HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
NCT ID: NCT03500172
Last Updated: 2026-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1391 participants
INTERVENTIONAL
2018-06-22
2022-01-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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DTP, Continue DTP if Responsive
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.
DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
DTP, Standard of Care (SoC) if Responsive
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.
DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
DTP, Continue DTP if Non-Responsive
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.
DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
DTP, DTP+ICM if Non-Responsive
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.
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.
ICM, Continue ICM if Responsive
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.
ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
ICM, SoC if Responsive
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.
ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
ICM, Continue ICM if Non-Responsive
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.
ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
ICM, ICM+DTP if Non-Responsive
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.
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.
Standard of Care (SoC)
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Assigned female sex at birth
3. ≥ 18 years of age
4. Living with HIV; diagnosed ≥ 6 months prior
5. Currently living in Durban
6. If on ART, initiated ≥2 months prior
Exclusion Criteria
2. Planning on leaving Durban for more than 3 months in the following 12 months
3. Pregnant at time of enrollment
4. On a second line or third ART regimen
5. Participating in an adherence club
18 Years
FEMALE
Yes
Sponsors
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University of the Western Cape
OTHER
TB HIV Care
OTHER
University of Toronto
OTHER
University of California, San Francisco
OTHER
National Institute for Communicable Diseases, South Africa
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Stefan Baral, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Harry Hausler, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
TB HIV Care
Locations
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TB HIV Care
Durban, , South Africa
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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