Adherence, Patient, Hiv
Conditions
Keywords
incarceration, linkage to care, retention in care
Brief 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. 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.
Interventions
BEHAVIORALTransition 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.
Sponsors
Aurum Institute
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Intervention arm will be masked to the field researchers and the investigators until unblinding during final analysis.
Intervention model description
Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Care at Six Months | 6 months after corrections release | Self-reported in TCAC or routine DoH clinical care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Linkage to HIV Care | 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 | 90 days after corrections release | Self-reported in TCAC or DoH clinical care |
| Viral Suppression (HIV RNA <400 c/mL) at Six Months | 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 | 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. |
| Proportion of Participants Verified in Care at Six Months | 6 months after corrections release | Clinical record (electronic or paper) verified in care |
| Proportion of Participants Employed or Self-employed | 6 months after corrections release | Self-reported employment |
| Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score) | 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 | 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 | 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. |
| Difference in HIV Stigma Index Score at Six Months | 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. |
Countries
South Africa
Participant flow
Recruitment details
Recruitment occurred at correctional facilities between March 2019 and November 2019
Participants by arm
| Arm | Count |
|---|---|
| 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. | 116 |
| Care as Usual (CAU) Care as usual participants will be referred to routine clinic HIV care on release from corrections. | 59 |
| Total | 175 |
Baseline characteristics
| Characteristic | Transition Community Adherence Club (TCAC) | Total | Care as Usual (CAU) |
|---|---|---|---|
| Age, Continuous | 34 years | 33 years | 33 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 111 Participants | 168 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 1 Participants |
| Region of Enrollment South Africa | 116 Participants | 175 Participants | 59 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 110 Participants | 166 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 116 | 0 / 59 |
| other Total, other adverse events | 0 / 116 | 0 / 59 |
| serious Total, serious adverse events | 0 / 116 | 0 / 59 |
Outcome results
Primary
Number of Participants in Care at Six Months
Self-reported in TCAC or routine DoH clinical care
Time frame: 6 months after corrections release
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transition Community Adherence Club (TCAC) | Number of Participants in Care at Six Months | 67 Participants |
| Care as Usual (CAU) | Number of Participants in Care at Six Months | 19 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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release
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)
Time frame: 6 months after corrections release
Secondary
Proportion of Participants Employed or Self-employed
Self-reported employment
Time frame: 6 months after corrections release
Secondary
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
Secondary
Proportion of Participants Verified in Care at Six Months
Clinical record (electronic or paper) verified in care
Time frame: 6 months after corrections release
Secondary
Time to Linkage to HIV Care
Number of days from end of intervention to first clinic visit
Time frame: 6 months after corrections release
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.
Time frame: 6 months after corrections release