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

Not Applicable

Completed

Conditions: Adherence, Patient
Hiv

Interventions: Behavioral: Transition Community Adherence Club (TCAC)

Registration Number: NCT03340428

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 176

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transition Community Adherence Club (TCAC)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Care at Six Months	6 months after corrections release	Self-reported in TCAC or routine DoH clinical care

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Verified in Care at Six Months	6 months after corrections release	Clinical record (electronic or paper) verified in care
Time to Linkage to HIV Care	6 months after corrections release	Number of days from end of intervention to first clinic visit
Proportion of Participants Linked to Care Within 90 Days of Corrections Release	90 days after corrections release	Self-reported in TCAC or DoH clinical care
Difference in Bonding Social Capital Score at Six Months	6 months after corrections release	Assessed using a 12-item scale with a higher score indicating greater bonding social capital. The median scores will be compared. Range 0-48.
Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)	6 months after corrections release	Feasibility of implementation will be assessed based on the proportion of participants meeting the following intervention milestones: TCAC visit, 6-month social capital questionnaire and stigma scale, and 6-month viral load ascertainment. The proportion of participants in the intervention arm who have completed all of these components with by used as a composite score (range 0-1)
Viral Suppression (HIV RNA <400 c/mL) at Six Months	6 months after corrections release	Viral load data at 6 months will be based on routinely collected viral load data (clinic records and the electronic National Health Laboratory System to determine 6 month viral load outcomes, successfully applied in prior studies) augmented by viral loads obtained by the study when 6 month viral load data are not available.
Acceptability of Transition Community Adherence Clubs	6 months after corrections release	Qualitative outcome assessed using in-depth interviews exploring participant views on the acceptability of the transition community adherence clubs. This is a qualitative analysis based on thematic coding.
Difference in Ex-inmate Stigma Index Score at Six Months	6 months after corrections release	Assessed using 28-item hybrid (study specific) stigma scale with median score used per stigma construct (internalized, anticipated, experienced). Higher values indicate more stigma. Higher values indicate more stigma. Ranges: experienced 38; anticipated 6; internalized 6.
Difference in HIV Stigma Index Score at Six Months	6 months after corrections release	Assessed using 28-item Berger stigma scale with median score used per stigma construct (internalized, anticipated, experienced). Higher values indicate more stigma. Ranges: experienced 38; anticipated 6; internalized 6.
Proportion of Participants Employed or Self-employed	6 months after corrections release	Self-reported employment