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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH115777 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Aurum Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Care as usual (CAU) | No Intervention | Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition Community Adherence Club (TCAC) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Care at Six Months | Self-reported in TCAC or routine DoH clinical care | 6 months after corrections release |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Verified in Care at Six Months | Clinical record (electronic or paper) verified in care | 6 months after corrections release |
| Time to Linkage to HIV Care | Number of days from end of intervention to first clinic visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hoffmann, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Correctional Services | Pretoria West | Pretoria | 0001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38071994 | Derived | 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. |
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De-identified trial data will be made available one year after completion of all study activities.
One year after completion of study activities.
Contact PI
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Recruitment occurred at correctional facilities between March 2019 and November 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Care as Usual (CAU) | Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Care at Six Months | Self-reported in TCAC or routine DoH clinical care | Posted | Count of Participants | Participants | 6 months after corrections release |
|
6 months post-corrections release
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Hoffmann | Johns Hopkins University | 410-614-4257 | choffmann@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2018 | Mar 31, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2018 | Mar 31, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
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Intervention arm will be masked to the field researchers and the investigators until unblinding during final analysis.
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| 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 | 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. | 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. | 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. | 6 months after corrections release |
| Proportion of Participants Employed or Self-employed | Self-reported employment | 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) | 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. | 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. | 6 months after corrections release |
| BG001 | Care as Usual (CAU) | Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Care as Usual (CAU) | Care as usual participants will be referred to routine clinic HIV care on release from corrections. |
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| Secondary | Proportion of Participants Verified in Care at Six Months | Clinical record (electronic or paper) verified in care | Not Posted | 6 months after corrections release | Participants |
| Secondary | Time to Linkage to HIV Care | Number of days from end of intervention to first clinic visit | Not Posted | 6 months after corrections release | Participants |
| Secondary | Proportion of Participants Linked to Care Within 90 Days of Corrections Release | Self-reported in TCAC or DoH clinical care | Not Posted | 90 days after corrections release | Participants |
| 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. | Not Posted | 6 months after corrections release | Participants |
| 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. | Not Posted | 6 months after corrections release | Participants |
| 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. | Not Posted | 6 months after corrections release | Participants |
| Secondary | Proportion of Participants Employed or Self-employed | Self-reported employment | Not Posted | 6 months after corrections release | Participants |
| 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) | Not Posted | 6 months after corrections release | Participants |
| 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. | Not Posted | 6 months after corrections release | Participants |
| 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. | Not Posted | 6 months after corrections release | Participants |
| 1 |
| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Care as Usual (CAU) | Care as usual participants will be referred to routine clinic HIV care on release from corrections. | 0 | 59 | 0 | 59 | 0 | 59 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |