Project Vuselela Feasibility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-13

Study Completion Date

2027-08-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Drug Users

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Project Vuselela

Intervention Type 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.

Standard of Care

Offered current harm reduction services at clinics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No