Peer support and ART provision for HIV-positive individuals transitioning from prison to community
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
This study is testing two new ways to help people with HIV who are leaving prison get better care and support in the community to see if they can achieve better health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Johannesburg, Gauteng) |
| Trial ID | NCT06027671 on ClinicalTrials.gov |
What this trial studies
This study aims to implement and evaluate two strategies, Full-SPARCS and ART-SPARCS, designed to improve HIV care continuity for individuals transitioning from correctional facilities to community settings in South Africa. The study will compare the effectiveness of these interventions against usual care to achieve HIV RNA suppression six months after release. It will also assess the implementation determinants and the scalability of these strategies through cost-effectiveness analysis. The interventions include direct ART provision and peer-led group sessions to enhance self-efficacy and social support.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals who are currently incarcerated and are expected to be released within three months.
Not a fit: Patients under 18 years of age or those with severe cognitive dysfunction or mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve HIV care retention and viral load suppression among individuals transitioning from incarceration to community life.
How similar studies have performed: Previous pilot studies of similar interventions have shown promising results in improving care continuity for HIV-positive individuals post-release.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Incarcerated at one of the participating study enrolment sites, awaiting trial (un-sentenced) and sentenced individuals. * Diagnosed with HIV and ART at the time of enrolment. * Anticipated release or trial date within three months of study enrolment. * Self-report expected to reside in an unrestricted environment within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the SPARCS intervention sites (i.e., within 20km, 45-minute travel time, or two local taxi minibus rides) * Willing to participate in study post-release follow-up activities and provide contact information for post-release follow-up. Exclusion Criteria: * \<18 years of age. * Condition (severe cognitive dysfunction or mental illness) rendering the individual unable to provide informed consent. * Unable to provide informed consent to participate in the study. * Assessment by DCS health staff indicating that the individual requires a high intensity of care exceeding that which can be provided in a differentiated model of care setting. * Not released from the correctional facility during the period of intervention delivery. * Release to a region outside of Gauteng.
Where this trial is running
Johannesburg, Gauteng
- The Aurum Institute - Head office — Johannesburg, Gauteng, South Africa (Recruiting)
Study contacts
- Principal investigator: Christopher Hoffmann — Johns Hopkins School of Medicine
- Study coordinator: Christopher Hoffmann
- Email: choffmann@jhmi.edu
- Phone: 4106144257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.