HivNCT03340428
Post-release Retention in HIV Care for Ex-inmates in South Africa
A study testing Transition Community Adherence Club (TCAC) in people with Hiv and Adherence, Patient, run by Johns Hopkins University at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hiv, Adherence, Patient
- What is being tested?
- Transition Community Adherence Club (TCAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Africa
- Study dates
- 9 Mar 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Department of Correctional Services
Pretoria West, Pretoria, 0001
About this study
Official title: Corrections2Community: 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.
Read the 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.
- Conditions
- Hiv, Adherence, Patient
- Being tested
- Transition Community Adherence Club (TCAC)
- Keywords
- incarceration, linkage to care, retention in care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition Community Adherence Club (TCAC)Behavioural
Also called Transition Community Adherence Club
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.
| Study group | Role | What they receive |
|---|---|---|
| Transition Community Adherence Club (TCAC) | Experimental | 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. Receives: Behavioral: Transition Community Adherence Club (TCAC) |
| Care as usual (CAU) | No intervention | Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Care at Six Months
Self-reported in TCAC or routine DoH clinical care
Measured: 6 months after corrections release
Secondary outcomes (10)
Proportion of Participants Verified in Care at Six Months
Clinical record (electronic or paper) verified in care
Measured: 6 months after corrections release
Time to Linkage to HIV Care
Number of days from end of intervention to first clinic visit
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after corrections release
Proportion of Participants Employed or Self-employed
Self-reported employment
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 6 months after corrections release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start9 Mar 2019
- Primary completion1 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Aurum Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Christopher Hoffmann, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340428
- Sponsor's protocol ID
- IRB00181117
- Other IDs
- 1R34MH115777
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2017
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified trial data will be made available one year after completion of all study activities.
Publications
Mabuto T, Woznica DM, Ndini P, Moyo D, Abraham M, Hanrahan C, Charalambous S, Zack B, Baral S, Owczarzak J, Hoffmann CJ. Transitional community adherence support for people leaving incarceration in South Africa: a pragmatic, open-label, randomised controlled trial. Lancet HIV. 2024 Jan;11(1):e11-e19. doi: 10.1016/S2352-3018(23)00235-7. Epub 2023 Dec 7.
PubMed 38071994
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa
- ClinicalTrials.gov ID
- NCT03340428
- Acronym / sponsor ID
- IRB00181117
- Conditions
- Hiv, Adherence, Patient
- Keywords
- incarceration, linkage to care, retention in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Aurum Institute, National Institute of Mental Health (NIMH)
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
| Arm | Type | Receives |
|---|---|---|
| Transition Community Adherence Club (TCAC) | Experimental | Behavioral: 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. |
| Care as usual (CAU) | No intervention | –Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition Community Adherence Club (TCAC)Also: Transition Community Adherence ClubA 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. | Behavioural | Transition Community Adherence Club (TCAC) |
Primary outcome
Number of Participants in Care at Six Months
Time frame: 6 months after corrections release
Self-reported in TCAC or routine DoH clinical care
10 secondary outcomes
Proportion of Participants Verified in Care at Six Months
Time frame: 6 months after corrections release
Time to Linkage to HIV Care
Time frame: 6 months after corrections release
Proportion of Participants Linked to Care Within 90 Days of Corrections Release
Time frame: 90 days after corrections release
Viral Suppression (HIV RNA <400 c/mL) at Six Months
Time frame: 6 months after corrections release
Difference in Bonding Social Capital Score at Six Months
Time frame: 6 months after corrections release
Difference in HIV Stigma Index Score at Six Months
Time frame: 6 months after corrections release
Proportion of Participants Employed or Self-employed
Time frame: 6 months after corrections release
Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)
Time frame: 6 months after corrections release
Acceptability of Transition Community Adherence Clubs
Time frame: 6 months after corrections release
Difference in Ex-inmate Stigma Index Score at Six Months
Time frame: 6 months after corrections release
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38071994Mabuto T, Woznica DM, Ndini P, Moyo D, Abraham M, Hanrahan C, Charalambous S, Zack B, Baral S, Owczarzak J, Hoffmann CJ. Transitional community adherence support for people leaving incarceration in South Africa: a pragmatic, open-label, randomised controlled trial. Lancet HIV. 2024 Jan;11(1):e11-e19. doi: 10.1016/S2352-3018(23)00235-7. Epub 2023 Dec 7.
- Individual participant dataSharing planned: Yes. De-identified trial data will be made available one year after completion of all study activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hoffmann, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Community Adherence Club (TCAC) in people with Hiv and Adherence, Patient, run by Johns Hopkins University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in Care at Six Months (time frame: 6 months after corrections release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.