HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)

NCT03500172 | Completed Results DMC

• 1 other identifier: R01NR016650
• Study Type: interventional
• Target: 1,391
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV-1 Virologic Response

Keywords

HIV; Female Sex Workers; Viral Suppression; South Africa; Decentralized care; Antiretroviral therapy; Differentiated care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Retention and Viral Suppression of Non-Responders

  18 months after enrollment

• Risk Factors of Loss to Follow-up

  Up to 18 months after enrollment

• Durability of Retention and Viral Suppression of Responders

  Up to 18 months after enrollment

• Adherence Assessment

  18 months

• Viral Suppression of Retained

  Up to 18 months after enrollment

Other Outcomes (3)

• Decentralized Treatment Provision (DTP) Pick-Ups

  Up to 18 months after enrollment

• ICM Phone-Based Contacts

  Up to 18 months after enrollment

• ICM In-Person Meetings

  Up to 18 months after enrollment

Study Arms (9)

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.

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.

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.

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.

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.

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.

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.

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.

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

Interventions

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.

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

ICM BEHAVIORAL

Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only cisgender women will be enrolled into the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: collaborator
• University of California, San Francisco: collaborator
• National Institute for Communicable Diseases, South Africa: collaborator
• Johns Hopkins Bloomberg School of Public Health: lead
• University of the Western Cape: collaborator
• TB HIV Care: collaborator

Study Sites (1)

TB HIV Care

Durban, South Africa

Location

Related Publications (5)

• 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.

  PMID: 40810449 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.

  PMID: 38776334 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.

  PMID: 37147708 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.

  PMID: 36474210 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.

  PMID: 35212470 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Stefan Baral
• Organization: Johns Hopkins Bloomberg School of Public Health

sbaral@jhu.edu

4105028975

Study Officials

• Stefan Baral, MD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Harry Hausler, MD, MPH

  TB HIV Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: June 22, 2018
• Primary Completion: November 24, 2021
• Study Completion: January 5, 2022
• Last Updated: January 14, 2026
• Results First Posted: September 21, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)