Implementing PrEP Services in Diverse Healthcare Settings

Abstract

Background

Uptake of pre-exposure prophylaxis (PrEP) in the US has been limited. Evidence for why and how PrEP has been successfully integrated into some clinical settings but not in others is minimal. To address this gap, we conducted a qualitative study to identify contextual factors that facilitated and challenged the implementation of PrEP services.

Setting

In partnership with the NYC Department of Health and Mental Hygiene, we convened a Planning Committee with expertise with groups highly affected by the HIV epidemic employed in diverse healthcare settings, to guide the project. Representatives from programs within New York were targeted for participatation initially and subsequently expanded nationally to enhance diversity in program type.

Methods

Using an interview guide informed by the Consolidated Framework for Implementation Research (CFIR), we conducted 20 interviews with participants who successfully implemented PrEP programs in different settings (e.g., primary care, emergency department, sexual health clinics), using different delivery models. We used template and matrix analysis to identify and characterize contextual determinants and implementation strategies.

Results

Participants frequently described determinants and strategies fluidly and conceptualized them in context-specifc terms. Commonly discussed CFIR constructs included implementation climate (tension for change, compatibility, relatively priority), stakeholders’ knowledge (or lack thereof) and beliefs about PrEP, and costs associated with PrEP implementation.

Conclusion

Our work identifies patterns in PrEP program implementation, describing how organizations dealt with determinants in their own context. Our research points to the need to connect rigorous implementation research with how frontline implementers conceptualize their work to inform and improve PrEP implementation.

Background

HIV prevention is one of the key pillars (Prevent) to ending the HIV epidemic (EHE) in the US.¹ Preexposure prophylaxis (PrEP) has the potential to reduce the number of incident infections,^2–4 yet it is underutilized.⁵ A May 2021 US Centers for Disease Control and Prevention (CDC) surveillance report noted that in 2019 less than a quarter of Americans eligible for PrEP (23%) were prescribed it.⁶ Moreover, significant racial/ethnic, gender, and sexual identity inequities persist in PrEP uptake, with Black and Hispanic men who have sex with men significantly less likely to have used PrEP within the last year, due, in part, to unequal access to, knowledge of, and prioritization of PrEP and perceptions of risk.^7–11

PrEP implementation has been challenging in all healthcare settings; barriers to the wide-scale implementation and adoption of PrEP are multi-level, complex,^12,13 and well-known.^14–18 A recent review identified a broad range of barriers such as lack of federal funding, questions around insurance coverage, lack of physical space within a care setting, low self-perceived HIV risk and poverty, which led to issues such as lack of transportation and limited health literacy.¹⁹ A key barrier is lack of PrEP provision in the healthcare system, particularly a breakdown in healthcare settings’ implementation of PrEP services and non-specialist providers often lacking knowledge and motivation to prescribe and manage PrEP.^20,21

Introducing PrEP programs into healthcare setting requires fiscal and political support, community buy-in, partnerships, supportive policies, organizational capacity, sustainability, strategic planning, and targeted demand-creation strategies.²² Numerous interventions have been initiated to promote uptake of PrEP.^23,24 However, more research is needed to develop and understand multi-level interventions that can address the complexities of and barriers to implementation. With the ultimate goal of informing programs that facilitate access to PrEP, we formed a collaboration between academic institutions and the NYC Department of Health and Mental Hygiene (NYC DOHMH) to understand what “successful” implementation looked like across healthcare settings that had implemented PrEP programs.

We conducted an inductive, in situ study using an implementation science (IS) framework to better understand the challenges of PrEP implementation from the perspective of frontline PrEP implementers (i.e., providers, staff, administrators who are implementing PrEP in their institution). Recent IS has sought to move beyond the identification of implementation barriers and facilitators alone, with new emphasis on understanding the relationships between barriers and the strategies used to facilitate implementation.^25–27 Our research aimed to identify patterns in barriers to PrEP implementation and the strategies used by participants to address those barriers across diverse healthcare settings including primary care, obstetrics/gynecology (OBGYN), Emergency Department (ED), and drug treatment/harm-reduction centers.

We chose the Consolidated Framework for Implementation Research (CFIR) as our IS framework because its breadth of domains and constructs would provide a flexible structure to categorize how frontline PrEP implementers across a variety of systems and settings thought and talked about their experiences implementing PrEP.²⁸ CFIR is a determinant framework, often used to describe and categorize dimensions of context, or “determinants”, that are faciltiators and barriers to implementation.²⁹ A qualitative approach was chosen to allow our participants the opportunity to explain their experience in their own words. Additionally, all but one of the PrEP programs described were not formal IS projects; therefore interview participants were not likely to discuss their work in formal implementation terms.³⁰ Our goal was to translate the perceptions and experiences of our interview participants from real-world descriptions of PrEP implementation through our qualitative analysis into the CFIR constructs and domains that would allow us to identify patterns across settings. We anticipate that findings from this analysis could be translated back to inform the pragmatic implementation of PrEP programs in the future.

Methods

To guide project activities, we sought diverse expertise by involving academic partners, the NYC DOHMH, and a Planning Committee (Table 1) of experts serving groups that are more highly affected by HIV in diverse healthcare settings (e.g., primary care, ED, OBGYN). The Planning Committee advised the co-authors on identification of PrEP programs and potential interview participants, the development of the interview guide, data collection procedures, and the analysis and interpretation of findings.

Table 1.

ETE Planning Committee Membership

Institutional Role	Institution	Care Setting/Relevant Focus Area
Director of HIV Services for the Emergency Department	NYC Health + Hospitals/Jacobi	ED
Chair, Department of Emergency Medicine	Mount Sinai Medical Center	ED HIV testing, PrEP
Director of the Division of Genetics and Genomics and System Vice Chair for Research in the Department of Obstetrics, Gynecology and Reproductive Science	Icahn School of Medicine at Mount Sinai	OB/GYN
Assistant Professor of Medicine	Montefiore Medical Center	Primary Care, MSM
Director of Adolescent Health	NYC DOHMH	Adolescent and School Health
Medical Director	AIDS Institute, NYSDOH	HIV Prevention
Clinical Lead of HIV Prevention Services	New York-Presbyterian Hospital	Primary Care, Adolescent Health
Attending Physician	NYC Health + Hospitals/Elmhurst	Preventive Medicine Specialist, Sexual Health
Nurse Practitioner and Clinical Coordinator	Columbia University Medical Center	Prenatal Care
Associate Medical Director of Harm Reduction in Healthcare	AIDS Institute, NYSDOH	Drug Treatment, Harm Reduction
Senior Director of Medical Services	Planned Parenthood Federation of America	Family Planning, Sexual Health

Interview guide development and domains

Based on input from the Planning Committee and a review of the PrEP literature, the research team (LJB, JEM, SH, EZF, TGA) developed a semi-structured interview guide to capture perceptions of and experiences with PrEP implementation. We then mapped the guide to CFIR: Outer Setting, Inner Setting, Characteristics of Individuals, Intervention Characteristics, and Process (Supplemental Table 1) to facilitate the analysis into well-known implementation constructs and domains to facilitate generalizability.²⁸ The initial draft of the interview guide was reviewed by the Planning Committee and subsequently revised.

Recruitment

Potential programs and key informants for each were initially identified through the Planning Committee; the initial goal was to recruit 20 participants, representing as broad a diversity of program types as possible. Additional participants were identified through snowball sampling (i.e., asking initial participants to recommend future potential participants).³¹ A research team member (TGA) emailed potential participants to explain the study, invite their participation, obtain agreement, and schedule an interview. We focused initially on NYC-based PrEP programs but expanded nationally to get a broader perspective on different types of programs (e.g., telePrEP) ultimately to integrate the information back to NYC implementers. This study was declared exempt by the three affiliated Institutional Review Boards (Albert Einstein College of Medicine/Montefiore Medical Center, New York State Psychiatric Institute, and NYC DOHMH).

Data Collection

A total of 37 potential key informants were invited to participate in an interview and ultimately 20 participated. Of the 17 that were not interviewed, four declined, six were passive refusals (agreed to interview but did not follow up with scheduling), and seven did not respond at all. Interviews averaging 45 minutes were conducted with 20 participants from 18 PrEP programs, by five research team members (LJB, JEM, SH, EZF, TGA) experienced in qualitative interviewing. In February-March 2020, nine interviews were conducted in-person, and the remaining 11 interviews were conducted virtually between August-November 2020 via HIPAA-compliant Zoom platform due to the COVID-19 pandemic. All but three were audio-recorded and transcribed; two interviewees declined to have their interviews recorded and one interview was not recorded due to technical issues. Interviewer notes from the unrecorded interviews were entered into Microsoft Word immediately after the interview.

Analysis

Interview transcripts were analyzed using template and matrix analysis methods.^32,33 Template analysis involves the development of a coding ‘template’ that summarizes themes identified by the research team as important in a dataset. It is well suited to describe the perspectives of different groups, in our case participants in diverse healthcare settings about PrEP implementation. Methods of template and matrix analysis are part of rapid qualitative approaches that are increasingly used in IS and public health research because of their adaptability and flexibility.^34,35 The summary template captured inductive a priori CFIR domains and constructs as well as themes that emerged deductively from how participants described the implementation of their programs. The template was drafted and piloted by the same five research team members who conducted the interviews. Following template revisions, all 20 interviews were summarized independently by two reviewers; discrepancies were reconciled and the versions were merged into a single summary. The summaries were then combined into a global matrix based on CFIR domains, separated into determinant and strategy for each construct because participants did not distinguish between them in formal IS terms. Analysis of the summaries and quotations within the matrix allowed for the identification of salient patterns of implementation vertically across programs and horizontally across domains and constructs.

Results

PrEP Programs Overview

Of the twenty key informants who participated in the interviews, most were medical providers (n=12: physicians, nurses, and pharmacists), followed by support staff (n=6: navigators and program coordinators), and administrators (n=2: CEOs/Founders). Participants represented 18 unique PrEP programs across the US (Table 2). There was a range of when the programs had been initiated: from 2012, when the US Food and Drug Administration approved PrEP,³⁶ until 2020 right before we began data collection. Three programs were exclusively clinic/hospital-based, of which two were in the ED and one was in an OBGYN service. Some were based in a hospital/clinic (e.g., sexual health, infectious diseases) but also offered home-based testing (n=1) or community services (n=1) or both (n=5). Eight programs offered both community-based or home-based PrEP services that were housed in community health organizations, whereas one was a research project, one was a community pharmacy, and one was an online medical practice. Most were based in New York (n=12). To protect participant confidentiality, we use participant ID number for the quotations and tables.

TABLE 2:

PROGRAM CHARACTERISTICS

Study ID	Program overview	Where (setting)	Who (PrEP providers)	On-site prescription vs. referral/linkage		From where do referrals come?	Funding source	Additional services
1007	OBGYN-led program focused on screening, navigation and delivery of PrEP to pregnant women and women with recent STIs. They are trying to implement universal HIV risk screening and delivery in other departments within the hospitals to capture a broader patient population.	Clinic/hospital-based: OBGYN (screening, navigation, prescription, monitoring, labs)	PrEP Prescription: OBGYN clinic: OBGYNs, midwives; Other departments: infectious disease (ID) specialists, primary care providers (PCPs) Screening: OBGYN clinic: OBGYNs, midwives; Other departments: Medical assistants, nurses Navigator: CHWs in OBGYN and ambulatory care navigate women towards PrEP, do follow ups, keep them engaged, and get HIV-positive partners into care. Social workers assist with insurance/benefits navigation.	On-site prescription	Within the hospital		Service grants: City and State DOH; Federal funding	• Ongoing PrEP care • Rapid HIV testing • Provider PrEP training (from external source) • Social work counselling
1006	Emergency department (ED)-based PrEP screening, navigation and linkage program. Patients are identified for PrEP by a navigator based on indications for HIV risk in the electronic medical record and presenting chief complaints. Eligible and interested patients are referred to the hospital’s ID clinic for PrEP initiation.	Clinic/hospital-based: ED (screening, navigation, referral)	PrEP Prescription: ED physicians do not officially provide PrEP but can under certain circumstances. Screening: PrEP navigator Navigator: PrEP Navigator assists with HIV risk screening, PrEP counselling and education, scheduling appointment with PrEP provider, and linkage navigation.	Referral/linkage to ID clinic within the hospital.	From within the ED		Service grant: Federal funding	• Rapid HIV testing • Provider PrEP training • PEP • HIV education • Linkage to PEP, STD and Hep C treatment
1001	Building on an HIV screening program in an ED using dedicated health educators, patients are offered screening for PrEP and referral if eligible and interested. They are planning more intensive education, counseling, telemedicine, and linkage services in the ED through grant funding. Also plan to implement PrEP screening and delivery in school-based health clinics.	Clinic/hospital-based: ED (screening, referral)	PrEP Prescription: No Screening: Health educator Navigator: Health educator supports referral/linkage navigation.	Referral/linkage (linkage site not specified)	From within the ED		None (Plan to use 340B*	• HIV and Hep C screening and linkage to care
1004	Not a formal program. PrEP was offered by OBGYNs as part of a research study and is now offered by some OBGYNs with the support of a PrEP navigator.	Clinic/hospital-based: OBGYN (screening, referral) Home-based: Telehealth (PrEP navigation)	PrEP Prescription: OBGYN providers can prescribe PrEP, but almost always refer patients to a specialty clinic. Screening: OBGYN providers screened patients using a PrEP screening tool as part of a research study. Navigator: Remote PrEP navigator serving hospital system provides PrEP counselling, education, insurance/benefits navigation and linkage to a provider.	Referral/linkage to the PrEP navigator and/or a specialty clinic within the hospital system.	From within the OBGYN clinics		Research grants: Federal funding	• Provider PrEP training and support (from external source)
1005	Traditional delivery of PrEP in an HIV/ID clinic by ID specialists. The clinic functions as the primary provider of PrEP services in the hospital. Most patients who are identified for HIV risk in other departments get referred to the HIV clinic; however, few patients are successfully linked.	Clinic/hospital-based: HIV clinic (screening, navigation, prescription, monitoring, labs) Community-based: Outreach events (education, counselling)	PrEP Prescription: ID specialists Screening: HIV clinic: ID specialists; Other departments: Providers and navigators Navigator: Community health workers and PrEP navigators within the hospital support benefits/insurance navigation, PrEP counselling, linkage to a social worker and mental health services.	On-site prescription	Providers and PrEP navigators within the hospital (ED, women's health center, primary care), outreach events, self-referral.		Service support: City DOH; Gilead Sciences	• Ongoing PrEP care • Community health workers lead outreach and engagement efforts (e.g., partner notification, adherence support, re-engagement) • Provider training • PEP, HIV/STI treatment
1003/ 1008	Comprehensive, patient-centered delivery of PrEP care in a hospital-based sexual health clinic focused on HIV primary care and prevention for adults and adolescents. The program collaborates with health departments, academic centers, school-based health centers, and community-based organizations (CBOs) to promote PrEP education and coordinated linkage to care.	Clinic/hospital-based: Sexual health clinic (prescription, monitoring, labs) Home-based: Self-sampling (HIV testing); SMS (monitoring) Community-based: School-based health clinic (prescription, monitoring); Outreach events (screening)	PrEP Prescription: A full-time physician (MD) and nurse practitioner (NP) Screening: Care coordinators; Patient navigators Navigators: Care coordinators and patient navigators support outreach efforts, PrEP education, eligibility screening, linkage to care, appointment scheduling, adherence counselling, re-engagement, insurance/benefits navigation.	On-site prescription	Nurses and MDs within the hospital, EDs, urgent care centers, community-based centers, outreach events, self-referral		Research and service grants: City and State DOH; Federal funding; Gilead Sciences	• Ongoing PrEP care • Same-day PrEP • PrEP starter kits • Medication delivery • SMS/text system for reporting/receiving HIV test results and addressing questions • Mental health services • Provider training • PEP, HIV/STI treatment • Provider PrEP training • Walk-in hours
2008	Program utilizes a pharmacy-based PrEP care model and telehealth to increase access to PrEP. The program works closely with health departments, community and academic partners to promote provider and community PrEP education and coordinated linkage to care.	Screening, intake, labs, prescription, monitoring: Clinic/hospital-based: ID clinic Community-based: Pharmacy, CBOs, drop-in centers Home-based: Telehealth	PrEP Prescription: PrEP specialist, ID specialist, NPs, clinical pharmacists. Screening: PrEP navigators Navigator: PrEP navigators complete intake (clinical assessments, sexual history, HIV risk/substance use, insurance status, social determinants, information about labs, linkage to wraparound services). They also provide ongoing assistance with medication coverage, adherence support and re-engage patients in care.	On-site prescription	CBOs, external health facilities, colleges and universities; self-referral		Research and Service grants: Sate DOH, Federal funding; 340B; Academic partnerships	• Ongoing PrEP Care • Labs done at a lab, CBO, pharmacy, the clinic or home using HIV/STI testing kits. A nurse can also be sent to patient’s home to draw blood. • Telekiosks at CBOs for patients who do not have a device or a private area to do telehealth. • Same-day PrEP • Home delivery of medication
2002	PrEP program in a CBO/community health center focused on addressing homelessness and HIV/AIDS using an integrated care delivery and harm reduction model. PrEP initiation and monitoring can be done in-person or remotely using telehealth and home testing kits.	Screening, navigation, prescription, monitoring, labs: Community-based: Community health center Home-based: Telehealth	PrEP Prescription: No centralized provider; all medical providers can prescribe PrEP. Screening: PrEP navigators Navigator: PrEP navigators meet with the clients, provide contract services, benefits/insurance navigation, and PrEP education, assess for sexual health history and social determinants, provide linkage to supportive services, ensure engagement and retention, and do HIV testing.	On-site prescription	Community partners, self-referral		Service grants: Federal funding; State DOH; 340B; community collaborations	• Ongoing PrEP care • Rapid HIV testing • Same-day start; Patients get 30-day prescription before metabolic test results • Provider PrEP training • PEP, HIV/STI treatment • Mental health services
2007	Program using a network of public health facilities to identify and link potential PrEP users to a remote clinical pharmacist for PrEP initiation and monitoring, with the support of PrEP navigators. The program is a collaboration between health departments and academic stakeholders.	Clinic/hospital-based: Public health facilities (screening, HIV testing) Community-based: Public health facilities (screening, HIV testing), Labs Home-based: Telehealth (navigation, prescription, monitoring)	PrEP Prescription: Clinical pharmacists Screening: Nurses, social workers, and health educators at STI clinics, HIV testing programs, and collaborating services programs. Remote clinical pharmacists re-assess individuals for PrEP. Navigator: PrEP navigator provides PrEP counselling and insurance/benefits navigation, coordinates visits and labs, and facilitates communication between participating sites.	On-site prescription	Staff in STI clinics, HIV testing programs, and partnering sites; self-referral		Research grant: State DOH, Federal funding; 340B	• Home delivery of medication • Provider PrEP training
2003	PrEP program primarily focused on screening and linkage/navigation. Individuals who may benefit from PrEP are identified using EMR data on recent STIs within the hospital. A PrEP navigator contacts these patients, offers them a home-testing kit, and navigates them to an on-site PrEP provider via telephone.	Clinic/hospital-based: OBGYN (screening, navigation, prescription, monitoring), labs Community-based: CBOs (screening, HIV testing) Home-based: Telehealth (outreach, navigation, referral, HIV testing)	PrEP Prescription: Midwives, physician assistants (PAs), residents, and attendings Screening: IT team generates a list of women who recently tested positive for STIs throughout the hospital. Patient care technicians, nurses and navigators also screen patients on-site using EMR prompts and at CBOs during outreach events. Navigator: Navigators call women who tested positive for STIs to discuss their recent test, offer them home HIV testing kits, and discuss evidence-based interventions, PrEP and PEP. Interested patients are referred to a prescribing provider for PrEP. Navigators follow up with patients to check in on side-effects and whether they picked up the medication. Navigators also link women to wraparound services.	On-site prescription	Program navigators; Other departments within the hospital (e.g., ED); CBOs		Service grants: City and State DOH, Federal funding	• Ongoing PrEP care • Rapid HIV testing • Provider PrEP training (from external source) • Walk in hours • Translation services
1002	Delivery of PrEP navigation and care in a hospital-affiliated community health center through PCPs and a PrEP navigator. PrEP services were built into an existing integrated HIV/AIDS and primary care program.	Community-based: Community-based health clinic (screening, prescription, monitoring), labs Home-based: Telehealth (PrEP navigation)	PrEP Prescription: PCPs Screening: PrEP navigator; Patient educator Navigator: PrEP navigator conducts chart reviews to see if PrEP was discussed with patients diagnosed with STIs. If not, they reach out to the provider and encourage them to consider PrEP for their patient. They also contact patients who were prescribed PrEP, with their providers' permission, to provide assistance and support with initiation and continuation (e.g., education, insurance navigation).	On-site prescription	Other providers within the clinic and hospital system, self-referral		Built into existing grant-funded programs supported by City and State DOH and Federal funding	• Ongoing PrEP care • Alternative dosing schedules • Provider PrEP training
2001	Comprehensive, patient-centered PrEP delivery in a hospital-affiliated, community-based sexual health clinic through telehealth and in-person services.	Screening, navigation, prescription, monitoring, labs: Community-based: Sexual health clinic Home-based: Telehealth	PrEP Prescription: ID-trained providers (PAs, NPs, attendings, OBGYNs) Screening: In-person visit: A nurse conducts brief eligibility screening to patients at triage. In-person and telehealth visit: Patients meet with the medical provider who does a full health and sexual history. Navigator: Peer workers and patient educators/navigators provide insurance/benefits navigation, adherence and retention support, and linkage to mental health services. For telehealth visits, they help patients obtain and complete home HIV test kits, report their results, and schedule televisits with the provider.	On-site prescription	Community partners, affilitated hospital system, self-referral		Service and research grants: City and State DOH; Federal funding	• Ongoing PrEP care • 24-hour pharmacy • PEP, HIV/STI treatment • Provider PrEP training
2004	Research study designed to promote access to PrEP and adherence among young MSM and TGW using telehealth without the need for in-person labs. The study is a collaboration between a medical provider and a non-profit focused on leveraging technology to promote young people's health and wellness.	Community-based: In-person labs (optional) Home-based: Telehealth (screening, navigation, prescription, labs monitoring)	PrEP Prescription: ID specialist (study physician) Screening: Self-assessment on study website, then by study physician during televisit. Navigator: Program Coordinator navigates individuals who are not enrolled in the PrEP Arm to a provider as standard of care (SOC), as well as individuals enrolled into the PrEP Arm for continuation of care after the study has ended. They also support insurance/benefits navigation during the linkage process.	On-site prescription (PrEP Arm) Referral/linkage to a provider within the program's community network for PrEP initiation (SOC Arm) or continuation (PrEP Arm).	Self-referral after learning about the study through advertisements on dating apps and LGBTQ-friendly venues and word-of-mouth		Research grants: Federal funding; Gilead Sciences	• Participants can opt-in to no in-person lab visits using a home lab service. • Asynchronous visits can be done with NPs or PAs. • Online pharmacy ships PrEP to participants' homes. • Customizable appointment and adherence reminders via SMS or email.
2010	Comprehensive, patient-centered delivery of PrEP services in a community health center with an on-site pharmacy. The program aims to optimize access to care through task-shifting, peer navigators and telehealth solutions.	Community-based: Community health center, pharmacy (screening, navigation, prescription, monitoring, labs); CBOs, schools (screening, linkage/referral) Home-based: Telehealth (Screening, navigation, prescription, monitoring, labs)	PrEP Prescription: All specialties (NPs, MDs, pharmacists, OBGYN, pediatricians) can prescribe in-person or remotely. Screening: Peer-like prevention navigators Navigator: Peer-like prevention navigators meet with all patients for every visit prior to meeting with the medical provider, either in-clinic or through videoconference. They talk to patients about their sexual history and HIV risk, provide adherence education, support insurance/benefits navigation, and link patients to wraparound services.	On-site prescription	Within the institution, CBOs, schools/universities, outreach via dating apps, self-referral		Service and research grants: State DOH; Federal funding; 340B program	• Ongoing PrEP care • On-site despensing of medication • Longer PrEP refills • Home testing kits • Home delivery of medication • Rapid HIV test • Extended operating hours • Same day PrEP • Nurses can conduct asynchronous visits • PEP, HIV/STI treatment • Mental health services
2009	Delivery of PrEP in a LGBTQ community health center where HIV counselors provide on-site care and PrEP is prescribed via telemedicine by a remote PrEP specialist. Patients can complete follow-up visits with a pharmacist.	Community-based: Community health clinic, pharmacy, CBOs (screening, labs) Home-based: Telehealth (prescription, monitoring)	PrEP Prescription: PrEP specialists (MD, PA, NP) Screening: HIV counselors Navigator: HIV counsellors assist with insurance/benefits navigation. At 6 months, they navigate patients to a PCP for long-term care.	On-site prescription	CBOs, self-referral		Service and research grants: State DOH; Federal funding; 340B	• Ongoing PrEP Care • SMS support • Rapid HIV test • Same-day PrEP • Walk-in; extended operating hours • Mental health services
2011	Pharmacist-initiated PrEP program in a community-based pharmacy. Clinical pharmacists provide end-to-end PrEP care to patients either on-site and/or using telemedicine.	Screening, intake, labs, prescription, monitoring: Community-based: Pharmacy Home-based: Telehealth	PrEP Prescription: Clinical pharmacist Screening: Clinical pharmacist Navigator: Pharmacy technician assists with insurance/benefits navigation	On-site prescription; however, patients are encouraged to establish care with a PCP after one year in the program.	Self-referral, affilitated clinic		Institution-funded; medical billing	• Clinical pharmacists provide PrEP counselling, education, adherence support • Labs can be done by the pharmacist, at a local lab, or via self-sampling using a home-testing kit. • Walk-in hours • Same-day PrEP • On-site PrEP despensing • Home delivery of medication
2005	For-profit telehealth platform that offers primary care services, including PrEP, to individuals in the U.S.	Community-based: In-person labs (optional) Home-based: Telehealth (screening, navigation, prescription, monitoring, labs)	PrEP Prescription: All clinicians can prescribe PrEP (Internal medicine, family medicine, primary care specialties) Screening: Patients complete a sexual health questionnaire online before their scheduled appointment with a physician. Physicians re-assess patients for eligibility at time of visit. Navigator: PrEP coordinator, care navigation services, insurance/benefits support	On-site prescription	Self-referral after learning about the service through online advertisements, social media, and television commercials		Medical billing	• Ongoing PrEP care • Adherence support via SMS • PrEP counselling • Home-testing • Mental health services
2006	Online, chat-based PrEP navigation service offering PrEP information and linkage/referrals to PrEP services.	Home-based: Online (PrEP navigation)	PrEP Prescription: No Screening: No Navigator: Visitors connected with a navigator through an online chat platform. During the chat, a navigator helped locate PrEP services (e.g., prescribing providers), offered links to HIV-prevention resources, and provided support with insurance/benefits navigation. Visitors could opt-in to be contacted by a navigator to ensure successful linkage to care and payment program enrollment.	Referral/linkage to a PrEP prescribing provider listed on the provider directory.	Self-referral after learning about the program online or from community agencies		Research and service grants: State DOH, Federal funding; community partners	Visitors from a variety of communities (patients, providers, navigators, investigators) could self-navigate through the website to find information on PrEP-related topics.

^*340B Drug Pricing Program offers hospitals and healthcare organizations with a large share of uninsured and low-income patients access to discounts on outpatient drugs, increasing the profitability of drug administration

Characterizing the Complexity of PrEP Implementation

Our analysis found that participants spoke of barriers and strategies flexibly, not identifying them specifically as either, and conceptualized them in terms inextricable from their specific context. Study participants mentioned concepts that we have categorized into contructs across all five CFIR domains (Inner Setting, Outer Setting, Intervention Characteristics, Characteristics of Individuals, and Process) either as a barrier or a strategy used in implementing PrEP. We have provided representative examples from all five CFIR domains in Table 3. We highlight below a few examples that demonstrate the complexity of PrEP implementation as well as highlight constructs that participants identified most often as critical to the implementation of PrEP in their contexts.

Table 3.

Representative Responses for a sample of CFIR Domains as Determinants and Strategies

CFIR Domain	Sample CFIR Constructs	Representative Responses
		Determinants	Strategies
Intervention Characteristics	Adaptability	“it’s pretty slow ‘cause most-- when they’re doing PrEP they have them come in the testing. I think we lose patients with the testing piece over and over again, meaning they don’t want to come in every three months. How do you render them still being HIV negative? It’s a dilemma. I think that’s where we lose them. You may have the person pick up the prescription for the first month, second month, third month, but the minute that prescription needs to be refilled, you get lost. I think there should be a whole study on that, but that’s just me. I think that deliverable there is a problem.” (2003)	And then, as part of primary care, we have built into our EHR records a sexual health assessment as well that gets done. It gets done for someone who’s there for Suboxone or for PrEP or for HIV. It’s just part of our standard practice, and that’s done at comps and initial appointments. (2002)
Outer Setting	Patient Needs and Resources	But we have found that clients are really-- the lab completion rate has plummeted very, very, very, very low. Clients to varying degrees of success, depending on how tech savvy they are, have largely been successful in completing clinical visits via telemedicine, but they are not going to LabCorp to get their labs done. (2002)	“Everybody really wanted me to do this, and we did a survey at that point of the community, and the community overwhelmingly wanted to be community-based. I based that research clinic there, and then once DOH offered it, it was everybody wanted to keep it there at the community.” (2009)
	External Policies and Incentives	I was hoping to - I don’t know if you’re familiar with NURX… they have like a home test kit. It comes to your house, you do your stuff, you pass it, you never have to leave your house. So, of course I wanted to make something very similar to that, but there were regulations in [our] state that forbid a lot of those testing at home. (2010)	if you really think about it, we’re just trying to get more from the grant perspective, because we’re driven by numbers, right. Like the DOH wants to see numbers, and so we’re trying to get numbers. So if our ED isn’t giving us the numbers then we need to go outside and expand. (1006)
Inner Setting	Networks and Communications	“So they’re not excited about talking about sex. They’re also not excited about advertising in a way that would recruit the right people.” (1003)	“I mean, it’s consistent, concerted communication with the director of the ED. It’s with knowing people down there. We’ve had a number of our nurses who have rotated through the ED or have actually gone to work full-time in the ED, and really being like, ‘Hey, talk to your people about this’”(1008)
	Leadership Engagement (under Readiness for Implementation)	“It really does start at the top that this is a commitment that the agency is making across the board. It’s not solely my responsibility or the executive director’s responsibility. It’s the responsibility of all of the staff members to reach that.” (2002)	“leadership supports our service. They think it’s a good public health impact… leadership that was supportive of our endeavors, that helped us troubleshoot barriers.” (2011)
Characteristics of Individuals	Personal Attributes (e.g., motivation, values, competence, capacity)	“But I think a lot of it is the people who are going to be good in the role are flexibility, you have to be flexible. You have to be comfortable with the unknowns,” especially given that patients don’t always follow the rules.” (2007)	“The bigger point of the staffing, that’s really what makes program successful is diversifying your staff to the point that they’re individuals of the community. They speak the languages. They understand things that are going on and also, that they care. I think that’s the big thing, too, is that they understand that we’ve been through a generation of seeing people being lost from AIDS and HIV. We now have the tools and the methods to prevent it…”(2001)
Process	Engaging	“People were pretty receptive, a little skeptical, a little skeptical in primary care, but not too - not for long” (1007)	“…we’re doing what we call TIYCHD, pushing for Trauma-Informed Youth-Centered Health Design, and those are projects where we go out and work with young people, and we help them use design research to identify issues that they want to address in their communities, and then come up with technology-based solutions.” (2004)

CFIR Domain: Inner Setting, Construct: Implementation Climate

Given the contextual specificity of implementation, implementation climate (CFIR Inner Setting) which encompasses concepts like tension for change, compatibility, and relative priority, was one of the most important constructs identified by partipants both as a determinant and a strategy. As a contextual determinant, participants mentioned lack of organizational readiness for change, organizational culture, and a climate of resistance to providing services focused on populations more highly affected by the HIV epidemic. Implementation climate was discussed both as a positive and a negative. Climate and organizational culture could be a barrier when it was not conducive to prioritizing PrEP.

Clinicians in these settings feel overburdened with the many medical needs and additional screenings they must address; HIV may not seem like a priority when diseases like diabetes, hypertension and heart disease are much more prevalent, even though the Bronx is a high HIV incidence area. (1002)

In contrast, another participant described a receptive organizational environment in which PrEP scale-up was aligned with the core mission of the organization.

So PrEP just was in line with that [institutional mission] when that [PrEP] became a biomedical intervention. So that wasn’t really like a huge discussion -- where I know that is different at other organizations. This is just really true to what our core mission is. So as going forward, we are constantly looking at ways to expand PrEP. (2009)

When participants talked about strategies that addressed implementation climate, they emphasized the need to engage stakeholders across multiple levels of the organization. Strategies included identifying and preparing champions, organizing team meetings, and informing local opinion leaders.²⁵ Some programs succeeded in overcoming their inner setting barriers because they had a PrEP champion; a respected clinical leader such as a nurse, physician, pharmacist, or division/department head, who persistently advocated for the integration of PrEP services and needed resources such as clinical space and staff.

I mean he [Head of Department] had our back regardless of what institutional things we were going for… Like he’s had that conversation a hundred times in different ways and they know that… but having his support, I mean- I wouldn’t have been able to do any of this without that. (1003)

Another approach often mentioned was knowing and understanding the strengths of their own setting and leveraging existing infrastructure built by previously successful initiatives. One program described “scaffolding” PrEP services onto an existing network of HIV care clinicians in neighborhood-based facilities. Another program described their experience in introducing HIV and hepatitis C testing as precedent and structure for including PrEP services. Other programs had a navigator workflow protocol in place for other programs (e.g., colon cancer screening) that was easily transferrable to include PrEP, or had peer navigators who provided adherence support, helped patients enroll in assistance programs, and mitigated challenges to wraparound services.

CFIR Domain:Characteristics of Individuals, Construct: Knowledge and Beliefs about the Intervention

Many interviewees identified individuals’ knowledge and beliefs about the intervention as a critical determinant. This applied both when they could take advantage of willingness and when they faced challenges with clinical providers feeling uncomfortable with or unprepared to have PrEP discussions with their patients. Reasons for this reluctance included lack of knowledge about how to determine PrEP eligibility and manage patients on PrEP, risk aversion to potential side effects of the medications, and stigma or discomfort with sexual health conversations. Interviewees mentioned the “purview paradox”³⁷ to describe clinicians’ conflicting views over which medical specialty should provide PrEP.²⁰

I think when you talk to primary care clinicians in areas where there’s high levels of HIV I think that purview paradox is less of an issue. But then when you go to places where there’s much lower rates of HIV I think it becomes much more of an issue. It’s like, ‘Oh, that’s not what I do or what I’m supposed to do; that’s ID people’. (1002)

Implementation strategies participants used to address providers’ lack of knowledge about or belief in PrEP included initial and ongoing PrEP education for providers and staff and modifying the electronic medical record (EMR) to include information on PrEP screening, required lab tests, and dosing.

You can sort of push people to use the PrEP/HIV risk assessment templates. If patient answers ‘yes’ to basic screen question, it triggers a question about about their last 3 days of risk in the provider note… the provider can’t close their note without asking the question.” (1007)

Other programs used context-specific implementation strategies, such as creating new clinical teams with a focus on racial, ethnic, and sexual and gender identity diversity representing the community they served.

…the bigger point of the staffing, that’s really what makes program successful is diversifying your staff to the point that they’re individuals of the community. They speak the languages. They understand things that are going on and also, that they care…(2001)

Regardless of how they described their local providers’ and staff’s knowledge and beliefs about PrEP, most participants recognized that ensuring buy-in from organizational and community stakeholders was critical to successful implementation of PrEP.

CFIR Domain: Intervention Characteritics, Construct: Cost

A third common determinant identified as critical to PrEP program implementation was the cost, and topics mentioned ranged from personnel costs to other types of resource use including professional development training, care coordination services, to insurance coverage for medications and laboratory tests.

Implementing… the barriers would be: are there resources in the facility for that? Is there a budget for that? That’s real. Is there a budget for somebody full-time to pay them forty-five thousand dollars a year, which is at cheap costs and labor, and give them benefits to actually be willing to do this work with patients?” (2003)

Most programs, however, discussed the cost of PrEP program implementation in terms of the strategies they had used to overcome what was often an implicit barrier. Some participants described advocating to their organization that provision of PrEP services (i.e., prescribing, associated labs, and navigation work) would yield a return on investment, such as increased patient engagement and retention, insurance reimbursement for visits, and use of their pharmacy.

We did want to figure out a business model of sustainability, the cost that you get off the medications can that be used for more services in the context of not having 340B, 318 designation or other funding mechanisms, because the academic center wasn’t built like that… over time, we could argue when you have 300 patients that we now need X, Y, and Z, but before it was very difficult to get anything HIV prevention. (2008)

Most programs accessed new funding as a strategy to initiate PrEP implementation, and often combined multiple funding sources to cover the range of PrEP services offered. Some reached out to other departments and resources in their hospital and some hired benefits navigators and care coordinators to help uninsured individuals enrolled in Medicaid, which reimburses PrEP services in some states. Others identified non-grant revenue streams through the 340B drug pricing initiative,³⁸ which can result in significant income for the organization through the purchase of discounted drugs and subsequent pharmacy rebates. Other programs earned revenue through continued use of services by those patients initially referred to the organization for PrEP and through insurance reimbursement for PrEP-related visits.

Discussion

Our findings illustrate the complexity of PrEP program implementation; barriers are multi-level and dynamic (i.e., varying in difficulty to overcome over time) and implementation strategies appear to be often ad hoc, not chosen to address specific contextual barriers but based on available resources. These relationships are made more complex to identify and characterize because multiple strategies are often used to address a single barrier and one strategy might serve to overcome more than one barrier.²⁷ Participants described facilitators in a different way, characterizing the approach they used to provide PrEP services as building on organizational strength and/or successful precedents. The shifting ways participants discussed determinants highlighted the fluidity with which they thought about context as intrinsic to their implementation, not conceptually divided into determinants and strategies as in formal IS.³⁹

Participants described a great diversity in the PrEP programs’ responses to the common determinants such as funding, implementation climate, and challenges specific to PrEP as an evidence-based intervention. Participants described aligning PrEP service provision with organizational mission and goals, sometimes as a determinant, sometimes as a pre-existing strategy that they leveraged. A common strategy addressing implementation climate were champions who were passionate about PrEP access and delivery and advocated in the face of evolving barriers within and across their own organizations to provide PrEP services.

Successful introduction of program innovations requires an infrastructure and understanding of how the specific organization enacts change. This includes awareness of who makes program decisions in the organization; competing priorities; shared agendas that can leverage change; and leadership who can advocate for the program. Another frequently reported determinant was providers’ knowledge and beliefs about PrEP.⁴⁰ Challenges with changing provider behavior are not specific to PrEP; similar issues have been addressed across healthcare delivery, including in diabetes, asthma, sepsis, cancer screening, and many other areas of healthcare.^41–45 Participants leveraged strategies such as finding partnerships, funding strategies, and sustainability approaches that addressed multiple barriers and were specific to their context. These included state law and local Department of Health support, engagement of partners who shared interest in implementing PrEP, and identification of existing infrastructure and programs that might provide a platform for adding PrEP services.

Participants’ programs addressed barriers by building on the specific strengths of their own setting, particularly existing infrastructure and organization of services that allowed integration of PrEP services. The strategies they described align with many of the 73 implementation strategies defined by Powell and colleagues in 2015²⁵ and support the findings of the mapping of strategies to determinants done with the CFIR-ERIC matching work.²⁷ Our in situ research of real world implementation confirms it is possible to use IS theories and methods pragmatically without requiring participants to be aware of the academic underpinings. The complexity of implementation itself, but also of the way people talk and think about implementation, highlight the need to translate IS into real-world settings. Implementation science needs these distinctions in order to move the field forward so that research findings are generalizable and consistent, but future work could focus on how to translate the findings of IS back into the field to inform real-time change.

Limitations

Our study has described only self-reported perceptions of determinants and implementation strategies; there was no formal testing of associations and effectiveness. There were also no community member respresentatives on the Planning Committee who could have offered important insights for the study, especially in the interpretation of findings. Additionally, future PrEP implementers may benefit from analyses based on the seven dimensions identified by Proctor et al: actor, the action, action targets, temporality, dose, implementation outcomes addressed, and theoretical justification.⁴⁶ Additional details on factors associated with PrEP program success could also be useful for implementers, including those that could be explored through quantative analyses (e.g., how long the programs had been implementing PrEP). Lastly, these findings may not be generalizable outside the US or NYC context, given the below 50% response rate.

Conclusion

Our work has sought to identify patterns in PrEP program implementation, describing how organizations dealt with determinants in their own context, despite having little guidance on navigating evidence-based implementation strategies, mechanisms, and outcomes. More research is needed to test and demonstrate effectiveness of single and multiple strategies that address PrEP- and context-specific determinants, using methods like concept mapping, group model building, conjoint analysis, and intervention mapping in pragmatic implementation work.^47,48 Implementation science is a scientific field like any other; it is useful to describe and understand the subject of interest – in this case the implementation of PrEP as an evidence-based practice and innovations into real-world setttings.

• Evidence-based innovation: Pre-exposure prophylaxis

• Innovation recipients: People at risk for HIV

• Setting: Clinics, hospitals, and online programs that have implemented PrEP

• Implementation gap: Significant, persistent racial/ethnic, gender, and sexual identity inequities in PrEP uptake

• Primary research goal: Translate real-world descriptions of PrEP implementation into implementation constructs in order to identify patterns across settings that could eventually inform the pragmatic implementation of PrEP programs in the future.