Trial Outcomes & Findings for Post-release Retention in HIV Care for Ex-inmates in South Africa (NCT NCT03340428)

Results Overview

Self-reported in TCAC or routine DoH clinical care

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

176 participants

Primary outcome timeframe

6 months after corrections release

Results posted on

2025-06-26

Participant Flow

Recruitment occurred at correctional facilities between March 2019 and November 2019

Participant milestones

Participant milestones
Measure	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.	Care as Usual (CAU) Care as usual participants will be referred to routine clinic HIV care on release from corrections.
Overall Study STARTED	117	59
Overall Study COMPLETED	116	59
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transition Community Adherence Club (TCAC) n=116 Participants 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.	Care as Usual (CAU) n=59 Participants Care as usual participants will be referred to routine clinic HIV care on release from corrections.	Total n=175 Participants Total of all reporting groups
Age, Continuous	34 years n=5 Participants	33 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	56 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	111 Participants n=5 Participants	57 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	116 Participants n=5 Participants	59 Participants n=7 Participants	175 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after corrections release

Self-reported in TCAC or routine DoH clinical care

Outcome measures

Outcome measures
Measure	Transition Community Adherence Club (TCAC) n=116 Participants 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.	Care as Usual (CAU) n=59 Participants Care as usual participants will be referred to routine clinic HIV care on release from corrections.
Number of Participants in Care at Six Months	67 Participants	19 Participants

SECONDARY outcome

Timeframe: 6 months after corrections release

Clinical record (electronic or paper) verified in care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after corrections release

Number of days from end of intervention to first clinic visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days after corrections release

Self-reported in TCAC or DoH clinical care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after corrections release

Self-reported employment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Transition Community Adherence Club (TCAC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Care as Usual (CAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Hoffmann

Johns Hopkins University

Phone: 410-614-4257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place