PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare
Conditions: PrEP Precriptions for Reproductive Aged Women
Sponsor: University of Alabama at Birmingham

PrEP4Her: Developing a Novel Strategy to Implement PrEP Into 
Women's Healthcare 
 
 
Study Protocol and Statistical Analysis Plan 
 
NCT07209722 
 
 
August 01, 2022 
 
 
Michael Mugavero, MD, Professor, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 

A. SIGNIFICANCE 
A1. HIV infection disproportionately affects the Southern U.S. with continuing inequities in rates among 
Black cis-gender women. Despite advances in antiretroviral therapy (ART), rates of HIV infection have 
increased among highly disenfranchised populations, accentuating health disparities. Black people comprise 
only 13% of the U.S population, but account for more than half of new HIV diagnoses.21 Adverse HIV outcomes 
are also higher, as Black people are less likely to be linked to or retained in care, contributing to lower rates of 
viral suppression and higher mortality.22-24 Notably, Black cis-gender women account for 57% of all new infections 
among women and the majority occur in those of reproductive age. 2, 21 These health inequities are most 
pronounced in the U.S. South. Despite comprising only a third of the U.S. population, the South accounts for 
nearly half of all new HIV infections, with the highest infection and mortality rates among Black populations.21, 25 
Furthermore, rural communities in the South have higher HIV infection rates, requiring targeted prevention 
strategies to address their unique cultural and structural barriers 25. This is especially true in Alabama, where 
rural counties have the highest rates of new HIV infections per 100,000 persons 26. Additionally, information-
based HIV prevention interventions are less effective due to poverty, income and social inequality due to 
institutional racism.27 This is reflected in Alabama’s local HIV epidemiology as Black cis-gender women are eight 
times more likely to be diagnosed with HIV compared to White women.28  
 
A2. PrEP is an effective biomedical prevention strategy for HIV infection, but underutilized by cis-gender 
women. Almost two-thirds of people prescribed PrEP are White and, of the 468,000 cis-gender women with a 
PrEP indication, only 19,000 (4%) are currently receiving prescriptions.29-33 Our university-affiliated infectious 
diseases-led PrEP Clinic in Alabama mirrors national trends in PrEP prescriptions, providing services for 
primarily White men who have sex with men (63% of clientele) with only 7% of our clientele being cis-gender 
women.34 Additionally, most studies evaluating PrEP uptake among cis-gender women have demonstrated that 
cis-gender women who access PrEP are mostly sero-discordant relationships with virally suppressed partners 
and, therefore, have minimal risk of transmission.35 Cited barriers for low uptake of PrEP among cis-gender 
women in the U.S. include: daily regimen, stigma from providers and peers, and perceived difficulty negotiating 
PrEP use with partners.36-38 However, these national studies may not be reflective of knowledge, attitudes and 
beliefs of cis-gender women living in Southern communities with unique social and structural determinants of 
health. This supports the need for theory-driven studies that focus on enhancing uptake of PrEP among cis-
gender women living in the South where access to PrEP services has been limited at best. Theory-driven studies 
that focus on enhancing uptake of PrEP among cis-gender women living in the South are critically needed, given 
the dearth of studies focused on increasing uptake of PrEP in this population with inequitable rates of HIV 
infection.39 Additionally, this research would provide insight into implementing PrEP into a unique clinical setting, 
as to date research has focused on integration of PrEP into family planning care and sexually transmitted disease 
clinics for cis-gender women.40-42   
 
A3. Clinical care settings focused on women’s health may be ideal for PrEP service delivery among cis-
gender women. Given the inequities in PrEP prescriptions among Black cis-gender women, there has been 
growing literature on how to optimize uptake among this underserved population. However, there have been a 
dearth of studies that have focused on resource-limited settings like the Southern U.S. Studies conducted within 
this setting have shown that Black cis-gender women were willing to use PrEP; however, limited uptake has 
been reported.43 Safety-net programs created for cis-gender women to receive reproductive healthcare, like 
family planning clinics, have been evaluated in Southern states as sites for PrEP implementation. 39, 44 Women 
recruited from family planning clinics reported preferring PrEP information to be delivered through advertising 
and conversations directly with providers, as well as focused on awareness and access. 45 Additionally, 
investigators working to implement PrEP in such settings noted low PrEP knowledge as a significant provider-
level barrier, resulting in deployment of PrEP informational trainings in family planning clinics located in Southern 
states (including Alabama) to improve PrEP knowledge.46 But, even in this implementation study that focused 
on addressing client- and provider-level barriers through deployment of evidence-based implementation 
strategies, only 18% of patients seen (67 out of 376 sexually active cis-gender women) accepted off-site PrEP 
referral purportedly preferring to seek services on-site in the family planning clinic.46-48  In another study 
conducted in Washington D.C. at a family planning clinic where PrEP was offered on-site, again provider-
knowledge and PrEP referral increased with provider trainings, but uptake was sub-optimal with only 6% of those 
referred using PrEP.49 These studies provide proof of concept that general practitioners who specialize in 
women’s health are able to gain foundational knowledge about PrEP indications for cis-gender women, but 
uptake was still limited and further research is needed on how to integrate PrEP care into routine women’s health 
visits to improve PrEP uptake.  
 

A4. In the state of Alabama, gynecology clinics may provide an ideal setting for PrEP service delivery 
tailored for cis-gender women, in a state where family planning clinics are not currently prescribing 
PrEP. There are limited settings that offer specialized care focused on women’s health, like family planning 
clinics. However, currently family planning clinics within the state of Alabama (AL) are not offering PrEP; 
furthermore, only one health department in Jefferson County, the county seat of Birmingham and the most 
populous county in AL, is providing PrEP services, limiting publicly-funded settings for cis-gender women to 
receive PrEP around the State. Similar barriers are likely to be found in other Southern states with similar 
restrictive policies. Therefore, additional clinical settings that offer routine women’s healthcare need to be 
identified as potential sites for PrEP service implementation. There is strong evidence to support that many 
women in the U.S. are seeking routine annual care for reproductive health and nearly half access only 
reproductive healthcare services.50, 51 While family planning clinics provide much needed reproductive and sexual 
health services for many women (especially for those un- or under-insured), they only reach about one-quarter 
of U.S. women presenting for such care.50, 52 Additionally, 81% of patients seen by gynecologists are of 
reproductive age (18-44 years), which also reflects the age range with greatest risk for HIV acquisition among 
cis-gender women.53  
 
A5. Refining an approach to implement PrEP in gynecology clinics grounded in the RE-AIM (Reach, 
Effectiveness, Adoption, Implementation, and Maintenance) framework. RE-AIM has robust support for its 
use in planning implementation as well as monitoring programs.54, 55 RE-AIM has been used in program 
implementation research studies to focus and engage all stakeholders in decision making as well as provide a 
framework for evaluation. RE-AIM consists of five elements: 1) Reach (individual-level) – the ability to engage 
the target population in the intervention, 2) Effectiveness/Efficacy (individual-level) – evaluating the effect of the 
intervention on the primary outcome as well as the effect modification, 3) Adoption (setting-level) – determining 
the ability of the setting’s staff to adopt the intervention, 4) Implementation (setting-level) – the extent to which 
the intervention was delivered as intended, AND 5) Maintenance (both individual- and setting-level) – evaluating 
the impact the finished intervention has on participants over time as well as the extent that the intervention is 
retained after the research period.56 There is also precedent to evaluate PrEP implementation at a family 
planning clinic in Washington, D.C., using the RE-AIM framework to evaluate feasibility and impact.49 Through 
utilization of this framework, the investigators identified the following: 1) facilitators included provider training, job 
aids to guide easy identification of guidelines for PrEP recommendation, order sets, documentation aids, 
educational materials in the waiting room and 2) barriers included lack of insurance and concerns among 
providers that discussing PrEP in such a setting may not be “patient-centered” especially for those seeking 
pregnancy termination. This proposal will focus on the initial planning stages, working with key-stakeholders and 
Black cis-gender women to assess Reach, Adoption and preliminary Effectiveness of integrating PrEP services 
within a gynecology clinic in Birmingham, AL providing women’s healthcare to underserved, Black cis-gender 
women with the ultimate goal of increasing uptake of PrEP.    
 
B. INNOVATION 
B1. Overcoming the purview paradox – integrating PrEP into routine GYN care. The “purview paradox” was 
initially described as a major theme from qualitative data, suggesting that patients may prefer to receive PrEP 
services from primary providers instead of HIV specialists.14 However, there are limited studies evaluating 
implementation of PrEP with gynecologists who often are the primary providers for cis-gender women.57 National 
data evaluating willingness to prescribe PrEP showed that GYN providers are more willing to prescribe PrEP 
compared to general practitioners.58 Our GYN pilot site is a large center that sees over 17,000 cis-gender women 
annually who reside across the state, in both urban and rural areas. Forty percent of patients seen are Black cis-
gender women, with the majority of reproductive age. (See Letter of Support) Prior work at UAB has shown cis-
gender women seeking routine care are largely under-recognized as benefiting from PrEP prescription and, to 
date, no patients seen at the pilot facility have been prescribed PrEP.59 Implementing PrEP for cis-gender women 
as a part of routine sexual and reproductive health would also been unique, in that our team will not focus solely 
on women peri-conception.60 Given the pilot site’s Southern location and patient population served, preliminary 
results from this pilot will provide substantial guidance on successful refinement and implementation of PrEP4Her 
in similar clinical-care settings across the South. 
 
B2. Development of a patient-centered implementation strategy, supported by end-user data to deliver 
PrEP services where, when, and how cis-gender women are most comfortable in engaging in the 
conversation. Because demand for PrEP among populations with the highest HIV incidence is low, there has 
been a push to increase awareness of PrEP through development of demand creation tools, which focuses on 
strategies related to successful marketing campaigns, empowerment branding, and creation of differen t PrEP 

delivery modalities (e.g. long-acting). These initiatives are crucial in improving HIV inequities.61, 62 Such 
techniques are often “human-centered”, focused on the end-user working with researchers to develop 
interventions and improve implementation strategies.63 In fact, preliminary research, utilizing discrete choice 
experiments to understand PrEP service delivery preferences among Black cis-gender women, has also 
provided a foundation for PrEP4Her to be patient-centered. Additionally, this research actively engaged the 
community, through partnerships with community-based organizations, to adequately understand barriers to 
PrEP uptake and desired attributes for PrEP services.13 However, PrEP4Her will be focused on the equally 
important barrier to increasing PrEP uptake (i.e. supply creation) by improving access and expanding provider 
options for those that may benefit from using PrEP as an effective HIV prevention tool. Both end-user demand 
and health system supply creation will be necessary to overcome the current “prevention crisis” we are facing 
attuned to the “purview paradox,”  in our goals to end the HIV epidemic and this study uniquely expands supply-
side options.64  
 
B3. Using implementation science methods to develop a clear understanding of optimal provision of 
PrEP services within the GYN clinic. PrEP is a proven, highly effective intervention to decrease HIV 
transmission in cis-gender women. However, its impact to decrease HIV transmission among cis-gender women 
has been hindered due to a poor understanding of how to effectively identify strategies to improve uptake. Our 
proposed implementation science study is grounded in a conceptual implementation research logic model that 
includes implementation outcomes drawn from the RE-AIM and Proctor outcomes framework.  Additionally, our 
study design includes evaluation of determinants for successful implementation of PrEP4Her by incorporating 
study aims to determine individual-, inner- and process- factor domains from the Consolidated Framework for 
Implementation Research (CFIR).65 In order to see public health gains from utilization of PrEP in real-world 
settings, more implementation science studies are needed with clearly outlined and reproducible methods, like 
what we have proposed in this grant.66  
 
C. APPROACH 
C1. Team Members  
Name/Affiliation  
Role 
Expertise 
Latesha Elopre, MD 
MSPH 
PI 
Physician-scientist (HIV and PrEP provider) w ith expertise in mixed-methods study designs, 
evaluating barriers to PrEP care for BMSM (K23MH112417)67, 68 and PrEP service delivery 
preferences among Black cis-gender w omen in urban and rural settings (Harold Amos 
Scholar, Robert Wood Johnson Foundation).13, 
59, 69 Her w ork has led to a better 
understanding of key determinants of w illingness to use PrEP among Black cis-gender w omen 
living in AL, including: social support, HIV know ledge, stigma related to HIV and PrEP, and 
perceived need for PrEP.13 
Additionally, she has led discrete choice experiments that 
informed the proposed research. She w ill lead scientific planning w ith community partners 
and oversee overall study design as w ell as implementation.  
Lynn T. Matthews, 
MD MPH 
Co-I 
Physician-scientist using mixed-methods approaches to evaluate PrEP uptake/ adherence by 
HIV-exposed cis-gender w omen planning for/ w ith pregnancy in Uganda and South Africa 
(R01MH108412).70, 
71 Dr. Mathew s is also funded through a Center for AIDS Research 
(CFAR) EHE supplement to investigate provider barriers to increase assess to PrEP among 
adolescent cis-gender w omen. Dr. Matthew s w ill lead qualitative data analyses in this 
proposal.  
Zoë Julian, MD, 
MPH 
Co-I 
Clinical Instructor in the Department of Obstetrics and Gynecology and a postdoctoral 
research fellow  in the Division of Preventive Medicine, her research focus is evaluating 
community-based interventions and clinician training programs to combat sexual and 
reproductive health inequities impacting Black cis-gender w omen, as w ell as Black queer, 
trans, and gender non-conforming individuals. She w ill be providing expertise in survey 
instrument development and in-depth interview  guide creation for gynecologic care providers. 
Mirjam-Colette 
Kempf, MPH, PhD 
Co-I 
Professor of Nursing, Epidemiology, Health Behavior and Infectious Diseases, has expertise 
in psychosocial and structural barriers to care among cis-gender w omen living w ith HIV and 
those at-risk for HIV infection.72, 73 Relevant to this proposal - she currently serves as PI for 
an NIH-funded study (i.e. WeExPAnd) on how  to implement PrEP services tailored to cis-
gender Black w omen seeking healthcare in Federally Qualified Health Centers in rural AL. 
Michael Mugavero, 
MD 
Co-I 
Professor in the Division of Infectious Diseases at the University of Alabama at Birmingham. 
He has expertise in implementing multiple interventions across the state to improve HIV  
outcomes through collaborations w ith Community-Based Organizations as w ell as local and 
state health departments.74-77 He also leads the CFAR Implementation Science Hub at UAB. 
He w ill be providing his expertise in our implementation study design.  
Jessica Sales 
Consultant 
Associate Professor at the Rollins School of Public Health at Emory University. Dr. Sales is a 
developmental psychologist and investigator at the Emory CFAR, w hose w ork specializes in 
dissemination and implementation of HIV prevention for w omen and girls living in the South.78-
80 Her w ork has largely focused on improving PrEP know ledge, referrals and care at Title X 

family planning clinics in the Southern US.46 She w ill provide consultation in intervention 
development. (Letter of Support provided).   
Community 
Partners: 
- UAB GYN 
- AL ACOG Chapter 
Community 
Partners 
- 
GYN Continuity Clinic goal is to provide high-quality care to underfunded and unfunded 
cis-gender w omen w ho have limited or no access to care.  
- 
The Alabama American College of OB/GYN Chapter AL is dedicated to improving 
w omen’s health in the state of AL. American Council of Obstetricians and Gynecologists 
(ACOG) chapter w ill aid in recruitment of gynecologists in AL to complete surveys. 
 
Building on our collective expertise in conducting implementation science, community engaged research, and 
intervention development to improve PrEP uptake among disenfranchised groups, we propose to develop 
PrEP4Her, an intervention tailored to Black cis-gender women to improve uptake of PrEP within gynecology 
clinic settings in the South. 
 
 
C2. Preliminary Studies 
Utilization of behavioral economics methods to understand Black women’s preferred PrEP care delivery 
models. Research on medical decision-making has increasingly used discrete choice experiments to evaluate 
intervention development for prevention tools, including HIV testing and the HPV vaccine. 81-84 We conducted a 
mixed-methods study to understand key barriers, facilitators and desired attributes for PrEP service delivery 
among Black cis-gender women living in both urban and rural counties with high HIV burden in AL. Focus groups 
provided major determinants for PrEP uptake and attributes to include in quantitative analyses. 13 Discrete choice 
analyses included five attributes with 3-6 levels each, including PrEP delivery: modality, location, provider, 
medication/refills, and office intervals (Figure 1). Hierarchical Bayes modeling was used to ascertain 
preferences. Of the 795 Black cis-gender women enrolled, the mean age was 35 and 28% were PrEP eligible 
based on CDC clinical guidelines. Nine percent were uninsured and about one-quarter had a household income 
<$25,000.  Approximately 30% (n=235) reported being willing to use PrEP, which was associated with higher 
HIV knowledge and perceived need. Average utilities were highest for PrEP services delivered in a doctor’s 
office (27.9, SD 34.2), by an OB/GYN (8.9, SD 26.5) and only having annual follow-up (29.3, SD 49.0). PrEP 
modality preferences were almost the same for a long-acting injectable (46.9, SD 64.0) versus a once daily pill 
(45.0, SD 89.5). Major PrEP service delivery preferences did not differ among urban and rural Black cis-gender 
women.13(under review) Informed by this innovative science to understand PrEP service delivery preferences 
for Black cis-gender women living in both urban and rural settings in the South, PrEP4Her has the potential to 
reach a greater proportion of women and change routine practice among gynecology specialists through 
implementation of PrEP services.  
 
C3. Research Design and Methods  
Study Overview: We will conduct formative work, evaluating multi-level determinants that will inform selection 
of components for our implementation strategy to improve PrEP services including prescription for Black cis-

gender in the South receiving routine gynecologic care. Determinants will be evaluated using concurrent mixed-
methodology to elucidate CFIR domains, including individual-, inner-setting, and process-level factors that may 
affect proximal, implementation outcomes.65 Working closely with a community-advisory board (CAB) of Black 
cis-gender women and key stakeholders at gynecology (GYN) clinics, we will solicit feedback about PrEP4Her 
implementation strategy components and procedures for the purposes of determining and refining PrEP4Her 
prior to piloting. Next, we will conduct a one-arm pilot study of PrEP4Her over a six-month period-of-time. Using 
the conceptual framework grounded in RE-AIM, the study will assess a wide range of implementation outcomes, 
including reach, adoption, preliminary effectiveness, feasibility, acceptability, and fidelity.20, 85  
 
Hypothesis: We hypothesize that integration of PrEP services into our GYN clinic site will be feasible and 
acceptable, with an increase in PrEP prescription (currently zero prescriptions) for Black cis-gender women due 
to this being an initial pilot requiring further refinement of components included in our implementation strategy.  
 
PrEP4Her Implementation Science Research Logic Model: This study is grounded in the RE-AIM framework 
to successfully implement PrEP into gynecologic (GYN) care that is cohesively organized by an implementation 
science research logic model. (Figure 2)  Our logic model has been adapted to provide clear representation of 
the causal pathways between components of our implementation strategy (i.e. methods to enhance 
implementation of PrEP in GYN settings in the South), change mechanisms (i.e. the process through which 
implementation strategies affect implementation outcomes) and proximal outcomes for the proposed intervention 
(i.e. PrEP4Her, implementing PrEP into women’s health clinics).20, 85, 86 Our model also includes hypothesized 
factors, selected based on our preliminary work and review of the literature, that may influence the effect of an 
implementation strategy on an outcome (i.e. moderators) as well as factors deemed necessary for 
implementation mechanisms to be activated (i.e. preconditions for mechanisms of action). 12, 13, 87 This 
comprehensive model will help us select key components for our implementation strategy that addresses 
contextual and individual barriers to PrEP prescription to Black cis-gender women.88 
 
Community advisory board (CAB): Throughout the study to promote researcher-community collaboration, we 
will convene a CAB of 6-8 individuals (not including involvement by Dr. Elopre as researcher representation) – 
including Black cis-gender women and gynecology practitioners. To ensure we obtain adequate feedback from 
community members, we will have at least half of our CAB be Black cis-gender women: aged 18-45, self-reported 
HIV negative, sexually active in the last 6 months and not in a monogamous relationship (to reflect potentially 
PrEP eligible women). We will recruit CAB members from prior research studies with Black cis-gender women 
and solicit referrals from the University of Alabama at Birmingham Center for Women’s Reproductive Health as 
well as the AL American College of Obstetricians and Gynecologists (see Letters of Support). In Aim 1, the CAB 
will meet monthly (following a kick-off meeting) to get initial feedback on our interview guide and help us to 

interpret our qualitative findings. In Aim 2, the CAB will meet bi-weekly for 3 months to engage in the process of 
selecting and refining components of our implementation strategy (PrEP4Her). In Aim 3, the CAB will advise on 
how to disseminate study results and will resume monthly meetings. We expect at least 10 meetings, during the 
study and we will adopt a shared decision making structure and take detailed notes to evaluate meeting 
processes. CAB members will receive a $10 stipend per meeting.89   
 
Specific Aim1. Evaluate key individual-, inner-setting, and process-level determinants for 
implementation of PrEP service delivery in gynecology clinic settings using concurrent mixed-methods 
study design.  Concurrent Mixed-methods Research Design: Quantitative and qualitative data will be 
collected concurrently and integrated using transformation integration procedures (i.e. quantifying themes and/or 
codes from qualitative data and incorporating it into quantitative databases),90  to determine major barriers and 
facilitators to implementing PrEP into gynecology care and, further aid in development and refining of 
components to include in PrEP4Her in Aim 2.91-93  
 
Sub-aim 1: Assess process and inner-setting determinants conducted with key-informants to explore perceived 
barriers and facilitators for integrating PrEP into routine gynecological clinical care.  
 
Qualitative Study Design: Key informant in-depth interviews will be conducted with gynecologists, practice 
managers, medical assistants, nurses and pharmacists at our clinical site. 
Sample: Open-ended qualitative interviews will be conducted with 15-20 key informants currently employed at 
our GYN clinical site.94  
Procedures and Qualitative 
Data 
Analysis. 
These 
interviews 
will 
provide 
contextual 
information 
on 
barriers 
to 
PrEP 
implementation, 
which 
will 
influence 
design 
of 
our 
implementation 
strategy.(Table. 1) Potential 
Interview  guide) Also, based 
on analyses from Aim 1, 
potential key determinants for 
intervention development will 
be 
vetted 
during 
these 
interviews to assess feasibility 
of intervention implementation. 
Medical service providers will include nurse practitioners, gynecologists and internist who provide women’s 
healthcare. We will also engage with case managers and social workers to discuss coverage for PrEP services 
and programs that exist for those not insured. Digital audio-recorders will be used to record all key informant 
interviews. Interviews will be conducted via teleconference. 
Data Analysis: Dr. Matthews will lead coding and analytic approach; she has extensive experience conducting 
qualitative research and working with analytic teams. Analytic steps will include: 1) After each interview, 
interviewers will document field notes including emerging topic areas for subsequent exploration. 2) After 
interviews have been completed and recordings transcribed, transcripts will be uploaded to an encrypted 
password protected computer and NVivo qualitative data management software (QSR International, Melbourne, 
Australia) will be used to organize coding and analysis. 3) A preliminary codebook will be developed to include 
inductive codes that emerge from data (e.g. barriers to PrEP implementation, suggested workflow models, etc.) 
and pattern codes that connect concepts to one another.95 4) The coding team will apply codes to a subset of 
transcripts in parallel, comparing coding strategies and adjusting code definitions until adequate inter -coder 
reliability is achieved. 5) As the team is applying codes, they will also continuously develop analytic memos 
reflecting dimensions and characteristics of each code, as well as noting major themes. 6) Data matrices will be 
created to visually represent relationships between key concepts and elicit patterns in the data. Throughout this 
process, the qualitative team will hold weekly analysis meetings. 
Quantitative Study Design: Cross-sectional study will be done in collaboration with the AL American College 
of Obstetricians and Gynecologists and the UAB Center for Women’s Reproductive Health in the Department of 
Obstetrics and Gynecology (letters of support provided) to understand barriers to future state-wide 
implementation that would need to be measured during this study pilot. 

Sample: Participants (N = 250) will be recruited from the state of Alabama. Inclusion criteria: 1) currently 
practicing gynecologists or advanced practitioners at GYN clinics 2) English speaking, 3) Age ≥ 18. 
Methods: Survey will evaluate structural barriers to PrEP, as well as incorporate potential provider-level barriers.   
Data Management: REDCap (Research Electronic Data Capture) will be used for electronic surveys and is a 
secure, Web-based application designed to support data capture for research studies.  
 
Data collection: Gynecologists will be recruited through direct referral (from AL ACOG and UAB 
OB/GYN Center for Research) either through email correspondence or direct communication. A prescreening 
electronic query that will identify whether they meet inclusion criteria will be given through email correspondence,  
followed by consent. Data will be collected using a secure electronic server and will by designed to only last 
approximately 15 minutes. Surveys will include sociodemographic variables and validated scales to determine 
HIV/PrEP knowledge96, 97, HIV/PrEP stigma98, 99 as well as questions to ascertain current routine testing and 
screening practices. 
Power Calculations and sample size considerations: We will administer our survey to 250 Alabama 
gynecologists.  This sample size will allow us to detect odds ratios of willingness to prescribe PrEP of 2.09 for 
binary variables (50% in each group across study) and 1.47 for a standard deviation change in con tinuous 
variables assuming 80% power, 30% baseline percentage of willingness to prescribe PrEP, no other variables 
in the model, and Type 1 error rate of 5%.  When covariates are included that have a correlation of 0.2 with the 
independent variable, the detectable ORs increase (2.27 and 1.54 respectively for binary and continuous 
variables). 
Primary outcome: Willingness to prescribe PrEP (categorical, yes vs no). 
 
Secondary outcome: Belief clinical-setting capable of providing PrEP services (ordinal, 1-10) 
 
Independent variables: Expected variables as listed in Table2.  
 
Table 2.  Expected Independent Variables, RE-AIM Constructs 
Independent Predictor Variable 
RE-AIM 
Construct 
Measures 
Clinical-setting level  
- 
Determine denominator (i.e. number of providers 
in clinical settings) willing to prescribe PrEP and 
factors associated with their willingness 
- 
Determine belief current clinical setting prepared 
to provide PrEP services 
Adoption 
- 
Socio-demographics: race/ethnicity, clinic name, gender, 
years of practice, clinic resources, characteristics of 
populations served  
- 
Know ledge: PrEP and HIV 
- 
Stigma: PrEP and HIV 
- 
Practice: Sexual history, STI testing, STI treatment 
 
Descriptive statistics: Frequencies for reported willingness to prescribe PrEP will be reported overall and 
for each independent variable. Descriptive statistics (median/interquartile ranges, frequencies/percentages) and 
comparisons between those willing to prescribe PrEP and not willing will be reported for each independent 
variable in bivariate logistic regressions. Multivariable logistic regression models will be performed adjusting 
each independent variable by a priori variables, such as age, race and sex, and other variables included based 
on literature review. 
 
Logistic regression analyses: Bivariate models will be fit and variables with p-values ≤ 0.1 will be 
included in multivariable logistic regression analyses. Model fit will be determined using Hosmer and Lemeshow 
tests. A priori variables will be selected and included based on literature review.  
 
 
Sub-aim 2: To further assess individual-level determinants, we will conduct focus groups with Black cis-gender 
women living in Alabama to explore desired PrEP educational materials and communication strategies from 
gynecologic care teams. 
Development of the Interview Guide. We will develop a semi-structured focus group guide for focus groups in 
collaboration with our CAB, refining it through pilot testing (Table 1). The guide will ensure that appropriate lines 
of inquiry are pursued among participants by providing topical area questions and probes, while also encouraging 
explorations of participants’ experiences and allowing for the emergence of novel concepts and ideas. The guide 
will include a mixture of descriptive/narrative questions (e.g., Tell me about experiences you or women you know 
have had visiting gynecology clinics) and questions structured around possible implementation strategy 
components guided by review of the literature (e.g., Tell me about your experiences discussing sexual health 
with your gynecologist) to facilitate a more granular understanding of : 1) Black cis-gender women’s perceptions 
of informational content needed to motivate engagement in PrEP care, 2) who in the healthcare team would they 
feel comfortable discussing sexual health and HIV prevention with and 3) specific implementation strategy 
components for GYN clinics that would aid in engaging Black cis-gender women in PrEP care. (Table 1. Includes 
possible topics for focus groups) 

Sample: Five focus groups, consisting of 5-6 people, will be conducted. Recruitment will be coordinated through 
flyers and direct referrals from UAB’s GYN Continuity Clinic. Sessions will be conducted in private rooms located 
in public buildings or, if the ability to conduct in-person interviews is affected by the COVID-19 pandemic, focus 
groups will be conducted virtually to ensure the safety of participants as well as staff. Inclusion criteria: 1) self-
reported HIV-negative status, 2) Black cis-gender women, 3) English speaking, 4) Age18-45 years (this age 
range is based on current HIV epidemiology supporting greatest incidence in cis-gender women aged < 54).1  
Procedures. Potential participants who are referred will be asked to complete an online screening tool to 
determine whether they meet eligibility criteria and to collect demographic data. If participants are eligible, study 
staff will contact them via phone to schedule focus groups. Focus groups will be conducted in private, quiet, 
mutually convenient locations by study staff who are trained in qualitative methods and interview techniques. 
Informed consent will be obtained prior to each focus group and participants will receive $50 in compensation 
upon completion. All focus groups will be digitally audio recorded, professionally transcribed, and de-identified.  
Qualitative Data Analysis. See Qualitative analyses sub-Aim 1.  
Data Integration: We will be integrating our qualitative and quantitative data findings through joint displays, 
bridging results using visual displays to connect major themes.90  
 
Expected Outcomes: Following evaluation of overall themes, findings from this aim will create an in-depth and 
granular understanding of key factors that are necessary to address in development and refinement of 
PrEP4Her, our implementation strategy to integrate PrEP services into routine GYN care. Large sampling of 
GYN providers will also allow for greater generalizability of our implementation strategy to other Southern sites.   
 
Specific Aim 2. Develop and refine a multi-component implementation strategy (PrEP4Her) to integrate 
PrEP in gynecology clinics using formative data from Aim 1 and a process of community-engaged 
research.   
Study 
Design: 
Intervention 
Mapping Approach. We will 
work with our CAB and draw on 
Intervention Mapping     (IM) 
techniques100 to guide translation 
of our Aim 1 results into a protocol 
for 
development 
of 
our 
implementation 
strategy 
with 
subsequent piloting in Aim 3. IM is 
an 
established 
process 
for 
systematically 
developing 
behavior change interventions, 
with iterative paths from problem 
identification 
to 
problem 
implementation (Table 3). We 
have chosen to use this process 
to select components for our 
implementation strategy, because 
the ultimate goal of this study is to change behavior of both providers and patients during routine GYN clinic 
visits. IM highlights the importance of incorporating data to map out the problem (i.e., PrEP underutilization by 
Black cis-gender women), its determinants (better refined in Aim 1), and potential implementation strategy 
components to facilitate identified goals. Specifically, Aim 2 will focus on Steps 1-4, which are the most relevant 
steps to intervention development.  In Step 1 – we will work with our planning group (the CAB and study team) 
and review the findings from Aim 1, identifying key barriers we feel need to be addressed among Black cis -
gender women and providers. In Step 2 – we will create a logic model of change, in which we focus on objectives, 
smaller goals than the larger overarching goal of improving PrEP prescriptions for Black cis-gender women.  In 
Step 3 – we will map out our implementation strategy components based on the logic model of change, and 
begin to link them to desired implementation outcomes (e.g., job aids, educational materials for Black cis-gender 
women, etc.). In Step 4 – we will develop specific content implementation strategies.  
 
Proposed PrEP4Her Implementation Strategy Components: The development of the PrEP4 Her 
Implementation Strategy begins with components already identified in existing studies where PrEP was 
implemented into family planning clinics in the South.  Aim 1 findings will then be used in Aim 2 to refine this 
initial list, by either eliminating unnecessary components, adding additional ones, or adapting existing 

components to respond to the unique GYN context. In Table 6, we have provided our hypothesized name, 
definition and operationalization of components based on the guidelines established by Proctor et al., in terms 
of seven dimensions of specificity, including: 1) actor (who delivers the strategy), 2) action (steps or processes 
to be taken), 3) target (what will be impacted by the strategy), 4) temporality (the order or sequence of t he 
strategy), 5) dose (intensity or amount of time spent for a strategy), 6) implementation outcomes affected 
(grounded and RE-AIM and included constructs from Procter et al) and 7) justification (rationale for selected 
components).85, 101, 102  
 
Table 4. Specification of Hypothesized Components of Implementation Strategy (“PrEP4Her”) 
Named 
PrEP4Her 
components 
1. 
Universal sexual health screening for GYN 
patients 
 
2. 
Synchronous Training of GYN care team 
on HIV, PrEP indication, PrEP care (for 
both daily and long-acting injectable 
regimens), and stigma 
 
3. 
PrEP indication job aids 
 
4. 
Electronic medical record documentation 
aids, including pre-templated notes and 
order sets 
5. 
Educational materials for Black cis-gender 
women on HIV and PrEP 
6. 
Asynchronous training on effective 
communication strategies with patients 
about sexual health and PrEP 
Implementation 
Strategy 
Number 1 
Number 2 
Number 3 
Number 4 
Number 5 
Number 6 
Actor 
Medical 
assistant or care 
provider 
Study staff/ 
PrEP expert 
PrEP expert 
PrEP expert and 
information 
technician 
PrEP expert and 
graphic 
designer 
PrEP expert 
Action 
Charts evidence 
based sexual 
history 
questionnaire in 
the medical 
record103 
Provides 1.5 
hour training on 
HIV, risk, and 
PrEP indications 
and care 
Creates easily 
accessible 
pocket cards 
w ith indications 
for PrEP104, 105 
Creates 
templates in 
electronic 
medical record 
for PrEP visits 
and order sets 
Develops 
informational 
content to 
include in 
educational 
materials 
tailored to Black 
cis-gender 
w omen 
Develops 15-30 
minute training 
tutorial on how  
to communicate 
w ith patients 
about sexual 
health and 
PrEP, tailored to 
Black cis-
gender w omen  
Target 
Patient 
Providers/staff 
Provider 
Provider 
Patient 
Patient 
Temporality 
Medical 
assistant – 
Before every 
patient 
encounter w ith a 
provider OR 
Provider – 
Beginning of 
every visit 
1-month prior to 
PrEP4Her being 
implemented at 
our pilot site 
Continuously 
carried by 
providers and 
displayed in 
shared 
w orkspaces 
1-month prior to 
PrEP4Her being 
implemented 
w ith instructions 
on how  to 
access placed 
in shared 
w orkspaces and 
sent through 
email 
communications 
Placed in 
w aiting areas 
and/or private 
exam rooms, 
accessible 
during every 
visit and 
replenished by 
study staff 
1-month prior to 
PrEP4Her being 
implemented 
and 
presentation 
accessible in 
shared w ork 
space as w ell as 
emailed to all 
providers 
Dose 
5-minute 
screener at 
every visit 
1.5 hour training 
occurring once 
prior to 6-month 
pilot 
As needed by 
providers during 
clinical care 
As needed by 
providers during 
charting 
Available during 
the entire 6-
month pilot for 
every clinic 
Once prior to 6-
month pilot and 
then available 
as needed 
Implementation 
Outcomes 
affected 
Please see Figure 2. for detailed description of how  each implementation strategy maps to implementation 
outcomes. In short, w e w ill be evaluating the follow ing proximal implementation outcomes: reach, adoption, 
fidelity, acceptability, and preliminary effectiveness. Distal outcomes w ill not be evaluated in this study.  
Justification 
Implementation strategy components selected for this study have been selected based on observed, researched 
or hypothesized barriers based on review  of the literature. These components may be subject to change based 
on findings in Aim 1 and feedback from our CAB.  
  
Pilot intervention development with CAB: We will engage members of our CAB, including key stakeholders 
in GYN clinic operations, care and management as well as Black cis-gender women (aged between 18-45) bi-
weekly over a 3-month period of time (see structure above). During this time, we will conduct IM (outlined above) 
and pilot materials developed as a part of selected implementation strategy components. After implementation 
strategy materials have been refined, we will review appropriate operational steps needed to integrate PrEP into 
our clinical site. For implementation strategy selection and content development, we will work closely with Dr. 
Sales who has expertise in implementation science working with family planning clinics in Southern settings to 
improve HIV prevention among Black cis-gender women. We will meet with Dr. Sales monthly, in one-hour 
meetings with a consultation fee of $100/hour. (See Letter of Support) 

 
Specific Aim 3. Pilot PrEP4Her, refined through Aim 2, to deliver PrEP for Black cis-gender women 
attending routine gynecologic care visits. 
PrEP4Her Study Design:  PrEP4Her, a multi-component implementation strategy with components defined as 
well as refined through prior aims, will be evaluated through a one-arm pilot at a university-affiliated GYN clinic. 
(Figure 3) We have chosen a one-arm trial because PrEP is not currently being offered routinely at GYN clinics 
and there are three Black cis-gender women on PrEP in the university-affiliated PrEP clinic, making a comparison 
either between other GYN clinics or between our PrEP clinic have limited meaning. Implementation processes 
will result from communication with our CAB and consultant (Dr. Sales). Upon completion of PrEP4Her 
development, we will begin engaging key GYN staff, practice managers and clinicians to begin training as well 
as implementing job and documentation aids within the clinic. Educational materials will be placed in all areas 
where patients are seen within the clinic. We will monitor implementation outcomes for PrEP4Her over a 6-month 
timeframe, with detailed procedures that we have described in the below section.  
 
PrEP4Her Components 
Universal Sexual History – Brief, gender-
neutral sexual history screening assessment.
106 
Job Aids – 2-sided pocket cards for white 
coats/scrubs that will include CDC guidance 
summary criteria for PrEP in cis-gender women 
and 5Ps.
105, 107  
Educational Materials – Pamphlets, tailored 
for Black cis-gender women that contain 
information about HIV and PrEP.
45 
Synchronous HIV and PrEP Training – ~ 
1.5 hour PrEP informational training (adapted 
from Sales et al. in family planning clinics) made 
available on UAB CFAR website.
46  
EMR Documentation/Order Aids – 
Premade order sets within UABs electronic 
medical record for initial and 3-month PrEP 
visits as well as a PrEP note template.  
Asynchronous Training on Communication 
Strategies – ~ 15 minute training on 
communicating empowering, “gain-framing” 
messaging, made available on CFAR website.
108  
 
Procedures for Evaluating Proximal Implementation Outcomes: 
Reach Outcome: For this study outcome, Reach (i.e. the number of individuals who are willing to participate in 
an initiative) is defined as the absolute number of Black cis-gender women who receive a PrEP prescription. We 
will also evaluate the proportion of women prescribed PrEP who had a PrEP indication.19, 109 PrEP indication will 
not be defined using the Center for Disease Control and Prevention (CDC) PrEP indication clinical guidelines 
due to evidence suggesting these criteria are too restrictive and may not predict risk.105 Instead we will define 
PrEP eligibility based on the CDC’s guidance summary criteria, deeming those PrEP eligible who meet any of 
the following criteria for cis-gender women not living with HIV (over a 6-month timeframe): HIV-positive sex 
partner, bacterial STI (gonorrhea or syphilis), more than one sex partner, inconsistent condom use, sex for 
exchange of goods, or being in a high-prevalence network.110 This data will be obtained based on the sexual risk 
screener (a component of implementation strategy) documented in the chart during patient visits.  
Procedures. Data will be collected from the university’s electronic medical record, looking at visit data for all cis-
gender women with clinic visits during the pilot timeframe. We will be able to extract prescription data directly, 
but PrEP eligibility and referral will require review of chart documentation.  
 
Preliminary Effectiveness Outcome: To evaluate effectiveness of PrEP4Her, we will determine increases in 
PrEP prescriptions over-time. We will also evaluate what patient factors are associated with PrEP prescription.109  
Procedures. A data extraction of the UAB electronic medical record will be done (as described above) at 3-
month time intervals after implementation of PrEP4Her (i.e. baseline, 3-months and 6-months’ time). We will 
collect the following patient demographics: age, race, ethnicity, and insurance status.  
Statistical analysis.  Frequencies for prescription will be reported overall and for each independent variable 
(i.e. patient demographics), at each of the 3 time points (baseline, 3 months and 6 months). Means, standard 
deviations and t-test comparisons between those referred and prescribed PrEP will be reported for continuous 

independent variables if normally distributed. For variables with excessive skewness or otherwise non -normal 
distribution, medians with upper and lower interquartile ranges will be reported compared by Wilcoxon rank sum 
test. Categorical independent variables will be reported as frequencies and percentages and compared by chi-
square and Fisher’s exact test. Bivariate models will be fit and variables with p-values ≤ 0.1 will be included in 
multivariable logistic regression analyses. Model fit will be determined using Hosmer and Lemeshow tests. 
 
Adoption Outcome: As a dimension within the RE-AIM framework, we define adoption as the proportion of key-
stakeholders within our pilot site who were willing to initiate our implementation strategy.19, 109 In order to assess 
this, we will conduct and document the following procedures. 
Procedures. Trainings: During synchronous trainings we will document the number of providers and staff who 
attend meeting. Asynchronous attendance will be captured through collecting para-data (to track clicks) on the 
number of providers and staff who visit the CFAR website and access training materials. Additionally, we will 
connect a REDCap survey link to the end of training materials that will include a single-item asking “Did you 
access these training materials to aid in PrEP implementation at the UAB GYN Continuity Clinic?”. Sexual 
History: We will conduct a chart review (similar to what was described above), to evaluate absolute number of 
patients seen during our pilot timeframe who had a sexual history taken.  
 
Acceptability Outcome: We are defining acceptability as the extent to which key stakeholders, both provider 
delivering the intervention and Black cis-gender women receiving it, felt PrEP4Her was acceptable. In order to 
assess this, we will conduct key-informant interviews with stakeholders.  
Sample. Key informants will include 15-20 stakeholders from our pilot site (including approximately 10 providers, 
managers, and other support staff), as well as Black cis-gender women (approximately 10-15) who were seen 
during the 6-month intervention pilot.  
Recruitment. We will recruit key stakeholders directly from our pilot site and Black cis-gender women will be 
recruited after the pilot through flyers and direct referral from clinical staff.  
Procedures. Interview guide questions will be grounded in a theoretical framework of acceptability from Sekhon 
et al., including seven constructs.111 (See Table 5) Interviews will conducted virtually, to allow for flexibility of 
clinical staff using a secure system. All interviews will be digitally audio recorded, professionally transcribed and 
de-identified.  
 
Table 5. Potential Interview Topics grounded in Sekhon et al. Theoretical Framework  
 
Constructs 
Operationalized Topics 
Prospective Acceptability: prior to 
participating in PrEP4Her 
 
 
 
Concurrent Acceptability: 
Whilst participating in PrEP4Her 
Affective Attitude 
 
Feelings about PrEP4Her 
Burden 
 
How  much effort w as required to participate 
in PrEP4Her 
Ethicality 
 
Did PrEP4Her align w ith your values 
Intervention Coherence 
 
How  w ell did you understand PrEP4Her and 
how  it w orked 
 
Opportunity Costs 
 
How  much values or perceived benefits w ere 
given up to engage in PrEP4Her 
Perceived Effectiveness 
 
How  w ell did PrEP4Her achieve its purpose 
Retrospective Acceptability: 
After participating in PrEP4Her 
Self-efficacy 
 
Confidence in performing behaviors required 
to participate in PrEP4Her 
Note: For Black cis-gender w omen, questions w ill be framed around the PrEP4Her implementation strategy that targeted patients. 
 
Data Analysis. Drs. Mathews and Elopre will lead coding and the analytic approach. We will develop a 
preliminary codebook including a priori deductive codes, based on constructs from our theoretical framework, 
inductive codes that emerge from the data and pattern codes that connect concepts to one another.95 The coding 
team will code a sub-set of transcripts in parallel to compare coding and adjust codebook definitions until 
adequate inter-coder reliability is achieved.  
 
Feasibility: We will measure whether PrEP4Her is appropriate for a larger, full-scale implementation trial by 
surveying out key-stakeholders prior to interviews (conducted to assess acceptability).  
Procedures. Feasibility will be measured using the validated scale Feasibility of Intervention Measure (FIM) 
(Cronbach’s alpha 0.85-0.91).112 This includes straightforward items such as “[PrEP4Her] was appealing to me”, 
“[PrEP4Her] seemed suitable”, and “[PrEP4Her] seemed easy to implement”, which respondents rate on a 5-
point Likert scale. 
Statistical Analysis:  Descriptive statistics, using medians and inter-quartile ranges and frequencies, will be 
calculated to characterize feasibility. 
 
Fidelity: We will evaluate the “fidelity” or degree to which our implementation strategy (PrEP4Her) was 
implemented as designed.113 Specifically, we have chosen to evaluate components of PrEP4Her that are 

measurable and reflect the end-user perspective, including: universal sexual health screening of cis-gender 
women seen within our GYN pilot site, receipt of educational material about PrEP,  communicated with a provider 
about PrEP. We have selected to evaluate fidelity to measure the effect of type III errors on overall effectiveness 
of PrEP4Her to increase PrEP uptake and to guide future, large-scale implementation.   
Procedures. During the 6-month pilot, all patients seen during this period will be given a flyer by staff upon clinic 
checkout with information to take a brief 5-minute on-line survey, with a compensation of $20. We will stop 
recruitment after 300 surveys have been completed. A QR code, website and contact information for study staff 
will be located on the clinic document. While this intervention is tailored to Black cis-gender women in terms of 
educational material and tailored communication with providers, implementation strategy components are 
universal to all patients seen and, therefore, we will not conduct targeted sampling. 
Methods. Brief electronic surveys will include the following questions: 1) Did your provider (or other clinical staff) 
take a history asking about your sexual activities and health?, 2) Did you see educational materials during your 
visit about HIV prevention and a prevention methods call PrEP, 3) Did you speak with a provider about PrEP? 
AND 4) For those who spoke with a provider about PrEP, would you please describe the conversation and how 
you felt about communicating with your provider about this prevention strategy? 
Data Management. REDCap (Research Electronic Data Capture) will be used for electronic surveys and is a 
secure, Web-based application designed to support data capture for research studies.  
Data Analysis. Quantitative survey data: Descriptive statistics, using medians and inter-quartile ranges and 
frequencies to determine fidelity. Qualitative survey data: A similar analytic approach used for data analysis of 
acceptability will be used, except deductive coding will not be included in analyses.   
 
Expected Outcomes: Completion of this aim will provide the necessary information to refine PrEP4Her for 
broader dissemination in a multi-site implementation study with a step-wedge design.  
 
C4. Potential Challenges and Alternative Strategies: (1) Provider uptake of PrEP4Her: It is often challenging 
to engage clinical care teams to conduct interventions due to workflow demands and time constraints. This may 
impact the overall efficacy of PrEP4Her due to low adoption and lack of fidelity to PrEP4Her components. To 
overcome this barrier, investigators will work with leadership in identifying “champions” within the clinic setting 
to encourage PrEP4Her implementation. Inclusion of a physician practicing in the GYN continuity clinic as a part 
of our investigative team embeds a committed champion within our pilot site. (2) Recruitment of Black cis-gender 
women: We plan to recruit Black cis-gender women from our clinical site, to take part in both interviews and 
quantitative surveys throughout this proposal. We will use well-established research advertising through UAB, 
but also will leverage provider referral and referral from our research staff to meet recruitment goals. Dr. Elopre 
has shown that such networks have been successful in recruiting almost 800 Black cis-gender women for PrEP 
research studies in AL.  (3) Selection bias: we acknowledge the potential for selection bias – Black cis-gender 
women who are interested in participating in our study may have less HIV and PrEP stigma than the general 
population. We will make efforts to recruit online and at our clinical site with non-stigmatizing, health promoting 
messaging to engage a representative sample. (4) Measuring PrEP adherence: due to time and budgetary 
constraints, we will not evaluate persistence or quantitate adherence with drug levels in the blood or hair, which 
would be the gold standard to measure adherence to PrEP for those prescribed; however, this is not currently a 
primary endpoint for this study. In a subsequent efficacy trial, we will measure adherence more definitively. 
 
C5. Study Timeline: See study timeline supplement for detailed timeline. 
Table 6. PrEP4Her 3-year study timeline 
Year 1 
Year 2 
Year 3 
Aim 1: Focus Groups Black w omen 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Key-informant Interview s 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Surveys of GYN providers 
 
 
 
 
 
 
 
 
 
Aim 2: Development and Refinement PrEP4Her 
 
 
 
 
 
 
 
 
 
 
Aim 3: PrEP4Her Intervention 
 
 
 
 
 
 
 
 
 
 
Manuscript Preparation and Dissemination 
 
 
 
C6. Impact and Future Directions: Upon completion of our Aims, we will have developed a culturally tailored 
strategy to improve uptake of PrEP among Black cis-gender women, ready for further testing. If PrEP4Her shows 
feasibility, acceptability and preliminary efficacy in enhancing PrEP uptake for Black cis-gender women, we will 
prepare a subsequent R01 application to conduct a fully powered, implementation science trial across multiple 
gynecological care sites across the South. Even in the absence of preliminary efficacy of the pilot, the knowledge 
gained around determinants and components to include in our PrEP4Her implementation strategy to integrate 
PrEP services into GYN settings will provide novel insights to inform future HIV prevention research among this 
highly impacted group.  
 

PrEP4Her Analysis Plan 
Specific Aim 3: Pilot PrEP4Her, refined through Aim 2, to deliver PrEP for Black 
cis-gender women attending routine gynecologic care visits. 
Started September 26, 2025 
 
Objectives 
(Primary manuscript)  Mixed methods paper evaluates  the implementation outcomes, 
using the RE-AIM framework, of the PrEP4Her intervention in a low barrier gynecology 
setting.  
(Primary/Fidelity) Described fidelity to PrEP4Her from the end-user perspective. 
Describe results from survey, compare/;contrast with EHR review (EHR data confirms 
the number of PrEP prescriptions) 
Study population: Reproductive aged women 18-45 who received the PrEP4Her 
intervention as a component of their standard care from January 2023 – August 2024 [ 
Pre-implementation stage Jan – July 2023; PrEP4Her implementation July 2023 
January 2024; Pilot January 2024-August 2024]. 
PreP4HER components -  Universal sexual history screener, synchronous PrEP 
training, job aides [pocket cards with CDC PrEP guidance and 5Ps, EHR 
documentation/order aids, educational materials, asynchronous training on 
communication strategies 
Outcomes Assessment 
Qualitative data- Grounded in Sekhon, et al. acceptability  framework 
1. 7 key informant interviews  
2. 18 participant interviews 
Quantitative data  
1. Visits per period (of intervention) with number of PrEP prescriptions 
a. Patient visits by intervention period; total n=4161 
b. PrEP prescriptions per period; n=11 
 
2. EHR review (to confirm PrEP prescriptions) 
a. Total charts reviewed n= 4635; missing =6 
 
3. Demographics of all patients 
a. Race 
b. Sex at birth assignment 
c. Gender in EHR 
d. Lab results 
i. Chlamydia  
ii. Gonorrhea 

iii. Syphilis 
iv. HIV 
 
4. Demographics of patients with a PrEP prescription 
a. Race 
b. Sex assigned at birth 
c. Gender assigned Iin HER 
d. Lab results 
i. Chlamydia  
ii. Gonorrhea 
iii. Syphilis 
iv. HIV 
 
5. Sexual health pre-screener survey; n=1135 
a. Sociodemographics 
i. Race 
ii. Sex assigned at birth 
iii. Gender in EHR 
iv. Lab results 
1. Chlamydia  
2. Gonorrhea 
3. Syphilis 
4. HIV 
 
b. Sexual health pre-screener outcomes; n=1135 
i. Types of sexual behaviors 
ii. Gender of partners 
iii. Sexually active in last year 
iv. Number of sexual partners in past year 
 
c. Data on when participants were seen (by month/year) 
 
6. Post visit (fidelity) survey data; n=242 
a. Demographics 
i. Race 
ii. Education 
iii. Employment 
iv. Insurance 
v. Estimated household income 
vi. Reason for visit 
vii. Anal sex in past 6 months 
viii. Condom use history 
ix. Number of partners 
x. Gonorrhea or syphilis diagnosis, past 6 months 
xi. Partner living with HIV and not on medication 
xii. Did provider take sexual history? 

xiii. Saw educational materials during visit? 
xiv. Spoke with provider about PrEP? 
xv. Prescribed PrEP during visit? 
 
b. Fidelity items 
i. Comfort discussing PrEP w/ provider 
ii. Understood side effects of PrEP after discussion w/ provider 
iii. Provider discussed how to pay for PrEP 
iv. Felt confident could take PrEP daily after visit 
 
c. Row percentages -Talked to doctor about PrEP and demographics 
 
7. PrEP prescriptions data with physician and intervention period 
a. Demographics of patient prescribed; n=11 
i. Race 
ii. Age 
iii. Lab results 
iv. Earliest Emtricitabine-Tenofovir 
v. Study Prescription Date 
vi. Order Date 
 
8. Number of women with a PrEP indication seen during the study visit (no 
indication/STI in last 12 months/multiple partners/STI in last 12 months and 
multiple partners); n=4241 
a. Data by visit date 
 
Paper 1: Mixed Methods Paper, guided by REAIM  
Procedures for Evaluating Proximal Implementation Outcomes: 
1. Reach: For this study outcome, Reach (i.e. the number of individuals who are 
participated in PrEP4Her) is defined as the absolute number of Black cis-gender 
women who receive a PrEP prescription. We will also evaluate the proportion of 
women prescribed PrEP who had a PrEP indication.  
PrEP eligibility is  based on the CDC’s guidance summary criteria, deeming those PrEP 
eligible who meet any of the following criteria for cis-gender women not living with HIV 
(over a 6-month timeframe): HIV-positive sex partner, bacterial STI (gonorrhea or 
syphilis), more than one sex partner, inconsistent condom use, sex for exchange of 
goods, or being in a high-prevalence network. This data will be obtained based on the 
sexual risk screener. 
Procedures: 
a. Visit data for all cis-gender women with clinic visits during the pilot 
timeframe 
b.  PrEP prescription data  

c.  PrEP eligibility and referral data  
 
2. Preliminary Effectiveness: Defined by increases in PrEP prescriptions over time. 
We will also evaluate what patient factors are associated with PrEP prescription. 
Procedures: 
a. Frequencies of PrEP prescriptions by  
b. Report demographics of patients prescribes PrEP  
 
3. Adoption: Defined as the proportion of key-stakeholders within our pilot site who 
were willing to initiate our implementation strategy. 
Procedures: 
a. Number of providers/staff who attended PrEP4Her trainings 
b. Track clicks for asynchronous training attendance 
c. RedCap survey item for providers – Did you access these training materials 
to aid in the PrEP implementation at the GYN Continuity Clinic? 
d. Chart review – number of patients seen during pilot who receiving a sexual 
history screener.  
 
4. Acceptability: Extent to which key stakeholders, both provider delivering the 
intervention and Black cis-gender women receiving it, felt PrEP4Her was acceptable. 
Procedures: 
a. IDIs and key informant interviews, grounded in Sekhon et al. 
[prospective/concurrent/retrospective acceptability] 
b. We also have AIM data – would that go here? 
 
5. Feasibility: Measure whether PrEP4Her is appropriate for a larger, full-scale 
implementation trial by surveying out key-stakeholders prior to interviews (conducted 
to assess acceptability). 
Procedures: 
a. Validated scale Feasibility of Intervention Measure (FIM) 
 
Paper 2: Fidelity Outcomes  
1. Fidelity: Degree to which our implementation strategy (PrEP4Her) was 
implemented as designed, from end user perspective.  
Procedures: Patient fidelity survey outcomes.