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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340428
• Other study ID #: IRB00181117
• Secondary ID: 1R34MH115777
• Status: Completed
• Phase: N/A
• Start date: March 9, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adherence, Patient
• Hiv

Intervention

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.

Locations

Country	Name	City	State
South Africa	Department of Correctional Services	Pretoria West	Pretoria

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Aurum Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Care at Six Months	Self-reported in TCAC or routine DoH clinical care	6 months after corrections release
Secondary	Proportion of Participants Verified in Care at Six Months	Clinical record (electronic or paper) verified in care	6 months after corrections release
Secondary	Time to Linkage to HIV Care	Number of days from end of intervention to first clinic visit	6 months after corrections release
Secondary	Proportion of Participants Linked to Care Within 90 Days of Corrections Release	Self-reported in TCAC or DoH clinical care	90 days after corrections release
Secondary	Viral Suppression (HIV RNA <400 c/mL) at Six Months	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.	6 months after corrections release
Secondary	Difference in Bonding Social Capital Score at Six Months	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 months after corrections release
Secondary	Difference in HIV Stigma Index Score at Six Months	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.	6 months after corrections release
Secondary	Proportion of Participants Employed or Self-employed	Self-reported employment	6 months after corrections release
Secondary	Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)	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)	6 months after corrections release
Secondary	Acceptability of Transition Community Adherence Clubs	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.	6 months after corrections release
Secondary	Difference in Ex-inmate Stigma Index Score at Six Months	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.	6 months after corrections release