Structured Peer-delivered ART and Reentry Community Strategy

Retention in Care Clinical Trial

— SPARCS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027671
• Other study ID #: IRB00386911
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2028

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Christopher Hoffmann
• Phone: 4106144257
• Email: choffmann[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this study is to implement both a transition community adherence club strategy (Group-SPARCS) and an ART provision strategy (ART-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The current proposal will allow for a fully powered effectiveness randomized clinical trial (RCT).

• To compare the effectiveness of Full-SPARCS, ART-SPARCS, and Group-SPARCS to care as usual and to each other to achieve HIV RNA suppression 6 months following correctional facility release

• To assess determinants of implementation of Full-SPARCS, ART-SPARCS, and Group-SPARCS.

• To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS, ART-SPARCS, and Group-SPARCS.

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, has two distinct components spanning six months post-release: direct provision of ART (ART-SPARCS) and 12 biweekly peer facilitator-led group sessions (Group-SPARCS). ART-SPARCS is designed to overcome clinic-level barriers through bimonthly distribution of ART without a group component. Group-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 without ART distribution. The current usual care is a supply of ART and a referral letter at the time of release from incarceration.

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 1:1:1:1 to either the standard of care, Full-SPARCS, Group-SPARCS, or ART-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 Group-SPARCS or ART-SPARCS will be asked to attend biweekly sessions. Group-SPARCS activities will include - structured curriculum, symptom screening, and routine laboratory monitoring. ART-SPARCS will include the distribution of pre-packed medication and routine laboratory monitoring. Full-SPARCS includes all components of Group-SPARCS and ART-SPARCS.

Study sample: A total of 640 participants will be randomized to one of the four arms. Sixty of the participants will be selected for participation in qualitative in-depth interviews. An additional 25 staff involved in Transition community adherence club (TCAC) referral, ART provision, implementation, coordination will be enrolled for qualitative in-depth interviews.

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. The proposal also fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 640
• Est. completion date: October 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retention in Care

Intervention

Behavioral:
• Group SPARCS Intervention
Each session will be led by two trained individuals: a peer (history of criminal justice involvement and living with HIV) and a social worker.30 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 Group-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church).
• ART-SPARCS Intervention
ART will be provided every two months from correctional facility release to 6 months post-release (months 2, 4, and 6). Participants with less than two months of ART at release will receive a top-off to reach two months. ART will be pre-packaged by the DoH "home clinic", collected by the facilitators, and distributed to the participants. At the time of distribution, the facilitators will conduct a standard DoH differentiated care symptom screen. Participants who report specific symptoms will be referred to the "home clinic" for further assessment per routine with Community Adherence Clubs.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Aurum Institute, National Institute of Mental Health (NIMH), Seoul National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of participants receiving ART at 6 months	Participants receiving ART by 6 months post-release.	6 months
Secondary	Percentage of participants receiving ART at 12 months	Participants receiving ART by 12 months post-release.	12 months