Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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

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

Run by Arizona State University · NCT07117656 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorArizona State University
Academic / other
Locations1 site (Johannesburg)
StatusRecruiting
StartedJuly 13, 2025
Main results expectedAugust 28, 2027
Study endsAugust 28, 2027
Registry record updatedAugust 12, 2025
Trial IDNCT07117656 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Anova Health Institute
    Johannesburg, South Africa
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.