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

Keywords

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

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• Active comparator
  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.

  Behavioral: DTP

• Active comparator
  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.

  Behavioral: DTP

• Active comparator
  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.

  Behavioral: DTP

• Active comparator
  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.

  Behavioral: DTP · Behavioral: ICM

• Active comparator
  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.

  Behavioral: ICM

• Active comparator
  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.

  Behavioral: ICM

• Active comparator
  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.

  Behavioral: ICM

• Active comparator
  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.

  Behavioral: DTP · Behavioral: ICM

• No intervention
  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

Interventions

• BehavioralDTP

  Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

• BehavioralICM

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

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.

   Time frame: 18 months after enrollment

Secondary outcomes

1. 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

   Time frame: 18 months after enrollment

2. Risk Factors of Loss to Follow-up

   Risk stratification to identify FSW at highest risk for loss to follow-up.

   Time frame: Up to 18 months after enrollment

3. 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)

   Time frame: Up to 18 months after enrollment

4. Adherence Assessment

   Self-reported adherence to assess adherence across arms

   Time frame: 18 months

5. Viral Suppression of Retained

   Among those retained, comparison of viral suppression across arms

   Time frame: Up to 18 months after enrollment

6. 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.

   Time frame: 18 months after study enrollment

7. Intervention Acceptability

   Participant reported intervention acceptability

   Time frame: Acceptability of each intervention at 6 month timepoint

8. 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

   Time frame: Up to 18 months after enrollment

9. ART Resistance

   Report and compare resistance across arms

   Time frame: Up to 18 months after enrollment

10. 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.

    Time frame: Baseline, Follow-up up to 5 months

Other outcomes

1. Decentralized Treatment Provision (DTP) Pick-Ups

   Number and percentage of DTP pick-ups attended among participants randomized to received DTP.

   Time frame: Up to 18 months after enrollment

2. ICM Phone-Based Contacts

   Number of ICM phone-based contacts

   Time frame: Up to 18 months after enrollment

3. ICM In-Person Meetings

   Percentage of face-to-face case manager sessions attended

   Time frame: Up to 18 months after enrollment

Baseline characteristics

23 further baseline measures are reported on the registry.

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 40810449 ↗
• 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. PubMed 38776334 ↗
• 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. PubMed 37147708 ↗
• 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. PubMed 36474210 ↗
• 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. PubMed 35212470 ↗

Study documents

• Protocol and statistical analysis plan · Apr 9, 2018
• Informed consent form · Apr 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No