Structured Peer-delivered ART and Reentry Community Strategy (SPARCS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Retention in Care
• Intervention / Treatment: Behavioral: Full-SPARCS Intervention

Detailed Description

Background: The South African government has devoted resources towards HIV care in correctional facilities that have resulted in antiretroviral therapy (ART) coverage of >90% and viral load (VL) suppression of >80% among incarcerated people living with HIV (PLWH). However, despite free post-release care, the investigators previously observed that only an estimated 34% were in care three months post-release. The investigators developed, tested, and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001), demonstrating effectiveness. Full-SPARCS involves 12 biweekly peer facilitator-led group sessions spanning six months post-release. Full-SPARCS is designed to increase self-efficacy, social support, and life skills through facilitated group discussion and curriculum including planning, problem solving, financial literacy, and living with HIV.

Methods: This research study will be conducted in Gauteng Province. Recruitment will occur within correctional facilities of the Department of Correctional Services (DCS) - Modderbee, Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in either Ekurhuleni District, Tshwane District or Johannesburg District. The study population will be comprised of adult (≥18 years old) corrections inmates, either male or female, with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1:1 to either the standard of care or Full-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff will contact participants to ascertain care status and update contact information at one week, one month, three months, six months, nine months, and twelve months from release. Participants assigned to Full-SPARCS will be asked to attend biweekly sessions. Full-SPARCS activities will include - structured curriculum, symptom screening, and routine laboratory monitoring.

Study sample: A total of 400 participants will be randomized to one of the two arms.

Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses." It also addresses "health disparities" through a focus on recently released inmates, a marginalized population, and fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Hoffmann; Phone Number: 4106144257; Email: choffmann@jhmi.edu
• Study Contact Backup: Name: Tonderai Mabuto; Email: tmabuto@auruminstitute.org

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Recruiting
      • The Aurum Institute - Head office
      • Contact: Pretty Ndini, Masters; Phone Number: +27793611894; Email: pndini@auruminstitute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care-as-usual (CAU) arm; 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.
Experimental: Full -SPARCS intervention arm; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	up to 12 months
Percentage of participants receiving ART at 6 months	Participants receiving ART by 6 months post-release.	6 months
Percentage of participants receiving ART at 12 months	Participants receiving ART by 12 months post-release.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH); Seoul National University; Aurum Institute
• Investigators: Principal Investigator: Christopher Hoffmann, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Prison; Transition; Viral Load Suppression; Care continuity
• Other Study ID Numbers: IRB00386911

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No