Women of childbearing age comprise a majority of adults living with HIV globally. They account for 20% of the 40,000+ new infections in the United States every year, with disproportionate impact on adolescent and young adult women (AYAW) in the South [1]. Black women in the South are disproportionately affected by HIV: 1 in 48 black women is diagnosed with HIV over their lifetime, nearly 20 times the risk for white women [2]. Southern states account for nearly half of new HIV diagnoses despite having only 37% of the population [3]. Effective prevention efforts tailored to the needs of AYAW are therefore needed not only to curb the epidemic among women but also to protect their sexual partners and prevent perinatal infection. Furthermore, scalable approaches that utilize individual-controlled prevention tools are required, as many AYAW are unable to successfully negotiate mutual monogamy or condom use and are unaware of their partner’s HIV status [4-6]. Pre-exposure prophylaxis (PrEP) is an effective [7,8], scalable, and individual-controlled HIV prevention strategy that is underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit [9].

The few available studies among US women report low knowledge and awareness of PrEP [9]. For example, in a US, multi-site study conducted in 2014, less than 10% of women at risk for HIV had heard of PrEP, but once informed, most women found the option to be attractive [10]. Although Centers for Disease Control and Prevention (CDC) estimates that 176,670 US women may benefit from PrEP to prevent sexual HIV acquisition [11], its use among US women remains low [12]. Despite CDC’s clinical guidance for offering PrEP to individuals at substantial risk, data from a national prescription drug database suggest that women, individuals younger than 25 years, and residents of the South have lower levels of PrEP use relative to new HIV diagnoses [13]. Thus, innovative delivery approaches are required to optimize access to PrEP for AYAW, particularly in the Southern United States.

Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health is of great appeal, as it may offer an ideal opportunity to reach women at risk for HIV and enhance their PrEP uptake and adherence. Family planning (FP) clinics in high HIV incidence settings may be ideal PrEP delivery settings as they are accessed by sexually active women of childbearing age and already provide sexual health services, including HIV testing and prevention counseling. Rather than standard primary care or sexually transmitted infection clinics, most (60%) AYAW utilize FP clinics for sexual health and preventative services [14], and they are viewed with trust among this group [10]. Importantly, shared decision making, a framework promoted in the Quality Family Planning recommendations [15] used by FP providers, is ideal for identifying AYAW at substantial risk of HIV and offering them comprehensive HIV prevention services, including PrEP. Shared decision making is a process in which clinicians and patients work together to make decisions about care (eg, birth control) based on clinical evidence that balances risks and expected outcomes with patient preferences and values. However, not all FP providers provide services to large enough numbers of AYAW at high risk of HIV to justify the potential costs associated with preparing for on-site PrEP provision and monitoring. Therefore, efforts to integrate PrEP in FP services should focus on clinics with the highest anticipated impact.

Specifically, Title X-funded FP clinics may be an ideal setting for integrating PrEP into FP services given that they (1) are important safety net sources of care for AYAW, (2) serve clients at risk for HIV infection, and (3) are expected to offer HIV prevention services as part of Quality Family Planning recommendations. The Title X National Family Planning Program provides grants to health department or county hospital–based programs, non-profit stand-alone clinics, and community health clinics such as federally qualifying health centers. Title X supports an extensive network of approximately 4000 nationwide service sites that serve over 4 million clients, 90% of whom were women, and over two-thirds of whom are younger than 30 years [16]. The program is designed to ensure access to contraception, particularly for low-income individuals, but serves as the usual source of medical care for the majority of female clients [17]. Title X clinics serve as safety net providers, particularly in regions without Medicaid expansion [18], which closely overlap with regions that would most benefit from expansion of HIV prevention services [13].

Despite its appeal as an effective, individual-controlled HIV prevention strategy, PrEP has not been widely integrated into FP services in the United States, or specifically, in Title X clinics in the Southern United States. A 2015 national survey of FP providers in the United States, many of whom were Title X clinic providers, found low PrEP knowledge and use; FP providers in the South had lower PrEP knowledge than those in the Northeast or West [19]. Only one-third of respondents could correctly define PrEP and its efficacy, and less than 5% had ever prescribed PrEP. The majority felt uncomfortable prescribing PrEP because of lack of training, revealing an additional challenge to PrEP delivery for women, especially in the South. Although this study showed high provider willingness to prescribe, little is known about provider education and training needs as well as the prioritization, capacity, barriers, and facilitators to integrate PrEP across clinical settings, including Title X funded clinics.

Knowledge gaps exist that prevent optimal implementation of PrEP in real world settings for AYAW in the United States. Limited PrEP implementation science research has been published to date, and most PrEP demonstration projects and implementation studies in the United States have not included cis-gender women [20]. Limited available data suggest that significant implementation challenges exist, particularly for AYAW. Data from a recent (2013-2016) study highlighted missed opportunities for PrEP delivery during care visits that preceded an HIV diagnosis; individuals with missed opportunities for PrEP were more likely to be female, black, and younger than 30 years [21]. A recent PrEP implementation project at a publicly funded community health center in Philadelphia showed that, while more than one-third of potential PrEP clients were women, only 15% of men and 8% of women who expressed interest and were referred ultimately started PrEP [22,23]. Although women were as likely as men to express interest, they were less likely to start, and attrition at each stage of the PrEP engagement process was higher for women [22], suggesting potential unique implementation challenges for women that need to be investigated.

Finally, few models exist describing the organizational processes and strategies associated with successful integration of PrEP delivery in new clinic settings, and none exist specifically for FP clinics [24,25], including those supported by Title X funding. To overcome the aforementioned potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies in the United States because (1) FP providers in these clinics may more readily adapt skills used in contraceptive counseling and provision (ie, shared decision making) to PrEP counseling and provision [15]; (2) they are a regular, trusted source of care for AYAW with HIV risk, including black AYAW [10]; (3) they routinely screen and make referrals for intimate partner violence [26] and other known barriers to adherence [27]; and (4) there are virtually no data on PrEP implementation among US women [24]. To address multiple gaps in our understanding of how to optimally provide PrEP and support its use among AYAW in the Southern United States, we devised a multiphase study (Phase 1 study and Phase 2 study). Phase 1 is a mixed methods assessment of Title X clinics across the South to ascertain critical elements of the inner and outer contexts of various Title X clinics relevant for integrating PrEP into FP services. Phase 2 is a hybrid type 1 effectiveness implementation study in 3 Atlanta Title X clinics to evaluate multilevel factors associated with PrEP reach, level of adoption, and implementation (eg, HIV testing and risk assessment screening and PrEP counseling and prescription) within and across clinics, while also thoroughly evaluating the effect on PrEP uptake, continuation, and adherence over a 6-month follow-up period.

The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is a research program that aims to defeat the rising HIV epidemic among adolescents and young adults in the United States. The overarching goal of the ATN is to increase awareness of HIV status in youth and, for those diagnosed with HIV, increase access to health care. The ATN develops and conducts behavioral, community-based, translational, therapeutic, microbicide, and vaccine trials in youth who are at risk for or living with HIV, with a focus on the inclusion of minors. Our study (ATN 155) is funded as part of the ATN. The combined findings and resulting tools and trainings will be valuable for PrEP integration in Title X-funded or similarly structured FP clinics and could inform future interventions to optimize PrEP delivery for AYAW. In this paper, we describe the research protocol for the Phase 1 study only.

Phase 1 of Planning4PrEP research activities began in October 2017 and are ongoing. To date, survey and key informant interview administration is near completion, with quantitative and qualitative data analysis scheduled to begin soon after data collection completion.

Although FP clinics may be an ideal setting for PrEP delivery, there is a lack of available data from health care providers and administrators to guide optimal integration of PrEP into various clinical settings, and in particular, for women’s health care settings [24,25]. These data are critical to improve PrEP access and delivery for women. Data gained from this study will facilitate the development of general and context-specific logic models to guide implementation for the adoption of the innovation (PrEP) in a new setting (Title X-funded FP clinics). Furthermore, these data are needed to develop PrEP implementation plans across women’s health care settings and to allow for gathering future data from women on PrEP uptake, adherence, and continuation to develop future interventions to support women’s successful use of PrEP.