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.

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.

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.

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.

"Let's Be a Person to Person and Have a Genuine Conversation": Comparing Perspectives on PrEP and Sexual Health Communication Between Black Sexual Minority Men and Healthcare Providers.

Patient-provider communication is a key factor affecting HIV pre-exposure prophylaxis (PrEP) awareness and access among Black sexual minority men (SMM). Optimizing patient-provider communication requires a deeper understanding of communication dynamics. In this study, we investigated the perspectives of both HIV-negative/status-unknown Black SMM and practicing community healthcare providers regarding patient-provider communication about PrEP and sexual health. We conducted eleven semi-structured qualitative focus groups (six with Black SMM; five with providers) in the Northeastern USA and thematically analyzed transcripts. A total of 36 Black SMM and 27 providers participated in the focus groups. Our analysis revealed points of alignment and divergence in the two groups' perspectives related to patient-provider communication. Points of alignment included: (1) the importance ascribed to maximizing patients' comfort and (2) belief in patients' right to non-discriminatory healthcare. Points of divergence included: (1) Black SMM's preference for sexual privacy versus providers' preference that patients share sexual information, (2) Black SMM's perception that providers have an ethical responsibility to initiate conversations about PrEP with patients versus providers' perception of such conversations as being optional, and (3) Black SMM's preference for personalized sexual health conversations versus providers' preference for standardized conversations. Findings underscore a need for providers to offer more patient-centered sexual healthcare to Black SMM, which should entail routinely presenting all prevention options available-including PrEP-and inviting open dialogue about sex, while also respecting patients' preferences for privacy about their sexuality. This approach could increase PrEP access and improve equity in the US healthcare system.

Optimizing Provider Preexposure Prophylaxis (PrEP) Training: A Cross-Sectional Analysis of Recommendations from Providers Across the PrEP Implementation Cascade.

Expanding PrEP access necessitates training that supports healthcare providers' progression along the PrEP implementation cascade, moving from PrEP awareness to prescription. We surveyed 359 USA providers about PrEP training content and format recommendations. We examined the association between cascade location and training recommendations. Most providers were aware of PrEP (100%), willing to prescribe PrEP (97.2%), had discussed PrEP with patients (92.2%), and had prescribed PrEP (79.9%). Latent class regression analysis revealed that cascade location was associated with training recommendations. Although all providers recommended PrEP-specific content (e.g., patient eligibility), providers who were located further along the cascade also recommended more comprehensive content, including sexual history-taking and sexual and gender minority competence training. Providers further along the cascade were also more likely to recommend interactive training formats (e.g., role-playing). These insights from providers furthest along the cascade indicate the importance of including comprehensive content and interactive formats in future PrEP training initiatives.

An Experimental Study of the Effects of Patient Race, Sexual Orientation, and Injection Drug Use on Providers' PrEP-Related Clinical Judgments.

Social biases may influence providers' judgments related to pre-exposure prophylaxis (PrEP) and patients' consequent PrEP access. US primary and HIV care providers (n = 370) completed an experimental survey. Each provider reviewed one fictitious medical record of a patient seeking PrEP. Records varied by patient race (Black or White) and risk behavior (man who has sex with men [MSM], has sex with women [MSW], or injects drugs [MID]). Providers reported clinical judgments and completed measures of prejudice. Minimal evidence of racially biased judgments emerged. Providers expressing low-to-moderate sexual prejudice judged the MSM as more likely than the MSW to adhere to PrEP, which was associated with greater PrEP prescribing intention; sexual prejudice was negatively associated with anticipated MSM adherence. Providers judged the MID to be at higher risk, less likely to adhere, less safety-conscious, and less responsible than both the MSM and MSW; adverse adherence and responsibility judgments were associated with lower prescribing intention.

RESUMEN: Los sesgos sociales pueden influir sobre los juicios de proveedores de salud con respecto a la profilaxis pre-exposición (PrEP) y el consecuente acceso de los pacientes a PrEP. Proveedores de cuidados primarios y de VIH en los Estados Unidos (n = 370) respondieron una encuesta experimental. Cada proveedor leyó una historia médica de un paciente ficticio interesado en obtener PrEP. Las historias médicas variaron la raza (Negro o Blanco) y conducta de riesgo (hombre que tiene sexo con hombres [HSH], hombre que tiene sexo con mujeres [HSM], u hombre  usuario de drogas inyectables [HDI]) del paciente. Los proveedores reportaron juicios clínicos y completaron medidas sobre prejuicio. La evidencia sobre sesgos raciales en los juicios clínicos fue mínima. Los proveedores que expresaron prejuicio sexual bajo a moderado, juzgaron que el paciente HSH tendría mayor adherencia a PrEP que el paciente HSM, lo cual se asoció con mayor intención de prescribir PrEP; el prejuicio sexual se asoció negativamente con la adherencia anticipada en HSH. El paciente HDI fue percibido como en mayor riesgo, con menor adherencia, menos preocupado por la seguridad, y menos responsable que los HSH y HSM; los juicios sobre baja adherencia y responsabilidad estuvieron asociados con menor intención de prescribir PrEP.

Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide for Human Immunodeficiency Virus Preexposure Prophylaxis at a Boston Community Health Center.

BACKGROUND: Efforts to end the human immunodeficiency virus (HIV) epidemic may be threatened if limited preexposure prophylaxis (PrEP) resources are funneled from tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) to tenofovir alafenamide with emtricitabine (TAF/FTC) without proportional clinical benefits. METHODS: The study population was patients at a Boston community health center who were assigned male sex at birth, aged ≥18 years, and prescribed TDF/FTC for PrEP in the 12 months before TAF/FTC approval (October 2019). We determined the frequency of switching to TAF/FTC in the 12 months after approval, including clinically indicated switching (ie, creatinine clearance <60 mL/minute or reduced bone density), potentially unnecessary switching (ie, no indications for switching and no cardiovascular risk factors), and potentially harmful switching (ie, no indications for switching and either obesity or dyslipidemia). RESULTS: Of 2892 TDF/FTC users, mean age was 38 years, 96.0% were cisgender men, and 78.9% were white. A total of 343 (11.9%) switched to TAF/FTC. Based on documented renal, bone, and cardiovascular risk factors, we identified 24 (7.0%) with clinically indicated switching, 271 (79.0%) with potentially unnecessary switching, and 48 (14.0%) with potentially harmful switching. When indications for switching additionally included hypertension, diabetes, and creatinine clearance 60-70 mL/minute, 27.1% of switching was clinically indicated. CONCLUSIONS: Few who switched to TAF/FTC had documented indications for switching, although some appear to have been switched in anticipation of indications developing. As generic TDF/FTC is further discounted, provider education and patient decision aids are needed to facilitate selection of PrEP medications that is both clinically sound and cost-effective.

Academic Detailing to Increase Prescribing of HIV Pre-exposure Prophylaxis.

Although HIV pre-exposure prophylaxis can decrease new cases of HIV by up to 99%, many patients who could benefit from pre-exposure prophylaxis never receive prescriptions for it. Because pre-exposure prophylaxis is indicated for patients who do not have an infectious disease, increasing pre-exposure prophylaxis prescribing by primary care and generalist clinicians represents a key element of the Ending the HIV Epidemic in the U.S. initiative. This review provides an overview of academic detailing and how it is currently being used to increase pre-exposure prophylaxis prescribing. Academic detailing is outreach education that engages with clinicians in 1-to-1 or small group interactions focused on identifying and addressing an individual clinician's needs to increase their use of evidence-based practices. Academic detailing has been proven in multiple previous research studies, and the principles required for successful implementation include interactivity, clinical relevance of content, and focus on defined behavior change objectives. Clinician barriers to pre-exposure prophylaxis prescribing may occur in the domains of knowledge, attitudes, or behavior, and academic detailing has the potential to address all of these areas. State and local health departments have developed academic detailing programs focused on pre-exposure prophylaxis prescribing and other elements of HIV prevention-sometimes describing the approach as public health detailing. Few studies of academic detailing for pre-exposure prophylaxis have been published to date; rigorous evaluation of HIV-specific adaptations and innovations of the approach would represent an important contribution. In the setting of the COVID-19 pandemic, interest in virtual delivery of academic detailing has grown, which could inform efforts to implement academic detailing in rural communities and other underserved areas. Increasing this capacity could make an important contribution to Ending the HIV Epidemic in the U.S. and other HIV prevention efforts.