Structured Peer-delivered ART and Reentry Community Strategy

NCT06027671 | Recruiting DMC

• 1 other identifier: IRB00386911
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Retention in Care

Keywords

Viral Load Suppression; Prison; Transition; Care continuity; HIV

Outcome Measures

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.

  6 months

Secondary Outcomes (4)

• HIV RNA (viral load) suppression at 12 months

  12 months

• Cost-effectiveness

  up to 12 months

• Percentage of participants receiving ART at 6 months

  6 months

• Percentage of participants receiving ART at 12 months

  12 months

Study Arms (2)

Care-as-usual (CAU) arm

NO INTERVENTION

Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART.

Full -SPARCS intervention arm

EXPERIMENTAL

The Full-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 approximately every-other-week (approximately every two weeks) post-release group sessions extending six months post-release. The SPARCS curriculum is designed to build goal setting, prioritizing, and planning skills during the 12 sessions. During each Full-SPARCS session, participants will work with facilitators to set, review, and update personal goals using standardized goal-setting worksheets. These goal sheets will document participant objectives, action steps, timelines, and progress assessments.

Behavioral: Full-SPARCS Intervention

Interventions

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).

Full -SPARCS intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Johns Hopkins University: lead
• Aurum Institute: collaborator
• Seoul National University: collaborator

Study Sites (1)

The Aurum Institute - Head office

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

Study Officials

• Christopher Hoffmann

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Hoffmann

CONTACT

4106144257; choffmann@jhmi.edu

Tonderai Mabuto

CONTACT

tmabuto@auruminstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators will perform individual randomization blocked by the correctional facility. Study staff will open numbered envelopes with the allocation following enrolment. Participants will be randomized 1:1 to one of the study arms using sequential envelopes with study arm determination sealed inside. Randomization will be stratified by study site and by sex. The randomization lists for each site/sex combination will be generated through randomly permuted blocks of two, four, and six study assignments with an equal number of group assignments within each block. Study assignments will be masked to staff performing outcome assessments (in-person and telephonic interviews) and the investigators until all outcome data have been collected.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a hybrid type 1 effectiveness-implementation study to compare care as usual with Full-SPARCS. The investigators will recruit participants from correctional facilities in the Department of Correctional Services (DCS) Gauteng Region, South Africa. Study activities for the intervention arm will be delivered in community venues near to where participants live in Tshwane District, Ekurhuleni District, and City of Johannesburg.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: November 18, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

ZA (1)