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NCT Number: NCT07117656

Project Vuselela Feasibility

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Drug Misuse Drug Users Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aim 2 PLHWID Inclusion Criteria

  • Any sex or gender
  • >18 years of age
  • HIV-positive as per medical record
  • Self-reported injection drug use behavior
  • Have not participated in the current ART-OST program
  • Initiating ART or OST
  • Identifies a potential family member who can provide support
  • Live in Johannesburg

Family Member Inclusion Criteria

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

Exclusion criteria

PLHWID Exclusion Criteria

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

Family Member Exclusion Criteria

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

Treatment and study plan

Project Vuselela

Behavioral

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 3 and 6 months

    Assess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.

  2. Antiretroviral Therapy Therapy (ART) Adherence

    Time frame: 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.

  3. Opioid Substitution Therapy (OST) Adherence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph A Daniels, PhD

CONTACT

[email protected]

206 459 5777

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PV

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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