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.

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.

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.

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=1,557 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.

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).

Analyzing HIV Pre-exposure Prophylaxis and Viral Suppression Disparities: Insights From America's HIV Epidemic Analysis Dashboard (AHEAD) National Database.

Despite advancements in human immunodeficiency virus (HIV) treatment and prevention, disparities in pre-exposure prophylaxis (PrEP) uptake and viral suppression persist across different demographics. This study analyzes data from America's HIV Epidemic Analysis Dashboard (AHEAD) National Database to identify and understand these disparities based on age, gender, and race/ethnicity. In this study, we utilized the AHEAD National Database, which tracks HIV indicators across various demographics, including age, gender, and race/ethnicity. Data from 2017 to 2022 were analyzed to assess trends in PrEP uptake and viral suppression rates. Viral suppression was defined as having less than 200 copies of HIV per milliliter of blood. Data analyses were conducted to identify disparities and trends over time. The study has found notable disparities in PrEP uptake and viral suppression. From 2017 to 2022, PrEP prescriptions significantly increased from 13.20% to 36% of those eligible, rising from 161,185 to 437,425. During the same period, viral suppression rates among people with HIV rose from 63.10% to 65.10%, with the total number of individuals achieving viral suppression growing from 538,414 to 663,121. Younger individuals and males had higher uptake rates compared to females. Racial and ethnic disparities were also evident, with higher PrEP uptake and viral suppression rates among White and multiracial individuals compared to Black/African American and Hispanic/Latino populations. Viral suppression rates generally improved across all groups but remained lower for marginalized communities. In conclusion, while there has been overall progress in PrEP uptake and viral suppression, significant disparities persist. Targeted interventions are needed to address these gaps, particularly among marginalized racial and ethnic groups and underserved age demographics. Continued monitoring and tailored public health strategies are essential for achieving equitable HIV care and prevention.

Formalized peer referral to HIV pre-exposure prophylaxis supported with self-testing: a mixed-methods pilot study among young Kenyan women.

Background: The uptake of daily oral HIV pre-exposure prophylaxis (PrEP)-a highly effective intervention-remains low among African adolescent girls and young women (AGYW) who could benefit. AGYW who initiate PrEP often do so through informal peer referral, which may be enhanced with formalized peer referral and peer-delivered HIV self-testing (HIVST). To understand the feasibility of this PrEP referral model among AGYW, we conducted a pilot study in Kenya. Method: From March to May 2022, we recruited AGYW (≥16-24 years) using PrEP (i.e., "peer providers") from public healthcare clinics in Kiambu County and trained them on HIV prevention, HIVST use, and peer-supported linkage to clinic-based HIV services. Following training, peer providers received eight HIVST kits and were encouraged to refer four peers (i.e., "peer clients") to PrEP. We completed surveys with peer providers and clients one month following intervention delivery to assess PrEP initiation among peer clients. Later, we conducted focus group discussions (FGDs) with peer providers and clients to identify factors that facilitated or challenged intervention outcomes. Results: We trained 16 peer providers (median age: 23 years, IQR 21-24) who reported delivering the intervention to 56 peer clients; 30 peer clients (median age: 21 years, IQR 19-22) contacted the study team and were enrolled. Most of the enrolled peer clients reported behaviors associated with HIV risk (e.g., condomless sex; 80%, 24/30) and were PrEP-naïve (87%, 26/30). At one-month, PrEP initiation among eligible PrEP-naïve peer clients was high, as reported by providers (78%, 43/55) and clients (85%, 22/26); recent HIVST use was also high among peer clients (provider report: 95%, 53/56; client report: 97%, 29/30). In the FGDs, participants reported that intervention outcomes were facilitated by close preexisting relationships, HIVST assistance, and being escorted to clinic-based HIV services by peer providers; intervention barriers included conflicting priorities and limited HIVST experience. Conclusion: A formalized model of peer referral with HIVST delivery supported PrEP initiation among Kenyan AGYW. These findings demonstrate the potential for peer-delivered interventions to engage AGYW in HIV prevention services; however, more research is needed on the effectiveness and sustainability of this approach at scale.

Supporting Pre-Exposure Prophylaxis Uptake: Exploring Social Network Characteristics among Black Women and Acceptability of Social Network Strategies.

Black women continue to be disproportionally burdened by HIV. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention option, which is underused by Black women. While social network interventions (SNIs) have been widely researched and implemented among some groups vulnerable to HIV, little is known about social network characteristics among Black women. To learn more about the social networks of Black women vulnerable to HIV and their knowledge of and interest in PrEP, we conducted a cross-sectional survey among 109 Black women aged 18-45 years attending a family planning clinic in Chicago, Illinois. In our study, 44% of women reported that they were moderately to extremely concerned about HIV. Over half of participants (53%) had a small personal network size (i.e., less than two). No statistically significant associations between having larger network sizes and having previously heard of PrEP, having an interest in starting PrEP, or having good PrEP knowledge were detected. Open-ended responses revealed high levels of trust in network connections with matters related to sexual health. Additionally, nearly all (94%) of women reported that SNIs were a good idea to promote PrEP. Future network studies are needed to inform the development of effective intervention strategies for women.

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.

Perspectives on a peer-driven intervention to promote pre-exposure prophylaxis (PrEP) uptake among men who have sex with men in southern New England: a qualitative study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a highly effective pharmaceutical intervention that prevents HIV infection, but PrEP uptake across the US has been slow among men who have sex with men (MSM), especially among Black/African American (B/AA) and Hispanic /Latino (H/L) MSM. This study investigates the acceptability and essential components of a peer-driven intervention (PDI) for promoting PrEP uptake among MSM, with a specific focus on B/AA and H/L communities. METHODS: We conducted 28 semi-structured, qualitative interviews with MSM in southern New England to explore the components of a PDI, including attitudes, content, and effective communication methods. A purposive sampling strategy was used to recruit diverse participants who reflect the communities with the highest burden of HIV infection. RESULTS: Of 28 study participants, the median age was 28 years (interquartile range [IQR]: 25, 35). The sample comprised B/AA (39%, n = 11) and H/L (50%, n = 14) individuals. Notably, nearly half of the participants (46%) were current PrEP users. We found that many participants were in favor of using a PDI approach for promoting PrEP. Additionally, several participants showed interest in becoming peer educators themselves. They emphasized the need for strong communication skills to effectively teach others about PrEP. Moreover, participants noted that peer education should cover key topics like how PrEP works, how effective it is, and any possible side effects. CONCLUSIONS: Our study shows that effective PDIs, facilitated by well-trained peers knowledgeable about PrEP, could enhance PrEP uptake among MSM, addressing health disparities and potentially reducing HIV transmission in B/AA and H/L communities.

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.

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.

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.

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.

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.

First Case of HIV Seroconversion With Integrase Resistance Mutations on Long-Acting Cabotegravir for Prevention in Routine Care.

Background: Long-acting cabotegravir (CAB-LA) is highly effective for HIV prevention, but delayed HIV diagnoses and integrase strand transfer inhibitor (INSTI) resistance were observed in trials. We report the first case in routine clinical care of HIV infection on CAB-LA with INSTI resistance. Methods: The SeroPrEP study enrolls individuals in the United States who acquire HIV on pre-exposure prophylaxis modalities to assess diagnostics, antiretroviral (ARV) drug levels, resistance, and treatment outcomes. Resistance mutations in full-length HIV-1 integrase were identified by single-genome sequencing (SGS). Cabotegravir concentrations in plasma and hair segments were measured by liquid chromatography-tandem mass spectrometry. Results: A 23-year-old gender-nonbinary person, male at birth, restarted CAB-LA 6 months after discontinuation due to losing insurance. Prior to restart, HIV-1 RNA was not detected, but 20 days elapsed before CAB-LA injection. After the second CAB-LA injection, HIV antigen/antibody returned reactive (HIV-1 RNA 451 copies/mL). SGS of plasma HIV-1 RNA identified INSTI mutation Q148R in 2/24 sequences 2 days postdiagnosis; commercial genotype failed amplification. Cabotegravir hair concentration was 0.190 ng/mg 2 weeks prediagnosis; plasma cabotegravir was high (3.37 µg/mL; ∼20× PA-IC90) 14 days postdiagnosis. Viral suppression was maintained for 6 months on darunavir/cobicistat/emtricitabine/tenofovir alafenamide, then switched to doravirine + emtricitabine/tenofovir alafenamide due to nausea. Conclusions: In this first case of HIV infection on CAB-LA with INSTI resistance in routine care, cabotegravir resistance was detected only with a sensitive research assay. Accelerated pathways to minimize time between HIV testing and CAB-LA initiation are needed to optimize acute HIV detection and mitigate resistance risk. Sustained product access regardless of insurance is imperative to reduce HIV infections on CAB-LA.

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.

Identifying Effective Strategies for Improving Engagement in HIV Prevention and Care Among Transgender Persons in the United States: A Systematic Review.

This systematic review synthesized published literature (2000 - 2023) to identify HIV interventions specifically designed for transgender persons in the United States (PROSPERO registration number: CRD42021256460). The review also summarized strategies for improving outcomes related to the four pillars of the Ending the HIV Epidemic (EHE) initiative in the United States: Diagnose, Treat, Prevent, and Respond. A comprehensive search was conducted using the Centers for Disease Control and Prevention's HIV Prevention Research Synthesis Project database, which included over 120,000 citations from routine systematic searches in CINAHL, EMBASE, Global Health, MEDLINE, PsycInfo, and Sociological Abstracts. Of 23 interventions that met inclusion criteria, 94% focused on transgender women of color and 22% focused on young transgender persons aged 15-29 years old. Most interventions focused on Treat or Prevent, few focused on Diagnosis, and none focused on Respond. Twenty interventions (87%) showed improvement in at least one EHE related outcome and a quarter of these effective interventions were tested with randomized controlled trials. Common strategies observed in effective interventions include the following: engaging the community in intervention development; pilot-testing with the focus population to ensure appropriateness and acceptability; addressing social determinants of health (e.g. stigma, discrimination, violence) through empowerment and gender-affirming approaches; increasing access to care, prevention, and services through co-location and one-stop shop models; and utilizing peer-led counseling, education, support, and navigation. Continuous effort is needed in addressing gaps, including more research for transgender men and rural settings and for how best to adopt and adapt best practices for subgroups of transgender population.

RESUMEN: Esta revisión sistemática sintetizó la literatura publicada (2000 ­ 2023) para identificar intervenciones relacionadas con el VIH diseñadas específicamente para personas transgénero en los Estados Unidos y resumió las estrategias para mejorar los resultados relacionados con los cuatro pilares de la iniciativa Poner fin a la Epidemia del VIH (EHE por sus siglas en inglés). Diagnosticar, Tratar, Prevenir y Responder. Este protocolo de estudio se registró en PROSPERO (CRD42022364101). Se realizó una búsqueda exhaustiva utilizando la base de datos del Proyecto de Síntesis de Investigación sobre Prevención del VIH de los Centros para el Control y la Prevención de Enfermedades, que incluyó más de 120.000 citas de búsquedas sistemáticas de rutina en CINAHL, EMBASE, Global Health, MEDLINE, PsycInfo y Sociological Abstracts. De las 23 intervenciones que cumplieron con los criterios de inclusión, el 94% se centró en mujeres transgénero de color y el 22% se centró en personas transgénero jóvenes de entre 15 y 29 años. La mayoría de las intervenciones se centraron en los pilares Tratar o Prevenir, pocas se centraron en el pilar de Diagnóstico y ninguna se centró en el pilar de Responder. Veinte intervenciones (87%) mostraron una mejora en al menos un resultado relacionado con la EHE; una cuarta parte de estas intervenciones efectivas se probaron con ensayos controlados aleatorios. Las intervenciones efectivas en todos los pilares compartían características comunes, como la participación de la comunidad en el desarrollo de la intervención; la realización de pruebas piloto con la población objetivo para garantizar la idoneidad y la aceptabilidad; el abordaje de los determinantes sociales de la salud (p.e., el estigma, la discriminación, la violencia, los problemas legales, la vulnerabilidad económica, la vivienda, el transporte, la alimentación) mediante enfoques de empoderamiento y afirmación de género; el aumento del acceso a la atención, la prevención y el servicio (p.e., Mediante la co-ubicación, y el sistema de ventanilla única); y el uso de asesoramiento, educación, apoyo y orientación dirigidos por pares. Se necesita un esfuerzo continuo para abordar las brechas, incluida una mayor investigación para los hombres transgénero y los entornos rurales y para determinar cuál es la mejor manera de adoptar y adaptar las mejores prácticas para los subgrupos de la población transgénero.