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

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ClinicalTrials.gov Identifier: NCT03340428
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Aurum Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Hiv Adherence, Patient Behavioral: Transition Community Adherence Club (TCAC) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Intervention arm will be masked to the field researchers and the investigators until unblinding during final analysis.
Primary Purpose: Health Services Research
Official Title: Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa
Actual Study Start Date : March 9, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Transition Community Adherence Club (TCAC)
Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.
Behavioral: Transition 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.
Other Name: Transition Community Adherence Club

No Intervention: Care as usual (CAU)
Care as usual participants will be referred to routine clinic HIV care on release from corrections.



Primary Outcome Measures :
  1. Proportion of participants in care at six months [ Time Frame: 6 months after corrections release ]
    Self-reported in TCAC or routine DoH clinical care


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340428


Contacts
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Contact: Christopher Hoffmann, MD, MPH 410-614-4257 choffmann@jhmi.edu

Locations
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South Africa
Department of Correctional Services Recruiting
Pretoria West, Pretoria, South Africa, 0001
Contact: Nieser Seatlholo    +27 10590-1000    nseatlholo@auruminstitute.org   
Sponsors and Collaborators
Johns Hopkins University
Aurum Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Christopher Hoffmann, MD, MPH Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03340428     History of Changes
Other Study ID Numbers: IRB00181117
1R34MH115777 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified trial data will be made available one year after completion of all study activities.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: One year after completion of study activities.
Access Criteria: Contact PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
incarceration
linkage to care
retention in care