Clinical Trials Directory

Trials / Completed

CompletedNCT03340428

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

Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
176 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALTransition 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.

Timeline

Start date
2019-03-09
Primary completion
2020-08-01
Completion
2020-11-30
First posted
2017-11-13
Last updated
2025-06-26
Results posted
2021-04-27

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT03340428. Inclusion in this directory is not an endorsement.