Health TrialsbyHealthPanel

Structured Peer-delivered ART and Reentry Community Strategy

ConditionRetention in Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

<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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Full-SPARCS Intervention

    Behavioral

    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).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Care-as-usual (CAU) armNo intervention 0 interventions
Group B: Full -SPARCS intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HIV RNA (viral load) suppression at 6 months

HIV RNA suppression will be defined as a viral load \<1000 copies/mL. Participants without viral load data will be assumed to have a viral load \>1000 c/mL.

Time frame
6 months

Secondary outcomes

1

HIV RNA (viral load) suppression at 12 months

HIV RNA suppression will be defined as a viral load \<1000 copies/mL. Participants without viral load data will be assumed to have a viral load \>1000 c/mL.

Time frame
12 months
2

Cost-effectiveness

Cost effectiveness will be measured by combining standardized data collection tools and an analytic framework developed from prior studies to document and classify resources used (e.g. direct human resources, consumables, capital assets) for all intervention-related activities from design, coordination, to direct delivery.

Time frame
up to 12 months
3

Percentage of participants receiving ART at 6 months

Participants receiving ART by 6 months post-release.

Time frame
6 months
4

Percentage of participants receiving ART at 12 months

Participants receiving ART by 12 months post-release.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Aurum Institute

Collaborator

Seoul National University

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
Apply now