Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa
Phase: NA
Conditions: Hiv, Adherence, Patient
Sponsor: Johns Hopkins University

 
 
 
Corrections2Community: 
Post-Release Retention in HIV Care for Ex-Inmates in South Africa 
 
 
 
Short title: Corrections2Community 
Protocol version: 1.0 dated 27 April 2018 
Funder: National Institute of Mental Health, USA (Grant #1R34MH115777-01) 
Implementing Partner: The Aurum Institute, South Africa 
Principal Investigators: Christopher Hoffmann 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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STUDY SUMMARY 
Background: This is a pilot randomized clinical trial (RCT) study to demonstrate the feasibility 
and acceptability of a transition in care strategy to improve retention in HIV care and 
antiretroviral therapy (ART) adherence for ex-inmates in South Africa. Our prior studies have 
identified the need for a retention in care strategy by documenting the substantial attrition in 
HIV care following release from corrections to the community. Our approach is informed by a 
conceptual model of key barriers to the care transition developed from our prior work along with 
a behavioral explanatory model, the Behavioral Model for Vulnerable Populations. 
The overarching goal of this study is to tailor and pilot a transition community adherence club 
(TCAC) strategy for HIV-positive individuals transitioning from correctional to community settings 
in South Africa. CACs represent an accepted HIV care delivery approach that is currently available 
to “stable” HIV patients in South Africa. CACs provide medication refills, a brief health screen, 
and health discussions in a group setting. Observational studies have found that CACs are more 
acceptable, lead to fewer missed visits and shorter visit times without queueing, and increase 
engagement in care. Improving engagement in care for HIV-positive ex-inmates could have an 
important impact on the HIV epidemic in South Africa, a country with the 11th highest global 
corrections population and an estimated HIV prevalence of 23% in corrections settings. 
 
Aims: The aims of the study are to pilot a randomized clinical trial of a transition community 
adherence club (TCAC) versus traditional care to study feasibility, acceptability, and preliminary 
effectiveness using mixed methods. 
 
Methods: This project is a pilot randomized clinical trial (RCT) to refine and test the feasibility, 
acceptability, and preliminary effectiveness of the TCAC. At the conclusion of the R34 grant 
period we will have a protocol and procedural manual ready for a full RCT powered for 
effectiveness. 
 
Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and 
the South African National Strategic Plan on HIV, TB, and STIs 2017-2022. The research addresses 
the HIV/AIDS Research Priority of “retention and engagement in these services, and achievement 
and maintenance of optimal prevention and treatment responses.” It also addresses “health 
disparities” through a focus on recently released inmates, a marginalized population. The 
proposal also fits with the South African National Strategic Plan prioritizing inmates as a key 
population for HIV services. 
 
 

 
 
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Key Personnel 
 
Name 
Responsibility 
Contact 
THE AURUM INSTITUTE 
Salome Charalambous  
Site Principal investigator  
 
Project management, stakeholder 
engagement, dissemination and 
manuscript preparation. 
Phone: +27 (0) 10 590 1389 
Mobile: +27 (0) 82 856 1146 
Email: 
SCharalambous@auruminstitute.org 
Tonderai Mabuto  
Co-Investigator/Project 
Manager 
 
Study design, protocol writing, 
study management, study 
implementation, data analysis, 
report writing, managerial 
oversight and support at the sites. 
Will lead the study and manage 
the study team. 
Contacts: Business: +27 10 590 1378  
Cell: +27(0) 71 354 7906 
Email: tmabuto@auruminstitute.org 
JOHNS HOPKINS UNIVERSITY 
Christopher Hoffmann 
Principal Investigator 
 
Developing TCAC procedures, 
project management, stakeholder 
engagement, dissemination and 
manuscript preparation. 
Phone: +1 (410) 614-4257   
Mobile: +1 (443) 602-2210 
Email: choffmann@jhmi.edu 
Stefan Baral  
Co-Investigator 
Responsible for design and 
analysis of in-depth interview 
components. 
Phone: +1 (410) 502-8975 
Email:  sbaral@jhu.edu 
Colleen Hanrahan  
Co-Investigator 
Assisting on social-behavioral 
intervention design and analysis. 
Phone: +1 (410) 502-9289 
Email: chanrah1@jhmi.edu 
Jill Owczarzak  
Co-Investigator 
 
Responsible for protocol writing, 
study management, study 
implementation, data analysis and 
report writing. 
Phone: +1 (410) 502-0026 
Email: jillowczarzak@jhu.edu 
Daniel Woznica  
Graduate Student 
 
Email: dwoznica@jhu.edu 
Elizabeth Bonomo  
Study Coordinator 
 
Phone: +1 (443) 287-4382  
Email: liz.bonomo@jhmi.edu 
 

 
 
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Contents 
 
1 
INTRODUCTION ................................................................................................................... 7 
1.1 
Background ............................................................................................................................ 7 
1.2 
Study objectives ..................................................................................................................... 8 
1.3 
Significance ............................................................................................................................ 9 
2 
METHODS ........................................................................................................................... 9 
2.1 
Study design ........................................................................................................................... 9 
2.2 
Study setting .......................................................................................................................... 9 
2.2.1 
Correctional Facilities ................................................................................................... 10 
2.2.2 
Description of the geographical areas of study implementation .............................. 10 
2.2.3 
Rationale for selecting geographical areas of study implementation ....................... 10 
2.3 
Study Population .................................................................................................................. 11 
2.3.1 
Inclusion criteria ........................................................................................................... 11 
2.3.2 
Exclusion criteria .......................................................................................................... 11 
2.4 
Sampling scheme ................................................................................................................. 11 
2.4.1 
Participant recruitment and informed consent .......................................................... 11 
2.4.2 
Randomization ............................................................................................................. 12 
2.5 
Pre-release study procedures ............................................................................................. 12 
2.5.1 
Care-as-usual (CAU) study arm .................................................................................... 12 
2.5.2 
TCAC study arm ............................................................................................................ 12 
2.6 
Verification of release .......................................................................................................... 13 
2.7 
Post release follow-up ......................................................................................................... 13 
2.7.1 
First post-release contact ............................................................................................ 13 
2.7.2 
Ascertainment of linkage to care ................................................................................ 14 
2.7.3 
Care verification ........................................................................................................... 14 
2.7.4 
Viral loads at 6 months ................................................................................................ 14 
2.8 
TCAC post-release procedures ............................................................................................ 15 
2.8.1 
TCAC post release contact ........................................................................................... 15 
2.8.2 
TCAC structure ............................................................................................................. 15 
2.8.3 
TCAC frequency and duration ..................................................................................... 15 
2.8.4 
TCAC eligibility .............................................................................................................. 15 
2.8.5 
TCAC confidentiality ..................................................................................................... 16 
2.8.6 
TCAC Facilitation .......................................................................................................... 16 
2.8.7 
TCAC medical support .................................................................................................. 16 
2.8.8 
TCAC content ................................................................................................................ 16 
2.8.9 
Schedule of TCAC medical evaluations ....................................................................... 17 
2.8.10 Ad-hoc participant specific components .................................................................... 18 
2.8.11 TCAC completion & transition to regular differentiated care ................................... 18 
2.9 
Outcomes and Ascertainment ............................................................................................ 18 
2.9.1 
Feasibility of TCACs ...................................................................................................... 18 

 
 
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2.9.2 
Effectiveness of TCACs ................................................................................................. 19 
2.9.3 
Acceptability ................................................................................................................. 20 
3 
Drugs/substances/devices ................................................................................................ 20 
4 
Study statistics .................................................................................................................. 21 
4.1 
Sample size ........................................................................................................................... 21 
4.2 
Analysis ................................................................................................................................. 22 
4.2.1 
Feasibility ...................................................................................................................... 22 
4.2.2 
Effectiveness ................................................................................................................. 22 
4.2.3 
Acceptability ................................................................................................................. 22 
5 
Data Management ............................................................................................................ 23 
5.1 
Data collection tools ............................................................................................................ 23 
5.2 
Schedule of case report forms ............................................................................................ 25 
5.3 
Database management ....................................................................................................... 26 
5.3.1 
Structure of the database ............................................................................................ 26 
5.3.2 
Database access ........................................................................................................... 27 
5.3.3 
Locking of final database ............................................................................................. 27 
5.3.4 
Data security ................................................................................................................. 27 
5.3.5 
Study limitations ........................................................................................................... 27 
6 
Protection of human participants ..................................................................................... 28 
6.1 
Regulatory approvals ........................................................................................................... 28 
6.2 
Risks and benefits ................................................................................................................ 28 
6.3 
Additional ethical considerations ........................................................................................ 29 
6.4 
Consent ................................................................................................................................ 31 
6.5 
Clinical trials registration ..................................................................................................... 31 
6.6 
Confidentiality ...................................................................................................................... 31 
6.7 
Data safety and monitoring ................................................................................................. 32 
7 
Project Governance and Management ............................................................................. 32 
7.1 
Research team ..................................................................................................................... 32 
7.2 
Publication policy ................................................................................................................. 33 
7.3 
Performance monitoring ..................................................................................................... 33 
8 
Participant reimbursement ............................................................................................... 33 
9 
Funding ............................................................................................................................. 33 
10 References ........................................................................................................................ 34 
 
 
 
 
 
 
 

 
 
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Glossary of Terms 
AIDS 
 
Acquired Immuno-deficiency Syndrome 
ART 
 
Antiretroviral Therapy 
CAC 
 
Community Adherence Club 
CAU 
 
Care as Usual 
CBO 
 
Community Based Organization 
CCD 
 
Community Corrections Department 
CCMDD 
Central Chronic Medicine Dispensing and Distribution (system or service) 
CRF 
 
Case Report Form 
DCS 
 
Department of Correctional Services 
DOH 
 
South African Department of Health 
HIV 
 
Human Immunodeficiency Virus 
LTFU  
loss to follow up 
NIH 
 
National Institutes of Health 
PHC 
 
Primary Health Clinic 
PIS 
 
Participant Information Sheet 
RCT 
 
Randomized Clinical Trial 
SA 
 
South Africa 
STI 
 
Sexually Transmitted Illnesses 
TB  
 
Tuberculosis 
TCAC   
Transition Community Adherence Club 
 
List of Tables 
 
Table 1: Scheduled visit windows ....................................................................................................... 14 
Table 2: Feasibility Indicators ............................................................................................................. 18 
Table 3: Effectiveness outcomes ........................................................................................................ 20 
Table 4 : Sample size for TCAC evaluation ......................................................................................... 21 
Table 5: List of data collection tools and intended use .................................................................... 23 
Table 6: Schedule of data collection within correctional facility ...................................................... 25 
Table 7: Scheduled study visit windows for all participants after release from correctional facility
.............................................................................................................................................................. 25 
Table 8: Scheduled TCAC visits ........................................................................................................... 26 
 
 
List of Figures 
 
Figure 1: Intervention impact model ................................................................................................. 16 
Figure 2: Proportions in care in CAU and TCAC that study is powered to detect with alpha of 0.05
.............................................................................................................................................................. 22 
Figure 3: Project Management Structure .......................................................................................... 33 
 
 

 
 
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1 INTRODUCTION 
1.1 Background  
HIV care in corrections: Inmates in most of the 240 correctional facilities in South Africa have on-
site access to HIV care provided by the Department of Correctional Services (DCS). Voluntary HIV 
testing is provided at facility entry, routinely during testing ‘campaigns,’ and in the corrections 
clinics. In addition, as per South Africa HIV treatment guidelines (2016), all inmates living with 
HIV were eligible for ART regardless of CD4 count.1 Within the correctional facilities, care 
engagement and adherence to medication are supported by inmate peer educators and inmate 
support groups. At the time of release from corrections, inmates are provided a referral letter 
that briefly summarizes their HIV care history and current medications. Inmates are released 
with between 15 and 90 days (median 30 days) supply of ART (Hoffmann unpublished data).  
 
Barriers to the transition from corrections to community care: Post-release, ex-inmates are 
expected to use the referral letter to establish care with Department of Health (DoH) clinics. It is 
the responsibility of the ex-inmate to identify the clinic and the appropriate days to go, and to 
advocate for his or her care. There is no active follow-up provided by DCS or DoH to confirm a 
successful transition, nor is there specific coordination between the DCS and the DoH regarding 
the release of ex-inmates receiving HIV care. Because of the absence of formal communication 
between the DCS and the DoH there is no documentation of the transition of care from 
corrections to community care to inform patient care, care continuum indicators, or quality 
improvement. The impressive HIV care outcomes observed in correctional settings in South 
Africa drop off dramatically following release from corrections. Ex-inmates living with HIV 
encounter unique care transition challenges across the socio-ecological framework. Qualitative 
and quantitative research conducted by the PI (Hoffmann) and co-I (Charalambous) with 492 ex-
inmates in South Africa, identified several important themes related to the transition in care 
among ex-inmates. These include the clinic experience, social capital, stigma, substance use 
(11% of participants with identified drug use), re-incarceration, and economic insecurity. 
Depression also affects the transition from corrections to community care in the United States, 
but has not been evaluated in this context in South Africa.16-23 Substance use is another barrier 
to the care transition. Substance use itself interferes with care seeking due to increased 
impulsivity as well as diminished social capital.24-26  As a result of these barriers, at 6-months 
following release, only 44% had continuity in antiretroviral therapy (Hoffmann unpublished 
data). 
 
Barriers to care engagement in the general population in Africa: Experience with the general 
population living with HIV provides additional insight regarding potential barriers for ex-inmates. 
On the individual level of the socio-ecological model, knowledge of HIV, self-efficacy, fatalism, 

 
 
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and depression are all positively or negatively associated with care engagement.27-29 On the 
interpersonal level, a network of supportive ties can assist with material and psychosocial 
support and provide encouragement to attend clinic, leading to increased engagement in care.30-
34 This type of supportive network can be characterized as individual (or micro) bonding social 
capital.35-37 On the community level, enacted stigma is also associated with lower linkage to care 
and ART uptake.38-40 On the clinic level41 clinic enacted stigma compromises retention in care 
because people tend to avoid places associated with stigmatization. The combination of HIV 
stigma and ex-inmate stigma may be especially challenging for men who were diagnosed with 
HIV during incarceration and return from corrections marked by both stigmas. Stigmatization 
appears to be especially insidious in regard to the care continuum when it occurs at the clinic 
where the negative effect on engagement in care is stronger than from stigma experienced in 
the community or family.42,43 Additional clinic level factors that are barriers include long waiting 
times, frequent visits, and the need to start queuing early in the morning.31,42,44,45  
 
Transitional Community Adherence Clubs: During follow-up focus groups with these ex-inmates , 
several solutions were suggested to facilitate the transition from corrections to community care 
including non-stigmatizing support groups or community adherence clubs (CACs) composed of 
individuals with similar experiences, assistance with locating skills training or starting a job 
search, and more efficient and non-stigmatizing care. CACs represent an accepted HIV care 
delivery approach that is currently available to “stable” HIV patients in South Africa. Community 
adherence clubs provide medication refills, a brief health screen, and health discussions in a 
group setting. Observational studies have found that CACs are more acceptable, lead to fewer 
missed visits and shorter visit times without queueing, and increase engagement in care.2-4 A 
tailored CAC for ex-inmates transitioning in care, here termed a transition community adherence 
club (TCAC), has the potential to simultaneously address multiple barriers at the individual, 
interpersonal, and care delivery levels.  
1.2 Study objectives 
The overarching goal of this study is to tailor and pilot a transition community adherence club 
(TCAC) strategy for HIV-positive individuals transitioning from correctional to community settings 
in South Africa. The current proposal will allow for developing and piloting of the TCAC strategy 
to assess the feasibility for a fully powered effectiveness randomized clinical trial (RCT) 
comparing the TCAC to traditional care with a primary outcome of being in care with an 
undetectable viral load six months after release. 
 
The primary objectives of this study are: 
1. To assess the feasibility of implementing TCACs and of endpoint ascertainment  

 
 
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2. To assess the effectiveness of TCACs compared to care as usual by the differences in 
proportions of self-reported care at six months following corrections release. 
3. To assess the acceptability of TCACs to ex-inmate participants and to implementing staff 
 
The secondary objectives of this study are: 
1. To assess the effectiveness of TCACs compared to care as usual with regards to: 
- 
Verified in care at six months 
- 
Time to linkage to care 
- 
Linkage to care within 90 days of corrections release 
- 
HIV RNA <400 c/mL at six months 
- 
Social capital score change 
- 
Stigma index score change 
- 
Employment or self-employment 
1.3 Significance 
This study fits with the South African National Strategic Plan prioritizing inmates as a key 
population for HIV services, particularly the priority of care continuity for this population. The 
study is also. is consistent with NIH HIV/AIDS highest priority research and the South African 
National Strategic Plan on HIV, TB, and STIs 2017-2022. The research addresses the HIV/AIDS 
Research Priority of “retention and engagement in these services, and achievement and 
maintenance of optimal prevention and treatment responses.” It also addresses “health 
disparities” through a focus on recently released inmates, a marginalized population. 
 
2 METHODS 
2.1 Study design 
This is a pilot randomized clinical trial (RCT) to refine and test the feasibility, acceptability, and 
preliminary effectiveness of TCACs.  
2.2 Study setting 
This pilot operational research study will be conducted in Gauteng Province. Recruitment will 
occur within correctional facilities of the Department of Correctional Services (DCS) (expected 
Kgosi Mampuru II and Modderbee).  The activities within the correctional facilities and in the 
Districts will build on ongoing Aurum Institute service delivery and research projects. 
All study interventions will occur following release in either Ekurhuleni District, Tshwane District 
or Johannesburg District.   

 
 
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2.2.1 Correctional Facilities 
Kgosi Mampuru II Correctional Centre is sub-divided into 4 centres namely: awaiting trial 
offenders sentenced male offenders, sentenced female offenders, and a maximum security 
centre. The Correctional Facility has a population of approximately 8,900 offenders. Modderbee 
Correctional Centre is sub-divided into 3 centres namely: awaiting trial offenders, medium 
security centre and a maximum security centre. The correctional facility has an estimated 
population of 6460 offenders. It also has two satellite centres (Devon and Nigel Correctional 
Centres) that accommodate inmates who are about to be released and those who have short to 
mid-term sentences, respectively. In all the selected study facilities, each centre has its own 
primary health clinic (PHC) which provides TB treatment services, and in addition, different 
sections share one main hospital in which the ART clinic is located and where ART patients 
receive care. Offenders from each section are allocated a specific day in the week to attend the 
ART clinic in an effort to avoid mixing of offenders from different centres.   
 
2.2.2 Description of the geographical areas of study implementation 
Ekurhuleni District: This is one of the 6 districts of Gauteng province of South Africa and the 
fourth largest Metropolitan municipality in South Africa. The district had an approximate 
population of 2.8 million people (City of Ekurhuleni Annual Report 2010-2011). In the last HIV 
antenatal survey conducted in 2010, Ekurhuleni had the highest HIV prevalence in the province 
(34.0%) compared to other districts (Department of Health, 2010). 
 
Tshwane District: This is one of the 6 districts of Gauteng province of South Africa and includes 
Pretoria. The total population of Tshwane is 2.9 million people.   
 
Johannesburg District: This is one of the 6 districts of Gauteng province of South Africa.  The total 
population is 4.4 million and total area is 1,645 km2.  
2.2.3 Rationale for selecting geographical areas of study implementation 
We selected the correctional facilities based on a long-standing working relationship between 
the PI, Aurum Institute, and these facilities.  This has included a prior study of linkage to care 
following corrections release and health systems strengthening work.  The districts have been 
selected because they are the three districts to which the majority of inmates from these 
correctional centers are released to.  

 
 
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2.3 Study Population 
The population is comprised of adult (≥18 years old) corrections inmates, either male or female, 
with known HIV infection and are receiving ART within the correctional facility and are expected 
to be released back into the community within 3 months of study enrollment. 
2.3.1 Inclusion criteria 
- 
Currently incarcerated (either an offender (sentenced inmates) or awaiting trial inmate 
(un-sentenced) 
- 
Housed at Modderbee or Kgosi Mampuru II Correctional Centres (including participating 
satellite centres)  
- 
Diagnosed with HIV 
- 
Currently receiving ART 
- 
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 20km, 45 minute 
travel time, or two local taxi minibus rides) 
- 
Agree to post-discharge follow-up 
- 
Medically stable based on DCS health assessment 
- 
On ART for >3 months at the expected time of corrections release 
2.3.2 Exclusion criteria 
- 
<18 years of age 
- 
Failure to provide informed consent to be followed up by study staff after release 
 
2.4 Sampling scheme 
2.4.1 Participant recruitment and informed consent 
In liaison with DCS health staff, study staff will develop a line list of offenders on ART which will 
be updated regularly to identify potentially eligible and newly enrolled offenders initiated on 
ART. Individuals referred by DCS staff to the study team will be provided a brief description of 
the study in the correctional facility clinic.  For those still interested in learning more, the study 
team member will proceed with the informed consent process including describing inclusion and 
exclusion criteria; post-release follow-up procedures including telephonic or home contact, 
clinical record review, and blood draw for viral load ascertainment at 6 months; the two study 
arms; and the randomization procedure. Consecutive offenders from the study sites who meet 
inclusion criteria and agree to be part of the study will be asked to provide written informed 
consent. Within the correctional facility, all the offenders who meet the inclusion criteria will be 

 
 
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invited to participate (Appendix A: EL001 Screening, eligibility and Enrolment). This process will 
take place between 1 week and 3 months prior to release. 
2.4.2 Randomization 
We will perform individual randomization blocked by correctional facility.  Study staff will open 
numbered envelopes with the allocation following enrollment. Participants will be randomized 
1:2 to either the standard of care or the TCAC using sequential envelopes with study arm 
determination sealed inside (blocked by study site and based on random number generation). 
Participants and members of the research team recruiting and implementing the strategy will be 
unmasked to randomization assignment due to the behavioral nature of the strategy and need 
for team members to explain the study arm procedures to participants. Study assignments will 
be masked to staff performing outcome assessments and the investigators until all outcome data 
have been collected. 
2.5 Pre-release study procedures 
All participants will have a baseline demographic, health, and incarceration history 
questionnaire. In addition the ASSIST substance use tool, social capital questionnaire, and stigma 
index will be used with all participants. Participants will have a second pre-release contact with 
study staff if release is more than one week from enrollment.  The purpose of this visit will be to 
review the study, the allocation arm, and to encourage linking to care following release.  
2.5.1 Care-as-usual (CAU) study arm 
Participants will have a pre-release session with a study team member.  The goal of the session is 
to review study procedures, review contact from the study team or contacting the study team 
following release, update any changes in contact information, and to encourage post-release 
linkage to care.  This session will occur 1 – 2 weeks prior to release. Per DCS routine, at release, 
participants will receive a referral letter form the DCS health services and will be dispensed ART 
(the duration ranges from 30-90 days and is determined by the DCS staff) prior to release.   
2.5.2 
TCAC study arm 
Participants will have a pre-release session with a study team member.  The goal of the session is 
to review contact from the study team or contacting the study team following release, update 
any changes in contact information, and to encourage post-release linkage to care.  In addition, 
participants will be reminded of the location and timing of the TCAC session that they have been 
assigned to and will be provided a contact number for a TCAC facilitator. At release the TCAC 
arm will also receive a referral letter describing ART regimen and a supply of ART (per DCS 
routine). 
 

 
 
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2.6 Verification of release 
Study staff will work with DCS health and security officials to, (1) verify whether participants have 
been released based on the release dates provided at study enrollment, and (2) identify inmates 
released without study staff knowledge.  
2.7 Post release follow-up 
The tracing of participants will primarily be based on the tracing plan developed with the 
participant during the in-correctional facility contact sessions (Appendix A: AD001 Locator and 
Tracing Plan). The tracing plan will contain information on alternative addresses at which the 
participant anticipates staying after release, if they plan to be at the same address in 3 months 
and 6 months, names and contacts of next of kin (part of informed consent), telephone 
numbers, and study staff contact information. After the participant has been released, study 
staff will also liaise with Community Corrections Department (CCD) staff to obtain extra 
information on where the participant is actually released to. The following strategies for tracing 
will be performed: 
- 
Participants will be educated to telephonically contact a study team member within 15 
days of release; for which they will receive a small incentive in the range of a ZAR 20 - 50 
(US$3-7) airtime vouchers. Offenders will be instructed to send “call-me” messages to an 
allocated study cell-phone number that the case manager can access and respond to, 
thereby making the calls free for the ex-offenders. 
- 
In the event that participants fail to initiate contact, study staff will use available contact 
information from the tracing plan or CCD staff to contact released offenders at the 
determined follow-up time points. 
- 
If no contact is made via participant or study staff initiation, the case worker will work 
with CCD staff (who have contact details for all paroled individuals) to contact the 
released offender. 
2.7.1 First post-release contact 
The first contact with participants post-release will be conducted during 1-15 days after the 
participant’s release. The purpose of this visit is to verify if the participant’s contact details 
provided are still applicable and to find out the geographical area where the participant was 
released and remind the participant of study procedures. All participants will be reminded about 
the importance of linking into care. Following the first contact standard “hello, are you well?” 
messages will be sent every 2 weeks to maintain connection with the participant. 

 
 
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2.7.2 Ascertainment of linkage to care 
Study staff will contact participants to ascertain care status and update contact information at 
30, 90 and 182 days from release.  Follow up will primarily be telephonic and will rely on 
participant self-report.  The scheduled visit windows are: Day 30 (from 20-70 days), Day 90 (from 
71-150 days), and Day 182 (from 151 – 245).  The last contact attempt will be made on Day 246. 
At the Day 182 visit, participants will be asked for in-person contact that will occur either at 
research offices or at a site convenient to the participant.  This study visit will be used to 
ascertain visit status, socio-demographic data, and to complete surveys on stigma, social capital, 
and care satisfaction.  In addition, a whole blood sample (8mL) will be obtained for HIV RNA 
quantification (viral load) if there are no clinic obtained HIV RNA results from within 60 days or 
182 days post-release. Refer to schedule of CRFs for data collection tools used at each study visit. 
 
Table 1: Scheduled visit windows  
Visit name 
Period 
Day 30 
20 – 70 days 
Day 90 
71-150 days 
Day 182 
151 – 245 days  
Day 246 (last contact attempt) 
246 days 
 
2.7.3 Care verification 
Clinical records will be accessed to determine linkage to care status, timing of linkage to care, 
ART continuation, retention in care, and HIV RNA results.  This will be done through reviewing 
paper clinic charts, electronic clinic data (tier.net), and electronic laboratory data (NHLS 
Trackcare system).  Linkage between participants and records will be based on matching 
surname, first name, date of birth, sex, and appropriate date range. 
2.7.4 Viral loads at 6 months 
Participants in the TCAC arm will have 6 month viral loads obtained at the TCAC.  Participants in 
the care as usual (CAU) arm will have a specimen (2mL) drawn at 6 months for viral load 
assessment. 
 

 
 
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2.8 TCAC post-release procedures 
2.8.1 TCAC post release contact  
Post-release, a study team member will make contact with the participant within 1 week to 
update contact details and to review attendance at TCAC sessions. 
2.8.2 TCAC structure 
TCACs will provide all the standard services the Department of Health provides for regular 
community adherence clubs. Similar to community adherence clubs, the TCACs will be affiliated 
with a clinic and provide visit and medication distribution to the clinic for monitoring and 
reporting purposes. Routine community adherence club activities include: 
- 
Documentation of visits 
- 
Symptom screen 
- 
Distributing prepacked medications 
- 
Routine laboratory monitoring 
TCACs will have a standard structure divided into four parts with each session lasting 
approximately two hours. Attendance and medication pick-up at the session will be recorded by 
the facilitator using an electronic attendance log. 
2.8.3 TCAC frequency and duration 
Unlike standard community adherence clubs, participants will be requested to attend monthly 
sessions. If a TCAC session is missed, the facilitator will send a text message to ask how he or she 
is doing and to remind him or her of the TCAC sessions. If a participant misses a TCAC session 
they will have 1 week to collect the pre-packaged medications at the home clinic (in accordance 
with standard Community Adherence Club protocols).  If the member collects the medications 
from the clinic he or she can return to the TCAC.  If a participant misses TCAC sessions for 2 
consecutive months, he or she will be considered out of care and will be referred to the local 
clinic for medication pick-up and medication evaluation.  The TCAC facilitator will be responsible 
for contacting a participant and letting him or her know the care plan. 
2.8.4 TCAC eligibility 
All study participants assigned to the TCAC arm will be eligible for the TCAC.  This includes 
individuals who may not meet community adherence club eligibility criteria.  The reason for this 
approach is that, at present, there is low linkage to care from corrections. Furthermore, those 
individuals with the greatest adherence and clinic attendance challenges are hypothesized to 
benefit the most from the TCAC interventions.  Thus all released inmates who meet the 
enrollment criteria will be eligible for TCACs – this is a critical component of the study. 

 
 
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2.8.5 TCAC confidentiality 
Confidentiality rules will be reviewed for each member at their initial TCAC visit.  In addition, 
each member will be asked to sign a pledge of confidentiality to re-enforce the importance of 
confidentiality.  This approach was used successfully by study team members in prior community 
adherence club research. 
2.8.6  TCAC Facilitation 
The TCAC will have two facilitators: 
- 
An ex-inmate peer trained in the TCAC facilitation approach, content, and health 
evaluation. 
- 
A social worker, trained in the facilitation approach, and health evaluation 
2.8.7 TCAC medical support 
Phlebotomy will be provided at TCAC sessions for routine laboratory testing as needed by a 
professional nurse (registered nurse equivalent). For clinic referrals, a standard symptom and 
vital sign algorithm will be used for care triage [Appendix – Medical Assessment CRF].  Any 
participant meeting concern for unmanaged acute or chronic illness will be referred to the local 
clinic and will be assisted to reach the clinic. 
2.8.8 TCAC content 
A schematic intervention-impact diagram is shown below in Figure 1. 
 
Figure 1: Intervention impact model 
Part 1: Group discussion and group cognitive behavioral training. 

 
 
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The first 45-60 minutes will involve facilitated discussions among participants related to issues 
salient to the group.  The facilitation of these sessions will seek to teach cognitive behavioral 
approaches. These approaches can be applied by a participant toward what is most salient to 
him or her.  This may include managing depression, harm reduction, or medication adherence.  
The overall method is through group cognitive behavioral therapy.   
Each session will include discussion on topics of salience to the group such as substance use, 
alcohol use, ART adherence, family and community relationships, and employment readiness.  
Facilitation will seek to have participation and involvement from all group members in sharing 
experiences, strategies, and resources.  
Part 2: Individual symptom screen and medication distribution. 
This is expected to take 15-20 minutes.  Participants will be called by the facilitators for individual 
symptom screen and medication distribution (60 day supply as is provided in standard 
community adherence clubs). Based on the symptom screen, participants may be referred for 
further evaluation at a local clinic. 
Part 3: Snacks/lunch: 15 – 20 minutes 
Part 4: Life skills training 
This will use a structured curriculum delivered by the facilitators or invited guest speakers.  
Topics will include: sustainable livelihoods5,6, with sessions and materials on education/bursaries, 
finding and maintaining jobs, income generation, and saving and emergency funds; transitional 
support7-9, with sessions and materials on transitional needs, transitional planning, and 
incarceration stigma and disclosure; and HIV care and treatment, with sessions and materials on 
HIV/AIDS, medication adherence, nutrition, treatment as prevention, and HIV stigma and 
disclosure. These skills training will partially use material adapted from ongoing routine programs 
in South Africa (e.g. Stepping Stones). 
2.8.9 Schedule of TCAC medical evaluations 
In addition to the standard structured group activities, there is a list of individual activities 
focused on health assessment and ART management and based on duration from release.  These 
components are as follows: 
1. First session: Health and ART history review, ASSIST substance use (alcohol and other 
drugs) screen, PHQ-9 depression screen, social capital, and stigma screens.  The results of 
these tools will be used for guiding referrals and session services.  This screening will 
occur on arrival at the TCAC session. 
2. Every session: At every session the following will be performed: symptom screen, weight 
measurement. An algorithm for action or non-action will be developed. Based on the 

 
 
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algorithm, study staff may collect sputum, or refer participants to a primary care clinic 
based on the symptom screen and weight. 
3. At 6 months: Laboratory assessment with HIV RNA, creatinine, and CD4 count. In 
addition, starting at 6 months, participants will be evaluated for transition to standard 
services including community adherence club, community chronic medication 
distribution, or clinic medication fast lanes. 
2.8.10 Ad-hoc participant specific components 
- 
Ad hoc counselling or case management / social work needs  
- 
Care documentation: standard DoH stationary will be used to record TCAC attendance, 
symptom screen, and medication receipt. 
- 
Missed visits: Any participant not reporting to a session and not collecting medication within 
1 week will be reported to the dispensing clinic and will be contacted by the facilitator (either 
telephonically or with a home visit 
2.8.11 TCAC completion & transition to regular differentiated care 
At the end of 6 months individuals will be encouraged to join the appropriate DoH differentiated 
care model.  These include standard clinic care, clinic fast lanes, community dispensing of 
chronic care medications, and standard community adherence clubs. The model will depend on 
the determination of the clinic.  
2.9 Outcomes and Ascertainment 
2.9.1 Feasibility of TCACs 
The goal of this assessment is both to evaluate the feasibility of implementing the TCAC and of 
endpoint ascertainment for a larger clinical trial of TCAC implementation.  
Specific feasibility considerations are:   
1) The proportion of participants who are able to navigate to the TCAC as defined by 
success with intended first TCAC visit 
2) Success of the study team to ascertain six month linkage to care status 
3) Ability to use social capital and stigma index tools and assess HIV RNA level at six months.  
Success will be based on a priori targets of ≥90% of those attempting to attend a TCAC session 
able to find the location, successful follow-up of ≥75% of participants, and viral load 
ascertainment for ≥95% of participants in care. 
 
Table 2: Feasibility Indicators 
Numerator 
Denominator 
Measure 

 
 
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Number with first TCAC visit 
Total in TCAC arm 
Proportion 
Number in TCAC arm with visit first to a clinic (not TCAC) 
Total in TCAC arm 
Proportion 
Number in TCAC at 6 months (at least 2 visits) 
Number with first TCAC visits 
Proportion 
Number in TCAC at 6 months 
Number in TCAC arm 
Proportion 
Number with no more than two missed visits in 6 months 
Number in TCAC arm 
Proportion 
Proportion of all participants with successful 6month care 
ascertainment assessed 
All study participants 
Proportion 
Proportion of all participants with 6 m social capital 
questionnaire and stigma scale 
All study participants 
Proportion 
Proportion among those in care with 6m VL ascertainment  
All study participants 
Proportion 
 
2.9.2 Effectiveness of TCACs 
Primary outcome: The primary outcome of this assessment is the proportion of participants with 
self-reported care at 6 months either in TCAC or DoH clinical care. Self-reported care at 6 
months will be defined as – having at least two post-release HIV care visits 90 days apart with the 
last visit between 5 and 7 months from release. We will perform an analysis of retention in care 
at 6 months among all randomized individuals as an intent to treat analysis.   
We will also perform an eligible for 6 month follow-up analysis.  This analysis will exclude: 
- 
Not released within 3 months of enrollment 
- 
Re-incarcerated within 6 months of release 
- 
Died within 6 months of release 
- 
Withdrew participation within 6 months of release 
 Secondary outcomes: We will also evaluate the effectiveness of TCACs compared to care-as-
usual for the following secondary outcomes: 
1. Verified in care at six months 
2. Time to linkage to care 
3. Linkage to care within 90 days of corrections release 
4. HIV RNA <400 c/mL at 6 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. 
5. Social capital score change 
6. Stigma index score change 
7. Employment or self-employment 
 

 
 
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Table 3: Effectiveness outcomes 
Primary outcome 
Self-reported in care at six months by arm 
Test of proportions (chi-square) 
Secondary 
outcomes 
Self-reported linkage to care by 90 days by arm 
Test of proportions (chi-square) 
Clinical record verified in care at six months by arm 
Test of proportions (chi-square) 
HIV RNA <400c/mL for those in care by arm 
Test of proportions (chi-square) 
Social capital score by arm 
Test of medians (Wilcoxon rank sum) 
Stigma index score by arm 
Test of medians (Wilcoxon rank sum) 
Employed or self-employed by arm 
Test of proportions (chi-square) 
2.9.3 Acceptability 
Participant in-depth interviews: We will interview up to 36 participants recruited through a 
purposive sampling strategy to obtain a maximum variation sample by strategy arm, transition in 
care status, timing of ART initiation, and age group. In-depth interviews will be conducted by 
trained experienced research assistants in the participant’s preferred language (e.g., Sepedi, 
isiZulu, isiXhosa, and Sesotho). Interviews will explore:  
- 
Perceptions of the care model they were assigned to 
- 
Interactions with other patients (either at a TCAC or traditional care) 
- 
Family and relationship status, housing stability, and sources of support (financial, social, 
emotional) 
- 
Experiences with HIV and other (non-HIV and non-allopathic) service providers, including 
perceived or experienced stigma related to their HIV or ex-inmate status, and v) ideas 
about what services they still need.  
Staff and TCAC facilitator in-depth interviews: We will interview approximately 12 staff members 
involved in TCAC referral, implementation, or coordination (sample size based on the anticipated 
number of individuals to have substantial involvement in transition in care in facilities and the 
community). Interviews will explore: i) Comfort with referring to TCAC and ii) adaptability of 
TCAC to routine operations.  
 
3 Drugs/substances/devices 
Study participants will receive standard-of-care (SOC) ARV (anti-retroviral) drugs to treat HIV 
infection that will be dispensed at the DoH primary care clinics or pre-packed by Department of 
Health primary care clinics.   
 

 
 
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4 Study statistics 
4.1 Sample size 
As a study of feasibility and acceptability we have selected a sample size that, based on prior 
experience, can easily be recruited within 6 months. From the most recent prior work, we 
recruited approximately 35 inmates per month (approximately 2% declined participation). Over a 
6 month period this would result in 210 released inmates. To be conservative, we will seek to 
recruit only 50% of the recruitment rate of the prior study, representing a total of 60 participants 
into the standard of care and 120 in the TCAC arm.  We will continue recruiting until we have 
reached 180 released inmates. 
 
Table 4 : Sample size for TCAC evaluation 
Arm 
Sample size 
Care as usual 
60 
TCAC 
120 
 
Recruiting 120 in the TCAC arm will provide four TCACs with 12-20 participants each (assuming 
40 to 66% successful transition in care to TCACs among participants in that arm). The 1:2 
enrollment provides a greater population in the TCAC arm for assessing acceptability. This 
sample size has an 80% power with an alpha of 0.05 to identify an approximate difference in 
proportion meeting the primary outcome (in care with an undetectable viral load at 6 months) of 
0.24 (e.g. 0.25 versus 0.49 meeting the primary outcome) assuming successful outcome 
ascertainment for 78% of participants (our success in a prior study) (Figure 2). We note that this 
is not an effectiveness study and we present these calculations purely to illustrate the power. 

 
 
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Figure 2: Proportions in care in CAU 
and TCAC that study is powered to 
detect with alpha of 0.05 
 
4.2 Analysis 
4.2.1 Feasibility 
Success will be based on a priori targets of ≥90% of those attempting to attend a TCAC session 
able to find the location, successful follow-up of ≥75% of participants (based on the challenging 
nature of follow-up of this population our prior work with 75% follow-up), and viral load 
ascertainment for ≥95% of participants in care. 
4.2.2 Effectiveness 
Effectiveness will be based on intention to treat comparing CAU and intervention group 
outcomes using assessed using mixed effects logistic regression with correctional facility 
included as a mixed effect. 
4.2.3 Acceptability 
All audio-recorded interviews will be transcribed and translated into English (as necessary). 
Transcripts will be uploaded into MAXQDA software for coding and analysis. All documents will 
first be coded by participant stratification (engaged vs. not engaged in care) and personal 
characteristics to allow for a search of documents and comparisons that explore differences 
among participants, regional patterns, and clinic specific characteristics. This will be followed by 
inductive and deductive coding based on a coding guide that reflects key analytic concepts, 
including stigma, social capital, and access to health care.  
Qualitative analysis will proceed by first listing variations in care experiences among study 
participants, and then explore similarities and differences in these experiences between 

 
 
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different types of patients. Particular attention will be paid to how participants in the TCAC arm 
talk about HIV care, stigma management, and the role of the TCAC in addressing these issues. 
Qualitative analysis will then explore the positive and negative experiences with health care 
providers; who they identify as trustworthy; and how they describe the role of family, friends, 
community members, and health care providers in supporting or impeding their efforts to access 
health care. Analysis will also assess whether participants have unmet needs and barriers to 
services, including level of comfort receiving services in different settings, experience navigating 
health and social service bureaucracies, instances of failure to follow up with care, and 
continuing unmet needs. 
 
5 Data Management 
 
Data will be collected to review study associated outcomes in order to evaluate the extent to 
which the case management goals and objectives are being met. To achieve this, data will be 
collected in the pre- and intervention study periods. In addition to this, data will also be collected 
to assess actual programme performance against planned activities. 
5.1 Data collection tools 
Table 5: List of data collection tools and intended use 
Name of tool 
Purpose 
Schedule 
Study arm 
Visit Contact 
Documentation  
(AD001) 
To collect and track information on all study 
contacts made with the participant during 
scheduled visit windows. 
Pre-release 
Post-release 
CAU 
TCAC 
Pre-release locator 
Form (AD002) 
To collect the participant’s personal information 
important for identifying and contacting the 
participant for follow up after release.  
Pre-release 
CAU 
TCAC 
Release Verification 
(AD003) 
To verify participant release from the correctional 
facility and collect information of the documented 
date of release.  
Post-release 
CAU 
TCAC 
Post-release locator 
Form (AD004) 
To collect the participant’s personal information 
important for identifying and contacting the 
participant for follow up after release.  
Pre-release 
CAU 
TCAC 
Off Study 
(AD005) 
To document discontinued participation in the 
study due to withdrawal, loss to follow up or end 
of the study procedures. 
Pre-release 
Post-release 
CAU 
TCAC 
Screening, Eligibility 
& Enrolment (EL001) 
To collect screen participant for eligibility, and 
collect enrolment information. 
Pre-release 
CAU 
TCAC 

 
 
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Baseline 
Demographics  
(DM001) 
To collect participant demographic information at 
the time of enrolment 
Pre-release 
CAU 
TCAC 
Demographics 
Follow-Up (DM002) 
To update participant demographic information 
(where necessary) after correctional facility 
release. 
Post-release 
CAU 
TCAC 
Pre-release 
Assessment (RK001) 
To collect information on health and ART history, 
ASSIST substance use (alcohol and other drugs) 
screen, PHQ-9 depression screen, social capital, 
and stigma screens) 
Pre-release 
CAU 
TCAC 
Post-release 
Assessment (RK002) 
To collect information on health and ART history, 
ASSIST substance use (alcohol and other drugs) 
screen, PHQ-9 depression screen, social capital, 
and stigma screens) 
Post-release 
CAU - Day 30 
visit 
TCAC– at first 
session 
Routine Health 
Screening (RK003) 
 
To closely monitor participant health status in 
order to guide referrals and session services 
following established study algorithms (includes 
symptom screen, and weight measurements).  
Post-release 
TCAC 
Health Seeking  
(SS001) 
To collect information on self-reported visits to 
access medical or non-medical HIV care and 
treatment services at any time after correctional 
centre release. 
Post-release 
CAU 
TCAC 
Clinic Visit (SS002) 
To collect details of self-reported participant clinic 
visits. 
Post-release 
CAU 
TCAC 
No Clinic Visit 
(SS003) 
To document the reasons for non-entry among 
participants who self-report that they have not 
gone to the clinic.  
Post-release 
CAU 
TCAC  
Self-reporting no 
clinic visits. 
Post-entry (SS004) 
To document information on additional clinic 
visits made by the participant after initial entry-
into-care 
Post-release 
CAU 
TCAC  
Self-reported 
clinic visits. 
Case note 
abstraction pre-
release (FV001) 
To abstract information on participant health and 
ART history reviews from correctional facility 
clinical management records. 
Pre-release 
CAU 
TCAC  
 
Case note 
abstraction post-
release (FV002) 
To verify self-reported clinic visits or identify 
unreported clinic visits (among participants that 
cannot be contacted from electronic health 
record sources), and abstract information on 
participant health and clinic management in 
community clinics. 
Pre-release 
CAU 
TCAC  
 

 
 
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Laboratory Testing 
(LT001) 
To document collection of lab specimens and 
results for HIV RNA, creatinine and CD4 counts.  
Post-release  
 
CAU 
TCAC  
TCAC Transition 
(TR001) 
To document transition of participants out of the 
TCAC.  
Post-release 
 
TCAC  
 
5.2 Schedule of case report forms 
Table 6: Schedule of data collection within correctional facility 
Case Report Form 
Form 
Code 
Visits: 
Visit 1 
Enrolment 
Visit 2 
Pre-release 
Visit Code: 
01.0 
02.0 
Screening, Eligibility & Enrolment 
EL001 
 
X 
 
Pre-release assessment 
RK001 
 
X 
 
Baseline Demographics  
DM001 
 
X 
 
Visit Contact Documentation   
AD001 
 
X 
[X] 
Pre-release Locator  
AD002 
 
X 
 
Case Note Abstraction Pre-release 
FV001 
 
[X] 
[X] 
X required CRF, [X] may be required if updated or as necessary 
 
Table 7: Scheduled study visit windows for all participants after release from correctional facility 
Case Report Form 
Form 
Code 
Visits: 
Visit 3 
Release 
Visit 4 
Post-
release 
Visit 5 
Post-
release 
Visit 6 
Post-
release 
Visit 71 
Post-release 
Time since 
release: 
0D 
30D 
900D 
182D 
90 days from 
time of entry 
Visit Code: 
03.0 
04.0 
05.0 
06.0 
07.0 
Release verification 
AD003 
 
X 
 
 
 
 
Post-release locator 
AD004 
 
 
[X] 
[X] 
[X] 
 
Demographics Follow-Up 
DM002 
 
 
[X] 
[X] 
[X] 
 
Health Seeking 
SS001 
 
 
[X] 
[X] 
[X] 
 
Clinic Visit  
SS002 
 
 
[X] 
[X] 
[X] 
 
HIV/TB Testing 
SS003 
 
 
[X] 
[X] 
[X] 
 

 
 
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No Clinic Visit 
SS004 
 
 
[X] 
[X] 
[X] 
 
Post entry into care 
SS005 
 
 
 
 
 
X 
Case Note Abstraction Post-
release 
FV002 
 
 
[X] 
[X] 
[X] 
[X] 
Off Study 
AD002 
 
 
[X] 
[X] 
[X] 
[X] 
X required CRF, [X] may be required if updated or as necessary 
Visit 7 only occurs if participant had entered into care by Visit 7 
 
Table 8: Scheduled TCAC visits 
 
 
Month 
1 
Month 
2 
Month 
3 
Month 
4 
Month 
5 
Month 6 
Routine Health Screening 
RK003 
X 
X 
X 
X 
X 
X 
TCAC Transition 
TR001 
[X] 
[X] 
[X] 
[X] 
[X] 
[X] 
X required CRF, [X] may be required if updated or as necessary 
 
5.3 Database management 
5.3.1  Structure of the database 
This study will rely on two databases.  One will be used to capture participant characteristics and 
outcomes (main database).  The other database will be a study administrative database used for 
monitoring of corrections release and communication with participants following release 
(administrative database).  Main study data will be captured into a secure web based REDCap™ 
(Research Electronic Data Capture) electronic database. The Redcap database provides; an 
intuitive interface for validated data entry; audit trails for tracking data manipulation and export 
procedures; automated export procedures for seamless data downloads to common statistical 
packages; and  procedures for importing data from external sources. The administrative 
database will be developed within Microsoft Access. This database will have an Access frontend 
connected to a SQL-based server to allow for simultaneous access and data-entry from multiple 
sites.  We will develop a separate database form within REDCap for each paper case report form 
(CRF).  All fields will have appropriate range-checks for validation during data-entry.  Field 
numbers and names in the database will correspond to numbers and names on the CRF.  Trained 
data capturers or research assistants will manually input all data into the electronic database 
from the paper CRFs.  
Data entry for the release and communication database will be maintained on a daily basis for 
real-time use of data.  On the day of enrolment, the identification and contact details will be 
entered into the release and communication database.  The release database will be updated 

 
 
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within seven days of the participant’s expected release using either participant self-reported 
information or confirmed DCS release dates.  Data entry validation and automatic range checks 
will be incorporated in most data fields to reduce data entry errors.  In addition, a data monitor 
will compare approximately 10% of CRFs with data within the database.  This will help to identify 
systematic errors.  Such problems may lead to a review of a larger proportion of CRFs.   In 
addition, bi-weekly electronic checks for inconsistencies within and across forms will be 
performed followed by CRF review of any data queries that are generated.  
5.3.2 Database access 
Access to the database (data entry, reporting, and extraction) is controlled by the Data Manager, 
Study Manager, and the REDCap Database Administrator. Study personnel requiring access to 
the database must complete required documentation and training prior to receiving the 
necessary username and password. 
5.3.3 Locking of final database 
The final study database is locked to changes after the clean file form has been signed. Final 
storage of the database is with the production folder structure together with all the Metadata, 
source data and the user written programs and the version of the system used to produce the 
database. The folder is given a special icon to show it is locked and the available choices are 
restricted to reading the data. 
5.3.4 Data security 
All paper study records (e.g. consent forms, screening logs) will be kept in a secure location 
accessible only to authorized study staff, investigators, and monitors.  All CRFs will be identified 
with study ID numbers and will not contain personnel identifiers.  
5.3.5 Study limitations 
The proposed implementation research has the following limitations: 
- 
The study depends on contact with incarcerated individuals following release. Such 
individuals may be more likely to come from unstable living situations and may be highly 
mobile, making follow up a challenge. However, our experience is that released offenders 
seek re-integration services and are required to provide accurate contact information for the 
purposes of compliance with parole. Thus we anticipate tracing a high percentage of 
released offenders. 
- 
Participant self-report regarding lapses in medications and entry into care may introduce bias 
as participants may favour the most socially acceptable responses. Verification of self-
reported entry-into-care using clinic records will be conducted, where possible, for all 
participants. Data abstraction forms will be submitted to health staff at the health centres 

 
 
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where participants will report to have linked (refer to out-of-correctional facility clinic data 
abstraction form). 
- 
Follow up and observation of participants in the pre-intervention period (more frequent than 
current standard of care) may result in modified or improved participant outcomes because 
of the fact that they are being studies.  
- 
Pre/post assessments that we intend to apply in this study are susceptible to secular trends 
and to differences in outcome ascertainment. We believe that secular trends in HIV care 
both in DCS centers and in the public sector will be minimal in terms of HIV care in 
correctional centers, care in the community, and the offender population. To account for 
potential population differences we will include disease state and personal characteristics in 
the logistic regression analysis.  
- 
A low proportion participating would markedly reduce the generalizability of the results (pre 
and post-intervention).  Our experience is with an interest and willingness of inmates to 
participate in studies.  Thus we do not anticipate this to be a significant limitation. 
 
6 Protection of human participants 
6.1 Regulatory approvals 
This study will be conducted according to Good Clinical Practice (GCP) guidelines and completed 
in compliance with international and local human subject research guidelines. Approvals will be 
sought from University of the Witwatersrand Human Research Ethics Committee, Ekurhuleni 
Research Committee and the Johns Hopkins University IRB. 
 
6.2 Risks and benefits 
- 
The nature of this research is focused on improving outcomes regarding a situation unique to 
incarcerated populations. The majority of potential benefit from research results will inform 
care for this vulnerable population.  The risk posed by the components of this study are equal 
to or less than that of daily life.  The primary risk will be of inadvertent disclosure of HIV 
status through contact with study staff after release from incarceration or participation in 
standard clinic care or transition community adherence clubs (TCACs) – risks present with 
obtaining public section HIV care in South Africa.  While this risk is what is faced in public 
section care, it is of serious concern for the study and will be addressed through training of 
study staff not to indicate nature of contact to anyone except the participant or an individual 
that the participant specifically designates and by conducted TCAC meetings in a private 
space.  In addition, as part of the assessment of the service delivery, at the end of 
participation we will ask about experiences, including inadvertent disclosure of HIV status.   

 
 
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- 
Disclosure to other TCAC members is unavoidable and intrinsically a component of the 
intervention.  This aspect of the study will be clearly described to potential participants 
during the informed consent process. 
- 
The other risk is that participants may have a delay in receiving higher level clinical services if 
they present to the TCAC with an acute illness.  TCAC facilitators will make every effort to 
transport a participant to the relevant level of care (primary care clinic, hospital) based on 
symptom screening results.  All symptom screen results and triage will be recorded and 
reviewed at least bi-weekly by the study team. We will be assessing for un-managed 
morbidity in both arms at each study follow-up (as a secondary outcome) to assess for any 
differences. 
- 
All participants will be eligible for nominal compensation for contact with study staff 
(approximately US$ 2-3 in airtime or data bundle).  Participants in the TCAC are may benefit 
from added services.  Whether this will truly reduce the burden of care, increase social 
capital, and lead to improved care continuum outcomes is the object of study. 
 
6.3 Additional ethical considerations 
As a study recruiting institutionalized individuals (detainees) additional human subjects 
protections need to be considered. Notably, although recruitment will occur among detained 
individuals, all intervention services will be provided post-release. We believe we meet the seven 
requirements specified in 45 CFR 46 for approval of research involving detainees and offenders.  
These are described below:   
1. Category of permissible research: Category iii research under 45 CFR 46.306(a) (2): 
Research on conditions particularly affecting prisoners (detainees and offenders).   
Post-release adjustment, including continued medical care, following prison release is a 
challenge uniquely faced by incarcerated populations.  Thus this research focuses on a 
condition only affecting detainees and offenders. 
2. No excessive inducements for participation. 
Detainees and offenders will not accrue any advantages due to participation in the 
research while incarcerated.  Following release, participants will receive cell phone 
airtime to enable on-going two-way communication with the case management team.  
While we agree that this is a reimbursement for the costs associated with participation, 
we do not believe that it represents undue incentive or pressures to participate within 
the South African context.  In addition, the potential harms of participation are 
approximately the same as encountered with daily life (risk of inadvertent disclosure in 
public clinic settings).  
3. The risks involved in the research are commensurate with risks that would be accepted by 
non-prisoner volunteers. 

 
 
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Risks for participation are negligible and commensurate with risks for non-prison 
volunteers enrolled in retention-in-care programs and studies.  This study places 
participants at minimal risk and may provide benefit if it is successful in increasing 
continuation of HIV or TB care. The greatest risk to the participants is a breach of 
confidentiality regarding HIV / TB status or incarceration history. This risk will be 
minimized by: secure storage with limited access of all documents, use of unique 
identifiers on all study forms, and use of discreet language that does not refer to 
incarceration history or HIV or TB diagnoses by case managers and tracers when speaking 
with the participants either telephonically or in person. 
4. Procedures for the selection of subjects within the prison are fair to all prisoners and 
immune from arbitrary intervention by prison authorities or prisoners.  
Participation will be open to all inmates receiving ART or TB treatment (without random 
or population-based selection).  There will be no control or intervention by prison 
authorities regarding potential participation. The study takes on a quasi-experimental 
approach in which outcomes of offenders released in the pre-intervention phase are 
compared to those in the intervention phase. Therefore, assignment to intervention or 
non-intervention is solely dependent on the offenders release date or sample size 
required for, whichever comes first. 
5. The information is presented in language that is understandable to the subject population. 
The Participant Information Sheet (PIS) and other study related communication is at the 
inmate level. Additionally, the PIS will be translated into 6 common local languages – 
Sesotho, isiXhosa, isiZulu, Setswana, Xitsonga, and Afrikaans.  We have extensive 
experience working with inmate peer educator groups and communicating on other ways 
with inmates.  Through this experience we believe that we will be able to explain the 
study at a level comprehensible to the inmate population.  
6. Adequate assurance exists that parole boards will not take into account a prisoner's 
participation in the research in making decisions regarding parole. 
Parole boards will have no information on agreeing to participate or declining from 
participation in this research.  
7. Where the IRB finds there may be a need for follow-up examination or care of participants 
after the end of their participation, adequate provision has been made for such 
examination or care, taking into account the varying lengths of individual prisoners' 
sentences, and for informing participants of this fact (45 CFR 46.305(a). 
The intervention occurs following release and is non-medical.  We are not planning on 
any medical follow-up for participants.  However, participants assigned to the non-
intervention arm will be offered additional counselling if they fail to enter community 
care within 90 days. In addition, participant contact information will be available should 
the need arise for follow-up after study completion.   

 
 
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6.4 Consent 
Written informed consent will be obtained from eligible participants while incarcerated and from 
health staff members and selected TCAC members prior to in depth interviews. The consent 
process will be done in a private area to ensure confidentiality. Informed written consent, using 
Ethics Committee/IRB-approved consent forms, will be obtained by trained study personnel prior 
to performing any study-specific procedures. Informed consent is a process that will be initiated 
prior to the individual’s agreeing to participate in the study and will continue throughout the 
individual’s study participation. Potential participants will receive information about risks and 
possible benefits of study participation, study objectives and procedures. Informed consent 
requires the legally effective signature or mark of the subject. A copy of the signed and dated 
informed consent document will be offered to each participant for his or her records.  Another 
copy will be placed in the participant’s corrections health file. The rights and welfare of the 
subjects will be protected by emphasizing to subjects that the treatment by clinicians will not be 
adversely affected if they decline to participate in this study, and that they may withdraw 
consent at any time. The investigator will retain a copy of the signed consent forms, which may 
be inspected at the monitor’s/auditor’s request.  The investigator will promptly report to the 
Ethics Committee/IRB of all changes in the research activity and all unanticipated problems 
involving risks to human subjects or others, and will not make changes in the research without 
Ethics Committee/IRB approval, except where necessary to eliminate apparent immediate 
hazards to human subjects. 
The informed consent process will include a verbal review of the study, provision on participant 
information sheets in relevant languages (Sesotho, isiXhosa, isiZulu, Sepedi, and English), review 
of the information sheets, and answering and questions. Participants unable to read or write will 
be asked to make a mark or thumbprint in the presence of a witness (verbal consent will not be 
obtained).  Only written informed consent will allow for study participation. 
6.5 Clinical trials registration 
The study will be registered with clinicaltrials.gov.  Key study information and results will have 
open-access availability on the clinicaltrials.gov website.  This is in accord with funder (NIH) 
regulations. 
6.6 Confidentiality 
All study records will be managed in a secure and confidential fashion. All records will be stored 
at the participating correctional centers and Aurum Head Office in locked filing cabinets and 
access to the records will be restricted to specified study team members. Case report forms and 
case management documents will be identified using the participant’s study number only, with 
locator information stored separately.   

 
 
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6.7 Data safety and monitoring 
A data safety and monitoring board will be established to review of the protocol and monitoring 
plan prior to commencement of enrollment into the RCT and meet virtually prior to commencing 
enrollment and then every 6 months to review of RCT progress, enrollment and outcomes data, 
and any potential adverse outcomes. The meetings will review safety to suggest procedural 
changes and study modifications. There will be no criteria for study termination based on 
effectiveness because this is a pilot feasibility study with a total sample size that may not allow 
clear assessment of difference. The DSMB will include 3-5 members including individuals with 
experience with corrections research, the corrections environment, and good clinical practice. 
 
7 Project Governance and Management 
7.1 Research team 
- Dr. Christopher Hoffmann, MD, MPH, MSc is a clinician scientist, Associate Professor at Johns 
Hopkins University and a Senior Scientist at Aurum. He has been working with Aurum on 
operational research since 2005 and is experienced with study design and statistical analysis 
and has published over 80 articles related to HIV care and treatment issues. He was the PI on 
a recently completed study implemented by the Aurum Institute in correctional facilities in 
Gauteng, South Africa.  Dr. Hoffmann will provide overall leadership for study 
implementation. 
- Dr Jill Owczarzak PhD, is an Assistant Professor at Johns Hopkins she has extensive 
international experience in qualitative and quantitative assessment of complex 
social/behavioral interventions.  She will lead qualitative components of the study.  
- Dr Stefan Baral MD is an Associate Professor at Johns Hopkins University with substantial 
experience on interventions for key populations, assessments of stigma, and study 
management.  He will leverage these skills to provide guidance and inputs on study design, 
implementation, and evaluation.  
- Dr Colleen Hanrahan PhD is a Scientist at Johns Hopkins University with experience 
implementing and evaluating community adherence club interventions in South Africa.   
- Dr. Salome Charalambous MBBCh, PhD, is the Director of Research at the Aurum Institute and 
has extensive experience leading research in collaboration with the DCS and the Department 
of Health.  She will manage stakeholder engagement with the DCS and Department of Health 
for this study.   
- Tonderai Mabuto, MSc is a Senior Program Manager for the Research Department with ten 
years’ experience with pragmatic clinical trials and other studies.  He led a prior study 
regarding linkage to care following corrections release as well as a clinical trial of accelerated 
linkage to care following HIV testing.  He will provide on the ground coordination.  
 

 
 
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The study team (PI and co-Is) will meet biweekly to review study progress.  The PI will meet 
weekly with Tonderai Mabuto to discuss operational aspects of the study implementation.  Dr 
Owczarzak will meet as needed for qualitative analysis components.  The PI will make 3 – 4 visits 
annually to study sites. 
 
 
Figure 3: Project Management Structure 
 
7.2 Publication policy 
The research findings will be presented first to national stakeholders, and disseminated to 
stakeholders and participants in each province by means of local meetings. The results will be 
written up as one or more articles for submission to a suitable scientific journal.  
7.3 Performance monitoring 
The principal investigator will complete a monthly progress report that will facilitate monitoring 
of study progress and keeping the funders informed. These reports will capture vital information, 
such as IRB timelines, status of protocol development, enrolment figures, and any issues/delays 
that the PI may be experiencing. 
 
8 Participant reimbursement 
Participants will not receive payment for participation in the study but will receive 
reimbursement for time (and travel when needed) for study visits. Provision of food at the TCAC 
sessions is in line with food provision for people queueing at some public clinics. 
9 Funding 
Funding for this study is provided by the National Institute of Mental Health, USA, Grant 
Number: 1R34MH115777. 
Co-Is 
Owczarzak 
Baral 
Hanrahan 
Mabuto 
Charalambous 
Research Manager  
(Mabuto) 
Research Field Team / 
Data management 
Qualitative Field Team 
 
Principal Investigator 
(Hoffmann) 
Technical Support  
Qualitative - Owczarzak 
DSMB Oversight 

 
 
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