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Project Vuselela Feasibility

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07117656
Acronym
PV
Enrollment
80
Registered
2025-08-12
Start date
2025-07-13
Completion date
2027-08-28
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Users, HIV

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.

Interventions

BEHAVIORALProject 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pilot study to understand intervention feasibility and preliminary impact on HIV and OST outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the intervention3 and 6 monthsAssess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.
Antiretroviral Therapy Therapy (ART) Adherence3 and 6 monthsMedical 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) Adherence3 and 6 monthsMedical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.

Countries

South Africa

Contacts

Primary ContactJoseph A Daniels, PhD
Joseph.A.Daniels@asu.edu206 459 5777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026