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

Johns Hopkins University

Status: Completed

Conditions: Adherence, Patient; Hiv

Treatments: Behavioral: Transition Community Adherence Club (TCAC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03340428

1R34MH115777 (U.S. NIH Grant/Contract)

IRB00181117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

Transition Community Adherence Club (TCAC)

Experimental group

Description:

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.

Treatment:

Behavioral: Transition Community Adherence Club (TCAC)

Care as usual (CAU)

No Intervention group

Description:

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