Cisgender women (subsequently referred to as “women”) account for 23% of new HIV diagnoses in the United States [1], highlighting the unrealized opportunity for tailored HIV prevention programs in this population. The HIV epidemic in the United States disproportionately affects Black women of reproductive age [1-3]. Among women, HIV transmission occurs primarily through heterosexual transmission (84%), principally receptive vaginal sex [4,5]. HIV is preventable through consistent use of barrier contraception and HIV pre-exposure prophylaxis (PrEP) [6-12]. Barrier contraception, specifically male condom use, is notably limited by partner power discordance and is implicitly dependent upon partner cooperation [13].

Both daily oral and long-acting injectable formulations of PrEP offer women-controlled options for HIV prevention before risk exposure, circumventing the need for cooperation from sex partners. Pharmacoprevention with either daily oral tenofovir disoproxil fumarate and emtricitabine or injectable bimonthly cabotegravir decreases HIV transmission by up to 99% in women [7-11]. Despite the efficacy of PrEP, the number of prescriptions of PrEP to women in the United States remains dwarfed by the number of women with indications for PrEP [14], highlighting the considerable unmet need for biomedical HIV prevention among women, especially Black women [15-19].

There are significant sociostructural barriers to engagement and retention in the PrEP cascade for women, including medical mistrust, cost, stigma, and lack of access [20-28]. Our previous research predominantly among Black women of reproductive age with demonstrable potential exposure to HIV [29-32] highlights the critical importance of health care provider [20,23,25,26,28,33-38] and community or peer support [20,25,26,28,35-37] in engagement and retention in the PrEP cascade. The Centers for Disease Control and Prevention (CDC) further highlighted the importance of health care providers as PrEP educators with their 2021 guidance that providers should educate all sexually active adults and adolescents about PrEP [39]. Despite their pivotal role, health care provider knowledge of and comfort with prescribing PrEP continues to lag across medical specialties [22,40-45], and despite the synergy of offering integrated PrEP services as part of routine women’s health care, most women’s health clinics do not routinely educate about or prescribe PrEP [23,44-46]. Both our formative work and the existing literature indicate the sociostructural nature of the factors influencing women’s engagement in the PrEP cascade; thus, we used the socioecological model as our guiding theoretical framework for intervention adaptation.

The socioecological model theorizes that an individual’s decisions and behaviors result from reciprocal interactions within and between the individual and their social, cultural, and structural environments [47]. Although health-related decisions or behaviors occur at the individual level, they are influenced by individual (ie, psychological), interpersonal (eg, relationship power and relationship commitment), community (ie, cultural norms and stigma), institutional (eg, equitable provision of care and appropriate services), and structural factors (eg, public policy and infrastructure) [48]. As applied to the PrEP cascade for women, our previously published survey of predominantly Black women found the intention to initiate PrEP was associated with different factors by level: at the individual level, positive attitudes toward PrEP and higher self-efficacy; at the community level, perceived acceptability of PrEP among peers and low fear of shame or stigma; and at the institutional level, having discussed PrEP with a health care provider [29]. Our findings underscore the importance of multilevel, clinic-based interventions for women, with education and tools to support women’s health providers as well as PrEP navigation to destigmatize PrEP and break down logistical barriers to PrEP initiation and continuation.

Given the critical role of providers as both PrEP educators and gatekeepers, we previously developed and tested HIV PrEP Services for Urban Women, a clinic-level educational intervention, which used a clinic-wide training and a provider toolkit to promote the provision of universal PrEP services. The intervention significantly improved the provision of PrEP services and PrEP uptake among women at a sexual health center in Washington, DC compared to baseline and was cited as an exemplar evidence-informed intervention (EII) in the CDC Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention [49,50]. While the HIV PrEP Services for Urban Women EII significantly improved the provision of PrEP by providers and PrEP uptake among women of color of reproductive age, it did not actively address the social barriers of stigma, lack of community or peer support, or medical mistrust that the literature indicated were critical to engagement and retention in the PrEP cascade.

In contrast, Project Shikamana was a sociostructural intervention, also developed by a member of our research team, which showed decreased HIV acquisition among female sex workers in Tanzania and was designated by the CDC as an evidence-based intervention (EBI) for HIV prevention [50-52]. Project Shikamana’s strengths include its community-driven, multilevel approach to HIV prevention, involving provider sensitivity training, peer education, navigation and support, community mobilization to address sociostructural factors such as stigma and discrimination, and a focus on women of reproductive age. Given notable differences between the intended populations and the medical infrastructure and medical culture in Tanzania compared to the United States, we chose an evidence-based framework to adapt Project Shikamana while retaining its core strengths.

In response to the lack of EBI to improve PrEP initiation, adherence, and persistence among women in the United States, we adapted and combined attributes of the two aforementioned CDC best practices for HIV prevention for women to develop the Women’s PrEP Project (W-PrEP), a clinic-level, sociostructural intervention. We designed W-PrEP to provide education, resources, and support to empower and enable sexual and reproductive health clinics to provide high-quality, nonstigmatizing, universal PrEP services to women with increased exposure to HIV, in particular Black women of reproductive age. This paper describes the formative work adapting and developing the W-PrEP intervention from the CDC best practices reviewed earlier.

We received institutional review board approval from the MedStar Health Research Institute Institutional Review Board (#0006908). We obtained written or electronic informed consent from all participants for participation in interviews and focus groups and the recording of these sessions. Participants were compensated with a US $100 gift card for completion of interviews or focus groups. All study data were stored behind a firewall and deidentified before qualitative analysis.

We used the Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, and Testing (ADAPT-ITT) model as a framework to develop a culturally appropriate and tailored EBI [53]. ADAPT-ITT has been used to successfully adapt a host of diverse HIV prevention interventions to meet the needs of a new intended population or setting [54-57]. We used the Project Shikamana EBI and the HIV PrEP Services for Urban Women EII as the base cases to initiate the intervention development process (Table 1). We focused on sociostructural factors that women in the region indicated were barriers to and facilitators of engagement in the PrEP cascade (ie, stigma and discrimination related to HIV and PrEP within health care settings, provider sensitization, and PrEP navigation and support). Using ADAPT-ITT, we built upon those findings and used multiple qualitative methods, such as in-depth interviews and focus group discussions, to refine the existing interventions (Table 2). This paper describes the first 6 steps in the model in preparation for pilot testing.

Washington, DC is an epicenter of the US HIV epidemic. At the time of the intervention refinement, the prevalence of HIV among women in Washington, DC was 1209 per 100,000, nearly 7-fold the national average (170 per 100,000) [58]; the prevalence among all women was 0.9%, but nearly double (1.7%) among Black women [58]. At the time of this study, Black women represented 1 in 4 new HIV diagnoses in Washington, DC and 90% of new diagnoses among women [58]. This formative study was conducted online by the research institute associated with an inner-city tertiary care center. Given the timing during the COVID-19 pandemic and to increase access for participants who would be unable to attend in person, all qualitative research was conducted remotely via a secure Microsoft Teams platform.

We conducted semistructured in-depth interviews with key informants as part of the Assessment phase. We sought key informants with intimate knowledge and understanding of barriers to and facilitators of PrEP among women, with a focus on individual, social, and structural factors. We identified key informants from local community-based organizations, hospitals, clinics, and HIV prevention organizations through referrals from the Washington, DC. Center for AIDS Research; our joint community and scientific advisory board; and clinical and community professional relationships of the research team. Target recruitment was 10 key informant interviews, and key informants were invited via email by the principal investigator to participate. The key informant interviews focused upon (1) factors influencing PrEP use among women and (2) intervention components key to improving equitable provision of PrEP on a clinic level as well as complementary tools and materials that may support community needs and priorities. Accordingly, interview questions focused on (1) sociostructural barriers to and facilitators of PrEP use among Black women of reproductive age and (2) assessment of the model components for adaptation. Salient themes and questions arising from the key informant interviews informed the focus group discussion guides.

We also conducted 7 focus group discussions, separating participants into groups of (1) health care providers with experience prescribing PrEP; (2) health care providers without experience prescribing PrEP; (3) PrEP clinical navigators, peer navigators, and educators; (4) Black women of reproductive age with experience taking PrEP (n=2 groups); and (5) Black women of reproductive age without previous experience taking PrEP (n=2 groups). Providers, navigators and educators, and patients were recruited from medical establishments (eg, hospital-based clinics and community health centers) throughout Washington, DC. We invited women’s health providers from varying fields (eg, obstetrics and gynecology, family medicine, and pediatrics), institution types (eg, free-standing reproductive health center, government-sponsored sexual health center, tertiary care center, and federally qualified community health center), and medical training types (ie, physician, nurse practitioner, and physician’s assistant) to participate via email. PrEP navigators and educators from differing institution types were also invited to participate via email. A formal email invitation to participate in interviews was sent by the principal investigator, and a research coordinator then followed up to assist with scheduling. Patient participants were identified from the women’s health clinics and the electronic health record (EHR) and were recruited and scheduled by research coordinators via phone.

Health care provider focus group guides concentrated on the proposed PrEP training materials and format, identification of key toolkit resources to provide PrEP services and integration of PrEP into sexual and reproductive health care, and inclusion of a PrEP navigator and educator in the clinic setting. Navigator and educator focus group guides centered on the roles and characteristics of the PrEP navigator as well as training and resources. Patient focus group guides explored women’s health priorities and barriers to preventive health, such as PrEP and ideal provision of PrEP services, including education and access, PrEP navigation and the key characteristics and roles of a PrEP navigator and educator, and social support.

We conducted theater testing of a mock-up of the adapted training and planned intervention and implementation flowchart among these same health care providers in 2 follow-up focus group discussions. Providers offered feedback on the content and delivery of Microsoft PowerPoint training modules and the multipronged intervention.

We audio recorded interviews and focus groups with the consent of participants, which were then transcribed verbatim. We applied rapid qualitative analysis [59-61] to systematically use qualitative feedback from the interviews and focus groups to refine the intervention. To this end, we developed summary templates to identify the coder, respondent role, and coding domain (ie, strengths, information gaps, and actionable improvements). We conducted analyses of a subset of interviews (ie, 1 from each respondent type) to ensure adequate fit of the template to the data, and then we coded the remaining transcripts. For the formative ADAPT-ITT phases (ie, assessment through integration), we developed and populated matrices to identify salient themes that represented topics, information, or activities to include in the adapted intervention. For the training and testing ADAPT-ITT phases, we developed and populated matrices to align with germane components of the practical, robust, implementation, and sustainability model implementation framework. These summaries guided team discussions and W-PrEP intervention refinement.

In preparation for the decision phase, the research team reviewed the findings of the key informant interview and focus group discussion rapid qualitative analyses and met with the joint advisory board and 5 additional national HIV prevention intervention experts to discuss existing resources and planned intervention strategies. The research team also updated a scoping review of the contemporary relevant literature. The research team reaffirmed the plan to adapt and build upon 2 base cases (Table 2), using the multipronged, sociostructural approach of Project Shikamana and the clinic-centered intervention setting and educational focus of the HIV PrEP Services for Urban Women. Notably, given the feedback from the key informant interviews on harnessing existing community support resources and the lack of consensus on social and community support mechanisms, the research team decided to focus on the “provider sensitivity training” and “education and navigation and support” components of Project Shikamana, specifically creating a nonstigmatizing, supportive, and safe environment for the provision of HIV prevention education and services within the clinic setting (with referrals to outside organizations) rather than creating an intervention-specific community support component. On the basis of our extensive background research and our findings in this formative work, the research team affirmed the decision to use the socioecological model given the multipronged and multilevel approach of the intervention [29,62,63].

Provider focus group participants were invited back for theater testing of the planned intervention flowchart and a mock-up of the adapted trainings and toolkits, expanding on the HIV PrEP Services for Urban Women and Project Shikamana’s provider sensitivity training, incorporating lessons learned from the assessment phase. We elicited topic-specific feedback on length, level of detail, and preferred formats and mediums for learning and skill enactment within the training modules as well as feedback on specific slides. In addition, we encouraged suggestions from participants to improve or refine the toolkits and intervention flowchart. Participants emphasized the overall approval of the intervention mock-up and provided detailed feedback to improve clarity and incorporate additional resources or tools, such as a badge card with reminders about prescribing requirements.

Incorporating the theater testing feedback, we fleshed out a prototype for each of the components of the multipronged intervention; Table 3 outlines the intervention components. We adapted and expanded upon the clinic-wide trainings, incorporating more role-play and segments with the patient perspective taken from previous qualitative work [30], as well as identified key topics, such as how to incorporate PrEP care into clinical practice. We curated a PrEP clinical navigator training program using materials from the Please PrEP Me navigator training while incorporating feedback from qualitative data collection [64-66]. In addition, we collated educational resources for the clinic team, PrEP navigators, and patients, including a patient-facing educational website. We updated and developed a variety of toolkits for the clinic-level rollout of W-PrEP and rollout of long-acting injectable PrEP as well as role-specific toolkits for the clinic team members and the PrEP navigator. We also created a PrEP clinical navigation flowchart, with multiple options for modification and adaptation depending on the availability of clinical space and when patients had downtime between clinical activities (eg, triage by medical assistant and evaluation by health care provider).

We engaged the community and scientific advisory committee as topical experts to review the prototypes developed in the production phase (ie, the intervention flowchart, toolkits, training modules, and educational resources). The committee expressed enthusiastic support for the adapted intervention and offered minimal feedback to incorporate into the intervention components.

Using the ADAPT-ITT model, we iteratively adapted two CDC best practices in HIV prevention, using the sociostructural approach of Project Shikamana and building from the training model of the HIV PrEP Services for Urban Women. We found that while the core elements of provider sensitivity training, navigation, and support of Project Shikamana were maintained, the urban mid-Atlantic context lent itself better to a clinic-based approach. Thus, we focused on a supportive, trauma-informed clinical environment without a separate community support venue. In addition, the navigation model shifted from a community peer support model to a PrEP navigator supporting clinic workflows to meet the needs of a bustling urban women’s health clinic with a high patient volume. The training from the HIV PrEP Services for Urban Women was significantly expanded to center the patient voice and prioritize shared decision-making throughout the modules. We incorporated group activities, discussions, and role-plays to make the training more interactive. Added content included a focus on social and structural determinants of health, trauma-informed care, and incorporation of PrEP counseling into clinical practice. The adapted W-PrEP intervention features clinic-level modular trainings; a toolkit and resources for clinic-level implementation of PrEP services; toolkits and resources for provider and clinic team members; a clinical PrEP navigation program, including training and resources; and patient-facing woman-centric educational and support resources, including a website focused on PrEP for women, all to be tested in the pilot testing phase.

At the time of intervention development, Project Shikamana and the HIV PrEP Services for Urban Women were the only two best practices in the CDC compendium addressing HIV prevention for women. W-PrEP is now among a growing number of interventions published in the last several years intended to increase engagement and retention in the PrEP cascade among women, several specifically responsive to Black women [67-71]. Similar to the POWER Up intervention [70], developed in parallel with W-PrEP and currently under evaluation, W-PrEP uses a sociostructural approach. As a clinic-level intervention, W-PrEP expands upon our previous work [49,72] to more fully address identified patient-, provider-, and clinic-level socioecological barriers, such as low awareness among patients, low knowledge and confidence in how to provide PrEP among providers, and clinic-level challenges of systems and logistics for obtaining prior authorization and tracking patient follow-up.

W-PrEP was adapted in an urban, mid-Atlantic setting and is specifically responsive to the barriers to PrEP for Black women. Although we posit that our developed intervention is likely generalizable to women with increased potential exposure to HIV throughout the United States, we recognize that there may be cultural differences specific to geographic regions. We catered the intervention development to sexual and reproductive health providers, given the natural synergy between HIV prevention and sexual and reproductive health and the patient populations that these providers care for. We again recognize that this intervention may need additional adaptation for implementation in the primary care setting, including additional modules for providers who also care for patients assigned male sex at birth.

This paper details the adaptation process of two CDC best practices to create a program that is responsive to the needs and experiences of the various groups involved in its delivery. We provide such details because the practicalities and logistics of adaptation are often unarticulated and completed behind a curtain. We sought to provide insights into the adaptation process from the ground level. The adaptation of the W-PrEP program integrated key elements of the local context for women with potential exposure to HIV as well as health care providers, clinic staff, and PrEP navigators. Next steps include piloting the adapted intervention in a real-world setting for feasibility, acceptability, and preliminary efficacy before launching a multisite trial to assess impact on the PrEP cascade.