Exploring Effects of Race and Differential Item Functioning on PrEP Stigma Experiences: Implications for Latent Stigma Measurement in Racially and Sexually Diverse Populations.

PrEP stigma measurement remains a challenge to the validity of studies and interventions addressing HIV prevention. It may lead to inaccurate assessment of the relationship between PrEP stigma and health outcomes such as PrEP persistence and care retention in groups experiencing HIV-related inequities. The present research explored the psychometric properties of a novel IV pre-exposure prophylaxis (PrEP) stigma scale in a cohort of racially diverse men who have sex with men (MSM). Using item response theory, analyses explored presence of differential item functioning (DIF) among Black and White respondents. Participants completed baseline surveys measuring psychosocial factors, sociodemographic factors, and PrEP stigma items. The primary analysis used a machine learning approach to assess (a) the presence of DIF; and (b) compare latent stigma between Black and White respondents, after correcting for any DIF. The model identified four out of 13 scale items as having a high probability of DIF for Black respondents, which is relatively good given that the original PrEP stigma scale was neither designed nor tested for validation comparing Black and White respondents. The DIF-adjusted latent PrEP stigma measure reveals statistically and substantially significantly higher levels of stigma for Black compared to White respondents (Diff.: 1.05 +/- 0.19). While most items performed well, findings demonstrate the importance of assessing measurement error in populations where stigma is rampant and being studied or intervened upon (and in this case, where multilevel and intersectional stigma may be present).

Pre-exposure Prophylaxis (PrEP) implementation among latino MSM: a qualitative scoping review of implementation determinants and change methods.

INTRODUCTION: The increasing rates of HIV among Latino men who have sex with men (MSM) necessitate innovative and rigorous studies to evaluate prevention and treatment strategies. Pre-exposure prophylaxis (PrEP) is a highly effective tool in preventing HIV acquisition and plays a crucial role in the Ending the HIV Epidemic in the U.S. initiative. However, there is a scarcity of PrEP research specifically focused on Latino MSM, and the factors influencing its implementation remain largely unknown. METHODS: To address this gap, we conducted a comprehensive review exploring the determinants (barriers and facilitators) of PrEP implementation among Latino MSM, as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to promote its adoption. Our review encompassed 43 peer-reviewed articles examining determinants and four articles assessing change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR 2.0) to understand the multilevel barriers and facilitators associated with implementation. RESULTS: The majority of research has focused on PrEP recipients (i.e., patients), primarily examining their awareness and willingness to use PrEP. Fewer studies have explored the factors influencing clinicians and service delivery systems. Additionally, the evaluation of change methods to enhance clinician adoption and adherence to PrEP and recipient adherence to PrEP has been limited. CONCLUSION: It is evident that there is a need for culturally adapted strategies tailored specifically for Latino MSM, as the current literature remains largely unexplored in this regard. By incorporating principles from implementation science, we can gain a clearer understanding of the knowledge, skills, and roles necessary for effective cultural adaptations. Future research should emphasize factors influencing implementation from a clinician standpoint and focus on innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence among Latino MSM.

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

BACKGROUND: 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. OBJECTIVE: Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Understanding the journey towards rabies vaccination for travellers: Results of a cross-sectional survey with patients and providers in the US, Germany, Sweden, and Switzerland.

BACKGROUND: Although cases of rabies in international travellers are uncommon, they are a fatal risk which can be alleviated through vaccination prior to travel. As international travel recovers post-COVID, it is vital that travellers are made aware of the risk of rabies when travelling to endemic countries and supported to receive the vaccine when eligible. METHODS: Online surveys were conducted in the US, Germany, Sweden and Switzerland between November 2022-January 2023 with both patients and healthcare providers (HCPs). Eligibility criteria for patients included those eligible for rabies pre-exposure prophylaxis (PrEP) due to travel location and activity; HCPs had to be providers of travel vaccinations. In both surveys, questions were asked about discussion of rabies vaccination, decision of whether to administer a rabies vaccine, recommendation to get the rabies vaccine, and final decision to get a vaccine. RESULTS: The final patient sample included n = 1557 patients who were eligible for rabies pre-exposure prophylaxis (US n = 504, Germany n = 353, Sweden n = 350, Switzerland n = 350) and n = 219 HCPs (US n = 75, Germany n = 75, Sweden n = 32, Switzerland n = 37). Although all patients in the sample were eligible for rabies vaccination, only 15 % felt they were at risk of getting rabies, and only 18 % received the rabies vaccine before their trip. HCPs reported discussing PrEP and/or PrEP and PEP with 30 % of patients presenting for travel vaccination advice, on average. CONCLUSIONS: Awareness and perception of rabies risk, and lack of consistent HCP discussion of the need for rabies PrEP may be major barriers to uptake of the vaccine for patients who are eligible to receive it.

Perceived risks and benefits of telePrEP interventions: An interview study with rural sexual minority men in Texas.

PURPOSE: Many rural areas lack brick-and-mortar HIV prevention resources despite the increasing rates of HIV. Although online HIV pre-exposure prophylaxis (PrEP) programs can potentially increase uptake among rural sexual minority men (SMM), their attitudes and preferences regarding telehealth-based PrEP (telePrEP) programming are uncertain. This qualitative study examined rural SMM's perceived risks and benefits of participating in a hypothetical telePrEP program. METHODS: Twenty rural SMM living in Texas completed a semi-structured online videoconferencing interview between April 12 and June 14, 2023. Data were analyzed with reflexive thematic analysis. FINDINGS: Four themes were constructed: (1) telePrEP interventions increase accessibility but completely online services might be inadequate; (2) telePrEP and mail-order interventions are convenient but face challenges; (3) telePrEP interventions need to address confidentiality and privacy within the context of the sociopolitical climate; and (4) telePrEP interventions need to address trustworthiness and transparency. CONCLUSIONS: Overall, our results indicate that rural SMM perceive telePrEP interventions that provide at-home and telehealth PrEP, HIV testing, and HIV care services as beneficial. However, overall utility and acceptability depend on perceptions of privacy, confidentiality, trustworthiness, and transparency. Given the HIV prevention and treatment service deserts in which many rural SMM live, telePrEP interventions must purposefully demonstrate how their operations and data will remain safe and secure. Further work should explore contextual or situational factors that influence the willingness and acceptability of rural SMM to participate in online HIV prevention intervention research studies.

Challenges and opportunities for hepatitis B virus screening in people attending PrEP services: a retrospective prevalence study.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir to prevent HIV in individuals with hepatitis B virus (HBV) raises concerns about HBV reactivation when stopping event-driven PrEP or redundancy in HBV treatment for continuous PrEP (since tenofovir alone would be enough for HBV). Real-world data from PrEP services could provide useful epidemiological information on HBV prevalence in PrEP attendees in low-prevalence countries. METHODS: A retrospective analysis on PrEP attendees of three services in northern Italy were conducted to assess HBV prevalence among PrEP attendees and the need for primary cycle/booster dose HBV vaccination despite previous vaccination during childhood (at birth or 12 years). Risk factors possibly associated with HBV exposure were evaluated with a binary logistic regression analysis, controlling for age, gender, place of birth (Italy vs abroad) and chemsex use (as a proxy of high-risk sexual behaviour for contracting sexually transmitted infections). RESULTS: Among 10 hepatitis B surface antigen (HBsAg)-positive out of 2152 PrEP attendees (0.46%), PrEP was started in 7 subjects mainly with a daily schedule, 1 has declined after counselling, 2 were lost to follow-up. Around three-fourth of the 2152 PrEP attendees were born in Italy after 1979, thus were previously vaccinated during childhood. The probability of needing a booster for low-titre HBs antibodies was higher among those vaccinated at birth with respect to those vaccinated at 12 years (OR 2.30, 95% CI 1.80 to 2.96). The risk of previous HBV exposure (resulting in either HBsAg+ or antibodies against HBV core antigen [HBcAb]+) was higher for increasing age (OR 3.07, 95% CI 2.49 to 3.78 per 10 years more) and lower for being born in Italy (OR 0.23, 95% CI 0.14 to 0.36). CONCLUSIONS: Our real-world data on a large PrEP cohort suggest that, although uncommon, HBV infection in PrEP users in low-prevalence countries should be considered and managed. In addition, HBV screening offers the opportunity to expand prevention services through vaccination.

Examining concordance of sexual-related factors and PrEP eligibility with HIV risk perception among adolescent girls and young women: cross-sectional insights from DREAMS sites in Kenya, Malawi, and Zambia.

BACKGROUND: HIV risk perception is an important cognition for prevention, theoretically engendering service-seeking and risk-reduction behaviors, but its composition remains poorly understood. We examined country-specific correlates of self-appraised HIV exposure risk among sexually active adolescent girls and young women (AGYW, aged 15-24 years) without HIV in Kenya, Malawi, and Zambia. We also explored overlaps between self-appraised HIV exposure risk and pre-exposure prophylaxis (PrEP) eligibility to identify engagement opportunities. METHODS: We analyzed cross-sectional data (2016/2017) to estimate sexual-related correlates of self-appraised HIV exposure risk (likely vs. not, temporally framed as "ever") using log-Poisson models with robust standard errors. For sexual-related factors with an unadjusted p ≤ 0.10, individual adjusted models were fitted, controlling for sociodemographic and cognitive factors with an unadjusted p ≤ 0.10. PrEP eligibility was defined using national guidelines; since conditional criteria are in Malawi's (age-disparate sex + ever-pregnant) and Zambia's (multiple partners + condomless sex) guidelines, we also assessed PrEP eligibility after decoupling these factors. RESULTS: Few AGYW reported likely HIV exposures (Kenya [N = 746]: 15.7%, Malawi [N = 1348]: 46.2%, Zambia [N = 349]: 9.5%) despite ubiquitous HIV risk (98.7%, 99.8%, and 98.9% of Kenyan, Malawian, and Zambian AGYW reported ≥ 1 sexual-related factor). However, the adjusted models found some actual-perceived risk concordance. Positive correlates of self-appraised likely HIV exposures included partner(s)' likely HIV exposure (all countries); partner(s)' unknown HIV status and other partners (Kenya, Malawi); STI symptoms and partner(s) living outside the community (Kenya); non-partner sexual violence (Zambia); and transactional sex, multiple partners, pre-coital alcohol use, and physical/sexual intimate partner violence (Malawi). Per national guidelines, PrEP eligibility criteria differentially identified HIV risk (Kenya: 93.6%, Malawi: 53.3%, Zambia: 44.6%), and self-appraised likely HIV exposures were low among PrEP-eligible AGYW (Kenya: 16.5%, Malawi: 48.5%, Zambia: 18.8%). Decoupling Malawi's and Zambia's conditional PrEP criteria could increase risk identification to > 85% and potential engagement by ~ 70% and ~ 30%, respectively. CONCLUSIONS: AGYW's HIV risk perceptions were mostly influenced by factors beyond their locus of control. Conditional PrEP eligibility criteria may inhibit AGYW's access and uptake in some settings: countries should consider decoupling these factors to minimize barriers. Intersections between autonomy, behaviors, and perceptions among AGYW in gender-inequitable settings warrants further investigation.

Complement therapeutic Factor H-IgG proteins as pre-exposure prophylaxes against Lyme borreliae infections.

Lyme disease (LD) is the most common vector-borne disease in the northern hemisphere and is caused by the bacteria Borrelia burgdorferi sensu lato (also known as Lyme borreliae) with no effective prevention available. Lyme borreliae evade complement killing, a critical arm of host immune defense, by producing outer surface proteins that bind to a host complement inhibitor, factor H (FH). These outer surface proteins include CspA and CspZ, which bind to the 6th and 7th short consensus repeats of FH (SCR(6-7)), and the OspE family of proteins (OspE), which bind to the 19th and 20th SCR (SCR19-20). In this study, we produced two chimeric proteins, FH-Fc, containing the Fc region of immunoglobulin G (Fc) with SCR(6-7) or SCR(19-20). We found that both FH-Fc constructs killed B. burgdorferi in the presence of complement and reduced bacterial colonization and LD-associated joint inflammation in vivo. While SCR(6-7)-Fc displayed Lyme borreliae species-specific bacterial killing, SCR(19-20)-Fc versatilely eradicated all tested bacterial species/strains. This correlated with SCR(6-7)-Fc binding to select variants of CspA and CspZ, but SCR(19-20)-Fc binding to all tested OspE variants. Overall, we demonstrated the concept of using FH-Fc constructs to kill Lyme borreliae and defined underlying mechanisms, highlighting the potential of FH-Fc as a pre-exposure prophylaxis against LD infection.

Innovative pre-exposure prophylaxis interventions among adolescent girls and young women during COVID-19 lockdown period in sub-Saharan Africa: A systematic review.

Adolescent girls and young women are key, and priority populations impacted by a higher risk of acquiring human immunodeficiency virus. In 2015, pre-exposure prophylaxis was introduced as a biomedical human immunodeficiency virus prevention tool. However, its uptake continues to be lower in sub-Saharan countries, particularly among adolescent girls and young women. The uptake may have worsened during the Coronavirus disease 2019 lockdown restrictions. Innovative interventions to improve its uptake were implemented, this review aimed to identify and describe these interventions in sub-Saharan Africa. We searched four electronic databases (PubMed, Scopus, Google Scholar, and MEDLINE) between 01 April 2019 and 30 April 2024 and 1212 articles were identified. Of these 287 full-text articles were assessed and ultimately, 14 articles were included since they reported on the pre-exposure prophylaxis interventions implemented before and during the lockdown period among adolescent girls and young women. Innovative interventions like using social media platforms and decentralizing pre-exposure prophylaxis through community delivery were identified across Sub-Saharan African countries. Irrespective of the challenges in implementing these interventions, improvements in pre-exposure prophylaxis uptake and adherence were observed. These interventions can potentially improve access to traditionally hard-to-reach individuals and address structural barriers to better access human immunodeficiency virus prevention service delivery.

Les adolescentes et les jeunes femmes constituent des populations clés et prioritaires exposées à un risque plus élevé de contracter le virus de l'immunodéficience humaine. En 2015, la prophylaxie pré-exposition a été introduite comme outil biomédical de prévention du virus de l'immunodéficience humaine. Cependant, son adoption continue d'être plus faible dans les pays subsahariens, en particulier chez les adolescentes et les jeunes femmes. L'adoption pourrait s'être aggravée pendant les restrictions de confinement liées à la maladie à coronavirus 2019. Des interventions innovantes pour améliorer son adoption ont été mises en œuvre, cette revue visait à identifier et décrire ces interventions en Afrique subsaharienne. Nous avons effectué des recherches dans quatre bases de données électroniques (PubMed, Scopus, Google Scholar et MEDLINE) entre le 1er avril 2019 et le 30 avril 2024 et 1 212 articles ont été identifiés. Parmi ces 287 articles en texte intégral ont été évalués et finalement, 14 articles ont été inclus car ils rendaient compte des interventions de prophylaxie pré-exposition mises en œuvre avant et pendant la période de confinement auprès des adolescentes et des jeunes femmes. Des interventions innovantes telles que l'utilisation des plateformes de médias sociaux et la décentralisation de la prophylaxie pré-exposition par le biais de la prestation communautaire ont été identifiées dans les pays d'Afrique subsaharienne. Indépendamment des difficultés liées à la mise en œuvre de ces interventions, des améliorations dans l'adoption et l'observance de la prophylaxie pré-exposition ont été observées. Ces interventions peuvent potentiellement améliorer l'accès aux personnes traditionnellement difficiles à atteindre et éliminer les obstacles structurels pour un meilleur accès à la prestation de services de prévention du virus de l'immunodéficience humaine.

Preferential Initiation of Long-Acting Injectable Versus Oral HIV Pre-Exposure Prophylaxis Among Women Who Inject Drugs.

Fifty-five of 62 women who inject drugs (WWID) selected long-acting cabotegravir (CAB-LA) over oral PrEP, and 51/55 received a first injection. More recent injection drug use and number of sexual partners were associated with selecting CAB-LA (P < .05). Findings provide preliminary evidence of a strong preference for longer-acting products among WWID.

Interest in Oral Pre-exposure Prophylaxis Among Men Who Have Sex with Men and Transfeminine Persons in HPTN 075, a Multi-center HIV Prevention Study in Sub-Saharan Africa (2015-2017).

Use of oral pre-exposure prophylaxis (O-PrEP) for HIV prevention has not been fully utilized in sub-Saharan Africa, especially among key populations with high HIV incidence and prevalence, including men who have sex with men (MSM) and transgender women (TGW). We examined correlates of interest in O-PrEP among participants in the HIV Prevention Trials Network (HPTN) Study 075, a prospective cohort study, conducted between 2015 and 2017, across 4 sites in Kenya, Malawi, and South Africa. The study included persons assigned male sex at birth, between 18 and 44 years of age, who reported anal intercourse with a man in the past 3 months. Interest in O-PrEP and potential correlates were assessed among 297 participants who were HIV negative. 52% of the participants reported being aware of PrEP and 73% indicated interest in PrEP once informed about it. PrEP interest was not significantly associated with any of the surveyed demographic or psychosocial variables except study site. Our findings suggest a broad and general interest in O-PrEP among MSM and TGW in sub-Saharan Africa, despite relatively low awareness. While the situation around PrEP will have changed in the included countries, major questions about successful implementation still need to be addressed.

RESUMEN: El uso de la profilaxis oral previa a la exposición (O-PrEP) para la prevención del VIH no se ha utilizado plenamente en el África subsahariana, especialmente entre poblaciones clave como los hombres que tienen sexo con hombres (HSH) y las mujeres transgénero (TGW), que demuestran alta Incidencia y prevalencia del VIH. Examinamos los correlatos de interés en O-PrEP entre los participantes en el Estudio 075 de la Red de Ensayos de Prevención del VIH (HPTN), un estudio de cohorte prospectivo, realizado entre 2015 y 2017, en 4 localidades en Kenia, Malawi y Sudáfrica. El estudio involucró a personas asignadas al sexo masculino al nacer que tenían entre 18 y 44 años de edad y que manifestaron haber tenido relaciones anales con un hombre en los últimos 3 meses. Se evaluó el interés en la O-PrEP y sus posibles correlatos entre 297 participantes que eran VIH negativos. El cincuenta y dos por ciento de los participantes reportaron tener conciencia de la existencia de PrEP y el 73% indicó interés en utilizar PrEP una vez informados sobre su existencia. El interés por la PrEP no se asoció significativamente con ninguna de las variables demográficas o psicosociales encuestadas, excepto el lugar del estudio. Nuestros hallazgos sugieren un interés amplio y general en la O-PrEP entre HSH y TGW en el África subsahariana, a pesar de un conocimiento relativamente bajo. Si bien la situación en torno a la PrEP habrá cambiado en los países incluidos, aún quedan importantes cuestiones por abordar sobre su implementación exitosa.

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol.

BACKGROUND: Incident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi. METHODS: PrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA's safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality. DISCUSSION: The PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region. TRIAL REGISTRATION NUMBER: NCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

Awareness of, willingness to use, and experiences with Pre-exposure prophylaxis among youth in Nigeria.

BACKGROUND: Youth (ages 14-24) in Nigeria have disproportionately high rates of new HIV infection. Pre-exposure prophylaxis could substantially reduce new infections among youth but has not been scaled up. This cross-sectional study aimed to assess Pre-exposure prophylaxis awareness, willingness to use, and prior use of Pre-exposure prophylaxis among youth in Nigeria. METHODS: This is a secondary analysis of cross-sectional data from a quasi-experimental pilot study (clinical trial NCT04070287). The analysis focused on Pre-exposure prophylaxis awareness, willingness to use, and prior use among 324 youth recruited between September 2019 to March 2020. Descriptive statistics were calculated as frequencies and percentages for categorical variables and means and standard deviations for continuous variables. RESULTS: Of the 324 participants, the mean age and standard deviation were 21.17 (± 2.20) years. The majority were 20-24 years old (75.9%) and male (57.7%). Only 30.7% used condoms consistently over three months. Regarding Pre-exposure prophylaxis awareness and willingness, 62.6% had never heard of Pre-exposure prophylaxis, and 158 (50.1%) reported willingness to use Pre-exposure prophylaxis. Only 10 (3.2%) reported having used Pre-exposure prophylaxis. CONCLUSION: Nigerian youth have low awareness of and prior use of Pre-exposure prophylaxis. Given the gap between prior use and willingness to use Pre-exposure prophylaxis, our findings suggest missed opportunities to prevent new HIV infections among youth in Nigeria. Efforts to increase awareness and uptake of Pre-exposure prophylaxis among this population should consider youth-led Pre-exposure prophylaxis outreach efforts and effectively communicate the benefits of Pre-exposure prophylaxis to this population. TRIAL REGISTRATION: NCT04070287, the Date of registration of the trial is 20-07-2019.

Adolescent Girls and Young Women Overcoming Adherence Challenges with Vaginal and Oral PrEP Use: A Longitudinal Qualitative Study from a Crossover Trial in South Africa, Uganda, and Zimbabwe.

Rates of HIV acquisition remain high among adolescent girls and young women (AGYW) in sub-Saharan Africa. We explored South African, Ugandan, and Zimbabwean AGYW's experiences in a crossover trial of two HIV prevention products: Daily oral pre-exposure prophylaxis pills and a monthly dapivirine vaginal ring. A subset of participants (n = 25) across all sites completed up to three serial in-depth interviews (SIDIs). The SIDIs explored barriers to product use, coping strategies, and the resulting outcomes. Coded textual data were analyzed using a product acceptability conceptual framework. Participants in the SIDIs described managing the array of challenges they encountered through formal adherence support, strategic product disclosure, and personally adapted strategies. For both products, perceived discreetness of the product and decision-making around disclosure was an important component of participants' narratives. Participants tailored their coping strategies based on available personal resources (e.g., cell phone alarms for PrEP reminders, social support through disclosure) or study provided resources (e.g., encouragement from staff, adherence groups). Notably, challenges participants encountered with each product during the crossover period helped inform product selection during the choice period. Our findings suggest that-even in a context where AGYW have access to several options for HIV prevention-challenges to consistent product use remain, but accessible support mechanisms and informed choice can help mitigate these challenges. Enacting that choice may also empower AGYW to reach their short and long-term life goals-including for HIV prevention. (NCT03593655, 20th July 2018).

Transgender-Specific Differentiated HIV Service Delivery Models in the South African Public Primary Health Care System (Jabula Uzibone): Protocol for an Implementation Study.

BACKGROUND: Almost 60% of transgender people in South Africa are living with HIV. Ending the HIV epidemic will require that transgender people successfully access HIV prevention and treatment. However, transgender people often avoid health services due to facility-based stigma and lack of availability of gender-affirming care. Transgender-specific differentiated service delivery (TG-DSD) may improve engagement and facilitate progress toward HIV elimination. Wits RHI, a renowned South African research institute, established 4 TG-DSD demonstration sites in 2019, with funding from the US Agency for International Development. These sites offer unique opportunities to evaluate the implementation of TG-DSD and test their effectiveness. OBJECTIVE: The Jabula Uzibone study seeks to assess the implementation, effectiveness, and cost of TG-DSD for viral suppression and prevention-effective adherence. METHODS: The Jabula Uzibone study collects baseline and 12-month observation checklists at 8 sites and 6 (12.5%) key informant interviews per site at 4 TG-DSD and 4 standard sites (n=48). We seek to enroll ≥600 transgender clients, 50% at TG-DSD and 50% at standard sites: 67% clients with HIV and 33% clients without HIV per site type. Participants complete interviewer-administered surveys quarterly, and blood is drawn at baseline and 12 months for HIV RNA levels among participants with HIV and tenofovir levels among participants on pre-exposure prophylaxis. A subset of 30 participants per site type will complete in-depth interviews at baseline and 12 months: 15 participants will be living with HIV and 15 participants will be HIV negative. Qualitative analyses will explore aspects of implementation; regression models will compare viral suppression and prevention-effective adherence by site type. Structural equation modeling will test for mediation by stigma and gender affirmation. Microcosting approaches will estimate the cost per service user served and per service user successfully treated at TG-DSD sites relative to standard sites, as well as the budget needed for a broader implementation of TG-DSD. RESULTS: Funded by the US National Institutes of Mental Health in April 2022, the study was approved by the Human Research Ethics Committee at University of Witwatersrand in June 2022 and the Duke University Health System Institutional Review Board in June 2023. Enrollment began in January 2024. As of July 31, 2024, a total of 593 transgender participants have been enrolled: 348 are living with HIV and 245 are HIV negative. We anticipate baseline enrollment will be complete by August 31, 2024, and the final study visit will take place no later than August 2025. CONCLUSIONS: Jabula Uzibone will provide data to inform HIV policies and practices in South Africa and generate the first evidence for implementation of TG-DSD in sub-Saharan Africa. Study findings may inform the use of TG-DSD strategies to increase care engagement and advance global progress toward HIV elimination goals. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64373.

Oral HIV pre-exposure prophylaxis use and resistance-associated mutations among men who have sex with men and transgender persons newly diagnosed with HIV in the Netherlands: results from the ATHENA cohort, 2018 to 2022.

BackgroundIn the Netherlands, HIV pre-exposure prophylaxis (PrEP) has been available since 2019. However, the extent of PrEP use prior to HIV diagnosis and development of PrEP-resistance-associated mutations (RAMs) is not known.AimWe assessed prior PrEP use and potential transmission of PrEP RAMs among men who have sex with men (MSM) and transgender persons (TGP) with a new HIV diagnosis in the Netherlands.MethodsData on prior PrEP use between 1 January 2018 and 31 December 2022 were available from the Dutch national ATHENA cohort. We assessed proportion of prior PrEP use, detected PrEP associated RAMs and assessed potential onward transmission of RAMs between 2010 and 2022 using a maximum likelihood tree.ResultsData on prior PrEP use were available for 583/1,552 (36.3%) individuals, with 16% (94/583) reporting prior PrEP use. In 489 individuals reporting no prior PrEP use, 51.5% did not use PrEP due to: low HIV-risk perception (29%), no access (19.1%), personal preference (13.1%), and being unaware of PrEP (19.1%). For PrEP users, 13/94 (13.8%) harboured a M184V/I mutation, of whom two also harboured a K65R mutation. In people with a recent HIV infection, detection of PrEP RAMs increased from 0.23% (2/862) before 2019 to 4.11% (9/219) from 2019. We found no evidence of onward transmission of PrEP RAMs.ConclusionThe prevalence of PrEP-associated RAMs has increased since PrEP became available in the Netherlands. More widespread access to PrEP and retaining people in PrEP programmes when still at substantial risk is crucial to preventing new HIV infections.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56587.

Perceived Versus Actual Costs of HIV Pre-Exposure Prophylaxis Among Gay, Bisexual, and Other Men Who Have Sex with Men in the United States.

Gay, bisexual, and other men who have sex with men (GBMSM) account for the highest proportion of HIV diagnoses in the United States, with daily pre-exposure prophylaxis (PrEP) significantly reducing transmission risk. Since 2021, the Affordable Care Act rules have required PrEP and accompanying care visits to be free for most Americans; nevertheless, insurers have found ways to circumvent no-cost PrEP and some employers are receiving exemptions from including it in their formularies. Despite this, perceived costs and indirect expenses still hinder PrEP adoption. This study examines the differences between perceived and actual costs among GBMSM who have and have not used PrEP. We conducted a one-time online survey with 692 adults from six New England states between May 2020 and October 2021. Participants who had never used PrEP estimated its cost, while those with prior PrEP experience reported their actual expenses. Bivariate analysis and multi-variable logistic regression were used to assess the data. Results showed a 60% difference between perceived ($48) and actual ($30) median monthly costs. Higher perceived costs among nonusers were linked to race and income, while high actual costs for prior users were associated with insurance type, income, wealth, race, and self-rated consumer credit. This significant disparity in PrEP cost perceptions highlights the need for targeted outreach and messaging to improve PrEP uptake among at-risk populations who have not yet accessed it.

Barriers and Facilitators That Influence HIV Pre-exposure Prophylaxis (PrEP)-Prescribing Behaviors Among Primary Care Providers in the Southern United States.

The Southern United States (US) bears the highest burden of HIV prevalence in the country, disproportionately affecting African American communities. Despite the proven efficacy of pre-exposure prophylaxis (PrEP) in reducing HIV transmission, its uptake remains suboptimal in this region. This study aimed to identify factors influencing PrEP-prescribing behaviors among primary care providers (PCPs) in the Southern US through the application of the transtheoretical model of behavior change. A cross-sectional survey was conducted among PCPs in 10 Southern states to assess their PrEP-prescribing practices, barriers, and facilitators. The results indicate that non-White PCPs and those practicing in urban and suburban settings are more likely to prescribe PrEP. Key barriers include lack of training, perceived stigma, and systemic issues such as health insurance coverage and time constraints. Significant facilitators are access to prescribing resources, streamlined insurance procedures, and patient motivation. Targeted educational programs and policy changes to address these barriers can enhance PrEP uptake, thereby reducing HIV transmission in high-risk populations. The findings underscore the need for tailored interventions to support PCPs in integrating PrEP into routine care, ultimately contributing to better public health outcomes in the Southern US.

At a crossroads: The crucial role of pharmacists in healthcare teams to end the HIV epidemic.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.