Project Vuselela Feasibility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Project Vuselela.
- Who it may be relevant to
- Registry conditions: HIV, Drug Users. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa
Overview
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
- 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.
Primary outcome measures
- Feasibility of the intervention [Time frame: 3 and 6 months]
- Antiretroviral Therapy Therapy (ART) Adherence [Time frame: 3 and 6 months]
- Opioid Substitution Therapy (OST) Adherence [Time frame: 3 and 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Africa · 1 center
- Anova Health Institute — Johannesburg
Identifiers
NCT: NCT07117656 · 11194429 · R34DA062367