PubMed 35212470
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
- ClinicalTrials.gov ID
- NCT03500172
- Acronym / sponsor ID
- R01NR016650
- Conditions
- HIV-1 Virologic Response
- Keywords
- HIV, Female Sex Workers, Viral Suppression, South Africa, Decentralized care, Antiretroviral therapy, Differentiated care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,391 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- University of the Western Cape, TB HIV Care, University of Toronto, University of California, San Francisco, National Institute for Communicable Diseases, South Africa
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- 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).
| Arm | Type | Receives |
|---|---|---|
| DTP, Continue DTP if Responsive | Active comparator | Behavioral: DTPDTP: * Standard of care (SoC), minus clinic referrals for antiretroviral therapy (ART) treatment initiation and management. * Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services Continues with DTP intervention if virally suppressed at 6 months. |
| DTP, Standard of Care (SoC) if Responsive | Active comparator | Behavioral: DTPDTP: * Standard of care, minus clinic referrals for ART treatment initiation and management. * Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services SoC: * HIV counseling and testing (HTC) * Sexually transmitted infection (STI) screening and treatment * Tuberculosis (TB) screening and referral * Health education through peer educators and peer supported follow-up related to linkages to care * Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management Returns to SoC if virally suppressed at 6 months. |
| DTP, Continue DTP if Non-Responsive | Active comparator | Behavioral: DTPDTP: * Standard of care, minus clinic referrals for ART treatment initiation and management. * Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services Continues with DTP intervention if not virally suppressed at 6 months. |
| DTP, DTP+ICM if Non-Responsive | Active comparator | Behavioral: DTP, Behavioral: ICMDTP: * Standard of care, minus clinic referrals for ART treatment initiation and management. * Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services ICM: * Standard of Care * Assignment of peer case manager * Face-to-face meeting to tailor ICM approach to FSW preference * Self-efficacy building in face-to-face sessions and bi-weekly text messages * Relational support through monthly calls, face-to-face meetings every three months, and additional support through female sex worker (FSW) initiated interaction Receives both interventions at 6 months if non-virally suppressed. |
| ICM, Continue ICM if Responsive | Active comparator | Behavioral: ICMICM: * Standard of Care * Assignment of peer case manager * Face-to-face meeting to tailor ICM approach to FSW preference * Self-efficacy building in face-to-face sessions and bi-weekly text messages * Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction Continues with ICM intervention at 6 months if virally suppressed. |
| ICM, SoC if Responsive | Active comparator | Behavioral: ICMICM: * Standard of Care * Assignment of peer case manager * Face-to-face meeting to tailor ICM approach to FSW preference * Self-efficacy building in face-to-face sessions and bi-weekly text messages * Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction SoC: * HIV counseling and testing (HTC) * STI screening and treatment * TB screening and referral * Health education through peer educators and peer supported follow-up related to linkages to care * Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management Returns to SoC if virally suppressed at 6 months. |
| ICM, Continue ICM if Non-Responsive | Active comparator | Behavioral: ICMICM: * Standard of Care * Assignment of peer case manager * Face-to-face meeting to tailor ICM approach to FSW preference * Self-efficacy building in face-to-face sessions and bi-weekly text messages * Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction Continues with ICM intervention at 6 months if non-virally suppressed. |
| ICM, ICM+DTP if Non-Responsive | Active comparator | Behavioral: DTP, Behavioral: ICMICM: * Standard of Care * Assignment of peer case manager * Face-to-face meeting to tailor ICM approach to FSW preference * Self-efficacy building in face-to-face sessions and bi-weekly text messages * Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction DTP: * Standard of care, minus clinic referrals for ART treatment initiation and management. * Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services Receives both interventions at 6 months if non-virally suppressed. |
| Standard of Care (SoC) | No intervention | –Standard of Care (SoC): * HIV counseling and testing (HTC) * Sexually transmitted infection (STI) screening and treatment * Tuberculosis (TB) screening and referral * Health education through peer educators and peer supported follow-up related to linkages to care * Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTPProvision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART. | Behavioural | DTP, Continue DTP if Non-Responsive, DTP, Continue DTP if Responsive, DTP, DTP+ICM if Non-Responsive, DTP, Standard of Care (SoC) if Responsive, ICM, ICM+DTP if Non-Responsive |
| ICMPeer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages. | Behavioural | DTP, DTP+ICM if Non-Responsive, ICM, Continue ICM if Non-Responsive, ICM, Continue ICM if Responsive, ICM, ICM+DTP if Non-Responsive, ICM, SoC if Responsive |
Primary outcome
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms
Time frame: 18 months after enrollment
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.
10 secondary outcomes
Retention and Viral Suppression of Non-Responders
Time frame: 18 months after enrollment
Risk Factors of Loss to Follow-up
Time frame: Up to 18 months after enrollment
Durability of Retention and Viral Suppression of Responders
Time frame: Up to 18 months after enrollment
Adherence Assessment
Time frame: 18 months
Viral Suppression of Retained
Time frame: Up to 18 months after enrollment
Loss-to-Follow-Up
Time frame: 18 months after study enrollment
Intervention Acceptability
Time frame: Acceptability of each intervention at 6 month timepoint
2nd/3rd Line ART
Time frame: Up to 18 months after enrollment
ART Resistance
Time frame: Up to 18 months after enrollment
Participants' Costs South in African Rand (ZAR)
Time frame: Baseline, Follow-up up to 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40810449Comins 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.
- Derived from this study: PubMed 38776334Comins 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.
- Derived from this study: PubMed 37147708Bhardwaj 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.
- Derived from this study: PubMed 36474210Chen 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.
- Derived from this study: PubMed 35212470Wang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Baral, MD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
Harry Hausler, MD, MPH principal investigator
TB HIV Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTP and ICM in people with HIV-1 Virologic Response, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms (time frame: 18 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500172, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.