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: 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., INTRODUCTION Sexual minority individuals represent 2−5% of the United States, yet account for more than two‐thirds of new HIV acquisitions [1−4]. Meanwhile, gender minority individuals (transgender [trans] men and trans [...]

Pre-exposure prophylaxis (PrEP) is a highly effective biobehavioral strategy for preventing HIV acquisition. Although PrEP uptake has increased steadily, discontinuation rates are high among members of key populations like gay and bisexual men (GBM). Understanding the challenges that arise for PrEP users is key to better PrEP implementation and sustained use over time. We report on barriers that arose for PrEP-using GBM, as well as facilitating factors that aided PrEP persistence, with the goal of informing PrEP implementation efforts. In 2015-2016, 103 PrEP-using GBM in NYC completed qualitative interviews about their engagement with PrEP, including their experiences navigating PrEP-related medical care. Interviews were transcribed verbatim, coded, and analyzed thematically. Over half of participants (53%) received their PrEP-related care from their primary care provider (PCP), one-third (33%) from a community-based health clinic, and 13% from multiple medical providers. Emergent themes regarding the barriers and facilitators to PrEP persistence fell into two categories: insurance- and medical appointment-related barriers and facilitators to continued PrEP use. The experiences of PrEP-using GBM can provide useful insights for providers, program developers, and policymakers aiming to improve the implementation of PrEP. To support PrEP persistence, reliable insurance coverage, cost-assistance, and easy appointment scheduling are key to maintenance. Removing insurance- and appointment-related barriers to persistence may prove essential for sustaining use among GBM.

Pre-Exposure Prophylaxis (PrEP) has been demonstrated effective at preventing HIV among key populations like gay and bisexual men (GBM). Yet, there remains a continued need to engage GBM in PrEP behavioral and clinical research (e.g., to monitor adherence and retention in the PrEP treatment cascade). We report on the factors motivating GBM to participate in a PrEP behavioral study, with the aim of our results to inform future recruitment efforts for future PrEP research. In 2015-2016, 103 PrEP-using GBM in NYC completed qualitative interviews about their experiences on PrEP. Participants were also asked about factors that motivated them to join the study. Thematic analysis was used analyze the data. We identified five salient themes as rationale for joining the study: 58.3% cited altruistic reasons, 32% reported intellectual curiosity in the subject matter, 30.1% indicated that remuneration inspired them, 18.4% indicated that familiarity or referral to the research institute influenced their decision. Researchers attempting to enroll PrEP-using GBM may benefit from attending to the altruistic and intellectually curious nature of this population. Further, researchers may benefit from establishing familiarity among diverse communities of GBM. This in turn may contribute to the successful engagement of GBM for PrEP research.

Since FDA approval in 2012, HIV pre-exposure prophylaxis (PrEP) has been adopted by key populations, including gay and bisexual men (GBM), to reduce their HIV transmission risk. Given that PrEP is optimally effective when taken as prescribed, it is critical to understand the adherence strategies GBM use. We conducted one-on-one, semi-structured interviews with GBM taking PrEP in 2015-2016 (n = 103). Using thematic analysis, we identified six adherence strategies, with most participants (84.3%) utilizing multiple strategies to maintain adequate adherence: (1) integrating PrEP into part of a daily routine, (2) using a pillbox, (3) cognitive strategies/visual cues, (4) setting recurring smartphone alarms or reminders, (5) keeping medication on oneself at all times, and (6) partner or peer support for reminders and/or pill sharing. Overall, participants reported high PrEP adherence (M = 1.6 missed doses in the prior 30 days), though nearly all described missing at least one dose unintentionally in the past. Participants credited their high levels of adherence in part to the strategies they adopted. Providers working with GBM prescribed PrEP, especially patients reporting difficulties with adherence, might consider recommending any or all of the six strategies described in this study.

HIV pre-exposure prophylaxis (PrEP) is being adopted by members of key populations, such as gay and bisexual men (GBM). Since adherence to a daily PrEP regimen ensures a maximum protection, it is critical to understand GBM's behavioral responses to having missed PrEP doses. We report on qualitative interviews with GBM taking PrEP. We identified three behavioral responses: (1) 59% continued with their next scheduled dose; (2) 49% described "making up" for a missed dose by taking medication as soon as possible; and (3) 11% reported "doubling" the next PrEP dose. Participants provided potentially contradictory narratives about their sexual behavior after a missed dose: (1) 54% described making no changes; (2) 49% described adjusting their sexual behavior to reduce HIV risk; and (3) 10% said their decision would be contingent upon how many doses were missed. For PrEP prescribers, our data provide a useful lens to understand patients' lived experiences with PrEP.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 5000 study, a U.S. national, internet-based cohort study of cisgender (cis) 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 nonexpanded 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 with those uninsured as a result of the pandemic. This suggests that there are uninsured cis gay and bisexual men and transgender individuals (GBT) 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. [ABSTRACT FROM AUTHOR]

Introduction: Pre-Exposure Prophylaxis (PrEP) use continues lag estimated need among gay and bisexual men in the United States. Studies report that challenges paying for PrEP may undermine continued use. Our study aimed to measure these challenges over time. Methods: Data were taken from a US national cohort study of cisgender gay and bisexual men and transgender individuals aged 16–49 years. We analyzed data from PrEP-using participants between 2019 and 2021 and observed cost-related and insurance-related challenges participants experienced while on PrEP across time points. We report McNemar and Cochrane Q test statistics to compare differences between groups by year(s). Results: In 2019, 16.5% (n = 828/5013) of participants were on PrEP; by 2020, 21% (n = 995/4727) were on PrEP, and by 2021, 24.5% (n = 1133/4617) were on PrEP. The proportion of those experiencing challenges paying for PrEP care decreased significantly across time points for clinical appointments, laboratory work, and prescriptions. Those experiencing insurance and copay approval issues did not change significantly. Although not statistically significant, the only proportion that increased over time was those reporting PrEP-related insurance approval issues. In a post hoc analysis, we found that those reporting PrEP use in the past year who were not currently on PrEP were significantly more likely to report experiencing most PrEP challenges, when compared with current PrEP users. Discussion: We found significant reductions in insurance and cost-related challenges between 2019 and 2021. However, those who discontinued PrEP within the past year reported greater challenges paying for PrEP, suggesting that cost and insurance issues may undermine PrEP persistence. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has disproportionately affected HIV-positive cisgender men who have sex with men (MSM). Between May and June in 2020, we conducted one-on-one semi-structured qualitative interviews with 20 HIV-positive MSM aiming to describe their (dis)connection to social, sexual, and health networks during the COVID-19 pandemic. All participants relied on social support networks to manage pandemic-based distress, using computer-mediated communication as well as physical proximity. To connect to sexual networks, this sample described adaptations to their partner selection strategies, such as enumerating harm reduction approaches. To connect to health networks, participants depended on reassuring providers, resourceful case managers, telehealth, and streamlined access to their antiretroviral therapy (ART) medications. Nonetheless, stay-at-home recommendations reduced community connection, sexual activity, and healthcare access for many participants, and perceptions of these losses were shaped by psychosocial burdens (e.g. loneliness), structural burdens (e.g. environmental barriers, financial difficulties), and health-protective factors (e.g. hopeful outlook, adherence to a regular routine). The COVID-19 pandemic appears to have exacerbated health-related issues for HIV-positive MSM. Given the ongoing COVID-19 mutations, community-based organisations, clinicians, and researchers might use these findings to modify HIV prevention and intervention efforts. [ABSTRACT FROM AUTHOR]

Since the onset of the COVID-19 pandemic, global research has suggested that the pandemic has negatively affected lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) populations, including by limiting health care access. There is little research on the impact of COVID-19 among transmasculine persons and men assigned female sex at birth (AFAB) in the United States, who face unique health care challenges outside of the pandemic context. Between May and June of 2020, 20 transmasculine individuals and AFAB men who have sex with men participated in semi-structured interviews about their experiences during the early months of the COVID-19 pandemic. Participants were asked how the pandemic affected their access to health care, overall health, and well-being. Interviews were analyzed using an inductive, thematic approach. Participants reported reduced access to in-person health care, which in some cases meant overdue hormone-related bloodwork and unmet health care needs. Most participants reported that they were able to maintain their testosterone regimen, although some were concerned about future access, citing anxiety about potential shortages. Three participants reported canceled or deferred gender-affirming procedures, which they were uncertain would be rescheduled soon. Participants generally reported that the expansion of telehealth improved access to care, particularly for gender-affirming psychotherapy that was otherwise inaccessible or inconvenient prior to the pandemic. Other salient themes include the pandemic's impact on health behaviors and daily routines. Although the COVID-19 pandemic created new challenges for maintaining health, it also expanded access to gender-affirming health care, largely through the expansion of telehealth. Our findings provide new insights for supporting the health of transmasculine individuals and AFAB men. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has brought renewed attention to the topic of challenging drug patents in the interest of public health. Pharmaceutical companies have already begun to patent existing medicines for the treatment and prevention of SARS-CoV-2, affording them exclusive manufacturing rights over vital medicines. Advocates have raised concerns regarding the pricing of COVID-19 drugs, as well as patent monopolies on the manufacture of COVID-19 treatments. The HIV/AIDS pandemic provides a useful lens through which we can analyse existing pathways for challenging pharmaceutical patents in the context of global pandemic. In this article, we review three legal pathways for overriding and seizing patents on medicines by describing cases in which they were employed to make antiretroviral drugs more accessible to people living with HIV. Last, we highlight the weaknesses inherent in these pathways and offer advocacy and policy suggestions for how to strengthen these pathways to improve access to COVID-19 treatments as they become available in the United States and globally. [ABSTRACT FROM AUTHOR]

There has been an influx of ads on social media seeking plaintiffs in lawsuits for harms/side-effects caused by tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC, Truvada) for PrEP. Community groups and researchers have suggested these ads may be undermining efforts to disseminate PrEP to key populations. In October 2019, we began assessing the impact of injury lawsuit ads on social media platforms in an ongoing U.S. national cohort study of HIV-negative cis men, trans men, and trans women who have sex with men. Although assessments are ongoing, given the alarming nature of our findings, we report data collected as of March 2020 (n = 2078). Most (59.9%) said they had seen ads for TDF-related lawsuits on social media. Twenty-eight percent said they would probably or definitely not start PrEP and 22.1% said they would not stay on PrEP (were they on it) as a result of seeing these ads. Next, 38.2% agreed or strongly agreed that seeing these ads made them think that TDF/FTC for PrEP was not safe. Black, Latinx, and/or multiracial individuals were most likely to be negatively impacted by the ads including perceptions that these ads made them think PrEP is not safe. In contrast, past year experience taking PrEP was positively associated with intentions to start and/or stay on PrEP despite seeing the ads. Due to forthcoming affordable/generic options, TDF/FTC is projected to become the most scalable option for disseminating PrEP to key populations. Results suggest that ads for TDF lawsuits on social media are having a negative impact on individual PrEP decision-making. Our findings highlight the urgency for accurate and balanced messaging on the benefits and risks of PrEP, so that individuals can make informed choices about whether PrEP is right for them. [ABSTRACT FROM AUTHOR]

Improving HIV testing rates and increasing early detection among men who have sex with men (MSM) are critical strategies for enhancing overall health and decreasing HIV transmission. Remote testing and phone delivery of HIV test results may reduce barriers such as geographic isolation or HIV-related stigma. In 2018–19, 50 MSM completed qualitative interviews about their experience receiving a positive HIV test result via phone through their participation in a research study that included remote HIV testing. Interview topics included the acceptability of, and concerns about, phone delivery of HIV results, as well as suggestions for improvement. Interviews were transcribed, coded, and analysed using an inductive thematic approach. Overall, participants reported high acceptability of phone delivery of HIV-positive results. Participants praised the support and information provided by study staff. Benefits identified included increased convenience compared to in-person medical visits, allowing participants to emotionally process their test results privately, as well as receiving the results from supportive and responsive staff members. A few participants indicated drawbacks to phone-based HIV test result delivery, such as logistical concerns about receiving a phone call during the day (e.g., while at work), reduced confidentiality, and the lack of in-person emotional support. Overall, participants described phone delivery of positive HIV-results as acceptable. At-home testing with phone delivery has the potential to increase HIV testing access, especially to geographically isolated or medically underserved patients. [ABSTRACT FROM AUTHOR]

Preexposure prophylaxis (PrEP) has been demonstrated effective at preventing HIV among key populations like gay and bisexual men (GBM). Yet, there remains a continued need to engage GBM in PrEP behavioral and clinical research (e.g., to monitor adherence and retention in the PrEP treatment cascade). Objectives: We report on the factors motivating GBM to participate in a PrEP behavioral study, with the aim of our results to inform future recruitment efforts for future PrEP research. Methods: In 2015–2016, 103 PrEP-using GBM in New York City completed qualitative interviews about their experiences on PrEP. Participants were also asked about factors that motivated them to join the study. Thematic analysis was used analyze the data. Results: We identified 5 salient themes as rationale for joining the study: 58.3% cited altruistic reasons, 32% reported intellectual curiosity in the subject matter, 30.1% indicated that remuneration inspired them, 18.4% indicated that familiarity or referral to the research institute influenced their decision. Conclusions: Researchers attempting to enroll PrEP-using GBM may benefit from attending to the altruistic and intellectually curious nature of this population. Further, researchers may benefit from establishing familiarity among diverse communities of GBM. This in turn may contribute to the successful engagement of GBM for PrEP research. [ABSTRACT FROM AUTHOR]

Background: Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. Objective: The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. Methods: We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. Results: The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. Conclusions: A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. International Registered Report Identifier (IRRID): RR1-10.2196/13715 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) is a highly effective biobehavioral strategy for preventing HIV acquisition. Although PrEP uptake has increased steadily, discontinuation rates are high among members of key populations like gay and bisexual men (GBM). Understanding the challenges that arise for PrEP users is key to better PrEP implementation and sustained use over time. We report on barriers that arose for PrEP-using GBM, as well as facilitating factors that aided PrEP persistence, with the goal of informing PrEP implementation efforts. In 2015-2016, 103 PrEP-using GBM in NYC completed qualitative interviews about their engagement with PrEP, including their experiences navigating PrEP-related medical care. Interviews were transcribed verbatim, coded, and analyzed thematically. Over half of participants (53%) received their PrEP-related care from their primary care provider (PCP), one-third (33%) from a community-based health clinic, and 13% from multiple medical providers. Emergent themes regarding the barriers and facilitators to PrEP persistence fell into two categories: insurance- and medical appointment-related barriers and facilitators to continued PrEP use. The experiences of PrEP-using GBM can provide useful insights for providers, program developers, and policymakers aiming to improve the implementation of PrEP. To support PrEP persistence, reliable insurance coverage, cost-assistance, and easy appointment scheduling are key to maintenance. Removing insurance- and appointment-related barriers to persistence may prove essential for sustaining use among GBM., (© Society of Behavioral Medicine 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)