N/A
N=176
Post-release Retention in HIV Care for Ex-inmates in South Africa
Hiv · Adherence, Patient
Bottom Line
View on ClinicalTrials.gov: NCT03340428 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants in Care at Six Months — 67; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transition Community Adherence Club (TCAC) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Care at Six Months |
67; 19 | — |
| SECONDARY Proportion of Participants Verified in Care at Six Months |
— | — |
| SECONDARY Time to Linkage to HIV Care |
— | — |
| SECONDARY Proportion of Participants Linked to Care Within 90 Days of Corrections Release |
— | — |
| SECONDARY Viral Suppression (HIV RNA <400 c/mL) at Six Months |
— | — |
| SECONDARY Difference in Bonding Social Capital Score at Six Months |
— | — |
| SECONDARY Difference in HIV Stigma Index Score at Six Months |
— | — |
| SECONDARY Proportion of Participants Employed or Self-employed |
— | — |
| SECONDARY Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score) |
— | — |
| SECONDARY Acceptability of Transition Community Adherence Clubs |
— | — |
| SECONDARY Difference in Ex-inmate Stigma Index Score at Six Months |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03340428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.