Search

Adherence to medications is a complex task that requires complex biobehavioral support. To better provide tools to assist with medication adherence, digital pills provide an option to directly measure medication taking behaviors. These systems comprise a gelatin capsule with radiofrequency emitter, a wearable Reader that collects the radio signal and a smartphone app that collects ingestion data displays it for patients and clinicians. These systems are feasible in measuring adherence in the real-world, even in stigmatized diseases like HIV treatment adherence. While the current iteration of the digital pill system utilizes a wearable Reader worn like a necklace, preliminary feedback demonstrated that a miniaturized system that was worn on the wrist could be more functional in the real-world. This paper therefore describes the development and preliminary field testing of a wrist-borne wearable Reader to facilitate acquisition of oral HIV pre-exposure prophylaxis (PrEP) adherence data among individual prescribed PrEP.

Background: Tobacco smoking increases frailty risk among the general population and is common among people with HIV (PWH) who experience higher rates of frailty at younger ages than the general population., Methods: We identified 8608 PWH across 6 Centers for AIDS Research Network of Integrated Clinical Systems sites who completed ≥2 patient-reported outcome assessments, including a frailty phenotype measuring unintentional weight loss, poor mobility, fatigue, and inactivity, and scored 0-4. Smoking was measured as baseline pack-years and time-updated never, former, or current use with cigarettes/day. We used Cox models to associate smoking with risk of incident frailty (score ≥3) and deterioration (frailty score increase by ≥2 points), adjusted for demographics, antiretroviral medication, and time-updated CD4 count., Results: The mean follow-up of PWH was 5.3 years (median: 5.0), the mean age at baseline was 45 years, 15% were female, and 52% were non-White. At baseline, 60% reported current or former smoking. Current (HR: 1.79; 95% confidence interval: 1.54 to 2.08) and former (HR: 1.31; 95% confidence interval: 1.12 to 1.53) smoking were associated with higher incident frailty risk, as were higher pack-years. Current smoking (among younger PWH) and pack-years, but not former smoking, were associated with higher risk of deterioration., Conclusions: Among PWH, smoking status and duration are associated with incident and worsening frailty., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Plasma vascular endothelial growth factor (VEGF) coreceptor neuropilin-1 (NRP-1) had the largest association with coronary plaque in the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) proteomics analysis. With little known about NRP-1 in people with human immunodeficiency virus (PWH), we explored its relation to other proteins in REPRIEVE and validated our findings through a Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) case-cohort study by assessing its relation to host factors and incident cardiovascular disease and cancer. Within REPRIEVE, NRP-1 was associated with proteins involved in angiogenesis, signal transduction, immunoregulation, and cell migration/adhesion. Within CNICS, NRP-1 was associated with key host factors, including older age and male sex. NRP-1 was associated with an increased hazard of multiple cancers but a decreased prostate cancer risk. Finally, NRP-1 was most strongly associated with mortality and type 2 myocardial infarction. These data suggest that NRP-1 is part of a clinically relevant immunoregulatory pathway related to multiple comorbidities in PWH. Clinical Trials Registration . NCT02344290., Competing Interests: Potential conflicts of interest. S. R. S. reports grant support through his institution from NIH/NIAID. M. V. Z. reports grant support through her institution from NIH/NIAID and Gilead Sciences, relevant to the conduct of the study, and grants from NIH/NIAID and NIH/NHLBI, outside the submitted work. M. T. reports grant support from NIH/NHLBI, American Heart Association, and Robert Wood Johnson Foundation, outside the submitted work. C. J. F. reports grant support through his institution from Gilead Sciences, ViiV Healthcare, GSK, Janssen, AbbVie, Merck, Amgen, and Cytodyn, outside the submitted work. J. J. E. reports grant support through his institution from Gilead Sciences, ViiV Healthcare, and Janssen and personal fees from ViiV Healthcare, Merck, and Gilead Sciences, outside the submitted work. J. M. J. reports grant support through his institution from NIH/NIAID. K. H. M. reports unrestricted research grants to his institution from Gilead Sciences, Merck, and ViiV Healthcare and has served on scientific advisory boards for Gilead and Merck, outside the submitted work. C. M. reports institutional research support by Lilly and honoraria from ViiV Healthcare and Gilead Sciences for advisory board membership, outside the submitted work. R. D. M. reports grant support to his institution from NIH/NIAID and NIH/National Institute on Drug Abuse (NIDA) relevant to the conduct of the study. T. U. reports grant support from NIH/NHLBI and Kowa Pharmaceuticals during the conduct of the study and grants from NIH/NIAID and NIH/National Institute on Aging (NIA), outside the submitted work. M. S. S. reports grant support from NIH/NIAID relevant to the conduct of the study. J. A. A. reports institutional research support for clinical trials from Emergent Biosolutions, Frontier Technologies, Gilead Sciences, GlaxoSmithKline, Janssen, Macrogenics, Merck, Pfizer, Regeneron, and ViiV Healthcare; personal fees for advisory boards from GlaxoSmithKline and Merck; and data and safety monitoring board membership for Kintor Pharmaceuticals, outside the submitted work. J. S. C. reports consulting fees from Merck and Co and Resvirlogix. J. A. C. D. reports through to his institution from NIH/NHLBI, outside the submitted work. H. J. R. reports grants from NIH/NIAID and NIH/NHLBI during the conduct of the study, as well as grants from NIH/NIAID, NIH/NHLBI, NIH/National Institute of Diabetes and Digestive and Kidney Diseases, and NIH/NIA, outside the submitted work. H. M. C. reports grants from NIH/NHLBI during the conduct of this study; grants through her institution from NIH/NIDA, the Agency for Healthcare Research and Quality, and ViiV Healthcare; and advisory board membership for Gilead, outside the submitted work. P. W. H. reports grant support through his institution from Gilead Sciences; drug donation for an NIH-sponsored clinical trial he is leading from Merck; and personal fees from ViiV Healthcare, Gilead Sciences, and Merck. S. K. G. reports grant support through his institution from Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare for the conduct of the study; and grants from Theratechnologies and Navidea, personal fees from Theratechnologies and ViiV, and service on the scientific advisory board of Marathon Asset Management, all outside the submitted work. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Purpose: We described the impact of alcohol use on longitudinal engagement in HIV care including loss to follow-up, durability of viral suppression, and death., Methods: We followed a cohort of 1781 people with HIV from enrolled in care at one of seven US clinics, 2011-2019 through 102 months. We used a multistate, time-varying Markov process and restricted mean time to summarize engagement in HIV care over follow-up according to baseline self-reported alcohol use (none, moderate, or unhealthy)., Results: Our sample (86% male, 54% White) had median age of 35 years. Over 102 months, people with no, moderate, and unhealthy alcohol use averaged 62.3, 61.1, and 59.5 months virally suppressed, respectively. People who reported unhealthy or moderate alcohol use spent 5.1 (95% confidence intervals (CI): 0.8, 9.3) and 7.6 (95%CI: 3.1, 11.7) more months lost to care than nondrinkers. Compared to no use, unhealthy alcohol use was associated with 3.4 (95%CI: -5.6, -1.6) fewer months in care, not virally suppressed. There were no statistically significant differences after adjustment for demographic and clinical characteristics., Conclusions: Moderate or unhealthy drinking at enrollment in HIV care was associated with poor retention in care. Alcohol use was not associated with time spent virally suppressed., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Stigmatization on the basis of race, sexuality, gender identity, and/or use of pre-exposure prophylaxis (PrEP) exacerbates HIV disparities for young men who have sex with men of color (YMSM). We explored resilience, healthcare experiences, stigma, and impact of coronavirus disease 2019 (COVID-19) on PrEP care needs among YMSM of color through virtual in-depth interviews. Analyses used adapted grounded theory/constant comparison. Regarding healthcare-based stigma, participants enacted multilevel resilience which was critical to their care retention during COVID-19 (Themes 1 and 2). Some participants noted that remote care could minimize healthcare stigma and promote retention in care and/or on PrEP (Theme 3). Participants were interested in long-acting injectable (LAI) PrEP but expressed concerns about cost, effectiveness, and side effects (Theme 4). Community-based venues like pharmacies were preferred spaces for getting LAI PrEP injections (Theme 4). Although expansion of telehealth that helped mitigate care retention challenges during COVID-19 was temporary, continued telehealth use may reduce stigmatization and promote long-term retention and PrEP persistence.

Background: Doxycycline post-exposure prophylaxis (doxyPEP) reduces bacterial sexually transmitted infection (STI) incidence in people with HIV (PWH) or using HIV preexposure prophylaxis (PrEP). Given concerns about widespread antibiotic use, we identified doxyPEP prescribing strategies to minimize use while maximizing impact on STIs., Methods: We used electronic health records of gay and bisexual men (GBM), transgender women, and non-binary people assigned male sex at birth with ≥2 STI tests (chlamydia, gonorrhea, syphilis) at an LGBTQ-focused health center during 2015-2020. We defined 10 hypothetical doxyPEP prescribing strategies based on PrEP use, HIV status, or STI history. We estimated doxyPEP use and STI diagnoses averted in counterfactual scenarios in which people meeting prescribing criteria received doxyPEP, assuming STI rates during use would have been reduced by clinical trial efficacy estimates., Results: Among 10,546 individuals (94% GBM), rate of any STI was 35.9/100 person-years. Prescribing doxyPEP to all individuals would have averted 71% of STI diagnoses (number needed to treat for one year to avert one STI diagnosis, NNT = 3.9); prescribing to PrEP users/PWH (52%/12% of individuals) would have averted 60% of STI diagnoses (NNT = 2.9). Prescribing doxyPEP for 12 months after STI diagnosis would have reduced the proportion using doxyPEP to 38% and averted 39% of STI diagnoses (NNT = 2.4). Prescribing after concurrent or repeated STIs would have maximized efficiency (lowest NNTs) but prevented fewer STIs., Conclusions: Prescribing doxyPEP to individuals with STIs, particularly concurrent or repeated STIs, could avert a substantial proportion of all STI diagnoses. The most efficient prescribing strategies are based on STI history rather than HIV status or PrEP use., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Objective: Evaluate associations between racialized and homophobia-based police harassment (RHBPH) and healthcare distrust and utilization among Black Sexual Minority Men (BSMM)., Methods: We utilized data from a longitudinal cohort study from HIV Prevention Trials Network (HPTN) 061 with baseline, six and 12 month follow-up assessments. Using multivariable analysis, we evaluated associations between RHBPH and healthcare distrust and utilization reported at the 6 and 12 month visits., Results: Of 1553 BSMM present at baseline, 1160 were available at six-month follow-up. In multivariable analysis, increasing frequency of RHBPH was associated with increasing levels of distrust in healthcare providers (aOR 1.31, 95% CI: 1.00, 1.74) and missing 50% or more of healthcare visits at six-month follow-up (aOR 1.93, 95% CI: 1.09, 3.43)., Conclusions: Recent experiences of RHBPH are associated with reduced trust in and access to healthcare among BSMM, with more frequent RHBPH associated with greater vulnerability., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Feelemyer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

We created a brief version of The Index, a validated patient-reported measure that has potential to quickly identify patients at risk for poor retention. We analyzed Index scores from 2406 patients from 2016 to 2017 in a national cohort of patients in human immunodeficiency virus (HIV) care. Index scores predicted poor retention 12 months after administered., Competing Interests: Potential conflicts of interest. K. A. C. reports participation on Gilead Sciences Medical Affairs Advisory Board. M. J. M. reports grants or contracts from the Merck Foundation (paid to institution). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives. To assess the performance of US federally qualified health centers (FQHCs) after 6 years of required sexual orientation and gender identity (SOGI) data reporting and update estimated proportions of sexual and gender minorities cared for at FQHCs. Methods. We conducted secondary analyses of data reported to the 2020 and 2021 Uniform Data System from 1297 FQHCs caring for nearly 30 000 000 patients annually. We used multivariable logistic regression to explore FQHC-level and patient-level factors associated with SOGI data completeness. Results. SOGI data were missing for 29.1% and 24.0% of patients, respectively. Among patients with reported SOGI data, 3.5% identified as sexual minorities and 1.5% identified as gender minorities. Southern FQHCs and those caring for more low-income and Black patients were more likely to have above-average SOGI data completeness. Larger FQHCs were more likely to have below-average SOGI data completeness. Conclusions. Substantial increases in SOGI data completeness at FQHCs over 6 years reflect the success of reporting mandates. Future research is needed to identify other patient-level and FQHC-level factors contributing to residual levels of SOGI data missingness. ( Am J Public Health. 2023;113(8):883-892. https://doi.org/10.2105/AJPH.2023.307323).

Incarceration among Black sexual minority men and Black transgender women (BSMM/BTW) is disproportionately high in the United States. Limited research has documented the disruptive effect of incarceration on sexual networks and sexual partnership exchange among BSMM/BTW. We estimate the influence of incarceration on selling sex and mediating pathways among 1169 BSMM/BTW enrolled in the HIV Prevention Trials Network (HPTN) 061 cohort to assess this relationship. Mediators investigated were social support, violence, illicit drug use, and distress due to experienced racism and homophobia. During the 6 months following baseline, 14% of the cohort was incarcerated, including 24% of BTW. After adjustment, recent incarceration was associated with 1.57 (95% CI 1.02, 2.42) times the risk of subsequently selling sex. The hypothesized mediators together explained 25% of the relationship, with an indirect effect risk ratio of 1.09 (95% CI 0.97, 1.24). Our results document an association and call for more research investigating mechanisms., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: People with human immunodeficiency virus (HIV) infection (PWH) are at higher risk of myocardial infarction (MI) than those without HIV. About half of MIs in PWH are type 2 (T2MI), resulting from mismatch between myocardial oxygen supply and demand, in contrast to type 1 MI (T1MI), which is due to primary plaque rupture or coronary thrombosis. Despite worse survival and rising incidence in the general population, evidence-based treatment recommendations for T2MI are lacking. We used polygenic risk scores (PRS) to explore genetic mechanisms of T2MI compared to T1MI in PWH., Methods: We derived 115 PRS for MI-related traits in 9541 PWH enrolled in the Centers for AIDS Research Network of Integrated Clinical Systems cohort with adjudicated T1MI and T2MI. We applied multivariate logistic regression analyses to determine the association with T1MI and T2MI. Based on initial findings, we performed gene set enrichment analysis of the top variants composing PRS associated with T2MI., Results: We found that T1MI was strongly associated with PRS for cardiovascular disease, lipid profiles, and metabolic traits. In contrast, PRS for alcohol dependence and cholecystitis, significantly enriched in energy metabolism pathways, were predictive of T2MI risk. The association remained after the adjustment for actual alcohol consumption., Conclusions: We demonstrate distinct genetic traits associated with T1MI and T2MI among PWH further highlighting their etiological differences and supporting the role of energy regulation in T2MI pathogenesis., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: The U.S. monkeypox (mpox) outbreak of 2022 was a unique emergent public health crisis disproportionately affecting Black sexual minority men (BSMM). Similar to other stigmas, mpox-related stigma may have adverse effects on BSMM, including deterring HIV prevention such as PrEP., Methods: Our study investigated the experiences and perceptions of BSMM related to mpox, including mpox-associated stigma, and PrEP engagement among BSMM. We conducted qualitative interviews of 24 BSMM attending HIV prevention-related events in the greater D.C. Metropolitan area. In-depth interviews were conducted via phone, and responses to questions specific to the mpox outbreak were analyzed using thematic analysis., Results: We identified three key themes from the analysis: Mpox-related stigma, Mpox vaccine availability concerns, and Mpox vaccine hesitancy. Participants also described relationships between each of these three themes and PrEP use. Mpox stigma was particularly relevant as it is related to sexual stigma and is a deterrent to PrEP use. A sense of health system neglect of BSMM, especially related to low mpox vaccine availability, was also described., Conclusions: We identified mpox stigma and challenges related to mpox vaccination as key themes among BSMM, with implications for PrEP use. Future research exploring medical mistrust among BSMM, particularly related to HIV prevention, is recommended.

Introduction: Pre-exposure prophylaxis (PrEP) has been available for young people for over a decade, yet only ∼15% of young people in the United States with indications for PrEP have a prescription for it. Next-generation PrEP modalities may address some of the challenges of daily oral PrEP. However, preferences for these products are unknown., Methods: From October 2020 to June 2021, we conducted an online survey of 737 cisgender, young men who have sex with men (age 15-24 years) without HIV across the United States who reported same-sex attraction or consensual sex with another man in the past 6 months. Participants completed a conjoint experiment comparing daily oral pills, event-driven oral pills, event-driven rectal douches, intramuscular injections, intravenous broadly neutralizing antibody (bnAb) infusions and subcutaneous implants. Participants ranked the products from most to least preferred. Exploded logit models examined the association between ranked preferences of PrEP modalities and socio-demographic and behavioural characteristics., Results: Participants' mean age was 21 years (SD = 2.3), and 56% identified as White. Nineteen percent were currently taking daily oral PrEP, and another 9% had previously taken it. Participants prioritized efficacy, absence of side effects and costs in the conjoint analyses. Daily oral PrEP had the highest preference ranking, followed by event-driven oral (OR = 0.89, p = 0.058), injectable (OR = 0.83, p = 0.005), implant (OR = 0.48, p < 0.0001), bnAb infusions (OR = 0.38, p < 0.0001) and rectal douches (OR = 0.24, p < 0.0001). There were differences in PrEP preferences across age, insurance status, sexual behaviour, PrEP use history, HIV and sexually transmitted infection (STI) testing history, and STI diagnoses (omnibus tests: p < 0.05). Participants also provided reasons for selecting their top product choice: ease of use for those who chose daily oral (99%) and daily event-driven (98.5%); feel more protected against HIV for those who chose injectable (95.4%) and implants (100%); not worrying about forgetting to take it for those who chose bnAbs (93.8%); and being able to stop taking it when they want for those who chose rectal douche (90.9%)., Conclusions: Next-generation modalities were less likely to be preferred over daily oral PrEP, with differences in the magnitude by socio-demographic and behavioural characteristics. Given the low uptake of daily oral PrEP, end-users' preferences for and concerns about PrEP products must be understood to ensure high acceptability and penetration., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

HIV incidence is disproportionately high among young cisgender men who have sex with men (YMSM), but YMSM are less likely than adults to use HIV pre-exposure prophylaxis (PrEP). Among YMSM living with HIV, peer navigation programs have been effective in linkage to care and increasing medication adherence; such programs may aid HIV-uninfected YMSM in overcoming barriers to engagement in PrEP care. We conducted 32 semi-structured qualitative interviews at a community health center in Massachusetts, USA, specializing in sexual and gender minority health with four sub-groups of YMSM who: (1) had never discussed PrEP with a medical provider, (2) had discussed PrEP with a medical provider but declined a prescription, (3) were prescribed PrEP and have sub-optimal adherence (taking fewer than 4 pills per week), and (4) were prescribed PrEP and were optimally adherent. Domains addressed in the interviews included knowledge of PrEP and HIV prevention, barriers and facilitators to PrEP adherence, and attitudes toward peer navigation for PrEP. Interviews were transcribed and coded using thematic analysis methodology. Multiple themes emerged from the interviews, including finding that perceived costs, anticipated stigma, sexual activity, and relationship status influence PrEP uptake and adherence; establishing pill-taking routines is an important adherence facilitator; and peer navigators could offer benefits for PrEP adherence., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: This study identified barriers and facilitators associated with providing culturally responsive care for sexual and gender minority (SGM) patients at federally qualified health centers (FQHCs) in the United States, from the perspective of clinical leadership. Methods: Between July and December 2018, 23 semistructured, in-depth qualitative interviews were held with clinical leaders representing six FQHCs residing in rural and urban settings. Stakeholders included Chief Executive Officer, Executive Director, Chief Medical Officer, Medical Director, Clinic Site Director, and Nurse Manager positions. Interview transcripts were analyzed using inductive thematic analysis. Results: Barriers included personnel factors related to lack of training and fear, competing priorities, and environments that focused on treating all patients similarly. Facilitators included established partnerships with external organizations, staff with prior SGM training and knowledge, and active initiatives in clinic settings targeting SGM care. Conclusions: Clinical leadership expressed strong support for evolving their FQHCs into organizations that provide culturally responsive care for their SGM patients. FQHC staff across all levels of clinical care would benefit from regularly occurring training sessions on culturally responsive care for SGM patients. To ensure sustainability, improve staff buy-in, and mitigate the impact of staff turnover, improving culturally competent care for SGM patients should be a shared goal and responsibility for leadership, medical providers, and administrative staff. CTN Registration: NCT03554785.

Describe health of transgender women (TW) with HIV vs. cisgender men and women (CM, CW) in a U.S. HIV care cohort. Data were from Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), 2005-2022. TW were identified using clinical data/identity measures. PWH (n = 1285) were included in analyses (275 TW, 547 CM, 463 CW). Cross-sectional multivariable analyses compared HIV outcomes/co-morbidities between TW/CM and TW/CW, and adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) were estimated. TW had poorer adherence (> 90% adherent; aOR 0.57; 95%CI 0.38, 0.87) and were more likely to miss ≥ 3 visits in the past year than CM (aOR 1.50, 95%CI 1.06, 2.10); indicated more anxiety compared to both CM and CW (p ≤ 0.001, p = 0.02); hepatitis C infection (p = 0.03) and past-year/lifetime substance treatment (p = 0.004/p = 0.001) compared to CM; and substance use relative to CW. TW with HIV differed in HIV clinical outcomes and co-morbidities from CM and CW., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective measures of adherence for antiretrovirals used as pre-exposure prophylaxis (PrEP) are critical for improving preventative efficacy in both clinical trials and real-world application. Current objective adherence measures either reflect only recent behavior (eg days for plasma or urine) or cumulative behavior (eg months for dried blood spots). Here, we measured the accumulation of the antiretroviral drug maraviroc (MVC) in hair strands by infrared matrix-assisted laser desorption electrospray ionization (IR-MALDESI) mass spectrometry imaging (MSI) to evaluate adherence behavior longitudinally at high temporal resolution. An MSI threshold for classifying daily adherence was established using clinical samples from healthy volunteers following directly observed dosing of 1 to 7 doses MVC/week. We then used the benchmarked MSI assay to classify adherence to MVC-based PrEP regimens in hair samples collected throughout the 48-week HPTN069/ACTGA5305 study. We found that only ~32% of investigated hair samples collected during the study's active dosing period showed consistent daily PrEP adherence throughout a retrospective period of 30 days, and also found that profiles of daily individual adherence from MSI hair analysis could identify when patients were and were not taking study drug. The assessment of adherence from MSI hair strand analysis was 62% lower than adherence classified using paired plasma samples, the latter of which may be influenced by white-coat adherence. These findings demonstrate the ability of MSI hair analysis to examine daily variability of adherence behavior over a longer-term measurement and offer the potential for longitudinal comparison with risk behavior to target patient-specific adherence interventions and improve outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Rosen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

State-level structural stigma and its consequences in healthcare settings shape access to pre-exposure prophylaxis (PrEP) for HIV prevention among gay, bisexual, and other men who have sex with men (GBMSM). Our objective was to assess the relationships between same-sex marriage laws, a measure of structural stigma at the state level, provider-patient communication about sex, and GBMSM awareness and use of PrEP. Using data from the Fenway Institute's MSM Internet Survey collected in 2013 (N = 3296), we conducted modified Poisson regression analyses to evaluate associations between same-sex marriage legality, measures of provider-patient communication, and PrEP awareness and use. Living in a state where same-sex marriage was legal was associated with PrEP awareness (aPR 1.27; 95% CI 1.14, 1.41), as were feeling comfortable discussing with primary care providers that they have had sex with a man (aPR 1.63; 95% CI 1.46, 1.82), discussing with their primary care provider having had condomless sex with a man (aPR 1.65; 95% CI 1.49, 1.82), and discussing with their primary care provider ways to prevent sexual transmission of HIV (aPR 1.39; 95% CI 1.26, 1.54). Each of these three measures of provider-patient communication were additionally associated with PrEP awareness and use. In sum, structural stigma was associated with reduced PrEP awareness and use. Policies that reduce stigma against GBMSM may help to promote PrEP and prevent HIV transmission., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Alcohol use among people with HIV is associated with worse HIV treatment outcomes. Its impact on self-reported health status is unclear., Setting: Longitudinal cohort of people with HIV engaged in care across 7 clinics participating in the Centers for AIDS Research Network of Integrated Care Systems between January 2011 and June 2014., Methods: A total of 5046 participants were studied. A quantile regression model estimated the association of alcohol use levels with subsequent self-reported health status score, accounting for multiple covariates including depressive symptoms. Women, men who have sex with women, and men who have sex with men were analyzed separately., Results: Prevalence of heavy alcohol use was 21%, 31%, and 37% among women, men who have sex with women, and men who have sex with men, respectively. Women with heavy alcohol use had a subsequently decreased median self-reported health status score compared to women with no or moderate alcohol use (odds ratio [OR]: 0.76; 95% confidence interval [CI]: 0.58-0.99); this association was not explained by the presence of depressive symptoms. There was no observed association of alcohol use level on subsequent self-reported health status among men who have sex with women. Men who have sex with men reporting no alcohol use had a subsequently decreased median self-reported health status compared to moderate alcohol use (OR: 0.88; 95% CI: 0.80-0.97)., Conclusion: Heavy alcohol use is associated with worsened self-reported health status at subsequent visits among women with HIV and not men with HIV., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

The effectiveness of HIV pre-exposure prophylaxis (PrEP) hinges on adherence, which has been restricted by multifaceted barriers. Uptake of PrEP has been impeded by poor access resulting from high costs, provider uncertainty, discrimination, stigma, and poor understanding within the health-care community and the public of who can benefit from PrEP. Other important barriers to adherence and persistence over time relate to individuals (eg, depression) and their community, partners, and family (eg, poor support), and their effects vary substantially with each person, population, and setting. Despite these challenges, key opportunities for improving PrEP adherence exist, including novel delivery systems, tailored individual interventions, mobile health and digital health interventions, and long-acting formulations. Objective monitoring strategies will help to improve adherence interventions and alignment of PrEP use with the need for HIV prevention (ie, prevention-effective adherence). The future of PrEP adherence lies in person-centred approaches to service delivery that meet the needs of individuals while creating supportive environments and facilitating health-care access and delivery., Competing Interests: Declaration of interests JEH reports consulting fees from Merck and owns stock in Natera. AM has received grants from Gilead Sciences, consulting fees from Viiv, and honoraria from Cepheid. KHM has received grants from and participated on scientific advisory boards for Gilead Sciences and Merck., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objectives: People with HIV have a higher risk of myocardial infarction (MI) than the general population, with a greater proportion of type 2 MI (T2MI) due to oxygen demand-supply mismatch compared with type 1 (T1MI) resulting from atherothrombotic plaque disruption. People living with HIV report a greater prevalence of cigarette and alcohol use than do the general population. Alcohol use and smoking as risk factors for MI by type are not well studied among people living with HIV. We examined longitudinal associations between smoking and alcohol use patterns and MI by type among people living with HIV., Design and Methods: Using longitudinal data from the Centers for AIDS Research Network of Integrated Clinical Systems cohort, we conducted time-updated Cox proportional hazards models to determine the impact of smoking and alcohol consumption on adjudicated T1MI and T2MI., Results: Among 13 506 people living with HIV, with a median 4 years of follow-up, we observed 177 T1MI and 141 T2MI. Current smoking was associated with a 60% increase in risk of both T1MI and T2MI. In addition, every cigarette smoked per day was associated with a 4% increase in risk of T1MI, with a suggestive, but not significant, 2% increase for T2MI. Cigarette use had a greater impact on T1MI for men than for women and on T2MI for women than for men. Increasing alcohol use was associated with a lower risk of T1MI but not T2MI. Frequency of heavy episodic alcohol use was not associated with MI., Conclusions: Our findings reinforce the prioritization of smoking reduction, even without cessation, and cessation among people living with HIV for MI prevention and highlight the different impacts on MI type by gender., (© 2023 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

HIV pre-exposure prophylaxis (PrEP) is highly effective, but PrEP use has been suboptimal. We describe a telementoring program for clinics in high-HIV burden areas, focusing on systems-level practice transformation and care for populations disproportionately affected by HIV. We developed and delivered a telementoring program for U.S. health centers. We analyzed participants' baseline and post-session surveys to ascertain experiences providing PrEP and caring for people disproportionately affected by HIV, comparing responses between medical and behavioral health clinicians. Forty-eight people from 16 health centers participated. Medical clinicians were more likely than behavioral health clinicians to care for people taking PrEP, but the groups did not differ in self-rated capacity to counsel about PrEP or care for populations disproportionately affected by HIV. Virtual training on practice transformation for PrEP, involving medical and behavioral health clinicians, is feasible and acceptable. PrEP training and delivery efforts should include behavioral health clinicians.

Objective: To adapt and validate an algorithm to ascertain transgender and gender diverse (TGD) patients within electronic health record (EHR) data., Methods: Using a previously unvalidated algorithm of identifying TGD persons within administrative claims data in a multistep, hierarchical process, we validated this algorithm in an EHR data set with self-reported gender identity., Results: Within an EHR data set of 52 746 adults with self-reported gender identity (gold standard) a previously unvalidated algorithm to identify TGD persons via TGD-related diagnosis and procedure codes, and gender-affirming hormone therapy prescription data had a sensitivity of 87.3% (95% confidence interval [CI] 86.4-88.2), specificity of 98.7% (95% CI 98.6-98.8), positive predictive value (PPV) of 88.7% (95% CI 87.9-89.4), and negative predictive value (NPV) of 98.5% (95% CI 98.4-98.6). The area under the curve (AUC) was 0.930 (95% CI 0.925-0.935). Steps to further categorize patients as presumably TGD men versus women based on prescription data performed well: sensitivity of 97.6%, specificity of 92.7%, PPV of 93.2%, and NPV of 97.4%. The AUC was 0.95 (95% CI 0.94-0.96)., Conclusions: In the absence of self-reported gender identity data, an algorithm to identify TGD patients in administrative data using TGD-related diagnosis and procedure codes, and gender-affirming hormone prescriptions performs well., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Antiretroviral therapy (ART) is recommended for people with HIV (PWH), irrespective of CD4 cell count, to improve their health and reduce the risk of transmission to sexual partners through long-term viral suppression. We identified risk factors for viral rebound among patients with a period of stable viral suppression to inform counseling and monitoring., Methods: We conducted a multisite, retrospective study of PWH with a 2-year period of sustained viral suppression in the United States using the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We used multivariable logistic regression to identify characteristics independently associated with any viral rebound (viral load [VL] ≥200 copies/mL) and sustained viral rebound (VL ≥200 copies/mL followed by a VL that was also ≥200 copies/mL within 6 months), within 2 years of follow-up., Results: Among 3496 eligible patients with a 2-year period of sustained viral suppression, most (90%) continued to have viral suppression over 2 additional years; 10% experienced viral rebound, and 4% experienced sustained viral rebound. In multivariable analyses, Black race, current smoking, integrase strand transfer inhibitor use, and 5- to 9-year duration of ART were positively associated, and being age ≥50 years was negatively associated, with any viral rebound. Only current smoking and 5- to 9-year (vs 2- to 4-year) duration of ART were positively associated, and being age ≥60 years was negatively associated, with sustained viral rebound., Conclusions: Most people retained in clinical care and with HIV viral suppression on ART will have persistent viral suppression. However, some patients may benefit from additional treatment adherence support., Competing Interests: Potential conflicts of interest. E.R.C. received unrestricted research funds paid to UC Regents from Gilead Sciences, Inc., and Merck for unrelated research topics and served on advisory boards for Gilead Sciences, Inc., and Theratechnologies on unrelated medical topics. K.C. served as a medical advisory board member for Gilead Sciences, Inc. K.H.M. received unrestricted research grants from Gilead Sciences, Inc., and Merck. A.R. received research funding from Merck on an unrelated research topic. C.G.B. received research funding from Gilead Sciences, Inc., for unrelated research topics. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Epidemiological monitoring of HIV among transgender women is minimal despite prioritisation of this group in the US National HIV/AIDS Strategy (2022-2025). We aimed to estimate HIV incidence in a multisite cohort of transgender women in the eastern and southern USA. Participant deaths were identified during follow-up; thus, we felt it was an ethical imperative to report mortality alongside HIV incidence., Methods: In this study, we established a multisite cohort across two modes: a site-based, technology-enhanced mode in six cities (Atlanta, Baltimore, Boston, Miami, New York City, and Washington, DC) and an exclusively digital mode that spanned 72 eastern and southern US cities that matched the six site-based cities based on population size and demographics. Trans feminine adults (≥18 years) who were not living with HIV were eligible and followed up for at least 24 months. Participants completed surveys and oral fluid HIV testing with clinical confirmation. We ascertained deaths through community and clinical sources. We estimated HIV incidence and mortality using the number of HIV seroconversions and deaths, respectively, divided by person-years accumulated from enrolment. Logistic regression models were used to identify predictors of HIV seroconversion (primary outcome) or death., Findings: Between March 22, 2018, and Aug 31, 2020, we enrolled 1312 participants with 734 (56%) in site-based and 578 (44%) in digital modes. At the 24-month assessment, 633 (59%) of 1076 eligible participants consented to extending participation. 1084 (83%) of 1312 participants were retained at this analysis based on the study definition of loss to follow-up. As of May 25, 2022, the cohort participants had contributed 2730 accumulated person-years to the analytical dataset. Overall HIV incidence was 5·5 (95% CI 2·7-8·3) per 1000 person-years and incidence was higher among Black participants and those living in the south. Nine participants died during the study. The overall mortality rate was 3·3 (95% CI 1·5-6·3) per 1000 person-years, and the rate was higher among Latinx participants. Identical predictors of HIV seroconversion and death included residence in southern cities, sexual partnerships with cisgender men, and use of stimulants. Participation in the digital cohort and seeking care for gender transition were inversely associated with both outcomes., Interpretation: As HIV research and interventions are increasingly delivered online, differences by mode highlight the need for continued community and location-based efforts to reach the most marginalised transgender women. Our findings underscore community calls for interventions that address social and structural contexts that affect survival and other health concerns alongside HIV prevention., Funding: National Institutes of Health., Translation: For the Spanish translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests KNA is a consultant for the All of Us Research Program. TCP is a consultant for ViiV Healthcare and received an honorarium for a lecture provided to Merck & Co staff. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: India is facing overlapping opioid injection and HIV epidemics among people who inject drugs (PWID) in several cities. Integrated Care Centers (ICCs) provide single-venue HIV and substance use services to PWID. We evaluated PWID engagement in daily observed buprenorphine treatment at 7 ICCs to inform interventions., Methods: We analyzed 1-year follow-up data for PWID initiating buprenorphine between 1 January - 31 December 2018, evaluating receipt frequency, treatment interruptions (no buprenorphine receipt for 60 consecutive days with subsequent re-engagement), and drop-out (no buprenorphine receipt for 60 consecutive days without re-engagement). Using descriptive statistics, we explored differences between ICCs in the opioid-endemic Northeast region and ICCs in the emerging opioid epidemic North/Central region. We used a multivariable logistic regression model to determine predictors of treatment drop-out by 6 months., Results: 1312 PWID initiated buprenorphine (76% North/Central ICCs vs. 24% Northeast ICCs). 31% of PWID in North/Central, and 25% in Northeast ICCs experienced ≥ 1 treatment interruption in 1 year. Over 6 months, 48% of PWID in North/Central vs. 60% in Northeast ICCs received buprenorphine ≤ 2 times/week (p < 0.0001). A third of PWID in North/Central vs. half in Northeast ICCs experienced treatment drop-out by 6 months (p < 0.001). In the multivariable model, living in Northeast cities was associated with increased odds of drop-out while counseling receipt was associated with decreased odds., Conclusions: Retention among PWID initiating buprenorphine at ICCs was comparable to global reports. However, regional heterogeneity in retention, and low daily buprenorphine receipt suggest patient-centered interventions adapted to regional contexts are urgently needed., Competing Interests: Conflicts of interest The authors have no conflicts of interest to declare., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Studies show that stressful life events (SLE) (e.g., discrimination, financial problems) can lead to psychosocial problems and exacerbate condomless anal sex (CAS) without protection via pre-exposure prophylaxis (PrEP) among men who have sex with men. However, few studies have examined this relationship among men who have sex with men in India, and none have examined this longitudinally., Methods: As a part of an HIV-prevention intervention, 608 MSM from Chennai and Mumbai, India, completed behavioral surveys at baseline, 4, 8, and 12 months. We used longitudinal generalized estimating equations (GEE) modeling to examine the relationship between SLE and its severity and subsequent psychosocial problems, CAS, and history of diagnosed sexually transmitted infection (STI). All models are adjusted for age, sexual identity, intervention arm, human immunodeficiency virus status, and recruitment city., Results: The number of SLE and their corresponding perceived impact score remained consistent at each time point. In multivariable GEE models, the number of SLE was predictive of CAS, depression, and harmful drinking. Similarly, the ratio of the impact of SLE was predictive of CAS, depression, and diagnosed STI. However, harmful drinking was not predictive in this model., Conclusions: These findings provide evidence that can inform future interventions, which can be used to enhance self-acceptance, coping skills, and other forms of resiliency.

Background: Transgender and gender diverse (TGD) individuals experience more severe psychological distress and may be at higher risk for suicide compared to cisgender individuals. The existing literature largely consists of small-sample studies that do not assess subgroup differences., Objective: To examine rates of self-reported suicidal ideation among four TGD groups compared to cisgender individuals., Design: Data were extracted from the electronic health records of patients receiving primary care at a community health center specializing in sexual and gender minority health. A logistic regression was used to examine the relationship between sociodemographic variables and the presence of current suicidal ideation., Participants: 29,988 patients receiving care at a community health center in Northeastern US between 2015 and 2018., Main Measures: Demographic questionnaire, 9-item Patient Health Questionnaire KEY RESULTS: Younger age, sexual and gender minority identity, and public/grants-based insurance were associated with significantly higher odds of suicidal ideation. Relative to cisgender men, transgender men (OR=2.08; 95% CI=1.29-3.36; p=.003), transgender women (OR=3.08; 95% CI=2.05-4.63; p<.001), nonbinary (NB) individuals assigned male at birth (AMAB; OR=3.55; 95% CI=1.86-6.77; p<001), and NB individuals assigned female at birth (AFAB; OR=2.49; 95% CI=1.52-4.07; p<001) all endorsed significantly higher odds of current suicidal ideation, controlling for age, race, ethnicity, sexual orientation, and insurance status. Larger proportions of transgender women (23.6%) and NB AMAB individuals (26.7%) reported suicidal ideation not only compared to cisgender men (6.1%) and women (6.6%), but also compared to transgender men (17.4%; χ 2 [5, n=25,959]=906.454, p<0.001)., Conclusions: TGD patients were at significantly increased risk of suicidal ideation, even after accounting for age, race, ethnicity, sexual orientation, and insurance status. Findings suggest distinct risk profiles by assigned sex at birth. Consistent assessment of and intervention for suicidal ideation should be prioritized in settings that serve TGD patients., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Objective: Frailty is common among people with HIV (PWH), so we developed frail risk in the short-term for care (RISC)-HIV, a frailty prediction risk score for HIV clinical decision-making., Design: We followed PWH for up to 2 years to identify short-term predictors of becoming frail., Methods: We predicted frailty risk among PWH at seven HIV clinics across the United States. A modified self-reported Fried Phenotype captured frailty, including fatigue, weight loss, inactivity, and poor mobility. PWH without frailty were separated into training and validation sets and followed until becoming frail or 2 years. Bayesian Model Averaging (BMA) and five-fold-cross-validation Lasso regression selected predictors of frailty. Predictors were selected by BMA if they had a greater than 45% probability of being in the best model and by Lasso if they minimized mean squared error. We included age, sex, and variables selected by both BMA and Lasso in Frail RISC-HIV by associating incident frailty with each selected variable in Cox models. Frail RISC-HIV performance was assessed in the validation set by Harrell's C and lift plots., Results: Among 3170 PWH (training set), 7% developed frailty, whereas among 1510 PWH (validation set), 12% developed frailty. BMA and Lasso selected baseline frailty score, prescribed antidepressants, prescribed antiretroviral therapy, depressive symptomology, and current marijuana and illicit opioid use. Discrimination was acceptable in the validation set, with Harrell's C of 0.76 (95% confidence interval: 0.73-0.79) and sensitivity of 80% and specificity of 61% at a 5% frailty risk cutoff., Conclusions: Frail RISC-HIV is a simple, easily implemented tool to assist in classifying PWH at risk for frailty in clinics., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Approximately 2% of the U.S. population identifies as transgender, and transgender people experience disproportionate rates of cardiovascular disease mortality. However, widely used cardiovascular disease risk estimators have not been validated in this population. This study sought to determine the impact on statin therapy recommendations using 3 different approaches to operationalizing sex in the American Health Association/American College of Cardiology Pooled Cohort Equation Risk Estimator., Methods: This is a cross-sectional analysis of baseline clinical data from LITE Plus, a prospective cohort study of Black and/or Latina transgender women with HIV. Data were collected from October 2020 to June 2022 and used to calculate Pooled Cohort Equation scores., Results: The 102 participants had a mean age of 43 years. A total of 88% were Black, and 18% were Latina. A total of 79% were taking gender-affirming hormones. The average Pooled Cohort Equation risk score was 6% when sex assigned at birth was used and statins would be recommended for the 31% with Pooled Cohort Equation >7.5%. The average risk score was 4%, and 18% met the criteria for statin initiation when current gender was used; the mean risk score was 5%, and 22% met the criteria for statin initiation when current hormone therapy was used., Conclusions: Average Pooled Cohort Equation risk scores vary substantially depending on the approach to operationalizing the sex variable, suggesting that widely used cardiovascular risk estimators may be unreliable predictors of cardiovascular disease risk in transgender populations. Collection of sex, gender, and hormone use in longitudinal studies of cardiovascular health is needed to address this important limitation of current risk estimators., (© 2023 The Author(s).)

Abstract: Modifications to Fried's frailty phenotype (FFP) are common. We evaluated a self-reported modified frailty phenotype (Mod-FP) used among people with HIV (PWH). Among 522 PWH engaged in two longitudinal studies, we assessed validity of the four-item Mod-FP compared with the five-item FFP. We compared the phenotypes via receiver operator characteristic curves, agreement in classifying frailty, and criterion validity via association with having experienced falls. Mod-FP classified 8% of PWH as frail, whereas FFP classified 9%. The area under the receiver operator characteristic curve for Mod-FP classifying frailty was 0.93 (95% CI = 0.91-0.96). We observed kappa ranging from 0.64 (unweighted) to 0.75 (weighted) for categorizing frailty status. Both definitions found frailty associated with a greater odds of experiencing a fall; FFP estimated a slightly greater magnitude (i.e., OR) for the association than Mod-FP. The Mod-FP has good performance in measuring frailty among PWH and is reasonable to use when the gold standards of observed assessments (i.e., weakness and slowness) are not feasible., (Copyright © 2023 Association of Nurses in AIDS Care.)

Background: Vaporized nicotine (VN) use is increasing among people with HIV (PWH). We examined demographics, patterns of use, depression, and panic symptoms associated with VN and combustible cigarette (CC) use among PWH., Methods: We analyzed VN use among PWH in care at 7 US sites. PWH completed a set of patient-reported outcomes, including substance use and mental health. We categorized VN use as never vs. ever with the frequency of use (days/month) and CC use as never, former, or current. We used relative risk regression to associate VN and CC use, depression, and panic symptoms. Linear regression estimated each relationship with VN frequency. Models were adjusted for demographics., Results: Among 7431 PWH, 812 (11%) reported ever-using VN, and 264 (4%) reported daily use. Half (51%) of VN users concurrently used CC. VN users were more likely than those without use to be younger, to be White, and to report ever-using CC. PWH reporting former CC use reported ≥8.5 more days per month of VN use compared with never CC use [95% confidence interval (95% CI): 5.5 to 11.5 days/month] or current CC use (95% CI: 6.6 to 10.5 days/month). Depression (relative risk: 1.20 [95% CI: 1.02 to 1.42]) and panic disorder (1.71 [95% CI: 1.43 to 2.05]) were more common among PWH ever-using VN. Depression was common among PWH using VN (27%) and CC (22%), as was panic disorder (21% for VN and 16% for CC)., Conclusion: Our study elucidated demographic associations with VN use among PWH, revealed the overlap of VN and CC use, and associations with depression/panic symptoms, suggesting roles of VN in self-medication and CC substitution, warranting further longitudinal/qualitative research., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

BACKGROUNDMosaic and consensus HIV-1 immunogens provide two distinct approaches to elicit greater breadth of coverage against globally circulating HIV-1 and have shown improved immunologic breadth in nonhuman primate models.METHODSThis double-blind randomized trial enrolled 105 healthy HIV-uninfected adults who received 3 doses of either a trivalent global mosaic, a group M consensus (CON-S), or a natural clade B (Nat-B) gp160 env DNA vaccine followed by 2 doses of a heterologous modified vaccinia Ankara-vectored HIV-1 vaccine or placebo. We performed prespecified blinded immunogenicity analyses at day 70 and day 238 after the first immunization. T cell responses to vaccine antigens and 5 heterologous Env variants were fully mapped.RESULTSEnv-specific CD4+ T cell responses were induced in 71% of the mosaic vaccine recipients versus 48% of the CON-S recipients and 48% of the natural Env recipients. The mean number of T cell epitopes recognized was 2.5 (95% CI, 1.2-4.2) for mosaic recipients, 1.6 (95% CI, 0.82-2.6) for CON-S recipients, and 1.1 (95% CI, 0.62-1.71) for Nat-B recipients. Mean breadth was significantly greater in the mosaic group than in the Nat-B group using overall (P = 0.014), prime-matched (P = 0.002), heterologous (P = 0.046), and boost-matched (P = 0.009) measures. Overall T cell breadth was largely due to Env-specific CD4+ T cell responses.CONCLUSIONPriming with a mosaic antigen significantly increased the number of epitopes recognized by Env-specific T cells and enabled more, albeit still limited, cross-recognition of heterologous variants. Mosaic and consensus immunogens are promising approaches to address global diversity of HIV-1.TRIAL REGISTRATIONClinicalTrials.gov NCT02296541.FUNDINGUS NIH grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069412, UL1 RR025758, P30 AI064518, UM1 AI100645, and UM1 AI144371, and Bill & Melinda Gates Foundation grant OPP52282.

This study characterized arrest, incarceration, and risk factors for incident incarceration among transgender women (TW) in the northeastern and southern United States. During semiannual study visits over 24 months in a multicenter cohort study, TW completed HIV testing and self-administered surveys. In total, 1571 TW completed baseline survey; 1,312 HIV-negative TW enrolled in the cohort and contributed 2134.3 person-years to the analysis. At baseline, 37% had been arrested and 21% had been incarcerated. Incident incarceration was 23.4 per 1,000 person-years (95% confidence interval [CI]: 16.9-29.9). Sex work was significantly associated with baseline and incident incarceration ( p  < .01). A history of incarceration at enrollment was the strongest predictor of incident incarceration (adjusted odds ratio [aOR] 6.99; 95% CI: 3.43-14.24). Living in the South (aOR 2.69, 95% CI: 1.22-5.93), income below the federal poverty level (aOR 2.65 95% CI: 3.43-14.24), and having a recent partner who had been incarcerated (aOR 2.62, 95% CI: 1.20-5.69) also increased the odds of incident incarceration in multivariable modeling. Structural interventions to reduce poverty and decriminalize sex work have the potential to reduce incarceration rates among TW.

Background: Black men who have sex with men (MSM) experience disproportionate rates of HIV infection in the USA, despite being no more likely to engage in sexual risk behaviors than other MSM racial/ethnic groups. HIV pre-exposure prophylaxis (PrEP) has been shown to reduce risk of HIV acquisition; however, rates of PrEP use among Black MSM remain low. Clinical, psychosocial, and structural factors have been shown to impact PrEP use and adherence among Black MSM. Care coordination of HIV prevention services has the potential to improve PrEP use and adherence for Black MSM, as it has been shown to improve HIV-related care outcomes among people living with HIV., Methods: Client-centered care coordination (C4) is a multi-level intervention designed to address clinical, psychosocial, and structural barriers to HIV prevention services for Black MSM within HPTN 073, a PrEP demonstration project among Black MSM in three cities in the USA. The current study examined the implementation process of C4, specifically investigating the activities, cost, time, and outcomes associated with the C4 intervention., Results: On average, participants engaged in five care coordination encounters. The vast majority of care coordination activities were conducted by counselors, averaging 30 min per encounter. The cost of care coordination was relatively low with a mean cost of $8.70 per client encounter., Conclusion: Although client-centered care coordination was initially implemented in well-resourced communities with robust HIV research and service infrastructure, our findings suggest that C4 can be successfully implemented in resource constrained communities., (© 2021. The Author(s).)

Objectives: After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression., Design: Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage., Methods: Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health., Results: Among the 144 participants virally unsuppressed at baseline, most had had a previous positive HIV test result; were Black, non-Hispanic, gay and bisexual men, aged 22-50. Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2])., Conclusions: Reaching targets of at least 90% sustained viral suppression among all people with HIV will likely require more than an individual-level CM approach that addresses barriers to optimal care and treatment at multiple levels., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Nonadherence, particularly among men who have sex with men (MSM) with substance use disorders, increases the risk of HIV acquisition. Measuring adherence to HIV pre-exposure chemoprophylaxis (PrEP), and responding to suboptimal adherence or changes in adherence behavior remains a challenging public health problem. Despite the importance of accurate adherence measurement, there is no gold standard for detecting medication ingestion events in HIV research. Current adherence measures indirectly infer ingestion events or measure medication concentrations over time, yet such approaches fail to provide direct confirmation of ingestions and contextual information surrounding adherence and nonadherence. A digital pill system (DPS) - a novel tool that leverages ingestible radiofrequency sensors to measure actual ingestion events - may advance adherence measurement in HIV research. We examined and compared the willingness of MSM across racial and ethnic identities to operate a DPS in the context of PrEP adherence measurement and suggest potential future applications of this technology.

Autonomy support is a concept that is derived from self-determination theory. Autonomy refers to the freedom to act as one chooses. The current study aimed to examine if autonomy support was associated with dried blood spot validated pre-exposure prophylaxis (PrEP) adherence, and whether the association was mediated by PrEP adherence goal setting and progress toward PrEP adherence goals. Our sample was drawn from Black men who have sex with men (MSM) from across three cities (Chapel Hill, NC; Los Angeles, CA; and Washington, DC) in the United States between February 2013 and September 2014. We used logistic regression to evaluate associations between study variables and path analysis to test mediation effects. Participants were, on average, 28 [standard deviation ( SD ) = 1.12] years old and 25% were unemployed. We found that MSM who experienced high autonomy support were more likely to adhere to PrEP [odds ratio (OR) = 1.17; 95% confidence interval: 1.00-1.38]. MSM who set PrEP adherence goals were more likely to adhere to PrEP. Moreover, MSM who reported making progress toward their goals were also more likely to adhere to PrEP. Finally, client perception of coordination quality enhanced the magnitude of the association between goal setting and goal progress and the effect size of goal progress on PrEP adherence. Autonomy support, goal setting, goal monitoring/evaluation, and care coordination quality influenced PrEP adherence among Black MSM. Our findings indicate that while it is important to set goals for PrEP adherence, goal setting may need to be accompanied by progress monitoring to achieve the maximal effect.

Transgender and gender diverse (TGD) populations experience health disparities due to societal stigma that increases TGD individuals' sources of stress and decreases access to health protective resources. Research has linked experiences of stigma to risky alcohol use, yet there remains a dearth of culturally sensitive alcohol use interventions that meet the needs of TGD people. The present study was conducted to inform modifications to the content and delivery of an existing brief, telehealth, motivational intervention to decrease at-risk alcohol use among TGD adults. Individual semi-structured in-depth qualitative interviews were conducted with TGD adults who reported recent alcohol use ( n = 18) to explore factors that facilitate positive interactions with health care providers and identify relevant information for alcohol use disorder treatment. Participants were recruited from an LGBTQ +-focused health center in Los Angeles, California. Two major themes and recommendations emerged: (a) A multicultural orientation of humility is important to develop productive therapeutic relationships with TGD clients when delivering motivational interviewing; (b) Due to insufficient appropriate data on alcohol use and health in TGD populations, feedback used in motivational alcohol counseling needs to be modified to better serve TGD clients. These findings show that counselors' philosophy and behavior, as well as session content, need to be considered when working with TGD populations within the context of alcohol counseling. These findings also have implications for intervention development, clinical treatment, and future research. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background: Prior research has found a high prevalence of childhood sexual abuse (CSA) among sexual minority men (SMM) in the US, and has indicated that CSA is associated with higher rates of alcohol and drug use disorders. However, most of these studies have focused almost exclusively on White SMM. We assessed associations of CSA, alcohol use, and drug use problems among adult Black SMM., Methods: Participants were 1,016 Black SMM recruited from six US cities (Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC) between July 2009 and December 2011. We used hierarchical logistic regression to evaluate the associations between CSA, alcohol use problems (≥ 8 AUDIT), and drug use problems (excluding marijuana)., Results: Mean (SD) age was 37.8 (11.7) years, and 28.6% and 49.2% reported alcohol and drug use disorders in the past six months, respectively. Most of the study participants reported history of CSA (70.3%). Adjusting for sociodemographic and confounding variables, CSA was associated with higher odds of alcohol use problems (odds ratio (OR) = 1.52, 95% CI 1.09, 2.12) and drug use problems (OR = 1.58, 95% CI 1.19, 2.10) than non-CSA group., Conclusion: Prevalence of CSA is high among BSMM in the US and is positively associated with alcohol and drug use problems. Substance use interventions should address the psychological health needs of BSMM with a history of CSA., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Shangani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

PrEP uptake and adherence among young Black sexual minority men (YBSMM), has been sub-optimal. Multiple studies identified sleep as an important determinant of medication adherence, although it has not been examined with regard to PrEP among YBSMM. This study utilized data collected from HIV-negative cisgender YBSMM in the Neighborhoods and Networks (N2) study in Chicago using PrEP (N = 70). Sleep quality was measured using the PHQ-9 and PrEP adherence questions were adapted from Reynolds et al., 2004. Bivariate and multivariable regression analyses were used to estimate associations between sleep and missing PrEP doses, controlling for relevant demographic and behavioral factors. YBSMM who reported sleep disturbance a moderate amount of time (aOR 7.59 [1.05 to 54.57]) were more likely to miss taking PrEP because they had too many pills to take. Sleep quality is an overlooked determinant of medication adherence, and may negatively impact YBSMM's ability to consistently take PrEP., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Prior research has attributed mental health disparities between marginalized and non-marginalized populations to socioeconomic differences (i.e., education, income, employment), stigma (e.g., HIV-related discrimination), and cognitive appraisal (i.e., optimism, hostility, satisfaction with life), but the relations among these variables have not been examined concomitantly. The current study utilized structural equation modeling to examine how race and socioeconomic status impact mental health outcomes through increased exposure to stigma and more negative cognitive appraisals. Data came from a randomized controlled trial of motivational interviewing to address heavy drinking in cisgender men with HIV who have sex with men (n = 180). We found that self-reported discrimination experiences related to race/ethnicity, sexual orientation, and HIV status significantly mediated the relation between socioeconomic status and mental health concerns, whereas cognitive appraisal did not. These findings suggest that, among heavy drinking men with HIV who have sex with men, having low socioeconomic resources may increase exposure to discrimination which, in turn, may worsen mental health. Interventions that address social determinants, like socioeconomic disadvantage, and that enhance coping resources related to stigma, may have positive effects on mental health.ClinicalTrials.gov Identifier NCT01328743. Date of Registration 09/09/2019., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Direct-acting antivirals (DAA) are highly effective against hepatitis C virus (HCV) infection among persons with human immunodeficiency virus (PWH). However, alcohol use post-DAA treatment poses a continued threat to the liver. Whether the focus on liver health alone during HCV treatment can impact alcohol consumption is unclear. Therefore, we examined the change in alcohol use among HCV-coinfected PWH who received DAA therapy by non-addiction medical providers., Methods: In our longitudinal clinical cohort study, we identified HCV-coinfected PWH who received interferon-free DAA therapy between January 2014 and June 2019 in the Centers for AIDS Research Network of Integrated Clinical Systems. The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) was the alcohol screening instrument. We used mixed-effects logistic regression models to estimate the longitudinal change in alcohol use upon DAA therapy., Results: Among 738 HCV-coinfected PWH, 339 (46 %) reported any alcohol use at the end of HCV treatment, including 113 (15 %) with high-risk use (i.e., AUDIT-C ≥3 for women, ≥4 for men). Concurrently, 280 (38 %) PWH noted active drug use, and 357 (48 %) were currently smoking. We observed no changes in the odds of any alcohol or high-risk alcohol use over time with DAA therapy. Findings were similar in the PWH subgroup with a history of alcohol use before DAA treatment., Conclusions: For PWH with HCV, alcohol use did not change following interferon-free DAA treatment by non-addiction medical providers. Thus, clinicians should consider integrating targeted alcohol use interventions into HCV care to motivate reduced alcohol consumption and safeguard future liver health., Competing Interests: Conflict of interest disclosures Po-Hung Chen reports serving as a Medical Safety Officer for the Non-Alcoholic Steatohepatitis Clinical Research Network, a Steering Committee member for the Alcohol-associated Liver Disease Special Interest Group of the American Association for the Study of Liver Diseases (AASLD), and a Practice Guidelines Committee member of AASLD. Edward R. Cachay reports receiving Gilead Sciences Unrestricted Research Grant, Merck Sharp & Dohme Unrestricted Research Grant, and consulting for Thera Technologies. H. Nina Kim reports receiving a grant from Gilead Sciences., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Young men who have sex with men (YMSM) remain at disproportionate risk for HIV acquisition in the United States (US), yet use of evidence-based prevention strategies, including routine HIV testing and pre-exposure prophylaxis (PrEP), remain low. Smartphones and mobile app usage are nearly ubiquitous in this population. Given the potential for scalability, a mobile app to increase HIV testing and PrEP use among YMSM has the potential to make an extraordinary public health impact if efficacious. Based on extensive formative, community-engaged research, we developed a theory-driven mobile app-MyChoices-to increase HIV testing and PrEP uptake among YMSM. In a pilot randomized controlled trial (RCT), participants (n = 60) were randomized 2:1 to receive MyChoices or standard of care (SOC). Data from 3 to 6-month post-baseline assessments demonstrate that the app was highly acceptable (System Usability Score; mean = 75.8, SD = 10.7) and feasible (94% used the MyChoices app at least once; mean = 15.3 sessions, SD = 9.8). While not powered to assess efficacy, those in the MyChoices arm had 22% higher prevalence of HIV testing over follow-up compared to those in the SOC arm (NS). There was no difference in PrEP uptake. A fully-powered efficacy trial is warranted; if efficacy is demonstrated, the MyChoices app could be easily scaled to reach YMSM across the US., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Healthcare providers who use controlling or coercive strategies may compel short-term enactment of HIV and sexually transmitted infection prevention behaviors but may inadvertently undermine their client's motivation to maintain those behaviors in the absence of external pressure. Autonomous motivation refers to the self-emanating and self-determined drive for engaging in health behaviors. It is associated with long-term maintenance of health behaviors. We used structural equation modeling to investigate whether autonomy support was associated with increased odds of therapeutic serum levels of pre-exposure prophylaxis, through a pathway that satisfies basic psychological needs for autonomous self-regulation and competence regarding pre-exposure prophylaxis use. We also investigated whether autonomy support was associated with decreased odds of condomless anal intercourse via the same psychological needs-satisfaction pathway of autonomous self-regulation and competence regarding condom use. We tested these two theorized pathways using secondary data from a longitudinal sample of Black men who have sex with men from across three cities in the US (N = 226). Data from the sample fit the theorized models regarding the pathways by which autonomy support leads to the presence of therapeutic PrEP levels in serum (χ 2  = 0.56; RMSEA = 0.04; CFI = .99, TLI = 0.98) and how it also leads to decreased odds of condomless anal intercourse (χ 2  = 0.58; RMSEA = 0.03; CFI = 0.99; TLI = 0.98). These findings provide scientific evidence for the utility of self-determination theory as a model to guide intervention approaches to optimize the implementation and impact of PrEP for Black men who have sex with men., (© 2022. The New York Academy of Medicine.)

HPTN 069/ACTG 5305 was designed to evaluate potential new PrEP regimens that included maraviroc, tenofovir disoproxil fumarate, and/or emtricitabine. The current analyses assessed antiretroviral (ARV) plasma concentrations in relation to sexual behavior in 224 cisgender men who have sex with men and 2 transgender women at risk for HIV. Poisson generalized estimating equations (GEE) regression were used to test for associations between self-reported sexual behavior, sociodemographic, behavioral variables, and study drug levels The median (IQR) age was 30 [25, 37] years old; 48.2% had completed college; 27.4% were Black and 21.7% Latino. At weeks 24 and 48, one third of participants reported condomless anal sex (CAS) in the prior month with more than one partner. CAS was associated with daily ARV drug use (χ 2  = 12.64, p = 0.002). Older individuals and those with greater education were more likely to ingest ARV drugs daily (χ 2  = 9.36, p = 0.009 and χ 2  = 8.63, p = 0.013, respectively), while neither race nor ethnicity was associated with daily ARV drug use. Participants who reported recent condomless anal sex and/or advanced education had higher rates of daily ARV drug use. These data support the need for ongoing adherence counseling in clinical trials of new PrEP modalities., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: This study was conducted to characterize documentation of sexual orientation and gender identity (SOGI) and provision of screening and preventive services in a diverse sample of community health centers (CHCs). Methods: Twelve CHCs provided data submitted to the Health Resources and Services Administration (HRSA) in 2018 from their Uniform Data System (UDS) reports. Prevalence of SOGI documentation, screenings, and preventive services were calculated. Sociodemographic correlates of documentation were analyzed using Fisher's exact test and Wilcoxon rank sum/Mann-Whitney U test. Results: Patient data recording sexual orientation (SO) were missing in 2%-93% of UDS reports from the 12 CHCs, and gender identity (GI) data were missing from 0% to 96% of UDS reports. CHCs were most likely to report body mass index and tobacco screening and least likely to report hepatitis A or B vaccination, independent of SO or GI. Transgender females were less likely to have mammography documented than cisgender females. Transgender males were less likely to have anal Pap tests, be vaccinated for hepatitis B, or be referred for risky alcohol use compared to cisgender males. Patients who identified as "another gender" were less likely to be referred for risky alcohol use, undergo mammography or anal Pap testing, or receive hepatitis A vaccination than cisgender people. Individuals who did not disclose their GI were less likely to be vaccinated for hepatitis A or B than cisgender people. Conclusion: SOGI status was often not documented by a diverse array of CHCs. However, when SOGI status was documented, we saw evidence of disparities in preventive interventions and referrals, particularly for transgender patients. Clinical trial registration number: NCT03554785.