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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
176
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.
Department of Correctional Services
Pretoria West, Pretoria, South Africa
Number of Participants in Care at Six Months
Self-reported in TCAC or routine DoH clinical care
Time frame: 6 months after corrections release
Proportion of Participants Verified in Care at Six Months
Clinical record (electronic or paper) verified in care
Time frame: 6 months after corrections release
Time to Linkage to HIV Care
Number of days from end of intervention to first clinic visit
Time frame: 6 months after corrections release
Proportion of Participants Linked to Care Within 90 Days of Corrections Release
Self-reported in TCAC or DoH clinical care
Time frame: 90 days after corrections release
Viral Suppression (HIV RNA <400 c/mL) at Six Months
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.
Time frame: 6 months after corrections release
Difference in Bonding Social Capital Score at Six Months
Assessed using a 12-item scale with a higher score indicating greater bonding social capital. The median scores will be compared. Range 0-48.
Time frame: 6 months after corrections release
Difference in HIV Stigma Index Score at Six Months
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.
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Time frame: 6 months after corrections release
Proportion of Participants Employed or Self-employed
Self-reported employment
Time frame: 6 months after corrections release
Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)
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)
Time frame: 6 months after corrections release
Acceptability of Transition Community Adherence Clubs
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.
Time frame: 6 months after corrections release
Difference in Ex-inmate Stigma Index Score at Six Months
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.
Time frame: 6 months after corrections release