Pre-exposure Prophylaxis Implementation Research Articles

Awareness, willingness to use pre-exposure prophylaxis, and use of post-exposure prophylaxis for HIV prevention among men who have sex with men in Mexico.

Little is known about awareness and willingness to use or purchase HIV pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in Mexico. MSM in Mexico were recruited via advertisements on online social venues to participate in Encuesta de Sexo Entre Hombres, an online behavioral survey. Awareness of PrEP, willingness to take PrEP if available for free, willingness to purchase PrEP, awareness of post-exposure prophylaxis (PEP), and ever PEP use were assessed in descriptive and multivariate analyses. Overall, 54.8% (4588/8376) of participants were aware of PrEP. Of those aware, 77.6% were willing to use PrEP if free and 52.6% were willing to purchase PrEP, generally at a maximum monthly cost of $500MXP. Both awareness of and willingness to use PrEP if free or for purchase were significantly greater among MSM who were younger, and varied by demographic, recent healthcare use, and behavioral risk factors. Only 8.2% had ever used PEP, which was highly associated with healthcare utilization. About half of Mexican MSM were aware of PrEP. The majority of those aware were willing to use PrEP if available for free and many were willing to purchase PrEP at low cost. Leveraging demographic, recent healthcare use, and behavioral risk characteristics associated with awareness and willingness to use PrEP could be useful in designing future PrEP programs for MSM in Mexico. Expanding healthcare settings in which PEP is available may also support identifying candidates for PrEP and scaling up PrEP implementation.

Facilitators, Barriers, and Opportunities to Implementing Sexual History Screening and Human Immunodeficiency Virus Pre-Exposure Prophylaxis at a Federally Qualified Health Center.

Sexual history screening (SHS) is recommended to determine risk for acquisition of human immunodeficiency virus (HIV) and eligibility for pre-exposure prophylaxis (PrEP). SHS and PrEP are underutilized, sequential screening, and prevention practices. This study aimed to understand factors impacting the implementation of SHS and PrEP at a multi-site federally qualified health center (FQHC) in Connecticut. Guided by the Consolidated Framework for Implementation Research, semistructured interviews were conducted on Zoom with primary care providers (PCPs), medical assistants, clinical leadership, and PrEP navigators. Convenience and purposive sampling took place via email until thematic saturation was achieved. Thematic analysis was conducted. Twenty-two participants were interviewed for this study. PCPs lacked knowledge and reported limited or no use of SHS to determine patients' level of HIV risk, which may explain why most PCPs relied on patients to request PrEP. While PCPs perceived organizational support to prescribe PrEP, clinical staff were unaware of structural resources. Lastly, participants described a vertical trajectory of influence from external sources (policies and insurance) to time allocated to appointments that limits their ability to implement SHS and PrEP, further complicated by the electronic health record and disparities in structural resources across clinical sites. This study provides foundational evidence for future research on implementation strategies to improve HIV prevention through universal, comprehensive SHS to identify patients for PrEP. Overcoming barriers to SHS and PrEP, particularly in clinical settings such as FQHCs that care for vulnerable populations, may improve identification, prevention, and treatment of HIV and aid in ending the HIV epidemic.

A decade of PrEP: the evolution of HIV pre-exposure prophylaxis content and sentiments in South African print news media, 2012–2021

After nearly a decade of HIV pre-exposure prophylaxis (PrEP) rollout in sub-Saharan Africa, there has been limited study of PrEP messaging in news media. We selected twenty South African newspapers with the highest circulation volumes to retrieve articles published in 2012–2021 mentioning PrEP (N = 249). Using inductive content analysis, we developed a structured codebook to characterise PrEP-related content and sentiments, as well as their evolution over time, in the South African press. Many articles espoused favourable attitudes towards PrEP (52%), but a sizeable fraction espoused unfavourable attitudes (11%). Relative to PrEP-favourable articles, PrEP-unfavourable articles were significantly more likely to emphasise the drawbacks/consequences of PrEP use, including adherence/persistence requirements (52% vs. 24%, p = .007), cost (48% vs. 11%, p < .001), and risk compensation (52% vs. 5%, p < .001). Nevertheless, the presence of these drawbacks/consequences in print media largely declined over time. Key populations (e.g. adolescents, female sex workers) were frequently mentioned potential PrEP candidates. Despite message variations over time, prevention effectiveness and adherence/persistence requirements were the most widely cited PrEP benefits and drawbacks, respectively. Study findings demonstrate the dynamic nature of PrEP coverage in the South African press, likely in response to PrEP scale-up and real-world PrEP implementation during the study period.

Avoiding Shots in the Dark: Learning from the Past To Inform the Implementation of Long-Acting Injectable Pre-Exposure Prophylaxis for Black American Cisgender Women.

The FDA's approval of long-acting injectable cabotegravir pre-exposure prophylaxis (LAI PrEP) as an alternative to daily oral PrEP represents a crucial development in HIV prevention, particularly for American Black cisgender women who face high HIV-1 risks. Yet, uptake may be hindered by racial and gender inequities. Addressing these requires learning from the roll-out of oral PrEP, creating culturally tailored PrEP campaigns, and enhancing provider training to meet Black women's needs. Tools for discussing PrEP within personal relationships and product preference research tailored to Black women's needs are essential for effective LAI PrEP delivery. Deliberative implementation of LAI PrEP must employ strategies that are community-sensitive, -responsive, and -inclusive. It should prioritize the incorporation of Black women's voices in decision-making and should promote community-led strategies. By addressing historical injustices and fostering trust, healthcare systems can enhance LAI PrEP uptake by Black women. Emphasizing a community-centered approach that ensures health equity and acknowledges the crucial role that social media and Black-led organizations play in promoting PrEP awareness and adoption within Black communities is necessary for successful implementation.

How Would You Manage HIV Pre-exposure Prophylaxis in This Patient With Medical Comorbidities? : Grand Rounds Discussion From Beth Israel Deaconess Medical Center.

Despite advances in treatment, HIV infection remains an important cause of morbidity and mortality, with more than 30 000 new cases diagnosed in the United States each year. There are several interventions traditionally used to prevent HIV transmission, but these vary in effectiveness and there are challenges to their implementation. In 2014, the Centers for Disease Control and Prevention published initial guidance on the use of antiretroviral pre-exposure prophylaxis (PrEP) to prevent transmission of HIV infection in persons at risk based on multiple studies that showed it to be highly efficacious in various populations. It was updated in 2021 to reflect new drug options. The U.S. Preventive Services Task Force also recently updated its recommendations for PrEP, which strongly support its use in persons at risk. Despite its well-established effectiveness, the implementation of PrEP in clinical practice has been variable, especially among populations underserved by the medical system and marginalized by society. Fewer than one third of persons in the United States who are eligible for PrEP currently receive it. Here, 2 physicians experienced in HIV PrEP debate how best to identify patients who might benefit from PrEP, how to decide what regimen to use, and how to monitor therapy.

Barriers and Facilitators to Long-Acting Injectable HIV Pre-Exposure Prophylaxis Implementation in Primary Care Since Its Approval in the United States.

HIV pre-exposure prophylaxis (PrEP) is a highly effective method to mitigate the HIV epidemic, but uptake of PrEP has been slow and is associated with racial and gender disparities. Oral PrEP requires high levels of adherence to be effective, which may disadvantage certain high-risk groups. The first injectable HIV PrEP, a drug given every 2 months rather than as a daily pill, was approved by the US Food & Drug Administration in December 2021. A Family Medicine practice in a single health organization in the United States (November 2022 to February 2023). We conducted interviews with patients and key stakeholders to characterize factors affecting long-acting injectable (LAI) PrEP implementation. Data collection and analysis were guided by the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed using guided content analysis. Twenty-five patients (n = 13) and practice stakeholders (n = 12) were interviewed. Overall, stakeholders described a very low uptake of LAI PrEP. Barriers to LAI PrEP included a lack of awareness, insurance and access issues, a lack of streamlined workflow, and a trust in pills over injectables. Facilitators to LAI PrEP implementation included the absence of a pill burden, a culture of shared decision making, and pharmacy support. Although uptake has been slow, we have identified several promising strategies for improving rollout and implementation of LAI PrEP. Approaches that can bolster rollout of LAI PrEP include having an interdisciplinary care team that is supported by PrEP navigators and pharmacists and are informed by a patient-centered model of care to increase patient engagement and trust.

Exploring Attitudes Toward Pre-Exposure Prophylaxis for HIV Prevention Prior to Implementation Among Female Sex Workers in Malaysia: Results from a Qualitative Study.

Pre-exposure prophylaxis (PrEP) is an effective method for prevention of HIV transmission. Female sex workers (FSW) in Malaysia are at substantially increased risk of acquiring HIV compared to the general female population, yet little is known about this population's current HIV prevention practices or acceptance of PrEP. This study aims to inform the culturally relevant implementation of PrEP through the qualitative exploration of (1) the potential need for PrEP in this population and (2) the factors that determine FSW willingness to use oral PrEP. In-depth, semi-structured interviews (n = 30) were conducted with FSW in English, Malay, or Tamil. Transcribed and translated interviews were analyzed using a grounded theory approach. FSW express positive interest in PrEP but prefer it as a supplement to condoms, not a replacement. Perceived challenges to PrEP use include cost, adherence, and side effects. The findings suggest that in combination with condom use, PrEP may be an acceptable method of HIV prevention. Effective PrEP rollout may also include condom promotion using a peer-driven model, cost subsidies, and sex work harm reduction and empowerment components.

Perspectives on Injectable HIV Pre-Exposure Prophylaxis: A Qualitative Study of Health Care Providers in the United States.

The introduction of injectable HIV pre-exposure prophylaxis (PrEP) has the potential to significantly change the biomedical HIV prevention landscape. However, effective implementation will require health care providers to adopt, prescribe, and administer injectable PrEP within clinical settings. This study qualitatively examined challenges and benefit of injectable PrEP implementation from the perspective of health care providers. From April to August 2022, we conducted 19 in-depth interviews with current PrEP-prescribing health care providers in New York State, including 3 physician assistants, 5 physicians, and 11 nurse practitioners. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed to report semantic-level themes regarding injectable PrEP implementation. More than half of participants (61%) were aware of injectable PrEP; only 21% had experience prescribing it. Qualitative findings highlighted five themes. Three themes represented implementation challenges, including speculative concerns about side effects, appointment compliance, and practical and logistical considerations. The remaining two themes described benefits of injectable PrEP relative to oral PrEP, which included greater convenience and enhanced privacy. Findings from this qualitative study make significant applied contributions to the sparse knowledge on health care provider perspectives of injectable PrEP post-US Food and Drug Administration approval and their concerns and considerations regarding implementation in real-world clinical settings.

“To do so in a patient-centred way is not particularly lucrative”: The effects of neoliberal health care on PrEP implementation and delivery

BackgroundHIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention used by HIV-negative people to prevent HIV acquisition. Despite increased use of PrEP worldwide, several barriers to PrEP implementation have resulted in insufficient uptake, inadequate adherence, and frequent discontinuation. Our objective was to interrogate the social, political, and economic conditions shaping PrEP implementation and delivery among gay, bisexual, queer and other men who have sex with men (GBQM) in Ontario, Canada. MethodsSix focus groups and three interviews with 20 stakeholders in Ontario (e.g., healthcare professionals, clinicians, community-based organization staff, and government staff) were conducted between July and October 2021. Participants were asked about the personal, workplace, and structural factors shaping PrEP delivery strategies for GBQM. Transcripts were analyzed using reflexive thematic analysis informed by the political economy of PrEP and employed a critique of neoliberalism. ResultsParticipants critiqued the problematic arrangements of the current healthcare system in Canada. Neoliberal governmentality and policies have resulted in inequitable PrEP care by establishing funding structures prioritizing profit and requiring patients and providers to function as individual entrepreneurs. Consequently, healthcare disparities are compounded for marginalized peoples who lack the resources and capacity to navigate existing healthcare systems. Participants identified several pathways to improve the implementation of PrEP, including greater institutional and governmental supports for PrEP and healthcare, leveraging communities and collaboration, and moving beyond risk-based health frameworks. ConclusionSocio-political-economic changes reflecting post-neoliberal principles are needed to overcome existing barriers to PrEP care, and sexual and reproductive healthcare more broadly.

What does the scale-up of long-acting HIV pre-exposure prophylaxis mean for the global hepatitis B epidemic?

The HIV and hepatitis B virus (HBV) epidemics are interconnected with shared routes of transmission and specific antiviral drugs that are effective against both viruses. Nearly, 300 million people around the world live with chronic HBV, many of whom are from priority populations who could benefit from HIV prevention services. Oral pre-exposure prophylaxis (PrEP) for HIV has implications in the prevention and treatment of HBV infection, but many people at increased risk of HIV acquisition may instead prefer long-acting formulations of PrEP, which are currently not active against HBV. People at increased risk for HIV acquisition may also be at risk for or already be living with HBV infection. Oral PrEP with tenofovir is effective in preventing both HIV and HBV, and tenofovir is also the recommended treatment for chronic HBV infection. Although implementation of oral PrEP has been challenging in sub-Saharan Africa, investments in its scale-up could secondarily reduce the clinical impact of HBV. Long-acting PrEP, including injectable medicines and implantable rings, may overcome some of the implementation challenges associated with oral PrEP, such as daily pill burden, adherence challenges and stigma; however, current formulations of long-acting PrEP do not have activity against HBV replication. Ideally, PrEP programmes would offer both oral and long-acting formulations with HBV screening to optimize HIV prevention services and HBV prevention and care, when appropriate. People who are not immune to HBV would benefit from being vaccinated against HBV before initiating long-acting PrEP. People who remain non-immune to HBV despite vaccination may benefit from being offered oral, tenofovir-based PrEP given its potential for HBV PrEP. People using PrEP and living with HBV who are not linked to dedicated HBV care would also benefit from laboratory monitoring at PrEP sites to ensure safety when using and after stopping tenofovir. PrEP programmes are ideal venues to offer HBV screening, HBV vaccination for people who are non-immune and treatment with tenofovir-based PrEP for people with indications for HBV therapy. Long-acting PrEP holds promise for reducing HIV incidence, but its implications for the HBV epidemic, particularly in sub-Saharan Africa, should not be overlooked.

Protocol for a systematic review and critical discourse analysis of research on HIV pre-exposure prophylaxis programme use among gay, bisexual, and other men who have sex with men

Background HIV pre-exposure prophylaxis (PrEP) is a pill that prevents the transmission of HIV from sexual partners living with HIV; it is frequently taken by gay, bisexual, and other men who have sex with men (gbMSM). PrEP is often provided through formal PrEP programmes. Research on these programmes may employ discourses shaped by heteronormativity and homophobia. Given that expert language influences how HIV prevention is understood and delivered, problematic discourses in research likely extends into PrEP programme implementation. This review will use critical discourse analysis (CDA) to explore research on PrEP programme implementation for gbMSM. Within this literature, we will identify interpretive repertoires used to discuss gbMSM; the subject positions afforded to gbMSM; and the implications of these interpretive repertoires and subject positions for gbMSM engaging with HIV PrEP programmes. Methods Relevant articles will be identified through timebound searching (2012-present) in ProQuest ASSIA, EBSCOhost PsycInfo, OVID Medline, OVID Embase, and EBSCOhost CINAHL, with forward and backward citation searching of included studies. Grey literature will be identified through ProQuest and Google Scholar. Screening will be conducted by two independent reviewers, who will conduct double screening for titles, abstracts, and full texts. Data will be analysed and synthesised using CDA informed by critical realism (CR). CDA focuses on relationships between language and power, including how language enables inequality. The analytic process will explore the background of included studies, identify overarching themes, analyse external and internal relations in included studies, and interpret the meaning of identified themes and relations. Conclusions Highlighting issues with discourses in PrEP implementation may enhance reflective engagement with assumptions underlying this research, preventing further stigmatisation of gbMSM’s sexual and protective practices. As PrEP programmes become more common globally, more diverse and inclusive perspectives in PrEP programme research may inform interventions that enhance their acceptability and ultimately their implementation.

Perceptions of Pre-exposure Prophylaxis (PrEP) for HIV prevention among men living with HIV in the context of reproductive goals in South Africa: a qualitative study

BackgroundPre-exposure Prophylaxis (PrEP) and Treatment as Prevention (TasP) are effective strategies to prevent HIV transmission within serodifferent couples. However, limited usage of PrEP, knowledge and interest has been amongst the barriers for men, alongside testing and treatment adherence. We explored the perceptions of PreP for HIV prevention with Men living with HIV (MWH) who have reproductive goals, to understand awareness and experiences related to PrEP use in the context of HIV prevention with their partners.MethodsWe undertook a qualitative study with 25 MWH aged 18 to 65 between April and September 2021 in South Africa. Potential participants were screened for eligibility and scheduled to participate in telephonic interviews. Interviews were audio recorded, transcribed, translated and thematically analysed.ResultsThemes were organized into opportunities and barriers that men with HIV articulate as important for using PrEP to meet individual, couple, and community reproductive goals. At the individual level, some men were willing to discuss PrEP with their partners to protect their partners and babies from acquiring HIV. Lack of knowledge about PrEP among men was a potential barrier to promoting PrEP among their female partners. At the couple level, PrEP use was seen as a way to strengthen relationships between partners, signifying care, trust, and protection and was seen as a tool to help serodifferent couples meet their reproductive goals safely. At the community level, PrEP was viewed as a tool to promote HIV testing and prevention efforts, especially among men, but participants emphasized the need for more education and awareness.ConclusionDespite PrEP implementation in South Africa, awareness of PrEP among men with HIV in rural areas remains low. Engaging MWH to support their partners in accessing PrEP could be an innovative strategy to promote HIV prevention. Additionally, providing men with comprehensive reproductive health information can empower them to make more informed decisions, adopt safer sexual practices, and challenge societal norms and stigmas around HIV.

Doxycycline in STI Prophylaxis—A Literature Review

Background: Since the implementation of pre-exposure prophylaxis (PrEP) in HIV prevention, a significant increase in the prevalence of other sexually transmitted infections (STIs) has been reported, especially among men who have sex with men (MSM). Doxycycline is being examined as a potential pharmacological agent in preventing these infections. This review aims to summarize available data on the effectiveness and potential side effects of doxycycline for the prevention of bacterial STIs. Methods: We reviewed the National Library of Medicine and the National Center of Biotechnology Information in order to find clinical trials and relevant observational studies regarding doxycycline usage in STI prophylaxis. Results: Doxycycline prophylaxis reduced the risk of acquiring chlamydia, syphilis, and, in a majority of the trials, the risk of gonorrhea. The clinical trials on doxycycline STI prophylaxis were underpowered to determine if doxycycline promotes the selection of resistance in Neisseria gonorrhoeae and Chlamydia trachomatis. Additionally, no serious side effects of this preventive measure have been reported. None of the studies aimed to compare the efficacy of post- and pre-exposure prophylaxis of STDs with doxycycline. Conclusions: The preliminary results regarding STI prophylaxis with doxycycline seem to be promising. Further research is needed to determine the potential risk of doxycycline prophylactic prescription.

High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa

In Southern and Eastern Africa, initiation of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been high among adolescent girls and young women (AGYW) offered PrEP. However, persistence and prevention-effective use of PrEP among this critical group continues to be a challenge. We conducted a qualitative sub-study of AGYW from the Community PrEP Study in Eastern Cape Province, South Africa who had high rates of pick up for monthly PrEP refills over two years, but differing levels of PrEP adherence based on tenofovir-diphosphate (TFV-DP) measurements in dried blood spots (DBS). Contrasting 22 AGYW with low versus high levels of TFV-DP in DBS, we qualitatively explored factors which influenced PrEP persistence vs. non-persistence, unique patterns of PrEP use (e.g., discarding or stockpiling), and participant recommendations for improving AGYW prevention-effective use of PrEP in the future. Results showed that PrEP misconceptions and mistrust among participants’ social networks negatively influenced adherence. In comparison, supportive families and/or partners and personal trust that PrEP works positively influenced adherence. Those with low adherence described being motivated to come to the site for other study benefits (e.g., reimbursement money, snacks, sanitary pads) and discarding PrEP to avoid stigma associated with being seen with pills. Future PrEP implementation strategies should focus on involving families and partners in PrEP support for AGYW and minimizing PrEP stigma at a community level.Trial registration NCT03977181. Retrospectively registered on June 6, 2019.

HIV pre-exposure prophylaxis services, provision, and delivery in the European treatment network of HIV, hepatitis and global emerging infectious diseases (NEAT ID).

We conducted a survey to evaluate HIV pre-exposure prophylaxis (PrEP) practices in a European clinical research network on HIV, hepatitis, and global infectious diseases (NEAT ID). An online survey comprising 22 questions was sent via a secure electronic tool to the investigating physician of each of the 342 NEAT ID study centres across 15 European countries in November 2020. In total, 50 sites from 12 countries responded (15% response rate). Most sites were in Western Europe, two were in Poland, and one was in Hungary. Of the responding sites, 45 provided PrEP services for a total of 27 416 PrEP users, with 1361 new PrEP initiators each month. These centres supplied PrEP for men who have sex with men (100%), people who inject drugs (84%), sex workers (84%), women (62%), and transgender women (31%). PrEP persistence after 1 year was >90%, 75%-90%, and 40%-75% in 17, 24, and 4 centres, respectively. In total, 32/45 (71%) centres reported strong community-based organization commitment at their site, and 15/45 (33%) centres developed task-shifting processes to deliver PrEP through nurses (11/15), pharmacists (5/15), and key-population peers (2/15). The biggest barriers to implementation of PrEP were low awareness of and knowledge about PrEP (47%), unwillingness to disclose sexual identity or at-risk behaviour (36%), and lack of administrative support (29%). Of the 45 centres, 32 (71%) have already been involved in PrEP research and 43 (96%) were interested in participating in such studies. The few NEAT ID centres that responded to the survey showed disparities in PrEP deployment and practices despite a common interest in participating in research in this field.

Addressing disparities in Pre-exposure Prophylaxis (PrEP) access: implementing a community-centered mobile PrEP program in South Florida

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.

HIV pre-exposure prophylaxis provision by U.S. health centers in 2021.

The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers. The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing. The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP. Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs. Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals.

An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya.

Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization and the Kenyan Ministry of Health for HIV prevention in pregnancy and postpartum for women at risk for HIV. Integration of PrEP into antenatal care is promising, but delivery gaps exist in the face of healthcare provider shortages in resource-limited settings. Between May and November 2021, we conducted a difference-in-differences study (3 months pre-intervention data collection and 3 months post-intervention data collection) analyzing four intervention facilities, where the strategies were implemented, and four comparison facilities, where no strategies were implemented. We tested a combination of three implementation strategies-video-based PrEP information in the waiting bay, HIV self-testing, and dispensing of PrEP in the antenatal care rooms-to improve PrEP delivery. We compared absolute changes in the proportion of antenatal attendees screened for PrEP (PrEP penetration), the proportion receiving all PrEP-specific steps in a visit (HIV testing, risk screening, and PrEP counseling) (PrEP fidelity), and client PrEP knowledge, client satisfaction, and waiting time and service time (a priori outcomes); post hoc, we compared the proportion offered PrEP (PrEP offer) and completing HIV testing. We measured provider perceptions of the acceptability and appropriateness of the implementation strategies. We observed significant improvements in PrEP penetration, PrEP offer, satisfaction, and knowledge (p < 0.05) and improvements in fidelity that trended towards significance (p = 0.057). PrEP penetration increased 5 percentage points (p = 0.008), PrEP fidelity increased 8 percentage points (p = 0.057), and PrEP offer increased 4 percentage points (p = 0.003) in intervention vs. comparison facilities. Client PrEP knowledge increased by 1.7 out of 6 total points (p < 0.001) and client satisfaction increased by 0.7 out of 24 total points (p = 0.003) in intervention vs. comparison facilities. We observed no changes in service time (0.09-min decrease; p = 0.435) and a small increase in waiting time (0.33-min increase; p = 0.005). HIV testing among those eligible did not change (1.5 percentage point decrease, p = 0.800). Providers felt the implementation strategies were acceptable and appropriate (median acceptability: 20/20; median appropriateness: 19.5/20). However, absolute levels of each step of the PrEP cascade remained suboptimal. An implementation strategy package with video information, HIV self-testing, and co-location of medication dispensing enhanced PrEP delivery across several implementation outcomes and client satisfaction, while not substantially increasing wait time or decreasing provider-client contact time. ClinicalTrials.gov , identifier, NCT04712994.

Procedural fairness inbenefit package design: inclusion ofpre-exposure prophylaxis ofHIV inUniversal Coverage Scheme inThailand.

Since 2002, Thailand's Universal Coverage Scheme (UCS) has adopted a comprehensive benefits package with few exclusions. A positive-list approach has gradually been applied, with pre-exposure prophylaxis (PrEP) of HIV recently being included. Disagreements resulting from competing values and diverging interests necessitate an emphasis on procedural fairness when making any decisions. This qualitative study analyses agenda setting, policy formulation and early implementation of PrEP from a procedural fairness lens. Literature reviews and in-depth interviews with 13 key stakeholders involved in PrEP policy processes were conducted. Civil society organizations (CSOs) and academia piloted PrEP service models and co-produced evidence on programmatic feasibility and outcomes. Through a broad stakeholder representation process, the Department of Disease Control proposed PrEP for inclusion in UCS benefits package in 2017. PrEP was shown to be cost-effective and affordable through rigorous health technology assessment, peer review, use of up-to-date evidence and safe-guards against conflicts of interest. In 2021, Thailand's National Health Security Board decided to include PrEP as a prevention and promotion package, free of charge, for the populations at risk. Favourable conditions for procedural fairness were created by Thailand's legislative provisions that enable responsive governance, notably inclusiveness, transparency, safeguarding public interest and accountable budgetallocations; longstanding institutional capacity to generate local evidence; and implementation capacity for realisation of procedural fairness criteria. Multiple stakeholders including CSOs, academia and the government deliberated in the policy process through working groups and sub-committees. However, a key lesson from Thailand's deliberative process concerns a possible 'over interpretation' of conflicts of interest, intended to promote impartial decision-making, which inadvertently limited the voices of key populations represented in the decision processes. Finally, this case study underscores the value of examining the full policy cycle when assessing procedural fairness, since some stages of the process may be more amenable to certain procedural criteria than others.

Implementing Differentiated and Integrated HIV Prevention Services for Adolescent Girls and Young Women: Experiences From Oral PrEP Rollout in Primary Care Services in South Africa

PurposeIn South Africa, adolescent girls and young women (AGYW, aged 15–24 years) are disproportionately affected by human immunodeficiency viruses (HIV). Oral pre-exposure prophylaxis (PrEP) has been available in South Africa since 2016; however, there is limited evidence on oral PrEP implementation and integration in real-world settings, particularly among AGYW. Project PrEP is an implementation science project that sought to inform the introduction and integration of oral PrEP as part of combination HIV prevention and sexual and reproductive health services (SRH) in South Africa. The project focused on AGYW, as a priority population in need of HIV prevention. This paper presents strategies Project PrEP employed to increase oral PrEP and SRH service access and utilization. MethodsWe present strategies employed to increase oral PrEP and SRH services uptake. Using routine monitoring data, facility assessments, stakeholder engagement, training and progress reports, and observations, we share implementation lessons learned and describe how strategies can be adapted by HIV prevention programs in different contexts. ResultsApproximately 22, 000 people initiated on oral PrEP (December 2018–December 2021) across eight facilities and four mobile clinics. Two-thirds (67%) of initiated clients were AGYW. DiscussionLessons are to be learned from the introduction of oral PrEP as implementers prepare for the introduction of new PrEP methods. Stakeholders must be continuously engaged to ensure buy-in, and social mobilization and demand creation should be contextual, focused, and innovative. Continuous staff training is needed to reinforce knowledge, and AGYW service delivery models must be local context relevant.