Implementation Determinants of HIV Testing and Pre-Exposure Prophylaxis in Community Pharmacies in Philadelphia,PA

Abstract

Delivering HIV testing and pre-exposure prophylaxis (PrEP) in community pharmacies can expand access to HIV services for populations with limited access to care. However, few pharmacies in the United States have successfully implemented these services. We investigated implementation barriers and facilitators of pharmacy-based HIV testing and PrEP initiation in Philadelphia, an Ending the HIV Epidemic priority jurisdiction with high rates of HIV and bacterial STIs, located in a state with relatively restrictive laws governing pharmacy scope of practice. Using a sequential, exploratory mixed-methods study design, we conducted 15 in-depth interviews with pharmacists and key implementing partners, followed by an online survey of pharmacists, pharmacy students, and technicians (n = 59). Interviews and surveys were analyzed using the Consolidated Framework for Implementation Research. Data were collected from October 31, 2023, to October 17, 2024. Interviewees representing three pharmacy sites had initiated HIV testing, but no sites had yet successfully implemented pharmacy-based PrEP. The primary barriers to delivering HIV testing were based on inner setting barriers (existing work burden, overly complex protocols). Legal restrictions and reimbursement concerns were the primary barriers to implementing pharmacy-based PrEP. Participants described potential solutions and mitigating strategies to these barriers, such as collaborative practice agreements and developing standing orders with medical providers, integration with telePrEP models, streamlined blueprints and protocols, and practice-based champions. Survey respondents indicated high levels of acceptability but lower levels of perceived implementation feasibility. To optimize implementation sustainability and success, implementation strategies need to adequately address legal barriers and reimbursement concerns and be integrated into the pharmacy workflow.

Introduction

Pharmacy-based service delivery is a promising strategy to increase HIV testing and pre-exposure prophylaxis (PrEP), particularly in communities most impacted by HIV. Pharmacists have experience providing counseling for antiretroviral therapy and PrEP,^1,2 managing medications and may see patients up to 10 times more frequently than primary care providers.³ In addition, pharmacies are often seen as nonstigmatized, trusted environments for delivering HIV services to key populations affected by HIV.^4
–6 Within the United States, pharmacies in several states have successfully implemented pharmacy-based HIV testing and PrEP, where a client can obtain rapid HIV testing and start PrEP that same day, without requiring a physician visit.^7
–9

However, widespread implementation of pharmacy-based HIV services has been low in the United States. Pharmacies that have implemented PrEP services have been largely limited to states with standing orders or protocols, which allow pharmacists to prescribe PrEP without a prescription from a primary care provider.¹⁰ More commonly, pharmacists can enter a collaborative practice agreement (CPA) with a primary care provider in all US states, which can expand pharmacists’ scope of practice to provide additional health services, such as PrEP. However, many states require CPAs to be patient-specific, where a patient must first have a visit with a primary care provider before a pharmacist can manage medications, thereby limiting the ability for pharmacists to independently initiate HIV services.¹⁰

Philadelphia, a northeastern US city located in Pennsylvania, is home to roughly 20,000 people with HIV and is prioritized as one of 48 counties by the Ending the HIV Epidemic (EHE) initiative. In 2023, Philadelphia had the highest rate of STIs among US metropolitan areas.¹¹ Surveillance data indicate that nearly 9000 residents may immediately benefit from PrEP, the majority of whom are Black and Latine individuals.¹² As part of the EHE initiative, the Philadelphia Department of Public Health provided technical training and testing supplies to three independently owned community pharmacies to offer rapid HIV testing.

Few studies have examined implementation determinants of HIV testing and PrEP services. While Pennsylvania law allows pharmacists to enter CPAs to provide PrEP and conduct tests that have obtained a Clinical Laboratory Improvement Amendments (CLIA) waiver, such as rapid HIV tests, these services are underutilized. To explore implementation determinants of pharmacy-based HIV prevention services, we conducted a mixed-methods study of pharmacists and key implementing partners in the Philadelphia area. The goal of this study was to understand barriers and facilitators of implementing pharmacy-based HIV testing and PrEP in pharmacies.

Methods

Study design

We used an exploratory, sequential mixed-methods study design grounded in the Consolidated Framework for Implementation Research (CFIR) to understand implementation barriers and facilitators.^13,14 This design utilizes the initial collection and analysis of qualitative data and then subsequently develops quantitative measures to explore key themes. We conducted in-depth interviews to identify salient themes related to implementation, which we then explored and quantified through an online survey. We chose this method due to the highly context-dependent nature of pharmacy-based HIV services, with a focus on assessing areas that were identified in our qualitative data as highly relevant to pharmacists and implementing partners.

Participants

Study investigators consulted community partners and public health personnel to identify prospective participants. We then recruited pharmacists and key implementing partners by email to participate in interviews. We initially recruited participants from pharmacies that offered HIV testing and implementing partners with HIV and public health expertise. We purposively sampled pharmacists in the region across a range of experience, roles, and practice settings. We also recruited pharmacy staff, including outreach managers and technicians with experience in implementing HIV-related programming. Interview participants received a $30 electronic gift card as compensation. For the quantitative survey, we recruited pharmacists, pharmacy students, and pharmacy technicians in the Philadelphia area through email promotion and pharmacist professional networks. Survey respondents received a $15 electronic gift card. All participants were at least 18 years of age. Data were collected from October 31, 2023, to October 17, 2024.

Data collection and analysis

Qualitative interview guide

The investigators developed a semi-structured interview guide based on the CFIR constructs, which was used to interview all participants. The interview guide consisted of open-ended questions designed to gather insight into implementation determinants across the major CFIR domains: innovation, inner setting, outer setting, individuals, and implementation process. Within each domain, interviews focused on exploring constructs that could elucidate barriers and facilitators to implementing HIV testing and PrEP services in pharmacies. If pharmacies had implemented HIV testing, we asked additional questions about barriers and facilitators to implementing rapid HIV testing. Two investigators (C.H.B.-G. and A.S.) conducted the interviews using video conferencing; audio was recorded for analysis.

Qualitative analysis

We utilized a rapid deductive approach to analyze interview audio recordings. This approach, developed for implementation science using CFIR, is a rigorous and efficient strategy to rapidly analyze qualitative data needed for implementation.¹⁵ After each interview, two analysts independently listened to audio recordings and took detailed notes in a matrix organized by CFIR construct. Analysts coded interviews based on deductive CFIR constructs and inductive themes that emerged from the interview. After the first three interviews, the two analysts reviewed the matrix to adjudicate and refine the codebook. The analysts met weekly to review differences. A primary analyst then created a high-level summary sheet and assigned valences based on implementation determinants (“+” to indicate an implementation facilitator, “−” to indicate an implementation barrier, and “+/−” to indicate a neutral or mixed determinant).

Quantitative measures

The results of our qualitative analysis informed the development of an online survey distributed to pharmacists, pharmacy technicians, and pharmacy students. Survey items included socio-demographics, occupation, type of pharmacy, location of pharmacy, attitudes, and knowledge of PrEP. We developed additional measures based on themes and CFIR constructs that emerged during our qualitative analysis. For instance, we asked participants to rate their agreement with statements about staffing resources, organizational support, and reimbursement. The survey also included items asking participants to rate their confidence performing various HIV prevention tasks related to providing HIV testing, oral PrEP, and injectable PrEP. To assess intervention acceptability, feasibility, and appropriateness, we adapted select measures from the Proctor implementation outcomes.¹⁶

Quantitative analysis

We calculated descriptive statistics to summarize participant characteristics based on their pharmacy experience, role in pharmacies, practice setting, and sociodemographic characteristics. We calculated mean scores and standard deviations (SDs) to describe continuous measures. Data were organized by CFIR constructs. Analyses were completed using STATA 15.0 (Stata Inc., College Station, TX).

Mixed-methods analysis

After sequential analysis of qualitative and then quantitative data, we created a joint display with key themes of implementation determinants from the qualitative strand and survey measure mean scores from the quantitative strand. We categorized data based on their CFIR domain. Within the joint display, we also highlighted potential solutions or mitigating strategies that emerged from the qualitative data. To validate our results with key implementing partners and the community,¹⁷ we then presented key findings in a public forum for HIV prevention and invited feedback. The public forum included study participants, in addition to community members and partners who had not participated in the study.

This study was reviewed and deemed exempt by the University of Pennsylvania Institutional Review Board.

Results

A total of 15 in-depth interviews with pharmacists (n = 12), a pharmacy technician (n = 1), and public health partners (n = 2) were completed during the qualitative phase of the study. A total of 10 pharmacies were represented in the study, of which three pharmacies offered HIV testing. No pharmacies had yet implemented pharmacy-based PrEP. During the quantitative phase, we surveyed a total of 59 pharmacists, students, and technicians between May 9, 2024, and July 31, 2024 (Table 1). Participants represented a range of practice settings, including chain pharmacies, hospital- and clinic-based pharmacies, specialty pharmacies, and independent community pharmacies.

Table 1.

Characteristics of Survey Participants (N = 59)

Characteristic	N (%)^a
Age (median, interquartile range)	26 (23–32)
Gender identity^b
Man	15 (25%)
Woman	42 (71%)
Prefer not to answer	2 (3%)
Race/ethnicity
American Indian or Alaska Native, non-Hispanic	1 (2%)
Black, non-Latine	3 (5%)
Asian, non-Latine	16 (27%)
White, non-Latine	28 (47%)
Hispanic/Latine, any race	6 (10%)
Other/unknown	5 (8%)
Education level
High school graduate or equivalent	4 (7%)
Some college level/technical/vocational degree	7 (12%)
Bachelor’s degree	19 (32%)
Doctor of pharmacy (or other advanced degree)	26 (44%)
Role
Pharmacist	25 (42%)
Chain and standalone pharmacy	6 (10%)
Hospital and clinic-based pharmacy	11 (19%)
Specialty pharmacy	2 (3%)
Independent pharmacy	6 (10%)
Pharmacy student	21 (36%)
Pharmacy technician	12 (20%)
Other: Pharmacist compliance officer	1 (2%)

Rows may not sum to total N due to responses of “prefer not to answer.”

Multiple nonbinary, transgender, and other options were included in the survey.

Major themes related to the challenges of implementing pharmacy-based PrEP were represented in all CFIR domains, with particular focus on constructs related to inner setting and outer setting domains (Fig. 1). Pharmacists also described potential mitigating solutions and strategies to implement pharmacy-based PrEP. We present key qualitative and quantitative data in a joint display (Table 2).

FIG. 1.

Barriers and facilitators to implementing pharmacy-based HIV services and PrEP organized by the CFIR domain. (+) denotes facilitator, (+/−) may be facilitator or barrier, and (−) denotes barrier. CFIR, Consolidated Framework for Implementation Research; PrEP, pre-exposure prophylaxis.

Table 2.

Major Themes in Implementing Pharmacy-Based HIV Testing and PrEP (N = 15 for Interviews, N = 59 for Survey)

Implementation determinant	CFIR domain	Key quotations from in-depth interviews	Online survey measures(1 = strongly disagree, 5 = strongly agree)	Mean agreement score (SD; range 1–5)	Potential solutions or mitigating strategies
Work burden and limited staffing in pharmacy (−)	Inner setting	“I’m afraid to give a test … I’m really busy … they want me to fill out a 5-page form [for each tester]! I can’t do that … I barely have time to give a flu shot.”—Community pharmacist“I think the most important thing is … to reduce the amount of time from interest to initiation. The shorter we can get that window, the more PrEP is on their mind. If they can’t get an appointment for two weeks … then that thought might not be front and center.”—HIV prevention coordinator	My pharmacy has enough staffing to provide drop-in PrEP visits.	2.86 (1.19)	Designated days or appointments for HIV services,Streamlined and simplified HIV testing and PrEP protocols
			My pharmacy has enough staffing to provide scheduled PrEP visits.	3.21 (1.20)
			I have the time to counsel clients on PrEP during my regular workday.	3.29 (1.14)
Supportive pharmacy culture for new services (+)	Inner setting	“I think this would be a really great service for patients especially because a lot of them have trusting relationships with their community pharmacist and we are so accessible.”—Pharmacy Resident, supermarket	My organization provides adequate training to provide services for sexual and gender minority populations (e.g., LGBTQ+ populations).	3.31 (1.18)	Funded training for providing new services
Supportive pharmacy culture for new services (+)	Inner setting		My organization provides adequate training to provide services for racial and ethnic minority groups.	3.73 (0.93)	Funded training for providing new services
Physical infrastructure (+/−)	Inner setting	“Some pharmacies just have a tiny hole in bulletproof glass for interaction”—Community pharmacist“The idea of going to a public space (like a pharmacy) to be tested and counseled is a barrier”—Patient care services manager	My pharmacy has adequate physical space to perform HIV testing.	3.47 (1.28)	Create private spaces with moveable privacy barriers, white noise machines
			My pharmacy has a separate, enclosed space to provide PrEP counseling.	3.34 (1.37)
			My pharmacy has adequate private physical space to administer intragluteal injectable PrEP.	3.40 (1.36)
Legal restrictions (−)	Outer setting	“If the laws allowed it in Philadelphia, since we already have it in other parts of the country that our company already provides, it would be pretty easy for us to move forward and start providing the service.”—Patient care pharmacist manager	N/A	N/A	CPAs or local standing ordersIntegration with existing telePrEP delivery models
Reimbursement and cost concerns (−)	Outer setting	“It’s all about the reimbursement. So, I think that’s definitely something that we need, is funding or some structure in which our businesses would be able to provide the service and also not lose money from it.”—Community pharmacist manager	I believe I would be reimbursed for time spent performing HIV testing.	2.92 (1.19)	Develop guidance for pharmacists to obtain provider status to bill for counseling services
Reimbursement and cost concerns (−)	Outer setting		I believe I would be reimbursed for time spent counseling for PrEP.	2.90 (1.24)
Stigma and health equity (+/−)	Implementation process	“It’s like, ‘I don’t need PrEP’ or ‘I don’t want to talk to someone about HIV’… And so, I think there would definitely have to be special focus on education with the general public about pharmacies providing this new service, and the stigma around it, the importance of just knowing your status.”—Pharmacist, community pharmacy	My pharmacy serves individuals from sexual and gender minority populations (e.g., LGBTQ+ populations).	3.53 (0.63)	Additional training to work with priority populations,Normalization of HIV services within pharmacy
			My pharmacy serves individuals from racial and ethnic minority groups.	3.79 (0.45)
			My pharmacy serves people who inject drugs.	3.49 (0.71)
HIV services champion (+)	Implementation process	“Having pharmacy owners that are the actual proprietor and the service provider having them be a champ for HIV services and HIV testing, a lot of them would like to do more. It’s really helpful to have champions in these spaces.”—Public health HIV prevention coordinator	Leadership at my pharmacy is receptive to new ideas to improve access to care.	4.08 (0.90)	Each site has a designated HIV testing and PrEP champion

Implementation determinants: (−) denotes implementation barrier, (+) denotes facilitator.

Key quotations were coded from in-depth interviews. Quantitative survey measures were from online surveys.

CFIR, Consolidated Framework for Implementation Research; PrEP, pre-exposure prophylaxis; SD, standard deviation.

CFIR inner setting domain

Heavy workload at pharmacies

Several pharmacists described feeling overwhelmed by existing workload and often having a bare minimum of pharmacy staff to meet demand. Among those who worked at pharmacies that provided HIV testing, one pharmacist expressed reluctance to provide HIV testing due to the burden it placed on workflow. In addition, reporting and documentation requirements were perceived as a barrier to testing.

Several participants indicated that time constraints and pharmacy busyness could limit the willingness of pharmacists to provide PrEP services, while noting the additional complexity of PrEP counseling.

[PrEP] will take longer: evaluating the patient, going through the labs. . . . [With] current services pharmacists manage medications, [it] doesn’t require a lot of intake or follow-up questions. (Pharmacy manager at specialty pharmacy)

To address some of these concerns, several pharmacists indicated that an appointment-based model could mitigate workflow barriers. While pharmacists acknowledged a walk-in model would be more convenient for clients, scheduled HIV testing and PrEP visits could help pharmacists prepare for the additional workload by having additional staff during appointments.

These findings were supported by our quantitative survey measures. We observed higher mean agreement scores to provide scheduled PrEP visits (mean 3.21, SD 1.20), compared with mean agreement scores to provide drop-in visits (mean 2.86, SD 1.19).

Supportive pharmacy culture

Pharmacists working in diverse clinical settings indicated their workplace culture as supportive of introducing new innovations, including pharmacy-based PrEP. Independent and specialty pharmacies that served priority populations noted strong organizational support for HIV programs. Among those who worked in independent pharmacies, providing pharmacy-based PrEP was seen as a potential competitive advantage they could offer over traditional retail pharmacies. Pharmacists working in independent pharmacies noted the need to adapt and be flexible to meet community needs.

They [pharmacists] have to be really open minded in general to survive here … We’re not working for a big chain; we’re working for ourselves. (Pharmacist and co-owner, community pharmacy)

Several participants also mentioned the COVID-19 pandemic as pivotal for pharmacies to expand their health services.

[Pharmacies] would be a great avenue to expand … we know people are using pharmacies for a variety of services, like the whole COVID strategy, it was through pharmacies … without pharmacies, we wouldn’t have gotten through the darkest days of the pandemic. (HIV prevention coordinator, public health)

Physical infrastructure needed to provide HIV services

Pharmacists and pharmacy staff described requiring additional physical space to provide HIV services. While pharmacies could be seen as a nonstigmatized environment, their spaces may not be well designed for providing HIV services. One pharmacist noted that only minor adjustments were needed to provide testing at their pharmacy, such as privacy barriers and white noise machines. However, some pharmacies may not have the necessary private space needed to conduct testing, counseling, or administer on-site injectable PrEP via gluteal administration.

CFIR outer setting domain

Addressing legal barriers to pharmacist-initiated PrEP

Most pharmacists and implementing partners cited legislative barriers and state laws governing pharmacists’ scope of practice as the main barrier to implementation. Several workarounds were proposed. Implementing partners in public health domains also described CPAs as a potential solution but were also hesitant that developing one could be too complex to implement and had not yet been utilized for PrEP in Pennsylvania.

“In other jurisdictions, there could be a standing order, and so anyone that a pharmacist identified as being eligible for PrEP, they would be able to initiate that person on PrEP and maybe get the labs et cetera. There are different models. . . . [but] if things don’t change from a regulatory standpoint, I think it might end up being like having the pharmacies work with [a] telePrEP program.” (Public health implementing partner)

However, while workarounds could support implementation in a few pharmacies, some pharmacists and implementing partners were skeptical that, without changes in state laws or clear regulatory guidance from the state Board of Pharmacy, adoption of pharmacy-based HIV services would be low.

Need for adequate service reimbursement

Participants also described concern about the lack of or inadequate reimbursement for PrEP-related services, including ancillary services such as counseling, laboratory monitoring, and HIV testing. One community pharmacist acknowledged that although services might lose money, offering additional services such as PrEP might have an overall benefit in bringing new clients into the pharmacy.

“This could be somewhat analogous to when pharmacies started doing COVID-19 testing. Yes, we’re having an additional service, but our pharmacy is seeing the direct benefits of all these additional services.” (Pharmacist, community pharmacy)

Several pharmacists said that if pharmacies are not adequately reimbursed, pharmacies would have little incentive to offer PrEP. These concerns were consistent with the quantitative data. On average, participants disagreed with statements that they would be adequately reimbursed for HIV testing (mean 2.92, SD 1.19) and time spent counseling for PrEP (mean 2.90, SD 1.24).

Implementation process

Introducing a new clinical service to pharmacies raised concerns about the complexity of the intervention being implemented. In order to perform HIV testing, pharmacists and technicians described that many steps were required, including obtaining a CLIA waiver, obtaining reagents, and completing training. Reporting and documentation requirements for HIV testing also felt burdensome to some participants. Ensuring the pharmacy had adequate staffing, testing supplies, and support for linkage to care were additional barriers to continuing HIV testing services.

Practice support and streamlined training

When implementing HIV testing, a pharmacy technician indicated that having a testing “champion” was helpful to its success. Similarly, when discussing PrEP implementation, several pharmacists described having an on-site PrEP champion and strong partnerships with physicians and public health partners would increase their confidence and comfort in implementation.

Most pharmacists indicated that clinical training and clear guidance on prescribing and collaborating with physicians would help facilitate PrEP prescription training. Minimizing unnecessary steps and streamlining the process were critical to feasibility.

As long as it’s simple. Quick. And we can fit it into our already hectic workflow, it’ll be fine, we’ll be alright… Very simple, bare bones, bare necessities. If it’s not necessary, don’t ask us to do it. (Pharmacist and manager, community pharmacy)

Addressing stigma and health equity

Pharmacists and pharmacy staff acknowledged that HIV stigma could be a barrier to obtaining HIV testing and PrEP at pharmacies. A manager at a community pharmacy felt there were high levels of anti-LGBTQ+ and anti-HIV stigma in their community, and pharmacy clientele may not feel comfortable discussing PrEP around people they may know.

The stigma in the African American community, it’s just tough to get around. A lot of our patients, we don’t even label the meds. We go through great lengths for a lot of people to hide this diagnosis from their own family, from the people living in their house. Just being openly gay in my community is not really accepted. (Pharmacist and manager, community pharmacy)

Pharmacists and implementing partners involved in pharmacy-based HIV testing described a few stigma reduction strategies. One pharmacist described putting out advertisements and a tent outside advertising HIV testing services outside the pharmacy, which successfully brought community members in to get testing. Others described normalizing HIV services as part of the buffet of health services that a pharmacy provides, such as COVID-19 testing and routine vaccinations.

Characteristics of the innovation

Innovation adaptability

Pharmacists and pharmacy resident trainees indicated that additional clinical training would be needed to increase their confidence and knowledge base to initiate PrEP, because they were not accustomed to starting medications. Both our qualitative and quantitative data reflected higher levels of confidence for counseling on side effects, adherence, and persistence on PrEP (Table 3).

Table 3.

Pharmacy Staff Attitudes Toward Providing HIV Prevention Services (N = 15 for Interviews, N = 59 for Survey)

HIV prevention service	Key quotations from in-depth interviews	Online survey measuresDescribe your confidence level in being able to:	Mean agreement score (SD), range 1–5^a
HIV testing	“My only concern is what to do with HIV positive test, and how to do the liver and kidney testing.”—Pharmacist and manager, LGBTQ+ health center	Provide counseling on rapid HIV test results.	3.24 (1.38)
		Conduct an assessment of HIV risk.	3.19 (1.34)
		Provide counseling on bacterial STI testing and treatment.	3.39 (1.20)
		Provide counseling on HIV postexposure prophylaxis.	3.27 (1.41)
Oral PrEP	“I just want to emphasize that if the pharmacist is the one initiating the treatment, they’re not used to doing that. We’re trained to follow orders like the military, and if anything happens, it’s the doctor’s fault.”—Pharmacist and co-owner, community pharmacy	Provide counseling on side effects of oral PrEP.	3.58 (1.27)
		Provide counseling on oral PrEP adherence.	3.90 (1.36)
		Discuss laboratory monitoring for oral PrEP.	3.34 (1.25)
		Assist patient in obtaining affordable coverage of PrEP.	3.66 (1.24)
Injectable PrEP	“I give all sorts of injections… My comfort level is fine. But when I saw Cabenuva, my other pharmacists were showing me what you do, and I would not want to give that injection. You might have some issues finding a professional who’s willing to give that shot.”—Pharmacist, community pharmacy	Provide counseling on side effects of injectable PrEP.	3.25 (1.36)
		Provide counseling on missing injection visits.	3.37 (1.35)
		Discuss laboratory monitoring for injectable PrEP.	3.15 (1.26)
		Assist patient in obtaining affordable coverage of injectable PrEP.	3.49 (1.36)

Likert scale of 1–5: 1, not confident at all; 2, not very confident; 3, neutral; 4, somewhat confident; 5, very confident.

PrEP, pre-exposure prophylaxis; SD, standard deviation.

In interviews, pharmacists described extensive experience and comfort with medication counseling. However, performing tasks such as PrEP lab monitoring or counseling around HIV testing felt less familiar and would require more training. Among those who conducted HIV testing in pharmacies, one recurring theme was uncertainty about what to do with positive results. To assuage these concerns, pharmacists wanted clear guidelines and protocols.

[Pharmacists] probably dispense these medications on the daily basis, so they’re comfortable with the medications. It’s just kind of that additional aspect of like ‘Oh, now this is something that I’m primarily responsible for.’ It’s not that they don’t know the knowledge, they just kind of want that additional reassurance. (Pharmacist, community pharmacy)

Acceptability, appropriateness, and feasibility of pharmacist-initiated PrEP

While mean scores for intervention acceptability and appropriateness were higher, scores for feasibility were lower (Table 4). One pharmacist also noted that pharmacies may be more open to expanded clinical services after the start of the COVID-19 pandemic:

Table 4.

Acceptability, Appropriateness, and Feasibility of Pharmacist-Initiated PrEP (n = 57)

Measure type	Measure, by participant workplace	Mean agreement score (SD), 1 = completely disagree, 5 = completely agree
Acceptability	I like the idea of pharmacist-initiated PrEP (PIP)	4.23 (0.82)
	Chain pharmacy	4.07 (1.00)
	Independent pharmacy	3.80 (0.92)
	Clinic/hospital-based pharmacy	4.43 (0.69)
	Specialty pharmacy	4.40 (0.55)
Acceptability	I would welcome PIP in my pharmacy	4.20 (0.81)
	Chain pharmacy	4.07 (1.00)
	Independent pharmacy	3.90 (0.88)
	Clinic/hospital-based pharmacy	4.37 (0.74)
	Specialty pharmacy	4.20 (0.45)
Appropriateness	PIP seems like it would be fitting to the pharmacy I work in	3.82 (1.16)
	Chain pharmacy	3.57 (1.28)
	Independent pharmacy	3.40 (1.35)
	Clinic/hospital-based pharmacy	4.11 (1.01)
	Specialty pharmacy	3.80 (1.10)
Appropriateness	PIP seems like a good match for the community that our pharmacy serves	4.00 (0.97)
	Chain pharmacy	3.57 (1.22)
	Independent pharmacy	3.90 (1.10)
	Clinic/hospital-based pharmacy	4.26 (0.76)
	Specialty pharmacy	4.00 (0.71)
Feasibility	PIP seems implementable, that the program can work and function, at the pharmacy I work in	3.57 (1.22)
	Chain pharmacy	3.29 (1.20)
	Independent pharmacy	3.40 (1.58)
	Clinic/hospital-based pharmacy	3.81 (1.08)
	Specialty pharmacy	3.40 (1.34)
Feasibility	PIP seems easy to do in the pharmacy I work in	3.43 (1.16)
	Chain pharmacy	3.07 (1.21)
	Independent pharmacy	3.10 (1.37)
	Clinic/hospital-based pharmacy	3.67 (1.04)
	Specialty pharmacy	3.80 (1.10)

Survey measures adapted from Proctor implementation measures for acceptability, appropriateness, and feasibility.¹⁶

PrEP, pre-exposure prophylaxis; SD, standard deviation.

“COVID helped normalize pharmacies offering additional services, like vaccines… [and] it’s a good opening for pharmacies who thought it was not possible to provide additional services.” (Pharmacy resident, community pharmacy)

Nonetheless, some pharmacists expressed that accepting pharmacy-based PrEP would require a change in their mindset.

Having a pharmacist actually initiate an order, the mindset might have to be changed a little bit. Rules have to be clearly spelled out, and their liability will have to be clearly spelled out too. I believe if there was a standing order where the pharmacist was able to say ‘Hey, it’s the doctor that I’m putting on the label.’ I think that they’re going to be, they’re going to feel a little bit easier. (Pharmacist and owner, community pharmacy)

Notably, Pennsylvania state regulations do not currently permit pharmacists to independently initiate medications without a CPA or standing order from a physician.

Discussion

Pharmacy-based HIV testing and PrEP are promising strategies to expand the reach of HIV prevention services in historically marginalized communities. Although prior research has focused on pharmacy-based PrEP in states with broad prescriptive authority or expansive CPA laws,^7
–9 there is a paucity of data on implementing pharmacy-based HIV services in states without broad pharmacist prescriptive authority, which comprise roughly 80% of all US states.¹⁰ Using the CFIR framework, our study expands this literature by exploring key implementation barriers and facilitators to pharmacy-based HIV testing and PrEP in a setting with significant legal restrictions on pharmacy-based PrEP.

Successful adaptation and integration of clinical services into pharmacies will need to address the inner setting barriers, particularly workflow concerns. Pharmacies that implemented HIV testing had diverse experiences, depending on how testing services had been implemented. Pharmacy staff did not like how HIV testing could pull staff away from other work duties, particularly when they already felt stretched thin by their work. These results are consistent with prior research on implementing medical management and CPAs in pharmacies.^18,19 Pharmacy staff felt that workload unpredictability could hamper PrEP implementation, particularly with drop-in services. While some participants acknowledged that drop-in services would be more patient-centered compared with scheduled visits, our qualitative and quantitative data supported using appointment-based models or offering services only during designated times.

Participants highlighted two interrelated policy-level determinants, legal restrictions and concerns about adequate reimbursement, as major barriers to the feasibility of pharmacy-based PrEP. Although our qualitative and quantitative data indicated high levels of acceptability of pharmacy-based PrEP, they also found lower levels of feasibility. Prior studies of pharmacy-based PrEP or pharmacist-initiated PrEP have been limited to states with expansive PrEP laws that permit PrEP prescription under a statewide standing order or relatively permissive CPA laws.^7,9,20 However, CPA laws vary from state to state, and pharmacists may still not be able to initiate PrEP under more restrictive CPA laws, such as in Pennsylvania. While several pharmacists and implementing partners acknowledged that pharmacy-based PrEP could be implemented in settings with restrictive legislation, concern about adequate reimbursement could hinder adoption.

Despite these barriers, the COVID-19 pandemic has increased recognition of the role pharmacists can play in delivering care. Pharmacists and other pharmacy personnel were generally supportive of implementing PrEP and saw potential competitive advantages in being able to offer additional clinical services. Our data supported designating an HIV or PrEP champion within the pharmacy to address emerging challenges, engage with leadership, and support intervention uptake. PrEP champions have been used to support PrEP implementation in primary care settings, where providers may not initially be comfortable prescribing PrEP.²¹ In addition, pharmacist-led programs have demonstrated success in providing long-acting ART management,²² which could be adapted for long-acting PrEP programs.

Our data strongly support developing tailored implementation strategies to overcome outer setting barriers for pharmacy-based PrEP to be feasible. Implementation strategies are the actions or steps that can address barriers and enhance the adoption and implementation of evidence-based interventions, such as PrEP.^19,23 A public health partner in our study proposed a hybrid pharmacy and telePrEP strategy as a potential solution to delivering PrEP in pharmacies. TelePrEP and home-based PrEP programs have been developed to expand PrEP access beyond traditional health care sites to deliver PrEP remotely, and could be integrated into pharmacy workflow.^24
–26 Another strategy to circumvent restrictive legislature is the development of local standing orders, which have been successfully implemented to deliver gonorrhea and chlamydia testing and treatment.²⁷ Compensation models can be adapted to better support pharmacist reimbursement as well. For instance, recent changes in the Pennsylvania state legislature have expanded the number of potential services for which pharmacists can bill.²⁸

This study has limitations. Our study was limited to the Philadelphia area in Pennsylvania, a state with comparatively restrictive laws governing pharmacist authority to prescribe PrEP, and generalizability is therefore limited. However, only nine states have legislation that permits pharmacists to independently initiate PrEP,¹⁰ so our findings may be applicable to the majority of states without statewide standing orders or protocols to prescribe PrEP from pharmacies. Our study therefore extends the literature beyond “early-adopters” in permissive legal environments. Second, our sample size was comparatively small, and the quantitative analysis was not designed to assess statistically significant differences between pharmacy settings or types of pharmacists. Third, only 20% of the survey sample represented pharmacists practicing in conventional independent or chain pharmacies. In addition, we did not interview potential pharmacy-based PrEP clients. Additional research is needed to ensure implementation strategies reach and meet the needs of historically marginalized groups that can benefit from PrEP.

Pharmacy-based HIV testing and PrEP can support widespread, low-barrier access to HIV prevention services. Our study identified key implementation barriers, particularly legal restrictions, reimbursement concerns, and pharmacy workflow, while also exploring potential mitigating solutions. Future research can use these data to refine implementation strategies.

Footnotes

Acknowledgments

The authors wish to thank study participants and staff from the Philadelphia Department of Public Health and colleagues from Saint Joseph’s University and the Philadelphia College of Pharmacy for their support in recruiting study participants.

Authors’ Contributions

Study conceptualization: C.H.B.-G. Study design: C.H.B.-G., A.S., J.B., and S.M.W. Analyzed the data: C.H.B.-G., A.S., and B.P. Wrote the article: C.H.B.-G. and A.S. Revised and edited the article: C.H.B.-G., A.S., B.P., J.W., K.A.B., M.J., D.K., J.B., and S.M.W. All authors have read and approved the final article.

Author Disclosure Statement

D.K. is an independent consultant at Merck and is part of the Speakers Bureau at ViiV Healthcare and Gilead. All other authors declare no conflicts of interest.

Funding Information

This research was supported by a grant from the Penn Center for AIDS Research (P30 AI 045008) and supported by a career development award (K23 MH 131468) to C.H.B.-G.

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