Clinical trial NCT06027671: Structured Peer-delivered ART and Reentry Community Strategy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retention in Care
Keywords: Viral Load Suppression
Prison
Transition
Care continuity
HIV
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Aurum Institute
name: Seoul National University
name: National Institute of Mental Health (NIMH)
First posted: 2023-09-07
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a hybrid type 1 effectiveness-implementation study with a factorial design to compare care as usual, Full-SPARCS, ART-SPARCS, or Group-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.
Primary purpose: TREATMENT

Brief 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.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HIV RNA (viral load) suppression at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: HIV RNA (viral load) suppression at 12 months
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: up to 12 months
measure: Percentage of participants receiving ART at 6 months
timeFrame: 6 months
measure: Percentage of participants receiving ART at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: The Aurum Institute - Head office
state: Gauteng
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Christopher Hoffmann
role: PRINCIPAL_INVESTIGATOR
References: