Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06027671

Structured Peer-delivered Antiretroviral Therapy (ART) and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa

Led by Johns Hopkins University · Updated on 2026-06-02

400

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

A

Aurum Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the Structured Peer-delivered Antiretroviral Therapy and Reentry Community Strategy (Full-SPARCS) for HIV-positive adults transitioning from correctional facilities to community settings in South Africa. The study seeks to compare Full-SPARCS to usual care in achieving HIV viral load suppression six months after release, while also assessing how well the program can be implemented and its cost-effectiveness. The focus is on improving continuity of HIV care among recently released inmates, a group facing many barriers to ongoing treatment. Participants will be randomly assigned to receive either standard care or the Full-SPARCS intervention. The Full-SPARCS program includes one individual session before release, one individual session after release, and 12 group sessions approximately every two weeks over six months. These group sessions, led by peer facilitators, aim to build life skills, social support, and self-efficacy through a structured curriculum covering topics like goal setting, problem solving, and living with HIV. Standard care involves referral letters and usually a 28-day supply of antiretroviral therapy at release. Throughout the study, participants will be followed up with at one week, one month, three months, six months, nine months, and twelve months after release to check on their HIV care status and update contact details. Assessments include symptom screening, laboratory monitoring, and tracking viral load suppression at six and twelve months. The study plans to enroll 400 adult participants who are receiving ART while incarcerated and are expected to return to specific community districts in Gauteng Province. The total duration for participant involvement is up to twelve months post-release.

CONDITIONS

Brief Title

Structured Peer-delivered ART and Reentry Community Strategy

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Incarcerated at one of the participating enrolment sites, including both un-sentenced and sentenced individuals
  • Diagnosed with HIV and receiving antiretroviral therapy (ART) at the time of enrolment
  • Expected release or trial date within three months of enrolment
  • Plan to live in an unrestricted environment within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province, close to a SPARCS intervention site
  • Willing to participate in follow-up activities after release and provide contact information
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Severe cognitive dysfunction or mental illness preventing informed consent
  • Unable to provide informed consent
  • Requires high intensity care beyond what the program offers as assessed by correctional health staff
  • Not released during the intervention period
  • Expected release to a location outside of Gauteng Province

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months post-release

Participants assigned to the Full-SPARCS intervention attend one individual pre-release session, one individual post-release session, and 12 biweekly peer facilitator-led group sessions over six months post-release. The sessions focus on building goal setting, prioritizing, and planning skills to support HIV care continuity during community re-entry.

1 pre-release individual session, 1 post-release individual session, and 12 group sessions approximately every two weeks

Follow-up

Duration - 12 months post-release

Participants are contacted at one week, one month, three months, six months, nine months, and twelve months post-release to ascertain care status and update contact information.

6 follow-up contacts after release

Trial Site Locations

Total: 1 location

1

The Aurum Institute - Head office

Johannesburg, Gauteng, South Africa, 2193

Actively Recruiting

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Research Team

C

Christopher Hoffmann

T

Tonderai Mabuto

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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