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BACKGROUND: Adherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence. METHODS: This randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with ClinicalTrials.gov (NCT03935464). FINDINGS: From March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03-12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion. INTERPRETATION: A low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence. FUNDING: National Institute of Allergy and Infectious Diseases and National Institutes of Health.

BACKGROUND: Exposure to antiretrovirals at or early after HIV acquisition can suppress viral replication and blunt antibody (Ab) responses; a reduced HIV detectability could impact diagnosis and blood donation screening. METHODS: We used three antigen (Ag)/Ab assays and one nucleic acid test (NAT) to analyze samples collected in pre-exposure prophylaxis (PrEP) trials (iPrEx; Partners PrEP) before infection detection by Ab-only rapid diagnostic tests (RDTs), and in early antiretroviral treatment (ART) initiation studies (RV254; SIPP). RESULTS: Reactivity using NAT and Ag/Ab assays in samples collected up to 8 weeks prior to the first reactive RDT from 251 PrEP trials participants varied between 49-61% for active PrEP users and between 27-37% for placebo users. Among RV254 participants, reactivity in Ag/Ab assays was

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) for HIV-1 infection is over 99% effective in protecting against HIV acquisition when used consistently and appropriately. However, PrEP uptake and persistent use remains suboptimal, with a substantial gap in utilization among key populations who could most benefit from PrEP. In Latin America specifically, there is poor understanding of barriers to PrEP uptake and persistence among transgender (trans) women. METHODS: In April-May 2018, we conducted qualitative interviews lasting 25-45 min as part of an end-of-project evaluation of TransPrEP, a pilot RCT that examined the impact of a social network-based peer support intervention on PrEP adherence among trans women in Lima, Peru. Participants in the qualitative evaluation, all adult trans women, included individuals who either (1) screened eligible to participate in the TransPrEP pilot, but opted not to enroll (n = 8), (2) enrolled, but later withdrew (n = 6), (3) were still actively enrolled at the time of interview and/or successfully completed the study (n = 16), or (4) were study staff (n = 4). Interviews were audio recorded and transcribed verbatim. Codebook development followed an immersion/crystallization approach, and coding was completed using Dedoose. RESULTS: Evaluation participants had a mean age of 28.2 years (range 19-47). When describing experiences taking PrEP, participant narratives highlighted side effects that spanned three domains: physical side effects, such as prolonged symptoms of gastrointestinal distress or somnolence; economic challenges, including lost income due to inability to work; and social concerns, including interpersonal conflicts due to HIV-related stigma. Participants described PrEP use within a broader context of social and economic marginalization, with a focus on daily survival, and how PrEP side effects negatively contributed to these stressors. Persistence was, in some cases, supported through the interventions educational workshops. CONCLUSION: This research highlights the ways that physical, economic, and social side effects of PrEP can impact acceptability and persistence among trans women in Peru, amplifying and layering onto existing stressors including economic precarity. Understanding the unique experiences of trans women taking PrEP is crucial to informing tailored interventions to improve uptake and persistence.

BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.

IntroductionIdentifying the optimal approaches to offering HIV prevention to meet the needs of those at risk is a high priority, particularly given the expanding toolkit of biomedical HIV prevention options. An ongoing study in rural East African communities evaluated the uptake of choices in product, testing mode and location of care delivery through a structured patient-centred HIV prevention delivery model. In this qualitative study, we sought to understand clients' experiences of this "dynamic choice prevention model" (DCP) and highlight pathways of action to inform HIV prevention delivery models.MethodsIn-depth semi-structured interviews were conducted from November 2021 through March 2022 with a purposively selected sample of n = 56 participants in DCP trials (across outpatient departments, antenatal clinics and community settings), and n = 21 healthcare providers (total n = 77). A seven-person multi-regional team translated and inductively coded transcript data. We used a framework analysis approach to identify emergent themes.ResultsIndividuals taking up HIV pre-exposure prophylaxis (PrEP) reported feelings of relief, liberation from fears of acquiring HIV and satisfaction with being able to take action despite partners' behaviours. Couples used a range of approaches afforded by the study to persuade partners to get tested and opt for PrEP. Post-exposure prophylaxis (PEP) use was less common, although women welcomed it in the event of sexual coercion or assault. Participants discussed switching from PEP to PrEP after familiarizing themselves with usage and ascertaining ongoing risk. Participants felt respected by providers, trusted them and appreciated being able to contact them directly for telephone support. Prevention uptake was hindered by stigma, limited experience with and knowledge of prevention methods, gendered and generational power dynamics within intimate partnerships and families, and negative perceptions of methods due to the products themselves. Participants anticipated long-acting injectable PrEP could solve their challenges regarding pill size, daily pill burden and the likelihood of unwanted disclosure.ConclusionsDiverse preferences and barriers to uptake of prevention require a choice of HIV prevention options, locations and delivery modalities-but in addition, flexible, competent and friendly care provision is crucial to promote uptake. Helping clients feel valued, and addressing their unique needs and challenges, enables their agency to prioritize their health.

IntroductionGlobally, transgender ('trans') women experience extreme social and economic marginalisation due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are oppressed multiple times. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, as well as race-based stigma to generate a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the 'most at-risk' group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups. Through extensive formative work, we developed Manas por Manas, a multilevel intervention using HIV prevention strategies with demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement in the HIV prevention continuum.Methods and analysisWe are conducting a two-arm randomised wait-list controlled trial of the intervention's efficacy in São Paulo, Brazil, to improve uptake of HIV testing and PrEP among transgender women (N=400). The primary outcomes are changes in HIV testing (self-testing and clinic based), changes in PrEP uptake and changes in PrEP persistence at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and disseminationThis study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Comissão Nacional de Ética em Pesquisa (Research Ethics National Commission, CAAE: 25215219.8.0000.5479) in Brazil. Participants provided informed consent before enrolment. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations.Trial registration numberNCT03081559.

In the pursuit of ending the HIV epidemic, U.S. emergency departments (EDs) have emerged as a valuable setting to increase HIV testing and linkage to care. There is limited data available, however, describing the incorporation of HIV prevention initiatives in U.S. EDs. Over the last decade, HIV pre-exposure prophylaxis (PrEP) has significantly changed the HIV prevention landscape globally and very little is known about the provision of PrEP in U.S. EDs. To address this gap in the literature, we conducted a systematic review of peer-reviewed quantitative studies and conference abstracts spanning July 2012 - October 2022. Of 433 citations, 11 articles and 13 abstracts meet our inclusion criteria, representing 18 unique studies addressing PrEP screening, prescribing, and/or linkage to PrEP care.Most studies describe screening processes to identify PrEP-eligible patients (n = 17); most studies leveraged a patients STI history as initial PrEP eligibility screening criteria. Fewer studies describe PrEP prescribing (n = 2) and/or linkage to PrEP care (n = 8).Findings from this systematic review highlight the potential for U.S. EDs to increase PrEP uptake among individuals at risk for HIV infection. Despite a growing number of studies exploring processes for incorporating PrEP into the ED setting, such studies are small-scale and time limited. Models providing prescribing PrEP in the ED show higher initiation rates than post-discharge engagement models. Electronic health record (EHR)-based HIV screening is valuable, but post-ED linkage rates are low. Our findings emphasize the need to establish best practices for initiating and supporting prevention effective PrEP use in the ED setting.

Developmental assets are critical to the health and wellbeing of youth. The current study examines the influence of developmental assets on PrEP use and HIV testing among YBMSM ages 18-24. Using a cross-sectional survey of YBMSM (N = 225), this study explored the role of external (e.g., family support, other adult support) and internal (e.g., personal responsibility) assets in explaining HIV prevention behaviors. Participants were recruited from Mechanical Turk (M-Turk) internet-based platform, social media sites, and community-based organizations. A path analysis was conducted to investigate the direct/indirect effects of internal and external assets on PrEP use and HIV testing. Family support (β = 0.40, p

IntroductionHPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.MethodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.ResultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).ConclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

BackgroundLong-acting (LA) antiretrovirals may provide meaningful benefit to people who use drugs and people experiencing homelessness (PEH) who face disproportionate structural and psychosocial barriers in adhering to daily oral HIV antiretroviral therapy or pre-exposure prophylaxis (PrEP), but their use in these populations has not been studied.SettingThe Maria X. Martinez Health Resource Center is a low-barrier (eg, no appointment) community-based clinic serving San Francisco PEH.MethodsA multidisciplinary care model with robust monitoring and outreach support was developed to provide LA antiretroviral therapy (ART) and LA-PrEP to eligible patients experiencing difficulties adhering to oral antiretrovirals. Feasibility was assessed by evaluating the rates of HIV viremia and on-time injections among patients receiving LA antiretrovirals over the first 24 months of program implementation.ResultsBetween November 2021 and November 2023, 33 patients initiated LA-ART or LA-PrEP (median age, 37 years; 27% transgender/nonbinary; 73% non-White; 27% street homeless; 52% sheltered homeless; 30% with opioid use disorder; 82% with methamphetamine use disorder). Among 18 patients with HIV, 14 initiated LA-ART injections with detectable viremia (median CD4 count, 340 cells/mm 3 ; mean log 10 viral load, 3.53; SD, 1.62), 8 had never previously been virally suppressed, and all but 1 achieved or maintained virologic suppression (mean, 9.67 months; SD, 8.30). Among 15 LA-PrEP patients, all remained HIV negative (mean, 4.73 months; SD, 2.89). Of 224 total injections administered, 8% were delayed >7 days.DiscussionThe implementation of LA antiretrovirals is feasible in low-barrier, highly supportive clinical settings serving vulnerable PEH. Expansion of such programs will be critical in ending the HIV epidemic.

BackgroundPregnant and postpartum women in Sub-Saharan Africa are at high risk of HIV acquisition. We evaluated a person-centered dynamic choice intervention for HIV prevention (DCP) among women attending antenatal and postnatal care.SettingRural Kenya and Uganda.MethodsWomen (aged 15 years or older) at risk of HIV acquisition seen at antenatal and postnatal care clinics were individually randomized to DCP vs. standard of care (SEARCH; NCT04810650). The DCP intervention included structured client choice of product (daily oral pre-exposure prophylaxis or postexposure prophylaxis), service location (clinic or out of facility), and HIV testing modality (self-test or provider-administered), with option to switch over time and person-centered care (phone access to clinician, structured barrier assessment and counseling, and provider training). The primary outcome was biomedical prevention coverage-proportion of 48-week follow-up with self-reported pre-exposure prophylaxis or postexposure prophylaxis use, compared between arms using targeted maximum likelihood estimation.ResultsBetween April and July 2021, we enrolled 400 women (203 intervention and 197 control); 38% were pregnant, 52% were aged 15-24 years, and 94% reported no pre-exposure prophylaxis or postexposure prophylaxis use for ≥6 months before baseline. Among 384/400 participants (96%) with outcome ascertained, DCP increased biomedical prevention coverage 40% (95% CI: 34% to 47%; P < 0.001); the coverage was 70% in intervention vs. 29% in control. DCP also increased coverage during months at risk of HIV (81% in intervention, 43% in control; 38% absolute increase; 95% CI: 31% to 45%; P < 0.001).ConclusionA person-centered dynamic choice intervention that provided flexibility in product, testing, and service location more than doubled biomedical HIV prevention coverage in a high-risk population already routinely offered access to biomedical prevention options.

BACKGROUND: Prior research has consistently shown that the involvement of families plays a vital role in reducing risk behaviors, such as engaging in condomless sex, and promoting HIV prevention behaviors among young Black men who have sex with men (YBMSM). With the aim of expanding the existing knowledge, this study aimed to examine the specific influence of families and other supportive adults in facilitating casual condom use, partner condom use, HIV testing, and preexposure prophylaxis (PrEP) utilization among young Black MSM. METHODS: A sample of YBMSM aged 18-29 years (N = 400) was collected online. We used a path analysis to examine the influence of family factors on PrEP stigma and PrEP use. Respondents were recruited from December 1, 2021, to January 31, 2022. We used a path analysis to examine the direct and indirect effects of family factors on PrEP use through HIV testing and encouraging condom use. RESULTS: Among BMSM, other adult support was positive and directly associated with condom use by both casual partners (β = 0.04, p

BACKGROUND: Pregnant and breastfeeding women (PBW) in sub-Saharan Africa have high HIV incidence rates and associated risk of vertical transmission to their infants. Oral preexposure prophylaxis (PrEP) and injectable PrEP (long-acting cabotegravir, or CAB-LA) can potentially reduce this HIV transmission, but population-level impacts are uncertain. METHODS: We extended a previously developed model of HIV and PrEP in South Africa to allow for variable PrEP duration and preference in PBW. We considered three potential scenarios for PrEP provision to PBW: oral PrEP only, CAB-LA only, and allowing oral/CAB-LA choice, with uptake and retention assumptions informed by South African data, each compared with a base scenario without PrEP for PBW. RESULTS: Without PrEP for PBW, the model estimates 1.31 million new infections will occur between 2025 and 2035 in South African adults and children, including 100 000 in PBW, 16 800 in infants at/before birth, and 35 200 in children through breastmilk. In the oral PrEP-only scenario, these numbers would reduce by 1.2% (95% CI: 0.7-1.7%), 8.6% (4.8-12.9%), 4.0% (2.1-5.8%), and 5.3% (3.0-8.2%) respectively. In the CAB-LA-only scenario, the corresponding reductions would be 6.1% (2.9-9.6%), 41.2% (19.8-65.0%), 12.6% (6.0-19.4%), and 29.5% (13.9-46.8%), respectively, and in the oral/CAB-LA choice scenario, similar reductions would be achieved [5.6% (3.4-8.0%), 39% (23.4-55.9%), 12.4% (7.4-16.8%) and 27.6% (16.5-39.9%) respectively]. CONCLUSION: CAB-LA has the potential to be substantially more effective than oral PrEP in preventing HIV acquisition in PBW and vertical transmission, and can also modestly reduce HIV incidence at a population level.

ObjectivePregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa.MethodsThe STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for Chlamydia trachomatis, Neisseria gonorhoeae and Trichomonas vaginalis (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes.ResultsWe enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age.ConclusionsPOC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW.Trial registration numberNCT03902418; Clinical Trials.gov; 1 April 2019.

BackgroundPrEP, a biomedical HIV prevention option, continues to be underutilized among transgender women who could benefit from sustained use, especially women of color and those who identify as Latina and/or reside in the southeastern US.ObjectiveWe explored the barriers and facilitators experienced by transgender women who live in Florida regarding accessing, using, and/or staying on PrEP.MethodsIn-depth interviews and focus groups were conducted in either Spanish or English with adult transgender women living in Florida (N = 22). The interviews were audio-recorded, transcribed, and coded in ATLAS.ti using thematic analyses.ResultsThe mean age of the participants was 42.2 years. Among the participants, 73% were Hispanic/Latina, 59% were foreign-born, and approximately one-third were living with HIV (but had past experience with PrEP). Transgender women cited the following barriers to accessing or considering PrEP: (1) costs and benefits of PrEP use; (2) under-representation in clinical trials resulting in unknown or misinformation regarding PrEP side effects; (3) chronic poverty; and (4) trauma and discrimination. Other stressors, such as behavioral healthcare needs, were identified.ConclusionsOur analysis revealed interlocking systems of oppression like transphobia, discrimination, and misgendering, which were common barriers experienced by our participants. These synergistically epidemic (i.e., syndemic) barriers contributed to their feelings of being systematically excluded in social spaces, research, public health planning and policies, laws, and social programs related to PrEP. These structural barriers are impediments to HIV preventive care but also act as a source of stress that contributes to mental health problems, financial vulnerability, substance abuse, and other deleterious health outcomes.

BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as sex workers. This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of PrEPare for Work,- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the PrEPare for Work Stage 1 intervention (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the PrEPare for Work Stage 2 intervention (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs unique life circumstances are urgently needed. In this study, we are evaluating whether PrEPare for Work can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Many patients who are at high risk of HIV transmission do not receive pre-exposure prophylaxis (PrEP). HIV risk counselling and PrEP initiation have historically been limited to outpatient settings. Here we describe a novel quality improvement project at San Franciscos main safety-net hospital designed to incorporate universal screening for active HIV risk factors and PrEP initiation into standard inpatient care. Interventions included education sessions and dissemination of clinical materials to increase providers knowledge and comfort with HIV risk screening, prevention counselling and prescribing PrEP. We implemented new workflows on the inpatient medicine service to encourage providers to universally screen all patients at the time of admission and initiate PrEP for appropriate patients during their hospitalisation. Over the first 9 months of the initiative, 14 inpatients were started on PrEP during their admission. As PrEP was initiated in particularly vulnerable patients, using inpatient admissions to engage at-risk patients in HIV prevention may help to reduce disparities in HIV outcomes.

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

BackgroundCisgender women account for 1 in 5 new HIV infections in the United States, yet remain under-engaged in HIV prevention. Women experiencing violence face risk for HIV due to biological and behavioral mechanisms, and barriers to prevention, such as challenges to Pre-Exposure Prophylaxis for HIV Prevention (PrEP) adherence. In this analysis, we aim to characterize intimate partner violence (IPV) among cisgender heterosexual women enrolled in a PrEP demonstration project and assess the associations with PrEP adherence.MethodsAdherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label study of PrEP adherence in HIV-negative cisgender women in Southern California (N = 130) offered daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). From 6/2016 to 10/2018, women completed a survey reporting HIV risk behavior and experiences of any IPV (past 90-days) and IPV sub-types (past-year, lifetime) and biological testing for HIV/STIs at baseline, and concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots at weeks 4, 12, 24, 36, and 48. Outcomes were TFV-DP concentrations consistent with ≥ 4 or ≥ 6 doses/week at one or multiple visits. Multivariable logistic regression models were conducted to examine associations.ResultsPast-90-day IPV was reported by 34.4% of participants, and past-year and lifetime subtypes reported by 11.5-41.5%, and 21.5-52.3%, respectively. Women who engaged in sex work and Black women were significantly more likely to report IPV than others. Lifetime physical IPV was negatively associated with adherence at ≥ 4 doses/week at ≥ 3 of 5 visits, while other relationships with any IPV and IPV sub-types were variable.ConclusionIPV is an indication for PrEP and important indicator of HIV risk; our findings suggest that physical IPV may also negatively impact long-term PrEP adherence.Clinical trials registrationNCT02584140 (ClinicalTrials.gov), registered 15/10/2015.

BackgroundElectronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.ObjectiveAs part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.MethodsEight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements.ResultsDue to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites.ConclusionsThe process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

Transgender women (TW) face inequities in HIV and unique barriers to PrEP, an effective biomedical intervention to prevent HIV acquisition. To improve PrEP retention among TW, we examined factors related to retention using a two-phase, sequential explanatory mixed methods approach. In Phase I, we used data from a trial of 170 TW who were provided oral PrEP to examine predictors of 24-week retention. In Phase II, we conducted 15 in-depth interviews with PrEP-experienced TW and used thematic analysis to explain Phase I findings. In Phase I, more participants who were not retained at 24 weeks reported sex work engagement (18% versus 7%) and substantial/severe drug use (18% versus 8%). In Phase II, participants reported drug use as a barrier to PrEP, often in the context of sex work, and we identified two subcategories of sex work. TW engaged in "non-survival sex work" had little difficulty staying on PrEP, while those engaged in "survival sex work" struggled to stay on PrEP. In Phase I, fewer participants not retained at 24 weeks reported gender-affirming hormone therapy (GAHT) use (56% versus 71%). In Phase II, participants prioritized medical gender affirmation services over PrEP but also described the bidirectional benefits of accessing GAHT and PrEP. TW who engaged in "survival sex work" experience barriers to PrEP retention (e.g., unstable housing, drug use) and may require additional support to stay in PrEP care.

OBJECTIVE: To compare pregnancy outcomes using self-reported and objective levels of intracellular tenofovir diphosphate (TFV-DP) in pregnant women using preexposure prophylaxis (PrEP). DESIGN: We enrolled pregnant women >15 years without HIV at first antenatal care visit in an observational cohort study to compare pregnancy outcomes by PrEP use. METHODS: Exposure defined as: any PrEP use [tenofovir disoproxil and emtricitabine (TDF/FTC]) prescription + reported taking PrEP], or objectively-measured TFV-DP in dried blood spots in PrEP-using pregnant women. The primary outcome was a composite of pregnancy loss, preterm birth (

Body weight is influenced by an interplay of individual and environmental factors. In people with human immunodeficiency virus (HIV), weight is also influenced by disease status with loss accompanying disease progression that is reversed with effective antiretroviral therapy. Weight changes in comparative antiretroviral therapy trials differ by regimen, with greater gains observed with the integrase strand transfer inhibitors dolutegravir and bictegravir, particularly when coadministered with tenofovir alafenamide fumarate, compared with regimens that include agents such as tenofovir disoproxil fumarate that attenuate weight gain. We review weight changes in major randomized trials of preexposure prophylaxis and initial and switch HIV therapy, highlighting the challenges to assessing the role of antiretroviral therapy in weight change. This examination forms the basis for a model that questions assumptions regarding an association between integrase strand transfer inhibitors and tenofovir alafenamide fumarate and excessive weight gain and calls for more careful consideration of these data when making HIV treatment decisions. [ABSTRACT FROM AUTHOR]

The article discusses the comparative use of tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) for human immunodeficiency virus (HIV) treatment. Topics discussed include the efficacy and safety profiles of TDF and TAF, their effects on body weight and metabolic health, and considerations for treatment in specific populations, such as those with advanced HIV disease and pregnant women.

Background: 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. Methods: 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. Results: 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 LAIPrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services. Conclusion: Pharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background The impact of migration on HIV risk among non-migrating household members is poorly understood. We measured HIV incidence among non-migrants living in households with and without migrants in Uganda. Methods We used four survey rounds of data collected from July 2011 to May 2018 from non-migrant participants aged 15–49 years in the Rakai Community Cohort Study. Non-migrants were individuals with no-migration between surveys or at the prior survey. Household migration was defined as ≥1 household member migrating into or out of the house from another community between surveys (∼18 months). Incident HIV was defined as testing HIV seropositive following a negative result. Incidence rate ratios (IRRs) were estimated using Poisson regression with generalized estimating equations. Analyses were stratified by gender, migration into or out of the household and the relationship between non-migrants and migrants (e.g. spouse, child). Results About 11 318 non-migrants (5674 women) were followed for 37 320 person-years. Twenty-eight percent (6059/21 370) of non-migrant person-visits had recent migration into or out of the household, and 240 HIV incident cases were identified. Overall, non-migrants in migrant households were not at greater risk of acquiring HIV than non-migrants in households without any migration. However, men were significantly more likely to acquire HIV if their spouse had recently migrated in [adjusted IRR: 2.12; 95% confidence interval (CI): 1.05–4.27] or out (adjusted IRR: 4.01; 95% CI, 2.16–7.44) compared with men with no spousal migration. Conclusions HIV incidence is higher among non-migrant men with migrant spouses. Targeted HIV testing and prevention interventions like pre-exposure prophylaxis could be considered for men with migrant spouses. [ABSTRACT FROM AUTHOR]

We emulated a hypothetical target trial in which hematological subjects cared at the University Hospital of Pisa (Italy) received or not SARS-CoV-2 prophylaxis with tixagevimab/cilgavimab. Subjects who received prophylaxis (cases) were compared to those who did not (controls). The main outcome was SARS-CoV-2 infection in the subsequent 6 months. Inverse probability weighting (IPW) was used to adjust for confounders. A multivariable analysis was performed to identify variables associated with SARS-CoV-2 infection. We recruited 462 patients: 228 received prophylaxis, 234 were controls. COVID-19 was lower in cases compared to controls (16.7% vs 24.8%, p = 0.03, after IPW 14.3% vs 24.6%, p = 0.01). On multivariable analysis, B-cell depleting therapies (HR 2.09, 95%CI 1.05-4.18, p = 0.037) were associated with increased risk of COVID-19, while tixagevimab/cilgavimab prophylaxis (HR 0.45, 95%CI 0.27-0.73, p = 0.001) and previous SARS-CoV-2 infection (HR 0.27, 95%CI 0.14-0.51, p < 0.001) were protective. In conclusion, prophylaxis with monoclonal antibodies may reduce the risk of COVID-19 in hematological patients. [ABSTRACT FROM AUTHOR]

Aims: Many transgender and gender diverse (TGD) individuals have expressed concerns about the potential for oral pre‐exposure prophylaxis to affect hormonal concentrations achieved from taking gender‐affirming hormone therapy (GAHT). The purpose of this study was to understand the bidirectional effects between hormone and intraerythrocytic tenofovir diphosphate concentrations when switching from tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to tenofovir alafenamide/emtricitabine (TAF/FTC) in TGD users/nonusers of GAHT. Methods: The study evaluated stored blood samples and dried blood spot cards from TGD adults without HIV who took ≥12 weeks of TDF/FTC and then switched to ≥12 weeks of TAF/FTC for pre‐exposure prophylaxis. Results: Thirty‐nine individuals met the study inclusion criteria. Regardless of sex assigned at birth and the use of GAHT, there were no significant differences in hormone concentrations when individuals taking GAHT were taking TDF/FTC and then switched to TAF/FTC. Further, there was no significant difference in intraerythrocytic tenofovir diphosphate concentrations between users and nonusers of GAHT. Conclusion: There are no bidirectional effects between hormone and intraerythocytic tenofovir diphosphate concentrations when switching from TDF/FTC to TAF/FTC in TGD users/nonusers of GAHT. [ABSTRACT FROM AUTHOR]

Objective: Separately, individuals with criminal legal involvement (CLI) and those who identify as a sexual minority are at heightened risk for experiencing discrimination and engaging in hazardous alcohol use; however, little is known about the prevalence of these experiences and behaviors among sexual minority individuals who also have a history of CLI. Method: We examined experiences of discrimination and hazardous alcohol use reported by individuals with CLI and compared prevalence between those who identify as a sexual minority and those who do not. Baseline, cross-sectional data of cisgender sexual minority individuals from a multisite, prospective cohort study examining pre-exposure prophylaxis acceptability and uptake among criminal legal-involved adults were analyzed (N = 362, 14% sexual minority). Results: Hazardous alcohol consumption was nearly twice as prevalent among participants who identified as a sexual minority compared to heterosexual participants, and a sexual minority identity was associated with higher discrimination scores. Additionally, hazardous drinking was more prevalent among those with higher discrimination scores. Conclusions: This study suggests that sexual minority individuals with a history of CLI are an especially high-risk group given the elevated rates of discrimination and hazardous alcohol use observed. More research is needed to further investigate the risk behaviors of this population and to develop interventions to intervene on their physical and mental health. [ABSTRACT FROM AUTHOR]

Although it is an effective HIV prevention method, pre-exposure prophylaxis (PrEP) is underutilized in the Southern US. Many people who use drugs (PWUD) have increased susceptibility to HIV which could be lessened by using PrEP. Potential barriers to PrEP use include lack of awareness of PrEP, low knowledge about HIV prevention, low self-efficacy for HIV prevention, inaccurate risk perceptions, and anticipated stigma. The current study examined predisposing, enabling, and reinforcing factors that may predict interest in PrEP. The purpose of the current study was to explore factors associated with interest in and willingness to use daily oral and long acting injectable PrEP among sexually active adult PWUD. The data were collected from adult participants (n = 270) residing in Harris County, TX, who self-reported problematic substance use and who reported oral, anal, or vaginal sex in the six months prior to completing the survey. The survey was distributed and completed online via Qualtrics Panels in March of 2022 and included measures of PrEP and HIV knowledge, PrEP stigma, sexual health self-efficacy, experiences of discrimination, health literacy, and medical mistrust. The majority of participants reported circumstances or behaviors that increased their susceptibility to HIV. Findings indicated that PrEP user stereotypes and PrEP anticipated disapproval by others were associated with interest in using daily oral PrEP and willingness to use long acting injectable PrEP. These results provide insight into reasons for low PrEP uptake among PWUD who live in a high HIV prevalence jurisdiction. Implications for HIV prevention intervention are discussed. [ABSTRACT FROM AUTHOR]

In the United States, immigrant Latino men who have sex with men (ILMSM) are, compared to white MSM, disproportionately burdened by HIV and lack access to highly effective HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). Qualitative research centered on exploring barriers that ILMSM experience in accessing PrEP and other sexual services is extremely limited, despite a high prevalence of HIV in this population. In this study, a purposive sample of ILMSM (n = 25) was recruited to participate in a semi-structured in-depth interview to identify the distinct barriers and facilitators ILMSM experience in accessing sexual health services given their complex intersectional identities of being an immigrant, Latino, and a sexual minority man. Using a thematic analysis approach, nine themes were generated from the data representing barriers and facilitators. Barriers included: (1) cost and a lack of health insurance, (2) complexity of PrEP assistance programs; (3) challenges related to the immigrant experience; (4) impact of gay stigma; and (5) communication challenges. Facilitators included: (1) improving affordability and accessibility of PrEP services; (2) receiving services from LGBT- or Latine LGBT-centered clinics; (3) receiving services from medical providers who are gay and/or Latino; and (4) providing targeted community outreach, education, and promotion of PrEP to ILMSM. While many of the barriers illuminated in the study were structural (e.g., cost and lack of health insurance), and not easy to overcome, the findings highlight a range of facilitators that can support access to PrEP and other sexual health services for ILMSM. Considering these findings, we suggest strategies that may enhance access to needed sexual health services among ILMSM. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus pre-exposure prophylaxis (PrEP) is considered as an effective protection against a human immunodeficiency virus (HIV) infection. However, it is still unclear, how PrEP use is associated with the incidence of sexually transmitted infections (STI) other than HIV. PrEP became reimbursable in Germany from September 1, 2019 for persons with statutory health insurance (SHI). With the EvE-PrEP study, the Federal Ministry of Health commissioned the evaluation of the effects of the new reimbursement situation in Germany. In the presented module of the EvE-PrEP study, routine data from three large German SHI funds were analyzed in anonymized form for the period January 1, 2019 to March 31, 2020. Data were analyzed regarding: Characteristics and adherence of PrEP users, treatment success of PrEP, and changes in STI incidence rates before and since PrEP use. The cooperating SHI funds collectively covered about 52% of the overall population in Germany in 2019. A total of 7102 persons with PrEP use were included into the analysis. These were predominantly male (99%), on average 37.4 years old and a high proportion of persons lived in large cities. The average quotient of PrEP daily defined doses and assumed days on PrEP was 87%. The average STI rates normalized per 100 person-years at individual level pre PrEP did not statistically significant differ compared to since PrEP (chlamydia: 17.5 vs. 17.6, gonococcal infection: 29.1 vs. 30.7, and syphilis: 14.6 vs.13.6). A large data set was used to evaluate the introduction of PrEP as a SHI benefit in Germany. A potentially suspected increase in bacterial STI incidence rates was not found. A rather high average adherence rate was observed. The very high proportion of men and people from the largest German cities among PrEP users is striking. These results could indicate barriers to PrEP access for people at risk of HIV, especially if they are women or people living in less urban areas. [ABSTRACT FROM AUTHOR]

Cisgender women and transgender men are less likely to be assessed for PrEP eligibility, prescribed PrEP, or retained in PrEP care. Thus, this pilot PrEP educational intervention was tailored for healthcare providers (HCPs) in obstetrics/gynecology who provide care to cisgender women and transgender men in an academically-affiliated, public hospital women's health clinic. The three-lecture educational curriculum designed for HCPs focused on PrEP eligibility and counseling, formulations and adherence, and prescription and payment assistance programs. Pre- and post-intervention surveys assessed HCP knowledge and barriers to PrEP counseling and prescription. Among n = 49 participants (mean age = 32.8 years; 85.7% cisgender women, mean years practicing = 4.2 years) pre-intervention, 8.7% had prior PrEP training and 61.2% felt very/somewhat uncomfortable prescribing PrEP. Post-intervention, knowledge of PrEP contraindications, eligibility, follow-up care, and assistance programs all increased. HCPs identified key barriers to PrEP care including lack of a dedicated PrEP navigator, culturally and linguistically appropriate patient materials on PrEP resources/costs, and PrEP-related content integrated into EHRs. Ongoing PrEP educational sessions can provide opportunities to practice PrEP counseling, including information on financial assistance. At the institutional level, incorporating PrEP screening in routine clinical practice via EMR prompts, facilitating PrEP medication monitoring, and enhancing telehealth for follow-up care could enhance PrEP prescription. [ABSTRACT FROM AUTHOR]

National responses should be improved and accelerated to meet the target of ending the Acquired ImmunoDeficiency Syndrome (AIDS) epidemic by 2030. In the Republic of Cyprus, Men who have Sex with Men (MSM) are disproportionately affected by Human Immunodeficiency Virus (HIV), accounting approximately for half of all annual HIV diagnoses. This study assesses the evolution of HIV incidence in MSM in Cyprus until 2030 using a model calibrated to Cypriot epidemiological data. Four scenarios were examined: status quo, two scenarios focusing on introducing Pre-Exposure Prophylaxis (PrEP), and a 90% HIV incidence reduction scenario. Reaching only the 95-95-95 HIV cascade of care targets among MSM would reduce HIV incidence by 48.6% by 2030 compared to 2015. Initiating a PrEP intervention only for high risk MSM would cause a modest further reduction in HIV incidence. To meet the 90% reduction target, PrEP should be expanded to both high and medium risk MSM and, after 2025, behavioral interventions should be implemented so as high-risk MSM gradually move to the medium-risk category. Cyprus will not reach the HIV incidence reduction target by 2030 unless PrEP is gradually promoted and delivered to all high and medium risk MSM along with awareness and behavioral interventions. [ABSTRACT FROM AUTHOR]

The United States Preventive Services Task Force recommends pre-exposure chemoprophylaxis for persons at high risk of HIV exposure. The optimal screening strategy for at-risk individuals in primary care is not known. We evaluated the strategy of universal screening and discussed challenges to the implementation of this recommendation in primary care. Around 430 of 500 (86%) screening surveys were completed. Mutual monogamy was common but monogamous partners with recent negative HIV testing were uncommon. Likewise, among heterosexually active men and women, inconsistent condom use was common. Such individuals would be on guideline for HIV pre-exposure prophylaxis (PrEP) if their partner was at risk for HIV exposure. None of these potentially at-risk individuals met the criteria for PrEP, but 13% lacked knowledge of their partners' sexual and behavioral risk factors, preventing a clear decision on whether PrEP should be used. Our screen identified no individuals who clearly met the guideline criteria for HIV PrEP. We conclude that universal screening for HIV PrEP in primary care is unlikely to be an efficient strategy; targeted screening is likely more appropriate. Moreover, the 2019 guidelines for heterosexually active men and women rely on information that is often unknown to the patient, which makes these guidelines difficult to implement. Future guidelines should address these problems. [ABSTRACT FROM AUTHOR]

Purpose of Review: Despite the growing availability of oral PrEP, coverage remains suboptimal. Through the introduction of additional PrEP methods, including vaginal rings and long-acting injectable formulations, health systems globally are on the cusp of offering PrEP methods that vary by route of administration, efficacy, and frequency of use. With PrEP choice, it will be important to explore PrEP use patterns to better understand how the ability to choose and switch products affects coverage and continuation. In this review, we draw parallels with family planning (FP) by summarizing how method choice and product switching affected contraceptive coverage globally, synthesize what is known about PrEP product switching, and outline evidence gaps to help guide future research on PrEP switching in the context of choice. Recent Findings: Decades of research in FP has demonstrated that product switching is common and can lead to more satisfaction and increases in contraceptive use. While research on PrEP product switching is nascent, findings suggest switching is common, and that providing more than one PrEP option can increase coverage. Key evidence gaps include understanding product switching in the context of full versus constrained choice, switching in the context of temporary need, and developing interventions that promote product switching for those who could benefit. Summary: Providing choice and allowing people to start, stop, and switch products according to their needs and desires is a core component of a rights-based approach to HIV prevention. More research is needed to better understand what drives use patterns, including switching, and how to leverage choice to improve coverage. Standard definitions —some of which have been proposed in this review—are needed to inform comparable measurement. Finally, there is a need to holistically frame PrEP use to acknowledge changes in need over the life course, thus making method switching a standard part of HIV prevention. [ABSTRACT FROM AUTHOR]

Daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, though efficacy depends on adherence. Digital pill systems (DPS) can enable direct, real-time adherence measurement. HIV-negative men who have sex with men (MSM) with substance use (excluding alcohol) utilized a DPS over 90 days and completed weekly surveys reporting sexual activity, condom use, and substance use. Responses indicating (1) any sexual activity and substance use or (2) condomless anal intercourse (CAI) in the prior week were categorized as high risk for HIV acquisition. PrEP adherence data for the 7-day period preceding each response was dichotomized as ≤ 3 and ≥ 4 doses/week, indicating prevention-effective adherence, and compared by HIV risk level. Thirteen MSM were analyzed (median age: 32). Of 113 surveys, 48.7% indicated high HIV risk, with 12.4% reporting CAI alone, 16.8% any sexual activity and substance use, and 19.5% both CAI and substance use. Weekly mean PrEP adherence was 90.3% (6.3 of 7 doses/week), with ≥ 4 doses/week recorded during 92.0% of weeks. The proportion of participants with ≥ 4 recorded doses/week was 88.9% during weeks with CAI alone, 89.5% during weeks with any sexual activity and substance use, 92.0% during weeks with both CAI and substance use, and 92.8% during lower risk weeks. Participants ingested ≥ 4 doses/week during 89.1% of all high-risk weeks and 94.8% of low-risk weeks. Overall, participants maintained high levels of PrEP adherence while engaging in HIV risk behaviors. DPS can be deployed concurrently with data collection tools to assess ingestion patterns during periods of elevated risk. [ABSTRACT FROM AUTHOR]

Mobile populations such as fisherfolk show high HIV incidence and prevalence. We pilot-tested implementation strategies to enhance pre-exposure prophylaxis (PrEP) uptake and adherence in the context of healthcare outreach events in two mainland fisherfolk communities on Lake Victoria, Uganda from September 2021 to February 2022. The implementation strategies included PrEP adherence supporters (selected from PrEP users' social networks), community workshops (to address misconceptions and stigma, and empower PrEP advocacy), and check-in calls (including refill reminders). PrEP medical records data were collected from 6-months pre-intervention to 6-months post-intervention. Qualitative interviews with 20 PrEP users (10 who continued, 10 who discontinued), 9 adherence supporters, and 7 key partners (providers, community leaders) explored acceptability. Percentages of PrEP initiators (of those eligible) were significantly higher during the intervention (96.5%) than 6-months before the intervention (84.5%), p < 0.0001; percentages of PrEP users who persisted (i.e., possessed a refill) 6-months post-initiation (47.9% vs. 6.7%) and had at least 80% PrEP coverage (based on their medication possession ratio) from the initiation date to 6-months later (35.9% vs. 0%) were higher during versus pre-intervention, p < 0.0001. A comparison fisherfolk community with better healthcare access had lower uptake (78.3%; p < 0.0001) and persistence at 6-months (34.0%; p < 0.001), but higher coverage during the intervention period (70.4%; p < 0.0001). Qualitative data suggested the strategies promoted PrEP use through reduced stigma and misconceptions. The intervention bundle cost was $223.95, $172.98, and $94.66 for each additional person for PrEP initiation, persistence, and coverage, respectively. Enhanced community-based PrEP implementation that fosters a supportive community environment can improve PrEP use in mobile populations without easy access to healthcare. (NCT05084716). [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP), including daily oral, on-demand, and long-acting injectable (LAI), is a promising HIV prevention intervention for men who have sex with men (MSM). We conducted a systematic review on engagement with the PrEP continuum among MSM in China. A total of 756 studies were initially identified and 36 studies were included (N = 26,021). In the 20 studies (N = 13,886) examining PrEP awareness, 32.4% (95% CI: 25.1–40.7) of MSM were aware of PrEP. In the 25 studies (N = 18,587) examining willingness, 54.5% (95% CI: 41.9–66.5) MSM indicated they were willing to use PrEP. The pooled prevalence of PrEP uptake from 9 studies (N = 6,575) was 4.9% (95% CI: 1.4–15.8%), while pooled estimates of adequate adherence from five studies (N = 2,344) among MSM on PrEP was 40.7% (95% CI: 20.0-65.2%). Subgroup analyses suggested studies conducted after 2015 (versus before) tended to report higher awareness and uptake. Awareness was highest for daily oral PrEP, followed by on-demand, and LAI PrEP; willingness to use was highest for LAI PrEP. The operationalization of willingness and adherence constructs varied across studies and complicated the interpretation of pooled estimates. This review revealed gaps in the PrEP care continuum among MSM in China, with relatively low awareness and uptake (in contrast to willingness and adherence) as the major potential barriers to widespread implementation and the need for a unified approach to defining and measuring PrEP outcomes. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide. Methods: We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB. Results: From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation. Conclusions: Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout. [ABSTRACT FROM AUTHOR]

Background: Women exposed to intimate partner violence (IPV) experience multiple social and structural barriers to accessing HIV pre-exposure prophylaxis (PrEP), despite being at increased risk for HIV. In addition, few existing HIV prevention interventions address IPV. A recently developed PrEP decision aid for women has the potential to reach IPV survivors at risk for HIV if it could be integrated into existing domestic violence agencies that prioritize trust and rapport with female IPV survivors. Leveraging non-traditional service delivery mechanisms in the community could expand reach to women who are IPV survivors for PrEP. Methods: We conducted qualitative interviews and online qualitative surveys with 33 IPV survivors and 9 domestic violence agency staff at two agencies in Connecticut. We applied the Consolidated Framework for Implementation Research (CFIR) to understand barriers and facilitators to delivering a novel PrEP decision aid to IPV survivors in the context of domestic violence service agencies. Results: Most IPV survivors and agency staff thought the PrEP decision aid intervention could be compatible with agencies' existing practices, especially if adapted to be trauma-responsive and delivered by trusted counselors and staff members. PrEP conversations could be packaged into already well-developed safety planning and wellness practices. Agency staff noted some concerns about prioritizing urgent safety needs over longer-term preventive health needs during crisis periods and expressed interest in receiving further training on PrEP to provide resources for their clients. Conclusions: IPV survivors and agency staff identified key intervention characteristics of a PrEP decision aid and inner setting factors of the service agencies that are compatible. Any HIV prevention intervention in this setting would need to be adapted to be trauma-responsive and staff would need to be equipped with proper training to be successful. [ABSTRACT FROM AUTHOR]

Background: Hydroxychloroquine (HCQ) has proved ineffective in treating patients hospitalised with Coronavirus Disease 2019 (COVID-19), but uncertainty remains over its safety and efficacy in chemoprevention. Previous chemoprevention randomised controlled trials (RCTs) did not individually show benefit of HCQ against COVID-19 and, although meta-analysis did suggest clinical benefit, guidelines recommend against its use. Methods and findings: Healthy adult participants from the healthcare setting, and later from the community, were enrolled in 26 centres in 11 countries to a double-blind, placebo-controlled, randomised trial of COVID-19 chemoprevention. HCQ was evaluated in Europe and Africa, and chloroquine (CQ) was evaluated in Asia, (both base equivalent of 155 mg once daily). The primary endpoint was symptomatic COVID-19, confirmed by PCR or seroconversion during the 3-month follow-up period. The secondary and tertiary endpoints were: asymptomatic laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection; severity of COVID-19 symptoms; all-cause PCR-confirmed symptomatic acute respiratory illness (including SARS-CoV-2 infection); participant reported number of workdays lost; genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity (not reported here); and health economic analyses of HCQ and CQ prophylaxis on costs and quality of life measures (not reported here). The primary and safety analyses were conducted in the intention-to-treat (ITT) population. Recruitment of 40,000 (20,000 HCQ arm, 20,000 CQ arm) participants was planned but was not possible because of protracted delays resulting from controversies over efficacy and adverse events with HCQ use, vaccine rollout in some countries, and other factors. Between 29 April 2020 and 10 March 2022, 4,652 participants (46% females) were enrolled (HCQ/CQ n = 2,320; placebo n = 2,332). The median (IQR) age was 29 (23 to 39) years. SARS-CoV-2 infections (symptomatic and asymptomatic) occurred in 1,071 (23%) participants. For the primary endpoint the incidence of symptomatic COVID-19 was 240/2,320 in the HCQ/CQ versus 284/2,332 in the placebo arms (risk ratio (RR) 0.85 [95% confidence interval, 0.72 to 1.00; p = 0.05]). For the secondary and tertiary outcomes asymptomatic SARS-CoV-2 infections occurred in 11.5% of HCQ/CQ recipients and 12.0% of placebo recipients: RR: 0.96 (95% CI, 0.82 to 1.12; p = 0.6). There were no differences in the severity of symptoms between the groups and no severe illnesses. HCQ/CQ chemoprevention was associated with fewer PCR-confirmed all-cause respiratory infections (predominantly SARS-CoV-2): RR 0.61 (95% CI, 0.42 to 0.88; p = 0.009) and fewer days lost to work because of illness: 104 days per 1,000 participants over 90 days (95% CI, 12 to 199 days; p < 0.001). The prespecified meta-analysis of all published pre-exposure RCTs indicates that HCQ/CQ prophylaxis provided a moderate protective benefit against symptomatic COVID-19: RR 0.80 (95% CI, 0.71 to 0.91). Both drugs were well tolerated with no drug-related serious adverse events (SAEs). Study limitations include the smaller than planned study size, the relatively low number of PCR-confirmed infections, and the lower comparative accuracy of serology endpoints (in particular, the adapted dried blood spot method) compared to the PCR endpoint. The COPCOV trial was registered with ClinicalTrials.gov; number NCT04303507. Interpretation: In this large placebo-controlled, double-blind randomised trial, HCQ and CQ were safe and well tolerated in COVID-19 chemoprevention, and there was evidence of moderate protective benefit in a meta-analysis including this trial and similar RCTs. Trial registration: ClinicalTrials.gov NCT04303507; ISRCTN Registry ISRCTN10207947. In a randomised controlled trial, William Schilling and co-workers investigate potential prevention of COVID-19 by chloroquine or hydroxychloroquine. Author summary: Why was this study done?: At the beginning of the Coronavirus Disease 2019 (COVID-19) pandemic, there was an urgent need to find ways to prevent COVID-19. Laboratory studies showed that the related 4-aminoquinolines, chloroquine (CQ), and hydroxychloroquine (HCQ), which had been used widely for over 50 years, had antiviral activity against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). HCQ proved ineffective in the treatment of hospitalised patients, and individual RCTs testing COVID-19 prophylaxis did not show benefit of HCQ. However, a meta-analysis of trial data did suggest some efficacy in preventing COVID-19. Current evidence-based guidelines using data from the same studies recommend strongly against the use of HCQ for prophylaxis. This study aimed to provide a definitive answer whether or not pre-exposure use of these drugs could prevent COVID-19. What did the researchers do and find?: The COPCOV study was a double-blind placebo-controlled evaluation of CQ and HCQ COVID-19 chemoprevention. It was the largest pre-exposure prophylaxis study in COVID-19. We found that CQ and HCQ were well tolerated and safe in prophylaxis. There was some evidence for protection against symptomatic COVID-19, and a reduction in workdays lost to illness. Our updated meta-analysis of all chemoprevention studies in COVID-19 confirms that chemoprophylaxis with CQ or HCQ is well tolerated, safe, and provides a moderate beneficial effect in preventing COVID-19. What do these findings mean?: Although CQ or HCQ are unlikely to be used in COVID-19 prevention at this stage, they could have been deployed with benefit earlier, and they might have value in future pandemics. Randomised controlled trial (RCT) evidence is essential in evaluating therapeutics in the context of a pandemic. Trials should be facilitated and protected so that evidence is generated rapidly and evidence-based policies can be implemented without delay to allow timely interventions. [ABSTRACT FROM AUTHOR]

Cabotegravir (CAB-LA), the only Food and Drug Administration-approved injectable pre-exposure prophylaxis (PrEP), is effective and may address PrEP uptake disparities among Black and Latino sexual and gender minority (SGM) men. Uptake of CAB-LA may require developing innovative non-clinic-based care delivery strategies in home-based settings. We explored SGM men’s opinions on a future home-based CAB-LA PrEP care service to guide the adaptation of PrEP@Home, an existing home-based PrEP system for oral PrEP. Through 14 in-depth interviews with current or former SGM male participants in the PrEP@Home study, we explored the acceptability of a home-based injectable PrEP system and examined visit and communication-related preferences. All participants considered home-based CAB-LA care to be acceptable and 8/14 would utilize the system if available. Convenience and comfort with using a home-based system impacted the overall acceptance of the approach. Factors influencing acceptability included clinical teams’ affiliation with healthcare systems, a credentialed two-person team, and staff identity verification methods. Logistical preferences included communicating pre-visit patient instructions, allowing flexible scheduling hours, and the use of text, phone calls, or mobile app communication methods based on urgency. Conclusively, a home-based CAB-LA PrEP delivery system was acceptable among the interviewed SGM men, guiding its development and future implementation.Trial registration: ClinicalTrials.gov identifier: NCT03569813. [ABSTRACT FROM AUTHOR]

Background: Awareness and uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) remains low among Black/African American cisgender women, partly due to low self-reported PrEP knowledge and comfort among primary care providers. Ensuring providers are trained on PrEP is crucial, as increased PrEP knowledge is associated with higher rates of PrEP prescription. Objective: We aimed to develop a PrEP training for providers to improve their self-efficacy in discussing and prescribing PrEP for Black women, with the ultimate goal of increasing PrEP awareness and utilization among Black women. Design: In this qualitative study, we conducted focus groups with medical providers at three federally qualified health centers in the Southern and Midwestern United States to identify themes informing the development of a provider PrEP training. Methods: Providers were asked for input on content/design of PrEP training. Transcripts underwent rapid qualitative analysis using the Stanford Lightning Report Method. Themes were identified and presented under the domains of the Consolidated Framework for Implementation Research. Results: Ten providers completed four focus groups. Themes included the individual characteristics of providers (low comfort initiating PrEP discussions, particularly among White providers) and the outer setting of client attitudes (perceptions of potential provider bias/racism, varying levels of concern about HIV acquisition). Opportunities were identified to maximize the benefit of training design (e.g., developing case scenarios to enhance providers' cultural competency with Black women and PrEP knowledge). Conclusion: This comprehensive PrEP training features both didactic material and interactive role-plays to equip providers with the clinical knowledge for prescribing PrEP while building their competency discussing PrEP with Black women. This training is particularly important for providers who have racial or gender discordance with Black women and express lower comfort discussing PrEP with these clients. Provider training could lead to minimizing racial- and gender-based inequities in PrEP use. Plain language summary: Increasing the use of pre-exposure prophylaxis (PrEP) among Black women: a study to improve provider knowledge through PrEP training Why was the study done? Use of pre-exposure prophylaxis (PrEP), a medication that can prevent the transmission of human immunodeficiency virus (HIV), is low among Black/African American women. Part of the reason why is because primary care providers (PCPs) report lower knowledge about PrEP and lower comfort talking about PrEP with clients. Making sure PCPs are trained on PrEP could help increase PrEP use among Black women. What did the researchers do? The research team held focus groups, during which they asked medical providers at federally qualified health centers (FQHCs) in the Southern and Midwestern United States questions about their experiences with discussing PrEP and what information should be included in a training about PrEP for providers to make sure the training would be helpful for them. What did the researchers find? A total of ten providers completed four focus groups. Important points mentioned in the focus groups included low comfort among providers when bringing up PrEP to clients, especially among White providers, as well as different levels of concern about HIV and feelings of potential provider bias/racism among clients. These points helped the researchers design a PrEP training that addresses providers' needs (such as creating case scenarios that help providers practice discussing PrEP with Black women and answering common questions about PrEP). What do the findings mean? A PrEP training for providers should have both information about prescribing PrEP and interactive role-plays to build providers' PrEP knowledge while improving their confidence and skill in talking about PrEP with Black women. This training is particularly important for providers who are a different race or gender than Black women and express lower rates of comfort discussing PrEP with these clients. Provider training could eventually lead to higher PrEP use among Black women. [ABSTRACT FROM AUTHOR]