Post-release Retention in HIV Care for Ex-inmates in South Africa

NCT ID: NCT03340428

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-09
• Study Completion Date: 2020-11-30

Brief Summary

HIV remains the leading cause of death in South Africa as a result of a failure of people living with HIV to seek HIV treatment and be retained in care. After initiating antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care. The goal of this research is to reduce mortality, morbidity, and HIV transmission by developing an actionable approach to retaining these individuals in HIV care.

Detailed Description

To pilot a randomized clinical trial (RCT) of a transition adherence club (TCAC) versus traditional care, among ex-inmates receiving antiretroviral therapy in South Africa, to study feasibility, acceptability, and preliminary effectiveness using mixed methods.

Investigators will pilot an RCT of the TCAC compared to traditional care among inmates/ex-inmates measuring transition in care, six-month viral load suppression, and follow-up of participants. Feasibility will be assessed by process measures. Acceptability will be assessed using in-depth interviews among 36 participants and 10 staff. Effectiveness will be assessed by a difference in proportions in-care with an undetectable viral load at 6 months and difference in bonding social capital and care satisfaction between arms.

Conditions

Hiv; Adherence, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Transition Community Adherence Club (TCAC)

Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.

Group Type: EXPERIMENTAL

Transition Community Adherence Club (TCAC)

Intervention Type: BEHAVIORAL

A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available.

Care as usual (CAU)

Care as usual participants will be referred to routine clinic HIV care on release from corrections.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transition Community Adherence Club (TCAC)

A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available.

Intervention Type: BEHAVIORAL

Other Intervention Names

Transition Community Adherence Club

Eligibility Criteria

Inclusion Criteria

• Currently incarcerated (either an offender/sentenced inmates or awaiting trial inmate/remandee)
• Housed at one of the study correctional facilities (including participating satellite centres)
• Diagnosed with HIV
• Currently receiving antiretroviral therapy
• Anticipated release or trial date within 3 months of study enrollment
• Self-report expected to reside within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the TCAC sites (within 20 km, 45 minute travel time, or two local taxi minibus rides)
• Agree to post-discharge follow-up
• Medically stable based on DCS health assessment (including not pregnant)
• On antiretroviral therapy (ART) for >3 months at the expected time of corrections release

Exclusion Criteria

• Failure to provide informed consent to be followed up by study staff after release
• Unable to speak one of the study languages (English, Sesotho, isiXhosa, isiZulu, Setswana, Xitsonga, and Afrikaans)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurum Institute

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Hoffmann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Department of Correctional Services

Pretoria West, Pretoria, South Africa

Countries

South Africa

References

Mabuto T, Woznica DM, Ndini P, Moyo D, Abraham M, Hanrahan C, Charalambous S, Zack B, Baral S, Owczarzak J, Hoffmann CJ. Transitional community adherence support for people leaving incarceration in South Africa: a pragmatic, open-label, randomised controlled trial. Lancet HIV. 2024 Jan;11(1):e11-e19. doi: 10.1016/S2352-3018(23)00235-7. Epub 2023 Dec 7.

Reference Type: DERIVED

PMID: 38071994 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34MH115777

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00181117

Identifier Type: -

Identifier Source: org_study_id