Clinical trial NCT03340428: Post-release Retention in HIV Care for Ex-inmates in South Africa
Official title: Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Adherence, Patient
Keywords: incarceration
linkage to care
retention in care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Aurum Institute
name: National Institute of Mental Health (NIMH)
First posted: 2017-11-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Number of Participants in Care at Six Months
timeFrame: 6 months after corrections release
Secondary outcomes:
measure: Proportion of Participants Verified in Care at Six Months
timeFrame: 6 months after corrections release
measure: Time to Linkage to HIV Care
timeFrame: 6 months after corrections release
measure: Proportion of Participants Linked to Care Within 90 Days of Corrections Release
timeFrame: 90 days after corrections release
measure: Viral Suppression (HIV RNA <400 c/mL) at Six Months
timeFrame: 6 months after corrections release
measure: Difference in Bonding Social Capital Score at Six Months
timeFrame: 6 months after corrections release
measure: Difference in HIV Stigma Index Score at Six Months
timeFrame: 6 months after corrections release
measure: Proportion of Participants Employed or Self-employed
timeFrame: 6 months after corrections release
measure: Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)
timeFrame: 6 months after corrections release
measure: Acceptability of Transition Community Adherence Clubs
timeFrame: 6 months after corrections release
measure: Difference in Ex-inmate Stigma Index Score at Six Months
timeFrame: 6 months after corrections release
Other outcomes:
Locations:
city: Pretoria West
country: South Africa
facility: Department of Correctional Services
state: Pretoria
Study officials:
affiliation: Johns Hopkins University
name: Christopher Hoffmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: