Pre-exposure Prophylaxis Provision Research Articles

Acceptability and Feasibility of Implementing a Home-Based HIV Pre-Exposure Prophylaxis Program in an Urban Clinic.

Personal and structural barriers to HIV pre-exposure prophylaxis (PrEP) care result in its underutilization and premature discontinuation. A home-based PrEP program comprised of telemedicine visits and/or self-administered lab testing may address some of these barriers. Our objective was to assess the acceptability and feasibility of a home-based PrEP program among stakeholders at an urban HIV and primary care clinic. We used the consolidated framework for implementation research to evaluate determinants of successful implementation of the program. We surveyed and interviewed PrEP patients and their health care team. In a baseline survey of PrEP users (n = 112) administered between May 2021 and August 2022, 65% expressed interest in switching to the home-based PrEP program. Seventeen patients over the course of follow-up through December 2023 started home-based PrEP, including 12 patients who completed both a telemedicine visit and a self-administered lab kit, and 5 patients who completed only a telemedicine visit. Of these, over 80% had positive feedback on the telemedicine visits. Survey results demonstrated excellent acceptability and feasibility of the lab kits. Patients indicated in interviews that the home-based PrEP program provided the strong advantage of convenience. Despite mixed feelings from PrEP providers on telemedicine visits (n = 5), most felt that the program made PrEP care delivery easier for patients and would encourage their patients to use the program if it were a good fit. Barriers to program success included shipping delays and staff turnover during program implementation. In conclusion, uptake of the home-based program was low but program participants expressed high acceptability.

Decision Support Tool to Improve Decision-Making for HIV Pre-Exposure Prophylaxis (PrEP): Development Process and Alpha Testing.

African, Caribbean, and Black (Black) communities in Canada are disproportionately affected by the HIV epidemic. Pre-exposure prophylaxis (PrEP) is a highly effective option for the prevention of HIV. However, the use of PrEP for HIV prevention among eligible Black clients in Canada remains far below the thresholds necessary to achieve the goal of zero new HIV infections. In a recent study in Toronto, PrEP-eligible Black clients were found to have decisional conflict and unmet decisional needs, which affected the quality of their decision-making process regarding the initiation and adherence to PrEP. There is evidence that decision support tools (DSTs) can improve the quality of a decision, the quality of the decision-making process, the implementation or continuation of the chosen option, and the appropriate use of health services. Despite these benefits, there is currently no DST for PrEP-eligible Black clients being asked to consider PrEP for HIV prevention. Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability. We developed and evaluated the PrEP DST for Black patients using the 7-step process outlined in the Ottawa Decision Support Group Guideline for the development and evaluation of DST. To facilitate the implementation of the Ottawa Decision Support Group guideline, we assembled a multidisciplinary team of primary health care providers, researchers, community members with lived experiences, and digital content designers to serve as the steering committee. First, we assessed patients' and primary health care providers' views on decisional support needs, after which we determined the content, design, and distribution plan for the DST. Subsequently, we conducted evidence synthesis, reviews, and appraisal before developing the PrEP DST prototype. The final tool was reviewed by steering committee members for completeness before acceptability and usability testing with potential Black clients and PrEP providers. The web-based DST yielded 27 pages divided into 6 distinct sections. The six sections include (1) an introduction of the DST, (2) clarify your decision, (3) knowledge, (4) a value clarification exercise, (5) support system, and (6) next steps. Both Black clients and PrEP providers reported ease of task performance, general satisfaction, and usefulness of the tool to support decision-making for Black clients. Feedback on usability centered on the need to add a user guide to increase usability. All feedback was incorporated into the final tool. A PrEP DST for Black clients developed using a systematic process and a multidisciplinary steering committee was acceptable and usable by both Black clients and PrEP providers. Further study (eg, randomized controlled trials) may be needed to evaluate the efficacy of the PrEP DST.

A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California.

Pre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP. In 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP. Half of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services. Pharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.

HIV Pre-Exposure Prophylaxis (PrEP) Users' Experiences of PrEP Access, Sexual Behaviour, and Well-Being During the COVID-19 Pandemic: A Welsh Qualitative Study.

HIV Pre-Exposure Prophylaxis (PrEP) has been available in Wales since 2017. The coronavirus disease (COVID-19) pandemic impacted UK sexual health services, leading to a reduction in service provision. There is a lack of research on the experiences of PrEP users during this time. We aimed to explore the experiences of PrEP users in Wales following the introduction of COVID-19 pandemic measures. We conducted a secondary data analysis of two prior interview studies (DO-PrEP and UPrEP). Data collection was undertaken between May 2020 and February 2021 using remote interviewing. Semi-structured interviews were conducted. Participants were ≥18 years of age, residents of Wales, current or previous PrEP users, and men who have sex with men (MSM). Reflexive thematic analysis was conducted. A total of 32 interviews were included in the analysis. Themes include the following: (1) PrEP use during COVID-19, (2) sexual behaviour and relationship changes following COVID-19 restrictions, (3) NHS service provision during the COVID-19 pandemic, and (4) wider contextual effects of the pandemic. Participants reported a change in PrEP use (pausing or switching to event-based PrEP). Participants reported reduced access to clinics and appointments. Support for changing to event-based PrEP was varied. Social isolation resulted in varied responses to lockdown rules, especially in later lockdowns. This study provides patient perspectives on the challenges the COVID-19 pandemic posed to PrEP use and access. It offers insights into the broader support needs around PrEP use when an individual's circumstances change. Flexible models of PrEP provision, which can be adapted to the patient's needs, will be essential as PrEP delivery extends into the wider community. Both the DO-PrEP and UPrEP studies received input from various stakeholders in the design of the topic guides for the study; these included public lay members, PrEP users, PrEP providers, and individuals involved with HIV advocacy and policy.

Drug-drug interactions between gender-affirming hormone therapy and antiretrovirals for treatment/prevention of HIV.

Transgender persons face a greater burden of HIV compared to cisgender counterparts. Concerns around drug-drug interactions (DDIs) have been cited as reasons for lower engagement in HIV care and lower pre-exposure prophylaxis (PrEP) uptake among transgender populations. It is therefore imperative for hormone therapy, PrEP and antiretroviral therapy providers to understand the DDI potential between these therapies. Studies of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) PrEP with feminizing hormone therapies (FHTs) show reduced plasma tenofovir concentrations, but intracellular concentrations of tenofovir-diphosphate are not reduced. Efficacy of PrEP is expected to be maintained despite this interaction. Masculinizing hormone therapies have no effect on tenofovir concentrations but may increase FTC to a nonclinically relevant extent. No interactions between FHT and cabotegravir or tenofovir alafenamide have been demonstrated. Administration of TDF/FTC PrEP has no effect on hormone levels in transmen or transwomen. PrEP is expected to be effective and safe in transpersons and should be provided to high-risk individuals regardless of gender affirming hormone use. Enzyme inducing/inhibiting antiretroviral therapy may decrease or increase, respectively, the concentrations of FHT and masculinizing hormone therapy. Unboosted integrase inhibitors or enzyme neutral non-nucleoside reverse transcriptase inhibitors are not expected to affect and are not affected by gender affirming hormones and can be considered in transmen and transwomen. Overlapping toxicities including weight gain, dyslipidaemia, cardiovascular disease and bone density effects should be considered, and antiretroviral modifications can be made to minimize toxicities. Interactions between supportive care medications should be assessed to avoid chelation interactions and hyperkalaemia.

Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.

HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. DERR1-10.2196/56587.

Knowledge and Attitudes About HIV Pre-Exposure Prophylaxis Among Sexually Active Black and Latina Cisgender Women: Findings from the 2017 and 2018 New York City Sexual Health Survey.

Pre-exposure prophylaxis (PrEP) is a highly effective tool to prevent HIV, yet it is underutilized among women. The current study aims to evaluate the awareness, attitudes, and perceptions of PrEP among a large survey sample of Black and Latina women in New York City (NYC). Interviewer-administered surveys were conducted in high HIV incidence neighborhoods in NYC among Black, Latina, and Afro-Latina women who reported recent sex with a man in 2017 (n = 398) and 2018 (n = 405). About 40% of participants were aware of PrEP, whereas 30.4% indicated interest in using it. The top reason for not utilizing it was low HIV risk perception. However, most participants supported the idea that using PrEP meant asserting control over their health (94.1%). Primary care providers and obstetricians/gynecologists were participants' preferred sources for PrEP (91.6%). Across survey cycles, compared to non-Black Latina participants, Black participants had significantly higher PrEP awareness (44.4% vs. 29.1%). PrEP awareness was also significantly higher among survey participants in 2018 (45.2%) than in 2017 (34.3%). Less than half of the participants were aware of PrEP, but those who were aware expressed largely positive attitudes toward the medication. Our findings may inform future PrEP implementation strategies to optimize awareness and access to PrEP among women disproportionately affected by HIV, like focusing on personal empowerment instead of risk-based messaging and training women's sexual health care providers in PrEP provision.

Integration of HIV pre-exposure prophylaxis (PrEP) services for pregnant and breastfeeding women in eight primary care clinics: results of an implementation science study

BackgroundAlthough HIV vertical transmission has declined significantly in sub-Saharan Africa, incident HIV infection in pregnant and postpartum women is estimated to account for over one-third of HIV vertical transmission. Oral pre-exposure prophylaxis (PrEP) for pregnant and breastfeeding women (PBFW) is included in South African PrEP guidelines since 2021; however, integration of PrEP services within ante- and postnatal care remains limited.MethodsBetween March 2022 and September 2023, we evaluated the integration of PrEP for PBFW in eight antenatal clinics in Cape Town, South Africa, following training and mentorship of providers. We applied an adapted Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate the integration of PrEP services for pregnant and breastfeeding women. Before the study, PrEP was not routinely offered. We implemented a staff didactic/practice-based training and mentorship on PrEP provision targeting PBFW. We evaluated the following: (1) Reach as the proportion of women initiating PrEP among women counselled and tested for HIV, (2) effectiveness as PrEP continuation up to 3 months by pregnant vs. breastfeeding women, (3) adoption of PrEP integration via pre- and post-training assessments and ongoing mentorship assessments, (4) implementation through clinic trends of PrEP offer over time, and (5) maintenance: continued PrEP offer 3 months following the intervention.ResultsIn 8 facilities providing ante- and postnatal care, we trained 224 healthcare providers (127 nurses and 37 counsellors). Of those, we mentored 60 nurses, midwives, and HIV counsellors working with pregnant and breastfeeding women, with 80% of nurse/midwives and 65% of counsellors scoring ≥ 80% on the final mentoring assessment. Overall, 12% of HIV-negative pregnant women started PrEP, and 41% of those continued PrEP up to 3 months. Among HIV-negative breastfeeding women, 14% initiated PrEP, and 25% continued PrEP up to 3 months. All eight facilities continued providing PrEP 3 months post intervention.ConclusionsIn these high HIV prevalence clinics, the proportion of pregnant and breastfeeding women initiating and continuing PrEP rapidly increased but was limited among breastfeeding women. Staff training, mentorship, and PrEP integration were well-adopted by nurses and counsellors, and services continued following the intervention. Barriers included limited HIV testing of breastfeeding mothers and need for additional PrEP-trained nurses.

Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape.

The Dual Prevention Pill (DPP) combines oral pre-exposure prophylaxis (PrEP) with oral contraception (OC) to prevent HIV and pregnancy. Noting the significant role played by the private sector in delivering family planning (FP) services in countries with high HIV burden, high level of private sector OC uptake, and the recent growth in self-care and technology-based private sector channels, we undertook qualitative research in Kenya, South Africa and Zimbabwe to prioritize private sector service delivery approaches for the introduction of the DPP. Between March 2022 and February 2023, we conducted a literature review and key informant interviews with 34 donors and implementing partners, 19 government representatives, 17 private sector organizations, 13 pharmacy and drug shop representatives, and 12 telehealth agencies to assess the feasibility of DPP introduction in private sector channels. Channels were analysed thematically based on policies, level of coordination with the public sector, data systems, supply chain, need for subsidy, scalability, sustainability and geographic coverage. Wide geographic reach, ongoing pharmacy-administered PrEP pilots in Kenya and South Africa, and over-the-counter OC availability in Zimbabwe make pharmacies a priority for DPP delivery, in addition to private networked clinics, already trusted for FP and HIV services. In Kenya and South Africa, newer, technology-based channels such as e-pharmacies, telehealth and telemedicine are prioritized as they have rapidly grown in popularity due to nationwide accessibility, convenience and privacy. Findings are limited by a lack of standardized data on service uptake in newer channels and gaps in information on commodity pricing and willingness-to-pay for all channels. The private sector provides a significant proportion of FP services in countries with high HIV burden yet is an untapped delivery source for PrEP. Offering users a range of access options for the DPP in non-traditional channels that minimize stigma, enhance discretion and increase convenience could increase uptake and continuation. Preparing these channels for PrEP provision requires engagement with Ministries of Health and providers and further research on pricing and willingness-to-pay. Aligning FP and PrEP delivery to meet the needs of those who want both HIV and pregnancy prevention will facilitate integrated service delivery and eventual DPP rollout, creating a platform for the private sector introduction of multipurpose prevention technologies.

Patient and Provider Perceptions of Barriers and Facilitators to Pre-exposure Prophylaxis Access and Adherence in Black and Latinx Young Men Who Have Sex with Men.

In the United States, the use of pre-exposure prophylaxis (PrEP) has led to a substantial decrease in HIV prevalence and incidence. However, some populations, including young men who have sex with men (YMSM) of color, continue to be disproportionately impacted, highlighting the need for tailored interventions addressing barriers to adequate PrEP access. In collaboration with partner clinics, we recruited 19 PrEP clients and 19 PrEP providers (n = 35) to participate in hour-long in-depth interviews. Although client interviews explored personal experiences with stigma, barriers, and motivators to PrEP and information preferences, provider interviews explored providers' perceived stigma in their clinic, perceived barriers and motivators to meeting clients' PrEP needs, and rapport building with clients. Most participants were affiliated with one of the southern partner clinics. Clients and providers noted similar determinants to PrEP access, uptake, and adherence. Both recognized the impact of personal barriers such as routine adjustments and perception of need, as well as institutional barriers such as transportation and financial difficulties. Clients emphasized the role of the client-provider relationship as part of contributing to willingness to disclose information such as HIV status and sexual practices. Providers noted the importance of sexual health and LGBTQ+ topics in their training. Despite limited geographical scope and the sensitive nature of HIV-related topics, this study has several implications. PrEP clinics may benefit from hiring providers who share identities and experiences with YMSM clients of color and operating with a flexible schedule. Medical provider training should include comprehensive sexual health and LGBTQ+ competencies to reduce bias in care.

Projecting the Potential Clinical and Economic Impact of Human Immunodeficiency Virus Prevention Resource Reallocation in Tennessee.

In 2023, Tennessee replaced $6.2 M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). We used a simulation model of HIV disease to compare the clinical impact of Current, the present allocation of condoms, preexposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/HSBW); with Reallocation, funding instead increased HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). Key model inputs included baseline condom use (45%-49%), PrEP provision (0.1%-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day HIV care linkage (57%-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/HSBW, whereas it would increase HIV testing among FR (+47%) and HIV care linkage (to 100%/90%) among PP/SST. Reallocation would lead to 166 additional HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. HIV testing reductions were most influential in sensitivity analysis; even a 24% reduction would result in 287 more deaths compared to Current. With pessimistic assumptions, we projected 1359 additional HIV transmissions, 712 additional deaths, and 2778 life-years lost over 10 years. Redirecting HIV prevention funding in Tennessee would greatly harm CDC priority populations while conferring minimal benefits to new priority populations.

HIV Pre-exposure Prophylaxis Use among Men Experiencing Incarceration in the United States: A Prospective Cohort Study

Background: Pre-exposure prophylaxis (PrEP) is an effective approach to preventing HIV acquisition and is recommended for populations overrepresented in carceral systems given the overlap with populations disproportionately impacted by HIV. However, few studies have focused on PrEP initiation outcomes in a carceral setting to maximize public health impact. Setting: This study was conducted in a unified jail/prison system within the state of Rhode Island located in the United States. Methods: A prospective observational cohort of men initiating PrEP within a jail setting were enrolled in this trial. Men were referred by providers, staff, or after self-presenting for HIV preventive care, these individuals were offered enrollment in the study which involved evaluation for clinical PrEP eligibility, PrEP initiation while incarcerated, continuation upon community re-entry and linkage to a community PrEP provider post-release. Results: A total of (N=100) men in the jail facility (e.g. “intake”) were enrolled in the cohort. Of the 100 men enrolled, 83% were determined to be PrEP eligible through standard clinical evaluation, 37% were prescribed PrEP, and 26% initiated PrEP while incarcerated. In total, 5% of enrolled individuals were linked successfully to PrEP care in the community. Conclusion: Our findings suggest preliminary feasibility and acceptability of initiating PrEP within a jail setting. There were significant challenges across the PrEP care continuum that can be used to inform future studies and practice.

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial.

A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. Participants in focus groups liked the "human touch" of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the "good" to "excellent" range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.

HIV Pre-Exposure Prophylaxis Education in Family Medicine Clerkships: A CERA Study.

Little is known about human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) education in family medicine clerkships during medical school. Our study aimed to describe coverage of PrEP education in family medicine clerkships and explore barriers if this education was absent. Data were collected through the 2023 Council of Academic Family Medicine (CAFM) Education Research Alliance (CERA) Family Medicine Clerkship Director Survey. We inquired about provision of PrEP to patients, faculty expertise with PrEP, PrEP curriculum in the clerkship, barriers to including PrEP in the clerkship curriculum, and willingness of directors to add PrEP online modules to the clerkship if available. The response rate was 56.8% (96/169). Nine participants did not complete the PrEP questions and were excluded from analyses. Nearly two-thirds of clerkship directors perceived PrEP as an important topic in the family medicine clerkship; however, only one-third of clerkships included PrEP curriculum through clinical experiences (58.5%), didactics (17.1%), or both (14.6%). Barriers to including PrEP were lack of time in the curriculum (63.5%) and having other more important topics to cover (25.7%), but 38.9% said they would include PrEP in the clerkship if free online modules were available. Clerkships were more likely to include PrEP curriculum in the family medicine clerkship if they had faculty with sufficient expertise or if clerkship directors believed it was important to teach PrEP in the curriculum. Offering accessible educational content can enhance educational opportunities on PrEP for medical students.

Estimating the costs and perceived benefits of oral pre-exposure prophylaxis (PrEP) delivery in ten counties of Kenya: a costing and a contingent valuation study.

Kenya included oral PrEP in the national guidelines as part of combination HIV prevention, and subsequently began providing PrEP to individuals who are at elevated risk of HIV infection in 2017. However, as scale-up continued, there was a recognized gap in knowledge on the cost of delivering oral PrEP. This gap limited the ability of the Government of Kenya to budget for its PrEP scale-up and to evaluate PrEP relative to other HIV prevention strategies. The following study calculated the actual costs of oral PrEP scale-up as it was being delivered in ten counties in Kenya. This costing also allowed for a comparison of various models of service delivery in different geographic regions from the perspective of service providers in Kenya. In addition, the analysis was also conducted to understand factors that indicate why some individuals place a greater value on PrEP than others, using a contingent valuation technique. Data collection was completed between November 2017 and September 2018. Costing data was collected from 44 Kenyan health facilities, consisting of 23 public facilities, 5 private facilities and 16 drop-in centers (DICEs) through a cross-sectional survey in ten counties. Financial and programmatic data were collected from financial and asset records and through interviewer administered questionnaires. The costs associated with PrEP provision were calculated using an ingredients-based costing approach which involved identification and costing of all the economic inputs (both direct and indirect) used in PrEP service delivery. In addition, a contingent valuation study was conducted at the same 44 facilities to understand factors that reveal why some individuals place a greater value on PrEP than others. Interviews were conducted with 2,258 individuals (1,940 current PrEP clients and 318 non-PrEP clients). A contingent valuation method using a "payment card approach" was used to determine the maximum willingness to pay (WTP) of respondents regarding obtaining access to oral PrEP services. The weighted cost of providing PrEP was $253 per person year, ranging from $217 at health centers to $283 at dispensaries. Drop-in centers (DICEs), which served about two-thirds of the client volume at surveyed facilities, had a unit cost of $276. The unit cost was highest for facilities targeting MSM ($355), while it was lowest for those targeting FSW ($248). The unit cost for facilities targeting AGYW was $323 per person year. The largest percentage of costs were attributable to personnel (58.5%), followed by the cost of drugs, which represented 25% of all costs. The median WTP for PrEP was $2 per month (mean was $4.07 per month). This covers only one-third of the monthly cost of the medication (approximately $6 per month) and less than 10% of the full cost of delivering PrEP ($21 per month). A sizable proportion of current clients (27%) were unwilling to pay anything for PrEP. Certain populations put a higher value on PrEP services, including: FSW and MSM, Muslims, individuals with higher education, persons between the ages of 20 and 35, and households with a higher income and expenditures. This is the most recent and comprehensive study on the cost of PrEP delivery in Kenya. These results will be used in determining resource requirements and for resource mobilization to facilitate sustainable PrEP scale-up in Kenya and beyond. This contingent valuation study does have important implications for Kenya's PrEP program. First, it indicates that some populations are more motivated to adopt oral PrEP, as indicated by their higher WTP for the service. MSM and FSW, for example, placed a higher value on PrEP than AGYW. Higher educated individuals, in turn, put a much higher value on PrEP than those with less education (which may also reflect the higher "ability to pay" among those with more education). This suggests that any attempt to increase demand or improve PrEP continuation should consider these differences in client populations. Cost recovery from existing PrEP clients would have potentially negative consequences for uptake and continuation.

HIV pre-exposure prophylaxis programme preferences among sexually active HIV-negative transgender and gender diverse adults in the United States: a conjoint analysis.

Current implementation efforts have failed to achieve equitable HIV pre-exposure prophylaxis (PrEP) provision for transgender and gender-diverse (trans) populations. We conducted a choice-based conjoint analysis to measure preferences for key attributes of hypothetical PrEP delivery programmes among a diverse online sample predominantly comprised of transmasculine and nonbinary individuals in the United States. Between April 2022 and June 2022, a national online survey with an embedded conjoint analysis experiment was conducted among 304 trans individuals aged ≥18 years in the United States to assess five PrEP programme attributes: out-of-pocket cost; dispensing venue; frequency of visits for PrEP-related care; travel time to PrEP provider; and ability to bundle PrEP-related care with gender-affirming hormone therapy services. Participants responded to five questions, each of which presented two PrEP programme scenarios and one opt-out option per question and selected their preferred programme in each question. We used hierarchical Bayes estimation and multinomial logistic regression to measure part-worth utility scores for the total sample and by respondents' PrEP status. The median age was 24 years (range 18-56); 75% were assigned female sex at birth; 54% identified as transmasculine; 32% as nonbinary; 14% as transfeminine. Out-of-pocket cost had the highest attribute importance score (44.3%), followed by the ability to bundle with gender-affirming hormone therapy services (18.7%). Minimal cost-sharing ($0 out-of-pocket cost) most positively influenced the attribute importance of cost (average conjoint part-worth utility coefficient of 2.5 [95% CI 2.4-2.6]). PrEP-experienced respondents preferred PrEP delivery in primary care settings (relative utility score 4.7); however, PrEP-naïve respondents preferred pharmacies (relative utility score 5.1). Participants preferred programmes that offered PrEP services without cost-sharing and bundled with gender-affirming hormone therapy services. Bolstering federal regulations to cover PrEP services and prioritizing programmes to expand low-barrier PrEP provision are critical to achieving equitable PrEP provision. Community-engaged implementation research conducted by and in close collaboration with trans community stakeholders and researchers are needed to streamline the design of patient-centred PrEP programmes and develop implementation strategies that are salient to the diverse sexual health needs of trans patients.

Barriers and facilitators to pre-exposure prophylaxis uptake among Black/African American men who have sex with other men in Iowa: COM-B model analysis.

In Iowa, men who have sex with men (MSM) accounted for 54% of persons with HIV in 2022 and Non-Hispanic Black/African Americans were over 10 times more likely to be diagnosed with HIV than Non-Hispanic white Iowans. To address this disparity in HIV incidence and prevalence, the United States (US) government ending the HIV epidemic (EHE) initiative seeks to expand pre-exposure prophylaxis (PrEP) coverage across the United States. Recent data showed that PrEP coverage is suboptimal in Iowa (a rural state), and Black Iowans were less likely to engage with PrEP services. Using capability, opportunity, motivation and behavior (COM-B) model for behavior change, this study sought to identify the key barriers and facilitators to PrEP uptake among Black/African American MSM in small urban areas in Iowa. This was a phenomenological study aimed to explore subjective views of Black MSM on PrEP use. In-depth semistructured interviews were conducted with 12 Black MSM aged 20-42 years in two small urban counties. Broad themes identified from the interview transcripts were analyzed inductively and mapped onto the COM-B constructs deductively. Results showed that barriers to PrEP uptake were closely associated with five (of six) COM-B subcomponents: physical capability, psychological capability, social opportunity, reflective motivation, and automatic motivation. The thematized barriers were (1) lack of medical insurance; (2) limited PrEP awareness; (3) PrEP stigma; (4) fear of distrust among partners; (5) anticipated side effects; and (6) doubt about PrEP effectiveness. Similarly, facilitators to PrEP uptake were aligned with four subcomponents of COM-B model: physical capability, psychological capability, social opportunity, and physical opportunity. The thematized facilitators were (1) increased PrEP awareness; (2) PrEP access without discrimination; (3) state provision of PrEP to uninsured; and (4) physicians buy-in and recommendation. No motivation-related facilitators were reported. To reduce the current disparity in HIV incidence and to achieve the EHE goals of expanding PrEP coverage in Iowa, efforts should be directed toward the provision of low-cost or free PrEP services, healthcare providers' training on cultural competence, and the development of culturally appropriate strategies to deliver PrEP to the Black MSM community.

The path towards an HIV-free generation: engaging adolescent boys and young men (ABYM) in sub-Saharan Africa from lessons learned and future directions

ABSTRACT This paper highlights the pressing need to address the HIV epidemic among adolescent boys and young men (ABYM) in sub-Saharan Africa. Despite progress in HIV prevention, ABYM still experience low diagnosis rates, treatment adherence, and linkage to care. The paper emphasizes ABYM’s vulnerability due to societal norms, limited healthcare access, and economic pressures. It calls for gender-responsive interventions, including comprehensive sexual education, youth-friendly health services, community engagement, and targeted outreach. Comprehensive sexual education is pivotal in HIV prevention for ABYM, providing them with age-appropriate sexual health knowledge and safer sexual practices to reduce HIV incidence. Harmful masculine norms must be countered to promote respectful relationships, benefiting boys, men, and their partners. Inadequate access to youth-friendly health services hampers HIV prevention. Establishing spaces with confidential, non-judgmental care offering testing, counselling, circumcision, and provision of pre-exposure prophylaxis (PrEP) is essential, especially considering ABYM’s unique clinic experiences. Engaging communities, leaders, educators, and peers combats stigma and discrimination. ABYM’s input in intervention design, targeted outreach, and innovative technology enhances effectiveness of HIV prevention programmes. Economic factors should also be addressed. Comprehensive multi-sectoral interventions, including conditional cash transfers, effective for AGYW, could benefit ABYM. Addressing structural factors alongside behaviour change and social support is key.

Prep provision in community organizations: a comparative study with conventional services.

To evaluate whether adolescents from sexual minorities who initiated pre-exposure prophylaxis (PrEP) in community-based organizations (COs) are more socially and HIV-vulnerable compared with their counterparts from a conventional health service. In addition, to evaluate whether these adolescents had more timely access to prophylaxis. A PrEP demonstration study was conducted in the city of São Paulo in two COs, located in the center (CO-center) and the outskirts (CO-outskirts), and a conventional HIV testing service (CTA-center). Between 2020 and 2022, cisgender male adolescents who have sex with men (aMSM), transgender and gender diverse adolescents (aTTrans) aged 15 to 19 years, HIV-negative, with higher-risk practices for HIV were eligible for PrEP. Indicators of timely access and vulnerabilities of adolescents initiating PrEP in COs were analyzed using CTA-center as a reference and multinomial logistic regression. 608 adolescents initiated PrEP in COs and CTA-center. Adolescents from COs were associated with a shorter time to PrEP initiation (1-7 days; CO-outskirts: ORa=2.91; 95%CI 1.22-6.92; CO-center: ORa=1.91; 95%CI 1.10-3.31); and a lower housing Human Development Index (HDI) (CO-center: ORa = 0.97; 95%CI 0.94-1.00; CO-outskirts: ORa=0.82; 95%CI 0.78-0.86). In CO-outskirts, there was an increased chance of adolescents being younger (ORa=3.06; 95%CI 1.63-5.75) and living closer to the service (ORa=0.82; 95%CI 0.78-0.86, mean 7.8 km). While adolescents from the CO-center were associated with greater prior knowledge of PrEP (ORa=2.01; 95%CI 1.10-3.91) and high-risk perception (ORa=2.02; 95%CI 1.18-3.44), adolescents from the COs were not associated with higher-risk sexual practices and situations of vulnerability to HIV. The provision of PrEP in the COs facilitated access for vulnerable adolescents and may contribute to reducing inequities.

Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5percent at $0 rose to 42.6percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0percent with out-of-pocket costs of more than $500 dropped to 7.3percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.