Project Vuselela Feasibility

Arizona State University80 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Drug Users

Interventions

Project VuselelaBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Anova Health Institute

Johannesburg, South Africa

RECRUITING

Outcomes

Primary Outcomes

Feasibility of the intervention

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

Time frame: 3 and 6 months

Antiretroviral Therapy Therapy (ART) Adherence

Medical chart review of monthly anti-retroviral therapy (ART) prescription refill data will be collected. ART is medication to manage HIV infection.

Time frame: 3 and 6 months

Opioid Substitution Therapy (OST) Adherence

Medical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.

Time frame: 3 and 6 months

Central Contacts

Joseph A Daniels, PhD

CONTACT

206 459 5777 Joseph.A.Daniels@asu.edu

Data from ClinicalTrials.gov

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