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Completed

NCT Number: NCT03340428

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Adherence, Patient Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Correctional Services

Pretoria West, Pretoria, 0001, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transition Community Adherence Club (TCAC)

Behavioral

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.

Other names: Transition Community Adherence Club

Primary outcomes

  1. Number of Participants in Care at Six Months

    Time frame: 6 months after corrections release

    Self-reported in TCAC or routine DoH clinical care

Secondary outcomes

  1. Proportion of Participants Verified in Care at Six Months

    Time frame: 6 months after corrections release

    Clinical record (electronic or paper) verified in care

  2. Time to Linkage to HIV Care

    Time frame: 6 months after corrections release

    Number of days from end of intervention to first clinic visit

  3. Proportion of Participants Linked to Care Within 90 Days of Corrections Release

    Time frame: 90 days after corrections release

    Self-reported in TCAC or DoH clinical care

  4. Viral Suppression (HIV RNA <400 c/mL) at Six Months

    Time frame: 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.

  5. Difference in Bonding Social Capital Score at Six Months

    Time frame: 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.

  6. Difference in HIV Stigma Index Score at Six Months

    Time frame: 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.

  7. Proportion of Participants Employed or Self-employed

    Time frame: 6 months after corrections release

    Self-reported employment

  8. Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)

    Time frame: 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)

  9. Acceptability of Transition Community Adherence Clubs

    Time frame: 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.

  10. Difference in Ex-inmate Stigma Index Score at Six Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Aurum Institute
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2017
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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