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Structured Peer-delivered ART and Reentry Community Strategy

NCT06027671 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-02-11

No results posted yet for this study

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

Conditions

  • Retention in Care

Interventions

BEHAVIORAL

Full-SPARCS Intervention

Within 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Full-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church).

Sponsors & Collaborators

  • Aurum Institute

    collaborator OTHER

  • Seoul National University

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Christopher Hoffmann · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027671 on ClinicalTrials.gov