Indications For Pre-exposure Prophylaxis Research Articles

Low Self-Perceived Need for PrEP and Behavioral Indications of MSM Who Recently Refused Daily PrEP: A Mixed Methods Study in Three U.S. Cities.

Pre-exposure prophylaxis (PrEP) reduces sexual risk for HIV transmission by 99% when used appropriately, but remains underutilized among gay, bisexual, and other men who have sex with men (MSM). In this mixed-method study, we describe reasons for PrEP refusal associated with low self-perceived need for PrEP among MSM who recently declined daily oral PrEP when offered by a provider. Data are from a quantitative behavioral survey of MSM (N = 93) living in Atlanta, Chicago, and Raleigh-Durham, who also either responded to an in-depth interview (n = 51) or participated in one of 12 focus groups (n = 42). Themes of low self-perceived need for PrEP were: low self-perceived risk for HIV acquisition (33% of respondents); confidence in remaining HIV-negative (35%); using condoms (81%); limiting number of partners and choosing partners carefully (48%); asking partners about their HIV status before having sex (45%); engaging in safer sexual positions or oral sex (28%); being in a monogamous relationship or exclusivity with one partner (26%); and regular HIV testing (18%). Low self-perceived risk for HIV acquisition and high confidence in other prevention strategies were important factors related to low self-perceived need in MSM refusing daily oral PrEP when offered. Providers should continue to discuss the benefits of PrEP as a safe and highly effective option for HIV prevention.

Missed Opportunities for HIV Prevention in a Large County Safety Net Health System.

HIV pre-exposure prophylaxis (PrEP) is effective at reducing HIV transmission. However, PrEP uptake is low for racial and ethnic minorities and women, especially in the Southern US Health care clinicians should be prepared to identify all patients eligible for PrEP, provide counseling, and prescribe PrEP. Retrospective analysis of persons newly diagnosed with HIV was conducted at a large public health system from January 2015 to June 2021. Interactions with the health system in the 5 years preceding HIV diagnosis were analyzed, and missed opportunities for HIV prevention interventions, including PrEP and condom use counseling, were identified. We identified 454 patients with a new HIV diagnosis with previous health system interactions. 166(36.6%) had at least 1 identifiable indication for PrEP: 42(9.3%) bacterial STI, 63(13.9%) inconsistent condom use, or 82(18%) injection drug use before HIV diagnosis. Only 7(1.5%) of patients were counseled on PrEP. Most patients (308; 67.8%) had no documented condom use history in the EHR before diagnosis, a surrogate marker for obtaining a sexual history. Patients who exclusively interacted with the emergency care setting did not receive PrEP education and were less likely to receive condom use counseling. Missed opportunities to offer HIV prevention before diagnosis were common among patients newly diagnosed with HIV. Most patients did not have sexual history documented in the chart before their HIV diagnosis. Educational interventions are needed to ensure that clinicians are prepared to identify those eligible and discuss the benefits of PrEP.

PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017-22.

In the US, sexual and gender minority populations are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is a key prevention method, but its effectiveness relies on consistent usage. Our four-year national cohort study explored PrEP discontinuation among sexual and gender minority people who initiated PrEP. We found a high annual rate of discontinuation (35-40percent) after PrEP initiation. Multivariable analysis with 6,410 person-years identified housing instability and prior history of PrEP discontinuation as predictors of discontinuation. Conversely, older age, clinical indication for PrEP, and having health insurance were associated with ongoing PrEP use. To promote sustained PrEP use, strategies should focus on supporting those at high risk for discontinuation, such as younger people, those without stable housing or health insurance, and prior PrEP discontinuers.

HIV Risk and Interest in Preexposure Prophylaxis in Justice-Involved Persons.

Preexposure prophylaxis (PrEP) is underused in persons who use drugs and justice-involved persons. In an ongoing randomized controlled trial in 4 US locations comparing patient navigation versus mobile health unit on time to initiation of HIV medication or PrEP for justice-involved persons who use stimulants or opioids and who are at risk for or living with HIV, we assessed HIV risk factors, perceived HIV risk, and interest in PrEP. Participants without HIV (n = 195) were 77% men, 65% White, 23% Black, and 26% Hispanic; 73% reported a recent history of condomless sex, mainly with partners of unknown HIV status. Of 34% (67/195) reporting injection drug use, 43% reported sharing equipment. Despite risk factors, many persons reported their risk for acquiring HIV as low (47%) or no (43%) risk, although 51/93 (55%) with PrEP indications reported interest in PrEP. Justice-involved persons who use drugs underestimated their HIV risk and might benefit from increased PrEP education efforts.

Co-delivery of HIV pre-exposure prophylaxis (PrEP) and HIV testing among publicly insured adolescents and young adults (AYA) receiving medication for opioid use disorder (MOUD)

BackgroundLow rates of HIV pre-exposure prophylaxis (PrEP) prescribing contribute to the disproportionate burden of HIV in the United States. Among adolescent and young adults (AYA) with opioid use disorder, HIV testing and PrEP co-prescription rates are poorly characterized. MethodsWe performed a retrospective analysis involving deidentified data from Philadelphia’s Medicaid beneficiaries ages 16–29 years who were prescribed medication for opioid use disorder (MOUD) from 2015 to 2020 and continuously Medicaid-enrolled for ≥6 months prior to that prescription. After identifying the presence of a qualifying diagnosis signifying a PrEP indication, we examined the outcome of appropriate PrEP co-prescriptions and HIV testing using generalized estimating equations (GEE) modeling. ResultsWe identified 795 AYA Medicaid beneficiaries with 1269 qualified treatment episodes. We calculated a PrEP prescribing rate of 29.47 per 1000 person-years among AYA receiving MOUD. The HIV testing rate was 63.47 per 1000 person-years among AYA receiving MOUD. GEE modeling revealed that individuals receiving methadone were more likely (aOR=2.62, 95% CI=1.06–6.49) to receive HIV testing within 6 months after a PrEP-qualifying diagnosis compared to those receiving other MOUD medications. Those who only saw outpatient behavioral health providers were less likely (aOR=0.48, 95% CI=0.24–0.99) to have received an HIV test within 6 months after the PrEP-qualifying diagnosis compared to those receiving inpatient behavioral health services. ConclusionsCo-prescription of PrEP and HIV testing among AYA receiving MOUD was rare in this large urban publicly insured population. Interventions are needed to increase HIV prevention services for this key population of AYA at risk for HIV infection.

Identifying Key Factors to PrEP Initiation and Persistence Among YMSM Through Focus Groups and Surveys in Two High-Priority Settings.

Cisgender men are diagnosed with HIV at a rate four times greater than cisgender women, with 71% of infections attributed to male-male sexual contact. Despite expanding accessibility, pre-exposure prophylaxis (PrEP) for HIV prevention is initiated by only 30% of people with PrEP indications. Five focus groups with 42 young men who have sex with men from New York and Alabama were conducted to identify key factors to PrEP initiation and persistence. Thirty focus group participants completed a survey on demographics, PrEP choices and health care attitudes. Findings suggest provider competency significantly influences PrEP use due to stigmatization in medical settings. Participants noted benefits of PrEP including HIV protection and sexual empowerment, yet barriers like cost and side effects were prevalent. Our findings outline barriers and facilitators to PrEP use among young men who have sex with men in two high priority settings that will inform PrEP care updates in participating clinics.

Age-related factors associated with intention to initiate pre-exposure prophylaxis among cisgender women in Washington D.C.

Pre-exposure prophylaxis (PrEP) utilization among cisgender women (subsequently 'women') is low across age groups, relative to their risk of HIV acquisition. We hypothesize that age-related differences in psychosocial factors also influence women's intention to initiate oral PrEP in Washington, D.C. A secondary analysis of a cross-sectional survey data was performed to evaluate factors influencing intention to initiate oral PrEP among women seen at a family planning and a sexual health clinic. A bivariate analysis was performed to identify differences by age group in demographic characteristics, indications for PrEP, and attitudes toward PrEP; we then performed additional bivariate analysis to assess these variables in relation to PrEP intention. Across age groups, perceived risk of HIV acquisition was not significantly different and was not associated with intention to initiate PrEP. Awareness of and attitude toward PrEP, injunctive norms, descriptive norms, and self-efficacy were not different across age, however there were significant age-associated differences in relation to PrEP intention. Specifically, among 18-24-year-olds, intention to start PrEP was associated with support from provider (p = 0.03), main sexual partner (p < 0.01), and peers (p < 0.01). For women 25-34 years old, having multiple sexual partners (p = 0.03) and support from casual sexual partners (p = 0.03) was also important. Among women 35-44 years old, prior awareness of PrEP (p = 0.02) and their children's support of PrEP uptake (p < 0.01) were associated with intention to initiate PrEP. Among 45-55 year-old women intention to initiate PrEP was positively associated with engaging in casual sex (p = 0.03) and negatively associated with stigma (p < 0.01). Overall, there were more similarities than differences in factors influencing intention to initiate PrEP across age groups. Observed differences offer an opportunity to tailor PrEP delivery and HIV prevention interventions to increase awareness and uptake for cisgender women.

PrEP initiation and discontinuation among transgender women in the United States: a longitudinal, mixed methods cohort study.

Transgender women in the United States experience high HIV incidence and suboptimal Pre-exposure prophylaxis (PrEP) engagement. We sought to estimate PrEP initiation and discontinuation rates and characterize PrEP discontinuation experiences among a prospective cohort of transgender women. Using a sequential, explanatory, mixed-methods design, 1312 transgender women at risk for HIV acquisition were enrolled from March 2018 to August 2020 and followed through July 2022 (median follow-up 24 months; interquartile range 15-36). Cox regression models assessed predictors of initiation and discontinuation. In-depth interviews were conducted among 18 participants, including life history calendars to explore key events and experiences surrounding discontinuations. Qualitative and quantitative data were integrated to generate typologies of discontinuation, inform meta-inferences and facilitate the interpretation of findings. 21.8% (n = 286) of participants reported taking PrEP at one or more study visits while under observation. We observed 139 PrEP initiations over 2127 person-years (6.5 initiations/100 person-years, 95% CI: 5.5-7.7). Predictors of initiation included identifying as Black and PrEP indication. The rate of initiation among those who were PrEP-indicated was 9.6 initiations/100 person-years (132/1372 person-years; 95% CI: 8.1-11.4). We observed 138 PrEP discontinuations over 368 person-years (37.5 discontinuations/100 person-years, 95% CI: 31.7-44.3). Predictors of discontinuation included high school education or less and initiating PrEP for the first time while under observation. Four discontinuation typologies emerged: (1) seroconversion following discontinuation; (2) ongoing HIV acquisition risk following discontinuation; (3) reassessment of HIV/STI prevention strategy following discontinuation; and (4) dynamic PrEP use coinciding with changes in HIV acquisition risk. PrEP initiation rates were low and discontinuation rates were high. Complex motivations to stop using PrEP did not consistently correspond with HIV acquisition risk reduction. Evidence-based interventions to increase PrEP persistence among transgender women with ongoing acquisition risk and provide HIV prevention support for those who discontinue PrEP are necessary to reduce HIV incidence in this population.

757. Bridging the Gap: An Educational Intervention to Increase HIV PrEP Access in Resident Primary Care Clinics

Abstract Background HIV Pre-Exposure Prophylaxis (PrEP) is a safe and effective way to prevent HIV acquisition. Yet, in 2020, only 25% of individuals in the US and Puerto Rico who had an indication for PrEP received a PrEP prescription. While PrEP is accessible to primary care clinicians, many do not feel comfortable prescribing PrEP. Clinician education has been identified as a key opportunity to increase access and comfort in prescribing PrEP. Methods An educational intervention was designed aiming to increase PrEP knowledge and prescribing among residents and preceptors in the primary care clinics at Brigham and Women’s Hospital (BWH). The intervention followed the six steps described in Kern’s model of curriculum development (Figure 1). After formal needs assessment, an in-person interactive teaching session was designed and presented. This was supplemented by an online reference guide and note template dot phrases accessible in the electronic medical record (EMR). The curriculum was evaluated with pre and post intervention surveys. Survey data were analyzed using descriptive statistics and one tailed T tests. Results Of the approximately 30 residents and preceptors who participated in the intervention, 19 completed the pre survey and 9 completed the post survey. Only 37% (7/19) of pre survey respondents reported having had PrEP education in the past. 21% (4/19) had prior teaching during medical school, 21% (4/19) during residency, and 16% (3/19) in continuing medical education courses. Participants indicated that their comfort with prescribing PrEP increased overall after the intervention with a statistically significant increase in reported confidence in their ability to prescribe PrEP (mean Likert scale value of 3.88 vs 2.95, p = 0.03) (table 1). Conclusion PrEP is an underutilized modality in preventing HIV transmission, but many primary care clinicians do not feel comfortable prescribing PrEP even though it is accessible in primary care settings. Systematic PrEP education is lacking in the UME, GME, and CME settings. Targeted, interactive, multimodal educational interventions can be effective in increasing comfort with PrEP prescribing. Support from leadership and learner buy-in is critical for effective training. Disclosures All Authors: No reported disclosures

PrEP Use and HIV Incidence Among Youth At-Risk for HIV Infection in Los Angeles and New Orleans: Findings From ATN 149.

Expanding HIV pre-exposure prophylaxis (PrEP) use is key to goals for lowering new HIV infections in the U.S. by 90% between 2022 and 2030. Unfortunately, youth aged 16-24 have the lowest PrEP use of any age group and the highest HIV incidence rates. To examine the relationship between HIV seroconversion and PrEP uptake, adherence, and continuity, we used survival analysis and multivariable logistic regression on data of 895 youth at-risk for HIV infection enrolled in Adolescent Trials Network for HIV Medicine protocol 149 in Los Angeles and New Orleans, assessed at 4-month intervals over 24 months. The sample was diverse in race/ethnicity (40% Black, 28% Latine, 20% White). Most participants (79%) were cis-gender gay/bisexual male but also included 7% transgender female and 14% trans masculine and nonbinary youth. Self-reported weekly PrEP adherence was high (98%). Twenty-seven participants acquired HIV during the study. HIV incidence among PrEP users (3.12 per 100 person year [PY]) was higher than those who never used PrEP (2.53/100 PY). The seroconversion incidence was highest among PrEP users with discontinuous use (3.36/100 PY). If oral PrEP users were adherent using 2-monthly long-acting injectables, our estimate suggests 2.06 infections per 100 PY could be averted. Discontinuous use of PrEP may increase risk of HIV acquisition among youth at higher risk for HIV infection and indications for PrEP. Thus, to realize the promise of PrEP in reducing new HIV infections, reducing clinical burdens for PrEP continuation are warranted.

Attitudes and Intentions toward Use of HIV Pre-Exposure Prophylaxis (PrEP) among Adults Receiving Treatment for Opioid Use

Background: Although pre-exposure prophylaxis (PrEP) prevents HIV, little is known about PrEP awareness and factors associated with intention to take PrEP among people with opioid use disorder (OUD). Methods: HIV-negative adults recruited from an outpatient treatment program in Cincinnati, Ohio completed self-administered surveys. Items derived from literature and health behavioral theory included demographics, sexual and drug use behaviors, HIV prevention practices, PrEP knowledge, and attitudes toward PrEP. Primary outcomes were 1) intention to ask a clinician about PrEP and 2) intention to accept PrEP if recommended by a clinician. Outcomes were dichotomized into higher vs. lower intention for analyses in logistic regression models. Results: Among 198 participants, 60.3% reported past injection drug use. Among 58 participants (29.3%) meeting criteria for PrEP, 24% were aware of PrEP, 15.5% had discussed it with a clinician, and 5% had taken it. Factors associated with intention to ask a clinician about PrEP included being somewhat confident about consistent condom use (p < 0.01), motivation to comply with normative beliefs (p < 0.01), and reporting that PrEP fits very well (p < 0.01) and is easy to fit (p < 0.01) into current prevention practices. Factors associated with intention to accept PrEP if recommended by a clinician included motivation to comply with normative beliefs (p < 0.01) and PrEP being easy to fit into current prevention practices (p < 0.01). Conclusion: Among participants meeting indications for PrEP, only 24% were aware of it and few had taken it. Interventions that normalize PrEP and target incorporating PrEP into current prevention practices may improve uptake among individuals with OUD.

Experience with Tixagevimab and Cilgavimab (Evusheld) in 86 rheumatic patients undergoing anti-B cell therapy with rituximab

The problem of prevention of coronavirus disease 2019 (COVID-19) in patients with immune-mediated inflammatory rheumatic diseases (IMRD) remains highly relevant. The presence of IRD is associated with a high risk of disease and severe course of COVID-19 during immunosuppressive treatment, primarily anti-B cell therapy with rituximab (RTX), and a low level of post-vaccination response in such patients. A new strategy for the prevention and treatment of COVID-19 are virus-neutralizing monoclonal antibodies to coronavirus; currently, combined long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld) are registered for prevention in the world and the Russian Federation. . Tixagevimab and cilgavimab (TC) show neutralizing activity against SARS-CoV-2, including the Omicron strain, primarily its variants BA.4, BA.5, BA.2.75 ("Centaur").Objective – to evaluate the efficacy and safety of TC for pre-exposure prophylaxis of COVID-19 in rheumatic patients receiving RTX, based on a prospective observational study.Materials and methods. The main group included 86 patients with various IMRD receiving RTX: 50 of them had ANCA-associated systemic vasculitis (AAV), 15 – rheumatoid arthritis, 9 – Sjogren’s syndrome (SS), 4 – IgG4-related disease, 3 – systemic lupus erythematosus (SLE), 3 – dermatomyositis (DM), 2 – systemic scleroderma (SSD). Median age was 59 (19–82) years; male : female ratio – 1:1,8. From March 26 to August 30 2022, patients received a single intramuscular injection of TC in a total dose of 300 mg, mainly after RTX (in 52% of cases, in 28% on the next day after RTX). The control group included 42 patients with AAV (median age – 45 (35–71) years; male : female ratio – 1:1), also treated with RTX, who did not receive pre-exposure prophylaxis of TC. The duration of observation was 7 months, until November 1 2022. At this time, 98% of confirmed cases of coronavirus in the Russian Federation were Omicron. A telephone and/or online survey of patient has been conducted to detect cases of COVID-19 and adverse reactions.Results. In the TC group, confirmed coronavirus infection have been detected in 17 (20%) patients (AAV – 10, SS – 3, SSD – 2, SLE – 1, DM – 1), with fever in 7 (8%), only in one case hospitalization was required (lung damage was not detected in computed tomography), in two cases, according to CT mild lung damage (CT 1–2), there were no deaths. Good TC’s tolerability was noted, signs not associated with COVID-19 or progression of IMRD after administration of TC were observed in 8 (9%) patients (GPA – 3 MPA – 1, RA – 2, SLE – 1, IgG4-related disease – 1), adverse reactions definitely associated with the use of TC were not found. The most serious event not associated with coronavirus infection was the progression of polyneuropathy in a patient with RA. In the control group, 3 (7%) patients were diagnosed with COVID-19, one with severe lung injury (CT 3, pulmonary embolism) and death.Conclusions. The data of clinical studies and our own clinical experience evidence the effectiveness of the use of a combination of long-acting monoclonal antibodies TC (Evusheld), registered for indications for pre-exposure prophylaxis and treatment of COVID-19. Patients with IMRD treated with RTX have a favorable safety profile of TC. The introduction of virus-neutralizing monoclonal antibodies, a new drug class for the prevention and treatment of infectious diseases, opens significant prospects for improving the prognosis of patients with IRD.

A cross-sectional analysis of psychosocial and structural barriers and facilitators associated with PrEP use among a sample of transgender women in Chicago, IL

BackgroundExpanding pre-exposure prophylaxis (PrEP) among transgender women in the United States is an important strategy to meet national HIV prevention goals, however self-reported use of PrEP is low in this group.MethodsThis study reports the findings of a cross-sectional analysis of the relationship of barriers as well as facilitators to recent PrEP use among transgender women enrolled in an evaluation of the TransLife Care project (Chicago, Illinois), a structural intervention designed to meet basic needs. We computed multivariable prevalence ratios for barriers, facilitators and recent PrEP use, controlling for demographics.ResultsFindings suggest that psychosocial and structural barriers, including moderate/high alcohol use, stimulant use, and history of incarceration were all positively associated with recent PrEP use among urban transgender women. In addition, a psychosocial facilitator, gender affirmation, was positively associated with recent PrEP use, while, while collective self-esteem, a was negatively associated with it. Finally, common indications for PrEP have high sensitivity, but low specificity and predictive value for identifying those on PrEP.ConclusionWe conclude that despite a large gap in PrEP use among those with indications, individuals experiencing psychosocial and structural barriers are more likely to use PrEP, and facilitators, such as psychological sense of affirmed gender may support its use.Trial registrationN/A.

Estimated Uncovered Costs For HIV Preexposure Prophylaxis In The US, 2018.

The cost of HIV preexposure prophylaxis (PrEP) medication and care is a key barrier to PrEP use. Using population-based surveys and published information, we estimated the number of people with uncovered costs for PrEP care among US adults with PrEP indications, stratified by HIV transmission risk group, insurance status, and income. Accounting for existing PrEP payer mechanisms, we estimated annual uncovered costs for PrEP medication, clinical visits, and laboratory testing based on the 2021 PrEP clinical practice guideline. Of 1.2million US adults with PrEP indications in 2018, we estimated that 49,860 (4percent) of them had PrEP-related uncovered costs, including 32,350 men who have sex with men, 7,600 heterosexual women, 5,070 heterosexual men, and 4,840 people who inject drugs. Of those 49,860 people with uncovered costs, 3,160 (6percent) incurred $18.9million in uncovered costs for PrEP medication, clinical visits, and lab testing, and 46,700 (94percent) incurred $83.5million in uncovered costs for only clinical visits and lab testing. The total annual uncovered costs for adults with PrEP indications were $102.4million in 2018. The proportion of people with uncovered costs for PrEP is less than 5percent among adults with PrEP indications, but the magnitude of costs is significant.

Medicare, Hospitals, Prevention, And More

Medicare, Hospitals, Prevention, And More

Sexual and Reproductive Healthcare Visits as a Venue for PrEP Service Delivery among Women in the United States: Results from a Nationally-Representative Survey.

Pre-Exposure Prophylaxis (PrEP) for HIV is disproportionately under prescribed to women. Centers for Disease Control and Prevention (CDC) guidelines identify a group of women at risk of HIV acquisition who should be offered PrEP, but opportunities remain to improve patient awareness of and provider counseling about PrEP, and to expand service delivery of PrEP. Using nationally representative data from the 2017-2019 National Survey of Family Growth, we compared women with (n = 689) and without (n = 5,452) CDC indications for PrEP on measures of PrEP awareness, counseling by a provider, and interaction with the health care system. Women with PrEP indications were no more likely to report awareness of PrEP (OR 1.03, 95% CI 0.82-1.29) or PrEP counseling by a provider (OR 1.32, 95% CI 0.77-2.27), compared to those without PrEP indications. However, women with PrEP indications were more likely than those without to report a birth control visit (OR 1.82, 95% CI 1.39-2.38) or an abortion within the last 12 months (OR 5.93, 95% CI 1.48-23.73), and to currently use prescription contraception (OR 1.45, 95% CI 1.19-1.78). A majority of both groups reported accessing prenatal care within the last 12 months. There remains a gap in PrEP awareness and counseling among women at highest risk for HIV acquisition. Sexual and reproductive health visits represent a logical and feasible venue for PrEP provision. Obstetrician-gynecologists and other family planning providers may be able to aid in service delivery innovations by providing PrEP alongside other sexual and reproductive health care.

Human immunodeficiency virus pre-exposure prophylaxis awareness among people who inject drugs in Portland, Oregon.

Pre-Exposure Prophylaxis (PrEP) to prevent transmission of human immunodeficiency virus (HIV) among people who inject drugs (PWID) has demonstrated efficacy yet awareness of PrEP among PWID is low. 2018 National Behavioral Health Survey data from the Portland, Oregon metropolitan statistical area was analyzed with chi-squared tests and generalized linear models to determine correlates of PrEP awareness among PWID. 80% of the sample had at least one indication for PrEP and 15% of the sample was aware of PrEP. Factors associated with higher PrEP awareness were: higher education level (PR = 1.083, CI = 1.018-1.153, p = .012), reporting transactional sex (PR = 1.154, CI = 1.019-1.307, p = .024), and men who have sex with men reporting condomless sex (PR = 1.376, CI = 1.081-1.752, p = .010). Lack of a usual source of care (PR = 0.884, CI = 0.824-0.949, p < .001) was negatively associated with PrEP awareness. Interventions to increase PrEP awareness need to target groups with particularly low awareness and be delivered in settings accessible to PWID.

Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods

HIV incidence estimates are published each year for all Ending the HIV Epidemic (EHE) counties, but they are not stratified by the demographic variables highly associated with risk of infection. Regularly updated estimates of HIV incident diagnoses available at local levels are required to monitor the epidemic in the United States over time and could contribute to background incidence rate estimates for alternative clinical trial designs for new HIV prevention products. We describe methods using existing, robust data sources within areas in the United States to reliably estimate longitudinal HIV incident diagnoses stratified by race and age categories among men who have sex with other men (MSM) eligible for pre-exposure prophylaxis (PrEP) but not taking it. This is a secondary analysis of existing data sources to develop new estimates of incident HIV diagnoses in MSM. We reviewed past methods used to estimate incident diagnoses and explored opportunities to improve these estimates. We will use existing surveillance data sources and population sizes of HIV PrEP-eligible MSM estimated from population-based data sources (eg, US Census data and pharmaceutical prescription databases) to develop metropolitan statistical area-level estimates of new HIV diagnoses among PrEP-eligible MSM. Required parameters are number of new diagnoses among MSM, estimates of MSM with an indication for PrEP, and prevalent PrEP use including median duration of use; these parameters will be stratified by jurisdiction and age group or race or ethnicity. Preliminary outputs will be available in 2023, and updated estimates will be produced annually thereafter. Data to parameterize new HIV diagnoses among PrEP-eligible MSM are available with varying levels of public availability and timeliness. In early 2023, the most recent available data on new HIV diagnoses were from the 2020 HIV surveillance report, which reports 30,689 new HIV infections in 2020, and 24,724 of them occurred in an MSA with a population of ≥500,000. Updated estimates for PrEP coverage based on commercial pharmacy claims data through February 2023 will be generated. The rate of new HIV diagnoses among MSM can be estimated from new diagnoses within each demographic group (numerator) and the total person-time at risk of diagnosis for each group (denominator) by metropolitan statistical area and year. To estimate time at risk, the person-time of individuals on PrEP or person-time after incident HIV infection but before diagnosis should be removed from stratified population size estimates of the total number of person-years with indications for PrEP. Reliable, serial, cross-sectional estimates for rates of new HIV diagnoses for MSM with PrEP indications can serve as benchmark community estimates of failures of HIV prevention and opportunities to improve services and will support public health epidemic monitoring and alternative clinical trial designs. DERR1-10.2196/42267.

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.

In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. We enrolled HIV-negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure ("high" adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as "high." Women who became pregnant were initially exited from the cohort by design; from March 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group. Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care. ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1.

Health Care Provider Decisions to Initiate Oral HIV Preexposure Prophylaxis in New York City Public Sexual Health Clinics.

Oral HIV preexposure prophylaxis (PrEP) is safe and effective but underutilized. Health care providers' beliefs about PrEP and attitudes toward people who could benefit may affect PrEP access. This mixed-methods study (2016-2018) was conducted in 8 New York City public sexual health clinics that implemented a PrEP program. Data included 32 in-depth qualitative interviews with clinicians, quantitatively coded to reflect their PrEP beliefs; a provider questionnaire; and 6 months of medical record visit data for these providers. Among patients with a PrEP indication, we examined the odds of a patient being initiated on PrEP associated with providers' PrEP beliefs and demographic characteristics, and patient characteristics. Providers reported strong support for offering PrEP to eligible patients. The majority denied concerns about possible development of drug-resistant viral strains, giving PrEP to people who might not benefit, and PrEP toxicity. Nevertheless, about one-third agreed with each of these concerns, and 55% thought PrEP use might limit condom use. Of 2176 patients with a PrEP indication, 20% were initiated. Providers with more restrictive PrEP beliefs did not have lower odds of initiating patients on PrEP. Women as well as Black and Latinx patients were less likely to be initiated on PrEP. Contrary to our hypotheses, providers' negative PrEP beliefs did not seem to reduce initiation of PrEP for eligible patients. This may be attributable to clear clinical protocols, strong staff support, and training on implementing PrEP in this setting. Racial and gender disparities in PrEP uptake urgently require attention.