Pre-exposure Prophylaxis Patients Research Articles

Markedly increased duodenal villous surface apoptosis in patients taking pre-exposure prophylaxis (PrEP) against human immunodeficiency virus.

Pre-exposure prophylaxis (PrEP) consists of combination antiretroviral therapy and is increasingly utilized to prevent human immunodeficiency virus (HIV) in high-risk populations. Two index cases noted during routine care showed markedly increased duodenal villous surface apoptosis in patients on PrEP. We sought to examine the prevalence of this finding and identify any clinicopathologic correlations. Gastrointestinal biopsy specimens from 23 male patients aged 18-40 years taking PrEP and 23 control patients were reviewed. Patients with HIV, inflammatory gastrointestinal diseases, and celiac disease were excluded. Apoptoses were counted on surface epithelium and deep crypts. The highest apoptotic body count per tissue fragment was recorded. Clusters were defined as groups of ≥5 apoptoses. Apoptotic counts between patients taking PrEP and controls were compared using t-tests. In PrEP patients, the median age was 35 years (range 25-40) and 83% (19/23) were white. The control patients were demographically similar (median age: 32 years [range 23-40]; 70% [16/23] white). Duodenal apoptosis in villous surface epithelium was increased in PrEP patients, with 14/23 (60.9%) patients having ≥10 surface apoptoses compared to 2/23 (8.7%) controls (P = 2.1 × 10-3 ) and 14/23 (61%) having clusters compared to 3/23 (13%) controls (P = 2.0 × 10-3 ). There was no significant association between increased surface apoptosis or clusters and clinical symptoms or duration of PrEP use. Markedly increased villous surface apoptosis, particularly in clusters, is often seen in the duodenum of patients taking PrEP. Although the mechanism and significance are unknown, knowledge of this peculiar finding may prevent unnecessary additional testing.

Pre-exposure Prophylaxis Use and Discontinuation in a Federally Qualified Health Center in a Mexico-US Border City.

Latino men who have sex with men (MSM) experience disproportionately high rates of HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) use is critical to reduce this inequity, but PrEP awareness, access, and use are low among Latino MSM. This study aims to describe patterns of PrEP persistence and discontinuation among predominately Latino MSM accessing PrEP in a federally qualified health center (FQHC) in El Paso, Texas. This retrospective cohort comprised individuals who were eligible for PrEP at a FQHC in El Paso, Texas, between January 30, 2019, and August 15, 2021. We defined hierarchical categories of PrEP use and discontinuation, which was defined as more than 120days between PrEP visits. We used Kaplan-Meier survival plots to estimate median time to first PrEP discontinuation. There were 292 patients evaluated for PrEP; 91% were Latino. The majority of PrEP patients (70%, 205/292) experienced any PrEP discontinuation, and the median time to first PrEP discontinuation was 202days (95% CI: 179-266). The proportion of patients who remained on PrEP at 3months after initiation was 82% (95% CI: 76%, 87%) and at 6months after initiation was 55% (95% CI: 46%, 62%). While 3-month PrEP retention was high in this predominately Latino MSM patient population, PrEP discontinuation was common. Interventions that enhance longer-term persistence and support for restarting PrEP are needed to reduce the persistent ethnoracial disparities in HIV incidence.

Disparities in Mpox Vaccination Among Priority Populations During the 2022 Outbreak.

The 2022 mpox outbreak disproportionately affected men who have sex with men and persons living with HIV (PLWH). A 2-dose mpox vaccine series was deployed in mid-2022. Structural racism and insurance status may have affected equitable vaccination. We defined 3 cohorts: PLWH with at least 1 clinic visit between 1 July 2021 and 1 July 2022 (n = 2066), HIV preexposure prophylaxis (PrEP) recipients as of 1 January 2022 (n = 262), and all mpox-vaccinated patients in our health system between 1 July 2022 and 30 November 2022 (n = 807). We identified patients with prior diagnosed sexually transmitted infections (STIs) as having a positive test result for gonorrhea, chlamydia, or syphilis between 1 July 2021-1 July 2022. The primary outcome was receipt of at least 1 dose of mpox vaccine. We identified 224 (10.8%) PLWH and 50 (19.0%) PrEP patients who received at least 1 dose of mpox vaccine. Among PLWH, White race (odds ratio [OR], 1.55; 95% CI, 1.11-2.16), private insurance (OR, 1.83; 95% CI, 1.01-3.34), prior STI (OR, 3.04; 95% CI, 2.16-4.27), prior COVID-19 vaccination (OR, 3.17; 95% CI, 1.93-5.20), and prior influenza vaccination (OR, 1.42; 95% CI, 1.30-1.96) independently predicted mpox vaccination. Within the PrEP cohort, prior COVID-19 vaccination and seasonal influenza vaccination predicted mpox vaccination. Uninsured patients were vaccinated later in the outbreak than patients with private insurance (median time to vaccination, 41 days in the privately insured group vs 83 days in the uninsured group; P < .0001). Race, insurance status, prior STI, and previous receipt of other vaccines influenced uptake of mpox vaccine. Addressing health disparities and vaccine acceptance will be essential in improving future outbreak response.

Sexually Transmitted Infections in Pre-Exposure Prophylaxis Patients

Background and Objective: Pre-exposure prophylaxis (PrEP) effectively prevents the spread of the human immunodeficiency virus (HIV). HIV is a disease primarily contracted by men who have sex with men or the sharing of needles, syringes, and other drug injection equipment. However, there is some disparity over the thought that PrEP patients have a disproportionate incidence of sexually transmitted infections (STIs) compared with non-PrEP patients. This study aims to clarify the disparity and identify if PrEP patients have a higher incidence of STIs. Methods: A survey of 143 respondents was conducted on STI incidence, risk factors, and abstinence from May 13, 2022, to June 20, 2022. The results were analyzed in Statistical Package for the Social Sciences (SPSS V28.0.0.0). SPSS was used to analyze the descriptive statistics associated with STI data obtained from the Naval Medical Readiness and Training Command, Camp Lejeune, Community Health Clinic Patient and Laboratory Tracker. Results: This study found a higher incidence of STIs among PrEP patients than non-PrEP patients and a statistical significance (p = 0.010) between the number of partners a person had sex with over the past year and the lifetime incidence of STIs. Portions of the data in the linear regression were used to calculate the significance and can be used as a predictor of STIs based on the number of partners a person has. This can help patients within this community understand their actual risk of contracting an STI based on a potential risk factor. Conclusion and Implications for Translation: This study found a higher incidence of STIs among PrEP patients than non-PrEP patients. Additionally, the study can help public health professionals understand the risks associated with military patients who take PrEP and target specific risk factors that influence the disparity in the incidence of STIs. Future studies may use survey data from this study to understand the implications of other risk factors and their association with STIs. Public health professionals can also use these data to develop a predictive index for many risk factors. A predictive index on STI risk is an extremely valuable tool as it allows users to view their risk of obtaining an STI. Copyright © 2023 Sleeman and Hoban. Published by Global Health and Education Projects, Inc.This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.

PrEP disclosure and discussions within social networks of people who inject drugs experiencing homelessness: a brief report

BackgroundIn the context of increasing injection-related HIV outbreaks across the United States, particularly among people who inject drugs (PWID) experiencing homelessness, there is an urgent need to expand access to pre-exposure prophylaxis (PrEP) for HIV prevention. Peer-based interventions for PrEP could be helpful for promoting PrEP uptake, yet the social experiences of using PrEP among PWID experiencing homelessness have not been thoroughly explored.MethodsTo better understand social experiences surrounding PrEP use among PWID experiencing homelessness, we conducted qualitative interviews from March-December 2020 with current and former PrEP patients of an innovative, low-threshold program implemented by Boston Health Care for the Homeless Program (BHCHP) in Boston, MA. Thematic analysis of coded interview data explored participants’ perspectives and experiences with PrEP disclosure and discussions within their social networks.ResultsAmong interviews with 21 participants, we identified the following four interrelated aspects of their social experiences using PrEP: (1) participants’ were aware of increasing HIV transmission within their social networks, which motivated their PrEP use and disclosure; (2) participants generally avoided disclosing their PrEP use within public spaces or casual conversations; (3) participants expressed greater willingness to discuss PrEP with their close social contacts; and (4) some participants self-identified as leaders or expressed interest in leading the dissemination of PrEP information within their social networks.ConclusionsFindings highlight the significance of PrEP disclosure and discussions within the social networks of PWID experiencing homelessness, suggesting a need for continued social network and intervention research—particularly to establish the feasibility and acceptability of peer-based interventions for promoting PrEP—with this marginalized population.

Abstract B052: Integrating HPV (human papillomavirus) vaccination into HIV prevention: Acceptability and information needs among PrEP (pre-exposure prophylaxis) patients at a federally qualified health center

Abstract Background: Anal cancer disproportionally impacts gay, bisexual, and other male sexual minorities (GBM). Human Papillomavirus (HPV) vaccination is a safe and effective method to prevent anal cancer; however, coverage of HPV vaccination among adult GBM is low. Key barriers to vaccination are lack of awareness and knowledge of anal cancer, low motivation to get vaccinated, and lack of access and availability. For many young GBM, regular interactions with the healthcare system center around HIV prevention. Thus, we propose that federally qualified health centers (FQHCs) can increase uptake and reach of HPV vaccination by integrating and promoting HPV vaccination in ongoing HIV preventive care (e.g., Pre-exposure Prophylaxis [PrEP]). The objectives of this project were to (1) assess the acceptability of integrating HPV vaccination with PrEP management and (2) determine needs for informed decision making. Methods: We conducted a web-based cross-sectional survey of unvaccinated GBM (18-45) who received PrEP care at a FQHC in Philadelphia. Data collection took place in 2021 and 2022. The main outcome was intent to initiate HPV vaccination within 12 months (5-point scale). Other measures included beliefs about HPV vaccination in PrEP care, perceived information needs, and preferred information delivery modes. Descriptive and bivariate statistics were used to analyze the data. Results: The sample (N=59) was ethnoracially diverse (50.0% non-White) and in the catchup (23.7%; 18-26 yrs.) or shared clinical decision making (76.3%; 27-45) age ranges. Most were gay identified (71.2%) cisgender men (74.6%). Just 23.7% were aware they were eligible for HPV vaccination and even fewer knew that vaccination could prevent anal cancer (11.9%). Overall vaccine intentions were high (M=3.7; SD=1.0). Intentions were 26.1% higher (M=4.4; SD=1.0) if HPV vaccination was offered during PrEP appointments. Most (88.7%) agreed that offering HPV vaccination during PrEP visits would increase the likelihood that they would get vaccinated; however, 64.4% strongly/somewhat agreed that they needed more information about HPV vaccination prior to making an informed decision. Perceived information need was inversely associated with vaccine intentions (r=-0.31, p=0.02). Most participants (&amp;gt;50%) indicated they wanted to know more about their risk for anal cancer and effectiveness of HPV vaccination. The majority (71.2%) preferred to get medically accurate information on anal cancer prevention from a website that they could go to on their own time. Other delivery modes were iPads at their doctor’s office (28.8%), printed information given to them by their doctor (28.8%), and text messages from a healthcare provider (25.4%). Conclusion: Offering and promoting HPV vaccination as part of PrEP management visits was highly acceptable among PrEP patients. Interventions should focus on raising awareness about anal cancer and promoting informed decision making for anal cancer prevention. Citation Format: Christopher W. Wheldon, Sarah Bass, Bradley Collins. Integrating HPV (human papillomavirus) vaccination into HIV prevention: Acceptability and information needs among PrEP (pre-exposure prophylaxis) patients at a federally qualified health center [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B052.

Would men who have sex with men support less frequent screening for asymptomatic chlamydia and gonorrhoea to improve antibiotic stewardship? A qualitative study.

Men who have sex with men (MSM) taking pre-exposure prophylaxis (PrEP) are recommended to have screening for asymptomatic chlamydia and gonorrhoea every 3months with high rates of asymptomatic chlamydia and gonorrhoea detected. However, there is little evidence about the effectiveness of this screening interval and there is increasing concern about antibiotic consumption and its impact on antimicrobial resistance. There have been calls to reconsider this frequent screening for chlamydia and gonorrhoea. We conducted interviews with MSM to assess their attitudes to 3-monthly chlamydia and gonorrhoea screening. Individual semi-structured interviews were conducted with MSM living in Victoria, Australia. Participants were aged 20-62years and had been taking PrEP for at least 6months. Interviews were audio-recorded and transcribed, and these data were investigated through reflexive thematic analysis. Thirteen interviews were conducted in August 2021. Participants were hesitant about reducing the screening frequency and reported that testing gave them a sense of security. While MSM recognised antimicrobial resistance was a concern, it did not impact their sexual behaviour, with many participants stating they would rather continue to take antibiotics to treat infections rather than adopt preventative measures such as condom use. Positive attitudes towards screening interval changes are more likely when PrEP patients are informed about the risks and benefits of sexual healthcare recommendations. While MSM on PrEP were initially hesitant to changes in screening frequency, changes may be acceptable if transparent communication, presenting the benefits and harms of screening and treatment, was delivered by a trusted healthcare professional.

1014. Patient perspectives on pharmacy experiences for antiretroviral refills

Abstract Background Control and prevention of HIV infection require sustained adherence to antiretroviral therapy (ART) for patients with HIV (PWH) or those on pre-exposure prophylaxis (PrEP). ART is increasingly designated by payers as a specialty medication and often mandates specialty mail-order pharmacy for refills. Little is known about patient perspectives of pharmacy choice preferences for ART. Methods A 20-question survey was distributed to patients (PWH and PrEP) of the Specialty Care Center in Omaha, NE. Participants &amp;gt;19 years, retained in care for &amp;gt;6 months, and experience with ART/PrEP refills at both local and mail-order pharmacies were considered for study participation. The survey was designed in 3 parts: perspectives on both pharmacy settings, ranking of pharmacy attributes, and pharmacy preference. Descriptive analyses were performed for all survey questions. Results Surveys were completed by 61 participants (N=156; 39.1%). Median age was 52 years, 85% White, 13% Black, 5% Latinx, and 80% commercially insured. Forty-eight participants (79%) reported insurance mandates to use a specialty mail-order pharmacy with 28 (58%) believing the mandate impacted their medical care. Forty-one participants (67%) preferred refilling prescriptions through a local pharmacy. Participants ranked “ease of refilling” as the most important attribute (Figure 1) and favored local pharmacies vs mail-order pharmacies for all pharmacy attributes (Figure 2). Scoring scale, 1=strongly disagree to 5=strongly agree. Conclusion Midwest PWH and PrEP patients generally preferred local pharmacies to refill their antiretroviral therapies versus mail-order pharmacies for nearly all pharmacy attributes. Further, many participants felt specialty pharmacy mandates negatively impacted their medical care. Insurance payers should consider removing restrictive specialty pharmacy mandates for ART/PrEP prescriptions. Disclosures All Authors: No reported disclosures.

A Demedicalized Model to Provide PrEP in a Sexual Health Clinic.

Sexual health clinics (SHCs) serve large numbers of patients who might benefit from preexposure prophylaxis (PrEP). Integrating longitudinal PrEP care into SHCs can overburden clinics. We implemented an SHC PrEP program that task shifted most PrEP operations to nonmedical staff, disease intervention specialists (DIS). We conducted a retrospective cohort analysis of PrEP patients in an SHC in Seattle, WA, from 2014 to 2020 to assess the number of patients served and factors associated with PrEP discontinuation. Clinicians provide same-day PrEP prescriptions, whereas DIS coordinate the program, act as navigators, and provide most follow-up care. Between 2014 and 2019, 1387 patients attended an initial PrEP visit, 93% of whom were men who have sex with men. The number of patients initiating PrEP per quarter year increased from 20 to 81. The number of PrEP starts doubled when the clinic shifted from PrEP initiation at scheduled visits to initiation integrated into routine walk-in visits. The percentage of visits performed by DIS increased from 3% in 2014 to 45% in 2019. Median duration on PrEP use was 11 months. PrEP discontinuation was associated with non-Hispanic black race/ethnicity [hazard ratio (HR) 1.34, 95% confidence interval (CI) 1.02 to 1.76], age <20 years (HR 2.17, 95% CI: 1.26 to 3.75), age between 20 and 29 years (HR 1.55, 95% CI: 1.06 to 2.28), and methamphetamine use (HR 1.98, 95% CI: 1.57 to 2.49). The clinic had 750 patients on PrEP in the final quarter of 2019. A demedicalized SHC PrEP model that task shifts most operations to DIS can provide PrEP at scale to high priority populations.

Parallel reductions in anxiety and HIV-related worry among pre-exposure prophylaxis (PrEP) users over time.

The threat of HIV has been proposed as a major contributing factor to the disproportionately higher rates of anxiety among gay and bisexual men compared to their heterosexual counterparts. The current study examined 12-month trajectories of anxiety symptoms and concomitant HIV-related worry among a cohort of preexposure prophylaxis (PrEP) users, compared to a comparison cohort who were not taking PrEP. SPARK was a community-based PrEP demonstration project conducted between February 2014 and May 2017. Self-report anxiety and worry data were collected from PrEP patients (n = 300) quarterly, and from non-PrEP patients (n = 131) at baseline, 3, and 12 months. We ran a series of unconditional latent growth curve models (LGCMs) to examine changes in anxiety and HIV worry over the 12-month study period, followed by parallel process LGCMs to examine the association between both intercepts and growth factors, adjusting for demographic factors. In a parallel process model, both an association between baseline levels of HIV worry and anxiety decreases in both variables over time among PrEP users but not among non-PrEP users. Additionally, a multigroup analysis was conducted, restricting both groups to 3 time points, and forcing a comparison of slopes between the 2 groups. This analysis revealed that there was no difference in the anxiety slopes between the 2 cohorts. However, the HIV worry slope remained significantly different among the PrEP cohort compared to the non-PrEP cohort. These data provide some of the first quantitative evidence for the potential of PrEP to reduce both HIV worry and anxiety symptoms. Emphasizing positive mental health "side effects" of PrEP may be a strategy for engaging priority populations in biomedical HIV prevention. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Brief Report: Transgender Women and Preexposure Prophylaxis Care: High Preexposure Prophylaxis Adherence in a Real-World Health Care Setting in New York City.

Transgender women and trans feminine individuals (TGW/TFI) are a high priority population for the provision of HIV preexposure prophylaxis (PrEP) care within the United States, but there is limited research that focuses specifically on PrEP adherence within this population. Observational study of patients prescribed PrEP at a community-based health center. We enrolled 100 TGW/TFI PrEP patients at a community health center during clinic visits. Adherence data were collected at 3 time points, using self-report surveys, patient interviews, and urine assays measuring tenofovir. Data were summarized descriptively. The sample was diverse in age, race/ethnicity, and socioeconomic characteristics. Participants demonstrated strong PrEP adherence; at least 80% of the sample reported 90% or greater adherence at each time point. Concordance between self-report and urine assay was high. Among patients who reported taking PrEP within the past 48 hours, 82%-92% had detectable urine tenofovir. However, many patients reported PrEP stop periods of 4 or more days (28%-39% per time point). Our data highlight TGW/TFI's capacity to adhere to daily PrEP and sustain PrEP use over time. The concordance between patient self-report and urine TFV levels suggest that providers can trust patient reports of PrEP adherence behavior and support the use of adherence conversations in clinical settings, without the need for point of care biological monitoring. Findings also underscore the importance of continued attention to drivers of PrEP stops at the patient, clinic, and systems levels and the development of strategies that support sustained PrEP use.

PrEP patient attitudes, beliefs and perceived barriers surrounding HPV vaccination: a qualitative study of semistructured interviews with PrEP patients in primary care clinics in Kansas and Missouri

ObjectivesMen who have sex with men who use pre-exposure prophylaxis (PrEP) have not traditionally been targets for human papillomavirus (HPV) vaccine programmes, despite their high risk for HPV-related cancers and...

Human Papillomavirus Prevalence and Vaccination Rates Among Users of Pre-Exposure Prophylaxis for Human Immunodeficiency Virus Prevention.

Introduction:Our study provides data on the prevalence of human papillomavirus (HPV) related disease and vaccination rates among users of pre-exposure prophylaxis (PrEP) in a primary care clinic. Results highlight an opportunity to partner HIV and HPV prevention efforts.Methods:This is a retrospective chart review of PrEP patients in an urban Midwestern Family Medicine clinic. We conducted univariate analyses for HPV vaccination status and the prevalence of any HPV-related disease. We then examined bivariate relationships between vaccination status and insurance coverage, provider type, and age.Results:Of all 78 PrEP patients identified, 21.8% (n = 17) were vaccinated. Of the 59 patients 45 years or younger, 28.8% (n = 17) were vaccinated. There was no association between insurance or provider type and vaccination status. Patients 26 years or younger were 3 times more likely to be vaccinated than those ages 27 to 45 (56.3% vs 18.6%, P = .0011). Three unvaccinated patients had HPV-related disease.Conclusions:Despite ongoing risk of HPV infection and frequent interaction with the medical system, this study found most PrEP users continue to be unvaccinated. This is a significant missed opportunity for HPV prevention. With the FDA approval of the HPV vaccine for individuals age 9 to 45, PrEP patients in this age range would benefit from clinicians partnering HPV vaccination with PrEP prescribing.

859. Suboptimal Uptake, Retention, and Adherence of Daily Oral PrEP Among People with OUD Receiving HCV Treatment

BackgroundDaily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) effectively prevents HIV among people who use drugs (PWUD). Despite rising rates of HIV incidence and injection drug use, PrEP use remains low and limited research exists on PrEP adherence and retention in this population.MethodsBased in Washington, DC and Baltimore, the ANCHOR investigation evaluated a community-based model of care collocating hepatitis C (HCV) therapy, medication for opioid use disorder (OUD), and PrEP in people with chronic HCV, OUD, and drug use within 1 year. PrEP counseling was offered from HCV treatment Day 0 until Week 24 and subjects could start any time during this window. PrEP patients were followed for 48 weeks and assessed for adherence by self-report and dried blood spot analysis of TDF. ANCHOR PrEP study enrollment and participant retention along the PrEP continuum.Results198 participants enrolled in ANCHOR, of whom 185 (93%) were HIV-negative. 29 subjects (16% of HIV-negative group) initiated PrEP. 116 subjects (63%) met 2014 CDC criteria for PrEP initiation due to IDU (82, 44%), sex (9, 5%), or both (25, 14%). Those who initiated were more likely to meet both CDC sexual and IDU risk criteria than those who declined PrEP (P=0.006). Providers recommended PrEP to 94 subjects (51%), which was associated with uptake (P=0.02). While median treatment duration was 104 days (IQR 28, 276), only 8 subjects were retained through Week 48. The most common reason for discontinuation was side effects in 7 subjects or 24% of PrEP subgroup. Treatment interruptions occurred in one-third of the PrEP subgroup. Adherence of 4 to 7 pills per week was variable over time by self-report and declined by TDF analysis. No HIV seroconversions occurred. Demographic and epidemiological background of the ANCHOR study population. Total duration, in days, on PrEP in the ANCHOR study. Discontinued participants are grouped by reason for cessation of therapy.PrEP Adherence Adherence to PrEP by ANCHOR study timepoint, assessed via self-report (above) and dried bloodspot analysis of tenofovir level (below).ConclusionIn this cohort of people with OUD and HCV, 16% of subjects started PrEP. While clinical recommendation was associated with uptake, high rates of disruption and discontinuation, compounded by variable pill adherence, made daily oral TDF/FTC a suboptimal preventive strategy in this cohort. Emerging PrEP modalities like long-acting injectables have potential to address these barriers, but PWUD have been excluded from their research and development to date. Additional work to identify vulnerable individuals and to promote use, adherence, and retention will be critical in implementing PrEP more effectively in this key population.Disclosures Sarah Kattakuzhy, MD, Gilead Sciences (Scientific Research Study Investigator, Research Grant or Support) Elana S. Rosenthal, MD, Gilead Sciences (Research Grant or Support)Merck (Research Grant or Support)

861. Impact of COVID-19 Mitigation Measures on PrEP Care at a Safety Net Health System in Atlanta

BackgroundThe Grady Health System pre-exposure prophylaxis (PrEP) program modified its care practices to accommodate COVID-19 mitigation measures. Changes enacted included: transition to telemedicine visits, medication mail delivery, and flexible timing of quarterly laboratory testing. These were implemented in March 2020 and remain in place presently. This study aimed to evaluate patients’ long-term acceptability of these modifications and to assess their impact on PrEP care. MethodsThis was a cross-sectional study in a convenience sample of PrEP patients, ages 18 and older, at an urban clinic in Atlanta. They were invited to complete a survey between December 2020 and April 2021. The survey assessed the impact of mitigation measures on overall PrEP care, follow up visits, medication access, and ability to complete laboratory testing. It also evaluated the usability, quality, satisfaction, and concerns with telemedicine. Data were examined using median and interquartile ranges, and proportions. ResultsOf 145 patients contacted, 61 completed the survey (median age 33 years, 72% Black, 75% cisgender men, 15% transgender women). Most participants did not report interruptions in their PrEP care (72%) or follow up visits (74%). Most found it easy to access medications (82%), as participants’ report of medication mail delivery usage increased from 57% (pre-pandemic) to 73% (in-pandemic period). Interruptions in completing quarterly labs were more frequently reported, as only 62% found this to be easy. Overall, 89% reported using telemedicine; telephone call was the most used method (78%). Telemedicine users’ ratings for quality, usability, and satisfaction of telemedicine was high (median score: 6/7) and nearly all users (97%) reported no concerns about its continued use for PrEP care. A few participants (5%) raised concerns about loss of telephone services due to financial issues, impacting their ability to complete telemedicine visits. ConclusionPrEP care at an urban clinic was well- maintained despite COVID-19 mitigation measures. Telemedicine was found to be acceptable and usable by surveyed participants. Future research on widescale implementation of telemedicine for PrEP care is neededDisclosures All Authors: No reported disclosures

Game Plan, a Web-Based Intervention to Improve Adherence and Persistence to HIV Pre-exposure Prophylaxis and Reduce Heavy Drinking in Gay, Bisexual, and Other Men Who Have Sex With Men: Usability and User Experience Testing.

BackgroundEncouraging consistent use of pre-exposure prophylaxis (PrEP) is essential for reducing HIV incidence, particularly among gay, bisexual, and other men who have sex with men (GBM), and especially those who engage in heavy drinking. Although practice guidelines recommend providing adherence counseling to PrEP patients, clinics and providers may not have the resources or expertise to provide it. Internet-facilitated interventions have been shown to improve HIV prevention outcomes, including medication and care adherence. Game Plan is a website we created to help users make a tangible plan for reducing their HIV risk. We designed additional components of Game Plan to address key individual level barriers to PrEP use.ObjectiveThe aim of this mixed methods research is to test the usability and user experience of these components with intended users: GBM who drink heavily and are on PrEP.MethodsIn study 1 (usability), we completed a detailed individual interview in which participants (n=10) walked through a prototype of the website, thinking aloud as they did, and completed a follow-up interview and web-based survey afterward. Study 2 (user experience) involved providing participants (n=40) with a link to the prototype website to explore on their own and asking them to complete the same follow-up survey afterward. Qualitative data were analyzed using thematic analysis, and descriptive statistics were used to analyze quantitative data.ResultsUsers in both studies gave the website excellent ratings for usability, overall satisfaction, and quality, and most often described the site as informative, helpful, and supportive. Users also rated the site’s content and feel as respectful of them and their autonomy, empathetic, and they stated that it conveyed confidence in their ability to change. The study 1 interviews highlighted the importance of the website’s esthetics to the participants’ engagement with it and its credibility in prompting genuine reflection.ConclusionsGBM who reported heavy drinking and used PrEP generally found a website focused on helping them to create a plan to use PrEP consistently to be helpful. Adopting user-centered design methods and attending to the esthetics of mobile health interventions are important steps toward encouraging engagement and reducing at-risk behaviors.

Trends in the Number and Characteristics of HIV Pre-Exposure Prophylaxis Providers in the United States, 2014-2019.

The number and characteristics of pre-exposure prophylaxis (PrEP) health care providers in the United States have not been reported. We analyzed a national pharmacy database that included >90% of all prescriptions dispensed by retail pharmacies and 60%-86% dispensed by mail-order outlets. We estimated the number of PrEP providers by year, provider type, physician specialty, and geographic location. We also measured the Gini coefficients for the distribution of PrEP patients among providers. The number of PrEP providers increased from 9621 in 2014 to 65,822 in 2019. In 2019, 68.1% of PrEP providers were physicians. The proportion of nurse practitioners or physician assistants increased from 18.0% in 2014 to 29.7% in 2019. Among all the US health care providers, those who prescribed PrEP increased from 0.7% in 2014 to 4.3% in 2019. Among all general practice/family medicine physicians, the percentage of who prescribed PrEP increased from 1.8% in 2014 to 13.6% in 2019 and from 14.2% to 34.2% among infectious disease physicians. The ratio of PrEP providers to 100 persons with PrEP indications was lowest in the South with 4.4. The Gini coefficient for the distribution of PrEP patients among providers was 0.75 in 2019, with 50% of the PrEP patients prescribed PrEP by 2.2% of PrEP providers. An increasing number of providers prescribed PrEP during 2014-2019. The South had the largest number of new HIV diagnoses and greatest need for HIV prevention but had less PrEP service capacity compared with other regions. Expanded access to PrEP services is needed in the United States.

MHealth for pre-exposure prophylaxis adherence by young adult men who have sex with men.

Young adult men who have sex with men (YMSM) are at increased risk for HIV, especially minority YMSM. Pre-exposure prophylaxis (PrEP) is a breakthrough daily pill to prevent HIV. Consistent adherence is key to PrEP effectiveness, which is why the CDC recommends adherence support be provided to all PrEP patients. Mobile health can overcome barriers to the delivery of adherence support, particularly for YMSM who may be most in need of it due, at least in part, to their young age. We created a culturally- and developmentally-sensitive PrEP adherence mobile app (called "Dot") that was tailored for culturally-diverse young adult MSM. After formative research and usability testing, we conducted a 6-week pre-post study to evaluate the impact of Dot on self-reported PrEP adherence, PrEP treatment self-efficacy, PrEP knowledge, and intention to practice safe sex among culturally-diverse YMSM, age 20-29. At 6 weeks, there were significant improvements in PrEP adherence, PrEP self-efficacy, and intention to practice safe sex. PrEP knowledge scores did not significantly change. The Dot app proved feasible and effective at improving PrEP adherence among culturally-diverse YMSM. Moreover, the app had a high-degree of user appeal, which is foundational to success of an mhealth intervention.

Loss to Follow-Up and Re-Engagement in HIV Pre-Exposure Prophylaxis Care in the United States, 2013-2019.

Retention in HIV pre-exposure prophylaxis (PrEP) care is critical for effective PrEP implementation. Few studies have reported long-term lost to follow-up (LTFU) and re-engagement in PrEP care in the United States. Medical record data for all cisgender patients presenting to the major Rhode Island PrEP clinic from 2013 to 2019 were included. LTFU was defined as no PrEP follow-up appointment within 98 days. Re-engagement in care was defined as individuals who were ever LTFU and later attended a follow-up appointment. Recurrent event survival analysis was performed to explore factors associated with PrEP retention over time. Of 654 PrEP patients, the median age was 31 years old [interquartile range (IQR): 25, 43]. The majority were male (96%), White (64%), non-Hispanic (82%), and insured (97%). Overall, 72% patients were ever LTFU and 27% of those ever LTFU re-engaged in care. Female patients were 1.37 times [crude hazard ratio (cHR): 1.37; 95% confidence interval (CI): 0.86-2.18] more likely to be LTFU than male patients, and a 1-year increase in age was associated with a 1% lower hazard of being LTFU (cHR: 0.99; CI: 0.98-0.99). Being either heterosexual (aHR: 2.25, 95% (CI): 1.70-2.99] or bisexual (aHR: 2.35, 95% CI: 1.15-4.82) was associated with a higher hazard of loss to follow-up compared with having same-sex partners only. The majority of PrEP users were LTFU, especially at the first 6 months of PrEP initiation. Although a significant number were re-engaged in care, targeted interventions are needed to improve retention in PrEP care. This study characterized the natural projection of loss to follow-up and re-engagement in HIV PrEP care using a longitudinal clinic cohort data and explored associated factors for guiding future interventions to improve retention in PrEP care.

Sexual satisfaction with daily oral HIV pre-exposure prophylaxis (PrEP) among gay and bisexual men at two urban PrEP clinics in the United States: an observational study.

We conducted a one-time, cross-sectional survey of MSM receiving PrEP care at two hospital-based PrEP clinics in Providence, Rhode Island and Boston, Massachusetts, USA (April-September 2017). We oversampled Black and Hispanic/Latino individuals. Participants completed the 20-item New Sexual Satisfaction Scale (NSSS) twice, once for before and once for after starting PrEP. Participants reported sexual behaviours, PrEP adherence, PrEP attitudes, and quality of life with PrEP. A total of 108 gay and bisexual men (GBM) participated. Overall, 15.7% were Black (non-Hispanic/Latino) and 23.1% were Hispanic/Latino, with an average age of 36.6 years. Most participants reported private health insurance coverage (71.3%), and 88.9% identified as homosexual, gay, or same gender-loving. The mean NSSS score before PrEP initiation across all 20 items was 3.94 (maximum = 5; 95% CI: 4.22, 4.43), and increased significantly after PrEP initiation (4.33, 95% CI: 4.22, 4.43; P < 0.001). Most participants (73.2%) reported that PrEP increased quality of life. This was associated with significant change in pre- to post-PrEP NSSS scores (linear regression coefficient = 1.21; 95% CI: 0.585, 1.84). Initiating PrEP and reporting improved quality of life were significantly associated with an increase in sexual satisfaction. PrEP implementation efforts should consider sexual satisfaction to promote PrEP engagement and retention, and researchers and providers should adopt a sex-positive approach with PrEP patients, especially among MSM.