Project Vuselela Feasibility

NCT07117656 | Recruiting

• 2 other identifiers: 11194429R34DA062367
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Drug Users

Outcome Measures

Primary Outcomes (3)

• Feasibility of the intervention

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

  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.

  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.

  3 and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Project Vuselela

Standard of Care

NO INTERVENTION

Offered current harm reduction services at clinics.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Anova Health Institute

Johannesburg, South Africa

RECRUITING

MeSH Terms

Conditions

Drug Misuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Joseph A Daniels, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 12, 2025
• Study Start: July 13, 2025
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): August 28, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

ZA (1)