N/A
N=1,391
HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
HIV-1 Virologic Response
Bottom Line
View on ClinicalTrials.gov: NCT03500172 ↗Enrolled (actual)
1,391
Serious AEs
1.8%
Results posted
Sep 2023
Primary outcome: Primary: Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms — 16.0; 14.1 percentage of participants — p=0.455
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DTP (Behavioral); ICM (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms |
16.0; 14.1 | 0.455 |
| SECONDARY Retention and Viral Suppression of Non-Responders |
11.4; 11.3 | 0.962 |
| SECONDARY Risk Factors of Loss to Follow-up |
87; 36; 159; 40; 227; 66 | <0.05 sig |
| SECONDARY Durability of Retention and Viral Suppression of Responders |
43.1; 40.0 | 0.756 |
| SECONDARY Adherence Assessment |
46.5; 51.6 | 0.295 |
| SECONDARY Viral Suppression of Retained |
29.0; 23.0 | 0.149 |
| SECONDARY Loss-to-Follow-Up |
45.0; 41.3 | 0.301 |
| SECONDARY Intervention Acceptability |
163; 156 | — |
| SECONDARY 2nd/3rd Line ART |
36; 32 | — |
| SECONDARY ART Resistance |
37; 34 | 0.212 |
| SECONDARY Participants' Costs South in African Rand (ZAR) |
186.8; 164.9; 127.7; 256.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03500172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.