NCT06027671 Structured Peer-delivered ART and Reentry Community Strategy
| NCT ID | NCT06027671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Retention in Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2028-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The overarching goal of this study is to implement a transition community adherence club strategy (Full-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The investigators seek to provide actionable findings to inform policy decisions to contribute to HIV care continuity with this population. The investigators note that effectiveness and scalability often conflict with intervention design; thus, the investigators have proposed testing whether a group approach is effective and the investigators will assess the costs of each component * To compare the effectiveness of Full-SPARCS to care as usual to achieve HIV RNA suppression 6 months following correctional facility release * To assess determinants of implementation of Full-SPARCS * To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS
Eligibility 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 c