Identifying early-treatment risks and providing decision guidance to stay engaged in HIV care
Behavioral Risk Identification and Decision Guidance for Engagement
This project tests a retention toolkit to help adults in South Africa who are starting or re-starting HIV treatment stay engaged in care during their first six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Johannesburg, Gauteng) |
| Trial ID | NCT07439003 on ClinicalTrials.gov |
What this trial studies
Retain6 focuses on the high-risk first six months after ART initiation or re-initiation, combining quantitative surveys and qualitative interviews to map patient-level preferences, barriers, and facilitators of care. The project uses this data to identify behavioral risk factors for disengagement and to design a retention toolkit aimed at the early treatment period. Preliminary, real-world tests of toolkit components have been conducted at participating clinics in Johannesburg, with input from patients and clinic staff. Findings are intended to inform practical guideline changes and care models to reduce early losses from HIV care.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) who are starting or re-starting ART at a participating South African clinic and who can be contacted by mobile phone and consent to provide survey or interview data.
Not a fit: People outside the early treatment window, under 18, receiving care at nonparticipating clinics, or not reachable by phone are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the toolkit could reduce early ART interruptions, increase retention and viral suppression, and improve long-term health outcomes for people starting treatment.
How similar studies have performed: Previous retention-support interventions in sub-Saharan Africa have shown mixed but promising results, while focused toolkits specifically targeting the first six months are a newer approach with limited large-scale proof.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group 1: * ≥18 years old at treatment initiation or re-initiation * Initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites. Group 2: * Seeking care at an intervention site during their early treatment period * Reachable at telephone (mobile) number provided * Consented to participate in qualitative data collection Group 3: * Employed by DOH or an implementing partner at a study site * Trained and participated in delivering the intervention * Consented to participate in qualitative data collection Exclusion Criteria: No exclusion criteria for any group.
Where this trial is running
Johannesburg, Gauteng
- Health Economics and Epidemiology Research Office — Johannesburg, Gauteng, South Africa (Recruiting)
Study contacts
- Principal investigator: Sydney Rosen — Boston University
- Study coordinator: Linda Sande
- Email: lsande@heroza.org
- Phone: 27 63 115 1952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.