Gay and Bisexual Men's Perceptions about a Potential HIV Vaccine within a Post-COVID-19 Era: A Qualitative Study.

To end the HIV epidemic, there is need for targeted strategies to reduce HIV incidence for those most vulnerable, including an HIV vaccine. This study seeks to understand the perceptions that non-PrEP using gay and bisexual men and other men who have sex with men (GBMSM) have about a potential HIV vaccine, while contextualizing their perspectives within the context of heightened vaccine hesitancy that has emerged since the COVID-19 pandemic. Between March and May of 2022, GBMSM (N = 20) participated in in-depth interviews, which assessed their perceptions about an HIV vaccine. Interviews were analysed using a codebook approach to thematic analysis. We oversampled for those unvaccinated against COVID-19 as a proxy for vaccine hesitation. Participants expressed a range of enthusiastic support, cautious optimism and skepticism when presented with the possibility of an HIV vaccine. Factors that drove willingness to receive an HIV vaccine included community-oriented altruism, individualized risk-benefit assessment, and/or the perception that a vaccine could provide a beneficial shift in sexual experiences. Participants also expressed hesitations about receiving an HIV vaccine, including concerns about potential side-effects and efficacy, as well as mistrust in the vaccine development process. Notably, participants often evaluated the vaccine in comparison to PrEP and condoms. Participants offered specific insights into information they would like to receive about an HIV and where/how they would like to receive it. Our findings can help inform future HIV vaccine implementation efforts by offering insights into the factors that motivate and deter GBMSM to receive an HIV vaccine.

Missed Opportunity or Cause for Concern? Methamphetamine Use Is Associated With Greater Interest in Event-Driven PrEP Among Sexual Minority Men.

Our study assessed the association between methamphetamine (i.e., crystal meth, CM) use and awareness and interest in event-driven (ED) PrEP among HIV-negative and those with unknown serostatus cisgender males and transgender people. We performed log-binomial regression analysis to predict awareness (i.e., having heard of ED PrEP) and being interested in ED PrEP. We found that participants who recently used CM were less likely to know of ED PrEP (aPR = 0.83, 95% CI [0.69, 0.99]) but more interested in ED PrEP (aPR = 1.12, 95% CI [1.01, 1.30]), after accounting for demographic and HIV-related behaviors. Opportunities to expand PrEP uptake and improve adherence among individuals who report CM use are essential to impact the HIV epidemic significantly. Continued research on the needs and best practices to work with this community is needed to ensure a successful rollout and implementation of ED PrEP.

Barriers to initial COVID-19 booster among U.S. adults who completed a primary vaccine series in the CHASING COVID cohort, September 2021 - October 2022.

It is crucial to understand factors associated with COVID-19 booster uptake in the U.S. given the updated COVID-19 vaccine recommendations. Using data from a national prospective cohort (N=4,616) between September 2021-October 2022, we examined socioeconomic, demographic, and behavioral factors of initial booster uptake among participants fully-vaccinated with the primary COVID-19 vaccines series. Cox proportional hazards models were used to estimate the associations of each factor with time to initial booster uptake. Most participants (86.5%) reported receiving their initial booster. After adjusting for age, race/ethnicity, education, region, and employment, participants with greater risk for severe COVID-19 had similar booster uptake compared with those with lower risk (aHR: 1.04; 95% CI: 0.95, 1.14). Participants with greater barriers to healthcare (aHR: 0.89; 95% CI: 0.84, 0.96), food insecurity (aHR: 0.82; 95% CI: 0.75, 0.89), and housing instability (aHR: 0.81; 95% CI: 0.73, 0.90) were less likely to report receiving initial booster compared with those without those barriers. Factors motivating the decision to vaccinate changed from safety-related concerns for the primary series to perceived need for the booster. It is key to address economic and health access barriers to achieve equitable COVID-19 vaccine uptake and continued protection against COVID-19.

Factors associated with PrEP-era HIV seroconversion in a 4-year U.S. national cohort of n = 6059 sexual and gender minority individuals who have sex with men, 2017-2022.

INTRODUCTION: Community-based cohort studies of HIV seroconversion can identify important avenues for enhancing HIV prevention efforts in the era of pre-exposure prophylaxis (PrEP). Within individuals, one can assess exposure and outcome variables repeatedly and with increased certainty regarding temporal ordering. This cohort study examined the association of several risk factors with subsequent HIV seroconversion. METHODS: We report data from a 4-year study (2017-2022) of 6059 HIV seronegative sexual and gender minority individuals who have sex with men who had indications for-, but were not using-, PrEP at enrolment. Participants completed repeat exposure assessments and self-collection of biospecimens for HIV testing. We examined the roles of race and ethnicity, socio-economic status, methamphetamine use and PrEP uptake over the course of follow-up in relation to HIV seroconversion. RESULTS: Over 4 years, 303 of the participants seroconverted across 18,421 person-years (incidence rate = 1.64 [95% CI: 1.59-1.70] per 100 person-years). In multivariable discrete-time survival analysis, factors independently associated with elevated HIV seroconversion risk included being Black/African American (adjusted risk ratio [aRR]: 2.44, 1.79-3.28), Hispanic/Latinx (1.53, 1.19-1.96), housing instability (1.58, 1.22-2.05) and past year methamphetamine use (3.82, 2.74-5.33). Conversely, time since study enrolment (24 vs. 12 months, 0.67, 0.51-0.87; 36 months, 0.60, 0.45-0.80; 48 months, 0.48, 0.35-0.66) and higher education (master's degree or higher vs. less than or equal to high school, 0.36, 0.17-0.66) were associated with reduced seroconversion risk. Compared to non-PrEP users in the past 2 years without a current clinical indication, those who started PrEP but then discontinued had higher seroconversion risk, irrespective of clinical indication (3.23, 1.74-6.46) or lack thereof (4.30, 1.85-9.88). However, those who initiated PrEP in the past year (0.14, 0.04-0.39) or persistently used PrEP in the past 2 years (0.33, 0.14-0.74) had a lower risk of seroconversion. Of all HIV seroconversions observed during follow-up assessments (12, 24, 36 and 48 months), methamphetamine was reported in the 12 months prior 128 (42.2%) times (overall). CONCLUSIONS: Interventions that acknowledge race and ethnicity, economic variables such as education and housing instability, and methamphetamine use are critically needed. Not only are interventions to engage individuals in PrEP care needed, but those that retain them, and re-engage those who may fall out of care are essential, given the exceptionally high risk of seroconversion in these groups.

Preference heterogeneity for HIV pre-exposure prophylaxis care among gay, bisexual, and other men who have sex with men in the United States: a large discrete choice experiment.

Background: PrEP uptake among Black and Latino gay, bisexual, and other men who have sex with men (GBM) remains low in the United States. The design and implementation of PrEP delivery programs that incorporate the preferences of Black and Latino GBM may overcome barriers to uptake. We aimed to identify preferences for PrEP care among high-priority GBM in the U.S. with a large discrete choice experiment. Methods: We conducted two discreet choice experiments (DCE) to elicit care preferences for (1) Starting PrEP and (2) Continuing PrEP care among GBM clinically indicated for PrEP. The DCE web-based survey was nested in a longitudinal cohort study of GBM in the U.S., implemented with video and audio directions among 16-49 year-old participants, not using PrEP, and verified to be HIV-negative. All participants were presented with 16 choice sets, with choices determined by BLGBM and PrEP implementation stakeholders. We calculated overall utility scores and relative importance and used latent class analyses (LCA) to identify classes within the Starting and Continuing PrEP DCE. Multivariable analysis was performed to identify factors associated with class membership. Findings: Among 1514 participants, mean age was 32 years; 46·5% identified as Latino, 21·4% Black, and 25·2 White; 37·5% had an income less than USD $20,000. Two latent classes were identified for Starting PrEP: Class 1 (n=431 [28·5%]) was driven by preference for more traditional in-person care, and Class 2 (n=1083 [71·5%]) preferred flexible care options and on-demand PrEP. In a multivariable model, having a sexual health doctor (adjusted OR 0·7, CI 0·5, 0·9), having a primary care provider (OR 0·7,CI 0·5, 0·9, p= 0·023), and concerns over PrEP side effects (OR 1·1, CI 1·0,1·2, p= 0·003) were all associated with class membership. Interpretation: The different preferences identified for PrEP care indicate the need for diverse care and formulation choices to improve PrEP uptake and persistence. Addressing these preferences and understanding the factors that shape them can inform the implementation of programs that increase PrEP uptake.

Housing instability among young men who have sex with men in a US national sample.

Background: Youth, including those experiencing housing instability, are among the fastest growing groups of individuals with new STI diagnoses, including HIV. The unpredictable nature of the lives of youth experiencing housing instability often leads to inconsistent or non-existent health care and preventive follow up, leaving gaps in our knowledge about the most prominent needs for intervention. Methods: Using data from the Together 5000 (T5K) study, we examined factors associated with housing instability in a sample of 2,228 youth between the ages of 16-24 who identified as sexual and gender minority (SGM) men having sex with men. Logistic regression was used to assess the most prominent factors associated with housing instability. The model included seven significant factors - former peer victimization, gender, age, sex work, IPV, social support, and health insurance status. Findings: Participants who reported more behavioral risk factors for STI and those who reported sex work in the last three months were more likely to experience housing instability (OR = 2.5 and 2.76 respectively). Youth with higher levels of reported social support, health insurance, and older age were more likely to report stable housing (OR = .98, 1.61, and 1.13 respectively). Surprisingly, youth with stable housing were more likely to report intimate partner violence than those experiencing housing instability (OR = .89). Discussion: Implications for addressing STIs among adolescent SGM men having sex with men are discussed including bolstering support systems and addressing basic needs deficits and trauma associated with sex work and behavioral risk factors for STI. Implications and contributions statement: The study examines correlates of housing instability among a sample of young sexual and gender minority men who have sex with other men. Correlates of housing instability included behavioral risk factors for sexually transmitted infection and reporting sex work in the last three months. Health insurance, older age, and higher levels of social support were correlated with more stable housing.

Perceptions about doxycycline post-exposure prophylaxis (Doxy-PEP) as an STI-prevention strategy among gay and bisexual men (GBM) in the United States: Results from a qualitative study.

OBJECTIVE: To leverage qualitative data to explore gay and bisexual men's (GBM) perceptions about doxycycline post-exposure prophylaxis (Doxy-PEP). Doxy-PEP is a novel biomedical STI-prevention strategy that helps reduce the risk of acquiring bacterial STIs. Little is known about Doxy-PEP's acceptability in the U.S., nor how best to engage those most vulnerable to STIs in taking up this nascent prevention strategy. METHOD: Between July and September of 2023, 24 GBM from across the U.S. completed qualitative interviews about their perceptions regarding Doxy-PEP. Interviews were analyzed using a codebook approach to thematic analysis. RESULTS: Participants were generally interested in using Doxy-PEP, but were concerned about the potential for antibiotic resistance, side-effects, medication interactions to occur, along with stigmatizing discourse around its use. Meanwhile, participants were motivated by the simplicity of Doxy-PEP and the protection it could confer on both an individual and community-level- as well as its potential to reduce STI-related anxiety. Finally, participants desired additional information on Doxy-PEP to address their concerns. CONCLUSIONS: There is a need for clear guidelines and expanded public health messaging on Doxy-PEP in the U.S.

PrEP Uptake and Methamphetamine Use Patterns in a 4-Year U.S. National Prospective Cohort Study of Sexual and Gender Minority People, 2017-2022.

Methamphetamine use is on the rise among sexual and gender minority people who have sex with men (SGMSM), escalating their HIV risk. Despite pre-exposure prophylaxis (PrEP) being an effective biomedical HIV prevention tool, its uptake in relation to methamphetamine use patterns in SGMSM has not been studied. In a U.S. cohort study from 2017 to 2022, 6,253 HIV-negative SGMSM indicated for but not using PrEP were followed for four years. Methamphetamine use was categorized (i.e., newly initiated, persistently used, never used, used but quit), and PrEP uptake assessed using generalized estimating equation (GEE), adjusted for attrition. Participants had a median age of 29, with 51.9% White, 11.1% Black, 24.5% Latinx, and 12.5% other races/ethnicities. Over the four years, PrEP use increased from 16.3 to 27.2%. GEE models identified risk factors including housing instability and food insecurity. In contrast, older age, health insurance, clinical indications, and prior PrEP use increased uptake. Notably, Latinx participants were more likely to use PrEP than Whites. Regarding methamphetamine use, those who newly initiated it were more likely to use PrEP compared to non-users. However, those who quit methamphetamine and those who persistently used it had PrEP usage rates comparable to those of non-users. Though PrEP uptake increased, it remained low in SGMSM. Methamphetamine use was associated with PrEP uptake. Healthcare providers should assess methamphetamine use for harm reduction. Prioritizing younger, uninsured SGMSM and addressing basic needs can enhance PrEP uptake and reduce HIV vulnerabilities.

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 (35-40 percent) 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.

Oral COVID-19 Antiviral Uptake Among a Highly Vaccinated US Cohort of Adults With SARS-CoV-2 Infection Between December 2021 and October 2022.

Background: We described the oral nirmatrelvir/ritonavir (NMV/r) and molnupiravir (MOV) uptake among a subgroup of highly vaccinated adults in a US national prospective cohort who were infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between 12/2021 and 10/2022. Methods: We estimate antiviral uptake within 5 days of SARS-CoV-2 infection, as well as age- and gender-adjusted antiviral uptake prevalence ratios by antiviral eligibility (based on age and comorbidities), sociodemographic characteristics, and clinical characteristics including vaccination status and history of long coronavirus disease 2019 (COVID). Results: NMV/r uptake was 13.6% (95% CI, 11.9%-15.2%) among 1594 participants, and MOV uptake was 1.4% (95% CI, 0.8%-2.1%) among 1398 participants. NMV/r uptake increased over time (1.9%; 95% CI, 1.0%-2.9%; between 12/2021 and 3/2022; 16.5%; 95% CI, 13.0%-20.0%; between 4/2022 and 7/2022; and 25.3%; 95% CI, 21.6%-29.0%; between 8/2022 and 10/2022). Participants age ≥65 and those who had comorbidities for severe COVID-19 had higher NMV/r uptake. There was lower NMV/r uptake among non-Hispanic Black participants (7.2%; 95% CI, 2.4%-12.0%; relative to other racial/ethnic groups) and among individuals in the lowest income groups (10.6%; 95% CI, 7.3%-13.8%; relative to higher income groups). Among a subset of 278 participants with SARS-CoV-2 infection after 12/2021 who also had a history of prior SARS-CoV-2 infection, those with (vs without) a history of long COVID reported greater NMV/r uptake (22.0% vs 7.9%; P = .001). Among those prescribed NMV/r (n = 216), 137 (63%; 95% CI, 57%-70%) reported that NMV/r was helpful for reducing COVID-19 symptoms. Conclusions: Despite proven effectiveness against severe outcomes, COVID-19 antiviral uptake remains low among those with SARS-CoV-2 infection in the United States. Further outreach to providers and patients to improve awareness of COVID-19 oral antivirals and indications is needed.

Seroincidence of SARS-CoV-2 infection prior to and during the rollout of vaccines in a community-based prospective cohort of U.S. adults.

This study used repeat serologic testing to estimate infection rates and risk factors in two overlapping cohorts of SARS-CoV-2 N protein seronegative U.S. adults. One mostly unvaccinated sub-cohort was tracked from April 2020 to March 2021 (pre-vaccine/wild-type era, n = 3421), and the other, mostly vaccinated cohort, from March 2021 to June 2022 (vaccine/variant era, n = 2735). Vaccine uptake was 0.53% and 91.3% in the pre-vaccine and vaccine/variant cohorts, respectively. Corresponding seroconversion rates were 9.6 and 25.7 per 100 person-years. In both cohorts, sociodemographic and epidemiologic risk factors for infection were similar, though new risk factors emerged in the vaccine/variant era, such as having a child in the household. Despite higher incidence rates in the vaccine/variant cohort, vaccine boosters, masking, and social distancing were associated with substantially reduced infection risk, even through major variant surges.

Sexual and Gender Minorities' Vaccine Uptake and Behavioral Change in Response to the Mpox Outbreak in the United States: August 2022 Through November 2022.

BACKGROUND: In the summer of 2022, the United States faced a nationwide outbreak of mpox, with cases concentrated in sexual and gender minorities who have sex with men. Understanding rates of mpox vaccine uptake and concomitant behavioral change is essential to guide the implementation of targeted public health responses to the potential reemergence of mpox. METHODS: Between August 2022 and November 2022, 8551 individuals recruited via geosocial networking apps completed a brief survey that assessed mpox vaccine uptake, intentions to get a mpox vaccine, and behavioral change. RESULTS: In August, 17.4% of participants reported having received at least 1 dose of the mpox vaccine. By November, this prevalence estimate was 35.0%. Black participants were significantly less likely to be vaccinated, and vaccine hesitancy increased among Black participants over time. Among those who had not yet received a vaccination, the intention to get vaccinated decreased over time. We observed trends that coincided with the evolving outbreak, such as decreased worry about mpox and less engagement in risk reduction behaviors over time. CONCLUSIONS: Despite a 2-fold increase in mpox vaccine uptake between August 2022 and November 2022 in sexual and gender minorities who have sex with men, disparities in vaccine uptake were observed among Black participants. Findings will guide the implementation of public health responses to the potential reemergence of mpox and other viral infectious diseases (eg, meningitis) with a specific focus on optimizing vaccine uptake in Black communities.

Depression and Anxiety Symptoms Among Cisgender Gay and Bisexual Men During the Onset of the COVID-19 Pandemic: Time Series Analysis of a US National Cohort Study.

BACKGROUND: The onset of the COVID-19 pandemic in the United States in March 2020 caused a dramatic change in the way many people lived. Few aspects of daily life were left undisrupted by the pandemic's onset as well as the accompanying policies to control the spread of the disease. Previous research has found that the pandemic may have significantly impacted the mental health of lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals-potentially more so than other individuals. However, the pandemic did not affect all areas of the United States at the same time, and there may be regional variation in the impact of the onset of the pandemic on depressive symptoms among LGBTQ individuals. OBJECTIVE: To assess regional variation of the impact of the pandemic, we conducted a time series analysis stratified by US geographic region to examine symptoms of depression and anxiety among a sample of primarily cisgender gay and bisexual men before and after the onset of the COVID-19 pandemic in the United States. METHODS: In total, 5007 participants completed assessments as part of the Together 5000 study, an ongoing prospective cohort study. Depressive and anxiety symptoms were measured using the Patient Health Questionnaire-4. Patient Health Questionnaire-4 scores were graphed as a function of days from March 15, 2020. Locally estimated scatterplot smoothing trend lines were applied. A sieve-bootstrap Mann-Kendall test for monotonic trend was conducted to assess the presence and direction of trends in the scatterplots. We then compared the observed trends to those observed for 1 year prior (2018-2019) to the pandemic onset using data collected from the same sample. RESULTS: Significant positive trends were detected for the Northeast (P=.03) and Midwest (P=.01) regions of the United States in the 2020 assessment, indicating that symptoms of anxiety and depression were increasing in the sample in these regions immediately prior to and during the onset of the pandemic. In contrast, these trends were not present in data from the 2018 to 2019 assessment window. CONCLUSIONS: Symptoms of anxiety and depression increased among the study population in the Northeast and Midwest during the beginning months of the COVID-19 pandemic, but similar increase was not observed in the South and West regions. These trends were also not found for any region in the 2018 to 2019 assessment window. This may indicate region-specific trends in anxiety and depression, potentially driven by the burden of the pandemic and policies that varied from region to region. Future studies should consider geographic variation in COVID-19 spread and policies as well as explore potential mechanisms by which this could influence the mental health of LGBTQ individuals.

'You have to trust their word': transmasculine experiences with sex partners and safety during the early COVID-19 outbreak.

The early months of the SARS-CoV2 pandemic exacerbated health disparities for vulnerable populations, including transgender (trans) communities, creating unique challenges for navigating sex and dating. This paper aims to expand upon the current literature regarding transmasculine populations by capturing their lived experiences during this critical time. We interviewed 20 assigned female sex at birth (AFAB) adults of the transmasculine spectrum - men, nonbinary, and transmasculine individuals - about their social and sexual experiences in the USA in May and June 2020. Transcripts were analysed using an inductive thematic approach. We found that sex drive decreased and uncertainty about health risks increased. Some participants found alternate ways to date and hook-up that reduced their COVID-19 risk, such as engaging in online sex (e.g. sexting, dating apps). Others expressed discomfort using virtual platforms for both personal/work and sexual lives, along with nuanced feelings around being objectified, compared to pornography, and fetishised as trans bodies. COVID-related shutdowns of queer spaces also amplified pre-existing concerns about interpersonal safety and rejection. When seeking new partners, participants sought behavioural characteristics that instilled trust. Future public health communications can take advantage of safety and sexual health strategies already present in trans communities to bolster wellbeing in trans lives.

HIV Prevention and Care Among Black Cisgender Sexual Minority Men and Transgender Women: Protocol for an HIV Status-Neutral Cohort Study Using an Observational-Implementation Hybrid Approach.

BACKGROUND: Black cisgender gay, bisexual, and other sexual minority men (SMM) and transgender women (TW) continue to be heavily affected by HIV. Further research is needed to better understand HIV prevention and care outcomes in this population. In particular, there is a need for research examining the impact of substance use and sleep health on HIV prevention and treatment outcomes among Black SMM and TW. OBJECTIVE: This paper outlines the study methods being used in the recently launched follow-up study to the Neighborhoods and Networks (N2) study, which we refer to as N2 Part 2 (N2P2). N2P2 aims to address this gap in the literature, build off the findings of the original N2 study, and identify socioenvironmental determinants of health, including whether neighborhood and network factors mediate and moderate these relationships. METHODS: Building on the N2 cohort study in Chicago from 2018 to 2022, N2P2 used a prospective longitudinal cohort design and an observational-implementation hybrid approach. With sustained high levels of community engagement, we aim to recruit a new sample of 600 Black SMM and TW participants residing in the Chicago metropolitan statistical area. Participants are asked to participate in 3 study visits across an 18-month study period (1 visit every 9 months). Four different forms of data are collected per wave: (1) an in-person survey, (2) biological specimen collection, (3) a daily remote ecological momentary assessment for 14 days after each study visit, and (4) data from electronic health records. These forms of data collection continue to assess neighborhood and network factors and specifically explore substance use, sleep, immune function, obesity, and the implementation of potential interventions that address relevant constructs (eg, alcohol use and pre-exposure prophylaxis adherence). RESULTS: The N2P2 study was funded in August 2021 by the National Institute of Drug Abuse (R01DA054553 and R21DA053156) and National Heart, Lung, and Blood Institute (R01HL160325). This study was launched in November 2022. Recruitment and enrollment for the first wave of data collection are currently ongoing. CONCLUSIONS: The N2P2 study is applying innovative methods to comprehensively explore the impacts of substance use and sleep health on HIV-related outcomes among an HIV status-neutral cohort of Black SMM and TW in Chicago. This study is applying an observational-implementation hybrid design to help us achieve findings that support rapid translation, a critical priority among populations such as Black SMM and TW that experience long-standing inequities with regard to HIV and other health-related outcomes. N2P2 will directly build off the findings that have resulted from the original N2 study among Black SMM and TW in Chicago. These findings provide a better understanding of multilevel (eg, individual, network, and neighborhood) factors that contribute to HIV-related outcomes and viral suppression among Black SMM and TW. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48548.

Changes in Health Insurance During COVID-19 Among a U.S. National Cohort of Cisgender Gay and Bisexual Men and Transgender Individuals.

The extant data suggest that LGBT communities were disproportionately impacted by the economic ramifications of the pandemic and were more likely to report being uninsured throughout the first two years of the pandemic. Additionally, these groups are at heightened vulnerability for several health conditions that require insurance to manage or prevent. Thus, there is a need to assess changes in pandemic-era insurance coverage among these populations. This study uses data collected as part of the Together 5,000 study, a U.S. national, internet-based cohort study of cisgender men, trans men, and trans women who have sex with men. We analyze insurance data across three different assessments between 2019 and 2021, exploring changes in insurance coverage and type. Among our sample, 6.4% lost their insurance in 2020 because of the pandemic. Insurance loss was associated with living in a state that had not expanded Medicaid, race/ethnicity, employment status, and income. Among those who lost their insurance in early 2020, most (59.2%) reported gaining insurance by 2021, with those living in non-expanded states less likely to gain insurance. Finally, those who were uninsured prior to the pandemic were less likely to report gaining insurance by 2021, when compared to those uninsured as a result of the pandemic. This suggests that there are uninsured cisgender gay and bisexual men and transgender individuals that continue to go unreached by policies to assuage uninsurance. Further policy intervention is needed to address uninsurance among LGBT individuals, which has important implications for addressing health disparities among these populations.

Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial.

BACKGROUND: Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. OBJECTIVE: PrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. METHODS: A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. RESULTS: Implementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. CONCLUSIONS: Lessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48459.

Seroincidence of SARS-CoV-2 infection prior to and during the rollout of vaccines in a community-based prospective cohort of U.S. adults.

Background: Infectious disease surveillance systems, which largely rely on diagnosed cases, underestimate the true incidence of SARS-CoV-2 infection, due to under-ascertainment and underreporting. We used repeat serologic testing to measure N-protein seroconversion in a well-characterized cohort of U.S. adults with no serologic evidence of SARS-CoV-2 infection to estimate the incidence of SARS-CoV-2 infection and characterize risk factors, with comparisons before and after the start of the SARS-CoV-2 vaccine and variant eras. Methods: We assessed the incidence rate of infection and risk factors in two sub-groups (cohorts) that were SARS-CoV-2 N-protein seronegative at the start of each follow-up period: 1) the pre-vaccine/wild-type era cohort (n=3,421), followed from April to November 2020; and 2) the vaccine/variant era cohort (n=2,735), followed from November 2020 to June 2022. Both cohorts underwent repeat serologic testing with an assay for antibodies to the SARS-CoV-2 N protein (Bio-Rad Platelia SARS-CoV-2 total Ab). We estimated crude incidence and sociodemographic/epidemiologic risk factors in both cohorts. We used multivariate Poisson models to compare the risk of SARS-CoV-2 infection in the pre-vaccine/wild-type era cohort (referent group) to that in the vaccine/variant era cohort, within strata of vaccination status and epidemiologic risk factors (essential worker status, child in the household, case in the household, social distancing). Findings: In the pre-vaccine/wild-type era cohort, only 18 of the 3,421 participants (0.53%) had ≥1 vaccine dose by the end of follow-up, compared with 2,497/2,735 (91.3%) in the vaccine/variant era cohort. We observed 323 and 815 seroconversions in the pre-vaccine/wild-type era and the vaccine/variant era and cohorts, respectively, with corresponding incidence rates of 9.6 (95% CI: 8.3-11.5) and 25.7 (95% CI: 24.2-27.3) per 100 person-years. Associations of sociodemographic and epidemiologic risk factors with SARS-CoV-2 incidence were largely similar in the pre-vaccine/wild-type and vaccine/variant era cohorts. However, some new epidemiologic risk factors emerged in the vaccine/variant era cohort, including having a child in the household, and never wearing a mask while using public transit. Adjusted incidence rate ratios (aIRR), with the entire pre-vaccine/wild-type era cohort as the referent group, showed markedly higher incidence in the vaccine/variant era cohort, but with more vaccine doses associated with lower incidence: aIRRun/undervaccinated=5.3 (95% CI: 4.2-6.7); aIRRprimary series only=5.1 (95% CI: 4.2-7.3); aIRRboosted once=2.5 (95% CI: 2.1-3.0), and aIRRboosted twice=1.65 (95% CI: 1.3-2.1). These associations were essentially unchanged in risk factor-stratified models. Interpretation: In SARS-CoV-2 N protein seronegative individuals, large increases in incidence and newly emerging epidemiologic risk factors in the vaccine/variant era likely resulted from multiple co-occurring factors, including policy changes, behavior changes, surges in transmission, and changes in SARS-CoV-2 variant properties. While SARS-CoV-2 incidence increased markedly in most groups in the vaccine/variant era, being up to date on vaccines and the use of non-pharmaceutical interventions (NPIs), such as masking and social distancing, remained reliable strategies to mitigate the risk of SARS-CoV-2 infection, even through major surges due to immune evasive variants. Repeat serologic testing in cohort studies is a useful and complementary strategy to characterize SARS-CoV-2 incidence and risk factors.