Project Vuselela Feasibility (PV)

Arizona State University (ASU)

Status: Enrolling

Conditions: Drug Users; HIV

Treatments: Behavioral: Project Vuselela

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07117656

11194429

R34DA062367 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

Four sessions on coping and communication skills to improve support for treatment among family members and people who inject drugs.

Treatment:

Behavioral: Project Vuselela

Standard of Care

No Intervention group

Description:

Offered current harm reduction services at clinics.