Project Vuselela Feasibility (PV)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Drug Users
• Intervention / Treatment: Behavioral: Project Vuselela

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph A Daniels, PhD; Phone Number: 206 459 5777; Email: Joseph.A.Daniels@asu.edu

Study Locations

• South Africa
  • Johannesburg, South Africa
    • Recruiting
    • Anova Health Institute
    • Contact: Albert Manyuchi, PhD; Phone Number: +27 71 588 5069; Email: manyuchi@anovahealth.co.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Four sessions on coping and communication skills to improve support for treatment among family members and people who inject drugs.	Behavioral: Project Vuselela; A four session intervention with people who inject drugs and family members. Delivered three group sessions and one dyad session. Session content designed to improve coping and communication skills that will in turn improve treatment outcomes.
No Intervention: Standard of Care; Offered current harm reduction services at clinics.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2025
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): August 28, 2027

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drug Misuse
• Other Study ID Numbers: 11194429; R34DA062367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No