Standardized Patient Encounters to Improve Counseling for Pre-Exposure Prophylaxis (PrEP) for HIV Prevention to Adolescent Girls and Young Women (AGYW) in Kenya
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of Washington

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
1 
 
 
 
 
 
 
 
 
 
Standardized Patient Encounters to Improve Counseling for Pre-Exposure Prophylaxis (PrEP) for 
HIV Prevention to Adolescent Girls and Young Women (AGYW) in Kenya 
 
 
 
 
 
 
 
Grant Number: R01 HD094630  
 
Principal Investigators: Pamela Kohler, PhD, MPH, RN and Grace John-Stewart, MD, PhD 
 
Version Number: 1.3 
 
May 16, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
2 
 
 
SUMMARY 
 
 
Background: The incidence of HIV in adolescent girls and young women (AGYW) continues to rise despite  
promising innovation in female-controlled HIV prevention strategies. In 2016, 34,000 women 
ages 15+ were infected with HIV in Kenya. Pre-exposure prophylaxis (PrEP) has been shown 
to reduce the risk of HIV acquisition through sexual intercourse by 92% among sero-discordant 
partners.  While PrEP is a highly efficacious intervention, its real-world effectiveness at scale 
is threatened by low adherence. Improving medication adherence through improved health 
counseling at the first clinical consultation is necessary. Standardized patient actors (SPs) are 
an effective tool for health providers to improve communication and counseling skills 
Evaluating the effectiveness of SP education for health care workers (HCWs) delivering PrEP 
to AGYW can identify new training approaches to facilitate improved communication and PrEP 
delivery for AGYW seeking PrEP services in Kenya. 
 
Goal:   
To facilitate AGYW uptake of and adherence to PrEP through a clinical training program using 
SPs to improve HCW communication skills and delivery of PrEP counseling services to AGYW 
at risk for HIV.   
 
Aims: 
1. To assess quality of PrEP counseling and adherence to National AIDS and STI Control 
Programme (NASCOP) guidelines among HCWs delivering PrEP to AGYW in Kenya. 
2. To implement and evaluate the effectiveness of an SP training intervention designed to 
improve HCW counseling and communication skills, and adherence to national guidelines, in 
delivery of PrEP to AGYW in Kenya 
Methods:  
During the first phase (Aim 1) we will conduct a cross-sectional baseline assessment of PrEP 
counseling practices using unannounced SP actors as evaluators at 24 facilities in Western 
Kenya.  We will then randomly assign 12 facilities to an SP training intervention and 12 facilities 
to a control arm where they will continue standard of care (Aim 2). We will evaluate outcomes 
of the training program through a parallel cluster-randomized trial, repeating the cross-sectional 
unannounced SP assessment.   
 
Population: HCWs who provide HIV care and treatment and/or PrEP services in Western Kenya. 
 
Outcomes: 
The primary outcome will be quality of the PrEP counseling session, defined as adherence to 
NASCOP guidelines of PrEP counseling/delivery and use of non-judgmental interpersonal 
skills, and measured as a score on a SP checklist after unannounced visits.  The secondary 
outcome will be HCWs communication quality, including clarity of information, non-judgment, 
listening without interruption, encouraging questions, empathetic statements, and showing 
interest in the patient’s concerns.   
 
Timeframe:    January 2019 to August 2022 
 
 
 
 
 
 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
3 
 
TABLE OF CONTENTS 
    
Title page 
 
 
 
 
 
 
 
 
 
 
1 
Summary 
 
 
 
 
 
 
 
 
 
 
2 
Table of contents 
 
 
 
 
 
 
 
 
 
3 
List of abbreviations  
 
 
 
 
 
 
 
 
4 
Key roles and contacts 
 
 
 
 
 
 
 
 
5-6 
Collaborations  
 
 
 
 
 
 
 
 
 
6 
 
Background and Literature Review  
 
 
 
 
 
 
7-8 
Rationale 
 
 
 
 
 
 
 
 
 
 
9 
 
Aims  
 
 
 
 
 
 
 
 
 
 
9 
Outcome measures 
 
 
 
 
 
 
 
 
 
9 
Methods 
Study design  
 
 
 
 
 
 
 
 
10 
Population and setting 
 
 
 
 
 
 
 
10 
Eligibility criteria 
 
 
 
 
 
 
 
 
10 
Sampling and sample size 
 
 
 
 
 
 
 
10 
Randomization 
 
 
 
 
 
 
 
 
10 
Recruitment 
 
 
 
 
 
 
 
 
 
10-11 
Study procedures 
 
 
 
 
 
 
 
 
 
11 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
11-13 
 
 
Statistical analysis 
 
 
 
 
 
 
 
 
11 
Sample size and power 
 
 
 
 
 
 
 
11-12 
Data management 
 
 
 
 
 
 
 
 
 
14-15 
Dissemination and Impact 
 
 
 
 
 
 
 
 
15 
Ethic/Protection of study participants 
 
Human subjects monitoring plan 
 
 
 
 
 
 
15 
 
Informed consent process 
 
 
 
 
 
 
 
15-16 
 
Participant withdrawal 
 
 
 
 
 
 
 
16 
 
Participant confidentiality 
 
 
 
 
 
 
 
16 
 
Risks and benefits 
 
 
 
 
 
 
 
 
16-17 
 
Safety management  
 
 
 
 
 
 
 
17 
Study schedule 
 
 
 
 
 
 
 
 
 
18 
Budget 
 
 
 
 
 
 
 
 
 
 
19 
References 
 
 
 
 
 
 
 
 
 
 
20-21 
 
 
 
 
 
 
 
 
 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
4 
 
 
LIST OF ABBREVIATIONS 
 
AGYW  
Adolescent girls and young women 
ARV 
 
Antiretroviral drugs 
ERC 
 
Ethics Review Committee  
GoK 
 
Government of Kenya 
HCWs  
Health care workers 
HIV 
 
Human immunodeficiency virus 
IDI 
 
In-depth interviews 
IRB 
 
Institutional Review Board 
KNH 
 
Kenyatta National Hospital 
MOH  
Ministry of Health 
NASCOP 
National AIDS and STI Control Programme 
PrEP  
Pre-exposure prophylaxis 
RCT 
 
Randomized control trials 
SPs 
 
Standardized Patient Actors  
STI 
 
Sexually transmitted infection 
UON  
University of Nairobi 
UW 
 
University of Washington 
WHO  
World Health Organization 
 
 
 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
5 
 
KEY ROLES AND CONTACTS 
 
Principal 
Investigators 
Pamela Kohler, PhD (MULTIPLE PRINCIPAL INVESTIGATOR) 
(Responsible for the overall project development, oversight, and science of the 
project, expert advisor on the SP content in the study) 
Assistant Professor 
Department of Psychosocial & Community Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359932, Seattle, WA 98104 
Tel:  +1-206-616-7962 
Email: pkohler2@uw.edu 
 
Grace John-Stewart, MD, PhD (MULTIPLE PRINCIPAL INVESTIGATOR) 
(Responsible for the overall project development, oversight, and science of the 
project) 
Professor  
Departments of Global Health, Medicine, Epidemiology and Pediatrics, 
University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-543-4278 
Fax: +1-206-543-4818 
Email:  gjohn@uw.edu 
 
Site Director 
John Kinuthia, MBBS, MD, MPH (SITE PRINCIPAL INVESTIGATOR)  
(Responsible for the development and overall project oversight and science and 
overseeing all implementing team members in Kenya) 
Obstetrician and Gynecologist 
Head, Department of Research & Programs, Kenyatta National Hospital 
PO Box 20723-00202, Nairobi, Kenya 
Tel: +254 0722 799-052 
Email: kinuthia@uw.edu 
Co-
Investigators  
 
Barbra Richardson, PhD (CO-INVESTIGATOR, STATISTICS CONSULTANT) 
(Responsible for protocol, data and analysis plan, and evaluation of the project) 
Research Professor 
Department of Biostatistics, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-744-2425 
Fax: +1-206-685-1732 
Email: barbrar@u.washington.edu 
 
Kristin Beima-Sofie, PhD (CO-INVESTIGATOR) 
(Responsible for qualitative protocol development and data analysis) 
Research Scientist 
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-221-4970 
Email: beimak@uw.edu 
 
Jillian Pintye, PhD (CO-INVESTIGATOR) 
(Responsible for study coordination, data management and analysis) 
Senior Research Fellow 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
6
 
 
 
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-437-9983 
Email: jpintye@uw.edu 
 
Kate Wilson, PhD (CO-INVESTIGATOR) 
(Responsible for protocol development data and analysis) 
Clinical Assistant Professor 
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-685-0583 
Email: ksw@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 
 
National AIDS & STI Control Programme (NASCOP) 
Afya Annex 
Kenyatta National Hospital Grounds 
P.O Box 19361 – 00202 
Nairobi, Kenya 
 
Funding 
Funding type: Grant 
Funding agency: The Eunice Kennedy Shriver National Institute of Child 
Health and Human Development (NICHD), National Institutes of Health (NIH) 
Principal Investigator on Proposal: Grace John-Stewart, Pamela Kohler 
Proposal Identification Number: 1 R01 HD094630-01 
Title:  PrEP Adherence Among AGYW: A Multidimensional Evaluation 
Dates: 07/01/17-6/30/22 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
7
BACKGROUND AND LITERATURE REVIEW 
1a. Background Information 
Adolescent girls and young women experience a disproportionate risk of HIV 
infection: Adolescent girls and young women (AGYW) in Southern and Eastern 
Africa are at high risk of HIV acquisition. In 2015, an estimated 390,000 new 
HIV infections occurred in AGYW ages 15-24, globally, and AGYW have a 9-
fold increase in HIV prevalence compared with males of the same age (2). 
Recent HIV prevention trials also show higher HIV incidence in AGYW cohorts 
than in cohorts of women in sero-discordant partnerships (Figure 1) (3-7). In 
these trials, the incidence of HIV among AGYW ranged from 5 to 9.1 HIV 
infections/100 person-years (3-7).  The 2016 United Nations Global Assembly 
Fast Track goals aim to decrease the annual number of new HIV infections 
among 15 to 24-year-old women to 100,000. This will require a 74% 
reduction in the current annual number of AGYW infected with HIV (8). 
 
PrEP is an effective tool to decrease HIV incidence in young women:   
The United Nations recommends a multifaceted approach that addresses structural determinants and gender 
inequity while leveraging powerful new biomedical tools for HIV prevention (9-12). Biomedical interventions, 
including expansion of antiretroviral treatment (ART) combined with pre-exposure prophylaxis (PrEP), offer 
alternatives to complement structural approaches to rapidly decrease HIV incidence in AGYW. PrEP, a once 
a day, oral ARV medication consisting of tenofovir (TDF) and emtricitabine (FTC), also known under the brand 
name, Truvada, has been shown to effectively prevent HIV transmission among sero-discordant partners (13, 
14).  In the Partners PrEP study among HIV uninfected women in sero-discordant partnerships, TDF-PrEP 
had 71% efficacy and TDF/FTC-PrEP had 66% efficacy; (3, 14, 15). High HIV incidence in AGYW 
necessitates action, and PrEP implementation is a practical intervention.   
 
Although PrEP is effective, adherence has been poor among AGYW participating in PrEP RCTs: Sub-
analyses of women in the Partners randomized control trial (RCT), showed that even among women with HIV 
risk factors such as high partner viral load count, unprotected sex, or diagnosis of a sexually transmitted 
infection (STI), PrEP retained efficacy (16).  However, to maximize PrEP effectiveness as an HIV prevention 
tool, high adherence to regimens is required. Momentum to scale-up PrEP was suppressed when two large 
RCTs of PrEP among young women, VOICE and FEMPrEP, failed to show PrEP efficacy, due to low retention 
and low PrEP adherence (5, 6, 17, 18).  A more recent meta-analysis of 5 PrEP studies in women estimated 
that PrEP would have had a protective effect, with a RR of 0.69 with PrEP if women had at least 75% 
adherence (19). As countries like Kenya [49] expand the availability and use of PrEP, it is imperative that 
efforts to scale-up PrEP in AGYW also focus on adherence. 
 
Health system interactions may influence PrEP uptake and adherence among AGYW: PrEP studies often 
involve project-dedicated staff who commit to optimizing interactions with clients, providing in-depth and 
thoughtful HIV prevention counseling and PrEP messaging. Initiatives for PrEP use in AGYW involve 
programmatic expansion into the public health sector and require an understanding of user experiences and 
motivation of AGYW as well as optimization of health system interactions within an already over-extended 
system (Figure 2). Health systems interactions, led by 
HCWs lacking training, resources, skills, or empathy, 
have been shown to decrease AGYW uptake of sexual 
and reproductive health services (20-22). Among 
AGYW, stigma, HCW bias, and HCW discrimination 
have been reported to be common and major barriers 
to uptake of health care and HIV services, (23-25).  
These barriers may influence AGYW’s attempt to seek 
and continue preventative services, like PrEP. 
Figure 1. New HIV infections by sex, 
sub-Saharan Africa, 2015 (1) 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
8
Standardized patient actors can accurately assess health service quality: Standardized patients (SPs) are 
actors who have been trained to portray patients in scripted, medically-themed scenarios for student and 
HCW evaluation and education.  This style of training has been used since the 1960s in clinical and medical 
education (12).  SPs have been used to develop and improve skills related to patient-centered communication: 
empathy, communication skills, and counseling for HCWs.  As an evaluation tool, SPs are considered the 
gold-standard in measuring care quality (12) and can accurately assess the competencies of a provider in a 
variety of clinical and teaching settings. (14-17). 
 
SP training programs can improve quality of care in low and middle-income countries (LMIC): In LMIC settings, 
SPs have been used to evaluate how services are delivered in practice. In a systematic review of 31 LMIC 
pharmacy studies, SPs helped identify whether providers were or were not adhering to prescription and 
diagnosis treatment guidelines (26). This review found that SPs were useful in describing counseling practices 
of pharmacists, however, few studies used SPs to provide feedback to HCWs. Global TB and STI program 
evaluations used SPs to demonstrate non-standard practices by clinical providers (27, 28).  Additionally, SPs 
were effective in training nurses and midwives in obstetric care to improve provider self-efficacy in emergent 
obstetric situations (29) 
 
A training intervention using SPs may improve the effectiveness of PrEP scale up for AGYW: Medical care 
involves transfer of information and skills in communication, cultural competence, and empathy. Use of SPs 
offers a pragmatic and effective way to improve HCW skills to facilitate PrEP counseling and delivery to 
AGYW. Ensuring AGYW take PrEP regularly decreases risk of acquiring HIV, interrupting the cycle of HIV 
transmission.  Through this interruption, PrEP can ultimately reduce new HIV infections, bringing the world 
one step closer towards reaching the UNAIDS goal of 90-90-90 by 2020 (30). 
 
1b. Rationale  
High HIV incidence in AGYW demands an urgent response and PrEP implementation is a reasonable 
approach. As countries like South Africa (31) and Kenya (32) expand PrEP it is paramount that efforts to scale 
PrEP in AGYW do so in a manner that ensures adherence – otherwise these efforts are futile. 
 
Offering PrEP to AGYW requires several challenging steps for busy HCWs, including incorporating discussion 
of HIV risk, providing information about PrEP, and encouraging PrEP adherence. Training health care workers 
for new programs typically incorporates didactic sessions but few practical tips on how to optimize interactions 
with clients. For clinicians working with adolescents, adolescent-friendly communication skills need to be 
trained. Medical care involves transfer of information and soft skills in communication, cultural competence, 
and empathy. Use of SPs, the gold standard for clinical training and assessment in high-resource settings, 
are a pragmatic and potentially effective way to improve HCW skills to facilitate PrEP delivery to AGYW. 
Clinical providers want to be ‘youth friendly’ but lack competence in this area, and often feel particularly 
unprepared for discussion of sexual risk with adolescents.  
 
SPs have been widely used for medical education since the 1960s, both for training and licensing. In 2011, 
90% of AAMC surveyed-US medical schools used SPs in medical training (33). A review of SP studies in 
2016 found that 24 of 33 SP programs were effective in increasing clinical competence (34). Experiential 
learning leads to enhanced competence in motivational interviewing; SPs (high school students) have been 
useful in US settings to provide medical students experiential learning in communication with adolescents (35, 
36). SPs have been shown to improve cultural competence in US providers (37). SPs can work with HCWs 
by acting out scenarios to help HCWs practice their communication strategies and be evaluated and provided 
with feedback regarding how to improve their abilities in counseling, information, and empathy.  
 
Providing SPs to HCW to guide the process of navigating challenging scenarios, like working with AGYW to 
use and adhere to PrEP, can provide HCWs competency and confidence that makes their interactions with 
AGYW easier and more effective in practice.  
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
9
There is substantial evidence that HCW interactions with SPs can improve service delivery and patient 
outcomes, though few data are available within the context of HIV prevention services among AGYW in 
African settings. Evaluating the effectiveness of SP education for HCWs within the context of PrEP use among 
AGYW populations will inform new training approaches to improve PrEP delivery practices and 
communication with AGYW in clinical settings. This study will address the gaps in delivering quality of PrEP 
services to AGYW through the following specific aims: 
 
2. SPECIFIC AIMS 
  
Aim 1: To assess quality of PrEP counseling and adherence to National AIDS and STI Control Programme 
(NASCOP) guidelines among HCWs delivering PrEP to AGYW in Kenya. 
Aim 2: To implement and evaluate the effectiveness of an SP training intervention designed to improve HCW 
counseling and communication skills, and adherence to national guidelines, in delivery of PrEP to AGYW in 
Kenya. 
 
3. STUDY OUTCOMES  
The primary outcome will be quality of PrEP counseling, summarized by an SP checklist score at 
unannounced clinic visits that will assess communication (e.g. listening without interruption, encouraged 
questions) and adherence to national guidelines on PrEP counseling and delivery (e.g. risk assessment, 
counseling on key messages, correct medication recommended).  The secondary outcome will be overall 
quality of provider communication skills with AGYW seeking PrEP services, measured by a score from SPs 
during the provider training intervention incorporating key domains including: ability to collect information, 
counseling and delivering information, rapport, and personal manner. Communications measures are adapted 
from the Kalamazoo Consensus Statement (38) and other published tools (39-41). 
 
4. STUDY DESIGN  
During the first phase (Aim 1) we will conduct a cross-sectional baseline assessment of PrEP counseling 
practices using unannounced SP actors as evaluators. SP actors are trained professional actors recruited 
from a Kenyan casting agency. They will be paid study staff, managed by our Study Coordinator. Before the 
study, actors will be trained in the SP methodology based on the study protocol. All SP actors will sign a 
confidentiality agreement and complete protection of human participants training before any contact with 
participants. Based on this assessment, we will develop and implement a clinical training program utilizing SP 
actors to improve adherence to national guidelines and communication skills. Finally, we will evaluate the 
training program through a parallel cluster-randomized trial of the SP training using repeat unannounced SP 
encounters at 24 health facilities purposively selected from all facilities in Western Kenya offering PrEP (Aim 
2).   
 
5. STUDY ENROLLMENT  
5a. Population and Setting  
The study will be implemented in 24 large public health facilities that provide PrEP care and counseling 
services to AGYW in Kisumu and other counties in Western Kenya. The facilities were purposively selected 
by the study team from among all facilities offering PrEP (37) based on factors such as size, location, and 
receptiveness of the facility to host research. The purposively selected study sites are: Chiga, Chulaimbo, 
Manywanda, Muhoroni, Nyalenda, Awasi, Koru, Ahero, Rabour, Lumumba, KCH, Migosi, Nightingale, Airport, 
Maseno, Bar Korwa, Railway, Rata, Nyan’goma, Nyalunya, Nyangande, Sondu, Ober-Kamoth, and Ojolla.  At 
each site, the study will include HCWs who provide HIV care and PrEP services for AGYW. Inclusion and 
exclusion criteria are shown in Table 1, below. 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
10
5b. Eligibility criteria  
Health Facility: Eligible facilities will include public health facilities that offer PrEP services and counseling to 
AGYW located within Western Kenya.  Facilities with ongoing PrEP interventions where study staff will be 
excluded. 
 
HCW participants: Eligible HCWs will be 18 years or older, current employees of one of the 24 facilities in the 
study, provide PrEP services to AGYW, and be able to provide informed consent. In Kenya, HCWs who 
provide PrEP therapy and counseling are most commonly trained nurses.  The nurses are specifically trained 
in delivering PrEP per NASCOP guidelines. 
  
Table 1.  Inclusion Criteria   
Population 
Selection 
N 
Inclusion Criteria 
Exclusion Criteria 
Health Facilities  
Facilities in Western 
County providing 
PrEP services for 
AGYW 
24 
Located in a county in Western 
Kenya 
 
Currently offering PrEP 
services   
Sites where PrEP services 
are staffed by study staff 
HCWs at selected 
facilities   
HCWs working in any 
of the selected health 
facility sites 
Up to 240 
Age 18 or over 
 
Able to provide consent 
 
Current employee of one of the 
24 selected facilities  
 
Currently providing PrEP 
services 
Study staff seconded to the 
site as part of a trial or 
intervention 
 
 
5c. Randomization  
Randomization will occur at the cluster level:  24 facilities will be purposively selected from a list of all facilities 
in Western Kenya with PrEP services. We will use stratified randomization, through which 12 facilities will be 
allocated to the intervention and 12 will be assigned standard of care according to facility size, to ensure 
balance by arm. A UW biostatistician will generate the randomization assignment for each clinic. 
 
5d. Recruitment 
We will obtain permission from the NASCOP and local county and district officials to include these facilities in 
our study. At each clinic, we will obtain permission from the appropriate facility leadership before recruitment 
and receive a list of all potential HCW participants. All HCWs who meet inclusion criteria from both control 
and intervention groups will be recruited to participate in the study. A member of the study team will be 
stationed at the facility and approach potential participants to learn more about the study and provide informed 
consent.  Based on previous studies, we estimate 10 HCWs per site, totaling approximately 240 HCWs. 
 
5e. Participant withdrawal and replacement 
Study facilities and participants may withdraw at any time. Reasons for a facility to withdraw may include 
closure or major changes in PrEP policies or procedures that would prevent or substantially limit ability to 
conduct the study. HCW participants may withdraw due to discomfort with the training, relocation, or leave of 
absence. The study team will record the timing and reasons for withdrawal of clinics or participants. Potential 
replacement of study facilities or HCW participants will be conducted but will not be required if it is not feasible 
because of design and logistical challenges.  
 
6. STUDY PROCEDURES 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
11
6a. Stakeholder engagement  
After obtaining NASCOP and local county and district official permission to 
enroll clinical study sites, the study team will meet with clinic leadership and 
managers to receive an overview of the study flow and procedures, and 
informed consent processes for participation (Figure 3).   
 
6b. Case script development and SP actor training  
Qualitative themes from previously conducted AGYW IDIs and focus group 
discussions, national guidelines, and key informant experiences will inform 
development of standardized case scripts. We will train professional Kenyan 
actors matching the ethnicity and languages of the local area to role play 
AGYW PrEP scenarios for both the unannounced assessments and HCW 
training. All SP actors are hired study staff. SP actors will be selected by a 
Kenyan casting agency based on their ability as actresses and their age, 
ethnicity, and language characteristics which match AGYW visiting health 
facilities in Western Kenya. The SP actors will be trained in the SP 
methodology by an expert consultant hired onto this study for this purpose. The SP actors will be trained on 
the specific standardized case scripts by study staff who are familiar with scenarios of AGYW seeking PrEP 
in Western Kenya. 
 
6c. Baseline health services evaluation 
A health facility survey will be administered to the facility manager in each facility to obtain baseline site 
characteristics on staffing, guidelines, and PrEP services. Unannounced SP actors will present to all study 
sites as AGYW seeking PrEP or HIV health services for an estimated 2-3 encounters per clinic. During the 
clinic encounter, SPs will act out their scripted scenario with enrolled HCW. After the encounter, the study 
assistant will administer a post-consultation questionnaire with the SP and will also work with the health facility 
to remove the SP information from the clinic forms and registers. Results from the baseline assessment will 
inform the HCW training on PrEP service delivery. 
 
6d. HCW SP Training on PrEP services  
All HCW participants at intervention facilities will be invited to complete a 2-day training.  The course will 
provide didactic sessions in communication skills, current PrEP guidelines, and counseling techniques, as 
well as role play sessions with the SPs.  We aim to train all eligible HCWs at intervention facilities in small 
groups of 5-10. HCW-SP interactions will be video-recorded for training purposes. SPs will give verbal and 
written feedback on communication and counseling skills and will score HCWs using a standardized checklist.  
Facilitated group debriefings will take place at the end of each day, including review and discussion of selected 
videos.  HCWs will complete a course evaluation and pre/post competency surveys. HCWs employed at the 
study facilities assigned to the control arm will not receive this training. They will perform their routine duties 
according to standard of care and will only take part in the unannounced SP assessments.  
 
6e. Training evaluation   
Once training is complete for all sites, unannounced SPs will repeat the assessment conducted during the 
baseline evaluation at all 24 intervention and control sites. 
  
 
 
 
 
Baseline Health Services 
Evaluation 
 
SP Training Conducted  
SP Training Evaluation 
Figure 3. Study Schema 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
12
7. DATA COLLECTION 
Health facility survey: This anonymous survey will be administered to a health facility manager at baseline to 
capture facility characteristics (number of staff, patient demographics, services provided, etc.), including turn-
over of SP-trained HCWs, patient volume, and any relevant changes in HIV policies and procedures. 
 
Unannounced SP checklist: A survey will be completed by each SP actor, following every clinical interaction 
with an HCW provider using electronic tablets. The surveys will be conducted at baseline and after the HCW 
training at all 24 sites. The tool will assess domains of counseling and communication skills, and adherence 
to national PrEP guidelines. 
 
SP training checklist: Standardized SP checklists will be used to evaluate the HCW encounter with the SP 
actor.  The SP will complete checklists based on individual scenarios to provide feedback for the HCW on 
their practice session and provide a score based on competencies met. 
 
HCW surveys: HCW participants will complete surveys prior to and after the SP training to assess knowledge 
of and self-rated competency in provision of PrEP to AGYW, beliefs about AGYW and HIV, and basic 
demographic and work information.   
 
HCW training evaluation surveys: Post-training surveys will be administered to HCW participates to obtain 
feedback on the quality, length, and relevance of the SP training.   
 
8. STATISTICAL CONSIDERATIONS 
8a. Sample Size and Power 
Given a fixed number of clusters (24 facilities), we estimated the minimum number of SP encounters required 
to detect a 20 percentage-point difference in PrEP counselor competency score between intervention and 
control arms. Because it is uncertain what baseline PrEP competency would be, we estimated sample sizes 
to detect a 20-percentage point difference between the intervention and control arm varying the baseline 
competency percent, shown in Table 2 (following page). Under these assumptions, if PrEP competency is 
20% in the control arm, we would need an estimated 192 total SP encounters (8 per site). Higher baseline 
competency would require a larger sample size to detect the same difference. Given this range, and logistical 
constraints of larger samples with this type of evaluation, the expected upper limit of SP encounters is 400. 
 
Table 2. Sample sizes of SP encounters to detect a 20% difference in competency at 80% power, 
correlation coefficient (k) of 0.15, =0.05 and 24 facilities 
Control group 
competency % 
Intervention group 
competency % 
Cluster per arm 
(fixed) 
SP encounters per 
cluster 
Total SP encounters 
0.2 
0.4 
12 
8 
192 
0.3 
0.5 
12 
10 
240 
0.4 
0.6 
12 
11 
264 
0.5 
0.7 
12 
12 
288 
0.6 
0.8 
12 
13 
312 
0.7 
0.9 
12 
30 
720 
 
8b. Analysis Plan 
A CONSORT diagram will be used to show the number of facilities and HCWs by arm during the trial, numbers 
excluded, and reasons for exclusion. Baseline characteristics of each facility by intervention arm will be 
presented as descriptive statistics to assess whether balance of these factors was achieved through 
randomization using t-tests and McNemar’s exact tests for continuous and dichotomous variables.  
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
13
An intention-to-treat (ITT) analysis will be used to evaluate whether the SP training intervention resulted in 
higher competency scores at intervention compared to control facilities. The primary outcome will be at the 
individual level, adjusted for relevant baseline characteristics by arm and baseline evaluation scores. 
Generalized linear models (GLMM) with a Poisson distribution and log link, will be used to estimate rate ratios, 
and accounting for facility cluster as a random effect. Secondary analysis will be conducted using a similar 
GLMM modeling approach with provider overall communication quality score percent as the outcome. In 
addition, we will evaluate the intervention effect on individual components of PrEP competency and 
communication quality in separate GLMM regression models.  
 
9. DATA MANAGEMENT  
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 
will be uploaded to the secure study cloud server using REDCap.  REDCap is a secure, web-based application 
designed to support data capture and management 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.  
 
9a. Data Capture and Storage Methods 
Video-recordings: Videos from HCW participants in SP training who have consented to allow their videos to 
be used for further training purposes will be stored on a secure server for at least three years after completion 
of the study by the University of Washington. 
 
Surveys and unannounced SP checklist: Health facility surveys and the unannounced SP checklist will be 
administered by study staff via electronic tablets using REDCap data collection software and uploaded daily 
during survey capture periods.  Data will be transported via secure socket layer (SSL) and only accessible by 
authenticated users. Weekly reports will be generated to monitor study progress and troubleshoot problems. 
All computers, tablets, and individual study databases will be encrypted, and password protected.  
 
SP training checklist: Data from the checklist will be shared with the HCW during the training session.  The 
original paper copies of the checklist will be identified using a study ID number. They will be stored in a 
secured locked cabinet in a study office accessible only to study staff.  
 
Data Custody and Retrieval: All data for this study will be under the custody of the Principal Investigators, Site 
PI, 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. 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, KNH, and federal requirements 
(http://f2.washington.edu/fm/recmgt/retentionschedules/gs/general/uwgsResearch#Research). All consents, 
study data and link between HCW participant identifiers and study ID codes will be retained following 
completion of the study for a period of time in accordance with UW and KNH requirements. 
 
Data handling procedures: Members of the research team have completed required training in human 
subjects, including training in data handling and confidentiality. All data for this study will be under the custody 
of the Principal Investigators, Site Leader, and authorized study staff. 
 
Security of electronic records: To protect participant identity, all data will be stored on password protected 
computers, accessible only to the study staff.  Authorized study staff members will download the datasets 
from the secure servers for routine quality checking and analyses. All downloaded data will be maintained on 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
14
a secured, password-protected study computer. From these data sources, the analysts will create merged 
datasets for planned analyses. 
 
10. ASSESSMENT OF SAFETY 
10a. IRB monitoring 
The IRB at the University of Washington (UW) and at the Kenya National Hospital Ethics Review Committee 
(KNH ERC). Will periodically review the study protocols and maintain ongoing oversight of the risks and 
benefits of the study and ensure compliance with institutional guidelines.  Monitoring of adverse events will 
be done by PI and project staff and any problems will be recorded in a study database. Research and clinical 
staff will be trained to identify potential adverse events and instructed to report them immediately to the site 
PIs and in-country research director.  
 
10b. Reporting adverse events or unanticipated 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. 
Adverse events and study procedure-specific adverse events are expected to be rare in this clinical training 
intervention. If any occur, they will be reported to the UW IRB and KNH ERC within 24 hours. Any breach or 
possible breach of confidentiality of any participants in this study will be reported to UW HSD and/or IRB within 
the timeframe established by these ethics committees. 
 
10c. Potential adverse events and mitigation 
Answering questions: We may ask questions that make participants feel embarrassed or uncomfortable. 
Some questions are about their beliefs, attitudes, and perceptions of providing counselling to AGYW about 
sexual history and health. In addition, provider participants in the intervention arm may feel discomfort sharing 
their views and training experiences during the group debriefing sessions. 
 
To minimize the risk of embarrassment, participants will be reminded that they can choose whether to answer 
any question. Participant answers will be confidential. Participants in the training intervention will be assured 
that it is a safe and non-judgemental space to share their views and experiences. 
 
Loss of Confidentiality: Others may learn that a participant is part of the study. We have procedures in place 
to protect confidentiality and will do everything possible to reduce this risk. HCWs who have consented to the 
study may be video recorded during SP encounters that take place in the training. There is a chance that 
others could find out about participants through these recordings.  However, each SP training participant will 
have the opportunity to sign a waiver to allow use of the SP encounter video footage outside of the study 
(e.g., dissemination activities, examples for future SP trainings, online courses, conference presentations). 
Videos containing footage of any participant who has not signed the waiver will not be used outside of the 
training.   
 
We will keep participant identity as research subjects confidential. Responses to questions will be kept private. 
No identifying information or any kind will be released to any other person or agency that is not working on 
this study without participant permission in writing. We will not publish or discuss in public anything that could 
identify participants.  All of their information, including the link between participant name and code number 
will be kept in a secure location at the clinic only.  Once the study is completed, we will maintain the link 
following Kenyatta National Hospital and University of Washington guidelines, after that period we will remove 
their name and all identifying information from the study files. Any publications of this study will not use their 
name or identify participants.  All of the information will be confidential.  However, if we learn that they intend 
to harm themselves or others, we must report that to the authorities. Although we will make every effort to 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
15
keep their information confidential, no system can be completely secure. It is possible that someone could 
find out a participant was in this study and could find out information about them. 
 
10d. Study oversight 
The trial data safety monitoring plan will be overseen by the Principal Investigators, Drs. Kohler and John-
Stewart.  An external oversight committee, appropriate to the level of risk for a trial of a training intervention, 
will be convened and meet regularly accordingly to written procedures to monitor recruitment, enrollment, 
adherence to protocol, and any potential social harms. The external committee will consist of experts in 
adolescent HIV prevention and treatment research and clinical practice. All program activities will be 
implemented through the standard routine PrEP clinical process. The protocol, data collection tools, and 
consent forms will be reviewed and approved by the UW IRB and the KNH ERC.  
 
11. ETHICS/PROTECTION OF STUDY PARTICIPANTS 
11a. Informed Consent Process  
Health facility participation: To ensure appropriate permissions and access at the facility level, we will engage 
with the Kenyan Ministry of Health, relevant county health management and facility administration teams prior 
to entering health facilities. Each facility designee will provide the study team with a list of potentially eligible 
HCWs to participate in the training. Facility managers will be asked separately to provide informed consent to 
complete an anonymous survey on facility characteristics at the start and end of the study. 
 
HCW participants:  All HCW participants will provide written consent prior to study activities. HCW participants 
will sign a standard written informed consent form describing the study procedures and risks. Consent forms 
will be IRB-approved, and the participant will be required to read and review the document or have the 
document read to him or her.  HCWs will be informed that they have the option to decline signing the consent.  
They will be informed that unannounced patient actors will present to their facility during the study, but they 
will not be told the specific time or date of SP visits. Participants will be informed that they are free to withdraw 
their permission at any time during the study. A copy of the informed consent document will be given to 
participants for their records. In the unlikely event of an HCW participating in an unannounced patient actor 
interaction prior to consent, any data collected from the interaction will be destroyed. 
 
Waiver to release SP training videos: HCWs will also have the opportunity to sign waivers to authorize use of 
SP encounter videos for educational purposes by the study team (e.g. dissemination activities, examples for 
future SP trainings, online courses, conference presentations). Waivers will be signed at the end of the 
training. 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 beyond the training. 
 
Exclusion of women or minorities: There are no exclusions of women or minorities for the HCW participants. 
Eligibility is based on age, occupation and employment status at the study facilities. 
  
11b. Participant Confidentiality  
Study staff will take strict measures to maintain confidentiality for all participants. No names will be recorded 
on data collection forms. HCW participants will be assigned unique study identification (ID) numbers. 
Participants will be assigned a non-identifiable study code upon enrollment. Study analysts will receive only 
coded data. The links to participant identifiers will be retained in a password-protected file on an encrypted 
computer. 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. Video data are potentially identifiable. Only 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
16
videos of HCWs who have signed release waivers will be stored after the two-day training. All other data will 
be kept in password-protected databases, in a locked study office, accessible only to study personnel.  
 
11c. Risks and Benefits 
Physical risks: There are no medical interventions associated with the study, therefore we anticipate no risk 
of serious physical harm to participating HCWs. 
 
Psychosocial or other risks: Other potential study risks to the HCW participants include breach of 
confidentiality, emotional distress associated with the sensitive nature of HIV counseling for AGYW, and stress 
associated with group critique/feedback of videotaped training encounters. 
 
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 HCWs.  For HCW training attendees, each clinical training intervention will begin 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 from the SP 
trainings outside of the learning group. 
 
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 for ensuring data security. 
Risk of breach of confidentiality of study data is low, as all HCW data collected will not include names and will 
be located on a password protected server and encrypted prior to upload. Study data is not very sensitive in 
nature and focuses on facility-level characteristics and provider experiences during SP encounters. 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. 
 
Direct benefits: HCWs will receive direct and immediate benefit in receipt of SP training to improve their skills 
in delivery of adolescent friendly HIV services and counseling. HCWs in previous studies have specifically 
requested this training. 
 
Indirect benefits: The study can identify important information regarding AGYW adherence of PrEP to guide 
the best model for PrEP delivery which will benefit individuals in Kenya and other African countries with high 
HIV prevalence.   
12. DISSEMINATION AND IMPACT 
12a. Community dissemination 
Results of the SP mystery shoppers and training program pilot evaluations will be shared with community 
groups, key stakeholders, HCWs and clinic program leaders. The SP training scenarios, curriculum, and 
approach will also be shared with Ministry of Health for consideration as a strategy to improve PrEP service 
quality, provider communication and counseling at public sector facilities in Kenya. 
 
12b. Anticipated impact from the study 
This study will provide detailed analyses of PrEP services in the context of PrEP counseling for AGYW in 
Kenya. These data are critical to understand programmatic effectiveness of new efforts to improve HCW 
adherence to guidelines and communication regarding PrEP for AGYW. Our study of unannounced SPs and 
SP training will provide evidence to support new interventions to improve PrEP counseling practices for 
AGYW, by improving communication with AGYW in PrEP service delivery.  The Kenya Ministry of Health and 
National AIDS Control Program prioritizes evidence-based strategies for HIV prevention, and throughout the 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
 
 
17
course of the study, results will be shared with the Ministry of Health as they become available to maximize 
translational impact.  

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
18
STUDY SCHEDULE 
ACTIVITY 
Q1 
2019 
Q2 
2019 
Q3 
2019 
Q4 
2019 
Q1 
2020 
Q2 
2020 
Q3 
2020 
Q4 
2020 
Q1 
2021 
Q2 
2021 
Q3 
2021 
Q4 
2021 
Q1 
2022 
Q2 
2022 
Recruitment 
and selection of 24 
health facility sites 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
Facility and HCW 
consent 
  
 
  
  
  
  
  
  
  
  
  
  
  
 
Facility site evaluation 
survey 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Training of SP actors 
with case scripts 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Unannounced SP 
baseline assessment  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
HCW SP training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unannounced SP 
assessment (post-
training) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis and 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
19
 
REFERENCES 
 
1. 
UNAIDS. On the Fast-Track to end AIDS by 2030: Focus on location andpopulation. Geneva, 
Switzertand: 2015. 
2. 
Joint United Nations Programme on HIV/AIDS (UNAIDS). Get on the Fast Track to HIV: The lifecycle 
approach to HIV 2016. Available from: http://www.unaids.org/en/resources/documents/2016/get-on-the-fast-
track. 
3. 
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen 
CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, 
Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, 
Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, 
Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, 
Lingappa JR, Celum C. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. The 
New England journal of medicine. 2012;367(5):399-410. Epub 2012/07/13. doi: 10.1056/NEJMoa1108524. 
PubMed PMID: 22784037; PMCID: PMC3770474. 
4. 
Celum C, Wald A, Lingappa JR, Magaret AS, Wang RS, Mugo N, Mujugira A, Baeten JM, Mullins JI, 
Hughes JP, Bukusi EA, Cohen CR, Katabira E, Ronald A, Kiarie J, Farquhar C, Stewart GJ, Makhema J, Essex 
M, Were E, Fife KH, de Bruyn G, Gray GE, McIntyre JA, Manongi R, Kapiga S, Coetzee D, Allen S, Inambao 
M, Kayitenkore K, Karita E, Kanweka W, Delany S, Rees H, Vwalika B, Stevens W, Campbell MS, Thomas 
KK, Coombs RW, Morrow R, Whittington WL, McElrath MJ, Barnes L, Ridzon R, Corey L. Acyclovir and 
transmission of HIV-1 from persons infected with HIV-1 and HSV-2. The New England journal of medicine. 
2010;362(5):427-39. Epub 2010/01/22. doi: 10.1056/NEJMoa0904849. PubMed PMID: 20089951; PMCID: 
PMC2838503. 
5. 
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van 
der Straten A, Noguchi L, Hendrix CW, Dai JY, Ganesh S, Mkhize B, Taljaard M, Parikh UM, Piper J, Masse 
B, Grossman C, Rooney J, Schwartz JL, Watts H, Marzinke MA, Hillier SL, McGowan IM, Chirenje ZM. 
Tenofovir-based preexposure prophylaxis for HIV infection among African women. The New England journal 
of medicine. 2015;372(6):509-18. Epub 2015/02/05. doi: 10.1056/NEJMoa1402269. PubMed PMID: 
25651245; PMCID: PMC4341965. 
6. 
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi 
R, Onyango J, Temu L, Monedi MC, Mak’Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, 
Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, 
Taylor D. Preexposure Prophylaxis for HIV Infection among African Women. The New England journal of 
medicine. 2012;367(5):411-22. doi: 10.1056/NEJMoa1202614. PubMed PMID: 22784040; PMCID: 
PMC3687217. 
7. 
Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, 
Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D, 
Group CT. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV 
infection in women. Science. 2010;329(5996):1168-74. doi: 10.1126/science.1193748. PubMed PMID: 
20643915; PMCID: 3001187. 
8. 
Joint United Nations Programme on HIV/AIDS (UNAIDS). Guidance:  HIV prevention among 
adolescent 
girls 
and 
young 
women 
2016. 
Available 
from: 
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_HIV_prevention_among_adolescent_girls_a
nd_young_women.pdf. 
9. 
Maughan-Brown B, Kenyon C, Lurie MN. Partner age differences and concurrency in South Africa: 
Implications for HIV-infection risk among young women. AIDS and behavior. 2014;18(12):2469-76. Epub 
2014/07/23. doi: 10.1007/s10461-014-0828-6. PubMed PMID: 25047687; PMCID: PMC4451824. 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
20
10. 
Pettifor A, MacPhail C, Selin A, Gomez-Olive FX, Rosenberg M, Wagner RG, Mabuza W, Hughes JP, 
Suchindran C, Piwowar-Manning E, Wang J, Twine R, Daniel T, Andrew P, Laeyendecker O, Agyei Y, 
Tollman S, Kahn K. HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV 
Infection in Young Women in South Africa-Study Design and Baseline Results. AIDS and behavior. 
2016;20(9):1863-82. Epub 2016/02/20. doi: 10.1007/s10461-015-1270-0. PubMed PMID: 26891839; PMCID: 
PMC4990514. 
11. 
Pettifor A, MacPhail C, Hughes JP, Selin A, Wang J, Gomez-Olive FX, Eshleman SH, Wagner RG, 
Mabuza W, Khoza N, Suchindran C, Mokoena I, Twine R, Andrew P, Townley E, Laeyendecker O, Agyei Y, 
Tollman S, Kahn K. The effect of a conditional cash transfer on HIV incidence in young women in rural South 
Africa (HPTN 068): a phase 3, randomised controlled trial. The Lancet Global health. 2016;4(12):e978-e88. 
Epub 2016/11/07. doi: 10.1016/s2214-109x(16)30253-4. PubMed PMID: 27815148; PMCID: PMC5626439. 
12. 
De Neve JW, Fink G, Subramanian SV, Moyo S, Bor J. Length of secondary schooling and risk of HIV 
infection in Botswana: evidence from a natural experiment. The Lancet Global health. 2015;3(8):e470-e7. Epub 
2015/07/03. doi: 10.1016/s2214-109x(15)00087-x. PubMed PMID: 26134875; PMCID: PMC4676715. 
13. 
World Health Organization (WHO). Guidance on Pre-Exposure Oral Prophylaxis (PrEP) for 
Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV: 
Recommendations for Use in the Context of Demonstration Projects 2012. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK132003/. 
14. 
Thomson KA, Baeten JM, Mugo NR, Bekker LG, Celum CL, Heffron R. Tenofovir-based oral 
preexposure prophylaxis prevents HIV infection among women. Current opinion in HIV and AIDS. 
2016;11(1):18-26. Epub 2015/09/30. doi: 10.1097/coh.0000000000000207. PubMed PMID: 26417954; 
PMCID: PMC4705855. 
15. 
Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, Tumwesigye E, Psaros C, Safren 
SA, Ware NC, Thomas KK, Donnell D, Krows M, Kidoguchi L, Celum C, Bangsberg DR. Adherence to 
antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples 
in East Africa. PLoS medicine. 2013;10(9):e1001511. doi: 10.1371/journal.pmed.1001511. PubMed PMID: 
24058300; PMCID: 3769210. 
16. 
Murnane PM, Celum C, Mugo N, Campbell JD, Donnell D, Bukusi E, Mujugira A, Tappero J, Kahle 
EM, Thomas KK, Baeten JM. Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk 
heterosexuals: subgroup analyses from a randomized trial. AIDS (London, England). 2013;27(13):2155-60. 
Epub 2014/01/05. doi: 10.1097/QAD.0b013e3283629037. PubMed PMID: 24384592; PMCID: PMC3882910. 
17. 
Tobin SC. VOICE reveals the need to improve adherence in PrEP trials. AIDS (London, England). 
2015;29(12):N9. Epub 2015/08/06. doi: 10.1097/qad.0000000000000693. PubMed PMID: 26244400. 
18. 
Corneli AL, McKenna K, Perry B, Ahmed K, Agot K, Malamatsho F, Skhosana J, Odhiambo J, Van 
Damme L. The science of being a study participant: FEM-PrEP participants' explanations for overreporting 
adherence to the study pills and for the whereabouts of unused pills. Journal of acquired immune deficiency 
syndromes (1999). 2015;68(5):578-84. Epub 2015/03/12. doi: 10.1097/qai.0000000000000525. PubMed 
PMID: 25761233. 
19. 
Hanscom B, Janes HE, Guarino PD, Huang Y, Brown ER, Chen YQ, Hammer SM, Gilbert PB, Donnell 
DJ. Brief Report: Preventing HIV-1 Infection in Women Using Oral Preexposure Prophylaxis: A Meta-analysis 
of Current Evidence. Journal of acquired immune deficiency syndromes (1999). 2016;73(5):606-8. Epub 
2016/11/16. doi: 10.1097/qai.0000000000001160. PubMed PMID: 27846073; PMCID: PMC5175411. 
20. 
Bender SS, Fulbright YK. Content analysis: a review of perceived barriers to sexual and reproductive 
health services by young people. The European journal of contraception & reproductive health care : the official 
journal of the European Society of Contraception. 2013;18(3):159-67. Epub 2013/03/27. doi: 
10.3109/13625187.2013.776672. PubMed PMID: 23527736. 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
21
21. 
Godia PM, Olenja JM, Hofman JJ, van den Broek N. Young people's perception of sexual and 
reproductive health services in Kenya. BMC health services research. 2014;14:172. doi: 10.1186/1472-6963-
14-172. PubMed PMID: 24731733; PMCID: 3996312. 
22. 
Godia PM, Olenja JM, Lavussa JA, Quinney D, Hofman JJ, van den Broek N. Sexual reproductive 
health service provision to young people in Kenya; health service providers' experiences. BMC health services 
research. 2013;13:476. doi: 10.1186/1472-6963-13-476. PubMed PMID: 24229365; PMCID: 4225671. 
23. 
Wagner AD, Mugo C, Bluemer-Miroite S, Mutiti PM, Wamalwa DC, Bukusi D, Neary J, Njuguna IN, 
O'Malley G, John-Stewart GC, Slyker JA, Kohler PK. Continuous quality improvement intervention for 
adolescent and young adult HIV testing services in Kenya improves HIV knowledge. AIDS (London, England). 
2017;31 Suppl 3:S243-S52. doi: 10.1097/QAD.0000000000001531. PubMed PMID: 28665882; PMCID: 
5497779. 
24. 
Luseno WK, Iritani B, Zietz S, Maman S, Mbai, II, Otieno F, Ongili B, Hallfors DD. Experiences along 
the HIV care continuum: perspectives of Kenyan adolescents and caregivers. African journal of AIDS research 
: AJAR. 2017;16(3):241-50. Epub 2017/10/06. doi: 10.2989/16085906.2017.1365089. PubMed PMID: 
28978294. 
25. 
Joint United Nations Programme on HIV/AIDS (UNAIDS). On the fast-track to an AIDS-free 
generation 
2016. 
Available 
from: 
http://www.unaids.org/sites/default/files/media_asset/GlobalPlan2016_en.pdf. 
26. 
Xu T, de Almeida Neto AC, Moles RJ. A systematic review of simulated-patient methods used in 
community pharmacy to assess the provision of non-prescription medicines. The International journal of 
pharmacy practice. 2012;20(5):307-19. Epub 2012/09/08. doi: 10.1111/j.2042-7174.2012.00201.x. PubMed 
PMID: 22953770. 
27. 
Satyanarayana S, Kwan A, Daniels B, Subbaraman R, McDowell A, Bergkvist S, Das RK, Das V, Das 
J, Pai M. Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban 
India: a cross-sectional study. The Lancet Infectious diseases. 2016;16(11):1261-8. doi: 10.1016/S1473-
3099(16)30215-8. PubMed PMID: 27568359; PMCID: 5067371. 
28. 
Das J, Kwan A, Daniels B, Satyanarayana S, Subbaraman R, Bergkvist S, Das RK, Das V, Pai M. Use 
of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study. The Lancet 
Infectious diseases. 2015;15(11):1305-13. doi: 10.1016/S1473-3099(15)00077-8. PubMed PMID: 26268690; 
PMCID: 4633317. 
29. 
Cohen SR, Cragin L, Wong B, Walker DM. Self-Efficacy Change With Low-Tech, High-Fidelity 
Obstetric Simulation Training for Midwives and Nurses in Mexico. Clinical Simulation in Nursing,. 
2012;8(1):e15-e24. doi: doi:10.1016/j.ecns.2010.05.004. 
30. 
Joint United Nations Programme on HIV/AIDS  (UNAIDS). 90-90-90 An ambitious treatment target 
to 
help 
end 
the 
AIDS 
epidemic 
2018. 
Available 
from: 
http://www.unaids.org/sites/default/files/media_asset/90-90-90_en.pdf   . 
31. 
Bekker LG, Rebe K, Venter F, Maartens G, Moorhouse M, Conradie F, Wallis C, Black V, Harley B, 
Eakles R. Southern African guidelines on the safe use of pre-exposure prophylaxis in persons at risk of 
acquiring HIV-1 infection. South Afr J HIV Med. 2016;17(1):455. Epub 2016/03/15. doi: 
10.4102/sajhivmed.v17i1.455. PubMed PMID: 29568613; PMCID: PMC5843155 may have inappropriately 
influenced them in writing this article. 
32. 
Health Mo. Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV in 
Kenya2016. 
33. 
Huang GC, Sacks H, Devita M, Reynolds R, Gammon W, Saleh M, Gliva-McConvey G, Owens T, 
Anderson J, Stillsmoking K, Cantrell M, Passiment M. Characteristics of simulation activities at North 
American medical schools and teaching hospitals: an AAMC-SSH-ASPE-AACN collaboration. Simulation in 
healthcare : journal of the Society for Simulation in Healthcare. 2012;7(6):329-33. Epub 2012/08/21. doi: 
10.1097/SIH.0b013e318262007e. PubMed PMID: 22902605. 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
22
34. 
Williams B, Song JJY. Are simulated patients effective in facilitating development of clinical 
competence for healthcare students? A scoping review. Advances in simulation (London, England). 2016;1:6. 
Epub 2016/02/16. doi: 10.1186/s41077-016-0006-1. PubMed PMID: 29449975; PMCID: PMC5796606. 
35. 
Cahill H, Coffey J, Sanci L. ‘I wouldn’t get that feedback from anywhere else’: learning partnerships 
and the use of high school students as simulated patients to enhance medical students’ communication skills.  
BMC Med Educ2015. 
36. 
Edwards EJ, Stapleton P, Williams K, Ball L. Building skills, knowledge and confidence in eating and 
exercise behavior change: brief motivational interviewing training for healthcare providers. Patient education 
and counseling. 2015;98(5):674-6. Epub 2015/03/03. doi: 10.1016/j.pec.2015.02.006. PubMed PMID: 
25727283. 
37. 
Paroz S, Daele A, Viret F, Vadot S, Bonvin R, Bodenmann P. Cultural competence and simulated 
patients. The clinical teacher. 2016;13(5):369-73. Epub 2016/01/20. doi: 10.1111/tct.12466. PubMed PMID: 
26783081. 
38. 
Rider EA, Hinrichs MM, Lown BA. A model for communication skills assessment across the 
undergraduate curriculum. Med Teach. 2006;28(5):e127-34. doi: 10.1080/01421590600726540. PubMed 
PMID: 16973446. 
39. 
Woods ER, Klein JD, Wingood GM, Rose ES, Wypij D, Harris SK, Diclemente RJ. Development of a 
new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV. J Adolesc Health. 
2006;38(6):753 e1-7. doi: 10.1016/j.jadohealth.2005.08.013. PubMed PMID: 16730606. 
40. 
van Zanten M, Boulet JR, McKinley D. Using standardized patients to assess the interpersonal skills of 
physicians: six years' experience with a high-stakes certification examination. Health Commun. 
2007;22(3):195-205. doi: 10.1080/10410230701626562. PubMed PMID: 17967142. 
41. 
Pilgrim N, Jani N, Mathur S, Kahabuka C, Saria V, Makyao N, Apicella L, Pulerwitz J. Provider 
perspectives on PrEP for adolescent girls and young women in Tanzania: The role of provider biases and quality 
of care. PLoS One. 2018;13(4):e0196280. doi: 10.1371/journal.pone.0196280. PubMed PMID: 29702659; 
PMCID: PMC5922529. 
 
 
 

AGYW SP STUDY PROTOCOL 
 
V 1.3 May 16, 2019 
 
  
23
APPENDICES 
 
Appendix I. Budget Summary and Justification (Overall Study including RCT using SP actors)  
Appendix II. Potential Adverse Events 
Appendix III. Facility Manager Consent Form 
Appendix IV. HCW Consent Form 
Appendix V. Facility Survey 
Appendix VI. Unannounced Standardized Patient (SP) Checklist 
Appendix VII. SP Training Checklist 
Appendix VIII. HCW Pre/Post Survey 
Appendix IX. HCW Training Evaluation Surveys