An interventional study of Transition Community Adherence Club (TCAC) in Hiv and Adherence, Patient, sponsored by Johns Hopkins University. Completed at 1 site in South Africa. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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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.
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.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's enrollment of 176 is above the median of 116 across 527 interventional studies indexed under Patient Compliance.
Browse Patient Compliance studies →Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Patient Compliance, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Care as usual participants will be referred to routine clinic HIV care on release from corrections.
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.
Also known as: Transition Community Adherence Club
Number of Participants in Care at Six Months
Self-reported in TCAC or routine DoH clinical care
Time frame: 6 months after corrections release
Proportion of Participants Verified in Care at Six Months
Clinical record (electronic or paper) verified in care
Time frame: 6 months after corrections release
Time to Linkage to HIV Care
Number of days from end of intervention to first clinic visit
Time frame: 6 months after corrections release
Proportion of Participants Linked to Care Within 90 Days of Corrections Release
Self-reported in TCAC or DoH clinical care
Time frame: 90 days after corrections release
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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
Proportion of Participants Employed or Self-employed
Self-reported employment
Time frame: 6 months after corrections release
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)
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
Recruitment occurred at correctional facilities between March 2019 and November 2019
| Milestone | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) |
|---|---|---|
| Started | 117 | 59 |
| Completed | 116 | 59 |
| Not completed | 1 | 0 |
Self-reported in TCAC or routine DoH clinical care
| Participants | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) |
|---|---|---|
| Number of Participants in Care at Six Months | 67 | 19 |
Clinical record (electronic or paper) verified in care
Results for this outcome have not been posted.
Number of days from end of intervention to first clinic visit
Results for this outcome have not been posted.
Self-reported in TCAC or DoH clinical care
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Assessed using a 12-item scale with a higher score indicating greater bonding social capital. The median scores will be compared. Range 0-48.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Self-reported employment
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 6 months post-corrections release. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transition Community Adherence Club (TCAC) | 1/116 (0.9%) | 0/116 (0%) | 0/116 (0%) |
| Care as Usual (CAU) | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Age, Continuous(years) | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) | Total |
|---|---|---|---|
| Median | 34 (29 to 37) | 33 (29 to 36) | 33 (29 to 37) |
| Sex: Female, Male(Participants) | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 110 | 56 | 166 |
| Race (NIH/OMB)(Participants) | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 111 | 57 | 168 |
| White | 4 | 1 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Transition Community Adherence Club (TCAC) | Care as Usual (CAU) | Total |
|---|---|---|---|
| South Africa | 116 | 59 | 175 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified trial data will be made available one year after completion of all study activities.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: One year after completion of study activities.
Access criteria: Contact PI
Ran from Mar 2019 to primary completion in Aug 2020, 16 months.
Results were first posted in Apr 2021, 8 months after primary completion.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 16 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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