Post-release Retention in HIV Care for Ex-inmates in South Africa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03340428|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hiv Adherence, Patient||Behavioral: Transition Community Adherence Club (TCAC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
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.
- Proportion of participants in care at six months [ Time Frame: 6 months after corrections release ]Self-reported in TCAC or routine DoH clinical care
- Proportion of participants verified in care at six months [ Time Frame: 6 months after corrections release ]Clinical record (electronic or paper) verified in care
- Time to linkage to HIV care [ Time Frame: 6 months after corrections release ]Number of days from end of intervention to first clinic visit
- 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
- 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.
- 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.
- 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.
- Proportion of participants employed or self-employed [ Time Frame: 6 months after corrections release ]Self-reported employment
- 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)
- 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.
- 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.
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
|Contact: Christopher Hoffmann, MD, MPHfirstname.lastname@example.org|
|Department of Correctional Services||Recruiting|
|Pretoria West, Pretoria, South Africa, 0001|
|Contact: Nieser Seatlholo +27 10590-1000 email@example.com|
|Principal Investigator:||Christopher Hoffmann, MD, MPH||Johns Hopkins University|