Factors associated with suboptimal retention in HIV pre-exposure prophylaxis care among men who have sex with men.

Despite the efficacy of HIV pre-exposure prophylaxis (PrEP), retention in care in the United States remains suboptimal. The goal of this study was to explore factors that lead to suboptimal retention in PrEP care for men who have sex with men (MSM) in real-world clinical settings in the United States. Trained interviewers conducted semi-structured interviews with MSM (N = 49) from three clinics who had been engaged in PrEP care in the Midwest (n = 15), South (n = 15), and Northeast (n = 19) geographic regions and had experienced a lapse in PrEP use. Factors that emerged as related to suboptimal retention in PrEP care included structural factors such as transportation and out-of-pocket costs; social factors such as misinformation on media and in personal networks; clinical factors such as frequency and timing of appointments; and behavioral factors such as changes in sexual behavior and low perceived risk for HIV. Participants suggested reducing the out-of-pocket costs of medications and lab visits, having flexible appointment times, culturally responsive services, and comprehensive patient navigation to help retention in care. These findings leveraged real-world experiences and opinions of patients to inform gaps in current services and how to make changes to optimize PrEP care.

Preferences for HIV Preexposure Prophylaxis Products Among Black Women in the U.S.

In a nationwide sample of Black women in the U.S., we assessed preferences for HIV preexposure prophylaxis (PrEP) products, including long-acting injectable (LAI) PrEP and once-daily oral PrEP. Among 315 respondents, 32.1% were aware of PrEP and 40.6% were interested in using it; interest increased to 62.2% if PrEP were provided for free. Oral PrEP was the preferred option (51.1%), followed by LAI PrEP (25.7%), vaginal gel (16.5%), and vaginal ring (6.7%). When examining oral and LAI PrEP alone, most (62.7%) preferred oral PrEP. LAI PrEP was more likely to be preferred among respondents with concerns about healthcare costs or PrEP-related stigma, and among those who reported inconsistent condom use and multiple sexual partners. Although most Black women preferred oral PrEP, LAI PrEP may be appealing to a subset with social and structural barriers to PrEP use, such as cost and stigma, and those at increased risk of HIV infection.

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions.

Stigma regarding HIV pre-exposure prophylaxis (PrEP) is commonly implicated as a factor limiting the scale-up of this highly effective HIV prevention modality. To quantify and characterize PrEP stigma, we developed and validated a brief HIV PrEP Stigma Scale (HPSS) among a group of 279 men who have sex with men (MSM). Scale development was informed by a theoretical model to enhance content validity. We assessed two scale versions, Semantic Differential and Likert, randomizing the order in which scales were presented to participants. Both scales demonstrated high internal consistency. The Likert scale had substantially better construct validity and was selected as the preferred option. Scale scores demonstrated construct validity through association with constructs of interest: healthcare distrust, HIV knowledge, perceived proportion of friends/partners on PrEP, perceived community evaluation of PrEP, and perceived effectiveness of PrEP. The scale accounted for 25% of the total variance in reported willingness to be on PrEP, indicating the substantial role PrEP stigma may have on decisions to initiate PrEP. Given increased efforts to roll-out PrEP, having a valid tool to determine the level and types of PrEP stigma in individuals, groups, and communities can help direct implementation plans, identify goals for stigma reduction, and monitor progress over time.

Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program.

We piloted PrEP@Home, a preexposure prophylaxis system of remote laboratory and behavioral monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden. The system was highly acceptable and in-demand for future use, and more than one-third of participants reported greater likelihood of persisting in care if available.

Behavioral Changes Following Uptake of HIV Pre-exposure Prophylaxis Among Men Who Have Sex with Men in a Clinical Setting.

We describe changes in sexual behaviors among men who have sex with men (MSM) following initiation of pre-exposure prophylaxis (PrEP) in a clinic-based sample of MSM initiating PrEP in Providence, Rhode Island. Data were collected at baseline, 3, and 6 months following PrEP initiation including total number of anal sex partners and condom use. A longitudinal mixed effects model assessed changes in number of partners and condom use over time, adjusting for age, race, and education. There was no statistically significant difference in total number of partners over time. There was a significant increase in number of condomless anal sex partners at the 6-month visit compared to baseline (mean change +1.31 partners, 95% confidence interval 0.09-2.53, P = 0.035). As condomless anal sex may increase following PrEP uptake, adherence counseling and efforts to retain patients in PrEP care, especially during periods of non-condom use, are important as PrEP is more widely implemented.

A Multicomponent Library Resource Model to Enhance Academic Global Health Education Among Residency Programs.

Global health is becoming an increasingly important component of medical education. Medical libraries have an opportunity to assist global health residents with their information needs, but first it is important to identify what those needs are and how best they can be addressed. This article reports a collaboration between global health faculty and an academic medical librarian to assess the information needs of global health pathway residents and how assessment data are used to create a multicomponent program designed to enhance global health education.

High Rates of Missed HIV Testing Among Oral PrEP Users in the United States From 2018-2021: A National Assessment on Compliance With HIV Testing Recommendations of the CDC PrEP Guidelines.

Background: The US Centers for Disease Control and Prevention recommends HIV testing every 3 months in oral PrEP users. We performed a national assessment of HIV testing compliance among oral PrEP users. Methods: We analyzed 408 910 PrEP prescriptions issued to 39 809 PrEP users using a national insurance claims database that contained commercial and Medicaid claims. We identified PrEP use based on pharmacy claims and outpatient diagnostic coding. We evaluated the percentage of PrEP prescription refills without HIV testing (identified by CPT codes) within the prior 3, 6, and 12 months using time to event methods. We performed subgroup and multivariate analyses by age, gender, race, insurance type, and geography. Results: Of 39 809 persons, 36 197 were commercially insured, 3612 were Medicaid-insured, and 96% identified as male; the median age (interquartile range) was 34 (29-44) years, and the Medicaid-insured PrEP users were 24% Black/African American, 44% White, and 9% Hispanic/Latinx. Within the prior 3, 6, and 12 months, respectively, the percentage of PrEP prescription fills in individuals without HIV Ag/Ab testing was 34.3% (95% CI, 34.2%-34.5%), 23.8% (95% CI, 23.7%-23.9%), and 16.6% (95% CI, 16.4%-16.7%), and the percentage without any type of HIV test was 25.8% (95% CI, 25.6%-25.9%), 14.6% (95% CI, 14.5%-14.7%), and 7.8% (95% CI, 7.7%-7.9%). Conclusions: Approximately 1 in 3 oral PrEP prescriptions were filled in persons who had not received an HIV Ag/Ab test within the prior 3 months, with evidence of health disparities. These findings inform clinical PrEP monitoring efforts and compliance with national HIV testing guidance to monitor PrEP users.

First Case of HIV Seroconversion With Integrase Resistance Mutations on Long-Acting Cabotegravir for Prevention in Routine Care.

Background: Long-acting cabotegravir (CAB-LA) is highly effective for HIV prevention, but delayed HIV diagnoses and integrase strand transfer inhibitor (INSTI) resistance were observed in trials. We report the first case in routine clinical care of HIV infection on CAB-LA with INSTI resistance. Methods: The SeroPrEP study enrolls individuals in the United States who acquire HIV on pre-exposure prophylaxis modalities to assess diagnostics, antiretroviral (ARV) drug levels, resistance, and treatment outcomes. Resistance mutations in full-length HIV-1 integrase were identified by single-genome sequencing (SGS). Cabotegravir concentrations in plasma and hair segments were measured by liquid chromatography-tandem mass spectrometry. Results: A 23-year-old gender-nonbinary person, male at birth, restarted CAB-LA 6 months after discontinuation due to losing insurance. Prior to restart, HIV-1 RNA was not detected, but 20 days elapsed before CAB-LA injection. After the second CAB-LA injection, HIV antigen/antibody returned reactive (HIV-1 RNA 451 copies/mL). SGS of plasma HIV-1 RNA identified INSTI mutation Q148R in 2/24 sequences 2 days postdiagnosis; commercial genotype failed amplification. Cabotegravir hair concentration was 0.190 ng/mg 2 weeks prediagnosis; plasma cabotegravir was high (3.37 µg/mL; ∼20× PA-IC90) 14 days postdiagnosis. Viral suppression was maintained for 6 months on darunavir/cobicistat/emtricitabine/tenofovir alafenamide, then switched to doravirine + emtricitabine/tenofovir alafenamide due to nausea. Conclusions: In this first case of HIV infection on CAB-LA with INSTI resistance in routine care, cabotegravir resistance was detected only with a sensitive research assay. Accelerated pathways to minimize time between HIV testing and CAB-LA initiation are needed to optimize acute HIV detection and mitigate resistance risk. Sustained product access regardless of insurance is imperative to reduce HIV infections on CAB-LA.

Projected Effects of Disruptions to Human Immunodeficiency Virus (HIV) Prevention Services During the Coronavirus Disease 2019 Pandemic Among Black/African American Men Who Have Sex With Men in an Ending the HIV Epidemic Priority Jurisdiction.

Background: Disruptions in access to in-person human immunodeficiency virus (HIV) preventive care during the coronavirus disease 2019 (COVID-19) pandemic may have a negative impact on our progress towards the Ending the HIV Epidemic goals in the United States. Methods: We used an agent-based model to simulate HIV transmission among Black/African American men who have sex with men in Mississippi over 5 years to estimate how different reductions in access affected the number of undiagnosed HIV cases, new pre-exposure prophylaxis (PrEP) starts, and HIV incidence. Results: We found that each additional 25% decrease in HIV testing and PrEP initiation was associated with decrease of 20% in the number of cases diagnosed and 23% in the number of new PrEP starts, leading to a 15% increase in HIV incidence from 2020 to 2022. Conclusions: Unmet need for HIV testing and PrEP prescriptions during the COVID-19 pandemic may temporarily increase HIV incidence in the years immediately after the disruption period.

Pre-exposure Prophylaxis Discontinuation During the COVID-19 Pandemic Among Men Who Have Sex With Men in a Multisite Clinical Cohort in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to put strain on health systems in the United States, leading to significant shifts in the delivery of routine clinical services, including those offering HIV pre-exposure prophylaxis (PrEP). We aimed to assess whether individuals discontinued PrEP use at higher rates during the COVID-19 pandemic and the extent to which disruptions to usual clinical care were mitigated through telehealth. METHODS: Using data from an ongoing prospective cohort of men who have sex with men (MSM) newly initiating PrEP in 3 mid-sized cities (n = 195), we calculated the rate of first-time discontinuation of PrEP use in the period before the COVID-19 pandemic and during the COVID-19 pandemic and compared these rates using incidence rate ratios (IRRs). Furthermore, we compared the characteristics of patients who discontinued PrEP use during these periods with those who continued to use PrEP during both periods. RESULTS: Rates of PrEP discontinuation before the COVID pandemic and during the COVID-19 pandemic were comparable [4.29 vs. 5.20 discontinuations per 100 person-months; IRR: 1.95; 95% confidence interval (CI): 0.83 to 1.77]. Although no significant differences in the PrEP discontinuation rate were observed in the overall population, the rate of PrEP discontinuation increased by almost 3-fold among participants aged 18-24 year old (IRR: 2.78; 95% CI: 1.48 to 5.23) and by 29% among participants covered by public insurance plans at enrollment (IRR: 1.29; 95% CI: 1.03 to 5.09). Those who continued to use PrEP were more likely to have had a follow-up clinical visit by telehealth in the early months of the pandemic (45% vs. 17%). CONCLUSIONS: In this study, rates of PrEP discontinuation were largely unchanged with the onset of the COVID-19 pandemic. The use of telehealth likely helped retain patients in PrEP care and should continue to be offered in the future.

Same-day prescribing of daily oral pre-exposure prophylaxis for HIV prevention.

Pre-exposure prophylaxis (PrEP) is highly effective in reducing HIV transmission but remains underutilised globally. Same-day PrEP prescribing and medication provision is an emerging implementation approach. The experiences of the three same-day PrEP programmes support the feasibility of the approach. Key elements of safe and effective same-day PrEP programmes include the ability to order laboratory tests at the time of the clinical visit and the ability to contact patients when laboratory results are available. Same-day PrEP has the potential to alleviate the attrition seen in usual care between initial evaluation and receipt of a PrEP prescription. A widespread application of same-day prescribing will be needed to assess its effect on PrEP usage.

Associations Among HIV Risk Perception, Sexual Health Efficacy, and Intent to Use PrEP Among Women: An Application of the Risk Perception Attitude Framework.

HIV risk perception is a known determinant of HIV prevention behaviors among vulnerable populations. Lesser known is the combined influence of risk perception and efficacy beliefs on PrEP use. We examined the associations between levels of risk perception and strength of efficacy beliefs on intent to use PrEP in a sample of adult Black and Latina women. Guided by the risk perception attitudes (RPA) framework, we used cluster analysis to identify four interpretable groups. We ran analysis of covariance models to determine the relationship between membership in the RPA framework groups and intention to use PrEP. Among the 908 women, the mean age was 29.9 years and participants were Latina (69.4%) and Black (25.6%). Results of the analysis show that women with low perception of HIV risk and strong efficacy beliefs had significantly less intent to use PrEP than women with high risk perception and weak efficacy beliefs.

Long-term retention in pre-exposure prophylaxis care among men who have sex with men and transgender women in the United States.

INTRODUCTION: Retention in HIV pre-exposure prophylaxis (PrEP) care in real-world settings, outside of controlled trials or demonstration projects, remains poorly understood. METHODS: We evaluated retention in PrEP care outcomes among men who have sex with men (MSM) and transgender women prescribed PrEP through March 2017 at three clinical sites in the United States (US): Jackson, Mississippi; Providence, Rhode Island; and St. Louis, Missouri. We determined retention rates by attendance of clinical visits every three months, per US Centers for Disease Control and Prevention (CDC) guidelines, as well as by the timing of patients' actual clinical visits. Multivariable analyses examined demographic and behavioural factors associated with retention. RESULTS: From 2013 to 2015, 282 MSM and transgender women were prescribed PrEP; 82% attended a follow-up visit. Based on CDC recommendations, 56% of patients were retained in PrEP care at the first follow-up visit, having attended a visit three months after initiation. However, 76% had a follow-up visit within eight months. Thirty-percent were retained at 12 months by CDC criteria, but 62% were retained when using a 16-month endpoint. Self-reported adherence was strongly correlated with retention. In multivariable analyses, younger age was associated with decreased odds of retention at initial follow-up, and completing college was associated with increased odds of retention at 16 months. Eight participants were newly diagnosed with HIV; six were African American, and seven were under 30 years of age. CONCLUSIONS: Measuring retention in PrEP care using three-month follow-up intervals may underestimate true retention. Nevertheless, retention in PrEP care is suboptimal in real-world settings and should be the focus of future interventions.

Lessons from a decade of voluntary medical male circumcision implementation and their application to HIV pre-exposure prophylaxis scale up.

Oral pre-exposure prophylaxis (PrEP) has the ability to curb HIV incidence worldwide and bring us closer to ending the HIV epidemic. Scale up of PrEP service delivery has many similar challenges to those faced by voluntary medical male circumcision (VMMC) services roll-out. This article outlines ten important lessons learned during the scale up of VMMC services in sub-Saharan Africa and their application to current oral PrEP implementation efforts to promote faster expansion for public health impact.

Pre-exposure prophylaxis for HIV prevention preferences among young adult African American men who have sex with men.

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infections among men who have sex with men (MSM). PrEP uptake and adherence remain low and product preferences are unknown, especially among young African American MSM who are most at-risk. We conducted 26 qualitative interviews from 2014-2016 among young adult HIV-negative African American MSM regarding PrEP product preferences in Missouri. While the pill and injectable were most liked of all modalities, about a quarter preferred rectal products or patches. Most participants preferred a long-acting injectable (LAI) to daily oral pills due to better medication adherence and a dislike for taking pills. Many participants preferred daily oral pills to on-demand oral PrEP due to the inability to predict sex and the perception that insufficient time or medication would not achieve HIV protection with on-demand. A fear of needles and the perception that there would not be therapeutic levels for a long duration were concerns with injectable PrEP. Study findings highlight the need for a range of prevention options for African American MSM and can inform PrEP product development as well as dissemination and implementation efforts.

Tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention in women with osteoporosis: a case report and review of the literature.

Pre-exposure prophylaxis (PrEP), using tenofovir disoproxil fumarate (TDF), can effectively prevent HIV acquisition. However, TDF can cause changes in bone mineral density (BMD). There is little information on the use of PrEP among patients with bone disease. We present a case report of a female with pre-existing osteoporosis who was prescribed PrEP. Over the course of 9 months of consistent PrEP use, verified by dried blood spot testing, we report a lack of BMD changes on serial dual-emission X-ray absorptiometry scans in this patient. This case can inform PrEP care for patients with pre-existing bone disease.

Missed Opportunities to Prescribe HIV Pre-Exposure Prophylaxis by Primary Care Providers in Saint Louis, Missouri.

PURPOSE: Optimal HIV pre-exposure prophylaxis (PrEP) scale-up in the United States requires prescribing by primary care providers (PCPs). We assessed barriers to patients obtaining PrEP from their PCPs. METHODS: Patients seeking PrEP at an Infectious Diseases (ID) Clinic in St. Louis, Missouri from 2014 to 2016 were asked about demographics, sexual behaviors, whether PrEP was initially sought from their PCP, and barriers to obtaining PrEP from their PCP. Multivariable logistic regression was performed to identify predictors for having asked a PCP for PrEP. RESULTS: Among 102 patients, the median age was 29 years, 58% were white, and 88% were men who have sex with men. Most (65%) had a PCP and, of these, 48% had asked their PCP for PrEP, but were not prescribed it. About half (52%) reported that their PCPs perceived prescribing PrEP as specialty care. Many (39%) indicated that they felt uncomfortable discussing their sexual behaviors with their PCP. Patients with an HIV-positive sex partner in the last 3 months were less likely to ask for PrEP from their PCPs than others (Adjusted Odds Ratio: 0.07; 95% CI: 0.01-0.53). Eighty-three percent of patients were referred to a new PCP with whom they could feel more comfortable discussing PrEP. CONCLUSIONS: During initial PrEP implementation, ID specialists can play an important role in providing education and linking PrEP patients to PCPs. However, PCPs may need additional training about PrEP and how to provide culturally sensitive sexual healthcare, if widespread scale-up is to be effective in decreasing HIV incidence.

Sex Venue-Based Network Analysis to Identify HIV Prevention Dissemination Targets for Men Who Have Sex with Men.

PURPOSE: The aim of this study was to identify sex venue-based networks among men who have sex with men (MSM) to inform HIV preexposure prophylaxis (PrEP) dissemination efforts. METHODS: Using a cross-sectional design, we interviewed MSM about the venues where their recent sexual partners were found. Venues were organized into network matrices grouped by condom use and race. We examined network structure, central venues, and network subgroups. RESULTS: Among 49 participants, the median age was 27 years, 49% were Black and 86% reported condomless anal sex (ncAS). Analysis revealed a map of 54 virtual and physical venues with an overlap in the ncAS and with condom anal sex (cAS) venues. In the ncAS network, virtual and physical locations were more interconnected. The ncAS venues reported by Blacks were more diffusely organized than those reported by Whites. CONCLUSION: The network structures of sex venues for at-risk MSM differed by race. Network information can enhance HIV prevention dissemination efforts among subpopulations, including PrEP implementation.