Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of Washington

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Simulated Patient Encounters to Promote Early 
Detection and Engagement in Care for 
Adolescents (SPEED) 
 
 
Grant Number: R01HD08507-01 
Principal Investigator: Pamela Kohler, PhD, MPH, RN 
 
Version Number:  7.0 
 
May 11, 2020

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LIST OF ABBREVIATIONS 
 
APS 
Adolescent package of services 
ART 
Antiretroviral therapy 
CAB 
Community advisory board 
CCC 
Comprehensive care clinic 
CATCH 
Counseling and testing for children at home 
CEA 
Cost-effectiveness analysis 
CQI 
Continuous quality improvement 
DALY 
Disability-adjusted life year 
DASH 
Developing adolescent strategies for HIV testing 
FGD 
Focus group discussion 
FP 
Family planning 
GBV 
Gender-based violence 
HCW 
Health care worker 
 
HIV 
Human Immunodeficiency Virus 
IDI 
In-depth interview 
KNH 
Kenyatta National Hospital 
NASCOP 
National AIDS and STI Control Programme 
PMTCT 
Prevention of mother-to-child transmission 
PUSH 
Pediatric urgent start of HAART 
STI 
Sexually transmitted infection 
VCT 
Voluntary counseling and testing 
WHO 
World Health Organization 
SP 
Standardized Patient Actor 
YFS 
Youth-friendly services 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
 
Title: 
Simulated Patient Encounters to Promote Early Detection and 
Engagement in Care for Adolescents (SPEED) 
 
Objective: 
This study aims to develop and evaluate a clinical training intervention 
utilizing standardized patient actors to improve communication and 
interpersonal skills of health care workers in working with adolescents, 
resulting in increased engagement in HIV care. 
  
Aims: 
Aim 1: To develop  case scripts specific to adolescent HIV care  for use 
in SP encounters  
 
Aim 2: To assess the impact of SP encounters on the likelihood of 
adolescent patients retained in care, and adherent to ART at public 
HIV treatment facilities in Kenya  
 
Aim 3: To estimate the cost-effectiveness of SP training per adolescent 
retained in care 
 
Methods 
Aim 1: Pilot testing and  standardization of SP training tools and 
scoring with 10 health care workers (HCW) in HIV care 
 
Aim 2: Stepped-wedge randomized controlled trial 
 
Aim 3: Cost-effectiveness and cost-utility analysis  
 
Population: 
Health care workers: Currently employed in HIV care services  
 
Adolescents: HIV-infected boys and girls ages 10-24 years  
 
Number of Sites: 
24 sites in Nairobi, Kiambu, Homa Bay, and Kisumu Counties in Kenya 
 
Study Duration: 
4 years 
 
Outcomes 
 
Aim 1: Final scripts/ tools and scoring rubric for use in SP encounters 
 
Aim 2: Trial 
 
Primary Outcome: Retention in HIV care 
o Return for 1st follow-up visit among newly enrolled 
clients OR follow-up visit after ‘re-engagement visit’ 
(after LTFU for >3 months) 
o Return for ANY follow-up visit within 3 months among 
currently enrolled HV-positive adolescent patients 
 
Secondary Outcomes: 
o Satisfaction (adolescents and HCWs) 
o HCW competency  in adolescent friendly counseling 

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o Medication adherence 
o Viral suppression 
o Assessment, referral, and linkage to affiliated services 
o AIDS defining illness 
o Outpatient visits and hospitalizations 
o Mortality 
 
Aim 3: Cost Effectiveness and Cost Utility analyses 
 
Cost per additional HIV-infected adolescent retained in care 
 
Cost per additional life year saved and disability-adjusted life 
(DALY) averted 
 
 

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KEY ROLES AND CONTACT INFORMATION 
Principal 
Investigator 
Pamela Kohler PhD, MPH, RN 
Assistant Professor, Global Health, Psychosocial & Community Health 
University of Washington 
325 9th Avenue, Box 359932 
Seattle WA 98104  USA 
Tel: 206.616.7962 / Fax: 206.221.4945 
Email: pkohler2@uw.edu  
 
Site Director 
Dalton Wamalwa MBChB, MMed, MPH 
Senior Lecturer, Paediatrics & Child Health 
University of Nairobi / Kenyatta National Hospital 
Email: dalton@africaonline.co.ke 
 
Co-
Investigators  
 
Grace John-Stewart, PhD, MPH, MD 
Professor, Medicine, Epidemiology, Pediatrics, Global Health 
University of Washington 
gjohn@uw.edu 
 
Barbra Richardson, PhD, MS 
Research Professor, Global Health, Biostatistics 
University of Washington 
barbrar@uw.edu  
 
Joseph Babigumira, PhD, MS, MBChB 
Assistant Professor, Global Health, Pharmacy 
University of Washington 
babijo@uw.edu  
 
Brandon Guthrie, PhD, MPH 
Assistant Professor, Global Health, Epidemiology 
University of Washington 
brguth@uw.edu  
 
Irene Inwani, MBChB, MMed 
Consultant Pediatrician 
Kenyatta National Hospital  
iinwani@yahoo.com 
 
David E. Bukusi, MBChB, MMed 
Head, KNH VCT and HIV Prevention Unit/Youth Centre  
Kenyatta National Hospital  
davidbukusi@gmail.com  
 
 
 
 

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Jennifer Slyker, PhD, MSc 
Assistant Professor, Global Health 
University of Washington 
jslyker@uw.edu  
 
Kate Wilson, PhD, MPH 
Postdoctoral Research Fellow, Global Health 
University of Washington 
ksw@uw.edu 
 
Cyrus Mugo Wachira, MBChB, MPHc 
Study Coordinator  
University of Nairobi / Kenyatta National Hospital 
cyrusmugodr@gmail.com  
 
Anjuli Wagner, PhD, MPH 
Postdoctoral Research Fellow, Global Health 
University of Washington 
anjuliw@uw.edu  
 
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 
Nairobi, Kenya 00202 
 
 
Funding 
National Institutes of Health (NIH) 
Grant: 1R01HD085807-01 (Kohler, PI) – “Simulated Patient Encounters to 
Promote Early Detection and Engagement in HIV 
Care for Adolescents” 
 
 
 
 
 
 
 
 

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1. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
1a. Background Information 
 
Sub-Saharan Africa has disproportionately high burden of adolescent HIV infection 
Despite enormous expansion of HIV testing and treatment services in resource-limited settings, 
adolescents (ages 10-19) and youth (ages 20-24) continue to be substantially and 
disproportionately affected by HIV [1]. In 2012, an estimated 2.1 million adolescents were living 
with HIV , and 300,000 adolescents were newly infected [2].  And while mortality has decreased 
in adult and pediatric populations, there has been a 50% increase in adolescent HIV-related 
deaths over the last 7 years. Sub-Saharan Africa is home to 80% of adolescents and youth 
living with HIV globally [3]. Kenya alone accounts for 7% of all new adolescent HIV infections 
[2].  
 
Substantial barriers for adolescent linkage to and retention in the HIV care cascade 
Although HIV services have expanded throughout Africa, there has been less programmatic 
focus on adolescent HIV care than on adult care [1, 4, 5]. Inadequate provision of accessible 
and acceptable HIV testing, counseling, and treatment services is cited as a barrier to uptake of 
and retention in HIV care among adolescents [6].  For example, a recent Kenyan HIV treatment 
cohort study reported that 25% of youth and adolescents did not return after their first visit, 41% 
were lost in the first 12-months of the pre-ART period, and 21% of those initiating ART were lost 
within one year; rates higher than reported in adult programs [7]. Optimizing impact of HIV 
treatment programs requires early identification of HIV status, prompt linkage to care, and 
sustained adherence to antiretroviral therapy (ART).  Loss throughout the care cascade 
translates to poor health outcomes and increased mortality, and subsequent HIV transmission 
due to uncontrolled viral load in all age groups.  There is an urgent need for evidence-based 
interventions that promote adolescent uptake of and retention in  HIV care [5]. 
 
HCWs lack confidence in their ability to provide HIV care for adolescents 
A study of reproductive health HCWs in Kenya documented a disconnect between advertised 
“youth friendly services” and HCWs’ lack of competency and training to carry out adolescent 
friendly care [8]. For example, while guidelines call for “adolescent friendly HIV testing”, few 
details are provided to define what an “adolescent friendly” approach actually entails.  Health 
HCWs expressed feeling a lack of competency in providing services to young people, especially 
related to counselling and interpersonal communication [8]. HCWs reported feeling conflicted 
between their own personal feelings, cultural and religious values and beliefs, and their wish to 
support young people's rights to accessing services.  
In our preliminary studies, health care workers tasked with providing adolescent HIV testing 
services also reported feeling inadequately prepared to cope with the needs of this age group 
Themes included concern over adolescent depression and mental health, provider lack of 
confidence in counseling skills or fear of doing the wrong thing, concern over how to 
handle/advise adolescent disclosure and parental issues, and questions of adolescent 
autonomy and consent.   

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Adolescents have unique needs in HIV care and treatment 
Few studies describe experiences of adolescents in accessing and engaging in HIV services. 
Adolescents experience unique physiological, developmental, and psychosocial changes that 
could potentially aggravate preexisting stressors associated with HIV infection [9-11]. Young 
people with HIV are particularly vulnerable to issues of mental health and depression, which can 
exacerbate poor adherence and retention in care [12]. Reported programmatic barriers include 
fear of harsh treatment by health care providers and lack of confidentiality or privacy in the 
health clinic [8].  
 
Although adolescent-friendly policies exist, evidence-based interventions to improve health care 
workers competencies to provide high quality adolescent care are lacking  
Globally, initiatives are underway to promote “adolescent friendly” health services.  The WHO 
recommendations for adolescent friendly services include development of adolescent-specific 
skills and behaviors of health providers, assuring health facilities are appropriately equipped and 
appealing for adolescents, adolescents are aware of where they can obtain health services, and 
communities are aware and supportive of the health-services needs of adolescents. Adolescent 
friendly care aims to ensure that health providers are “non-judgmental and considerate in their 
dealings with adolescents” and that they have the “competencies to deliver the right health 
services in the right way” [13].  
 
Patient-centered care is the missing link in the implementation ‘know-do’ gap to enhance 
adolescent HIV care 
The impact and effectiveness of antiretroviral treatment (ART) is diminished by failure to 
adequately cover the adolescent population and to deliver services in an approachable and 
accessible manner. This type of “know-do” gap has been suggested to be rooted in lack of 
attention to quality in implementation of proven interventions like ART [14]. Quality of care is 
defined by the Institute of Medicine as safe, effective, patient-centered, efficient, timely and 
equitable [15]. Patient-centered communication, as defined by the Kalamazoo Consensus, 
includes building a relationship, opening discussion, gathering information, understanding the 
patient perspective, sharing information, reaching an agreement and providing closure [16]. 
These key components of care are often under-trained and under-implemented in resource-
limited settings. A recent health facility assessment of HIV linkage and retention in care in Kenya 
noted that reported barriers (stigma associated with health facilities, poor provider-patient 
interactions) reflected a need for a new patient-centered approach to HIV care [17]. 
 
There is evidence that standardized patient actors improve quality of clinical care 
Standardized patients (SPs) are trained actors that work with health care providers in mock 
clinical encounters for the purposes of training and evaluation [18].  Used since the 1960s in 
clinical and medical education and for licensing exams,[19] SPs are increasingly used as a 
mechanism to develop and improve skills related to patient-centered communication: empathy, 
communication skills, and counseling.  As an evaluation tool, SPs are considered the gold-
standard in measuring quality of care [19] and have been shown to accurately assess provider 

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performance in a variety of settings.[20-23] Not only are SPs an accurate measurement of care, 
reliably predicting provider behavior and clinical performance, but they can be used as a 
teaching mechanism. For example, in Mexico, training of delivery-room staff with low-tech 
simulations of obstetric emergencies resulted in improved process outcomes of health care 
provider knowledge and self-efficacy, but also significantly improved client health outcomes 
including perinatal mortality, eclampsia, and cesarean deliveries [24-26]. Other uses of actors 
include breaking bad news for oncology fellows [27], motivational interviewing training for 
community substance abuse providers [28], and end of life difficult conversations for surgical 
intensive care unit personnel.[29] 
 
Improving clinical care and adolescent-friendly services may result in increased engagement in 
care 
Despite clear guidelines for the type of behaviors and messaging to be practiced by health care 
providers, we are unaware of any scalable, evidence-based interventions that build adolescent 
friendly capacities in health care providers and that have been linked to improved adolescent 
care outcomes.  A systematic review of adolescent friendly interventions found few rigorous 
studies of adolescent provider training programs [30]. Given the success of standardized patient 
and simulation programs in other settings, it is plausible that high-quality, patient-centered 
approaches could increase linkage to care, retention, and ART adherence among HIV-infected 
adolescents in sub-Saharan Africa.  
 
1b. Rationale 
An SP intervention for health providers has the potential to promote high-quality patient 
centered HIV services for adolescents by providing health workers with technical skills and 
pragmatic experiences. This improvement in delivery of care can, in turn, address barriers cited 
by adolescents and improve linkage to, and retention in, vital HIV services. By increasing 
engagement in care, the program can ultimately improve survival and decrease subsequent HIV 
transmission among adolescents in Kenya. 
 
2. OBJECTIVES 
 
2a. Study Objective 
This study aims to develop and evaluate a clinical training intervention utilizing standardized 
patient actors to improve communication and interpersonal skills of health care workers in 
caring for HIV infected adolescents (ages 10-24 years), resulting in increased engagement in 
HIV care. 
 
2b. Specific Aims 
Aim 1: To develop patient case scripts specific to adolescent HIV-related care and 
counseling needs in Kenya, and to establish the number of training interactions 
necessary to reach competency 
Hypothesis: Utilization of real-world adolescent experiences in a simulated patient actor training 

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program will improve health care provider communication and counseling skills with adolescents 
in Kenyan HIV care programs 
 
Approach: Case scripts will be developed for male and female SP actors, derived from in-depth 
interviews with HIV-infected adolescents. We will establish competency scores and pass/fail cut-
offs with a pilot sample of 10 health care workers (HCWs). 
 
Aim 2: To assess the impact of SP encounters on the likelihood of adolescent patients 
retained in HIV care, and adherent to ART at public HIV treatment facilities in Kenya  
Hypothesis: SP encounters will increase provider confidence and capacity to facilitate HIV 
status disclosure and provide supportive interactions with HIV-infected youth, which will 
significantly increase retention in HIV care and improve ART adherence among adolescents.  
 
Approach: We will utilize a stepped wedge study design to assess retention in HIV services 
among HIV-infected adolescents. We will compare periods when clinics have received the SP 
training (‘exposed periods’) to ‘control periods’ prior to this training, when clinics are providing 
standard care. Data will be extracted via electronic medical records.  
 
Aim 3: To estimate the cost-effectiveness of SP training per additional adolescent 
retained in care and cost-utility per life-year saved and per disability-adjusted life-year 
(DALY) averted for each adolescent  
Hypothesis: An interactive SP training program will be cost-effective  
 
Approach: We will measure detailed healthcare and program costs. We will use these costs to 
(1) estimate the short-term cost-effectiveness (measured as cost per additional adolescent 
retained in care) and (2), use modeling methods to estimate the long-term cost utility (measured 
as cost per disability-adjusted life-year averted). 
 
 
3. STUDY OUTCOMES 
 
3a. Primary outcomes 
Aim 2: Stepped-wedge randomized controlled trial (RCT) 
The primary outcome for this study is adolescent retention in HIV care, defined as: 
 
 
Return for 1st follow-up visit after first enrollment visit OR return for follow-up visit 
after a ‘re-engagement visit’ among adolescents who had previously been lost to 
follow-up (LTFU)  

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 
Retention in care for ANY follow-up visit within 3 months among adolescents 
currently enrolled in HIV care (which can be referred to as “actively enrolled”) 
 
Description: 
First follow-up visit after enrollment visit: The number and proportion of adolescents who 
return to clinic within 3 months of an enrollment visit   
 
Follow-up visit after re-engagement in care among LTFU adolescents: Lost to follow-up 
is defined as no clinic record for at least 3 months, and no record of death or transfer to 
another facility. Among adolescents who return to clinic after LTFU, we will collect the 
number and proportion of adolescents who return for a subsequent visit within 3 months.   
Return for follow-up among those currently enrolled in care: To evaluate whether the 
SPEED intervention may result in better adherence to visit schedule among adolescents 
currently enrolled in HIV care (i.e. not newly enrolled or previously LTFU), we will also 
measure return for any follow-up visit within 3 and 6 months.  
 
3b. Secondary outcomes:  
 
Aim 1: Pilot testing of case scripts and establishment of competency 
 
 
Final case scripts 
 
Numeric scores on HCW checklist 
 
Proportion of HCWs with pass/fail scores 
 
Numeric scores on actor feedback checklists 
 
Numeric scores on HCW satisfaction survey 
 
Numeric scores on HCW self-rated competency survey 
 
Aim 2: Stepped-wedge randomized controlled trial 
In addition to the primary outcomes, the RCT will have several secondary outcomes, 
summarized in in Table 1: 
 
Analyses of process outcomes to understand intervention mechanism will include:  
 
Pre/post-measures of HCW and patient satisfaction  
 
Pre/post-measures of HCW competency scores  
 
Associations between HCW competency scores and care outcomes  
 
Associations between HCW competency scores and adolescent satisfaction 
outcomes  

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 
Exit interviews in a purposeful sample of HCW participants at the end of the trial 
 
Table 1. Summary of process outcomes, exploratory outcomes, and indicators in Aim 
2 RCT 
 
Process Outcomes 
Indicator  
Source  
HCW competency  
 
Mean HCW scores per clinic  
 
Faculty graded scores 
Exit interviews 
HCW satisfaction 
Mean HCW score per clinic 
HCW survey 
Adolescent patient satisfaction  
Mean adolescent score per clinic  
Tablet-based questionnaire  
Clinical/Exploratory Outcomes  
Adherence  
Refills within 1 week of scheduled 
return visit 
Clinic/pharmacy records  
Viral suppression  
Viral load (VL) <1000 copies per ml and 
a second analysis using VL <400 
copies/ml  
Clinic records  
Linkage to APS services  
STI/TB 
screening, 
Contraception 
uptake, mental health referral  
Clinic records  
AIDS defining illness 
Diagnosis of at least one AIDS defining 
illness per national guidelines 
Clinic record 
Mortality  
Death during follow up  
Clinic records  
 
 
Aim 3: Cost Effectiveness Analysis (CEA) and Cost Utility Analysis (CUA) 
      This aim will assess the following measures: 
 
SPEED intervention costs 
 
Cost per additional HIV-infected adolescent retained in care  
 
Cost per additional life year saved and disability-adjusted life year (DALY) averted. 
This estimate is the gold standard in health economics. This analysis will be 
performed once an adequate mathematical model of adolescent DALYs is 
developed. 
 
Additional exploratory outcomes 
 
Cost per additional HIV-infected adolescent with ≥80% adherence 
 
Cost  per additional HIV-infected adolescent virally suppressed 
 
Cost  per additional HIV-infected adolescent linked to APS services 
 

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4. STUDY DESIGN 
This study uses a stepped wedge approach to evaluate a clinical training intervention which 
utilizes standardized patient actors to improve communication and interpersonal skills of health 
care workers in working with adolescents, resulting in increased engagement in HIV care.  
 
The pilot phase will inform the creation of case scripts and test them in a sample of health care 
workers. The trial phase will evaluate effectiveness of the SP training intervention through a 
stepped-wedge trial design. This study design is well-suited to interventions that occur at the 
clinic, rather than individual, level and to interventions that are not feasible to implement 
simultaneously at a large number of clinics. The randomization at a clinic level to when the 
intervention is introduced allows for the traditional benefits of randomization. Additional analyses 
will measure the cost-effectiveness and cost-utility of the intervention. 

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5. STUDY ENROLLMENT AND WITHDRAWAL 
 
5a. Study sites 
The pilot phase will recruit health workers from Kenyatta National Hospital (KNH) in Nairobi, 
Kenya. The randomized controlled trial (RCT) will enroll health workers from up to 24 clinics that 
provide adolescent HIV care services in Nairobi and Western Kenya. 
 
5b. Study population 
The SP intervention involves a training program for HCWs who provide clinical services to 
adolescents living with HIV. Enrolled HCWs include clinical officers, psychologists (where 
available), doctors, and nurses. Additional cadres may be included, depending on their roles at 
the site, if they provide direct clinical services to adolescents. The study will enroll adolescent 
clients at each study site to assess outcomes of patient satisfaction, however adolescent 
retention and clinical outcomes will be assed via a de-identified audit of clinic electronic medical 
records (EMR).   
 
Justification for involvement of adolescents:  In sub-Saharan Africa, adolescents are at high 
risk for acquiring HIV, have poor HIV testing coverage, and are at high risk for poor treatment 
adherence. The purpose of this research is to improve adolescent HIV care. Collection of data 
about adolescents is necessary to determine the effectiveness and cost-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 2 below. 
Eligible clinics must have at least 40 adolescents enrolled in care, a current EMR system, and 
no other special adolescent interventions. The eligibility criteria for the pilot phase is the same 
as for HCWs in the RCT. Health care worker participants must be 18 years of age or older, 
employed at trial sites and provide clinical services to adolescents. Adolescent records will be 
abstracted among 10-24 year olds enrolled in HIV care.  Adolescent clients between the ages of 
10-24 presenting for HIV care at enrolled sites will be eligible to complete patient satisfaction 
surveys.  
 
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 training intervention at that site and/or the 
collection of outcome measures.  
 

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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. This applies both to the pilot phase and the RCT.  
Table 2. Inclusion Criteria for all Participants 
Population 
Sampling 
N 
Inclusion Criteria 
Clinic clusters  
Selected from clinics 
with ≥40 adolescent 
clients 
24 
 
≥40 adolescents currently in HIV 
care 
 
EMR data system 
 
No concurrent adolescent 
interventions 
Health Care Workers (e.g. 
doctors, nurses, clinical 
officers, nurse counselors) 
Up to 10 per clinic  
240 
>18 years of age 
 
Employed at trial site in clinical care 
for at least three months and/or have 
a 1 year contract (i.e. not temporary 
staff) 
 
Provides clinical services to 
adolescents 
Adolescent client records  
Complete record 
audit 
Up to 
50,000 
Records of clients age 10-24 in trial 
sites 
Adolescent clients 
Up to 20 per clinic 
per time point 
Up to 
2,400 
Ages 10-24 
 
Seeking counseling or treatment 
services at trial site 
 
HIV-infected 
5e. Strategies for recruitment and retention 
 
Pilot phase  
 
Up to 10 HCWs who are >18 years of age, and employed in HIV care at Comprehensive Care 
Centers (CCCs) and adolescent clinics at KNH will be recruited to participate in the pilot testing 
of study tools and scoring rubric. We will obtain permission from the clinic directors before 
recruitment. We will receive a list of potential participants. A member of the study team will be 
stationed at the clinics and approach potential participants to learn more about the pilot testing 
phase of the study. In this phase, HCW participants will take part in a pilot 2-3 day training that 
includes a didactic component, 6-7 SP encounters, group debriefing and discussion. 
Participants will provide their contact information to ensure completion of the training.  
 

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Stepped-wedge randomized controlled trial 
 
 
Clinics/individual HCW participants: For the stepped-wedge trial, the SPEED study team 
will identify up to 24 clinics that meet study eligibility criteria. We will receive permission 
from NASCOP and local administrative teams 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 SP intervention 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 
first to gain access to providers. A study staff member will then approach those providers 
to invite them to learn more about the study.  
Within participating clinics, all clinical providers who have contact with adolescent clients 
will be approached for participation.  Eligible providers at that facility will give informed 
consent (see Section 13). Eligible providers at that facility will give informed consent. We 
anticipate an average of 10 HCWs per site, depending on clinic size. 
 
 
Adolescents attending clinics: A clinical staff member will be instructed by our Study 
Team to refer consecutively, all adolescents seeking HIV care on a given day, to the 
Study Team member. This Team member will be at each clinic to invite adolescents to 
complete an anonymous, tablet-based survey to assess satisfaction with their 
counseling or treatment encounter. We will track numbers of adolescents referred 
compared to total adolescent patients, and reasons for not referring to identify any 
differences in referrals by time of day or day of week. 
We expect to enroll at least 5 adolescents per clinic per time period and up to 20, 
depending on clinic volume (20 adolescents X 5 time periods X 24 clinics = up to 2,400). 
A Study Team member will be at each clinic for 1-3 days for recruitment.  
 
 
Retention strategies for HCWs and adolescents: While the intervention targets health 
facilities, we will track individual providers to assess retention in service provision at 
clinical intervention sites, using a facility survey to monitor staff turnover.  In addition, 
provider names and phone numbers will be recorded, and we will assess the provider’s 
continued employment at the sites, as well as any cross-over to other study sites, at 
each measurement time point.   Adolescent surveys will be cross-sectional at each time 
point. Accordingly, there is no need for a retention strategy for this group.   
 
Cost Effectiveness Analysis and Cost Utility Analysis (CUA) 
 
No participants will be recruited specifically for this analysis. Questions on direct and indirect 
costs, as well as clinic and hospital visits, to the adolescents will be included in the adolescent 
satisfaction survey (Appendices). Other cost data will be drawn from program data, the 
literature, and our prior studies.  
 
 
 
5f. Randomization procedures 

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For the stepped-wedge randomized controlled trial, the 24 clinics will be randomized to the time 
when they receive the SPEED intervention. In this one-way cross-over design, all 24 sites will 
eventually receive the intervention. Groups of 6 clinics will be randomized to receive the 
intervention in one of four waves. We will use stratified randomization where facilities are also 
allocated to waves according to region and by facility size, defined as ‘high volume’, more than 
73 AYA enrolled and medium volume, 73 or fewer AYA enrolled, based on the median, to ensure 
balance of characteristics in each wave [31]. A UW Biostatistician will generate the 
randomization assignment for each clinic in R Statistical Software (R Core Team, Vienna, 
Austria). 
 
5g. Masking procedures 
 
Because this a clinic training intervention using a pragmatic trial design, there will be no 
masking procedures.  
 
5h. Participant Withdrawal 
Participants may withdraw from the study at any time or the investigator may terminate a 
participant’s participation. 
 
Reasons for Withdrawal 
Reasons for a study clinic to withdraw may include: clinic closure or major changes in HIV 
testing and treatment policies, procedures, or organization structural that would prevent or 
substantially limit our ability to conduct this study.  
Reasons for HCW participant withdrawal may include: discomfort or distress as a result of the 
training, lack of time to complete the follow-up surveys, or job termination or relocation.   
Reasons for an adolescent participant to not complete the satisfaction survey may include, lack 
of time, comfort, or interest in answering the questions. 
An investigator may terminate a study participant’s 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 if a HCW participant behaves in a way that disrupts 
or prevents the successful conduct of the SP encounter training.  
 
 
Handling of participant withdrawals   
 
The study team will track the withdrawal of any clinic during the trial. The timing and reasons for 
withdrawal will be recorded, and reported to the PI. HCW participants in the clinical intervention 
may withdraw at any time without affecting their regular job. The study team will record the 
timing and reasons for withdrawal of individual HCW participants. The participant will be 
thanked for their time in the study and not contacted further by the study team. No replacement 
of study clinics or HCW participants will be conducted because of design and logistical 
challenges. 

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6. SPEED STUDY INTERVENTION  
 
This study is evaluating a clinical training intervention utilizing standardized patients (SPs) that 
is anchored in social learning and behavioral theories [31, 32]. Standardized patients (SPs) are 
trained actors that work with health care providers in mock clinical training encounters, with a 
focus on improving communication skills and empathy. Through SP encounters, HCWs learn 
through 
cycles 
of 
concrete 
experiences, 
reflection, 
conceptualization, 
and 
active 
experimentation in a safe and controlled setting. We hypothesize that improved communication 
skills, competency, and empathy that HCWs will gain through this training will motivate 
adolescent patients to stay engaged in HIV care, including initiating and adhering to ART. 
The clinical training intervention will consist of a combination of didactic sessions and SP 
encounters. Provider participants will receive orientation to the SP actor methodology as well as 
content related to communication skills and adolescent care. The intervention training schedule 
will be planned to minimize disruption to clinic operations.  
 
For each wave of six clinics in the RCT, we estimate that it will take about 2 weeks (not more 
than 4 weeks) to train all HCWs in the Nairobi/Kiambu and Western Kenya sites. This timeframe 
will vary based on HCW availability and travel.  
 

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7. STUDY PROCEDURES   
Study procedures for the SPEED study consist of a pilot phase, which aims to test training 
materials and establish competency scores for participating providers; and a randomized trial 
phase, which will implement and evaluate the SP training intervention. 
 
Note on recruitment, hiring, and training of SP actors 
We will contract with a professional Kenyan casting agency to identify and train 6-7 actors over 
18 who are able to portray adolescent cases ages 14 – 19.  These actors will be part of the 
study staff and are not participants.  
The actors will be trained on each adolescent patient case by a behavioral expert before the 
pilot phase. They will also be trained in human participants protections because of their contact 
with study participants (HCW participants). Actors will sign confidentiality agreements to ensure 
that they do not discuss the SP encounters, and other identifying information, to people outside 
of the study.  
Actors will receive annual refresher training in the case scripts. The Study Team will monitor the 
actors’ attendance at all HCW trainings, and report any problems to the casting agency.  
 
7a. Pilot Phase 
 
Development of adolescent case scripts 
We have analyzed in-depth interviews of HIV-positive adolescents enrolled in an ongoing study 
on HIV testing and counseling at KNH to develop the case scripts which the actors will portray. 
Each case describes medical and social history of the adolescent, and the primary concern at 
that visit which the HCW must identify. The cases were developed to reflect a range of issues 
that may affect adolescent patients seeking HIV care, including around disclosure, depression, 
fertility desire, sexual behavior and sexuality, and gender-based violence. There are male and 
female cases, ranging in ages between 14 and 19.   
 
Materials piloting and competency assessment 
In the pilot phase, we will determine the logistics of the training timing and schedule and 
establish pass/fail cut-off scores for acceptable competency. HCWs will sign standard written 
informed consent. The pilot phase will consist of the intervention training for 10 HCWs in HIV 
care at Kenyatta National Hospital. The training will take place over approximately 2-3 days and 
include didactic and role-playing experiences with the SPs.  During the training, provider 
participants will rotate through up to 7 video-taped SP encounters. Each encounter will last 
approximately 10-15 minutes. During the encounter, the HCW will counsel the SP as if they 
were a real client. Encounters will be followed by facilitated group debriefing sessions. The 
trainer will facilitate discussion and each provider will have the opportunity to discuss their 
experience and receive feedback from peers and actors. Faculty experts will review and grade 
the videotapes via an online learning management system. A study team of faculty and experts 
from Kenya and the US with expertise in adolescent health will provide structured feedback on 
participants’ technical competency according to a faculty checklist.  

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Training evaluation 
At completion of the training session, all HCW participants will complete a training satisfaction 
survey and a competency survey. Due to COVID-19 pandemic starting March 2020, HCW 
surveys for Wave 4 will be conducted by phone instead of in-person at a healthcare facility.  
After the implementation period, about 5 HCWs will be invited to participate in brief exit 
interviews on relevance of the training to their work, and barriers and facilitators to implementing 
skills they learned. Exit interviews will be conducted by a study staff member in a private room 
and last up to 30 minutes. 
 
7b. Stepped Wedge Randomized Controlled Trial (RCT) 
 
We will conduct a stepped wedge randomized controlled trial (RCT) to test the impact of the 
finalized clinical training intervention on health seeking behaviors of HIV-infected adolescents.   
 
Baseline assessment  
At each of the enrolled clinics, we will conduct a baseline assessment of all clinical and 
satisfaction endpoints, including audits of adolescent client clinical records, and adolescent 
satisfaction surveys.  Facility surveys will be conducted with a clinic representative to assess 
staffing, training experience, and current services for adolescent HIV care.  
 
Intervention waves 
Each intervention wave will train HCWs from 6 clinics. At the beginning of training, participant 
HCWs will fill out social demographic forms. They will then complete the training sessions, 
including didactic lessons, videotaped encounters, and debriefing sessions. Feedback and 
scoring will be provided using SP checklists for emotional responses, faculty checklist for 
technical skill, and group discussion for peer support.  Intervention waves will be repeated until 
all sites have received the training (see timeline). 
 
7c. Procedures for training interventionists and monitoring intervention fidelity 
 
A consultant expert will train the SP actors on procedures for conducting the encounters and 
giving feedback. Intervention fidelity (fidelity of the actors to their assigned cases) will be 
monitored during the trial through period assessments of actor fidelity. Study team members will 
review a random sample of video-taped encounters in each intervention wave, and rate actor 
fidelity according to a standard actor fidelity checklist (see Appendices). In addition, the trainer 
will provide periodic refresher trainings for the actors during the trial.  
 
7d. Assessment of participant compliance with study intervention 
 
Once the training is completed, we will regularly conduct facility surveys to monitor turn-over of 
SPEED trained HCWs, changes in clinic policies and procedures, and other facility-level factors 
that could affect intervention fidelity.  
  

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8. STUDY SCHEDULE 
 
In this trial, there will be 4 waves of 6 clinics per wave, and 5 measurement periods, including 
baseline (Table 3). Total duration of the trial is approximately 3 years. Each wave will be rolled 
out approximately every nine months. Data pulls will occur 15 months after the HCW training, to 
ensure that all clients who present within the exposure time period have a full 6 months to return 
for care.  
 
Table 3. Overview of stepped-wedge trial timing, by cluster wave 
Introduction of Intervention 
Clinic clusters 
Baseline 
Month 1 
Month 10 
 Month 19 
Month 28 
Wave 1: Sites 1-6 
0 
X 
X 
X 
X 
Wave 2: Sites 7-12 
0 
0 
X 
X 
X 
Wave 3: Sites 13-18 
0 
0 
0 
X 
X 
Wave 4: Sites 19-24 
0 
0 
0 
0 
X 
  
 
An overview of the anticipated overall study schedule for one wave is shown in Table 4, 
following page. The study will be conducted over five years.  During year one, we anticipate 
script development, recruiting and training SPs, developing measurement checklists, and 
piloting initial encounters at Kenyatta National Hospital.  During year two, we will recruit and 
randomize study sites, and begin implementation of the intervention.  The intervention will be 
rolled out in waves, completing measurement and intervention cycles during year 4.  Year 5 will 
be dedicated to statistical outcome analyses, cost effectiveness analyses and modeling, and 
dissemination of study findings both locally and internationally. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 4. Overview of SPEED Study 2015 - 2020 
 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Actor Training 
  
  
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Pilot phase 
  
  
 
   
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Consents & Randomization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline OR 
EMR data pull 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
X 
 
 
Wave 1 
  
  
  
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exposure time & data pull (X) 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Wave 2 
  
  
  
 
 X 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exposure time & data pull (X) 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Wave 3 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exposure time & data pull (X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Wave 4 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exposure time & data pull (X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Post-trial data pull  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Analysis  
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
Reports to stakeholders 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript development 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. ASSESSMENT OF SAFETY 
 
The SPEED study is a randomized trial of a clinical training intervention. 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 HIV counseling and treatment (client surveys and HCWs in training), 
breech of patient confidentiality during data extraction (adolescent clinic records), and fear of or 
actual loss of employment associated with disclosure of grades checklists (HCWs in training).  
 
There is a possibility for social harm (depression, violence after disclosure, abandonment) 
related to disclosure of HIV status during clinical encounters at HIV care enrollment or 
subsequent clinic visits. However, the possibility of this social harm would exist if this 
intervention were not conducted.  
 
9a. Specification of Safety Parameters 
 
The risks in this study fall under ‘unanticipated problems,’ as defined by the Office for Human 
Research Protections (OHRP) and the University of Washington (UW). Unanticipated problems 
are defined as a problem or event that meets all of the following criteria: 
 
Unexpected 
 
Related or possibly related to participation in the research 
 
Suggests that the research places (or could have placed) participants or others at a 
greater risk of harm than was previously known or recognized. This includes physical, 
psychological, economic or social harm 
 
We will periodically monitor all study sites for unanticipated problems, and record any 
unanticipated problems in a study database. Monitoring will be conducted on-site through 
observation of and feedback during training, follow-up data collection, and feedback from clinic 
leadership and staff.  
 
9b. 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. 

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10. STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of 
an External Advisory Panel (EAP) composed of members with expertise in stepped-wedge trial 
design, HIV research, and pediatric/adolescent health. The EAP will meet once yearly to assess 
unanticipated problems, study conduct, and progress.  If major concerns arise, more frequent 
meetings may be held.    

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11.  DATA COLLECTION 
 
All data collection tools submitted with this application can be found in the Appendices. 
 
Data sources for HCW participants 
 
 
Audio-visual recordings:  Video-recordings, locally recorded on a web-camera and 
uploaded to the SPEED learning management system (LMS), will be made of each 
HCW-SP interaction for training, scoring, and debriefing/feedback purposes in the pilot 
and in the RCT. The LMS will utilize Canvas software, a program available only to the 
Study Team and HCW participants. Each HCW will have a study ID number assigned to 
them and will log in to the LMS using a user name and private password.   
 
 
Surveys:  
o Actor feedback checklist (used in training only): Actors will complete an actor 
feedback checklist and review it with each HCW during the training.  
 
o Faculty checklist (used in training only): Faculty experts will review the videos 
and complete a faculty checklist with a final competency score for each HCW 
immediately after the training. These scores will be stored with each user record.  
 
o HCW sociodemographic and satisfaction survey: HCW participants will complete 
the sociodemographic and satisfaction questions at baseline and in the SPEED 
training.  
 
o HCW self-rated competency: HCW participants will complete the competency 
survey immediately after their training and at the end of each wave to assess 
perceived competency to care for adolescent patients. The survey will be 
repeated to assess changes in competency over time during the trial. The final 
survey will be conducted by telephone due to COVID-19. 
 
o Exit interviews: A purposeful sample of HCW participants from each wave will 
take part in one semi-structured exit interview each at the end of the RCT to 
better understand barriers and facilitators to applying the skills they learned in the 
SPEED intervention to their routine practice. The interview will follow a structured 
interview guide.  
 
o Facility survey: This survey will be administered to a health facility representative 
at baseline and at the end of each wave of the RCT to capture facility 
characteristics, including turn-over of SPEED-trained HCWs, patient volume, and 
any relevant changes in HIV policies and procedures. 
 
 
Program records:  
o Cost data: Direct and indirect cost data for the CEA/CUA analyses will be 
obtained from clinic program data (e.g. HCW salaries from employment records) 

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using an Excel spreadsheet. These data will be collected at baseline 
assessment. Cost data will be updated, as needed, at the end of the trial. 
 
 
Data sources from adolescents 
 
 
Clinic records: De-identified adolescent clinic records from the EMR system will 
extracted at baseline, and at the end of each wave to assess primary and clinical 
outcomes, according to our data use agreement with NASCOP. Data from each pull will 
capture all records until the previous data pull. Examples of data will be visit dates, 
enrollment status (newly enrolled or existing), date of birth/age, sex, viral load and CD4 
counts, pharmacy records, and referrals to family planning/TB/STI services.  
 
 
Adolescent satisfaction, cost, and sexual behavior surveys: Anonymous post-visit 
surveys will be conducted with adolescents using electronic tablets. These surveys will 
be conducted at baseline and at the end of each wave in all sites. Information will 
include basic demographics (age, schooling), type of service received/reason for visit, 
satisfaction with services received, perception of judgment by the health HCWs, and 
intent to return for services. Questions will also ask about direct and indirect costs 
associated with seeking care that the facility (e.g. cost of transportation, lost wages). The 
last section of the survey will be self-administered and ask questions about sexual 
behavior and sexual partners using electronic tablets. These surveys will be conducted 
at immediately after the satisfaction and costs surveys.  
 
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 statistical team for reporting, data cleaning, 
study monitoring, and interim analyses. Study data uploaded to the secure study cloud server 
using Open Data Kit (ODK).  Open Data Kit is a secure, web-based application designed by UW 
faculty 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 
 
 
Video-recordings will be stored on Canvas, a secured learning management system 
(LMS) utilized by the University of Washington. HCW participants will be able to log in to 
view the SP encounter videos and faculty scores. The LMS uses industry standard 
security will be password protected.  
 
 
HCW surveys, adolescent surveys, and the facility survey will be carried out by trained 
study staff members using ODK on tablets, 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 NASCOP. We will provide a list of variables and records for 

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a NASCOP-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 data base accessible only to authorized members of the study team. 
 
 
Program cost data (excluding the facility survey) will be stored in an Excel file for use in 
the CEA/CUA analyses. These data will not contain personal identifiers. 
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 (i.e. surveys 
and videos) 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 
 
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 participant identifiers and study ID codes will be retained 
for 6 years following completion of the study. Video data will be destroyed after 6 years, unless a 
waiver has been signed. HCW 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. No identifying data will be collected for 
the adolescent satisfaction surveys. 
 
 
 
12. STATISTICAL CONSIDERATIONS 
 
12a. Sample Size Considerations  
For the Aim 2 RCT, we based our sample size and power calculations on the primary outcome 
of retention in care, obtained from EMR data. This outcome is binary on the individual level. We 
used the methods described by Hussey and Hughes [32]  to determine power assuming an 
evaluation with 24 clusters and 5 time points (including baseline). We include 24 clinics in this 
study to account for the possibility that 15% drop-out without replacement. We assumed that 
only a small proportion of the 40 HIV-positive adolescents enrolled in HIV care per clinic may be 
newly enrolled or recently re-engaged in care. As such, we estimated the minimum number of 
records per clinic for 80% power to detect a 15% difference between control and intervention 
periods. We assumed a coefficient of variation (𝜏/𝜇) of 0.25 and calculated the power for a two-
tailed test with α=0.05. Based on relevant published data [7], we assumed that 75% of 
adolescents in the control period will return to clinic after first visit. Under these assumptions, we 
estimate needing at least 5 adolescents per clinic. As such, the lower bound of the sample size 
required is estimated to be 720 clinic records (6 records/site X 24 sites X 5time points). If N=20 

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clinics are retained, we would need 7 adolescents per site, per time point, or a minimum of 700 
records total.  
In the optimal scenario with an average of 40 adolescents in care at each facility, our estimated 
analysis sample size would be at least  4,800 (5 time points). Under the same assumptions 
described above, we would have >99% power to detect a 15% difference in retention between 
the intervention and control periods.  
We expect to have adequate power to detect an intervention effect for the analysis with a 
broader definition of retention in care (return for any follow-up visit within 6 months), because 
this is likely a more common pattern of follow-up than either return among newly enrolled or 
return after re-engagement in care .   
 
12b. Planned interim analyses (if applicable) 
Because this is a randomized trial with a stepped-wedge (staggered roll-out) design, there will 
be no interim analyses or stopping rules.  
 
12c. Overview of analysis plan 
 
Pilot phase 
 
Qualitative feedback from participants, actors, and faculty experts will be used to finalize the 
case scripts, actor checklist, and HCW satisfaction survey. 
Data from the completed faculty checklists will be used to establish competency scores. 
Participants, faculty experts, and actors will be asked to provide qualitative feedback on the 
checklist indicators. Inter-rater reliability of the faculty checklist will be determined using Cohen’s 
kappa. We will assess correlation of checklist variables and utilize principal component analysis 
to reduce the number of variables, using a scree test method to plot eigenvalues. Pass/fail cut-
off scores will utilize relative and absolute standard-setting processes [33].  In relative 
processes, initial pass/fail determinations will depend on the performance of the cohort, such 
that all scoring less than 1 standard deviation below the mean receives a fail. Relative 
standards are useful with new trainings where there is no prior performance data. Subsequently 
we will explore standard-setting using an iterative combination of the Angoff item-based method 
and the Hofstee whole-test method. The Angoff method establishes the probability of a 
borderline student to accomplish each item on the checklist. The sum of probabilities across 
items is then equal to a passing score. A team review process is convened in which reviewers 
discuss outlier ratings, assess performance data after pilot testing, and revision of ratings if 
necessary. The Hofstee whole-test method combines normative and absolute judgments, in that 
checklist reviewers make four determinations: the minimum and maximum acceptable passing 
scores, and the minimum and maximum proportions of students failing. A final cut-off 
determination will be made by averaging the Hofstee and Angoff scores. 
 
Stepped-Wedge Randomized Controlled Trial 
The primary analysis will be an intent-to-treat (ITT) analysis, assuming that adolescents who 
receive care at clinics after the SPEED training will be ‘exposed’ to HCWs trained in the SPEED 
intervention until the end of the study. 

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A CONSORT diagram, adapted for a stepped-wedge design [34] will be used to show the 
number of HCW-participants within clusters and flow of randomized stepped wedge clusters 
though the five time periods. We will report the number of clinics selected for inclusion, 
assignment to intervention or control at each time period, and the number of HCWs trained at 
each facility. We will report number of excluded clusters and any reasons for exclusion. No 
replacement will be used. Facility-specific information – adolescent patient volume, number of 
HCWs and presence of any adolescent-specific service (peer groups, clinics etc.) prior to the 
intervention – will be grouped by clinic and recorded. Baseline values of primary and process 
outcomes, and socio-demographic characteristics of adolescents and HCWs will be presented 
in a descriptive table.  
We will use generalized linear mixed models (GLMM), which are more efficient than paired t-
tests and linear mixed models (LMMs) in the analysis of cluster RCTs when the size of clusters 
is unequal [32] to compare the probability of an adolescent returning to clinic after enrollment 
visit OR second visit after >3 months LTFU between the intervention and control periods [35]. To 
estimate the effect of the intervention (Xij) on the individual level, we will use a GLMM model 
with a Poisson distribution and robust standard errors, allowing for random effects for clusters 
(ui) and fixed effects for time (j). This approach models individual level outcomes, adjusts for 
temporal trends and accounts for correlation of outcomes within a cluster (clinic). We will 
estimate adjusted risk ratios (ARR), adjusted risk differences (ARDs) and 95% confidence 
intervals at the 5% significance level (two-sided). Adjusted risk ratios will be estimated for 
secondary outcomes: initiating and adherent to ART (≥80% in the dosing period by pharmacy 
records), 12-month retention in care; viral suppression (<100 copies/ml, <1000 copies/ml), and 
referred for ancillary services (family planning and TB screening). Models will be adjusted for 
facility type, patient volume, and exposure to prior adolescent health interventions (c).  
 
The equation for a generic model is:  Yijk = 0 + jtime + effectXij,+ cXij, ui + ij 
 
 
Analyses of process outcomes to understand intervention mechanisms will include: 
 
o Mean HCW competency (passing score proportion per clinic) before and after the 
intervention 
o Association between mean HCW competency scores per facility and adolescent 
satisfaction scores  
o Associations between mean adolescent satisfaction scores and 1) retention in care 
(binary), 2) referral to APS services (binary), 3) ART adherence (binary or mean 
percent), and 4) viral suppression (binary) comparing the exposed and unexposed 
periods. 
 
 
Evaluation of temporal trends: Temporal trends that change over time (e.g. introduction 
of new HIV treatment guidelines, COVID-19) and potentially impact study outcomes can 
lead to a biased effect estimate in a stepped-wedge trial design [34]. To assess this 
possibility, we will repeat the primary analyses including an interaction term between a 
time indicator (e.g. coded as ‘pre’ versus ‘post’ policy/program change) and the variable 
for the main effect. A p-value for the interaction <0.1 will be evidence of interaction. We 
will report these results in a separate table showing any differences in intervention effect 
by this temporal change.  

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 
Lag effects of SPEED intervention: Because the effect of the intervention may not be 
immediate or it may diminish over time, we will evaluate these possibilities in two ways. 
HCWs may take time to put skills they learned in the training into practice. In addition, 
trained HCWs may decrease or stop using these new skills. Intervention lag will be 
modeled by re-coding the first month after the intervention as a control period, as 
recommended by Davey et al.  [34]. We will model the reduction of the intervention effect 
over time by using a fractional term for the coefficient of primary effect estimate, which 
will have a value of 1 (assumes 100% exposure) and get smaller at each time step (e.g. 
75%, 50%, 25%).  
 
 
Qualitative analysis of exit interviews: Qualitative data from the HCW exit interviews will 
be coded in Atlas.ti. Data will be analyzed by two reviewers using thematic analysis 
according to the interview guide. These results will be utilized to complement results 
from the structured HCW satisfaction surveys.  
 
Cost-effectiveness Analysis (CEA) and Cost Utility Analysis (CUA) 
We will develop a cost-effectiveness analysis (CEA) and mathematical model to determine cost-
effectiveness of the SP intervention. Costing data will be sourced from actual study costs using 
local rates, as well as primary data collection from adolescents supplemented by published 
literature to estimate direct medical costs, direct non-medical costs and indirect costs. Direct 
costs include laboratory tests, and personnel. Direct non-medical costs include transportation 
costs and field allowances. We will estimate the cost-effectiveness of the SP intervention in 
terms of cost per additional HIV-infected adolescent identified and retained in care. 
 
We will also model the cost-utility of the intervention in terms of cost per life year saved and 
disability-adjusted life year (DALY) averted by maintaining HIV-infected adolescents in care, 
including subsequent decreases in HIV transmission/acquisition.  
We will examine how these estimates vary through one-way and probabilistic sensitivity 
analyses in settings with varying adolescent HIV prevalence, health care HCW wages, 
population density, and linkage to care rate; identifying scenarios where the intervention is most 
cost-effective, allowing policymakers to determine incremental costs and net benefits of the 
intervention. Analyses will be performed both from the programmatic perspective of the Kenyan 
government and from the societal perspective. All benefits and costs will be discounted at 3% 
per year. 
 

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13. ETHICS/PROTECTION OF STUDY PARTICIPANTS 
 
13a. Informed Consent Process 
 
Clinic participation  
This intervention will be at facility level therefore, we will engage with the Kenyan Ministry of 
Health, relevant 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 not seek individual consent of adolescent patients for de-
identified clinic records.   
 
HCW participants  
HCW participants will provide standard written informed consent. A consent form describing in 
detail the study procedures and risks will be provided. For the wave 4 surveys, participants who 
have already provided informed consent will be read a telephone script and asked to provide 
verbal permission to take the final survey by telephone. Verbal permission will be documented in 
the tablet survey and in the call log. 
Waiver to release SP encounter videos: HCWs will also have the opportunity to sign waivers to 
authorize use of SP encounter videos for educational purposes by UW and UoN (e.g. 
dissemination activities, examples for future SP trainings, on-line courses, conference 
presentations). Waivers will be signed before the start of the pilot phase and the RCT. Actors are 
study staff and will sign a waiver as condition of employment. Only videos where participants 
have signed waivers will be used for these purposes. Videos where a participant has not 
signed the waiver will not be used.  
Participants will be informed that they are free to decline signing a waiver, 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. Videos will not be altered 
(e.g. blurring of faces). As such, participants may be identifiable in the recordings. Participants 
who sign the waiver will understand that, due to logistical reasons, they will not be able to 
review the videos prior to their release. 
 
Adolescent patients – rationale for procedures for adolescents and caregivers 
Adolescent patients will be provided with an information sheet and have the opportunity to 
provide oral consent to participate in surveys. If a caregiver is present and the adolescent is 
<18, the caregiver will also provide oral consent. An oral consent is appropriate because the 
only risk associated with the anonymous survey is the possible breach of confidentiality due to 
written documentation of consent. Kenyan guidelines allow mature minors (married, sexually 
active, pregnant) to consent for their own HIV test, a far riskier procedure than an anonymous 
survey. In addition, completion of the survey would present no risk beyond what would occur as 
part of routine HIV care. Finally, many adolescents present to HIV testing and care alone or 
accompanied by a non-parent support person. 
 
The consent and assent process by age is described below: 

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1) 
Adolescents ages 10-17 who come with a caregiver: Oral consent will be sought from 
the caregiver and oral assent will be sought from the minor. We will not enroll any 
adolescent between ages 10 and 13 who is unaccompanied by a caregiver. 
2) 
Adolescents ages 14-17 who come without any caregiver: A waiver of parental consent 
is sought. Oral consent will be sought only from the adolescent.  
3) 
Adolescents 18-19: Regardless of whether they are accompanied, adolescents will 
provide oral consent. 
Justification for a waiver of parental consent for adolescents ages 14-17 who are 
unaccompanied:  
For adolescents ages 14-17 who present at the clinic without a caregiver, there will be a waiver 
of parental/caregiver consent. Our justifications are: 1) Many adolescents 14-17 come for HIV 
testing without a caregiver, specifically because they do not want a caregiver present; 2) Some 
adolescents are orphaned, married, and/or do not have a caregiver, 3) Getting a caregiver’s 
signature would pose an added logistical challenge, including scheduling a follow-up visit when 
both caregivers and adolescents can present at the clinic; 4) There would be a strong possibility 
of selection bias if we are limited to adolescents 14-17 who have caregivers present and willing 
to provide consent. 
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 (HCWs) or provide oral consent 
(adolescent patients) 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 or information sheet 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. 
 
Documentation of Oral Consent and Assent 
We will document informed consent with a consent log, which will be completed by our study 
staff member who recruits participants. This log will contain numbered rows for each person 
(adolescents in HIV care) who is approached to take part in the survey. No identifying 
information will be recorded. For each row there will be two columns “oral consent obtained” and 
“declined to give consent.” The study staff member will tick the appropriate box for each row to 
document whether the individual gave oral consent or declined to take part in the study. This log 
will be maintained in a secure filing cabinet at our study office. 
 
Exclusion of Women, Minorities, and Children  
There are no exclusions of women or minorities for the HCW participants. Eligibility is based on 
age and occupation. Adolescent patients under age 10 will be excluded from this study because 
the target population is adolescents and youth ages 10-24. 
 

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13b. Participant Confidentiality  
Study staff will take strict measures to maintain confidentiality for participants. Data collected will 
be kept confidential and access restricted to study staff. All video-recordings of the SP 
encounters will be kept in an encrypted cloud server. 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.  
 
13c. 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 or adolescents. 
 
 
Other: Other study risks include emotional distress associated with the sensitive nature 
of HIV counseling and treatment (client surveys and HCWs in training), breach of patient 
confidentiality during data extraction (adolescent clinic records), and fear of or actual 
loss of employment associated with disclosure of grades checklists (HCWs in training). 
We are not directly enrolling adolescent clients other than to take part in anonymous 
cost, and sexual behavior 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 enrollment or subsequent clinic visits. However, 
the possibility of this social harm would exist if this intervention were not conducted. In 
addition, there is a risk of discomfort related to answering sensitive questions about 
sexual behavior. However, these questions are similar to what would be asked as part of 
routine HIV care. 
 
 
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.  Trained 
facilitators will oversee debriefing sessions with health care HCWs.   Each clinical 
training intervention will open with a session on professional standards, expectations, 
and confidentiality, building an atmosphere of peer-support and collaboration.  All HCW 
participants will agree to not share individual performance information outside of the 
learning group. Kenyan study personnel experienced in research with AYA will conduct 
the adolescent surveys. Adolescent participants will be informed that they can skip any 
question or stop the questionnaire altogether at any time. The questions on sexual 
behavior will be self-administered. Participants will be offered support or referral to 
additional services, as needed, according to standard procedures. 
 
 
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 

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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. Adolescent participants will be assured that their sensitive 
information will not be shared with anyone outside the study team, including a parent, 
caregiver, or partner who may be present. In the rare situation that an AYA participant 
tells the study nurse that they are experiencing violence or threat of violence by a sexual 
partner, the study nurse will offer a referral to the appropriate clinic staff member 
according to study SOPs. Study staff will be trained in the importance of confidentiality 
during human participants training prior to study implementation. We will not share 
individual-level HCW data with health facilities in order to minimize risk of a negative 
reaction by an employer if they choose to participate or not participate in this study.  In 
the event of reported social harm, we have developed standard operating procedures for 
referrals to local social agencies that will be incorporated into the HCW training. 
 
 
The adolescent survey will not include any reference to HIV status. The survey is 
designed to collect data on satisfaction with the patient-HCW experience overall and not 
specific HIV-related services. In addition, this 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 anonymous adolescent satisfaction surveys. These protections will depend on 
adolescents’ age and whether they are accompanied by a caregiver. 
 
Potential Benefits 
 
HCWs:  Health care workers (HCW) will receive direct and immediate benefit in receipt 
of training to improve their skills in delivery of adolescent friendly HIV services. HCWs in 
previous studies have specifically requested this training. 
 
 
Adolescent clients (surveys): Adolescent clients participating in the surveys will be able 
to inform study personnel and program leaders about their experiences in accessing 
testing and treatment services, which may in turn improve the way care is delivered and 
make it more acceptable to them.  The benefit is direct, but is not likely to be immediate. 
 
 
Adolescent client (clinic attendees):  Adolescent clients who do not participate in the 
surveys but are clients of participating health facilities may benefit directly from the 
improved care and counseling services they receive from trained HCWs. 
 
 
 
 
 
 

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Budget summary for SPEED Study (2015-2020) 
 
CATEGORY 
COST (USD) 
Salaries 
451,246 
Consultants/Country Staff 
320,826 
Other Svcs 
73,831 
Subcontracts 
299,571 
Travel 
63,888 
Supplies 
21,300 
Benefits 
119,163 
TOTAL DIRECT COSTS 
1,352,601 
TOTAL INDIRECT COSTS 
503,050 
TOTAL COSTS 
1,855,650 
 
 
 
 
 
 
 
 
 
 
 
 

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