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

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

Perceptions of and preferences for PrEP use among African American women and providers in the U.S. South: a qualitative study.

OBJECTIVE: African American (AA) women in the U.S. South experience significant HIV incidence, and efforts to support antiretroviral pre-exposure prophylaxis (PrEP) uptake and maintenance among this group have been insufficient. This study aimed to explore perceptions, attitudes, and implementation preferences surrounding PrEP use for AA women in the U.S. South. METHODS AND MEASURES: The study team conducted qualitative interviews with AA cisgender women clients (n = 21) and their providers (n = 20) in Federally Qualified Health Centers and HIV clinics in Alabama. The research team employed directed qualitative content analysis to analyze interview data. RESULTS: Five themes emerged: a) inconsistent access to PrEP and PrEP knowledge, b) need for improving low PrEP awareness, c) managing hesitancy to prescribe or use PrEP, d) perceived HIV vulnerability and inherent stigma, and e) normalizing PrEP as part of routine sexual healthcare to increase uptake and maintenance. Interviews revealed an openness towards PrEP as an HIV prevention strategy for AA, cisgender women in Alabama. CONCLUSION: Improving PrEP uptake and maintenance among AA women in the U.S. South must go beyond increasing awareness to improving PrEP access and trust through visibility of AA women's PrEP use and incorporating PrEP education and services into routine sexual healthcare.

Emergency department visits in the United States by adults with a complaint of diarrhea (2016-2021).

Objectives: For adults with a complaint of diarrhea presenting to United States emergency departments (EDs) from 2016 to 2021, we examined the: (1) occurrence and temporal trends in these ED visits, (2) frequency with which services were provided (laboratory testing, radiologic imaging, and intravenous fluids (IV fluids) administration) and patients were admitted; and (3) factors associated with service provision and admission. Methods: Data from the National Hospital Ambulatory Medical Care Survey (2016-2021) were analyzed. Multivariable logistic regression modeling was employed to examine factors associated with service provision and admission, according to patient demographic characteristics, healthcare insurance status, and associated clinical symptoms; ED geographic location; and type of ED medical staff who evaluated the patient. Results: From 2016 to 2017, there were 3.3-3.7 million ED visits/year by adults with a complaint of diarrhea (3.1% [95% CI 2.9-3.3] of all adult US ED visits). Services were provided and patients were admitted per these frequencies: complete blood count (80%; 95% CI 76-83); blood culture (8%; 95% CI 6-9); metabolic panel (94%; 95% CI 86-97); ultrasound (8%; 95% CI 7-10); abdominal/pelvic CT (33%; 95% CI 29-35); IV fluids (63%; 95% CI 50-66); and admission (16%; 95% CI 14-18). Factors associated with receipt of these services and admission included other presenting symptoms (abdominal pain, vomiting, and nausea), ED geographic location, ED medical staff member evaluating the patient, race, Hispanic ethnicity, and type of health insurance. Conclusion: For adult patients presenting to US EDs with a complaint of diarrhea, US EDs highly utilized selected laboratory tests and radiologic imaging. Differences in utilization raise concerns about equitable healthcare delivery and call for further investigation into the underlying reasons, as well as the development and adoption of standardized care pathways.

Using Electronic Health Records to Improve HIV Preexposure Prophylaxis Care: A Randomized Trial.

BACKGROUND: Preexposure prophylaxis (PrEP) use remains limited and inequitable, and strategies are needed to improve PrEP provision in primary care. METHODS: We conducted a cluster randomized trial at Kaiser Permanente, San Francisco, to evaluate the effectiveness of a clinical decision support intervention guided by an electronic health record (EHR)-based HIV risk prediction model to improve PrEP provision. Primary care providers (PCPs) were randomized to usual care or intervention, with PCPs who provide care to people with HIV balanced between arms. PCPs in the intervention arm received an EHR-based staff message with prompts to discuss HIV prevention and PrEP before upcoming in-person or video visits with patients whose predicted 3-year HIV risk was above a prespecified threshold. The main study outcome was initiation of PrEP care within 90 days, defined as PrEP discussions, referrals, or prescription fills. RESULTS: One hundred twenty-one PCPs had 5051 appointments with eligible patients (2580 usual care; 2471 intervention). There was a nonsignificant increase in initiation of PrEP care in the intervention arm (6.0% vs 4.5%, HR 1.32, 95% CI: 0.84 to 2.1). There was a significant interaction by HIV provider status, with an intervention HR of 2.59 (95% CI: 1.30 to 5.16) for HIV providers and 0.89 (95% CI: 0.59 to 1.35) for non-HIV providers (P-interaction <0.001). CONCLUSION: An EHR-based intervention guided by an HIV risk prediction model substantially increased initiation of PrEP care among patients of PCPs who also care for people with HIV. Higher-intensity interventions may be needed to improve PrEP provision among PCPs less familiar with PrEP and HIV care.

Causal Effects of Stochastic PrEP Interventions on HIV Incidence Among Men Who Have Sex With Men.

Antiretroviral preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection, but uptake has been limited and inequitable. Although interventions to increase PrEP uptake are being evaluated in clinical trials among men who have sex with men (MSM), those trials cannot evaluate effects on HIV incidence. Estimates from observational studies of the causal effects of PrEP-uptake interventions on HIV incidence can inform decisions about intervention scale-up. We used longitudinal electronic health record data from HIV-negative MSM accessing care at Fenway Health, a community health center in Boston, Massachusetts, from January 2012 through February 2018, with 2 years of follow-up. We considered stochastic interventions that increased the chance of initiating PrEP in several high-priority subgroups. We estimated the effects of these interventions on population-level HIV incidence using a novel inverse-probability weighted estimator of the generalized g-formula, adjusting for baseline and time-varying confounders. Our results suggest that even modest increases in PrEP initiation in high-priority subgroups of MSM could meaningfully reduce HIV incidence in the overall population of MSM. Interventions tailored to Black and Latino MSM should be prioritized to maximize equity and impact.

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

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

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

HIV/Sexually Transmitted Infection Screening and Eligibility for HIV Preexposure Prophylaxis Among Women Incarcerated in an Urban County Jail.

BACKGROUND: Incarcerated women experience high rates of HIV and sexually transmitted infections (STIs); few are offered HIV preexposure prophylaxis (PrEP). We aimed to examine HIV/STI screening rates in this population and identify PrEP eligibility. METHODS: Results of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) urine and HIV/syphilis screening in cisgender women in the Dallas County Jail were compiled from January to October 2020. An electronic health record review was conducted for a subgroup in March 2020 to identify PrEP eligibility. RESULTS: Overall, 4398 of 13,292 women were screened for CT and 4389 of 13,292 for GC, and among them, 479 (11%) screened for HIV and 562 (13%) for syphilis. Furthermore, 462 of 4398 (11%) were positive for CT, 323 of 4389 (7%) were positive for GC, 10 of 479 (2%) had positive HIV test results, of whom 6 (1.3%) were new diagnoses and 75 (13%) had a reactive rapid plasma reagin test. In March 2020, of 541 women screened, 90 tested positive for CT or GC. Of these 90, 70 (78%) did not receive HIV or syphilis screening, including women with these risk factors: 10 (14%) were homeless, 11 (16%) reported heroin use, and 10 (14%) reported methamphetamine use. Based on the presence of an acute bacterial STI, 17% (96 of 541) were PrEP eligible. CONCLUSIONS: Incarcerated women had high STI rates and other risk factors for HIV acquisition, although only 1 in 5 with acute STIs (11% overall) was also screened for HIV or syphilis. HIV prevention efforts should include comprehensive STI/HIV screening, linkage to treatment, and identification of PrEP candidates.

Potential impact of doxycycline post-exposure prophylaxis prescribing strategies on incidence of bacterial sexually transmitted infections.

BACKGROUND: Doxycycline post-exposure prophylaxis (doxyPEP) reduces bacterial sexually transmitted infection (STI) incidence in people with HIV (PWH) or using HIV preexposure prophylaxis (PrEP). Given concerns about widespread antibiotic use, we identified doxyPEP prescribing strategies to minimize use while maximizing impact on STIs. METHODS: We used electronic health records of gay and bisexual men (GBM), transgender women, and non-binary people assigned male sex at birth with ≥2 STI tests (chlamydia, gonorrhea, syphilis) at an LGBTQ-focused health center during 2015-2020. We defined 10 hypothetical doxyPEP prescribing strategies based on PrEP use, HIV status, or STI history. We estimated doxyPEP use and STI diagnoses averted in counterfactual scenarios in which people meeting prescribing criteria received doxyPEP, assuming STI rates during use would have been reduced by clinical trial efficacy estimates. RESULTS: Among 10,546 individuals (94% GBM), rate of any STI was 35.9/100 person-years. Prescribing doxyPEP to all individuals would have averted 71% of STI diagnoses (number needed to treat for one year to avert one STI diagnosis, NNT = 3.9); prescribing to PrEP users/PWH (52%/12% of individuals) would have averted 60% of STI diagnoses (NNT = 2.9). Prescribing doxyPEP for 12 months after STI diagnosis would have reduced the proportion using doxyPEP to 38% and averted 39% of STI diagnoses (NNT = 2.4). Prescribing after concurrent or repeated STIs would have maximized efficiency (lowest NNTs) but prevented fewer STIs. CONCLUSIONS: Prescribing doxyPEP to individuals with STIs, particularly concurrent or repeated STIs, could avert a substantial proportion of all STI diagnoses. The most efficient prescribing strategies are based on STI history rather than HIV status or PrEP use.

Prioritising the values of potential users to promote uptake of HIV pre-exposure prophylaxis.

Benefits of pre-exposure prophylaxis (PrEP) extend beyond HIV risk reduction. Users report a range of physical, emotional, and social effects, including reduced anxiety, increased intimacy, and greater sexual satisfaction. For some people, these benefits are the primary motivation for using PrEP. To successfully engage in shared decision making about HIV prevention methods, clinicians need to be able to discuss all potential risks and benefits of PrEP. These risks and benefits include not only those related to HIV risk reduction and other clinical outcomes, but also those related to experiences and relationships that people value. However, national and international clinical resources on the provision of PrEP do not include user-reported outcomes that are values-based or reflect positive effects on personal, social, or sexual wellbeing. To better integrate the values of potential users into discussions about PrEP, clinician training programmes and clinical guidelines need to be guided by community-driven frameworks and expanded to include user-reported outcomes of PrEP use, including beneficial effects. Achieving PrEP uptake and equity goals will require an approach to PrEP provision that centres the values and desired experiences of potential users, particularly those from populations with the greatest unmet need for PrEP.

Acceptability and Effectiveness of a One-Hour Healthcare Provider Intervention Integrating HIV Pre-Exposure Prophylaxis and Cultural Competence Training.

Enhanced provider training could improve PrEP access and equity. We conducted a pilot randomized controlled trial comparing (a) a one-hour, group-based provider intervention integrating PrEP and Cultural Competence (PCC) training with (b) a standard HIV continuing medical education session (n = 56). PCC participants favorably rated the intervention and reported increased PrEP knowledge. The PCC intervention increased their confidence performing PrEP-related clinical activities and intention to prescribe PrEP. The percentage of participants discussing PrEP with patients increased marginally in both study conditions. The percentage of participants who prescribed PrEP and self-rated cultural competence did not change in either study condition.

RESUMEN: Una mejor capacitación de los proveedores podría mejorar el acceso y la equidad de la PrEP. Realizamos un ensayo controlado aleatorizado piloto que comparó (a) una intervención grupal de proveedores de una hora que integraba la capacitación en PrEP y competencia cultural (PCC) con (b) una sesión estándar de educación médica continua sobre el VIH (n = 56). Los participantes de PCC calificaron favorablemente la intervención e informaron un mayor conocimiento de la PrEP. La intervención de PCC aumentó su confianza en la realización de actividades clínicas relacionadas con la PrEP y su intención de prescribir la PrEP. El porcentaje de participantes que discutieron la PrEP con los pacientes aumentó marginalmente en ambas condiciones del estudio. El porcentaje de participantes que prescribieron la PrEP y la competencia cultural autoevaluada no cambió en ninguna de las condiciones del estudio.

Survey assessment of HIV pre-exposure prophylaxis availability in student health services in New England colleges and universities.

Objective: To determine HIV pre-exposure prophylaxis (PrEP) availability at student health services (SHS) in New England. Methods: We conducted an electronic survey of medical directors of SHS at New England colleges and universities. We measured the availability and volume of PrEP prescribing, barriers and facilitators to prescribing and provider knowledge. Results: Of 143 institutions surveyed, 39% completed questionnaires; 75% were private and 93% were 4 years. Thirty-six percent of institutions did not offer PrEP. Those offering PrEP started a mean of 2.0 per 1000 students/year. PrEP was available at more schools with higher vs. lower endowments (100 vs. 38%, p = 0.002), 4- vs. 2-year programs (68 vs. 0%, p = 0.042), and private vs. public schools (73 vs. 38%, p = 0.043). Conclusions: PrEP was not available at one in three New England SHS and prescribing rates at institutions that offered PrEP were low. Interventions are needed to improve PrEP access.

Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA.

INTRODUCTION: African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population. METHODS AND ANALYSIS: The goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA. ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations. TRIAL REGISTRATION NUMBER: NCT04373551.

A Multicomponent Intervention to Train and Support Family Medicine Providers to Promote Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in the Deep South: Protocol for the PrEP-Pro Study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention intervention and a major strategy for reducing the HIV burden in the United States. However, PrEP provision and uptake remain lower than estimated needs, and in ways that may exacerbate HIV disparities among Black adolescent girls and young women in the southern United States. Data suggest that gaps in provider knowledge of HIV epidemiology and PrEP and skills assessing sexual health practices are important barriers to provision and uptake, with limited evidence-based interventions to address these gaps. OBJECTIVE: This paper describes the "PrEP-Pro" intervention, a multicomponent intervention to train and support family medicine (FM) trainees to promote PrEP for adolescent girls and young women in Alabama. METHODS: The PrEP-Pro intervention comprises 3 main components guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model for behavioral change and the Consolidated Framework for Implementation Research (CFIR): (1) provider HIV epidemiology and PrEP education, (2) sexual history taking, and (3) PrEP Champions. In phase 1, we will work with community advisory boards (providers and clients) and then conduct focus groups with FM trainees to adapt content to train FM residents on HIV epidemiology and PrEP and develop implementation strategies, including provider-facing tools and client-facing educational materials. In phase 2, we will pretest and then pilot-test the initially adapted PrEP-Pro intervention with FM trainees. FM trainees will complete baseline, 3-, and 6-month questionnaires post PrEP-Pro intervention. We will also conduct in-depth interviews (IDIs) with FM pilot participants, adolescent girls and young women who accessed care after the PrEP-Pro pilot, and key stakeholders. The primary outcomes are PrEP-Pro acceptability and feasibility, which would be assessed using validated instruments at months 3 (among pretest participants) and 6 (among pilot participants). Secondary outcomes will also be assessed, including PrEP knowledge, sexual history-taking attitudes and practices, PrEP prescriptions among adolescent girls and young women encounters, and sexually transmitted infections (STIs) and HIV testing among adolescent girls and young women encounters in 6 months. RESULTS: Study results will be disseminated to practices, state health officials, and other key stakeholders to solicit feedback on implementation opportunities and challenges to inform a hybrid effectiveness implementation trial. Our results will also be presented at local and national conferences and submitted to peer-reviewed journals. CONCLUSIONS: As PrEP grows, there is a pressing need to train FM providers and develop appropriate, contextually relevant tools to support PrEP implementation. The PrEP-Pro intervention is a multicomponent intervention to train FM residents across Alabama on sexual history-taking, PrEP provision for adolescent girls and young women, and supporting practice-based PrEP Champions. The PrEP-Pro intervention is anticipated to increase PrEP prescriptions for adolescent girls and young women and expand comprehensive sexual and reproductive health care for adolescent girls and young women in rural and urban Alabama. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44908.

Provider Implicit Bias in Prescribing HIV Pre-exposure Prophylaxis (PrEP) to People Who Inject Drugs.

BACKGROUND: Multiple HIV outbreaks among people who inject drugs (PWIDs) have occurred in the USA since 2015, highlighting the need for additional HIV prevention tools. Despite high levels of need, pre-exposure prophylaxis (PrEP) is drastically underutilized among PWIDs. Implicit bias toward PWID held by clinicians may impede PrEP scale-up among these underserved patients. This study examined how primary care providers' (PCPs) clinical decisions related to PrEP can be impacted by biases when the patient has a history of substance use. METHODS: We conducted an online survey of PCPs (n = 208). The survey included the implicit association test (IAT) to assess unconscious attitudes toward PWIDs, direct questions regarding clinicians' explicit PWID attitudes, and an embedded experiment in which we systematically varied the risk behavior of a hypothetical patient and asked PCPs to make clinical judgments. RESULTS: A minority (32%) of PCPs reported explicit PWID bias. The IAT indicated strong implicit PWID bias (meant IAT score = 0.59, p < .0001) among 88% of the sample. Only 9% of PCPs had no implicit or explicit PWID bias. PWID patients were judged as less likely to adhere to a PrEP regimen, less responsible, and less HIV safety conscious than heterosexual or gay male patients. Anticipated lack of adherence mediated PCPs' intent to prescribe PrEP to PWID. CONCLUSIONS: PCPs' bias may contribute to PrEP being under-prescribed to PWID. Implicit and explicit PWID biases were common in our sample. This study illustrates the need to develop and test tailored interventions to decrease biases against PWID in primary care settings.

Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs.

BACKGROUND: HIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low. METHODS: We describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of "PrEP for Health," a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the "PrEP for Health" intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex). DISCUSSION: Findings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the "PrEP for Health" intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population. TRIAL REGISTRATION: ClinicalTrials.gov number NCT04430257, registered June 12, 2020.

Perspectives of Young Men Who Have Sex with Men on PrEP Adherence and Peer Navigation: A Qualitative Study.

HIV incidence is disproportionately high among young cisgender men who have sex with men (YMSM), but YMSM are less likely than adults to use HIV pre-exposure prophylaxis (PrEP). Among YMSM living with HIV, peer navigation programs have been effective in linkage to care and increasing medication adherence; such programs may aid HIV-uninfected YMSM in overcoming barriers to engagement in PrEP care. We conducted 32 semi-structured qualitative interviews at a community health center in Massachusetts, USA, specializing in sexual and gender minority health with four sub-groups of YMSM who: (1) had never discussed PrEP with a medical provider, (2) had discussed PrEP with a medical provider but declined a prescription, (3) were prescribed PrEP and have sub-optimal adherence (taking fewer than 4 pills per week), and (4) were prescribed PrEP and were optimally adherent. Domains addressed in the interviews included knowledge of PrEP and HIV prevention, barriers and facilitators to PrEP adherence, and attitudes toward peer navigation for PrEP. Interviews were transcribed and coded using thematic analysis methodology. Multiple themes emerged from the interviews, including finding that perceived costs, anticipated stigma, sexual activity, and relationship status influence PrEP uptake and adherence; establishing pill-taking routines is an important adherence facilitator; and peer navigators could offer benefits for PrEP adherence.

Case report: human granulocytic anaplasmosis causes acute myopericarditis with atrial fibrillation.

Background: Tick-borne illness are becoming increasingly common, in a spreading geographic area. Lyme disease is a well-known cause of cardiovascular disease, but anaplasmosis has previously had relatively little reported association with conduction and myocardial disease. Case Summary: A 65-year-old man with fever and malaise was admitted to the intensive care unit in shock. Electrocardiogram showed new atrial fibrillation and conduction abnormalities. Transthoracic echocardiogram demonstrated normal left ventricular ejection fraction but significant right ventricle dysfunction. Cardiac magnetic resonance imaging findings were consistent with myopericarditis. Workup revealed human granulocytic anaplasmosis without Lyme. He recovered with doxycycline. Conclusion: To our knowledge, this is one of the first reported cases of anaplasmosis causing electrical conduction and myocardial disease with haemodynamic instability in an isolated infection. Treatment with appropriate antibiotics and supportive care allowed the patient to recover to his functional baseline within a month from being discharged from the hospital. Recognition of anaplasmosis in the absence of Lyme disease as a potential cause of electrical and myocardial disease is important in the context of increasing anaplasmosis incidence across the United States.