Project Vuselela: family-supported care for people who inject drugs with HIV

Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa

This project will try a multi-session, family-led support program to help adults in Johannesburg who inject drugs and have HIV stay on HIV treatment and opioid substitution therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Arizona State University (Academic / other)
• Locations: 1 site (Johannesburg)
• Trial ID: NCT07117656 on ClinicalTrials.gov

What this trial studies

Project Vuselela will develop and pilot-test a multi-session, skills-building intervention that engages family members to support people living with HIV who inject drugs (PLWHIDs). Trained peer navigators will lead sessions attended by both PLWHIDs and their identified family supporters to build coping skills and concrete treatment action plans. The pilot will compare participants receiving the intervention to those in the current ART‑OST program at Yeoville Clinic to measure acceptability and preliminary effects. Outcomes include feasibility metrics and early signals of impact on ART and OST adherence and retention.

Who should consider this trial

Good fit: Adults (age ≥18) living in Johannesburg who are HIV-positive, report injection drug use, are initiating ART or OST, have not participated in the current ART-OST program, and can identify a family member willing to participate.

Not a fit: People already on ART or OST, those unable to identify a supportive family member, non-injectors, or individuals living outside Johannesburg are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could improve ART and OST adherence and retention by strengthening family support and reducing relapse, leading to better health outcomes for people who inject drugs.

How similar studies have performed: Family-support and peer‑navigator approaches have improved adherence in other HIV and substance‑use settings, but applying a family-focused model specifically for people who inject drugs in South Africa is relatively novel.

Eligibility criteria

Inclusion Criteria:

Aim 2 PLHWID Inclusion Criteria

1. Any sex or gender
2. \>18 years of age
3. HIV-positive as per medical record
4. Self-reported injection drug use behavior
5. Have not participated in the current ART-OST program
6. Initiating ART or OST
7. Identifies a potential family member who can provide support
8. Live in Johannesburg

Family Member Inclusion Criteria

1. 18 years of age or older
2. Confirms family member (parent, sibling, partner, aunt, uncle, grandparent, cousin)
3. Knowledge of the drug using behavior by the PLWHID, but knowledge of their HIV status is not required.
4. No recent history of self-reported drug-using behavior (\< 5 years)

Exclusion Criteria:

PLHWID Exclusion Criteria

1. Under 18 years of age
2. HIV-negative as per medical record
3. Notself-reported injection drug use behavior
4. Has participated in the current ART-OST program
5. Taking ART or OST
6. Cannot identify a potential family member who can provide support
7. Does not live in Johannesburg

Family Member Exclusion Criteria

1. Under 18 years of age
2. Not a family member
3. Does not know about drug using behavior by the PLWHID
4. Recent history of self-reported drug-using behavior (\< 5 years)

Where this trial is running

Johannesburg

• Anova Health Institute — Johannesburg, South Africa (Recruiting)

Study contacts

• Study coordinator: Joseph A Daniels, PhD

Conditions HIV; Drug Users