Project Vuselela Feasibility

Not Applicable

Recruiting

• Conditions: HIV; Drug Users

• Registration Number: NCT07117656
• Lead Sponsor: Arizona State University

Brief Summary

To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes.

Detailed Description

In response to increased injection drug use in Johannesburg, South Africa, and low ART and OST treatment retention rates, we will develop and pilot-test the intervention, Project Vuselela. The intervention is designed to engage family members in treatment support using a multi-session skill-building approach that is led by trained peer navigators. Both PLWHIDs and their family members will attend sessions to develop these skills and treatment action plans, facilitated by peer navigators. We will assess PLWHID and family acceptability of the intervention and preliminary impact on PLWHID ART and OST treatment adherence when compared to those in the current program as standard of care. The study will be conducted at Yeoville Clinic in Johannesburg, a setting with high rates of injection drug use and the only OST clinic in the city.

Study Timeline

• Study Start: 2025-07-13
• Study First Submitted: 2025-07-15
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-08-28
• Study Completion: 2027-08-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	3 and 6 months	Assess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.
Antiretroviral Therapy Therapy (ART) Adherence	3 and 6 months	Medical chart review of monthly anti-retroviral therapy (ART) prescription refill data will be collected. ART is medication to manage HIV infection.
Opioid Substitution Therapy (OST) Adherence	3 and 6 months	Medical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.

Trial Locations

Locations (1)

Anova Health Institute; 🇿🇦 Johannesburg, South Africa