From Tanzania to Washington, DC: Application of the Consolidated Framework for Implementation Research and ADAPT-ITT Model to Guide the Development of a Community-Based PrEP Intervention for Black Adults.

HIV testing/counseling is a critical point during which non-clinical staff could intervene, discuss and/or refer clients for pre-exposure prophylaxis (PrEP). This analysis investigated the contextual factors affecting PrEP implementation within HIV testing sites. Two generalized linear mixed models were conducted to estimate PrEP implementation as a function of constructs from the Consolidated Framework for Implementation Research (CFIR). Qualitative interviews were analyzed thematically. Data integration occurred via joint analysis and triangulation. Constructs from the CFIR domain Characteristics of Individuals did not predict PrEP implementation when controlling for demographic characteristics; qualitative data signaled divergent findings in PrEP knowledge. Within the CFIR domains Inner and Outer Settings, relevant priority and available resources predicted PrEP implementation; qualitative data confirmed the importance of available resources and provided insight into the impact of cosmopolitanism and leadership. Addressing the contextual factors that affect PrEP implementation may help HIV testing staff to better implement PrEP programs.

Black cisgender women (hereafter referred to as "women") experience one of the highest incidences of HIV among all populations in the United States. Pre-exposure prophylaxis (PrEP) is an effective biomedical HIV prevention option, but uptake among women is low. Despite tailored strategies for certain populations, including men who have sex with men and transgender women, Black women are frequently overlooked in HIV prevention efforts. Strategies to increase PrEP awareness and use among Black women are needed at multiple levels (ie, community, system or clinic, provider, and individual or patient). This study aimed to identify barriers and facilitators to PrEP uptake and persistence among Black cisgender women and to map implementation strategies to identified barriers using the CFIR (Consolidated Framework for Implementation Research)-ERIC (Expert Recommendations for Implementing Change) Implementation Strategy Matching Tool. We conducted a secondary analysis of previous qualitative studies completed by a multidisciplinary team of HIV physicians, implementation scientists, and epidemiologists. Studies involved focus groups and interviews with medical providers and women at a federally qualified health center in Chicago, Illinois. Implementation science frameworks such as the CFIR were used to investigate determinants of PrEP use among Black women. In this secondary analysis, data from 45 total transcripts were analyzed. We identified barriers and facilitators to PrEP uptake and persistence among cisgender women across each CFIR domain. The CFIR-ERIC Implementation Strategy Matching Tool was used to map appropriate implementation strategies to address barriers and increase PrEP uptake among Black women. Barriers to PrEP uptake were identified across the CFIR domains. Barriers included being unaware that PrEP was available (characteristics of individuals), worrying about side effects and impacts on fertility and pregnancy (intervention characteristics), and being unsure about how to pay for PrEP (outer setting). Providers identified lack of training (characteristics of individuals), need for additional clinical support for PrEP protocols (inner setting), and need for practicing discussions about PrEP with women (intervention characteristics). ERIC mapping resulted in 5 distinct implementation strategies to address barriers and improve PrEP uptake: patient education, provider training, PrEP navigation, clinical champions, and electronic medical record optimization. Evidence-based implementation strategies that address individual, provider, and clinic factors are needed to engage women in the PrEP care continuum. Tailoring implementation strategies to address identified barriers increases the probability of successfully improving PrEP uptake. Our results provide an overview of a comprehensive, multilevel implementation strategy (ie, "POWER Up") to improve PrEP uptake among women. RR2-10.1371/journal.pone.0285858.

Applying CFIR to assess multi-level barriers to PrEP delivery in rural South Africa: Processes, gaps and opportunities for service delivery of current and future PrEP modalities

IntroductionAcross sub-Saharan Africa, ministries of health have proposed integrating pre-exposure prophylaxis (PrEP) for HIV prevention into family planning (FP) services to reach adolescent girls and young women (AGYW); however, evidence on effective implementation strategies is still limited. We conducted a qualitative study of integrated PrEP-FP service implementation at two FP clinics in Kisumu, Kenya.MethodsFrom June 2017 to May 2020, the Prevention Options for Women Evaluation Research (POWER) study enrolled 1000 sexually active, HIV-negative AGYW age 16 to 25. Actions taken to implement PrEP were captured prospectively in 214 monitoring and evaluation documents and 15 interviews with PrEP implementers. We analysed data using conventional and directed content analysis, with the latter informed by the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation.ResultsPOWER deployed a variety of implementation strategies to train and educate stakeholders (e.g., having new providers shadow PrEP providers); develop stakeholder interrelationships (e.g., organizing support teams with protected time to reflect on implementation progress and make refinements); provide technical assistance; and change physical infrastructure and workflow. Although these strategies reportedly influenced contextual factors across four of the five CFIR domains, they primarily interacted with contextual factors relevant to inner setting, especially implementation climate and readiness for implementation. Overall, implementing PrEP proved easier and less labor-intensive at a private, youth-friendly clinic than a public FP clinic, largely because the baseline structural characteristics (e.g., space, workflow) and organizational mission of the former were more conducive to offering AGYW-centered care. Nevertheless, adoption of PrEP delivery among non-study staff at both sites was low, likely due to the widespread perception that PrEP was not within their scope of work.ConclusionsSome FP clinics may be “lower-hanging fruit” than others for PrEP implementation. Approaching PrEP implementation as a behavioral intervention for FP providers may help ensure that providers have the requisite capability, opportunity, and motivation to adopt the clinical innovation. In particular, PrEP implementers should assess the need for implementation strategies that support providers’ clinical decision-making, establish worker expectations and accountability, and address workload constraints.Trial registrationClinical Trial Number: NCT03490058.

Background: Innovative interventions, such as social media platforms and telemedicine, were implemented during the COVID-19 lockdown period for HIV prevention and treatment services. However, limited studies have reported on the facilitators and barriers of these innovations for HIV pre-exposure prophylaxis (PrEP) service continuity. Therefore, this study aimed to identify the barriers and facilitators of the implemented PrEP innovative interventions during COVID-19 among adolescent girls and young women (AGYW). Methods: A qualitative exploratory design was used to conduct semi-structured interviews with twelve stakeholders in the Dr Kenneth Kaunda District, North West Province of South Africa. Participants included various TB HIV Care programme stakeholders, comprising professional nurses, case managers, peer educators, and counsellors. The Consolidated Framework for Implementation Research (CFIR) 2.0 domains and constructs guided the interview questions and the analysis process. Additionally, all interviews were audio-taped, transcribed verbatim, and analyzed through thematic analysis. The facilitators and barriers of the PrEP innovative interventions were categorized according to the five CFIR domains. Results: The findings showed that despite the COVID-19 disruptions in healthcare services, the implemented innovative PrEP interventions enhanced the HIV prevention services. Facilitators included sufficient mobile data, teamwork, clear communication from managers, resilience, and existing media pages that supported social media-based PrEP service continuity. The implementation barriers included service users’ lack of cell phone devices, incorrect personal information, fear of contracting COVID-19, and limited individual movements. Conclusion: Social media and digital technologies played a crucial role in the continuation of HIV PrEP services among AGYW. These evaluations also illustrated the potential of social media platforms to be leveraged for HIV service delivery during periods of disruption, such as the COVID-19 lockdown period, for HIV service delivery. Furthermore, lessons learned from this study are significant and offer practical considerations for sustaining PrEP during service disruptions.

BackgroundTitle X-funded family planning clinics have been identified as optimal sites for delivery of pre-exposure prophylaxis (PrEP) for HIV prevention. However, PrEP has not been widely integrated into family planning services, especially in the Southern US, and data suggest there may be significant implementation challenges in this setting. Because Title X clinics vary greatly in provider-, organizational-, and systems-level characteristics, there is likely variation in capacity to implement PrEP across clinics.MethodsWe conducted a survey from February to June 2018 among providers and administrators of non-PrEP-providing Title X-funded clinics across 18 southern states. Survey items were designed using the Consolidated Framework for Implementation Research (CFIR) to assess constructs relevant to PrEP implementation. To explore the heterogeneity of CFIR-related implementation determinants and identify distinct sub-groups of Title X clinics, a latent profile analysis was conducted using nine CFIR constructs: complexity, relative advantage, cost, attitudes, implementation climate, compatibility, leadership engagement, available resources, and cosmopolitanism. We then conducted a multi-level analysis (accounting for nesting of participants within clinics) to test whether group membership was associated with readiness for implementation of PrEP, controlling for key sociodemographic characteristics.ResultsFour hundred and fourteen healthcare providers/administrators from 227 non-PrEP-providing Title X clinics participated in the study. We identified six sub-groups of clinics that each had distinct patterns of PrEP implementation determinants. Clinic sub-groups included “Highest Capacity for Implementation”, “Favorable Conditions for Implementation”, “Mixed Implementation Context”, “Neutral Implementation Context”, “Incompatible Setting for Implementation”, and “Resource-Strained Setting”. Group membership was related to numerous provider-level (i.e., ability to prescribe medication) and clinic-level (i.e., provision of primary care) characteristics. In comparison to the “Neutral” group (which held neutral perceptions across the implementation determinants), the “Highest Capacity” and “Favorable Conditions” groups had significantly higher levels of implementation readiness, and the “Resource-Strained” group had a significantly lower level of implementation readiness.ConclusionsLatent profile analyses can help researchers understand how implementation readiness varies across healthcare settings, promoting tailoring of implementation strategies to unique contexts.

HIV test counselors are well positioned to refer individuals to pre-exposure prophylaxis (PrEP) and behavioral health treatments. HIV test counselors in Miami-Dade County (N = 20), a priority jurisdiction for Ending the HIV Epidemic, completed interviews to assess determinants of PrEP and behavioral health treatment referrals. To identify determinants, we used a rapid deductive qualitative analysis approach and the Consolidated Framework for Implementation Research (CFIR). Identified determinants sometimes served as facilitators (e.g., relative priority, leadership importance) and sometimes as barriers (e.g., lack of access to knowledge and information, available resources for referrals) to making referrals. We also observed differences in determinants between PrEP and behavioral health referrals. For example, complexity (perceived difficulty of the referral) was a barrier to behavioral health more often than PrEP referral. Our findings suggest that determinants across many CFIR domains affect referral implementation, and the corresponding need for multiple implementation strategies to improve implementation of PrEP and behavioral health referrals in the context of HIV testing.

BackgroundPre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but disparities in PrEP access remain considerable, particularly among Black and Latino men who have sex with men (MSM). To address this, the University of Miami Mobile PrEP Program was created, offering mobile HIV prevention/PrEP services in areas throughout South Florida where HIV incidence is high and PrEP access is geographically limited. Using a community-centered participatory approach, the program strategized and executed expansion into the Liberty City neighborhood of Miami. This study qualitatively assessed factors affecting Mobile PrEP implementation as perceived by community stakeholders, clients, and program staff.MethodsForty-one in-depth interviews were conducted with 21 Mobile PrEP clients, 10 key informants from local health organizations, and 10 program staff. Interview questions queried perceived organizational and positional barriers and facilitators to mobile clinic implementation. Service satisfaction, setting preferences, social factors, and likelihood of recommending Mobile PrEP were also assessed. A thematic content analysis was performed using the Consolidated Framework for Implementation Research (CFIR) taxonomy as the guiding constructs for the analysis.ResultsParticipant statements indicated that providing no-cost services, convenient location, program-covered rideshares, individualized patient navigation, and a community-centric approach to patient care, which included staff members with shared lived experiences to increase positive interactions and renewed trust among poorly served communities, were facilitators of PrEP access and intervention uptake. The importance of program familiarization with the community before implementation, particularly for Black and African American communities, who may experience unique barriers to accessing sexual healthcare was strongly emphasized by participants.ConclusionsThe Mobile PrEP intervention was found to be an acceptable and accessible mode of HIV/STI preventive care. The importance of pre-implementation community engagement and preparation is emphasized. Future research is needed to refine understanding of the intervention’s components and evaluate implementation determinants in other highly impacted neighborhoods.

BackgroundPre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but disparities in PrEP access remain considerable, particularly among Black and Latino men who have sex with men (MSM). To address this, the University of Miami Mobile PrEP Program was created, offering mobile HIV prevention/PrEP services in areas throughout South Florida where HIV incidence is high and PrEP access is geographically limited. Using a community-centered participatory approach, the program strategized and executed expansion into the Liberty City neighborhood of Miami. This study qualitatively assessed factors affecting Mobile PrEP implementation as perceived by community stakeholders, clients, and program staff.MethodsForty-one in-depth interviews were conducted with 21 Mobile PrEP clients, 10 key informants from local health organizations, and 10 program staff. Interview questions queried perceived organizational and positional barriers and facilitators to mobile clinic implementation. Service satisfaction, setting preferences, social factors, and likelihood of recommending Mobile PrEP were also assessed. A thematic content analysis was performed using the Consolidated Framework for Implementation Research (CFIR) taxonomy as the guiding constructs for the analysis.ResultsParticipant statements indicated that providing no-cost services, convenient location, program-covered rideshares, individualized patient navigation, and a community-centric approach to patient care, which included staff members with shared lived experiences to increase positive interactions and renewed trust among poorly served communities, were facilitators of PrEP access and intervention uptake. The importance of program familiarization with the community before implementation, particularly for Black and African American communities, who may experience unique barriers to accessing sexual healthcare was strongly emphasized by participants.ConclusionsThe Mobile PrEP intervention was found to be an acceptable and accessible mode of HIV/STI preventive care. The importance of pre-implementation community engagement and preparation is emphasized. Future research is needed to refine understanding of the intervention’s components and evaluate implementation determinants in other highly impacted neighborhoods.

New modalities of Pre-exposure Prophylaxis (PrEP) such as long-acting injectable PrEP (LAI-PrEP) promise increased prevention of HIV transmission; however, similar biomedical interventions have not been met with universal adoption by healthcare providers or populations most affected by HIV. This qualitative study explores healthcare provider considerations for the rollout of LAI-PrEP. Eleven key-informant in-depth interviews were conducted with clinicians who prescribe daily oral PrEP. Participants reviewed a currently proposed LAI regimen and were asked to reflect on its implications for their clinical practice. Interviews were transcribed verbatim and thematically coded, with results organized using the Consolidated Framework for Implementation Research (CFIR). All participants expressed interest in prescribing LAI-PrEP and anticipated that at least some patients would be interested. Participants identified characteristics of the intervention, inner intervention setting, and outer intervention setting that will be influential in bringing LAI-PrEP to scale. Clinicians in the South have unique insights into the challenges of and opportunities for successful rollout of future PrEP regimens. Bringing these insights into a CFIR framework highlights the nuances surrounding LAI-PrEP, including structural concerns such as cost barriers and access to in-person healthcare services. It is critical to address these challenges to ensure successful implementation of new PrEP formulations.

For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers. We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR). From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff. Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

Among the estimated 12,500 new HIV infections in Malawi among people aged 15-24 each year, 70 percent occur in Adolescent Girls and Young Women (AGYW). The Ministry of Health (MoH) in Malawi rolled out an oral Pre-Exposure Prophylaxis (PrEP) prevention program targeting populations at elevated risk of HIV acquisition, including AGYW, in 2021. Since PrEP roll-out, there has been limited research exploring the factors that influence uptake of PrEP among AGYW. This study explored the barriers and facilitators to the uptake of PrEP among AGYW at elevated risk of HIV acquisition. it was an exploratory qualitative study conducted at Kawale Health Center in Lilongwe, Malawi, in February 2023, which employed a phenomenological design. Data were collected using semi-structured in-depth interviews and vignettes from purposively sampled 20 AGYW and 10 health care workers (HCWs) based on their PrEP status (on PrEP versus not on PrEP) and involvement in PrEP provision, respectively. The data were digitally recorded, managed using NVivo software and analysed using a thematic approach guided by the Consolidated Framework for Implementation Research (CFIR). AGYW identified perceived HIV risk and vulnerability and PrEP knowledge as facilitators. HCWs identified AGYW perceived HIV risk, HCW altitudes, and availability of youth friendly service center and resources as facilitators to PrEP uptake. Barriers identified by AGYW included PrEP side effects, limited PrEP information, lack of privacy, stigma, and lack of transportation. HCWs identified limited resources and burden of work as barriers. In conclusion, PrEP's full potential as an HIV prevention tool for AGYW requires a holistic approach that considers their particular requirements, removes systemic hurdles, and guarantees access to high-quality services. In addition, there is a need to create demand to increase the uptake of PrEP.

Toward Greater Pre-exposure Prophylaxis Equity: Increasing Provision and Uptake for Black and Hispanic/Latino Individuals in the U.S.

Expanding access to pre-exposure prophylaxis (PrEP) is crucial for ending the HIV epidemic in the United States and reducing disparities in HIV incidence among marginalized populations. Telehealth models for the delivery of PrEP have the potential to improve access, acceptability, and adherence. In 2022, Philadelphia established the Philadelphia TelePrEP Program to deliver HIV prevention services through telehealth. This qualitative descriptive study aims to identify implementation determinants for telehealth PrEP services in Philadelphia. We completed nine in-depth interviews with staff at the Philadelphia TelePrEP Program (n = 5) and external stakeholders in the HIV prevention workforce (n = 4) using a semi-structured interview guide based on the Consolidated Framework for Implementation Research (CFIR). Thematic analysis was used to identify key facilitators and barriers to implementation. Interviews revealed that telePrEP improved convenience and flexibility in accessing PrEP, but online marketing may exclude certain populations with limited digital presence. Dedicated patient navigators and ongoing staff training were key facilitators, whereas limited provider capacity was a challenge. Sustainable funding through grants and 340B revenue enabled the Philadelphia TelePrEP Program to serve uninsured patients. The digital divide, lack of PrEP awareness, and competition from commercial telePrEP providers were identified as potential barriers to engaging priority populations. TelePrEP has the potential to expand the availability of PrEP services and reach communities that currently face barriers to access. However, overcoming key structural and social barriers around public awareness, technology access, and organizational capacity will be critical for successful implementation.

BackgroundOver 60 implementation frameworks exist. Using multiple frameworks may help researchers to address multiple study purposes, levels, and degrees of theoretical heritage and operationalizability; however, using multiple frameworks may result in unnecessary complexity and redundancy if doing so does not address study needs. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) are both well-operationalized, multi-level implementation determinant frameworks derived from theory. As such, the rationale for using the frameworks in combination (i.e., CFIR + TDF) is unclear. The objective of this systematic review was to elucidate the rationale for using CFIR + TDF by (1) describing studies that have used CFIR + TDF, (2) how they used CFIR + TDF, and (2) their stated rationale for using CFIR + TDF.MethodsWe undertook a systematic review to identify studies that mentioned both the CFIR and the TDF, were written in English, were peer-reviewed, and reported either a protocol or results of an empirical study in MEDLINE/PubMed, PsycInfo, Web of Science, or Google Scholar. We then abstracted data into a matrix and analyzed it qualitatively, identifying salient themes.FindingsWe identified five protocols and seven completed studies that used CFIR + TDF. CFIR + TDF was applied to studies in several countries, to a range of healthcare interventions, and at multiple intervention phases; used many designs, methods, and units of analysis; and assessed a variety of outcomes. Three studies indicated that using CFIR + TDF addressed multiple study purposes. Six studies indicated that using CFIR + TDF addressed multiple conceptual levels. Four studies did not explicitly state their rationale for using CFIR + TDF.ConclusionsDifferences in the purposes that authors of the CFIR (e.g., comprehensive set of implementation determinants) and the TDF (e.g., intervention development) propose help to justify the use of CFIR + TDF. Given that the CFIR and the TDF are both multi-level frameworks, the rationale that using CFIR + TDF is needed to address multiple conceptual levels may reflect potentially misleading conventional wisdom. On the other hand, using CFIR + TDF may more fully define the multi-level nature of implementation. To avoid concerns about unnecessary complexity and redundancy, scholars who use CFIR + TDF and combinations of other frameworks should specify how the frameworks contribute to their study.Trial registrationPROSPERO CRD42015027615