Adolescent Transition to Adult Care for HIV-infected Adolescents in Kenya
Phase: NA
Conditions: Adolescent Behavior, HIV, Transition, Adolescent Development, Disclosure
Sponsor: University of Washington

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The ATTACH Study: 
Adolescent Transition To Adult Care for HIV-infected adolescents in Kenya 
(ATTACH) 
 
 
 
Study sponsor: National Institutes of Health, Grant Number 
1R01HD089850-01 
Principal Investigator: Grace John-Stewart, MD, MPH, PhD 
 
Version Number: 2.6 
 
December 29, 2020 
 

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Table of Contents 
LIST OF ABBREVIATIONS AND ACRONYMS ........................................................................... III 
INVESTIGATORS ..................................................................................................................... IV 
SIGNATURE PAGE ................................................................................................................... VI 
PROTOCOL SUMMARY .......................................................................................................... VII 
SECTION 1: BACKGROUND INFORMATION AND LITERATURE REVIEW .............................. 1 
1a. Background Information ............................................................................................... 1 
1b. Literature Review ......................................................................................................... 2 
1c. Rationale ...................................................................................................................... 4 
SECTION 2: OBJECTIVES ......................................................................................................... 5 
2a. Study Objective ............................................................................................................ 5 
2b. Specific Objectives ....................................................................................................... 5 
SECTION 3: STUDY OUTCOMES .............................................................................................. 6 
Table 1: Outcome, metric and data source ......................................................................... 7 
SECTION 4: STUDY DESIGN .................................................................................................... 8 
SECTION 5: STUDY SITES AND POPULATIONS .................................................................... 10 
5a. Study sites .................................................................................................................. 10 
5b. Study population ......................................................................................................... 11 
Table 2: Purposive sampling scheme and data collection details for Aim 2 ....................... 12 
Table 3: Details of cluster RCT design, enrollment and data collection ............................. 13 
5c. Participant inclusion criteria ........................................................................................ 14 
5d. Site/participant exclusion criteria ................................................................................ 15 
Table 4. Inclusion Criteria for all participants/clinics .......................................................... 16 
5e. Randomization procedures ......................................................................................... 18 
5f. Masking procedures .................................................................................................... 19 
5g. Participant Withdrawal ................................................................................................ 19 
SECTION 6: STUDY INTERVENTION ...................................................................................... 20 
Table 5: Core elements of the Got Transition Program ..................................................... 20 
SECTION 7: STUDY PROCEDURES ....................................................................................... 21 
7a. Programmatic data analysis and facility surveys ......................................................... 22 
7b. Adapt and Optimize phase .......................................................................................... 24 
7c. Cluster Randomized Controlled Trial (RCT) ................................................................ 30 
7d. Implementation Evaluation ......................................................................................... 34 
7e. Assessment of participant compliance with study intervention .................................... 40 
SECTION 8: STUDY SCHEDULE ............................................................................................. 41 
Table 6a:  Overall study schedule: 2016-2021 .................................................................. 41 
SECTION 9: ASSESSMENT OF SAFETY ................................................................................ 42 
9a. Reporting of unanticipated problems and other events ............................................... 42 
SECTION 10:  DATA COLLECTION .......................................................................................... 42 
SECTION 11: STATISTICAL CONSIDERATIONS ..................................................................... 47 
11a. Sample Size Considerations ..................................................................................... 47 

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Table 7: Precision estimates for prevalence of retention and viral load suppression in 
HIV-infected adolescents ...................................................................................... 47 
Table 8: Power and sample size ranges ........................................................................... 48 
11b. Overview of analysis plan ......................................................................................... 49 
SECTION 12: ETHICS/PROTECTION OF STUDY PARTICIPANTS ......................................... 50 
12a. Informed Consent Process ....................................................................................... 50 
12b. Participant Confidentiality ......................................................................................... 52 
12c. Potential Risks and Benefits ..................................................................................... 53 
SECTION 13: USE OF INFORMATION AND PUBLICATIONS .................................................. 55 
SECTION 14: LIMITATIONS ..................................................................................................... 55 
REFERENCES ......................................................................................................................... 57 
APPENDICES ........................................................................................................................... 60 
 
 
 

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LIST OF ABBREVIATIONS AND ACRONYMS 
 
AAFP 
American Academy of Family Physicians 
AAP 
American Academy of Pediatrics  
ACP  
American College of Physicians 
ACT 
Accelerating Children’s HIV/AIDS Treatment 
AIDS  
Acquired Immunodeficiency Syndrome  
ATP 
Adolescent Transition Package 
ART 
Antiretroviral therapy 
CCC 
Comprehensive care clinic 
CIPHER  
Collaborative Initiative for HIV Education and Research 
EMR 
Electronic Medical Records  
FACES  
Family AIDS Care and Education Services  
FGD 
Focus Group Discussion 
HCW 
Health Care Worker 
HIV 
Human Immunodeficiency Virus 
IeDEA 
International Epidemiologic Databases to Evaluate AIDS  
IDI 
In-depth interview 
KNH 
Kenyatta National Hospital 
LVCT 
Liverpool Voluntary Counseling and Testing  
MoH 
Ministry of Health  
NASCOP  
National AIDS and STI Control Program 
PEPFAR 
President's Emergency Plan for AIDS Relief 
RCT 
Randomized controlled trial  
SOC 
Standard of Care 
TRQ 
Transition Readiness Questionnaire  
UNAIDS 
The Joint United Nations Programme on HIV/AIDS 
US  
United States 
UW 
University of Washington 
WHO 
World Health Organization 
 
 
 
 

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INVESTIGATORS 
  
Principal 
Investigator 
Grace John-Stewart 
Professor, Medicine, Epidemiology, Pediatrics, Global Health 
University of Washington 
Harborview Medical Center 
325 9th Avenue, Box 359932 
Seattle WA 98104  USA 
Tel:  +1-206-543-4278 
Email: gjohn@uw.edu 
 
Co-Principal 
Investigator 
Dalton Wamalwa MBChB, MMed, MPH 
Associate Professor, Paediatrics & Child Health 
University of Nairobi / Kenyatta National Hospital 
Tel: +254721239493 
Email: dalton@africaonline.co.ke 
 
Co-
Investigators  
 
Kristin Beima-Sofie, PhD, MPH 
Acting Assistant Professor, Global Health 
University of Washington 
beimak@uw.edu 
 
Gabrielle O’Malley, PhD 
Associate Professor, Global Health 
University of Washington  
gomalley@uw.edu 
 
Bartilol Kigen, MBChB, MMed     
Head, National AIDS and STI Control Program,  
Ministry of Health, Kenya  
head@nascop.or.ke                      
 
Martin Sirengo, MBChB, MMed 
Head, National AIDS and STI Control Program,  
Ministry of Health, Kenya  
msirengo@nascop.or.ke  
 
Laura Oyiengo, MBChB, MMed 
Program Manager, Pediatrics 
National AIDS and STI Control Program,  
Ministry of Health, Kenya  
bonarerimk@gmail.com 
 
Cyrus Mugo Wachira, MBChB, MPHc 
Study Coordinator  
University of Nairobi / Kenyatta National Hospital 
cyrusmugodr@gmail.com  

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Irene Njuguna, MBChB, Msc., MPHc 
Research Scientist 
Kenyatta National Hospital / University of Washington 
irenen@uw.edu 
 
Collaborating 
Institutions 
University of Washington 
4333 Brooklyn Avenue NE 
Box 359472 
Seattle WA 98195 USA 
 
University of Nairobi / Kenyatta National Hospital   
Off Ngong Road 
PO Box 19676-00202 
Nairobi, Kenya  
 
National AIDS and STI Control Program (NASCOP),  
Ministry of Health 
P.O. Box 19361-00202 
Nairobi, Kenya  
 
 
 
Funding 
Agencies 
National Institutes of Health (NIH) 
Grant: 1R01HD089850-01 (John-Stewart, PI) – “Transitioning from Pediatric 
to Adult HIV care in Kenya” 
 

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SIGNATURE PAGE 
 
Grace John-Stewart, MD, PhD 
 
 
 
 
April, 20, 2018 
gjohn@uw.edu  
 
 
Principal Investigator signature 
 
Date 
 
 
Dalton Wamalwa MBChB, MMed, MPH ________________________ 
 
April, 20, 2018 
dalton@africaonline.co.ke  
 
Co-Investigator signature 
 
            Date 
 
 
Kristin Beima-Sofie, PhD, MPH      
 
 
 
April, 20, 2018 
beimak@uw.edu  
 
 
Co-Investigator signature 
 
 
Date 
 
 
Gabrielle O’Malley, PhD  
 
 
 
 
April, 20, 2018 
gomalley@uw.edu  
 
 
Co-Investigator signature 
 
 
Date 
 
 
Bartilol Kigen, MBChB, MMed                           
 
 
 
 
April, 20, 2018  
head@nascop.or.ke                           Co-Investigator signature                              Date                                        
 
 
Martin Sirengo, MBChB, MMed                   
 
 
 
 
April, 20, 2018 
msirengo@nascop.or.ke  
 
Co-Investigator signature 
 
 
Date 
 
 
Laura Oyiengo, MBChB, MMed  
 
 
 
 
 
 
April, 20, 2018 
bonarerimk@gmail.com   
 
Co-Investigator signature 
 
 
Date 
 
 
Cyrus Mugo Wachira, MBChB            
 
 
 
 
April, 20, 2018 
cyrusmugodr@gmail.com                  Co-Investigator signature 
 
 
Date 
 
 
Irene Njuguna, MBChB, Msc.          
  
 
 
 
April, 20, 2018 
irenen@uw.edu 
 
 
Co-Investigator signature 
 
 
Date 
 
 

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PROTOCOL SUMMARY 
 
Design 
This implementation science research study aims to understand and 
implement best practices for adolescent “transition” from pediatric HIV 
care to autonomous adult care in Kenya.  
 
To do this we will evaluate current transition procedures and rates in 
a large sample of HIV treatment programs, and will adapt, implement, 
and evaluate an Adolescent Transition Package (ATP) that combines 
existing transition tool and disclosure tools that have been validated 
in other populations.  
 
The study will involve data abstraction and facility surveys to 
determine transition practices and co-factors of effective transition 
(AIM 1), adapting and optimizing a transition tool (AIM 2) and 
implementation and evaluation of the transition tool and a validated 
disclosure booklet (Adolescent transition package [ATP]) in a cluster 
RCT (AIM 3).   
  
Population  
Aim 1: Facility heads at a random sample of Kenyan clinics and 
routinely collected programmatic data on HIV-infected adolescents 
from the same clinics.  Aim 2: Health Care Workers (HCWs) currently 
employed in HIV care services, HIV-infected adolescents and youth 
ages 14-24 years, caregivers of HIV-infected adolescents, facility 
administrators and policy makers at the national, county and program 
level. Aim 3: HIV-infected children, adolescents and youth ages 6-24 
years and HCWs providing adolescent HIV care.  
 
Sample size 
Aim 1: 102 clinics providing HIV care in Kenya. Aim 2: 24 focus group 
discussions with adolescents and caregivers, and 68 interviews with 
health care workers, hospital administrators and policy makers; 
workshop with 12 HCWs. Aim 3: 20 clinics providing HIV care (10 
randomized to receive the ATP and 10 standard of care [SOC]); Early-
trial: Repeated surveys and FGDs with 200 implementing HCWs, 400 
pre-trial surveys with adolescents; 200 pre-trial surveys with HCWs; 
During Trial: Repeated (6-monthly surveys) with up to 4000 
adolescents; Post-trial: 96 interviews with adolescents and 60 in-
depth interviews with HCWs, 400 post-trial surveys with adolescents 
and 200 post-trial surveys with HCWs.  
 
Treatment  
Aim 3: 10 clinics will receive the Adolescent transition package  
 
Study sites: 
Aim 1: Random sample of HIV clinics in Kenya. Aim 2: Interviews and 
focus groups at a sub-set of clinics participating in Aim 1, working 
group with HCWs from throughout Kenya. Aim 3: 20 HIV clinics in 
Nairobi, Homabay, Kajiado and Nakuru Counties.  
 
Study Duration: 
5 Years 
 

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SECTION 1: BACKGROUND INFORMATION AND LITERATURE REVIEW  
1a. Background Information 
With recent impetus to increase pediatric HIV diagnosis and treatment, an expanding number of 
HIV-infected children will reach adolescence and need to transition to adult HIV care. As has been 
seen with a variety of chronic diseases, there are challenges as children transition from pediatric 
to adult HIV care. Transitional care tools have evolved to help children, caregivers, and providers 
systematically optimize transition for children with chronic diseases in a variety of disease 
scenarios. These are largely untested or not used in settings with high HIV prevalence.  
 
In Kenya, in large urban HIV Treatment Centers, children are seen in dedicated pediatric HIV 
clinics and transition to the separate adult HIV clinic at ~15-24 years of age. In other HIV 
Treatment Programs, children are seen on pediatric days with a team that may be identical or 
overlap considerably with the team providing care on separate adult care days. Finally, some 
clinics utilize the same team and days to offer care to children and adults, with a transition involved 
when a child no longer needs a caregiver/parent at visits and starts to receive independent care. 
In all scenarios, adult HIV care demands a higher level of autonomy and is associated with less 
specialized support than pediatric HIV care. Well-conceived transitional models are needed 
because adolescents and young adults are a particularly vulnerable group. Adolescent HIV 
retention in care is lower than in adults, and adolescents have had increasing HIV-related 
mortality in contrast to declining mortality risk in adults. This underscores the need for 
enhanced transitional care between pediatric and adult models of care. 
 
In order for children to assume their own care, there must be accurate, well-conducted, and timely 
disclosure of their HIV status. However, in Kenya, we and others have noted that a large 
proportion of HIV-infected children have not been formally told they have HIV (disclosed) because 
of concerns of inadvertent disclosure to others, parental guilt regarding transmission, or concerns 
that the child will be unable to cope. Informing a child of any chronic illness is challenging because 
of a child’s developmental limitations or because caregivers desire to protect children from 
negative consequences. However, delayed or poor disclosure practices can result in persistent 
mistrust of the health system. Without disclosure, transition to adult HIV care cannot occur. 
Disclosure to the child may also improve treatment adherence, physical health outcomes, and 
psychological adjustment to illness and family relationships. Programs are starting to address 
disclosure of HIV status to children, however, there are few systematic tools for disclosure and 
limited evaluation of impact of these tools. There is therefore an urgent need to develop interventions 
to assist HCWs with the challenging, but crucial process of HIV disclosure to children and adolescents.  
 
Transitional care is a complementary urgent priority for aging children with HIV. With poor 
disclosure and transitional care, adolescents will have higher morbidity, mortality, and risk 
of onward transmission. There are huge gaps in HIV transitional care evidence-base – including 
the lack of a clear definition of transition, lack of evidence for effective transition tools, and 
challenges with integration of data from systems built separately for adults and children. We 
propose to evaluate rates and cofactors of effective transition in HIV Treatment Programs in 
Kenya and to adapt, implement, and evaluate an Adolescent Transition Package that combines 
an adapted US-based transition tool and a disclosure tool associated with improved disclosure 
outcomes in Namibia. 
 

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1b. Literature Review  
Pediatric antiretroviral treatment (ART) coverage is rapidly expanding and 
children are surviving to adulthood  
An estimated 2.6 million children under 15 years old are HIV-infected worldwide, almost 90% in 
Africa (UNAIDS 2015)[1]. To date, pediatric ART coverage has lagged behind adult coverage – 
the WHO estimated that only 32% of HIV-infected children <14 years old received ART in 2014 
compared to 41% of HIV-infected adults[2]. To address this gap, the Accelerating Children’s 
HIV/AIDS Treatment (ACT) program of PEPFAR, a $200 million initiative, was initiated in 2014 to 
provide ART for 300,000 children with HIV in Africa[3]. Access to antiretroviral therapy (ART) has 
already improved survival of HIV-infected children and the ACT initiative will result in an increasing 
number of HIV-infected ART-treated children reaching adolescence and early adulthood [4-7].  
 
Adolescents with HIV have unique needs and high risk for poor outcomes  
An estimated 2.0 million adolescents (10-19 years old) worldwide are HIV-infected, and 220,000 
adolescents aged 15-19 years old were newly infected in 2014. The majority (62%) of newly 
infected adolescents were female[8]. Unfortunately, global estimates of adolescent HIV and ART 
coverage are lacking because individuals between 10-15 years of age are considered children 
and those >15 years of age are considered adults. This makes it difficult to derive estimates for 
the group of adolescents and young adults between 10-24 years of age. In Kenya, an estimated 
140,000 adolescents are HIV-infected, however, data are scant regarding adolescent ART 
coverage[8]. In a recent programmatic analysis of 22,832 adolescents and young adults aged 10-
24 receiving ART in Kenya, young adolescents (aged 10-14) had a significantly lower CD4 at 
enrollment into HIV care than youth aged 15-24[9]. However, 15-24 year old youth had 2-fold 
higher loss to follow-up than younger adolescents. In another study of global trends, adolescents 
aged 10-19 years were noted to have a 50% increase in HIV-related mortality between 2005-2012 
compared to a 32% decrease in non-adolescents during this same period[10]. This may be due 
to long-term complications from perinatally acquired infection or to poor adherence or motivation 
to continue in care. It is also possible that poor transition between pediatric to adult HIV treatment 
programs may contribute to poor adolescent outcomes. 
 
Effective transition of children with HIV to self-directed health care requires disclosure of 
their diagnosis, however, pediatric HIV disclosure remains a challenge  
In order for children to assume their own care, there must be accurate, well-conducted, and timely 
disclosure of their HIV status. Informing a child of any chronic illness is challenging because of a 
child’s developmental limitations or because caregivers desire to protect children from negative 
consequences[11]. The complexities of disclosure are amplified for pediatric HIV because rather 
than affecting only the child, HIV is often a family infection and includes concerns about stigma 
and transmissibility [12-14]. Caregivers and HCWs are tasked with informing HIV-infected children 
that they have a chronic, potentially life-threatening, highly stigmatized disease during a critical 
time in the child’s or adolescent’s physical and psychosocial development.  
 
Studies in African countries have noted low rates of disclosure ranging from 3-41%, including 
studies of older children and adolescents [15-22]. US and European programs report rates of 
disclosure ranging from 17-75% [23-30]. Median ages of disclosure for children in US and 
European studies (7.5-10 years) are lower than in studies from Africa (8.7-15 years)[16, 23, 27-
33]. Rates of disclosure in Africa remain low even in programs where the majority of children (73-
85%) are receiving ART [16, 21, 32] Disclosure of HIV status requires that children comprehend 
information regarding the diagnosis and its implications. Thus, the age, cognitive development, and 
level of education of a child can significantly influence timing of disclosure [17, 21, 26-28, 32, 34]. 

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Because pediatric HIV may result in neurocognitive impairments, emotional/cognitive maturity may 
be delayed therefore also delaying disclosure. In addition, caregivers are often reluctant to inform 
children of their HIV diagnosis because of concerns regarding inadvertent disclosure of the family’s 
HIV status, perceptions of the child’s inability to cope with results, and guilt regarding transmission 
[35-40]. Caregivers may have witnessed children lose friends and social standing when their 
status became known [41, 42]. Caregivers, who are often also infected with HIV, may have had 
difficulty when they learned their own HIV status, which then impacts their perception of the benefits 
of disclosure. Previous studies have demonstrated that the HIV serostatus of the caregiver is a 
key factor in disclosure [17, 28]. Among HIV positive caregivers, studies in Europe, South Africa, 
and Ethiopia observed that caregivers who had disclosed their own status were more likely to 
have also disclosed the child’s status to the child [17, 19, 27].   
 
Despite these challenges, disclosure to the child may improve treatment adherence, physical 
health outcomes, and psychological adjustment to illness and family relationships.[43-46] 
Furthermore, late, abrupt or inadvertent disclosure often has significant adverse effects on the 
child’s emotional and physical health including diminished trust in Health Care Workers (HCWs) 
and caregivers, reduced adherence, increased rates of opportunistic infections, and fatalistic or 
suicidal mentalities. A 2014 national study in Kenya showed that adolescents who know their 
status had significantly lower rates of mortality and higher retention in HIV treatment 
programs[47]. Knowledge of HIV status has a potential public health benefit in that infected 
adolescents who know their HIV status may be more likely to use available HIV preventive 
interventions. The World Health Organization (WHO) and Kenyan guidelines recommend that 
school-aged children be fully informed of their HIV diagnosis and younger children told partial 
information about their diagnosis[48]. However, neither set of guidelines provides specific 
approaches for implementing disclosure in practice, nor do they accurately address the real world 
challenges HCWs and caregivers are encountering [48-50].  
 
Adapting validated disclosure interventions may improve disclosure rates and experiences 
for HIV-infected adolescents 
There is an urgent need to develop interventions to assist HCWs with the challenging, but crucial 
process of HIV disclosure to children and adolescents. We evaluated a disclosure tool used 
nationally in pediatric HIV treatment and care programs in Namibia and saw improved confidence 
in and comfort with disclosure in HCWs and caregivers, and improved knowledge and clinical 
outcomes in children exposed to the intervention[51]. The disclosure intervention is intended to 
be used with children aged 6-18. The centerpiece of the intervention is a 5-chapter cartoon book 
which uses empowering language and metaphors of body soldiers being strengthened by 
medicine (ARVs) and keeping the “bad guys” (HIV virus) asleep. The further the child progresses 
in reading the book, the more information about his or her disease and the role of medications is 
revealed. It is not until Chapter 5 that the words “HIV” or “ARV” are mentioned. A portion of the 
book is read, or re-read, at each visit by a HCW until the caregiver and child are ready to read 
Chapter 5 in which full disclosure occurs. The chapters are read in a highly interactive manner 
with each one taking approximately 5-10 minutes to complete the first time it is read. A disclosure 
form is attached to the patient care booklet on which the HCW notes how far in the disclosure 
book the child has gone at each visit and why the child thinks they are taking medicine. These 
notations help HCWs check comprehension and strengthen continuity across visits. A readiness 
assessment form helps HCWs assess the child’s and family’s readiness to engage in the full 
disclosure process. The intervention also includes HCW training on pediatric disclosure and the 
intervention tools. The Namibian disclosure intervention provides a helpful tool that could be 
adapted and used in other settings to improve rates and experiences with HIV disclosure.   
 
Transition models are in standard use for varied diseases  

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The model for transitional care recommended by the American Academy of Pediatrics (AAP), 
American Academy of Family Physicians (AAFP), and American College of Physicians (ACP) is 
based on expert consensus and initiates discussion of transition at 12 years of age and includes 
standardized age-triggered actions to enhance transition[52]. General resources to guide 
transition aligned with the AAP, AAFP, and ACP Clinical Report on Transition have been recently 
developed 
by 
the 
Got 
Transition/Center 
for 
Health 
Transition 
Improvement 
(http://www.gottransition.org). These include 6 Core Elements: 1)Transition Policy, 2)Transition 
Tracking and Monitoring, 3)Transition Readiness, 4)Transition Planning/Integration into Adult 
Approach to Care, 5)Transfer to Adult Approach to Care, 6)Transfer Complete, Ongoing Adult 
Approach to Care. The guidance incorporates a framework that includes child, caregiver and 
HCW readiness for transition and involves a several year process with repeated iterative planning 
towards transition. This model is useful both for children who switch from pediatric to adult health 
care providers and for children who retain their provider but transition to an adult approach to 
care. In both models children need to transition to independent care when they reach adulthood. 
Regardless of program structure, it is important to systematically incorporate transition planning 
with input from primary caregivers, adolescents, and HCWs to ensure a smooth transition to 
autonomous care.  
 
Transitional care models are not yet well-defined for HIV  
As many children survive to adulthood with a variety of chronic diseases, models of transitional 
care have evolved to address the challenges of navigating transition. Recently Zhang and 
colleagues conducted a systematic review of transitional care models; the review identified 10 
transition tools, 7 of which were disease specific, only 1 of which addressed HIV[53]. The HIV 
model utilized the Transition Readiness Questionnaire (TRQ), which included 21 questions to 
assess readiness for transition. The TRQ score improved following a transition program. However, 
it is not known if the TRQ was useful in predicting transition readiness. All published transitional 
care tools in the systematic review were from US or high-resource settings and none have been 
evaluated for impact on transition outcomes. The results of the systematic review illustrate the 
need for transition tool use and assessment in high HIV prevalence settings, such as Africa. The 
Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International  
AIDS Society and the IeDEA Coordinating Center Vanderbilt University convened a workshop in 
2015 to focus on adolescent HIV transition[54]. As part of the workshop, Soeters and colleagues 
summarized data from 218 facilities in 23 countries, focusing on adolescent HIV services. In this 
WHO supported survey, an estimated 51% of facilities included some process to guide ‘transition’ 
and the mean age of transition was 18 years of age. Most clinics had clinic days dedicated to 
either adult or pediatric services. The 2015 CIPHER Adolescent Transition Report highlighted 
huge gaps in transitional care evidence-base – including the lack of a clear definition of transition, 
lack of evidence for effective transition tools, and challenges with integration of data from systems 
built separately for adults and children[54].  
 
1c. Rationale 
As many HIV-infected children on ART survive to adulthood in sub-Saharan Africa, improving 
systems for disclosure and transition to adult care is a high priority. There is need for better data 
on transition in high volume HIV clinics in Africa, and these clinics require feasible,effective 
systematic approaches to improve disclosure and transition. A disclosure tool used in Namibia 
demonstrates effectiveness and acceptability and could be adapted for use in other settings. In 
addition, the Got Transition model, which was developed following broad expert consensus and 
programmatic evaluation in US settings, has a clear framework and useful resources relevant to 
pediatric HIV transition in Africa. Combining these interventions using an implementation science 

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approach (program evaluation, adaptation and a cluster RCT) has potential to provide high quality 
evidence for broader use of these approaches and to improve long-term outcomes for 
adolescents with HIV. 
 
SECTION 2: OBJECTIVES 
2a. Study Objective 
This study aims to evaluate rates and co-factors of effective transition in HIV treatment programs 
in Kenya and to adapt, implement, and evaluate an Adolescent Transition Package (ATP) that 
combines an adapted US-based transition tool and a disclosure tool associated with improved 
disclosure outcomes in Namibia.  
2b. Specific Objectives 
Aim 1: To use programmatic data (KenyaEMR and paper files) to estimate prevalence of 
transition and disclosure, age at transition and disclosure, and individual-level co-factors 
of effective transition from pediatric to adult HIV care and retention and HIV disclosure 
among 10-24 year olds. To determine transition practices in Kenyan clinics using a facility 
survey.                                           
Effective transition will be defined as enrollment into adult care within 6 months of exiting the 
pediatric care and continued clinical follow-up for at least 6 months thereafter, as evidenced by a 
second clinic visit recorded in the EMR.  
Hypothesis: Transition will occur at varied ages (median 18 years); effective transition and earlier 
transition age will be associated with the presence of a transition plan and adolescent friendly 
services at the facility, later age at child HIV diagnosis, earlier age of HIV disclosure, parent on 
ART, better health status of the child at enrollment into HIV care and at transfer (CD4, WHO stage, 
viral load), pregnancy or marital status of the adolescent, and evidence of consistent adherence 
and retention prior to transition.  
Approach: We will perform a retrospective records review from a randomly drawn sample of 
clinics with electronic medical record (EMR) systems in place to determine current health indicator 
outcomes in adolescents. All adolescent health data for this objective will be obtained from 
existing medical record data, including EMR data, paper records, and the adolescent checklist. 
Concurrent with data abstraction, we will conduct facility surveys to determine pediatric clinic 
model (separate days or integrated), presence and type of transition planning approach, 
recommended age for transition, and available adolescent and transition services. 
Secondary Analysis: To determine baseline rates and correlates of other key health indicators 
for adolescents with HIV, including viral suppression, CD4 count, ARV regimens and switch to 
second line therapy, adherence, and other sociodemographic, physical and mental health 
information captured in existing medical records. Information from this secondary analysis can 
help inform other factors delaying or influencing disclosure and transition readiness and 
occurrence. 
Aim 
2: 
To 
adapt 
and 
optimize 
a 
transition 
tool 
(Got 
Transition; 
http://www.gottransition.org/) developed in the US, for use Kenyan HIV clinics based on 
adolescent, caregiver, HCW, clinic and country administrator, and policy maker 
perspectives.  
Hypothesis: The US ‘Got Transition’ tool will be adaptable and relevant for pediatric HIV transition 
in Kenya.  
Approach: We will conduct semi-structured focus group discussions with adolescents and  

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caregivers and individual interviews with HCWs, facility administrators and policy makers to 
understand experiences, challenges and potential solutions for transition and use this information 
to adapt and refine the transition tool. We will hold a working group meeting with purposively 
selected HCWs to further adapt the transition tool.  
Aim 3: To evaluate the Adolescent Transition Package (ATP) in a cluster randomized trial 
of 20 clinics (10 with ATP and 10 with Standard of Care (SOC) processes). The Adolescent 
Transition Package (ATP) will contain a validated disclosure tool and the optimized transition tool 
from Aim 2. 
Hypothesis: The ATP will increase proportion of children and younger adolescents with 
disclosure, will result in earlier disclosure, will increase proportion of older youth ready to transition 
to adult care and improve satisfaction with transition.  
Approach: We will randomize 20 clinics to receive the ATP or no intervention (SOC) and compare 
disclosure and appropriate transition using pre-specified milestones among a group of children 
and adolescents with heterogeneous ages. During early implementation, we will monitor fidelity 
to the intervention using modified plan-do-study-act (PDSA) cycles. We will track implementation 
outcomes and factors influencing implementation during the initial ATP implementation phase (6 
months). During this time, the study team will discuss and support changes to refine the tool as 
needed at each facility. Following the initial implementation period, HCWs will take part in focus 
group discussions to share their suggestions for optimizing the transition tool based on their 
experience. Understanding personal experiences with the tool will provide an opportunity for 
lessons learned and continued refinement of the intervention. At the end of the study, we will 
qualitatively evaluate acceptability, appropriateness and feasibility of the ATP by conducting 
interviews and FGDs with all HCWs from implementing sites and adolescents from a sub-set of 
intervention sites, purposively selecting to include participants from high and low performing 
facilities. We will also conduct pre-trial and post-trial surveys with adolescents and HCWs to 
quantitatively assess acceptability, appropriateness, feasibility of the ATP and implementation 
intervention fidelity.  At 6-monthly intervals, we will collect readiness assessment information from 
adolescents in participating clinics.  
 
SECTION 3: STUDY OUTCOMES 
Aim 1  
• 
Prevalence of transition  
• 
Age at transition 
• 
Co-factors for retention  
• 
Age at disclosure 
• 
Co-factors of disclosure  
• 
Individual level co-factors of effective transition 
• 
Facility level co-factors of effective transition  
 
Aim 2  
• 
Adapted transition tool 
 
Aim 3  
• 
The primary outcome is disclosure among non-disclosed adolescents and effective 
transition and transition readiness among disclosed adolescents  

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o Disclosure will be defined as no, partial or complete disclosure. Time to disclosure and 
age at disclosure will also be assessed.  
o Effective transition with retention in care will be defined as completing a visit on the 
adult day or completing a visit without a caregiver and repeat visits continuing for at 
least 6 months after transition.  
o Transition readiness will be defined as change in response to readiness assessment 
questions administered every 6 months  
o We will also evaluate other key behavioral indicators of transition identified in 
AIM 2 as being associated with successful transition and included in transition 
study tools such as clinic attendance without a caregiver present, complete 
comprehension of ARVs and importance of adherence, and knowledge of and 
future plan for HIV management. Time to and age at effective transition will 
also be assessed.  
The intervention period is not long enough to observe all adolescents passing from disclosure to 
effective transition; however, the use of milestone-specific outcomes among a group of 
adolescents within a heterogeneous stage of transition allows assessment of the full transition 
process. Adolescents will be observed during the portion of the transition process that they 
undergo, and milestone-specific achievement within their transition stage will be assessed. For 
example, an adolescent who is undisclosed at the beginning of the study will be assessed for 
whether they have completed no, partial, or full disclosure by the end of the study. Fully disclosed 
adolescents will be assessed for their progression to independent care within the adult system. 
The specific indicators for progressing beyond disclosure will be based on the adaptation of the 
Got Transition tool in aim 2. The first 6 months of the intervention will be considered a “catch up” 
period; while outcomes will be compared during the full study period, a sub-group analysis is 
planned for the first 6 months to see if the effect of the intervention is greater during the “catch-
up” period.  
• 
Secondary outcomes 
o Overall viral suppression  
o Overall retention  
o HCW and adolescent satisfaction with the transition process 
o Selected cost measures to be used in future cost-modeling  
o Age at and time to reaching transition specific-milestones 
o Acceptability and feasibility of the intervention 
o Intervention adaptation and fidelity to intervention implementation 
o Penetration and adoption of the ATP during implementation 
 
Table 1 summaries the outcomes, metrics and data sources for Aim 3.   
Table 1: Outcome, metric and data source  
 
Analysis Type 
Group  
Outcomes  
Outcome metric * 
Data source  
 
Quantitative 
Non-disclosed 
adolescents 
Disclosure 
Disclosure 
readiness 
Disclosure 
readiness 
assessment 

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Proportion initiated 
disclosure 
intervention 
Disclosure 
checklist 
Proportion reached 
complete 
disclosure 
Age at and time to 
disclosure 
Satisfaction with 
disclosure  
Post-trial 
surveys  
 
Quantitative 
 
Disclosed 
adolescents 
 
Transition and 
readiness 
Change in 
transition 
readiness over 
time  
Transition 
readiness 
assessment  
Proportion of 
adolescents who 
initiate and exit 
pediatric care 
Transition 
checklist 
Proportion with 
effective transition  
Age at and time to 
transition  
Satisfaction with 
transition 
Post-trial 
surveys 
Qualitative and 
Quantitative 
Adolescents 
and HCWs 
ATP 
Implementation 
Acceptability of 
ATP 
In-depth 
interviews, 
FGDs, and pre, 
during and 
post-trial 
surveys 
Feasibility of ATP 
Appropriateness of 
ATP 
Intervention 
Adaptation and 
Fidelity 
Penetration and 
Adoption of the 
ATP 
 
 
 
 
 
 
*Additional transition process indicators and data sources will be included after the 
adaptation of the transition tool. For example we will identify specific outcomes from the 
adapted tools to track the transition process before full transition occurs.  
 
SECTION 4: STUDY DESIGN 
 
Design Overview: We will use mixed methods approach to describe current processes, adapt 
intervention tools and implement a package of tools for adolescent transition to adult care. Our 
methods include 3 distinct processes over formative and evaluative phases (Figure 1a):  

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Formative phase: 
1) A retrospective records review of adolescent HIV outcomes and health facility surveys 
assessing current transition practices and gaps 
2) Policy maker, hospital and county administrator, HCW, caregiver and adolescent 
interviews and focus groups, and a HCW working group meeting to develop, adapt, and 
refine the transition tool 
Evaluative phase: 
3) A cluster RCT to evaluate effectiveness, acceptability, appropriateness, feasibility, and 
intervention fidelity of the ATP intervention.  
 
Figure 1a: Study design overview  
 
 
Aim 1: 
Retrospective Records Review: This retrospective records review will utilize routine clinic program 
data, including the Adolescent package of Services (APS) checklist, recently rolled out in Kenya, 
when available, to assess adolescent HIV health outcomes related to transition for up to 15000 
adolescents enrolled in HIV care at participating facilities. We will determine rates and correlates 
of important transition outcomes in HIV-infected adolescents.  
 
Facility Surveys: A survey will be administered to a facility manager or his/her designee in 102 
HIV clinics selected among a random sample of all clinics with EMR systems in place. We will 
include a mixture of small, medium and large clinics. 
 
Aim 2: 
Adaptation Interviews and focus groups: We will conduct 8 focus group discussions with 
caregivers of HIV-infected adolescents, 16 focus group discussions with adolescents and youth, 
38 IDIs with HCWs from 6-10 clinics participating in the facility survey and 30 IDIs with hospital 
administrators or policy makers at national and county level. Clinic sites will be purposively 
selected from among those included in the facility survey (Aim 1). We will use stratified purposive 
sampling to recruit adolescents and caregivers of adolescents to capture adolescents who have 
and have not yet transitioned to adult care. We will use purposive sampling to include clinics with 
varying models of providing care for youth, including models where the same providers care for 
adults and youth, and models where different providers care for adults and youth. We will use 
information from the facility survey to identify different care models. We will use purposive 

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sampling to recruit HCWs, policy makers and hospital administrators who can speak most 
knowledgably about adolescent HIV care. HCWs will also be recruited to include representation 
from clinics with different models of care. Interviews will be conducted with policy makers, HCWs 
and hospital administrators to accommodate busy schedules and ensure participation. We will 
purposively select policy-makers involved in assisting with development or implementation of 
adolescent HIV care and treatment policies in Kenya. Interviews can provide rich data about 
personal experiences and rationale informing decision-making. Focus group discussion can 
provide important information on the range of experiences and beliefs in thinking about a topic 
and group discussion can help stimulate thinking by other group members. Focus group 
discussions with adolescents and their caregivers will provide information on experiences 
receiving HIV care for the adolescent and opinions on support and strategies for transition.  
 
Working Group Meeting: We will host a 2 day working group meeting with a purposively selected 
group of an estimated 40 HCWs and policy makers to inform the adaptation of the Got Transition 
tool. We will present analyzed interview data to HCWs and use a targeted agenda to adapt tools 
for use in Kenyan clinics, ensuring adapted tools incorporate the views of all stakeholders. 
Selected HCWs will have expertise in caring for HIV-infected adolescents in varied settings 
throughout Kenya. 
 
Aim 3 
We will conduct a cluster RCT to evaluate a combined disclosure intervention and adapted 
transition tool (ATP) to increase disclosure among young adolescents and improve effective 
transition to adult care for pediatric patients. Cluster RCTs are well-suited to interventions that 
occur at the clinic, rather than individual level. The randomization at a clinic level allows for the 
traditional benefits of randomization. We will include a total of 20 clinics in the RCT, 10 receiving 
standard of care and 10 receiving the intervention and compare disclosure and transition 
outcomes between the 2 arms. We will periodically abstract routinely collected medical record 
information to determine proportions of adolescents with full disclosure and transitioned to adult 
care in addition to routinely extracting data from study data collection tools. We will conduct pre-
study baseline surveys with adolescents and HCWs. We will also monitor initial implementation 
using modified plan-do-study-act cycles and surveys and FGDs with implementing HCWs. At the 
end of the study, we will conduct qualitative interviews and focus groups with adolescents and 
HCWs in the intervention sites, including 10 study nurses implementing trial procedures, and post-
study surveys with adolescents and HCW to assess acceptability, appropriateness, feasibility, and 
intervention fidelity of the tools. Throughout the study, at 6-monthly intervals, we will collect 
readiness assessment data from caregivers of children and young adolescents preparing for 
disclosure, and adolescents and young adults ages 10-24 who have attained full disclosure.  
 
SECTION 5: STUDY SITES AND POPULATIONS 
5a. Study sites 
Aim 1: We will perform facility surveys and abstract routinely collected programmatic data at 
102 clinics in Kenya utilizing EMR systems. Clinics will be randomly selected from among clinics 
with EMR.  
 
Aim 2: We will recruit HCWs from clinics throughout Kenya for the working group meeting. We 
will select caregivers of HIV-infected adolescents, HIV-infected adolescents, and HCWs from 
KNH and 6-10 facilities participating in AIM 1 for individual interviews and focus groups. We will 

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invite policy makers from national and county level institutions and hospital administrators from 
facilities participating in Aim 1.  
 
Aim 3: We will enroll 20 clinics located in Nairobi, Homabay, Kajiado and Nakuru counties.  
Adolescents and HCWs in intervention sites will participate in post-trial interviews, HCWs from 
intervention sites will participate in pre and post-trial surveys, PDSA cycles and FGDs, and a 
sample of adolescents in all sites will participate in pre and post-trial surveys. Caregivers of 
children and young adults who have not yet reached disclosure, as well as fully disclosed 
adolescents and young adults, will also participate in 6-monthly readiness assessment surveys.  
 
5b. Study population 
AIM 1:  
Facility Survey: Stratified random sampling will be used to select up to 102 clinics based on 
clinic volume. The sampling frame of all national facilities currently using EMR will be utilized in 
this approach. We will exclude clinics with less than 300 patients in HIV care, given that the 
number of adolescents attending the clinic would be small and hard to evaluate, and divide the 
remaining clinics equally into tertiles. The tertiles will represent the small, medium, and large 
clinic sizes. Within each stratum, the clinics will be chosen using equal probability sampling and 
we will select 34 clinics per stratum. One or two designees per facility will be enrolled to 
complete the facility survey.  
 
Retrospective Records Review: The study will include extraction of routinely collected health 
records of up to 15,000 adolescents aged 10-24, currently engaged in HIV care in Kenya and 
attending the facilities included in the facility survey.   
 
AIM 2:  
Adaptation Interviews (Table 2): We will conduct 16 focus group discussions with HIV infected 
adolescents aged 14-24 years, 8 focus group discussions with caregivers of HIV infected 
adolescents aged 14-24 years, 38 interviews with HCWs providing pediatric and adolescent HIV 
care, and 30 hospital administrators and policy makers identified by national and local health 
administration offices. We will recruit adolescents, primary caregivers and HCWs from KNH and 
6-10 facilities that participated in Aim 1. 
 
Working Group Meeting: For this aim of the study, we will enroll approximately 40 HCWs from 
clinics throughout Kenya providing HIV care for adolescents.  

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Table 2: Purposive sampling scheme and data collection details for Aim 2 
 
AIM 3:  
We will enroll 20 facilities to participate in the cluster RCT. The intervention will involve working 
with and training HCWs at selected facilities and abstracting routinely collected programmatic 
data for HIV-infected children, adolescents and young adults aged 6-24 years attending the 
selected clinics (Table 3). We will also routinely abstract data from intervention tools being used 
at the facilities. We anticipate including up to 200 HCWs per intervention arm in the HCW 
training and intervention implementation and up to 2000 adolescents per arm. We will also 
enroll 400 adolescents and 200 HCWs to complete pre-trial surveys and 400 adolescents and 
200 HCWs to complete post-trial surveys. HCWs from implementing sites will also participate in 
repeated surveys and planning meetings twice per month during the first 6 months of 
implementation of the ATP. We will conduct semi-structured interviews with up to 96 adolescents 
and 60 HCWs from all clinics included in the intervention arm of the trial. We will also complete 
FGDs with all HCWs from implementing facilities at 6 months into and at the end of the trial. At 
6-monthly intervals, we will collect readiness assessment data from caregivers of children and 
adolescents who have not yet reached full disclosure, and adolescents and young adults ages 
10-24 years who have attained full disclosure. 
Working Group to 
ADAPT/REIVSE
Same 
providers; 
same 
day/clinic
Same 
providers; 
different 
day/clinic
Different 
providers; 
different 
day/clinic
Same 
providers; 
same 
day/clinic
Same 
providers; 
different 
day/clinic
Different 
providers; 
different 
day/clinic
Yes  
N/A
2 FGDs 
(5-6 
adolescents 
in each)
2 FGDs 
(5-6 
adolescents 
in each)
Yes  
6 IDIs
6 IDIs
10 IDIs
No 
N/A
2 FGDs 
(5-6 
adolescents 
in each)
2 FGDs 
(5-6 
adolescents 
in each)
No 
N/A
6 IDIs
10 IDIs
Same 
providers; 
same 
day/clinic
Same 
providers; 
different 
day/clinic
Different 
providers; 
different 
day/clinic
Same 
providers; 
same 
day/clinic
Same 
providers; 
different 
day/clinic
Different 
providers; 
different 
day/clinic
Yes  
N/A
2 FGDs 
(5-6 
adolescents 
in each)
2 FGDs 
(5-6 
adolescents 
in each)
Yes  
N/A
2 FGDs 
(5-6 
caregivers 
in each)
2 FGDs 
(5-6 
caregivers 
in each)
No 
N/A
2 FGDs 
(5-6 
adolescents 
in each)
2 FGDs 
(5-6 
adolescents 
in each)
No 
N/A
2 FGDs 
(5-6 
caregivers 
in each)
2 FGDs 
(5-6 
caregivers 
in each)
Focus Groups and Interviews to DEVELOP
Clinic Design
Already Transitioned HIV-Infected Adolescents: 
Ages 16-24 years 
(N=48 adolescents)
Sampling 
Categories
Transition 
Tools
Healthcare Workers 
(N=38 healthcare workers)
Sampling 
Categories
Clinic Design
Transition 
Tools
Policy-makers & 
Administrators 
Disclosed but Not Transitioned HIV-Infected Adolescents: 
Ages 14-19 years
(N=48 adolescents)
Sampling 
Categories
Clinic Design
Transition 
Tools
Caregivers of HIV-Infected Adolescents: 
Ages 14-24 years
(N=48 caregivers)
Sampling 
Categories
Clinic Design
Transition 
Tools
National and 
County Ministry of 
Health 
representatives, 
Facility 
administrators
Healthcare 
workers
2-day workshop 
with experienced 
HCWs and policy 
makers involved in
HIV treatment and 
care provision
N = 40
N = 30

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Program data abstraction: We will abstract program level data at baseline, and throughout the 
RCT to assess outcomes. Table 3 summarizes enrollment characteristics and data collection 
tools in the RCT arms.  
Table 3: Details of cluster RCT design, enrollment and data collection 
 
Control arm  
Intervention arm  
Required Facility 
Characteristic 
>300 clients in HIV care  
>300 clients in HIV care  
Estimated number of clients 
aged 6-24 per clinic 
50-500 
50-500 
Minimum number of clients 
aged 6-24 per RCT arm 
2000 
2000 
Procedures  
Standard clinic procedures  
Adolescent transition package  
Disclosure checklist  
√ 
 
√ 
 
Transition checklist  
√ 
 
√ 
Process indicators  
- 
 
Disclosure milestones 
Transition milestones  
HCW, caregiver and client 
satisfaction  
Maximum number of 
adolescents completing pre-
trial surveys 
200 
200 
Maximum number of HCWs 
completing pre-trial surveys 
 
200 
Maximum number of HCWs 
participating in repeated 
surveys and planning meetings 
 
200 
Maximum number of HCWs 
participating FGDs at 6 months 
 
200 
Maximum number of 
adolescents completing 
transition readiness 
assessment form 
2000 
2000 
Maximum number of children 
completing disclosure 
readiness assessment form 
 
1000 
Maximum number of 
adolescents completing post-
trial surveys 
200 
200 
Maximum number of HCWs 
completing post-trial surveys 
- 
200 
Adolescents completing IDIs 
- 
96 
HCWs completing post-trial 
IDIs 
- 
60 
HCWs completing post-trial 
FGDs 
 
200 

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Maximum  number of HCWs 
completing IDIs for cost 
estimation and time and 
motion observation 
 
60 
 
Justification for involvement of adolescents:  In sub-Saharan Africa, HIV-infected adolescents 
are at high risk of loss to follow-up and poor adherence resulting to poor outcomes. The purpose 
of this research is to improve adolescent HIV disclosure processes and transition to adult care, 
therefore improving retention in care and morbidity and mortality outcomes in HIV-infected 
adolescents. Collection of data about adolescents and from adolescents is necessary to 
determine the effectiveness of this intervention aimed at improving adolescent HIV care. 
 
5c. Participant inclusion criteria 
To be eligible for this study, an individual or clinic must meet the criteria listed in Table 4 below. 
Additional details related to participant inclusion are outlined below. 
Aim 1:  
To participate in Aim 1, facility leadership must be willing to serve as a study site. Clinics selected 
for Aim 1 must have an EMR system in place and be above 300 total patients in HIV care at the 
site. HCW designees completing facility surveys must be ≥18 years of age, employed at the facility 
for ≥1 year, and involved in adolescent or pediatric HIV care. Adolescent data that will be 
abstracted from routinely collected medical records will include information on adolescent medical 
care and demographic information for all adolescents ages 10-24 attending facilities included in 
the facility survey.  
Aim 2:  
Adolescents participating in focus group discussions must be aged 14-24 years old and must 
know that they are HIV positive and have attended HIV care for at least 1 year. Caregivers 
participating in focus group discussions must be ≥18 years of age and the primary caregiver of 
an adolescent ages 14-24 years old. HCWs participating in interviews should be employed at trial 
sites for at least 6 months prior to the interview date and provide clinical or counselling services 
to HIV-infected adolescents. Policy makers must be ≥18 years of age and employed at the 
national, county or HIV implementing partner (NGOs or Universities) organization in a policy 
making role. Hospital administrators must be ≥18 years of age and serve at an administrative and 
local policy making level within facilities.  
Aim 3:  
To participate in the RCT, facility leadership must be willing to implement the intervention. Clinics 
already actively using transition or disclosure tools will be excluded. Child and adolescent records 
will be abstracted for all 6-24 year olds enrolled in HIV care at participating facilities. In addition, 
every 6 months, we will collect readiness assessment data from adolescents and young adults 
up to the age of 24 years who have attained full disclosure and caregivers of children and 
adolescents who have not yet reached full disclosure. Adolescents and/or caregivers will give 
consent and/or assent to participate in readiness assessments.  HCWs who complete interviews, 
focus groups or surveys must be ≥18 years of age and employed at trial sites or by the ATTACH 
study during the intervention period and providing clinical services or performing study activities 
with adolescents. Adolescents who complete the interviews must be ≥18 years or must have 
caregiver consent to participate if less than 18 years. Adolescents who participate in interviews 
must know their HIV status. Adolescents who complete the pre-trial and post-trial surveys must 

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give oral consent or assent for participation, and be between the ages of 12 and 24 years of age 
and know their HIV status.  
5d. Site/participant exclusion criteria 
Facilities will be excluded if they do not meet inclusion criteria. A facility may also be excluded if 
anything would prevent the complete conduct of the intervention at that site and/or the collection 
of outcome measures. An example of this would be if a separate transition intervention was being 
developed at the site concurrent to our study. 
An individual who meets any of the following criteria will be excluded from participation in this 
study: Conditions that would place the individual at increased risk or preclude the individual’s full 
compliance with or completion of the study.  
 
 

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Table 4. Inclusion Criteria for all participants/clinics  
 
Population 
Sampling 
N 
Inclusion Criteria 
AIM 1: Program data abstraction  
Facility Survey 
Site 
HIV care 
clinics 
Selected randomly 
from clinics with EMR 
systems in place and 
>300 patients in HIV 
care 
102 
EMR system in place 
>300 patients in HIV care 
Facility Survey 
Designee 
HCW 
Selected as 
representative for 
clinic to complete 
facility survey; will 
enroll 1-2 HCWs to 
help complete the 
survey per study site 
102 sites 
≥18 years of age 
 
Employed at facility in clinical care 
for at least 6 months and/or have a 
1 year contract (i.e. not temporary 
staff) 
 
Provides clinical services to 
adolescents 
Retrospective 
Records Review 
Adolescents 
ages 10-24 
All adolescents from 
the 102 selected 
facilities 
Up to 15,000 
-Aged 10-24 years of age 
-Attended clinic ≥1 time after 
January 1, 2016 
-Attended clinic included in facility 
survey 
Aim 2: ADAPT and OPTIMIZE  
Working Group  
HCWs   
Purposively selected 
from HCWs providing 
adolescent care  
 
40 for 
Working 
Group 
 
 
-≥18 years of age 
-Employed at clinic in Kenya 
-Employed in clinical care for at 
least 6 months and/or have a 1 year 
contract (i.e. not temporary staff) 
-Provides clinical services to 
adolescents 
Adaptation IDI and 
FGDs 
Adolescents 
(aged 14-24 
years) 
Adolescents in HIV 
care (8 FGDs for 
adolescents who 
have not completed 
transition, 8 FGDs for 
adolescents who 
have completed 
transition) 
16 FGDs and 
96 
adolescents 
total (from 
clinics with 
different 
models of 
care ) 
-Ages 14-24 
-Seeking treatment services at 
facilities assessed in Aim 1 
-Knows that they have HIV  
-Attended clinic for at least 1 year 
Caregivers of 
HIV-infected 
adolescents 
aged 14-24 
years 
Caregivers of 
adolescents who 
have and have not 
completed transition 
8 FGDs and 
48 caregivers 
total (from 
clinics with 
different 
models of 
care ) 
-≥18 years of age 
-Seeking treatment services at 
facilities assessed in Aim 1 
-Caregiver of adolescent age 14-24 
years seeking treatment at selected 
site 
-Adolescent has attended clinics for 
at least 1 year 

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HCWs  
Interviews with HCWs 
involved in 
pediatric/adolescent 
HIV care 
38 (selected 
from clinics 
with different 
models of 
care)  
≥18 years of age 
 
-Provide clinical services to HIV-
infected children and adolescents 
-Employed at facility in clinical care 
for at least 6 months and/or have a 
1 year contract (i.e. not temporary 
staff) 
Policy maker 
and 
administrator 
heads  
Policy makers at 
National and County 
level and HIV care 
partners or 
administrator head at 
facilities offering HIV 
care  
30 interviews 
≥18 years of age 
-Employed by Ministry of Health at 
National or County level or a HIV 
care partner, at a level that involves 
policy making or in an administrative 
position at facilities offering HIV care  
Aim 3: RCT 
Cluster RCT 
Clinic clusters  
Selected from clinics 
with >500 clients in 
care 
20 clinics 
-≥50 adolescents currently in HIV 
care 
-EMR data system  
-Facility leadership willing to take up 
intervention at their sites  
-Not actively already using transition 
or disclosure tools  
Facility Survey 
Designee 
HCW 
Selected as 
representative for 
clinic to complete 
facility survey; will 
enroll 1-2 HCWs to 
help complete the 
survey per study site 
20 clinics; 
surveys 
completed at 
baseline and 
study end 
≥18 years of age 
 
Employed at facility in clinical care 
for at least 6 months and/or have a 
1 year contract (i.e. not temporary 
staff) 
 
Provides clinical services to 
adolescents 
Pre-trial surveys 
 
Adolescent  
Selected from 
intervention and 
control sites  
400 surveys  
- Between 12 and 24 years of age 
-Willing to complete anonymous 
survey  
- Knows HIV status 
HCW 
Selected from 
intervention sites 
200 surveys 
-≥18 years of age 
-Working in intervention clinics 
during the intervention 
-Providing adolescent HIV care   
Intervention 
Implementation 
Monitoring 
 
HCW  
 
Selected from 
intervention sites 
 
Repeated 
surveys every 
2 weeks 
-≥18 years of age 
-Working in intervention clinics 
during the first 6 months of 
intervention implementation 
-Providing adolescent HIV care   
Repeated 
planning 
sessions 
every 2 
weeks 
-≥18 years of age 
-Working in intervention clinics 
during the first 6 months of 
intervention implementation 
-Providing adolescent HIV care   
10 FGDs 
(1/intervention 
facility) 
-≥18 years of age 
-Working in intervention clinics 
during the first 6 months of 
intervention implementation 
-Providing adolescent HIV care   

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Post-trial IDIs and 
FGDs  
 
Adolescents 
who have 
completed 
disclosure 
process  
Up to 16 selected 
from intervention sites  
16 (from a 
subset of 
clinics 
reporting use 
of disclosure 
tools)  
-Attained full HIV disclosure during 
the intervention period or recently 
(<24 months) disclosed to 
-Between 14 and 24 years of age  
Adolescents 
who were 
exposed to the 
intervention 
6-10 selected from 
each intervention site  
80 (from all 
intervention 
clinics) 
-Exposed to the intervention during 
the intervention period  
-Between 14 and 24 years of age 
HCW  
 
5-10 HCW selected 
from each selected 
intervention site  
60 IDI  (from 
all 
intervention 
clinics) 
-≥18 years of age 
-Working in intervention clinics or on 
the ATTACH study during the 
intervention 
-Providing adolescent HIV care   
All HCWs from 
intervention sites 
10 FGDs 
(1/facility) 
-≥18 years of age 
-Working in intervention clinics 
during the intervention 
-Providing adolescent HIV care   
Post-trial surveys  
Adolescent  
Selected from 
intervention and 
control sites  
400 surveys  
- Between 12 and 24 years of age 
-Willing to complete anonymous 
survey  
- Knows HIV status 
HCW 
Selected from 
intervention sites  
200 
-≥18 years of age 
-Working in intervention clinics for at 
least 6 months during the 
intervention 
-Providing adolescent HIV care   
Transition 
Readiness 
assessment 
surveys 
Adolescents 
ages 10-24 
years 
Selected from all 20 
selected facilities 
Up to 4000 
(2000 per 
arm) 
-Aged 10-24 years of age 
-Willing to complete survey  
- Knows HIV status 
Disclosure 
Readiness 
assessment 
surveys 
Caregivers of 
children or 
adolescents 
ages 6-17 who 
do not know 
their HIV 
status 
Selected from 
intervention facilities 
Up to 1000  
-≥18 years of age 
-Caregiver of adolescent aged 6-18 
who does not yet know their HIV 
status 
-Willing to complete survey 
Retrospective 
Records Review 
Adolescents 
ages 10-24 
All adolescents from 
the 20 selected 
facilities 
Up to 4000 
(2000 per 
arm) 
-Aged 6-24 years of age 
-Attended clinic ≥1 time during the 
RCT timeline 
 
5e. Randomization procedures 
For the RCT, 20 clinics will be randomized to receive the ATP intervention or no intervention 
(SOC). Depending on the heterogeneity of baseline facility factors, restricted randomization may 
be used to ensure an equal distribution of potentially confounding factors. Dr. Richardson 
(Biostatistician) will generate the randomization assignment.  

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5f. Masking procedures 
Because this is a clinic-level intervention using a pragmatic trial design, there will be no masking 
procedures.  
5g. Participant Withdrawal 
Participants or clinics may withdraw from the study at any time or the investigator may terminate 
a participant’s or clinic’s participation. 
Reasons for withdrawal 
Reasons for a study clinic to withdraw may include: clinic closure or major changes in HIV care 
policies, procedures, or organizational structures that would prevent or substantially limit our 
ability to conduct this study.  
 
Reasons for HCW, policy maker or hospital administrator participant withdrawal may include: 
discomfort or distress during the focus group discussion, interview, lack of time to participate, or 
job termination or relocation. 
   
Reasons for an adolescent participant or caregiver not to complete the in-depth interviews or 
focus group discussions may include, lack of time, discomfort, or disinterest in answering the 
questions. 
 
An investigator may terminate a participants’ or clinic involvement in the study if any medical 
condition or situation occurs such that continued participation in the study would not be in the 
best interest of the participant or clinic.  
 
Handling of participant withdrawals   
 
The study team will track the withdrawal of any clinic or participant during the trial. The timing 
and reasons for withdrawal will be recorded, and reported to the PI. HCW participants may 
withdraw at any time without affecting their regular job. Adolescent and caregiver participants 
may withdraw at any time without affecting their access to services at the clinic. The study team 
will record the timing and reasons for withdrawal of individual adolescent, caregiver or HCW 
participants. The participant will be thanked for their time in the study and not contacted further 
by the study team.  
 
 

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SECTION 6: STUDY INTERVENTION  
The Adolescent Transition Package (ATP) will include two components. The validated Namibia 
comic book for disclosure (to be used with children over 6 years of age) and an adapted US 
transition toolkit (“Got Transition”). 
The disclosure tool includes a cartoon book, readiness and tracking tools used in clinic and a 
HCW training. The intervention progresses from incomplete to complete disclosure using a 
narrative about soldiers fighting the battle of infection as the rationale for taking medicine. This 
tool has been validated for use in Namibia.  
The Got Transition model is based on health care perspectives of adolescents, caregivers, and 
providers and program evaluations in the US. It has 6 core elements that were iteratively 
developed and offer a standardized approach that can be used in varied settings (Table 5). The 
Core Elements address inter-related health systems components relevant to diverse HIV 
programs in Kenya. The Transition tools for the ATP include a transition flipchart, readiness 
assessment, and transition progress tracking tool. In addition, the study team will develop training 
materials to support the implementation of the transition tools.  
Table 5: Core elements of the Got Transition Program 
 
 
 
 
 
 
 
The validated Namibia booklet and the Got Transition tool can be found in the appendices.   
Each clinic team in the intervention sites will implement the tools guided by the study team with 
twice-monthly check-ins and evaluation. The twice-monthly check-ins will use modified PDSA 
cycle materials to facilitate feedback and adaptations to optimize ATP implementation.  
The study will aim to optimize implementation of ATP over a 6-month period at each intervention 
site with continued clinic support throughout the course of implementation and measure the effect 
of the well-implemented ATP on transition outcomes over a 2-year period. 
 
 

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SECTION 7: STUDY PROCEDURES   
 
COVID-19 ADAPTED STUDY PROCEDURES 
As a result of the COVID-19 pandemic and resultant changes to visit schedules and client 
contact time, we propose the following changes to study procedures during the pandemic 
period:  
 
The transition intervention will be delivered either in person or on phone by clinic based health 
care workers where possible, or by phone by hired study staff. Delivery will be guided by current 
recommendations and guidelines from the Kenyan MOH regarding care for adolescents living 
with HIV and country mandates.   
 
Transition readiness assessments will be conducted through phone interview rather than in 
person. These were already conducted by study staff, and will continue to be conducted by the 
same hired study staff.  
 
Enrolled participants will give oral consent by phone (using the phone interview guide) to 
continue with transition readiness assessments by phone. This will be obtained and 
documented by study staff. Study link logs will be converted to electronic logs with password 
protection and accessible only to study staff to limit visits to the clinic by study staff. 
 
Enrolled participants in intervention and control sites will receive phone calls from study staff to 
see how they are coping, adhering to treatment and receive COVID-19 related information.  
 
Participants will be reimbursed via mobile money transfer for the 6 monthly transition readiness 
assessments.  
 
All new enrollment is suspended, but may be reopened when identified as safe and clinical 
procedures for adolescents living with HIV are returned to normal in the country. 
 
In-person disclosure related study activities are suspended; however, HCWs in facilities can use 
disclosure tools as needed to assist them with providing routine care for adolescents living with 
HIV and their primary caregivers.  
  
In-person continuous quality improvements (CQI) activities are suspended, phone based or 
other virtual CQI activities may resume if possible and may include multiple shorter check-in 
phone visits with individual, rather than groups, of healthcare providers, and will check in on 
healthcare providers well-being including how they are coping with COVID-19.  
 
FGDs scheduled to be held with HCWs after 6 months of intervention implementation will be 
postponed until it is deemed safe to meet in person or virtual delivery/hosting platforms have 
been identified and organized.  
 
When determined to be safe, and in accordance with MOH and country-specific 
guidelines, study procedures will return to those detailed below that involve in-person 
interactions. 

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Overview: 
Study procedures consist of:  
Aim 1: A programmatic data capture and facility survey describe phase aimed at identifying 
baseline rates of transition and HIV treatment and care outcomes, current HIV treatment and care 
procedures and policies, and barriers and facilitators to successful transition.  
Aim 2: An adapt phase aimed at adapting an adolescent transition tool. 
Aim 3: An RCT phase aimed at testing effectiveness of an adolescent transition package 
(consisting of a validated disclosure booklet and adapted transition tool), with simultaneous 
qualitative and quantitative evaluation of the intervention effectiveness and implementation 
context.  
7a. Programmatic data analysis and facility surveys 
Potential clinics will be identified by facility lists obtained from the Kenyan MOH. The MOH will 
provide the team with a list of clinics using EMR and the size of the patient population at each 
clinic. A random sample of clinics will be selected, based on clinic size, from among all potentially 
eligible clinics. Use of EMR will be confirmed for each potentially eligible clinic randomized for 
inclusion and new clinics will be substituted in for clinics lacking EMR. Eligible clinics will be 
recruited by the study team by sending letters to County health directors to request for access 
and a formal letter of support to enroll these clinics. After county-level approval, we will send 
letters to administrative teams of randomly selected clinics. The letter will have information on the 
objectives of the evaluation and will include a formal request for the clinic to be part of the 
evaluation. This will be sent with a letter of support from the respective County Health Director. 
Oral agreement to participate in this aspect of the study will be obtained from administrative 
authorities at health facilities of interest. 
 
Programmatic data analysis  
Recruitment and Enrollment 
For each clinic that agrees to participate, routine clinic data will be abstracted from the EMR 
system and from paper forms when EMR systems are not available. The medical records 
collected from the patient charts will include data tracking routine services offered and 
laboratory measurements collected. EMR or other medical record data will be abstracted 
directly from clinics or from implementing partners, whichever is most convenient for the clinic. If 
data staff at the partner organization or at the clinic are unable to extract the data on their own, 
hired technicians or study staff will travel to sites and assist with data abstraction directly. All 
medical records for adolescents ages 10-24 attending the clinic at least 1 time between January 
1, 2016 and the date of data abstraction (but not later than December 31, 2017) will be pulled. 
 
Data Collection Procedures: 
For EMR data, data will be extracted by running a standardized query of the EMR database. 
The query will pull serial records for all adolescents ages 10-24 years who have at least 1 visit 
on or following January 1, 2016 and attend a clinic selected to participate in the facility survey. 
This will include all data on each adolescent from January 1, 2016 up until the date when data is 
abstracted but not later than December 31, 2017. We will not obtain individual consent for 
pulling adolescent records from the EMR. We will obtain a waiver of consent to obtain this 
information. Data collected will obtain basic demographic and HIV-specific clinical care 
outcomes as detailed in the attached file listing variables to be collected. This information is 
already charted as part of routine care. For paper records, data will be abstracted using Case 

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Report Forms (CRFs) and Open Data Kit (ODK) or REDCap. We will abstract selected variables 
from the EMR and paper based records including: client age at enrollment, caregiver type, sex, 
date/age of HIV diagnosis, CD4 count or percent, date of ART initiation, attendance at pediatric 
or adult clinic day (data obtained from facility survey and calculated by visit dates), and 
presence of caregiver at the visit (in EMR counseling notes). Serial data will be obtained on 
follow-up at the clinic. A list of variables that will be collected is attached.  
 
Patient data collected will contain health facility code, unique patient number (numeric code used 
in CCCs), sex, DOB, and other attributes. Once collected, we will remove patient IDs from all data 
and replace them with our own unique patient identifiers. Once all data from a facility is collected, 
we will not save the original data files with patient identifiers. Data will be handed to the team via 
encrypted hard drives and flash drives or securely through approved online data storage systems 
(One Drive for Business, Catalyst). Because the data was originally collected for the primary 
purpose of patient care, and the study is using the data in a secondary manner, we will not seek 
permission from the individual patients to use the data. Instead, we will request a waiver of 
consent from KNH ERC and UW IRBs for the use of this data.  
 
Once obtained, the study team will follow UW-recommended procedures for transmission, 
storage, and access to data files. In alignment with these procedures, data will be stored on a 
password protected computer and secure website and data will be backed up daily to a password 
protected external hard disk located in the study data office. Backing up to a local external hard 
drive will enable rapid restoration of files in case of computer malfunction, and backing up to the 
external website will ensure safety of the data in case of fire/theft at the study data office.   
 
Facility surveys 
Recruitment and enrollment:  
For the health facility survey, we will ask the facility manager at each facility to identify an 
appropriate person to participate in a facility survey. We will either call or visit eligible health 
facilities to make this request. The participant will be either the facility manager or a designee 
identified by the facility manager (such as a provider who is involved in adolescent HIV care). A 
script outlining talking points for recruitment is attached. The facility survey will be conducted by 
phone or in person. Prior to the phone or in person interview, we will make a phone call or personal 
visit to the facility. The purpose of this call or visit will be to discuss the study procedures and 
review the consent form with the potential participant. Potential participants will also be given a 
time to ask any questions they might have about the study. If the facility manager or designee 
agrees to participate, study staff will schedule a time at a later date to complete the facility 
questionnaire.  During this initial call or visit, we will also obtain an email address for the participant 
to send the consent and questionnaire for their review prior to our phone or in-person scheduled 
time for conducting the survey interview. If the facility manager or designee does not have access 
to email, the study questionnaire and consent form will be mailed by G4S courier service to the 
individual. Sending the consent and questionnaire to the facility point-person beforehand will give 
him/her ample time to prepare for the survey interview and sign and return a written consent form 
prior to the survey time. Participants with email and participating via phone will return the signed 
written consent form via email or text message while those without email or access to a phone 
may return the signed consent form via G4S courier services. All survey participants will be 
reimbursed 1000 KSH to cover the shipping costs or internet access data charges for returning 
consent forms. Refusal to participate in the survey will have no impact or repercussions for the 
health provider. In the event that a selected health provider is unable or unwilling to complete the 
baseline survey, they may refer the study staff member to another health provider in the facility 
that meets the eligibility criteria. Written consent will be given to conduct the survey. 
 

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Data Collection Procedures: 
During the facility survey we will collect information on the following: clinic staffing, clinic volume 
and space, pediatric clinic model (separate days or integrated), presence and type of transition 
planning approach, recommended age for transition, and available adolescent and transition 
services. We will also gather information on available adolescent friendly services, number of 
adolescents in HIV care; adolescent HIV services provided; health care provider training; 
presence and content of disclosure and transition guidelines; ART provision, availability of peer 
groups; mental health assessment processes, and important services lacking in clinics. A draft 
form of the facility survey is attached. We request permission to modify this form to make minor 
changes in the wording of questions to read more appropriately or clarify confusing statements, 
or make minor changes and formatting of questions. These minor changes will not affect the 
general content of information being collected. Any questions asking for collection of new content 
areas will be submitted for approval as a modification.  
 
Evaluation staff will call or visit each selected clinic and ask to speak with the facility manager or 
his/her designee (a provider who offers adolescent HIV services). We will capture basic 
demographic information on the cadre of health provider including age, sex and years of 
experience. In a separate file we will record the health provider’s name and contact information 
for purposes of scheduling the survey and mailing the consent materials. This information will not 
be stored with the data collected during the survey but will be linked to the provider in a separate 
link log document.  
 
To minimize disruption of participation in routine clinic activities, the survey will be conducted 
during a pre-arranged appointment time convenient for the participant. The provider will be 
required to have access to a quiet, private location during the time of the interview and will be 
asked to identify another time for the interview to take place if a quiet private location is 
unavailable during the time of recruitment or their previously pre-arranged time. No 
reimbursement will be provided other than for reimbursing costs associated with mailing or 
emailing consent forms to the main office in Nairobi at 1000 KSH/participant. Once the survey 
interview is completed, hardcopies of survey responses will be stored without links to any 
identifiers, i.e. anonymously, in a locked cabinet in the UW Kenya Pediatric Studies offices in 
Nairobi for up to six years. 
 
7b. Adapt and Optimize phase  
This phase will consist of 2 steps: The adapt step consisting of in-depth interviews (IDI), focus 
group discussions (FGDs), and a HCW working group to adapt and refine the transition tool.   
 
Adapt phase interviews 
Recruitment and enrollment  
A member of the study team will be stationed at the clinics to recruit HCWs, adolescents and 
caregivers and schedule interviews.  
 
For focus group discussions, evaluation staff will recruit eligible adolescents or caregivers from 
pediatric/adolescent clinics or CCC settings. Routine clinical staff will help with recruitment. 
Routine clinic staff will review patient charts and identify eligible adolescents and their caregivers. 
They will use patient charts to identify adolescents who meet the age criteria and know their HIV 
status. They will select adolescents who have and have not yet transitioned to adult care, as noted 
in their files. They will contact eligible adolescents and/or their caregivers to briefly tell them about 
the study. Caregivers and adolescents who are interested will be invited for participation and 

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asked to meet with study staff. It will be emphasized that participation is completely voluntary. 
Adolescents and caregivers will be recruited for these focus group discussions until up to 96 
adolescents have participated in 16 FGDs and 48 caregivers have participated in 8 FGDs, 
following the stratification pattern described in Table 2. Stratification for focus groups will include: 
whether or not they/ their children have completed the transition process, and the clinic model of 
care.  Eligible participants will undergo the informed consent (caregivers and/or adolescents ≥18 
years of age) or assent process (adolescents ages 14-17). The age of majority in Kenya is 18 
years of age. Adolescents who are 18 years of age or older will provide their own adult consent, 
without the need for parental consent. Adolescents who are between the ages of 14 and 17 will 
provide written assent and their parent or primary caregiver will provide written informed consent.  
 
Specifically, adolescents who are 18 years of age or older, or caregivers of adolescents who are 
between 14 and 17 years of age, who are eligible to participate, will be identified by the HIV 
counselors and clinicians within their respective clinics and will be told about the study during a 
routine clinic visit or by a phone call from a routine provider. Because adolescents typically only 
visit the clinic every 3 months, providers will need to call adolescents (≥18) or their caregivers 
(adolescents ages 14-17) specifically for the purpose of recruiting them into the study. HIV 
counselors and clinicians involved in routine clinical care at selected clinics will be given a 
recruitment script with talking points to help guide them on what to say. A script outlining talking 
points for recruitment is attached as an appendix. Adolescents aged 18 or older, or caregivers of 
adolescents ages 14-17, who are interested in participating or having their adolescent participate, 
will be asked to either stay after their visit (if already there for an appointment) or come to the 
clinic on a specific selected date to sign consent forms and participate in a FGD.  
 
When the potential participant arrives on the date of the FGD, the adolescent or 
caregiver/adolescent team will meet with study staff to go through a consent/assent process. Prior 
to conducting consent and beginning each FGD, study staff will confirm that the adolescent knows 
their HIV status by asking “why do you come to this clinic” and/or “why do you take medications” 
and “how old are you.” Adolescents and caregivers who are eligible will begin the consent/assent 
process. During the consent process, they will be informed of more details of the study purposes 
and procedures. Caregivers will be told that participation in the study will not affect their child’s or 
their own personal care at their clinic. Adolescents who meet the screening criteria and provide 
informed consent will be enrolled in the study.  
 
Adolescents younger than age 18 cannot provide informed consent but will be asked to provide 
assent. For adolescents younger than age 18, an age appropriate explanation of the study 
purpose and procedures will be given to the adolescent and the adolescent will be asked to give 
their assent to participate. In addition, the parent or legal guardian of the adolescent must provide 
consent on the child’s behalf. Caregivers willing and eligible to have their adolescent participate 
will be asked to sign a written consent form. Adolescents and caregivers will each read through 
the consent or assent form on their own and one of the study personnel will then go through it 
with them verbally. Those adolescents whose caregivers provide consent and who themselves 
give assent will become enrolled in the study and participate in a FGD with study staff. This could 
be after one of their routine clinic visits or on a separate date.  
 
Parents or caregivers with adolescents between the ages of 14 and 24 who are on regular follow 
up at the clinic will be eligible for the study. Parents or caregivers who are eligible to participate 
in the study will be identified by regular clinic staff (physicians, counselors, psychologists) during 
routine clinic visits or by reviewing patient charts and calling eligible caregivers. Routine clinic 
staff will be given a recruitment script with talking points to help guide them on what to say. A 
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the study in confidence without the knowledge of their adolescent. To ensure this confidentiality, 
caregivers will be told of the study only when meeting individually with the healthcare worker or 
over the phone. Caregivers will be told that participation in the study will not affect their child’s or 
their own personal care at the clinic. Caregivers interested in participating will be asked to return 
to the clinic to meet with study staff if recruited over the phone or sent directly to study staff if 
recruited during routine clinic visits for a more detailed description of the study and to obtain 
consent to participate. If the caregiver is interested in participating, the study staff will take them 
through the consent process. Prior to conducting consent and beginning each caregiver FGD, 
study staff will confirm that the caregiver is the primary guardian of an HIV-infected adolescent by 
asking “why does your child come to this clinic” and “how old is the child you bring to this clinic” 
and “are you this child’s primary guardian.” Those who provide consent and meet screening 
criteria are eligible to participate.  
 
Caregivers willing and eligible to participate will be asked to sign a written consent form. They will 
read through the consent form on their own. One of the study personnel will then go through it 
with them verbally. Those who provide consent are eligible to participate in one of the study FGDs. 
 
 
Consent forms for all participants are attached as appendices.  
 
HCWs from selected clinics will be purposively sampled. All health providers (medical officers, 
nurses, physicians, counselors and psychologists) who currently work with HIV positive 
adolescents will be told about the study by study team personnel and offered the opportunity to 
participate. Specifically, study staff will visit the clinic and meet with health providers involved in 
the care of HIV infected adolescents and will verbally inform them of the study. A script outlining 
talking points for recruitment is attached as an appendix. Those willing and eligible to participate 
will be asked to give written consent to be part of an individual interview and have the discussion 
audio recorded. It will be emphasized that participation is completely voluntary and opting not to 
participate will have no repercussions on the provider’s employment. They will be asked to sign 
a written consent form. They will read through the consent form on their own. One of the study 
personnel will then go through it with them verbally and answer any questions they might have. 
Those who consent will participate in an individual interview conducted by the study staff. 
 
Policy makers and hospital administrators will be purposively selected based on knowledge of 
their involvement in public office or employment within the hospital. Study staff will use public 
databases and other in-country resources to identify potential participants. Potential participants 
will be contacted by phone, email or in person by study staff to schedule interviews. A script 
outlining talking points for recruitment is attached as an appendix. Those willing and eligible to 
participate will be asked to give written consent to be part of an individual interview and have the 
discussion audio recorded. It will be emphasized that participation is completely voluntary and 
opting not to participate will have no repercussions on the policy maker’s or administrator’s 
employment. They will be asked to sign a written consent form. They will read through the consent 
form on their own. One of the study personnel will then go through it with them verbally and answer 
any questions they might have. Those who consent will participate in an individual interview 
conducted by the study staff. 
 
All participants will provide their contact information (phone, name, email if necessary) for follow-
up until interview is conducted.  

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Data Collection Procedures:  
Interviews:  
We will conduct 16 focus group discussions with HIV-infected adolescents aged 14-24 years, 8 
focus group discussions with caregivers of HIV-infected adolescents age 14-24 years, 38 
interviews with HCWs caring for HIV-infected adolescents and 30 policy makers and healthcare 
administrators. During each IDI or FGD, participants will share their experiences receiving clinical 
care for HIV and with disclosure and transition processes at their clinics and provide feedback on 
areas that could be improved or strengthened. Draft guides for all interviews and focus group 
discussions are attached as appendices. The attached guides provide example open-ended 
questions. Adolescent focus group discussion questions will focus on experiences with HIV 
disclosure and/or transition and seeking and receiving HIV treatment and care services. Caregiver 
interview guides will focus on eliciting personal experiences of those involved in caring for HIV-
infected adolescents centered on the topic areas of disclosure, support, and treatment services, 
and transition. For HCWs, discussion questions will focus on the services offered to adolescents 
at their facility and personal experiences with service provision to adolescents. For policy makers 
and administrators, discussion questions will focus on their views on what they envision as good 
transition practices, what would work in their setting, how this would work, and to share their 
experiences on challenges and successes at national or county policy level and facility level. We 
may also present the transition tool to the participants and ask them to provide direct feedback 
on the tools regarding cultural relevance and acceptability, programmatic or logistical concerns, 
as well as offer creative solutions for innovation. 
 
Discussion guides will be validated by piloting the guides with study staff following initial IRB and 
ERC approval. During the piloting phase, interviewers and discussion leaders will have the 
opportunity to practice asking and phrasing questions, determine whether the organization order 
of the guides are appropriate, and whether there is ample time to ask all of the questions posed 
in the draft guides. Following piloting of draft guides, final interview guides will be developed that 
include optimal phrasing, timing and ordering of discussion questions. The basic content included 
in the guides will not change between the pilot and final versions of the guides. Guides will be 
submitted as modifications if the content of the interview questions change during the pilot and 
final guide development phase.  
 
IDIs and FGDs will be conducted by a trained interviewer with previous experience in interviewing 
different populations, using a semi-structured flexible guide and will take approximately 60 
minutes to 2 hours to complete. IDIs and FGDs will be conducted in Kiswahili, Luo, English or 
other language appropriate for the location where activities are taking place. With consent from 
participants, discussions will be audio-recorded. At the beginning of the interview or FGD, 
interviewers will describe the goal of the interview or discussion and information about 
participation, including the ability to skip questions and the confidentiality of information shared. 
Prior to conducting the interview or FGD, interviewers will help the participant complete a short 
demographic form to collect socio-demographic information about the participant. Demographic 
surveys are attached as appendices. During the interview or FGD, the interviewer will guide the 
flow of discussion and will take notes to document participants’ attitudes, non-verbal gestures, 
body language, and responses. The audio file may include the participant’s first name (not full 

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name). Neither the transcribed notes from the interviews or FGDs, or transcripts, will include any 
personal identifiers, including the participant’s first name. If present in the audio recording, the 
participant’s name will be removed during transcription. For caregivers and adolescents, 
reimbursement for transportation costs, up to KES 600 ($6-7) per participant and if applicable, 
their guardian, will be provided. After completing their interviews, HCW participants will receive 
KES. 1000 ($11) as reimbursement for their time. Participants may also receive light refreshments 
while they are participating in the interview or FGD. Data will be transcribed verbatim to English 
and compared with audio-recordings to fill in missing information. A portion of translated 
transcripts will be back-translated to ensure accuracy. Collected transcript data will be de-
identified. The audio recordings of discussions will be destroyed after study participation and data 
analysis has been completed and no later than 6 years after the interview or FGD took place. 
Audio files and English transcripts will be uploaded to a password protected secure website for 
back-up. ATLAS.ti will be used for data management and analysis.  
 
Interview list of procedures:  
a) Invitation to participate in in-depth interview or focus group discussion 
b) Collection of locator information (phone number) and scheduling interview 
c) Written informed consent from participants aged ≥18 years or caregiver consent and 
assent from adolescent if under 18 years 
d) Complete demographic survey with study staff 
e) Conduct in-depth interview or focus group discussion with study staff 
 
 
Adapt Phase Working Group Meeting 
Recruitment and Enrollment: 
We will conduct a 2 day working meeting with an estimated 40 selected HCWs and policy makers 
from throughout Kenya with expertise in caring for HIV infected children and adolescents. HCWs 
with significant experience in assisting with HIV treatment and care for HIV infected adolescents 
will be purposively recruited from high performing clinics from Aim 1 with already existing transition 
policies and practices in place and/or adolescent friendly services and programs or through 
referral from policy makers and administrators interviewed in aim 2. We may also recruit 
healthcare workers known for their work in adolescent HIV treatment and care through reviewing 
peer-reviewed published articles or presentations at scientific meetings.  
 
HCWs and policy makers participating in the working group will be purposively selected and 
contacted by phone, email or in person by the study coordinator. They will be told the details of 
the working group, including its purpose and scope of work.  A script outlining talking points used 
for recruitment is attached as an appendix. Those willing and eligible to participate will be asked 
to give written consent to be part of the working group and have the discussions audio recorded 
and information about the process written up into a publishable manuscript. It will be emphasized 
that participation is completely voluntary and opting not to participate will have no repercussions 
on the HCWs employment. They will read through the consent form on their own. One of the study 
personnel will then go through it with them verbally and answer any questions they might have. 
Those who consent will participate in a 2 day workshop with study staff to refine and adapt the 
transition tools. All participants will provide their contact information (phone, name, email if 
necessary) for follow-up until the working group meeting is conducted.  
 

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Working meeting  
The workshop will be led by study team members. During the workshop, we will first present 
synthesized data from the in-depth interviews. HCWs will also be presented with working 
summaries of the synthesized data to refer to throughout the workshop to ensure that the views 
of all stake-holders will be incorporated as much as is possible in the adapted tool. We will then 
introduce the Got Transition tool to the HCWs and discuss in detail each of the sections of the 
tool including: core elements, key concepts, data collection tools, and both qualitative and 
quantitative evaluation tools. The purpose of introducing the tool to the HCWs will be to create a 
framework from which they can develop core elements, concepts, data collection tools and 
evaluative measures that are suitable for their setting. HCWs will be encouraged to think about 
what would work in their work setting, while incorporating the views of stakeholders, rather than 
working from what is presented in the tool. HCWs and study team members will work to develop 
the core elements and key concepts as a group, we may then split the HCWs to smaller groups 
to refine, and develop data collection tools which will then be presented to the whole group and 
refined as needed.  HCWs will be encouraged to be participatory and as practical as possible, 
and to develop the most inclusive and simplest tools that would work in the largest number of 
facilities in Kenya. Once a draft tool has been developed, it will be presented to the whole group 
and iteratively refined. We will provide reimbursement for transportation costs, accommodation 
and meals during the workshop and provide a per-diem allowance equal to current rates used by 
organizations or facilities where the HCWs work.  
The workshop agenda will be developed by the study team, and daily discussions will be led by 
a combination of study team members and invited working group participants.   
 
Data Collection Procedures: 
 
Prior to the working group meeting, HCWs will complete a short demographic form to collect socio-
demographic information. Demographic surveys are attached as appendices. Neither the 
transcribed notes from the workshop or transcripts will include any personal identifiers other than 
the participant’s first name. Data will be transcribed verbatim to English and compared with audio-
recordings to fill in missing information. A portion of translated transcripts will be back-translated 
to ensure accuracy. Collected transcript data will be de-identified. The audio recordings of 
discussions will be destroyed after study participation and data analysis has been completed and 
no later than 6 years after the workshop took place. Audio files and English transcripts will be 
uploaded to a password protected secure website for back-up. ATLAS.ti will be used for data 
management and analysis.  
List of procedures for workshop  
Listed below are all the required procedures.  
a) Invitation to participate in HCW working group meeting   
b) Collect locator information (phone number) and schedule meeting dates 
c) Provide a copy of the transition tool to review prior to the meeting  
d) Present results of the in-depth interview 
e) Provide summary document of synthesized data  
f) Discussion on the Got transition tool: The discussion will focus on the following key areas 
i. 
Core elements  
ii. 
Key concepts for each core element 
iii. 
Draft tools or measures for key concepts  
iv. 
Assessment of transition activities in clinics (tools and procedures) 
g) Group discussion on key elements and concepts  
h) Small group discussions to develop tools and refine core elements and key concepts  

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i) Whole group presentations on all transition tool items, with iterative refinement  
j) Presentation of refined tool  
 
 
7c. Cluster Randomized Controlled Trial (RCT) 
Recruitment and Enrollment: 
The study team will identify 20 clinics in Nairobi, Homabay, Kajiado or Nakuru counties that meet 
study eligibility criteria. These clinics may be part of those selected for aim 1 or new clinics not 
included in aim 1. We will use information from the facility survey to help with selection of clinics. 
We will conduct facility surveys with all 20 facilities prior to implementation of aim 3 activities. The 
facility survey will be repeated at the end of the trial, to capture new information on clinic practices 
and changes in staffing. Procedures for the survey are similar to those described in aim 1. The 
same facility survey tool used in aim 1 will be used to capture this data. For any selected clinic 
that was not part of aim 1, we will conduct the facility survey done in aim 1 before randomization 
using the same procedures discussed in aim 1. This will ensure we have the same clinic baseline 
information available for all 20 clinics participating in the RCT, as well as updated information on 
routine clinic procedures and staffing numbers throughout the entire RCT.. Prior to initiation of the 
trial, we will conduct pre-trial anonymous surveys with adolescents at both intervention and control 
sites. We will also conduct pre-trial surveys with all HCWs from intervention sites. Because of 
clinic staff turnover, a new facility designee can complete the survey at each time point.  
We will receive permission from county administrative teams and HIV care partners to enroll these 
clinics. We will then send letters to administrative teams of the selected clinics. The letter will have 
information on the objectives of the study and will include a formal request for the clinic to be part 
of the intervention. The study team will meet with clinic leadership and managers and provide 
more information on the study. Clinic leadership and staff in the adolescent clinic will give oral 
consent for the clinic to participate in the study.   
Twenty clinics will be selected based on location, size, use of EMR, willingness to participate in 
the RCT and taking into consideration other transition interventions ongoing at the site based on 
information collected in the facility survey or through conversations between clinic staff and study 
staff when recruiting clinics not in aim 1. To the best of our ability, clinics with transition or 
disclosure tools already in use will not be included in the RCT. 10 clinics will be randomized to 
receive the ATP intervention and 10 to receive no intervention. Depending on the heterogeneity 
of baseline facility factors, restricted randomization may be used to ensure an equal distribution 
of potentially confounding factors such as urban vs. rural site or clinic size. Dr. Richardson 
(Biostatistician) will generate the randomization assignment.   
All health providers (medical officers, nurses, physicians, counselors and psychologists) who 
currently work with HIV positive adolescents in intervention facilities will be told about the study 
by study team personnel and offered the opportunity to participate in the early implementation 
monitoring activities. This includes the HCW pre-trial survey and twice-monthly planning and 
feedback meetings and surveys. Specifically, study staff will visit the clinic and meet with all health 
providers involved in the care of HIV-infected adolescents and will verbally inform them of the 
study. A script outlining talking points for recruitment is attached as an appendix. Those willing 
and eligible to participate will be asked to give written consent to be part of the early 
implementation phase activities that will take place for 6 months. These activities include the pre-
trial survey, twice-monthly surveys, and trice-monthly PDSA meetings. HCWs who join the clinic 
after the trial has started will have the opportunity to consent when they join the clinic. HCWs who 

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joint the clinic after the trial has started will not have the opportunity to participate in the pre-trial 
survey. It will be emphasized that participation is completely voluntary and opting not to participate 
will have no repercussions on the provider’s employment. They will read through the consent form 
on their own. One of the study personnel will then go through it with them verbally and answer 
any questions they might have. Those who consent will participate in the early implementation 
phase activities of the study. HCWs participating in the early implementation phase activities will 
receive reimbursement for their time attending twice-monthly meetings and completing surveys. 
As a token of appreciation for their time, we anticipate paying HCWs 500KES for each feedback 
session they attend and 300KES for each survey they complete. They will also receive 500KES 
if they complete the pre-trial survey.  
 
We will conduct transition readiness surveys with adolescents aged 15-24 years who have 
attained full disclosure. Surveys will be conducted at baseline (clinical trial start) and every 6 
months thereafter.     
 
All adolescents 15-24 years who have attained full disclosure and are attending clinic visits will 
be eligible to participate in the surveys. Adolescents will be recruited during clinic visits by a 
member of the study team or by phone prior to returning to clinic for their study visit. A recruitment 
script with guiding information is provided in the appendices. If an adolescent is interested in 
participating, eligibility will be assessed by clinic or study staff by asking adolescents a series of 
questions. These questions will confirm that the adolescent knows their HIV status and is within 
the appropriate age range to participate. Example questions that study staff might ask include: 
“why do you come to this clinic” and/or “why do you take medications” and “how old are you.” 
Adolescents who meet eligibility criteria and are interested in participating will give written assent 
or consent to participate in the surveys. We will also request a waiver of parental permission for 
adolescents ages 15-17 who do not meet emancipated minor criteria. The information collected 
in the survey is not sensitive and can be classified as minimal risk. In addition, many adolescents 
ages 15-17 who have already attained full disclosure will be receiving care in the absence of their 
caregivers. Adolescents will be informed that their data will be linked to their medical record data, 
but this survey will not contain their name, only their ID. All adolescents who provide consent or 
assent will be enrolled and participate in this survey. Adolescents who provide assent or consent 
will take the transition readiness surveys every 6 months. Adolescents will receive 600 KES for 
completing the survey each time.  
We will conduct disclosure readiness surveys at intervention sites with caregivers of children and 
adolescents aged 6-19 years who have not yet attained full disclosure. Surveys will be conducted 
at baseline (clinical trial start) and every 6 months thereafter until the study ends or the 
child/adolescent has reached full disclosure.     
All caregivers of children and adolescents ages 6-19 years who have not yet attained full 
disclosure and are attending clinic visits at intervention sites will be eligible to participate in the 
surveys. Caregivers will be recruited during clinic visits by a member of the study team or by 
phone prior to returning to clinic for their child’s study visit. A recruitment script with guiding 
information is provided in the appendices. If a caregiver is interested in participating, eligibility will 
be assessed by clinic or study staff by asking a series of questions. These questions will confirm 
that the caregiver is someone responsible for caring for the child and that the child or adolescent 
does not know their HIV status. Example questions that study staff might ask include: “how old is 
the child you bring to this clinic,” “does the child know that they have HIV” and “are you this child’s 
primary guardian.”  

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Caregivers who meet eligibility criteria and are interested in participating will give written consent 
to participate in the surveys. Caregivers will be informed that their data will be linked to their child’s 
medical record data, but this survey will not contain their name, only their ID. All caregivers who 
provide consent will be enrolled and participate in this survey. Caregivers who provide consent 
will take the disclosure readiness surveys every 6 months and will receive 600 KES for completing 
the survey each time.  
 
Data collection procedures:   
The study is not blinded and clinic leadership will be informed of the allocation, either to 
intervention or no intervention. For both groups, the study team will conduct study specific training. 
For intervention sites, training will include the use of the disclosure tools, transition tools and other 
study data collection material. Control sites will undergo training on collection of study related 
data.  
 
Intervention clinics: The study will aim to optimize implementation of the ATP over the 6-month 
period at each intervention site and will measure the effect of the well-implemented ATP on 
transition over a 2-year period.  
Enrolled HCWs will be asked to complete a demographic and implementation climate survey one 
time following enrollment in the early implementation phase activities. This will capture basic 
demographic information on the cadre of health provider including age, sex and years of 
experience. The survey will also capture the organizational readiness for change and baseline 
knowledge of transition services at the clinic. The survey will also assess initial impressions of the 
ATP. The survey will be administered after obtaining written consent. At each intervention clinic, 
all enrolled HCWs will meet twice-monthly for the first 6 months of implementation for planning 
and feedback meetings. The timing of when these meetings will occur will be determined through 
conversations between study staff and clinic staff. Planning and feedback discussions will focus 
on identifying ATP implementation challenges and successes, how challenges were addressed, 
and identify coordinated ideas for small changes that can improve implementation. Meetings will 
be audio recorded and transcribed verbatim and used to complete an adaptation-tracking log and PDSA 
worksheet. The log and worksheet will capture major and minor changes, reasons for changes, date 
changes were made, and the challenges and successes that were encountered as they used the tools 
and new innovative ways to address challenges. The log will not include personal identifying information, 
but will be identified at the clinic level only. We anticipate the meetings will last 1-2 hours in length. Audio 
files and English transcripts will be uploaded to a password protected secure website for back-up. 
ATLAS.ti will be used for data management and analysis. 
During each planning and feedback meeting, HCWs will also be asked to complete brief surveys that 
includes questions to assess individual acceptability, feasibility and appropriateness of the adapted 
intervention. These surveys will also ask questions to probe intervention fidelity. Surveys will be 
administered immediately before the twice-monthly meetings. During these first 6 months, study 
coordinators will actively support the clinic in the implementation process. During the adaptation 
phase, the core elements and key concepts of the tools will be preserved as much as possible. 
Surveys will be completed on paper and later entered into REDCap or will be directly entered into 
REDCap using tablets or smart phones. HCWs will be assigned a study ID that will be used 
throughout the early implementation phase data collection activities. This ID will be used to link 
changes in acceptability and feasibility over time. HCW names will be stored alongside their study 
IDs in the link log. The link log will be kept separate from other data collected and stored in a 
locked cabinet that only trained study staff have access to.   

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The study will introduce new tools to be used in routine data collection at both intervention and 
control sites. These are the disclosure checklist and the transition log (attached as appendices). 
We will also introduce tracking forms and cartoon books to improve disclosure and transition 
processes at intervention sites. These forms and tools are attached as appendices and include a 
transition booklet called Taking Charge, a disclosure booklet called “Why I take my Medicines, a 
transition tracking form, a disclosure readiness assessment, and a transition readiness 
assessment. During implementation, study coordinators will work with the clinic to determine the 
best model for data collection in each of the clinics. The data will be collected on paper forms. 
The new tools will contain a participant identifier, as used in the clinic. At data entry, participant 
clinic ID numbers will be recorded. This will allow us to link data between study tools and routinely 
collected patient data. Before analysis, all original patient ID numbers will be replaced with a study 
ID. We will use a link log to link the participant clinic identifier with the study code. The link log will 
be stored in a lockable cabinet in the clinic and will only be accessible to study staff. The paper 
forms will be stored in facilities together with other clinic records. Data will be entered using the 
Open Data Kit (ODK) platform or mobile REDCap on Android smart phones or study tablets. Data 
will be uploaded directly to the study's secure server from the smart phone or tablet that is used 
to collect data, at which point it will be deleted from the phone or tablet. Android phones and 
tablets will be password protected with a password known only to the study staff using the device. 
The secure server that warehouses data will be password protected and accessible only to study 
personnel directly involved in data cleaning and analysis. We will plan to use either wireless 
internet or 3G to send digital data. To protect the data, the website to which data will be uploaded 
will use existing well-known SSL/TLS (Secure Socket Layer/Transport Layer Security), as 
indicated by "HTTPS" in the URL. SSL/TLS is used by sites such as Google to protect data. All 
digital data will be sent and received using HTTPS. 
 
To track intervention effectiveness for improving adolescent outcomes, we will also abstract data 
from EMR systems and paper forms in both intervention and control sites (adolescent checklist 
and other paper based forms) at baseline (before RCT start), and throughout the duration of the 
RCT. We will work with data personnel in each of the facilities to develop operating procedures 
on data abstraction, making use of currently used systems and procedures for reporting data that 
are already in place at that clinic. All data handled by the study team will be handled and stored 
as described in aim 1 procedures. 
Transition readiness surveys and disclosure readiness surveys will be collected either on paper 
CRFs or using REDCap on Tablets. This survey will be administered by a trained clinic staff 
member or hired study staff. The readiness assessment survey tools are provided as an appendix. 
Data collected on paper forms will be entered into REDCap by study staff.    
 
 
List of procedures for the RCT  
a. Meeting with clinic team and leadership to present study and study team 
b. Select 20 clinics for randomization 
c. Conduct baseline pre-trial surveys with adolescents and HCWs  
d. Training of clinic staff on the use of the ATP (intervention sites only)  
e. Training on data collection tools for all sites (disclosure and transition checklists) 
f. Share baseline data with clinic if available 
g. Pre-trial surveys with HCWs on implementation climate  
h. 6 month intensive clinic support and optimization of ATP implementation  
i. 
Twice-monthly surveys with HCWs and meetings facilitated by the study team aimed at 
making adaptations and changes to the tool as needed  
j. 
Completion of study adaptation log and PDSA worksheet 

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k. Completion of baseline and 6-monthly transition readiness surveys with adolescents ages 
15-24  
l. 
Completion of baseline and 6-monthly disclosure readiness surveys with caregivers of 
adolescents ages 6-17 who do not know their HIV status 
m. Extraction of routine medical records for adolescents ages 6-24 
n. Extraction of data from intervention tracking forms 
o. Continuous support as needed for implementation  
 
7d. Implementation Evaluation  
During implementation, we will use quantitative and qualitative tools to measure how well the 
transition tool is implemented in the intervention sites. Assessment will occur both in the middle 
and at the end of the intervention period and will include collection of qualitative and/or quantitative 
information on the acceptability, appropriateness, feasibility of the intervention and intervention 
fidelity. We will also assess penetration and adoption at each intervention facility. We will gather 
this information through semi-structured interviews with adolescents and HCWs, FGDs with 
HCWs at intervention sites, HCW post-trial surveys at intervention sites, data abstraction from 
study tools and patient charts, and post-trial surveys with adolescents at intervention and non-
intervention sites.  
 
Implementation Evaluation FGDs 
All HCWs from intervention facilities will be invited to participate in FGDs at 6 months and at the 
end of the trial. All health providers (medical officers, nurses, physicians, counselors and 
psychologists) who have been implementing the ATP at intervention sites will be offered the 
opportunity to participate. Specifically, study staff will visit the clinic and meet with all health 
providers involved in implementing the ATP and will verbally inform them of the study. A script 
outlining talking points for recruitment is attached as an appendix. Those willing and eligible to 
participate will be asked to give written consent to be part of the FGD. It will be emphasized that 
participation is completely voluntary and opting not to participate will have no repercussions on 
the HCWs employment. They will read through the consent form on their own. One of the study 
personnel will then go through it with them verbally and answer any questions they might have. 
Those who consent will participate in a FGD at either 6 months or post-intervention 
implementation. HCWs can participate in an FGD at 6 months, at the end of the trial, or both. 
 
FGDs will assess overall perceptions on the ATP, and include questions to measure constructs 
from the Consolidated Framework for Implementation Research (CFIR). The CFIR is a meta-
theoretical framework designed to identify implementation determinants by guiding data collection, 
analysis, and evidence interpretation. Application of the CFIR in this study will generate key 
information about the role of context in influencing implementation, thereby informing the future 
packaging of the intervention and increasing the relevancy of study findings for other settings. We 
will ask questions to learn from HCW experiences implementing the ATP so that the tool can be 
revised and adapted for future scale-up. Draft guides for FGDs are attached as appendices. The 
attached guides provide example open-ended questions. Discussion guides will be validated by 
piloting practicing the guides with study staff following initial IRB and ERC approval. During the 
piloting phase, discussion leaders will have the opportunity to practice asking and phrasing 
questions, determine whether the organization order of the guides are appropriate, and whether 

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there is ample time to ask all of the questions posed in the draft guides. Following piloting of draft 
guides, final discussion guides will be developed that include optimal phrasing, timing and 
ordering of discussion questions. While the order and phrasing of guides may change from the 
guides submitted to the IRB/ERC, the basic content included in the guides will not change 
between the pilot and final versions of the guides. Guides will be submitted as modifications if the 
content of the interview questions change during the pilot and final guide development phase.  
 
We will use focus groups because they are useful in fostering rich discussion between group 
members and participant comments stimulate the thinking and responses of others. Additionally, 
focus group discussions help to elicit divergent or convergent viewpoints among participants. 
Focus groups will be used to understand HCW perspectives on implementing the ATP at their 
facility and how the ATP can be improved. We will also ask questions about delivery of the 
intervention by phone, as it was adapted in response to COVID-19. It will be emphasized that 
participation is completely voluntary and opting not to participate will have no repercussions on 
the HCW’s employment. They will also be reminded that they do not have to participate in the 
FGDs even if they participated in the early phase implementation activities. HCWs from 
intervention sites will have the opportunity to participate in the FGDs at 6 months, at trial end, or 
both.  HCWs will provide separate written informed consent to participate in each of the FGDs. 
During FGDs, participants will meet with trained moderators and note takers in private rooms. 
FGDs will be conducted by a trained interviewer with previous experience in interviewing different 
populations, using a semi-structured flexible interview guide and will take approximately 1 ½ to 2 
hours to complete. FGDs will be conducted in English or Kiswahili and discussions will be audio-
recorded. At the beginning of the focus group discussion, the interviewer will describe the goal of 
the focus group discussion and information about participation, including the ability not to answer 
questions and the confidentiality of information shared, and also ask that no names be used during 
the discussion. The interviewer will also remind participants not to share information about the 
FGD with other people, including what was discussed and who was present. Before the FGD 
starts, participants will receive unique identification numbers and will not be addressed with their 
real names during discussions so as to maintain confidentiality. They will also complete a short 
demographic form to collect socio-demographic information and information on their background 
in providing clinical care. In addition, surveys will quantify the implementation outcomes of fidelity and 
penetration with questions regarding exposure to training, personal and facility use of the ATP.  Their 
survey information will be recorded in separate forms from the interview data.  
 
The moderator will guide the flow of discussion and will document topics that generate the most 
discussion, participants’ attitudes, non-verbal gestures, body language, and interactions among 
group members. To ensure that no data are lost, notes will also be taken by a note taker during 
the interview. The note-taker will record; date, venue, participant information, unique identification 
numbers, and track participant responses. Despite our best attempts to have participant refrain 
from using each other’s names, the audio file may include the participant’s first name (not full 
name). Neither the transcribed notes from the interviews or transcripts will include any personal 
identifiers, including the participant’s first name. If present in the audio recording, the participant’s 
name will be removed during transcription. Participants will receive KES. 1000 ($11) as 
reimbursement for their time. Participants may also receive light refreshments during their time 

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participating in the focus group. Data will be transcribed verbatim to English and compared with 
audio-recordings to fill in missing information. A portion of translated transcripts will be back-
translated to ensure accuracy. Collected transcript data will be de-identified. The audio recordings 
of FGDs will be destroyed after study participation and data analysis has been completed and no 
later than 6 years after the FGD took place. Audio files and English transcripts will be uploaded 
to a password protected secure website for back-up. ATLAS.ti will be used for data management 
and analysis. 
 
List of procedures  
Listed below are all the required procedures for the FGDs.  
a) Invitation to participate in the FGD  
b) Consent for FGD participation 
c) Schedule FGD date 
d) Complete short demographic and implementation survey 
e) Conduct FGD  
 
Qualitative Interviews 
Recruitment and enrollment:  
A member of the study team will be stationed at intervention clinics to recruit potential participants 
and schedule interviews. We will conduct a total of 16 (estimating limited intervention exposure 
due to COVID-19) individual interviews with HIV-infected adolescents who have attained full 
disclosure of their HIV status during the intervention period or recently (defined within the previous 
24 month) and 80 (estimating 6-10 adolescents total from all intervention sites) individual 
interviews with adolescents who were exposed to the transition intervention during the 
intervention period. We will also conduct 60 individual interviews with 5-10 HCWs at selected 
intervention clinics, including 10 IDIs with ATTACH study nurses. All clinics will participate in end 
of trial data collection.  
 
Adolescents and HCWs will be recruited and enrolled using similar procedures as those described 
for interviews in Aim 2. Briefly, during clinic visits, adolescents will be invited by study staff to 
return to the clinic or stay after their current appointment to participate in individual interviews. 
Adolescents will be recruited for these in-depth interviews until they reach pre-defined target 
numbers (8/group/site) or reach data saturation during the interviews (no new information 
emerges). Before participation in in-depth interviews, each adolescent >18years will give their 
consent to participate.  Adolescents aged less than 18 years will give assent to participate; and 
their caregivers will give consent for participation. HCWs who meet eligibility criteria will be 
recruited by study team members to participate in the interviews. It will be emphasized that 
participation is completely voluntary and opting not to participate will have no repercussions on 
the provider’s employment or clinical care the adolescent receives in the clinic. Prior to conducting 
consent and beginning each adolescent interview, the interviewer will confirm that the adolescent 
knows their HIV status by asking “why do you come to this clinic” and/or “why do you take 
medications” and “how old are you.” Before participation in in-depth interviews, participants will 
give written consent or assent to participate. Interviews will be conducted by study staff and will 
be audio recorded.  
 

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During each IDI, participants will share their experiences with disclosure and transition processes 
at their clinics and provide feedback on areas that could be improved or strengthened. HCWs will 
also provide direct feedback on their use of the ATP, drawing again from the CFIR constructs to 
assess determinants impacting implementation outcomes. Draft guides for all interviews are 
attached as appendices. The attached guides provide example open-ended questions. 
Discussion guides will be validated by piloting practicing the guides with study staff following initial 
IRB and ERC approval. During the piloting phase, interviewers and discussion leaders will have 
the opportunity to practice asking and phrasing questions, determine whether the organization 
order of the guides are appropriate, and whether there is ample time to ask all of the questions 
posed in the draft guides. Following piloting of draft guides, final interview guides will be developed 
that include optimal phrasing, timing and ordering of discussion questions. While the order and 
phrasing of guides may change from the guides submitted to the IRB/ERC, the basic content 
included in the guides will not change between the pilot and final versions of the guides. Guides 
will be submitted as modifications if the content of the interview questions change during the pilot 
and final guide development phase.  
 
Adolescent interview questions will focus on personal experiences with HIV disclosure and/or 
transition, exposure to intervention materials, and seeking and receiving HIV treatment and care 
services. For HCWs, discussion questions will focus on the services offered to adolescents at 
their facility and personal experiences with use of the transition and disclosure tools, as well as 
delivery of the intervention by phone. IDIs will be conducted by a trained interviewer using a semi-
structured flexible interview guide and will take approximately 60 minutes to complete. IDIs will 
be conducted in Kiswahili, Luo, English or other language appropriate for the location where 
activities are taking place. With consent from participants, discussions will be audio-recorded. At 
the beginning of the interview, interviewers will describe the goal of the interview and information 
about participation, including the ability to skip questions and the confidentiality of information 
shared.  
 
Data Collection Procedures:  
Prior to conducting the interview, interviewers will help the participant complete a short 
demographic survey to collect socio-demographic information about the participant. HCW surveys 
will also assess intervention training, uptake of tools and perception of tools use at the facility they 
work in. Demographic surveys are attached as appendices. During the interview, the interviewer 
will guide the flow of discussion and will take notes to document participants’ attitudes, non-verbal 
gestures, body language, and responses.  
 
During each IDI, participants will share their experiences with disclosure and transition processes 
at their clinics and provide feedback on areas that could be improved or strengthened. Draft 
guides for all interviews are attached as appendices. The attached guides provide example open-
ended questions. Discussion guides will be validated by piloting practicing the guides with study 
staff, peer educators or other staff at clinics not participating in the IDIs. Piloting will happen 
following initial IRB and ERC approval. During the piloting phase, interviewers and discussion 
leaders will have the opportunity to practice asking and phrasing questions, determine whether 
the organization order of the guides are appropriate, and whether there is ample time to ask all of 

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the questions posed in the draft guides. Following piloting of draft guides, final interview guides 
will be developed that include optimal phrasing, timing and ordering of discussion questions. 
While the order and phrasing of guides may change from the guides submitted to the IRB/ERC, 
the basic content included in the guides will not change between the pilot and final versions of the 
guides. Guides will be submitted as modifications if the content of the interview questions change 
during the pilot and final guide development phase.  
 
Adolescent interview questions will focus on personal experiences with HIV disclosure and/or 
transition and seeking and receiving HIV treatment and care services. For HCWs, discussion 
questions will focus on the services offered to adolescents at their facility and personal 
experiences with use of the transition and disclosure tools. Similar to the FGD discussion guides, 
IDI guides for HCWs will include questions to assess implementation context based on the 
constructs and domains from CFIR. ATTACH study nurse IDIs will include questions to evaluate 
delivery of the transition readiness assessment, a tool only administered by study staff. IDIs will 
be conducted by a trained interviewer using a semi-structured flexible interview guide and will 
take approximately 60 minutes to complete. IDIs will be conducted in Kiswahili, Luo, English or 
other language appropriate for the location where activities are taking place. With consent from 
participants, discussions will be audio-recorded. At the beginning of the interview, interviewers will 
describe the goal of the interview and information about participation, including the ability to skip 
questions and the confidentiality of information shared.  
 
The interview audio file may include the participant’s first name (not full name). Neither the 
transcribed notes from the interviews or transcripts will include any personal identifiers, including 
the participant’s first name. If present in the audio recording, the participant’s name will be 
removed during transcription. For caregivers (of minor adolescents) and adolescents, 
reimbursement for transportation costs, up to KES 600 ($6-7) per participant or accompanying 
guardian, will be provided. After completing their interviews, HCW participants will receive KES. 
1000 ($11) as reimbursement for their time. Participants may also receive light refreshments 
during their time participating in the interview. Data will be transcribed verbatim to English and 
compared with audio-recordings to fill in missing information. A portion of translated transcripts 
will be back-translated to ensure accuracy. Collected transcript data will be de-identified. The 
audio recordings of interview discussions will be destroyed after study participation and data 
analysis has been completed and no later than 6 years after the interview took place. Audio files 
and English transcripts will be uploaded to a password protected secure website for back-up. 
ATLAS.ti will be used for data management and analysis.  
 
List of procedures for individual interviews 
a) Invitation to participate in in-depth interview 
b) Collection of locator information (phone number) and scheduling interview 
c) Written informed consent from participants aged ≥18 years or caregiver consent and 
assent from adolescents if under 18 years 
d) Complete demographic survey with study staff 
e) Conduct in-depth interview  
 
Pre and Post-Trial surveys 

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Recruitment and Enrollment: 
We will conduct 400 pre-trial and 400 post-trial anonymous surveys with adolescents aged 12-24 
years at both intervention and control sites and 200 post-trial surveys with HCWs from intervention 
sites to determine satisfaction with the disclosure and transition processes, and acceptability, 
feasibility and appropriateness of the intervention. HCW surveys will also assess fidelity, 
penetration, and adoption of the ATP.  
 
All adolescents attending clinic visits will be eligible to participate in the anonymous surveys. 
Adolescents will be recruited during clinic visits by a member of the study team. A recruitment 
script with guiding information is provided in the appendices. If an adolescent is interested in 
participating, eligibility will be assessed by clinic staff by asking adolescents a series of questions. 
These questions will confirm that the adolescent knows their HIV status and is within the 
appropriate age range to participate. Example questions that study staff might ask include: “why 
do you come to this clinic” and/or “why do you take medications” and “how old are you.” 
Adolescents who meet eligibility criteria and are interested in participating will give oral assent or 
consent to participate in the anonymous surveys. A recruitment script with guiding information is 
provided in the appendices. They will be informed that no identifiable information will be collected 
in the surveys and that the study teams will not collect any names. All adolescents will provide 
oral assent or consent to participate in the surveys. Since no identifying information will be 
collected, we will request waiver of written consent for participation in the surveys. We will also 
request a waiver of obtaining parental consent for adolescents ages 12-17. We are looking at 
evaluating transition to adult care, and many adolescents ages 12-17 will have already 
transitioned to adult care and be receiving care in the absence of their caregivers. All adolescents 
who provide oral assent or consent will be enrolled and participate in an anonymous survey.  
 
All HCWs working with HIV-infected adolescents at intervention sites are eligible to participate in 
exit surveys. HCWs who meet eligibility criteria will be recruited by study team members to 
participate. They will be informed that no identifiable information will be collected. It will be 
emphasized that participation is completely voluntary and opting not to participate will have no 
repercussions on the provider’s employment. All HCWs who provide oral consent will be enrolled 
and participate in an anonymous survey. 
 
Data collection procedures 
Pre and post-trial surveys will be collected either on paper CRFs or using mobile REDCap on 
tablets. These surveys are provided in the appendices. Data collected on paper forms will be 
entered into REDCap as described earlier.    
 
List of procedures for pre and post-trial surveys 
a. Recruitment to participate in anonymous survey 
b. Oral consent or assent  
c. Complete survey 
 
Post-Trial procedures- Control sites:  
At the end of the trial control sites will be offered study tools used in the intervention sites and 
will be offered training on how to use them. Any material developed including tracking tools will 
be shared with the control sites to allow them to use tools they find useful. Results of the trial 
will be presented to all sites in site close-up meetings.  
 

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7e. Assessment of participant compliance with study intervention 
 
We will regularly monitor turn-over of trained HCWs, changes in clinic policies and procedures, 
and other facility-level factors that could affect intervention fidelity.  
  
 
 

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SECTION 8: STUDY SCHEDULE 
An overview of the anticipated overall study schedule for is shown in Table 6a and 6b (by aim). 
The study will be conducted over five years. AIM 1 will be implemented in year 1. In year 2 we will 
complete and disseminate results of AIM 1 and complete AIM 2 and select sites for cRCT in AIM 
3 as well as finalize adapted transition tool. In Y3 we will initiate the RCT with 2-year follow-up to 
be completed by mid-Y5. The final 6 months of the study will be used for manuscript preparation 
and dissemination of results of AIM 3 to community and global stakeholders.  
Table 6a:  Overall study schedule: 2016-2021 
 
 
Y1 
 
Y2 
 
Y3 
 
Y4 
 
Y5 
 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Study Planning 
 
 
 
 
 
 
 
 
 
 
 
Protocol 
development 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
IRB 
Submissions 
  
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Implementation 
 
 
 
 
 
 
 
 
 
 
 
Site selection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EMR data 
extraction for 
AIM 1   
  
  
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Facility 
surveys  
  
  
 
   
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
IDIs for adapt    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HCW 
workshop 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HCW FGD to 
adapt  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site 
randomization   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-trial 
surveys  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study training  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RCT  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data pull  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Post-trial 
surveys  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation 
IDIs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis  
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
Reports to 
stakeholders 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript 
development 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 6b: Study timeline by aims 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5  
 
P1 
P2 
P1 
P2 
P1 
P2 
P1 
P2 
P1 
P2 
Develop study material and ethical approval  
x 
X 
 
 
 
 
 
 
 
 
Aim 1: Facility surveys, EMR data abstraction 
 
 
x 
x 
 
 
 
 
 
 
Aim 2: Adaptation and optimization of transition tool  
 
 
x 
x 
x 
 
 
 
 
 
Aim 3: Cluster RCT 
 
 
 
 
 
x 
x 
x 
x 
 
Data analysis  
 
 
 
x 
x 
 
 
 
x 
 
Dissemination and manuscript preparation  
 
 
 
 
x 
 
 
 
x 
x 
 
 
SECTION 9: ASSESSMENT OF SAFETY 
 
There are no medical interventions associated with the study, therefore we anticipate no risk of 
serious harm to participating HCWs or adolescents. Other study risks include emotional distress 
associated with the sensitive nature of the disclosure and transition process, breech of patient 
confidentiality during data extraction or by participation in FGDs and fear of or actual loss of 
employment associated use of transition tools and checklists.  
 
There is a possibility for social harm (depression, violence after disclosure, abandonment) related 
to disclosure of HIV status during clinical encounters. However, the possibility of this social harm 
would exist if this intervention were not conducted.  
We will periodically monitor all study sites for unanticipated problems, and record any 
unanticipated problems. Monitoring will be conducted on-site through observation, follow-up data 
collection, and feedback from clinic leadership and staff.  
 
9a. Reporting of unanticipated problems and other events 
In compliance with federal regulations and UW policy, the Principal Investigator will notify the UW 
Human Subjects Division (HSD) and/or UW Institutional Review Board (IRB), Kenyan Ethics 
Committee, and relevant local Kenyan authorities (i.e. Ministry of Health) of any unanticipated 
problems within 10 business days. Any breach or possible breach of confidentiality of any 
participants in this study will be reported to UW HSD and/or IRB within 24 hours. 
 
SECTION 10:  DATA COLLECTION 
Data collection tools submitted with this application can be found in the Appendices. 
• 
Prospective Data - Facility survey: This will be administered to a health facility representative 
and will  capture facility characteristics including pediatric clinic model (separate days or 
integrated), presence and type of transition planning approach, recommended age for 
transition, and available adolescent and transition services.  
• 
Prospective Data - In-depth interviews and focus group discussions: These will be conducted 
using an interview or discussion guide. Guides for all proposed interviews and focus group 
discussions are included as appendices. Interviews and focus groups will be audio-recorded 
and transcribed.  

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• 
Prospective Data - Demographic information: We will collect demographic information for all 
participating in the FGD/IDIs. Demographic surveys for each population included in IDIs or 
FGDs are attached as appendices.  
• 
Retrospective and Prospective Data - Clinic records: Adolescent clinic records from the EMR 
system and routinely collected paper forms will be extracted from all clinics participating in 
Aim 1 and at baseline, and throughout the RCT, for clinics participating in Aim 3 to assess 
clinical adolescent outcomes. Data from each pull will capture all records until the previous 
data pull (Aim 3) or from between January 1, 2016 and December 31, 2017 (Aim 1). Examples 
of data will be enrollment age, CD4, viral load (where available), WHO stage, hospitalization, 
caregiver presence, serial visits since enrollment, pediatric or adult clinic day of attendance 
and reported adherence. This will be collected from the clinic medical records database or 
paper clinic records, a clinic partner organization, or other location where medical record data 
for selected clinics is being stored and managed such as the Kenyan National Data 
Warehouse. 
• 
Prospective Data - Disclosure checklist: This will be completed at every clinic visit to obtain 
more detailed data on partial and full disclosure in both intervention and control sites. This 
data will be abstracted from patient files routinely throughout the RCT.  
• 
Prospective Data - Transition booklet tracking form: This will be completed at every clinic visit 
to obtain more detailed data on transition in intervention sites. This data will be abstracted 
from patient files routinely throughout the RCT.  
• 
Prospective Data - Transition tracking log: This will be completed at transition to adult clinics 
and for next 6 months for both intervention and control sites. This data will be abstracted from 
patient files routinely throughout the RCT. . 
• 
Prospective Data - Pre-Trial surveys: Surveys will be conducted with adolescents who have 
completed disclosure or transitioned to adult care and HCWs from intervention sites. 
Adolescent surveys will be conducted for both intervention and control sites at the beginning 
of the study. Information will include basic demographics (age, schooling) and satisfaction with 
services received. HCW surveys include basic demographic information, initial impressions of 
the ATP, and implementation climate.  
• 
Prospective Data - Post-trial surveys: The surveys will focus on client satisfaction based on 
the new adapted transition tool and will therefore be refined once the transition tool has been 
adapted and optimized.  
o Adolescent post-trial surveys: Surveys will be conducted with adolescents who have 
fully completed disclosure or fully transitioned. These surveys will be conducted for 
both intervention and control sites at the end of the study. Information will include basic 
demographics (age, schooling) and satisfaction with transition or disclosure services 
received.  
o HCW post-trial survey: Surveys will be conducted with HCWs working at intervention 
sites. Information will include basic demographics, satisfaction with disclosure and 
transition tools in the ATP, and acceptability of the ATP. Surveys will also assess 
training in intervention implementation, use of intervention tools, fidelity to 
implementation and feasibility of implementing study tools and processes. 
• 
Prospective Data – Transition readiness surveys: Surveys will be conducted every 6 months 
with adolescents ages 10-24 years who have attained full disclosure. The survey will focus on 
adolescent readiness for transition and will be conducted for both intervention and control 
sites. Surveys will assess medical knowledge and skills in being independent.  

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• 
Prospective Data – Disclosure readiness surveys: Surveys will be conducted every 6 months 
with caregivers of children and adolescents ages 6-17 who have not reached full disclosure 
from intervention sites. Surveys will assess caregiver readiness for disclosure.  
 
Data Management Responsibilities 
A dedicated data team will be responsible for the entry, management, and monitoring of study 
data, in accordance with standard operating procedures. The Nairobi data team will communicate 
frequently with the Seattle-based study team for reporting, data cleaning, study monitoring, and 
interim analyses. Study data will be uploaded to the secure study cloud server using Open Data 
Kit (ODK) or REDCap.  Open Data Kit is a secure, web-based application designed by UW faculty 
to support data capture for research studies. REDCap is a free, secure, web-based application 
designed to support data capture for research studies. The software provides 1) an intuitive 
interface for validated data entry; 2) automated export procedures for seamless data downloads; 
and 3) procedures for importing data from external sources.  
 
Data Capture and Storage Methods 
Study personnel conducting recruitment procedures will have access to direct identifiers. All 
study personnel involved in recruitment will be trained in the Protection of Human Subjects. 
The study staff involved in recruitment team will take every precaution to protect participants’ 
confidentiality.  
 
• 
During the study, we will collect the following identifiers for participants:  
• 
Patient IDs for participants providing medical records – we will remove these 
once all data for a facility has been collected and linked.  
• 
Names/phone numbers for potential participants identified by clinic staff for 
interviews, focus groups, the working group, and facility surveys – we will destroy 
this information for all participants who do not elect to participate once we have 
finished recruitment at that clinic site. We will retain this information linked to their 
study ID in a secure link log for people who enroll in the study. Links between 
participant identifiers and study IDs will be kept for a period of 6 years after the 
end of the study, at which time the link between participant identifiers and study 
IDs will be destroyed. 
 
• 
Audio-recordings will be translated and transcribed and will be stored on University of 
Washington supported One drive for business or other UW IT approved data storage 
system that becomes available after approval of the study. We will ensure that the storage 
website uses LMS, has industry standard security, and will be password protected.  
 
• 
Facility surveys, pre-trial surveys, post-trial surveys, and transition readiness surveys will 
be carried out by trained study staff members using ODK or mobile REDcap on tablets or 
android phones, and stored on a secure cloud server. 
 
• 
Disclosure and transition readiness assessments and transition tracking logs and 
transition booklet tracking forms will be entered to ODK or REDCap by study staff 

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members using ODK or REDCap on tablets or android phones, and stored on a secure 
cloud server.   
 
• 
The methods of EMR data extraction in the study clinics will follow a data use agreement 
between the study team and site partners. We will provide a list of variables and records 
for a site partner designated data administrator to extract. We will receive data in a secure, 
password protected format (e.g. USB or cloud server). These data will be stored in a 
password-protected database accessible only to authorized members of the study team. 
 
• 
Until we finish collecting data and linking patient files together from the multiple data 
sources (paper forms and electronic medical records), we will retain unique clinic patient 
IDs alongside their medical record information. We will replace their unique ID with a study 
unique ID once all data collection from medical records at that clinic has been completed. 
A document that links the names from the consent forms to the study ID will be maintained 
for all procedures involving written informed consent. The document will be password 
protected and accessible only to authorized study staff. The document with the link 
information will be maintained in a file that does not have study data. Following completion 
of data collection and cleaning, the data will be in non-identifiable form (coded by study 
number only). Only de-identified information will be shared. The file containing the link 
between participant information and study ID will NOT be shared. 
 
• 
The study PI will oversee and manage data sharing and use of data for future studies. If 
possible in the future, we will use these data for additional research on issues related to 
adolescents and/or HIV. Study participants would be able to withdraw their information 
from any future research up until 6 years after the study has been completed and the link 
log is destroyed.    
• 
Data Collected: We will obtain names, ages (for adolescents), phone numbers and email 
addresses for all potential participants who are not participating in the anonymous surveys 
in order to contact them about the study at appropriate points in time as detailed in the 
protocol. This information will be provided to study staff by clinic personnel and written 
down. For participants who decline participation, we will store this information only until 
we have completed recruitment at their clinic site and will keep the information during 
recruitment to ensure that we do not contact them again. For participants who decide to 
enroll in the study and are not part of the anonymous surveys, we will keep a record of the 
name, age (for adolescents) and phone number (and email address for HCWs) linked to 
their study ID. This information will be stored separately from any data collected during 
the study and will be stored for 6 years.   
 
Data Custody and Retrieval Procedures 
All data for this study will be under the custody of the Principal Investigator, Site Leader, and 
authorized study staff. Data retrieval procedures will be similar for all types of data in this study. 
Authorized study staff members will download the datasets from the secure servers for routine 
quality checking and analyses. Similarly, EMR data will be retrieved from a secure server or USB, 
and transferred to a study computer at scheduled intervals. All downloaded data will be 
maintained on a secured, password-protected study computer. From these data sources, the 
analysts will create merged datasets for planned analyses.  
 
Study Records Retention 

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Retention 
of 
study 
records 
will 
comply 
with 
UW 
and 
Federal 
requirement 
(http://f2.washington.edu/fm/recmgt/retentionschedules/gs/general/uwgsResearch#Research).  
All study data and link between HCW, adolescent or caregiver participant identifiers and study ID 
codes will be retained for 6 years following completion of the study. Audio data will be destroyed 
after 6 years, unless a waiver has been signed. Participant consents will be retained for 6 years 
after the end of the study. The link between participant identifiers and study IDs will be kept under 
lock and key. After this time, links to identifiable data will be destroyed.  
 
 
 
 

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SECTION 11: STATISTICAL CONSIDERATIONS 
 
11a. Sample Size Considerations  
Aim 1: We will base our sample size on MOH facilities with EMR systems in place and current 
estimates of adolescent client volumes based on total HIV clients in care. We will stratify clinics 
to have an equal number of small, medium and large clinics. We propose an evaluation with 102 
clinics, 34 clinics per clinic size cluster, and a maximum total sample size of 15,000 adolescents. 
For the retrospective records review, EMR records for all adolescents aged 10-19 from selected 
clinics will be included in the analysis. All adolescents who have at least one visit on or after 
January 1, 2016 will have their medical records pulled.  
 
Based on previous data, we anticipate that we will be able to identify at least 50 adolescents per 
clinic for a total of at least 5000 adolescents. Assuming a prevalence of 60%, an intra-class 
coefficient (ICC) of 0.05 and a clinic size of 50 we would need to select 102 clinics for estimating 
the expected proportion with a 2.5% absolute precision and 95% confidence. With a sample size 
of 5,000 adolescents who are enrolled in HIV care during the previous 12-24 months, the precision 
of the estimates across possible ranges (50%-90%) of prevalence of retention in care or viral load 
suppression will range from ±2.6% to ±1.5% (Table 5). Thus, with 5000 adolescents or more, our 
study will have high precision in estimating the prevalence of retention in care and HIV viral load 
suppression, providing valuable input for understanding impact of interventions aimed at 
improving these adolescent HIV outcomes.  
 
Table 7: Precision estimates for prevalence of retention and viral load suppression in 
HIV-infected adolescents 
Indicator 
Adolescents 
evaluated 
Observed 
Prevalence 
Events 
CI 
Precision  
Retention 
or 
suppressed 
viral load 
5000 
50% 
2500 
47.4-52.6% 
+/-2.6% 
5000 
60% 
3000 
57.5-62.5% 
+/-2.5% 
5000 
70% 
3500 
67.6-72.4% 
+/-2.4% 
5000 
80% 
4000 
77.9-82.1% 
+/-2.1% 
5000 
90% 
4500 
88.5-91.5% 
+/-1.5% 
 
Aim 2: Given that the goal of the interviews conducted in this aim is to gather information on 
experiences with disclosure and transition and use this information to refine study tools, we 
believe that conducting 16 focus group discussions with adolescents (N=96), 16 focus group 
discussions with primary caregivers of adolescents (N=48), 38 interviews with HCWs and 30 
interviews with administrators and policy makers, will give us adequate numbers to reach our 
study goal and enough diversity in experiences to ensure different perspectives are accurately 
represented in study tool refinement. A working group comprised of approximately 40 HCWs with 
significant expertise in providing care for HIV-infected children, adolescents and adults will be 

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sufficient to foster rich discussions around study tools. Including approximately 40 HCWs, will 
allow participation of all stakeholders.  
 
Aim 3: For the RCT, using a conservative estimate of 20% of clients being between 10-24 years 
old and each clinic having at least 500 active clients, we anticipate 200 eligible clients per clinic, 
for a total of 1000 eligible clients per randomization arm.  
• 
We assume that 100 of these eligible clients will be aged 6-15 and that the rate of complete 
disclosure will be 15% in the control clinics based on our prior studies and the literature 
with increased prevalence per year of age in this age-window.  
• 
We assume that 100 of these eligible clients will be aged 15-24 years and that 20% (n=20) 
will be receiving care in a pediatric program and could be eligible to transition (200 per 
RCT arm). During 2-year follow-up, we anticipate that in the control arm 20% will transition 
and 10% will transition effectively.  
 
With 10 intervention and 10 control sites, we will have sufficient power to detect an increase in 
proportion of adolescents with disclosure from 30% to 50%, an increase in proportion who initiate 
transition from 50% to >80%, and an increase in proportion with effective transition from 10% to 
20%. This assumes alpha of 0.05, 80% power, and a conservative estimate of the coefficient of 
variation of 0.3 (Table 6). Heterogeneity between clusters is expected to decrease with control for 
baseline testing rates, leading to increased power beyond that which is noted above.  
Table 8: Power and sample size ranges 
 
 
 
 
 
 
 
 
 
 
 
 
For the provider and adolescent IDIs, we will select healthcare providers and adolescents from 
ATP-implementing clinics for individual interviews. Clinics will be purposively selected from among 
all ATP-implementing clinics. We will purposively select clinics for interviews based on 
performance, including high and low performing sites as appropriate based on the outcome of the 
intervention. If the majority of clinics do well, we will purposively select a higher proportion of low 
performing clinics to understand why they had challenges. If the majority of the clinics do poorly, 
we will purposively select a higher proportion of high performing clinics to understand how they 
succeeded.  
 

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A total of up to 60 providers will be selected from among all providers at intervention facilities, 
including 10 IDIs with ATTACH study staff. HCWs will be purposively selected to represent 
different cadres of HCWs who provide services for adolescents and are directly involved in 
implementation of the ATP. We believe that 5 providers per site (50 total), and 10 ATTACH study 
nurses, will give us adequate numbers to attain saturation during data collection and enough 
diversity in health provider cadre to ensure different perspectives are accurately represented.  
A total of up to 96 adolescents will be selected for interviews. We will purposively select 
adolescents with a range of ages and intervention exposure. Clinic providers will assist in 
identifying and referring adolescents who are aware of their HIV status and have been through 
disclosure as well as adolescents who have been exposed to the ATP. Eligibility of adolescents 
will be confirmed by reviewing their chart for documentation of disclosure and transition 
intervention exposure. We believe that 6-10 adolescents from each site (96 total) will give us 
adequate numbers to attain saturation during data collection and will provide enough diversity in 
experiences to ensure different perspectives are accurately represented.  
 
11b. Overview of analysis plan 
Aim 1 
Follow-up at 6-month post-enrollment and annually thereafter will be determined and summarized 
as proportion retained for given interval (e.g., 6-month retention, 12-month retention, 36-month 
retention) with anticipated denominator in follow-up based on enrollment date. Cofactors for loss 
to follow-up will be determined using Cox regression. Potential cofactors of loss to follow-up 
include age at enrollment, CD4, caregiver type (biologic, mother or father), age at HIV diagnosis, 
sex, illness or hospitalization, and evidence of transition. Proportion with evidence of transition 
and mean/median age of transition will be computed. Cofactors of transition will be determined 
including child/adolescent age, age at HIV diagnosis, evidence of disclosure, caregiver type using 
logistic regression. Post-transition retention will be determined and cofactors of effective transition 
(documented 6-month or longer follow-up after transition) will be assessed using logistic 
regression. 
 
Aim 2  
Focus group discussions and interviews will be recorded and transcribed verbatim. Transcripts 
will be coded and thematic analysis will be conducted on the transcripts using ATLAS.ti. At least 
2 researchers will independently code the data, coordinating their findings and analyses to create 
a comprehensive codebook and concept map. Themes related to how to culturally adapt and 
improve the described transition intervention, and how to improve clinical care for HIV-infected 
adolescents, will be identified and used to revise the implementation of the intervention.  
 
Aim 3  
The primary analysis will be an intent-to-treat (ITT) analysis.  
We will use generalized estimating equations (GEE) clustered on facility level to compare 
differences in age-appropriate disclosure and change in transition readiness over time between 
control and intervention communities during baseline and intervention periods. In order to 
decrease variability between our sites and increase precision of our outcome measures, we will 
control for baseline adolescent disclosure and transition proportions in our models. We 
hypothesize that the increases in disclosure and transition proportions between the baseline and 
intervention periods will be greater among intervention than control facilities. 

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The first 6 months of the intervention will be considered a “catch up” period; while outcomes will 
be compared during the full study period, a sub-group analysis is planned for the first 6 months 
to see if the effect of the intervention is greater during the “catch-up” period. 
Focus group discussions and interviews will be recorded and transcribed verbatim. Transcripts 
will be coded and thematic analysis will be conducted on the transcripts using ATLAS.ti. At least 
2 researchers will independently code the data, coordinating their findings and analyses to create 
a comprehensive codebook and concept map. Themes related to implementation acceptability, 
feasibility, appropriateness and challenges and successes will be identified. Proportions satisfied 
with the transition and disclosure process will be compared between the 2 arms.  
 
 
SECTION 12: ETHICS/PROTECTION OF STUDY PARTICIPANTS 
 
COVID-19 ADAPTED STUDY PROCEDURES 
As a result of the COVID-19 pandemic, some activities will be move to being offered by 
phone. For adolescents, study activities conducted by phone pose potential additional 
risks of inadvertent disclosure of adolescent HIV status for participating adolescents. 
However, healthcare providers already routinely call adolescents to remind them of clinic 
visits and support groups, and may be moving to provide more services by phone to 
minimize exposure at clinics during the COVID-19 pandemic. To minimize potential 
disclosure risks, we will first confirm that the person on the phone is the enrolled study 
participant. We will also ask the participant to confirm willingness to participate in phone-
based activities. We are also only offering services to adolescents who know their status, 
as part of the inclusion criteria for enrolling in the transition intervention activities.  
12a. Informed Consent Process 
Clinic participation  
This intervention will be at facility level therefore, we will engage with the relevant HIV care 
partners, county health management and facility administration teams prior to entering health 
facilities. Because we will be collecting routinely collected program data on adolescent retention 
and health outcomes, we will request a waiver of individual consent of adolescent patients for 
abstracting clinic records.   
 
HCW and Policy makers and administrators   
HCW participants will provide written informed consent for participation in IDIs, FGDs, 
implementation evaluation activities, and the working group.  
For post-trial surveys among HCWs, we will request waiver of written consent as no identifying 
information will be collected. 
Policy makers and administrators will provide written informed consent for participation in IDIs. 
 
Adolescent patients  
The consent and assent process for IDIs and FGDs by age is described below: 

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1) 
Adolescents ages 14-17 who come with a caregiver: Written informed consent will be 
sought from the caregiver and written assent will be sought from the minor. We will not 
enroll any adolescent between ages 14 and 17 who is unaccompanied by a caregiver.  
2) 
Adolescents >18: Regardless of whether they are accompanied, adolescents will provide 
written informed consent. 
Pre and post- trial surveys: We will request a waiver of written assent or consent for these 
participants. We will also request a waiver of parental permission for adolescents ages 12-17. As 
we will not be collecting any personal information, breach of confidentiality is of higher risk with 
written documentation rather than verbal agreement. We request waiver of parental consent 
because many adolescents attend the care clinic independently, without their caregivers. If 
caregivers are present with the child participant, we will respect caregivers’ wishes if they do not 
want the child to complete the anonymous survey. Requirement of parental consent would be 
problematic for adolescents who have transitioned (eg, have assumed autonomy for their own 
care), and for those whose caregivers would be unavailable to come in and provide consent. 
Excluding these adolescents would bias the study population. 
Transition readiness surveys: Written informed consent or assent will be sought from the 
adolescent ages 10-24 years. We will request a waiver of parental permission for adolescents 
ages 15-17 years because many adolescents present to clinic for care unaccompanied and the 
survey questions are minimal risk and ask about non-sensitive information. Requirement of 
parental consent would be problematic for adolescents 15-17 years who have attained full 
disclosure and potentially transitioned (e.g., have assumed autonomy for their own care), and for 
those whose caregivers would be unavailable to come in and provide consent. Excluding these 
adolescents would bias the study population. 
Caregivers of HIV-infected adolescents  
Caregivers will provide written informed consent.  
Consent Details: 
A consent form describing in detail the study procedures and risks will be provided. Participants 
will be informed that they are free to decline participation, and that declining to give permission 
will have no impact on their role in this study. Participants will be informed that they are free to 
withdraw their permission at any time during the study.  
Consent forms and information sheets will be IRB-approved, and the participant is required to 
read and review the document or have the document read to him or her.  The study team member 
will explain the research study to the participant and answer any questions that may arise.  The 
individual will sign the informed consent document prior to any study-related assessments or 
procedures. Participants will be given the opportunity to discuss the study with their surrogates or 
think about it prior to agreeing to participate.  They may withdraw consent at any time throughout 
the course of the study.  A copy of the informed consent document will be given to participants for 
their records. The rights and welfare of the participants will be protected by emphasizing to them 
that the quality of their clinical care will not be adversely affected if they decline to participate in 
this study. 
Comprehension will be assessed by asking the participant to repeat back what was explained 
and encourage them to ask questions. Study staff may ask the participant questions like the 
following to assess comprehension:  

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b) "Just so that I'm sure you understand what is expected of you, would you please explain 
to me what you think we're asking you to do?" 
c) "Describe in your own words the purpose of the study." 
d) "What more would you like to know?" 
e) "What is the possible benefit to you of participating in this study? What are the possible 
risks?" 
If the participant is unable to answer these questions, study staff will go through the consent form 
with them again. If a participant continues to be unable to understand the study procedures and 
risks and benefits, the staff person will thank them for their time and let them go without enrolling 
them into the study. 
For all participants that are unable to read, we will ensure that the consent form is read aloud to 
them and that there is a witness present when they sign the consent form. We will ensure that the 
witness also signs the form documenting observation of the consent process and the participant’s 
willingness to participate. 
Exclusion of Women, Minorities, and Children  
There are no exclusions of women or minorities. Eligibility is based on age and occupation. 
Adolescent patients under age 6 will be excluded from this study because the target population 
is children, adolescents and youth ages 6-24. 
Translation of Materials: 
We anticipate that the majority of study participants will be fluent in either Kiswahili, Luo, or English 
or other language appropriate for where the research study is taking place. We will generate study 
materials specific to each of those languages. For interviews and focus group discussions, we 
will ensure that the interviewer is fluent in the preferred language spoken by patients at the clinic. 
We will not provide interpretation services. We will require that our research coordinator(s) and 
qualitative study staff be fluent in English, Swahili, Luo or another local language spoken in the 
region where research is taking place. Only participants who understand English, Swahili and/or 
Luo or another language appropriate for where the study is taking place will be eligible for the 
study.  
At least 1 study staff member will be fluent in every language we will be creating consent and 
other study related materials for. We will ensure that participants speak with a study staff member 
fluent in their preferred language when they have questions or concerns about the study. 
We will work with translators/interpreters who are fluent in English, Swahili, and other relevant 
tribal languages to translate consent forms to the appropriate languages. Once consents are 
translated and transcribed into their appropriate language, they will be back translated to English 
by another translator/interpreter who has not seen the original English consent form to ensure 
that the messages and material included in the consent form is accurate. We will correct any 
information in the translated consents that is not correctly back translated and get approval from 
the ERC for all translated study materials. 
12b. Participant Confidentiality  
 
All key personnel will be trained in the Protection of Human Subjects. The field team will take 
every precaution to protect participants’ confidentiality. To ensure confidentiality, focus group 
discussions and interviews will take place in rooms where the door to the room can be shut 
during the discussion. Only designated study staff and the individuals involved in the focus 

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group discussion or interview will be allowed in the room during the focus group discussion or 
interview. 
We only will collect personal identifiers for the purposes of identifying and contacting 
participants about the study. This information will include the names, telephone numbers and 
emails for those identified as interested in participating in the study. We will not collect patient 
identifiers for participants completing pre, during and post-trial anonymous surveys. Personal 
identifiers will be used to contact participants to remind them of their upcoming study visit and 
also to contact them if they fail to appear for their scheduled study visit. This information will 
also be used to contact them again to verify the accuracy of the information collected or to 
elaborate or clarify certain information provided during study procedures if they select the option 
to be re-contacted on the consent form.  
All participants will be assigned a study identification number (ID).  Health information and 
phone numbers will be recorded and stored under this study ID.  Participant identifiers will be 
linked to their study ID and will be stored in binder in a locked cabinet separately from all other 
study data. Only necessary study staff will have linkage to this linkage binder. 
A limited number of study staff will have access to patient identifiers and will not share this 
information with other study staff or with others outside of this study. Links between patient 
identifiers and unique study IDs will be kept for a maximum period of 6 years after the study has 
ended, at which time the link between patient IDs and identifiers will be destroyed. All consent 
forms will be kept in locked offices and file cabinets, and will be in separate files from data with 
identifiers. 
Study staff will take strict measures to maintain confidentiality for participants. Data collected will 
be kept confidential and access restricted to study staff. All audio-recordings of the IDIs will be 
kept in a secure database. All other data will be kept in password-protected databases, in a 
locked study office, accessible only to study personnel. Study identifiers will be linked to coded 
data; clinical staff will have access to patient identifiers, but the analysts will receive only coded 
data. Links between patient identifiers and study codes will be kept for a period of 6 years after 
the end of the study, at which time the link between patient IDs and codes will be destroyed.  
12c. Potential Risks and Benefits 
 
Potential Risks 
• 
Physical: There are no medical interventions associated with the study, therefore we 
anticipate no risk of serious harm to participating HCWs, adolescents, caregivers, hospital 
administrators or policy makers. 
 
• 
Other: Other study risks include emotional distress associated with the sensitive nature of 
the disclosure process, breech of patient confidentiality during data extraction (adolescent 
clinic records), and fear of or actual loss of employment associated with implementing the 
ATP. We are not directly enrolling adolescent clients other than to take part in in-depth 
interviews, focus group discussions, and anonymous surveys. However, there is a 
possibility for social harm (depression, violence after disclosure, abandonment) related to 
disclosure of HIV status during clinical encounters at HIV care. However, the possibility of 
this social harm would exist if this intervention were not conducted. For the FGDs, it is 
also possible that a participant may know another member in the discussion and by 
participating in the discussion the other member might learn of their HIV status. We have 
outlined this potential risk in the consent form.  
 

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• 
Other: There is a possibility that during a clinical encounter with a HCW using the more 
comprehensive tools that are part of the adolescent transition package that an adolescent 
patient may be more comfortable disclosing that they are suffering from previously 
undiagnosed mental health problems such as depression. Any patients with potential 
mental health problems will be referred for psychosocial support at the facility or nearest 
referral hospital, according to standard HIV care and treatment guidelines for adolescents 
at that clinic and within the country. 
 
• 
Alternative treatments or procedures: Not applicable 
 
• 
Procedures to minimize psychological risks:  All participants will be assured that their 
participation is voluntary and that they may withdraw from the study at any time. Study 
personnel experienced with adolescents will perform the disclosure intervention. 
Adolescent participants will be informed that they can skip any question or stop the 
interview, focus group or surveys at any time.  We will ask all the members in focus group 
discussions to protect each other’s privacy, and not to repeat anything that is said or 
learned once the discussion is over.  
 
• 
Procedures to minimize other risks: Study staff will be trained to take all precautions to 
ensure confidentiality of participation and data collected, and will have standardized 
operating procedures to follow to minimize the risks of a participant’s loss of confidentially. 
Risk of breach of confidentiality of study data is low, as all patient data collected will not 
include names and will be located on a password protected server, and encrypted prior to 
upload. Study staff will be trained in the importance of confidentiality during human 
participants training prior to study implementation.  
 
• 
The systematic disclosure approach will minimize the possibility of involuntary disclosure 
of HIV status to an adolescent. Some adolescent patients are receiving HIV care and take 
ART (which may be called ‘medicine’ and not HIV medicine), but may not yet know their 
HIV status, because the caregiver is not ready for the child to learn this information. 
 
• 
Additional protection for children:  Additional protections will be afforded to participants in 
the in-depth interviews or focus group discussions. These protections will depend on 
adolescents’ age and whether they are accompanied by a caregiver.  Adolescents 
accompanied by caregivers will be given the option of having their caregiver present 
during the interview or focus group. Adolescents will also be given the opportunity to meet 
with a nurse counselor, or other similar staff member, if they request to see one or if the 
interviewer believes they should see one following the interview or focus group discussion. 
 
Potential Benefits 
• 
HCWs and clinics: HCWs in the intervention sites will receive direct and immediate benefit 
in receipt of disclosure skills and transition tools that may improve outcomes in their 
facilities.  
 
• 
Adolescent client (clinic attendees):  Adolescent clients of participating health facilities may 
benefit directly from the improved disclosure services and transition services they receive 
from trained HCWs. 
 
Unanticipated Problems 

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In compliance with federal regulations and UW policy, the Principal Investigator will notify the UW 
Human Subjects Division (HSD) and or UW Institutional Review Board (IRB) of any unanticipated 
problems within 10 business days and  the Kenyan Ethics Committee, and relevant local Kenyan 
authorities (i.e. Ministry of Health) within 3 business days. Any breach or possible breach of 
confidentiality of any participants in this study will be reported to UW HSD and/or IRB within 24 
hours. 
Data Safety and Monitoring 
A DSMP is not required for this study. However, we are planning to create an External Advisory 
Panel (EAP) to act in an advisory capacity to the National Institute of Child Health and Human 
Development (NICHD), the University of Washington, School of Medicine, and the University of 
Nairobi, to monitor recruitment, enrollment, and potential social harms of the intervention. 
 
SECTION 13: USE OF INFORMATION AND PUBLICATIONS 
Study results will be presented to all participating sites at the end of the study period. This study 
will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed 
journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon 
acceptance for publication.   
 
SECTION 14: LIMITATIONS  
 
We recognize that clinics utilizing EMR systems for capturing patient information may not be 
representative of all clinics in Kenya and that selecting only sites with EMR systems in place may 
limit the generalizability of our findings in Aim 1 regarding current systems in place for adolescent 
HIV treatment and care.  
 
The generalizability of the intervention in this study may be limited due to the small number of 
clinics included and inability to have proportional geographically representation. We will rely on 
clinics to implement the interventions within the regular clinic schedule. Clinics may differ in 
implementation, we will however collect data to measure how well the intervention is 
implemented. One strength of this proposal is the ability of qualitative methods to uncover detailed 
information about questions of interest, including identification of the barriers and facilitators to 
successful implementation. However, due to the nature of qualitative research methods, there will 
only be a small number of interviews and focus groups conducted, limiting the generalizability of 
the data collected. Although findings may not be generalizable to a larger audience, we believe 
that our results can help improve current knowledge about transition and disclosure, development 
of appropriate tools for assisting with transition, and implementation of the ATP.   
 
 
 
 
 

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19. 
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37. 
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Psychosocial Implications of HIV Serostatus Disclosure to Youth with Perinatally 
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Vreeman RC, Gramelspacher AM, Gisore PO, Scanlon ML, Nyandiko WM. Disclosure of 
HIV status to children in resource-limited settings: a systematic review. J Int AIDS Soc 
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47. 
Ngugi ENB, Katana A, Nganga L, Waruru A, Gichangi A, Mukui I, Inwani I. HIV 
disclosure and clinical outcomes among HIV-infected adolescents enrolled in HIV care in 
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48. 
Krauss B, Letteney S, De Baets A, Murugi J, Okero FA. Guideline on HIV disclosure 
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Guidelines for Antriretroviral Therapy in Kenya: 4th Edition 2011. In. 4th Edition ed. 
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51. 
Brandt L, Beima-Sofie K, Hamunime N, Shepard M, Ferris L, Ingo P, et al. Growing-up 
just like everyone else: key components of a successful pediatric HIV disclosure 
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52. 
AAP A, ACP. Clinical Report: Supporting the Health Care Transition from Adolescence to 
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53. 
Zhang LF, Ho JS, Kennedy SE. A systematic review of the psychometric properties of 
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54. 
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APPENDICES 
The following documents are included as appendices in this application.  
 
Study Tools:  
1. Adapted Namibia disclosure booklet  
2. Taking charge booklet  
 
Data Collection Tools: 
Activity 
Data collection tool 
Aim 1 
Facility Survey 
Facility Survey CRF 
Retrospective Records Review 
Variables to be abstracted 
Aim 2 
Adolescents in HIV care (48 not completed 
transition, 48 transitioned) 
General - Adolescent Demographic Survey 
Adolescent Focus Group Discussion 
Guide – Informational 
Caregivers of adolescents who have and 
have not completed transition (48 total) 
Caregiver Demographic Survey 
Caregiver Focus Group Discussion Guide 
– Informational 
HCWs involved in pediatric/adolescent HIV 
care 
General - HCW Demographic Form 
HCW Interview Guide - Informational 
Policy makers or administrator heads 
Policy-maker/Admin Demographic Form 
Policy-maker/Admin Interview Guide – 
Informational 
Aim 3 
Disclosure outcome 
 
Disclosure Checklist  
Disclosure Readiness assessment  
Transition outcome 
 
Transition Tracking Log  
Transition booklet tracking 
Transition readiness assessment (HCW) 
Transition readiness survey (adolescents) 
Pre-trial surveys 
 
Pre-trial Adolescent Survey 
 
Pre-trial HCW Survey 
Implementation period  
 
HCW FGD Guide  
HCW implementation survey  
HCW PDSA Worksheet  
HCW FGD Demographic Form 
Post-trial IDIs 
 
General - Adolescent Demographic Form 
Post-Trial Adolescent Interview Guide – 
Disclosure Focus 
Post-Trial Adolescent Interview Guide – 
Transition Focus 
General - HCW Demographic Form 

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Post-Trial HCW Interview Guide 
Post-Trial ATTACH Staff Interview Guide 
Post-trial surveys 
Adolescent Survey  
HCW Survey 
COVID-19 Adapted Forms 
 
CQI Phone Delivery Script 
Transition Readiness Assessment Delivery 
Script 
Transition Intervention Delivery Script 

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Consent Forms: 
 
*Same as aim 2 document  
Study Activity 
Consent document 
Aim 1 
Facility Survey  
Consent for facility survey  
Aim 2  
 
Adolescents in HIV care (48 not 
completed transition, 48 
effectively transitioned) 
Adolescent Assent (Age 14-17) for Focus Group Discussion 
Parental consent for Adolescent Informational Focus Group 
Discussion  (Age 14-17) 
Consent for Adolescent Informational Focus Group Discussion  
(Age 18-24) 
Caregivers  
Consent for Caregiver Informational Focus Group Discussion 
Policy makers  
Consent for Policy maker Informational Interview   
HCW/Administrator 
Consent for HCW/Administrator Informational Interview   
Working group  
Consent for HCW Working group  
Aim 3 
 
Pre-Trial Surveys  
Oral consent for anonymous Adolescent Pre-Trial Survey (age 
≥18) 
Oral assent for anonymous Adolescent Pre-Trial Survey (ages 12-
17) 
Implementation Activities 
HCW IS Activities Consent Form 
Post-trial IDI  
Adolescent Assent (ages 14-17)* 
Consent for Adolescent Post-Intervention IDI (Age 18-24) 
Parental Consent for Adolescent Post-Trial IDI (Age 14-17) 
Consent for HCW Post-Trial IDI 
Implementation FGDs 
HCW Implementation FGD Consent Form 
Transition readiness surveys 
Assent and Consent Form for Adolescent Transition Readiness 
Assessment Survey (10-24 years old) 
Disclosure readiness surveys  
Caregiver consent for disclosure readiness survey 
Post-trial surveys  
Oral consent for anonymous Adolescent Post-Trial Survey  (age 
≥18) 
Oral assent for anonymous Adolescent Post-Trial Survey (ages 
12-17) 
Oral consent for anonymous HCW Post-Trial Survey 

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Recruitment Scripts: 
 
*Same as aim 2 document  
 
 
Study Activity 
Recruitment Script 
Aim 1` 
Facility Survey 
Facility Survey Recruitment Script  
Aim 2  
 
Adolescents in HIV care (48 not completed 
transition, 48 transitioned) 
NA 
Caregiver recruitment script for adolescent 
IDI and FGD 
Adolescent recruitment script 
Caregivers  
Caregiver recruitment script  
Policy makers  
Policy maker/Admin/HCW recruitment script  
HCW/Administrator 
Policy maker/Admin/HCW recruitment script 
Working group  
HCW recruitment script for Workshop 
Aim 3  
 
Pre-Trial surveys  
Adolescent Recruitment Script* 
Implementation Activities 
HCW IS Activities Recruitment Script 
Post-trial IDI  
NA 
Adolescent recruitment script* 
Caregiver recruitment script*  
HCW recruitment script* 
Implementation FGDs 
HCW FGD Recruitment Script 
Transition readiness 
Adolescent recruitment script* 
Disclosure readiness  
Caregiver recruitment script 
Post-trial surveys  
Adolescent recruitment script* 
HCW recruitment script* 

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ATTACH STUDY ANALYSIS PLAN (Finalized 2.13.2020) 
 
SUMMARY  
 
Study Purpose: To determine whether an adolescent transition package (with transition and 
disclosure tools) improves mean transition readiness among HIV positive adolescents in care 
in Kenya.   
 
Study Design: Cluster randomized trial  
 
Study Population and Sites:  
Population:  
• HIV-positive adolescents and youth between the ages of 10 and 24 
Sites: 
• 20 HIV clinics in Nairobi, Nakuru, Homabay and Kajiado, Kenya 
 
Study Duration: Estimated 18 months total (enrollment and 1-year follow-up) 
 
Randomization: 10 clinics randomized to intervention sites and 10 to control.  
 
Intervention:  
Adolescent Transition Package (ATP): The ATP will consist of a validated disclosure booklet and 
disclosure tracking tool, and a HCW administered transition booklet and transition tracking logs, 
implemented in intervention sites. HCW in intervention sites will be trained on implementation of 
the ATP with continued support for the clinic in the first 3 months of the intervention. In control 
sites, parallel data collection for primary outcomes will be conducted.  
 
Primary endpoints: Transition readiness  
 
Secondary endpoints: Overall clinic retention and overall viral suppression  
 
Exploratory outcome: % with full disclosure, Time to full disclosure, Post transition retention 
 
 

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DATA ANALYSIS  
 
Primary outcome: transition readiness among HIV positive adolescents age 15-24  
a. 
Transition readiness score overall (all domains)  
b. 
Treatment literacy readiness score  
c. 
Self-management readiness score  
d. 
Communication readiness score  
e. 
Support readiness score   
 
Analysis  
Primary analysis ITT:  Mixed effects linear regression to compare transition readiness scores 
(overall and by domain) over time in control and intervention sites with adjustment for multiple 
testing (Benjamin-Hochberg method).  
Time points: Enrollment, month 6, month 12 
 
Sample size and power table 
Assumptions: 80% power, alpha 0.05, ICC 0.2, average cluster size of 50   
Mean difference 
SD 
Number of Clusters per Arm  
0.5 
1 
4 
0.5 
2 
15 
1.0 
2 
4 
1.0 
3 
9 
1.5 
3 
4 
1.5 
4 
7 
2.0  
5 
6 
2.0  
6 
9 
 
 
Secondary outcomes 
a. Overall retention in 10-24year olds: defined as proportion of 10-24 year olds 
completing visits within 6 months of last visit  
b. Overall viral suppression: defined as proportion of 10-24 year olds with viral load of 
less than 1000 copies per ml after at least 6 months of ART  
 
Analysis 
Overall retention/suppression: Generalized estimating equations (GEE) to compare retention and 
viral suppression in intervention and control sites  
Time-points: Baseline, month 6, month 12  
 
Minimum detectable differences in proportions with outcomes  
Assumption: 80% power, alpha 0.05, ICC 0.2, 10 clusters per arm, average cluster size of 50   
Proportion with 
outcome in arm 1 
Proportion 
with outcome 
in arm 2 
0.2 
0.31 
0.3 
0.44 
0.4 
0.56 

ATTACH Protocol, Version 2.6 
December 29, 2020 
 
 
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66 
0.5 
0.69 
0.6 
0.81 
0.7 
0.93 
 
Exploratory analyses  
1. Post-transition retention defined as completing and adult clinic visit day after transfer to adult 
services and at least 1 other visit within 6 months of the adult visit (total of 2 visits):  
Analysis: GEE to compare post-transition retention in intervention and control sites 
 
2. Principal components analysis to identify the most representative components of data in the 
4 domains of the readiness assessment checklist (HIV treatment literacy (Q 1-5), self-
management (Q6, 7, 9-14, communication Q16-19, support 20-22) and then factor analysis 
to determine the most important components.  
 
3. Proportion of children with full disclosure and time to full disclosure. Children who do not know 
their HIV status from HCW assessment. Child will be asked why they are taking medicine; if 
they report they have HIV they have reached full disclosure. If they mention any other illness 
or other responses they will not have reached full disclosure.  
End point: Child says they have HIV in response to the question “why are you taking your 
medicine”  
Analysis: Descriptive %, time to full disclosure  
 
 
Appendix 1: Schedule for data collection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*only in adolescent models of care  
 
 
Tools  
Mo 
0  
Mo 
3  
Mo 
6  
Mo 
9  
Mo 
12  
Primary outcome  
Transition readiness   
Transition readiness 
assessment 
X 
 
X 
 
X 
Secondary outcome  
% with full disclosure   
Disclosure checklist  
X 
X 
X 
X 
X 
Time to full disclosure  
Disclosure checklist  
X 
X 
X 
X 
X 
Age at full disclosure  
Disclosure checklist  
X 
X 
X 
X 
X 
Post transition retention*  
Transition log  
X 
X 
X 
X 
X 
Overall retention  
EMR  
X 
 
X 
 
X 
Overall viral suppression  
EMR  
X 
 
X 
 
X