Developing an HIV Pre-Exposure Prophylaxis Toolkit for Adolescent and Young Adults: Serving Primary Care Providers to Support Future Implementation Using the Consolidated Framework for Implementation Research

Abstract

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy for adolescents and young adults (AYAs, ages 14–26). PrEP uptake among AYAs remains low. Barriers to uptake include provider discomfort discussing sexuality, challenges engaging parents in sexual health conversations, and low perceived HIV risk. To address these gaps, we aimed to develop a toolkit to enhance AYA-serving primary care providers’ (PCPs) comfort and confidence in discussing and prescribing PrEP. The Consolidated Framework for Implementation Research informed our approach. Four focus groups with youth-serving PCPs across three clinics in a Northeastern US city were held in April and May 2024. PCPs included residents (n = 10), attending physicians (n = 11), nurse practitioners (n = 2), and a physician assistant (n = 1). Debrief summaries were created following each focus group and analyzed. We used a rapid qualitative process, guided by an a priori codebook and reflexive thematic analysis. PCPs emphasized that the toolkit should be easy to access, interactive, and provide practical, age-appropriate prescribing information. They identified outer-setting factors such as the role of parents in AYAs’ health care, sexual health education in schools, and uncertainty around laws that impact PrEP provision to minors. Within the clinical setting, providers noted that limited time often hindered sexual health discussions. Individually, PCPs reported moderate comfort with PrEP and were motivated to prescribe PrEP when AYAs expressed interest. Findings informed the development of a PrEP toolkit tailored for AYA-serving PCPs and future implementation tailored for AYA-serving PCPs. This approach may help expand access and address persistent barriers to PrEP uptake among AYAs.

Keywords

HIV prevention primary care adolescents implementation science pre-exposure prophylaxis

Introduction

Pre-exposure prophylaxis (PrEP) is an effective biomedical HIV prevention strategy recommended by the Centers for Disease Control and Prevention (CDC), the U.S. Preventive Services Task Force, and numerous professional organizations for individuals at risk of HIV infection, including adolescents and young adults (AYAs) aged 14–26.^1–4 In the United States, AYA experience disproportionately high rates of new HIV diagnoses.⁵ Although the U.S. Food and Drug Administration approved daily oral PrEP for adolescents in 2018, uptake in this age group remains low and is relatively understudied.^6,7 In its 2021 clinical guideline update, the CDC broadened PrEP eligibility criteria, which created new opportunities to tailor HIV prevention to the needs of AYA.¹

Despite these advancements, previous guidelines have been difficult for health care providers to implement, particularly for AYA-serving primary care providers (PCPs) such as pediatric, family medicine, and internal medicine/pediatric providers.^8,9 Multiple determinants to PrEP uptake among AYAs have been identified at both the provider and patient levels. Barriers providers experience include avoiding conversations about sexuality due to limited time, discomfort, and lack of PrEP training.^10–12 Additionally, many providers struggle with navigating parental involvement in sexual health discussions, managing confidentiality, and addressing low HIV risk perception among AYAs.¹³ Known facilitators to AYA engagement in PrEP include youth-friendly health care environments, trusting relationships with providers, and a strong desire among both AYAs and their parents to receive accurate sexual health information from medical professionals.^13–15

Although overall HIV incidence in the United States has stabilized due to the success of highly active antiretroviral therapy (HAART) and the expansion of prevention strategies including PrEP, disparities persist among certain populations. Gay, bisexual, and other men who have sex with men (MSM) represent the majority of individuals living with HIV in the United States, and transgender women (TGW) who have sex with men have one of the highest burdens of infection.¹⁶ However, existing epidemiological categories such as MSM, TGW, or the broader term “sexual and gender minority,” may not fully reflect the evolving ways in which AYAs identify their gender and sexuality. Increasingly, young people describe themselves using fluid or nonbinary labels—such as queer, pansexual, or nonbinary—that may not align with traditional, and often binary, risk-based classifications but still reflect meaningful variations in sexual health behavior and vulnerability to HIV.^17,18 Yet, youth-serving providers rarely receive training on taking an inclusive, identity-affirming sexual health history with AYAs, leading to a lack of confidence among providers in identifying AYA potentially eligible for PrEP.^19–21

Implementation science provides valuable frameworks for translating evidence-based interventions, such as PrEP, into routine clinical practice—especially in settings where PrEP uptake has been historically low.^22–25 By systematically studying the processes and contextual factors that influence implementation, researchers and practitioners can better understand how to adapt and sustain interventions in real-world settings.²⁶ The Consolidated Framework for Implementation Research (CFIR) is a widely used determinant framework that offers a comprehensive approach to identifying multilevel factors—such as characteristics of the intervention, individuals involved, inner and outer settings, and implementation processes—that can act as barriers or facilitators to implementation.^27,28 Applying CFIR to assess PrEP delivery among AYA-serving PCPs allows for structured exploration of providers’ perspectives, clinic environments, and broader contextual influences (e.g., parental involvement and state policies). This framework is especially relevant for addressing the complex, intersecting challenges related to AYA sexual health, confidentiality, and identity-affirming care, and for informing the development of tailored implementation approaches and toolkit design features that meet the needs of both providers and AYA populations.

Toolkits have been shown to serve as effective change methods when they target recipients—such as patients or clients—by improving motivation, self-efficacy, or capacity to initiate and sustain engagement with health interventions like PrEP, both at the point of uptake and over the long term.²⁹ While similar training resources have been developed for providers, such resources are limited for general youth-serving PCPs, who see a broader and more diverse AYA population.^12,30

This study addresses a critical gap in HIV prevention by supporting AYA-serving PCPs in providing PrEP to AYAs at risk for HIV, informed by implementation science and focused on identifying determinants to guide toolkit development and future implementation efforts. Specifically, we aimed to elicit provider input with the goal of developing a toolkit designed to enhance PCP comfort and confidence in engaging AYAs in PrEP-related care (see Supplementary Data). This toolkit is currently undergoing acceptability and feasibility testing as part of a subsequent study. At the time of the present analysis, the toolkit had been developed in a prototype format informed by these qualitative findings, but implementation testing was not part of this study. If the toolkit is effective, it could contribute meaningfully to expanding equitable access to PrEP and reducing HIV transmission among AYA.

Methods

Formative focus groups

Sample

We held four focus groups with AYA-serving PCPs across three clinics in a Northeastern US city. One of the clinics had two focus groups so we could meet with the residents and attending physicians separately, given the large size of the group as well as the potential for power dynamics between residents and attendings to lead to less open conversations with both groups. Eligibility criteria included: (1) English speaking, (2) attending physician, resident physician, or advanced practice provider, and (3) providing primary care services to AYAs aged 14–26.

Data collection

This study was determined to involve minimal risk and was therefore approved as exempt by our institutional review board. Research personnel contacted clinic leaders who then advertised the study through word-of-mouth to PCPs. Those interested filled out a screening survey on REDCap, an online, HIPAA-compliant data collection tool. If eligible, PCPs reviewed an information sheet with basic elements of informed consent and agreed (or not) to participate. Those who agreed to participate were asked to complete a short demographics survey. Focus groups were then scheduled with clinic leaders for PCPs from each clinic site. Two trained facilitators co-facilitated each focus group using a semi-structured guide, and each group was facilitated by a different pair of facilitators. Focus groups were conducted in person or remotely using a HIPAA-compliant, video conferencing platform (i.e., Zoom for Healthcare, San Jose, CA), as determined by provider availability and clinic leader preference. Each participant received a $50 electronic gift card via email as renumeration.

The CFIR 2.0 determinant framework was used to guide focus groups in assessing multilevel barriers and facilitators related to: (1) AYA-serving PCPs prescribing PrEP and (2) the refinement of a PrEP toolkit to support future implementation among AYA-serving PCPs.^27,28 Focus group guides included the following topic areas, informed by CFIR: intervention characteristics (e.g., perceived complexity and relative advantage of a PrEP toolkit), outer setting (e.g., external policies, community needs, and parental involvement), inner setting (e.g., clinic culture and workflow constraints), characteristics of individuals (e.g., AYA-serving PCPs’ knowledge, self-efficacy, and attitudes toward PrEP), and process (e.g., engagement strategies and readiness for implementation). The CFIR was specifically selected to guide the focus groups for both its comprehensiveness and applicability to health care settings, particularly in identifying multilevel factors relevant to adopting and integrating interventions into practice. Additionally, focus groups included questions on how providers communicate with AYAs and caregivers about sexual health, including HIV prevention methods such as PrEP. Each focus group lasted roughly 45–60 min.

Data analysis

All focus groups were audio recorded. Each focus group was co-facilitated by two trained researchers. One facilitator directed each focus group, while the other facilitator took detailed notes. After each focus group was conducted, one of the facilitators listened to the audio recording and reviewed existing notes to create a detailed debrief summary. The debrief summaries had a section for each focus group topic discussed: (1) provider and practice characteristics, (2) sexual health communication, PrEP knowledge, experiences, and impressions, and (3) intervention (e.g., content to include in intervention, barriers and facilitators to using intervention, and preference in intervention format). Data were reviewed and analyzed on an ongoing basis throughout data collection using an iterative process, whereby debrief summaries were coded using a priori coding framework, preliminary themes were developed, and findings were compared across focus groups.

The lead and senior authors developed an a priori coding framework using the CFIR 2.0^27,28 with a focus on identifying themes and site-specific insights that would inform the development and future implementation planning of the PrEP toolkit. The lead author trained four members of the research team (J.R., H.P., E.G., H.M.) on qualitative coding and the schedule, then all five team members independently coded the debrief summaries using the a priori coding framework. To ensure intercoder reliability, all debrief summaries were coded by two researchers. Team meetings were held regularly to discuss coding discrepancies and reach a consensus. New codes were created and defined when a piece of text from a debrief summary represented an important new idea. Our team utilized a rapid qualitative approach³¹ and conducted reflexive thematic analysis, in which themes were actively constructed through iterative interpretation of finalized codes and reflexive team discussion, rather than derived through frequency counts. Team discussions incorporated reflexive consideration of researchers’ clinical and implementation science perspectives during theme interpretation. Findings were then organized by CFIR domains (e.g., Innovation Characteristics, Outer Setting). Given the aims of this study, four focus groups provided sufficient data to identify salient implementation determinants and inform development of the PrEP toolkit.

Results

Sample

Four focus groups were conducted with a total of 19 AYA-serving PCPs in April and May of 2024. Most PCPs identified as White (n = 16, 84.2%) and all identified as non-Hispanic/Latinx. Ten (52.6%) identified as female, seven (36.8%) as male, and two (10.5%) declined to respond. Providers represented a range of professional roles, including physicians (MD/DO; n = 16), nurse practitioners (n = 2), and a physician assistant (n = 1). Among the physicians, six were residents (37.5%) and ten were attendings (62.5%). Each focus group was reasonably balanced in size: Focus Group 1 included six PCPs, Focus Group 2 included five PCPs, and Focus Groups 3 and 4 each included four PCPs. The four clinics represented a range of practice types including an academic adolescent medicine clinic, an academic internal medicine/pediatrics clinic, and a community-based LGBTQ-focused clinic. Providers reported varying levels of experience with PrEP counseling for AYAs, with nine (47.4%) indicating limited experience, four (21.1%) with moderate experience, and six (31.6%) with extensive experience. The majority (n = 12, 63.2%) reported feeling somewhat comfortable providing PrEP counseling to AYAs.

Themes

Guided by the CFIR 2.0, findings were organized across four domains: Innovation Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals. Table 1 summarizes the relevant CFIR constructs, emergent themes, and theme descriptions.

Table 1.

CFIR-Guided Themes Identified from Focus Groups with Adolescent and Young Adult-Serving Primary Care Providers on PrEP Toolkit Development and Future Implementation

CFIR domain	Construct	Identified theme	Theme description
Innovation: PrEP Toolkit	Toolkit design	Integrate toolkit with existing resources/Centralized information hub	• Easily accessible to PCPs, online, and integrated into existing EHR platforms • Linked to existing resources • Concise checklist with specific points for quick reference
		Up-to-Date PrEP information maintenance feature	• Mechanism to keep the information current
		Patient-facing information resources	• Include patient-facing PrEP education resources through various formats, including QR codes, one-page summaries, podcasts, and posters
		Multiple formats for provider PrEP training	• Include a variety of training avenues (e.g., short videos, an app for phone or desktop, and physical handouts)
		User-friendly navigation	• Easy to find, as condensed as possible, interactive design, and visually pleasing
	Toolkit content	PrEP description & selection guidance	• Descriptions of different PrEP modalities (i.e., daily oral PrEP, on-demand oral PrEP, and injectable PrEP), side effects, and counseling patients • CDC PrEP guidelines
		Practical PrEP prescription information	• Practical information to use when discussing PrEP (e.g., PrEP eligibility screening algorithm, EHR checklist, and all necessary labs) • How to start the PrEP conversation with AYAs (e.g., talking points and conversation starters)
		Fill gaps in the PrEP guidelines	• Address “real world” problems not covered in existing PrEP guidelines • Contingency plans for when AYA patients do not return to clinic or complete labs
		AYA specific legal information	• Details on the legal implications of prescribing PrEP to AYA and state-specific regulations regarding PrEP
		PrEP adherence techniques for AYA	• Techniques to enhance AYA PrEP adherence, specific to each PrEP modality (e.g., daily oral, “on-demand,” and injectable)
		AYA confidentiality concerns	• How to navigate AYA confidentiality concerns (e.g., parental insurance)
		PrEP payment options	• Insurance coverage for PrEP and resources to help pay for PrEP
Outer setting	Local conditions	Lack of existing PrEP sexual health education in schools	• PrEP is often not included in the sexual health education provided at schools
	Local conditions	Obstacles to guardian participation in PrEP care	• Attending PrEP follow-up appointments and paying for PrEP using parental health insurance when they do not want their parents involved in their care
	Policies and laws	AYA privacy from guardian	• Parents asked to leave the room during the AYAs’ visit to facilitate confidential conversation about sexual health • Some providers are allowed to obtain the AYAs’ phone numbers to contact them directly about sexual health screening results • Some parents and AYAs talked openly about sexual health, making confidentiality less of a challenge
		Limited accessibility of injectable PrEP	• Some institutions require that injectable PrEP be prescribed and administered by an infectious disease physician
		Routine STI screening practices for AYAs	• Providers employed a variety of routine STIs screening practices for AYAs • Providers strived to destigmatize STI testing
		PrEP refill policies	• Vague existing PrEP refill policies and lab requirements do not address how to manage AYAs who are nonadherent or unable to attend lab follow-up visits
Inner setting	Work infrastructure	Utilization of nurses to prescribe PrEP	• Standing orders make it possible for nurses to discuss PrEP with patients, refill PrEP, and obtain lab work
	Relative priority	Other existing clinic priorities	• Time is often a barrier to discussing PrEP when other health topics need to be prioritized
	Relative priority	Priority of PrEP discussion varied	• Sexual health conversations are incorporated into what is ‘necessary’ to discuss at the visit • Range of how PCPs determined if PrEP is necessary to discuss
Individuals (Youth-serving PCPs)	Need/Capability	Providers somewhat comfortable with PrEP	• Many providers had some experience prescribing PrEP and reported being somewhat comfortable with PrEP counseling for AYAs
	Need/Capability	PrEP screening policy confusing	• Existing PrEP guidelines are confusing and specific policies regarding PrEP for AYAs would be helpful
	Opportunity	Providers discuss sexual health regularly	• Sexual health and STI testing are discussed at most annual physical/wellness visits
	Motivation	High provider motivation to prescribe PrEP	• All PCPs were motivated to prescribe PrEP, even if they lacked comfort and/or experience prescribing PrEP
	Motivation	Providers value AYA decision-making autonomy	• Providers acknowledge and respect when patients who initially express interest in PrEP later change their minds

AYAs, adolescent and young adults; CDC, Centers for Disease Control and Prevention; CFIR, Consolidated Framework for Implementation Research; PCPs, primary care providers; PrEP, pre-exposure prophylaxis; STIs, sexually transmitted infections.

Below, we present key findings organized by CFIR construct within each domain, describe the toolkit-related themes identified, and provide exemplar quotes.

Innovation

Toolkit design

PCPs consistently highlighted that the perceived usefulness of a PrEP toolkit was closely tied to its integration into existing clinical workflows and EHR systems. Providers expressed strong support for a centralized, user-friendly toolkit tailored to AYA-serving PCPs, noting that resources requiring additional steps or external navigation were unlikely to be used in busy clinical settings. One participant shared: “I spend way too much time trying to find effective communication pieces that are adapted to [EHR system] that don’t involve me chasing them somewhere else would be helpful, I would take advantage of that.”—Focus Group (FG) 1

Another participant shared how incorporating the toolkit into existing systems would make utilizing the toolkit more feasible.

“I think… anything that is… incorporated into something we’re already doing, so like we have templates for clinic already, if it was something that was built into that template, then I think it would be pretty easy to do. Anything extra or anything tangible paper-wise I think is just like another step if you’re really busy that would get easily forgotten, but I think since we already have these existing templates if there is something that we could just insert it into the template when we were just going through it… like screening questions, and if they were a candidate we got more information, and if they weren’t, we just had that in our note… it would be quite helpful I think.”—FG1

PCPs voiced a preference for resources that were easy to use, concise, visually appealing, and interactive. Multiple training formats for the PrEP toolkit were recommended, including brief videos, mobile-accessible content, and printable handouts. These formats were suggested to help accommodate diverse learning styles and time constraints. One participant highlighted the need for multiple formats: “I would say multiple formats… it just depends on the person.”—FG2

Another participant mentioned that useful features include an interactive website and a quick method to add information to the EHR such as a “dot phrase” (i.e., EHR lingo for a method of using a few keystrokes to add templated text to a note or patient-facing handout):

“I think… if there’s a website component, having it be something kind of interactive, like you could click through an algorithm and be like ‘OK, these are the answers to these questions,’ or like, ‘This is a potential barrier, which one would you recommend?” things like that. I think getting just like a static handout can be hard to sort through in the moment of a busy clinic, but if there was like a usable dot phrase and like a corresponding… if you needed more information or something outside of just what you wanted in your note that you could actually just click through and get recommendations would be really helpful.”—FG1

In addition to provider-facing tools, participants emphasized the importance of including patient-facing materials, particularly youth-specific and multilingual resources that could be easily utilized in clinic settings:

“One of the things that’s lacking significantly are materials as part of [other examples of a] toolkit that the office itself can deploy for like attention, especially like handouts that are directed towards youth and that are like multilingual. I’ m like scouring the internet for toolkits for things that have links for various different options, like a pdf of like recommendations…pdfs of handouts that we could put on the wall, those are things that are immensely helpful in a toolkit.”—FG3

Toolkit content

PCPs highlighted that the toolkit content must address both clinical knowledge gaps and real-world implementation challenges. Participants stressed the need for up-to-date, centralized information on PrEP options, side effects, and CDC guidelines, noting that uncertainty about medication differences and safety often limited provider confidence. One participant emphasized the need for information on the specific differences in PrEP medications: “[Helpful content would be]… very clear indications for when PrEP is indicated, the differences between Truvada and Descovy… and then I think anyone who is not as familiar is always worried about the side effects.” — FG2. Another participant emphasized that having PrEP information in one place would be helpful: “People don’t understand or [are] nervous about taking it [PrEP] incorrectly, having it [PrEP information] in one place would be helpful for patient and provider.”—FG1.

Other suggestions included the desire for practical tools such as a PrEP eligibility screening algorithm, unique conversation starters for how to introduce PrEP to AYAs, and patient-facing educational materials. For example, one participant highlighted the need for tips for starting the conversation about PrEP with patients:

“So if somebody is hesitant to start the conversation, as I think like a lot of people early in their training, or maybe even med students…if there were like a simple, evidence-based way to introduce the conversation about PrEP, that might make them [providers] more comfortable to start it.”—FG2

PCPs highlighted the need for legal guidance on prescribing PrEP to AYA who are minors and/or dependents on their parent’s insurance. One PCP noted concerns about confidentiality and insurance coverage for PrEP, particularly when prescribing to AYA whose parents may be involved in their health care decisions:

“There have to be people who worry about confidentiality issues, especially adolescents, so whether they want to participate in the conversation, they [adolescents] worry about their parents finding out, or a medication being prescribed and it’s going to be on their insurance and their parents will find out… I wonder what means there are to help preserve confidentiality, both going through insurance or not, and if that could be part of a toolkit… like we should always encourage people to be open in talking with their caregivers or parents, but if that’s not an option, here’s an alternative to consider, like that should not be a barrier to keep us from doing it [discussing PrEP].”—FG2

Finally, PCPs emphasized the need for strategies to address common challenges in prescribing PrEP to AYA such as patient adherence and payment navigation. As one participant noted:

“One of the biggest challenges is compliance. Patients don’t come back to clinic, and they don’t go get their [lab work]…we can all read the CDC guidelines, we know what we’re supposed to do, but sometimes the patient doesn’t follow the textbook, and so what are we supposed to do? How unsafe is it?…Do I withhold the prescription in the interest of them getting their labs, or do I just keep prescribing it and keep my fingers crossed that their liver function is fine?…Those are the kind of practical, on the ground tips that I think a toolkit would be helpful with.”—FG3

Outer setting

Local conditions

External contextual factors significantly influenced PCPs’ ability to provide PrEP services to AYAs. A lack of PrEP-related content in high school sexual health education curriculum was noted as a possible reason for low awareness and acceptability of PrEP among youth. One PCP emphasized this point by saying:

“I wonder how much the communities and the schools are doing some of this too, I start to think back to sexual health in the school, and I feel like, you know, some of this stuff could be shared in their health class, I mean they learn all the other biology and about contraception and… sex in their health class… it’d be great if PrEP was in there.” — FG2

Providers also noted difficulties engaging parents in ongoing PrEP care for their AYA. This was especially true when AYAs wished to maintain confidentiality and/or avoid using parental insurance; for example, one PCP said:

“If they’re under their parent’s insurance and they don’t want their parents to know [they are on PrEP], that for me is actually the biggest barrier. That is really hard to overcome…not just for the actual getting of the medication, but also for thinking about labs, doctor’s appointments and things like that, there’s a lot of fears surrounding sort of like, when are my parents’ going to find out, when am I going to be charged, is this something I can afford…how do I explain to my parents?”—FG4

Policies and laws

PCPs described variation in policies regarding AYA privacy and confidentiality depending on the clinic setting, including whether parents are asked to leave the room during sexual health discussions and whether PCPs are allowed to contact AYA directly. One PCP emphasized the importance of having a portion of the visit without parents present:

“… it [whether to ask parent to leave the room] depends on what you’re trying to cover, and the pace of the visit, and what needs to get done, and what time frame, but most of the time … it would be an expectation that generally part of that visit would be held separately [from parents]… but that is also a spectrum, I have parents and kids who are very open with each other about practices, and behaviors, and expectations and others where… I still think the separation is important because I don’t know that everybody’s going to share everything, but I think that time exists for most people.” — FG2

Limited access to injectable PrEP (cabotegravir) was also noted, with some institutions restricting its prescription and administration to infectious disease specialists. This concept is supported by the following quote:

“We did do injectable PrEP once in the recovery clinic for a guy… but it’s a major barrier-you actually cannot do it unless it’s in a ID [infectious disease] clinic-we did it and then got in trouble and had to write to the P&T [pharmacy and therapeutics] committee to get a one-time approval for this patient, but there’s no way to document it, and they told us we shouldn’t have been able to do it to begin with- it needed to go through ID- it was a barrier.” — FG2

Practices regarding sexually transmitted infections (STIs) screening were inconsistent, with some providers using specific protocols for managing AYAs who miss follow-up labs or are nonadherent, whereas others had no protocols. One PCP described their practice and how they tell patients they screen everyone for STIs to normalize the screening:

“I screen everybody 12 and up [for STIs] at their well visit for sure… when [the safe sex conversation] comes in… the STI discussion goes there, and I tell patients that I screen everyone, they are welcome to tell their parents that that’s what we’re doing with the urine in the room today- they don’t have to- I get their cell phone number in case they don’t want the parents knowing what’s going on… to avoid bias I screen everyone, even if they say like ‘I’ m not having sex,’ I’ m like I totally, 100% believe you, but I screen everybody… I’ll just be honest, and I’ve caught so many patients with STIs that way versus like trying to pick and choose.” — FG2

Inner setting

Work infrastructure

The presence of workflows and staff capable of supporting PrEP delivery varied across sites. One of the clinics had successfully implemented standing orders that allowed nurses to initiate PrEP discussions and prescriptions, which served as a strategy to alleviate some of the time burden on other providers. One PCP describes how the nurses have their own protocols for PrEP: “Our nurses have general protocols for prescribing PrEP, and if something goes off of that protocol, or that typical standard patient, then the provider gets called in…it definitely increases access [to PrEP].”—FG4

Relative priority

Clinic-level factors, particularly time constraints and competing priorities, were described as barriers to integrating PrEP into routine visits. Providers shared that PrEP discussions often had to be deprioritized to address acute concerns, especially when patients came in for a reason not related to sexual health. This PCP noted that patients often have multiple health concerns, and PrEP is not always a top priority:

“I think in the adolescent visits in general time is just a big barrier of the patients we see in that age range… [they] either have like nothing going on or they have a lot going on is kind of my experience and so there’s so much to talk about that I think while I’ m still relatively uncomfortable or just unfamiliar with the process of starting PrEP that seems just like a big time barrier in the visit… so I think the time in that precious visit is a barrier.” — FG1

Characteristics of individuals

Need/Capability

At the individual level, most PCPs reported being somewhat comfortable discussing and prescribing PrEP to AYAs. However, the level of experience that PCPs had prescribing PrEP was more varied. Some providers noted that their experience prescribing PrEP to AYAs was limited. Many PCPs described confusion regarding existing PrEP guidelines and expressed the need for clearer protocols specifically tailored to AYAs. One PCP highlighted this with the following statement: “I struggle a little bit with reconciling the CDC recommendations on who should be on PrEP.”—FG3

Opportunity

Despite challenges, many PCPs reported that they still discuss sexual health and STI testing at most AYAs’ annual wellness visits. This PCP emphasized the importance of understanding the sexual health of their patients: “[It] doesn’t matter if it’s a specialty visit or primary care; outside of sick visits, it’s important for me to understand sexual health of all of my patients.”—FG3

Motivation

PCPs voiced strong motivation to prescribe PrEP when AYAs showed interest, while also stressing the importance of honoring AYAs autonomy in decision-making. One PCP emphasized the importance of having patient-facing PrEP education materials to empower AYAs and help them explore whether PrEP may be right for them:

“I think assuming providers are willing and able to prescribe the medication, in some ways it really is the patient’s decision, so having [the toolkit] be patient-facing, you know, information direct to the patient-whether it’s a video, or a podcast-so provider could be like, oh you seem like a candidate, why don’t you listen to/watch/read this thing, and then we can follow-up in a week or two and talk about it, ask questions, and we can go ahead and prescribe.”—FG3

Discussion

This study identified numerous implementation gaps in AYA-serving primary care settings related to PrEP for AYAs, underscoring the critical need for implementation research focused on optimizing HIV prevention strategies like PrEP in these settings. By leveraging the CFIR framework, we identified key determinants influencing the uptake of PrEP among AYA-serving PCPs. Through focus groups with four distinct sets of PCPs, we uncovered both barriers and facilitators relevant to future implementation. The themes that emerged—ranging from the importance of toolkit usability and content relevance to clinic-level constraints and provider-level comfort—highlight actionable areas that should be addressed prior to integrating PrEP tools into AYA-centered primary care, and will inform our work to develop an AYA-serving PCP PrEP toolkit.

A key finding highlighted by this study is the emphasis on usability—an essential feature for any resource designed for AYA-serving PCPs operating within highly constrained clinical environments. With primary care visits often limited to just 15 min, and competing demands that include addressing sensitive and complex topics like sexual health, PCPs consistently emphasized that any toolkit must be intuitive, efficient, and immediately actionable. Providers expressed a clear preference for a resource that is easy to access, interactive, and offers concise, age-appropriate guidance on PrEP prescribing. This aligns with the characteristics of other widely used clinical tools, such as UpToDate, that support rapid decision-making at the point of care.³² Although not explored in depth in this study, emerging research suggests the potential utility of artificial intelligence (AI)-powered solutions—such as chatbots—to deliver high-quality, tailored clinical guidance in real time, including in the context of HIV prevention.^33,34 This represents a promising direction for future work aimed at enhancing toolkit accessibility and impact.

Clinicians in this study described several outer-setting factors that complicated their ability to deliver high-quality HIV prevention services to AYAs. Primary care setting type, including differences between pediatric and family medicine practices, may influence PrEP use among AYA, and targeted interventions in family medicine settings have shown promise in improving both access and prescribing confidence. Consistent with findings from prior research,^35–37 PCPs emphasized the persistent challenge of navigating the dual responsibilities of engaging parents—who are often seen as protectors of their child’s health—while also honoring the AYAs’ growing autonomy and need for confidential care. The tension between these priorities was especially pronounced when discussing sensitive topics like sexual health and PrEP. The lack of comprehensive sexual health education in schools further compounds this issue, because PrEP is rarely addressed in educational settings. AYAs often arrive with limited knowledge, requiring clinicians to fill these gaps within already brief appointments. A few PCPs brought up parent-AYA sexual health communication that is open and honest as a facilitator to PrEP uptake, which is consistent with our work and others.^38–41 While we anticipated more discussion of state-level legal barriers to PrEP access for minors, most PCPs instead emphasized clinic-level variation in policies, which are discussed in more detail below. This may be partly explained by the fact that all participating clinics were located in a single state with relatively supportive policies around AYAs ages 16 and 17 accessing health services like PrEP without parental consent, as well as mechanisms to redirect insurance-related documents like explanation of benefit forms (EOBs).^42,43

Within the clinical (inner) setting, providers described persistent time constraints and competing demands as major barriers to engaging AYAs in conversations about HIV prevention and PrEP. The average primary care visit in the United States is estimated to last approximately 15–20 min,^44,45 leaving limited opportunity for in-depth discussions about sexual health. One study found PCPs spent an average of 36 s talking to adolescents about sexual health during well visits.⁴⁶ This challenge is further compounded by the fact that most AYAs present with acute concerns unrelated to sexual health, making it difficult for providers to pivot toward preventive services like PrEP. Notably, one clinic in our study addressed this challenge through a task-shifting strategy, utilizing nurses to conduct follow-up visits for existing PrEP patients. This allowed providers to focus on patients who were newly considering PrEP—encounters that often require more time and nuanced conversation. Similar task-shifting models have been used effectively in other clinical contexts to expand PrEP delivery,⁴⁷ alongside emerging strategies such as telemedicine to improve access and efficiency.⁴⁸

Limitations

There are several limitations to this study. First, the findings are based on a sample of PCPs practicing in the Northeastern United States, which may limit generalizability to other geographic regions and areas outside the United States. All PCPs reported at least a little experience prescribing PrEP, which may not reflect the perspectives of providers with no experience. Second, the sample was predominantly White and included many clinicians from academic-affiliated clinics, limiting representation of the broader diversity of clinicians and practice settings that may be AYA-serving. While these factors may affect generalizability, the toolkit developed is likely to be adaptable to other contexts with minimal tailoring. Lastly, we used rapid qualitative methods based on debrief summaries; full transcription and line-by-line coding may have yielded additional nuance.

The results of this study add to the growing literature on PrEP implementation for AYAs in primary care settings by centering the perspectives of AYA-serving PCPs and using a structured implementation science framework to guide formative research. Findings will inform the development of a practical, adaptable PrEP toolkit that addresses known barriers to PrEP uptake among AYAs and supports provider readiness to prescribe PrEP for AYAs. This study represents the formative phase of toolkit development. At the time of analysis, the toolkit had been translated into a prototype resource informed by the qualitative findings reported here. Evaluation of toolkit feasibility, acceptability, and implementation is occurring in a subsequent phase of research. As next steps, we will use these findings to inform the toolkit content and format, and then the toolkit will be piloted by AYA-serving PCPs in clinical practice to assess the feasibility and acceptability of the toolkit and its implementation. If effective and scalable, this intervention has the potential to expand equitable access to PrEP and reduce HIV transmission among AYAs in several different contexts.

Footnotes

Acknowledgments

Our study team gratefully acknowledge the participants for their thoughtful feedback and invaluable contributions to this study.

Authors’ Contributions

T.A. and J.R. led the conceptualization of this article. T.A., J.R., H.P., E.G., H.M., B.G.R., P.A.C., and A.R.E. completed the literature search and study design. T.A., J.R., H.P., E.G., and H.M. assisted with analyzing and interpreting the data. T.A., J.R., and H.P. finalized the results and implementation concepts of the study. All the authors read and approved the final article.

Ethical Considerations

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was exempted by the Rhode Island Hospital Institutional Review Board.

Consent to Participate

Informed consent was obtained from all individual participants included in the study.

Data Availability Statement

De-identified data from this study will be available via the Brown University Digital Repository archive. De-identified data from this study will also be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.

Author Disclosure Statement

All authors declare that they have no conflicts of interest or competing interests.

Funding Information

This study was funded by Institutional Development Award Number U54GM115677 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Rhode Island Clinical and Translational Research (Advance RI-CTR). Support from the Biostatistics, Epidemiology, and Research Design Core of Advance RI-CTR was received. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additionally, work by T.A. was supported by the National Institute of Mental Health Grant (K23MH124539-01A1) and the Providence/Boston Center for AIDS Research (P30AI042853). J.R. is supported by the NIMH (K23MH123335). A.R.E. is supported by a Department of Veterans Affairs Research Career Scientist Award (RCS 23-018).

Supplemental Material

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