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Background: The US Centers for Disease Control and Prevention recommends HIV testing every 3 months in oral PrEP users. We performed a national assessment of HIV testing compliance among oral PrEP users., Methods: We analyzed 408 910 PrEP prescriptions issued to 39 809 PrEP users using a national insurance claims database that contained commercial and Medicaid claims. We identified PrEP use based on pharmacy claims and outpatient diagnostic coding. We evaluated the percentage of PrEP prescription refills without HIV testing (identified by CPT codes) within the prior 3, 6, and 12 months using time to event methods. We performed subgroup and multivariate analyses by age, gender, race, insurance type, and geography., Results: Of 39 809 persons, 36 197 were commercially insured, 3612 were Medicaid-insured, and 96% identified as male; the median age (interquartile range) was 34 (29-44) years, and the Medicaid-insured PrEP users were 24% Black/African American, 44% White, and 9% Hispanic/Latinx. Within the prior 3, 6, and 12 months, respectively, the percentage of PrEP prescription fills in individuals without HIV Ag/Ab testing was 34.3% (95% CI, 34.2%-34.5%), 23.8% (95% CI, 23.7%-23.9%), and 16.6% (95% CI, 16.4%-16.7%), and the percentage without any type of HIV test was 25.8% (95% CI, 25.6%-25.9%), 14.6% (95% CI, 14.5%-14.7%), and 7.8% (95% CI, 7.7%-7.9%)., Conclusions: Approximately 1 in 3 oral PrEP prescriptions were filled in persons who had not received an HIV Ag/Ab test within the prior 3 months, with evidence of health disparities. These findings inform clinical PrEP monitoring efforts and compliance with national HIV testing guidance to monitor PrEP users., Competing Interests: Potential conflicts of interest. Jason Baron, MD, Tamar Tchelidze, MD, MPH, Ben La Brot, MD, and Nicole Robinson, PhD, are employees of Roche Diagnostics, receiving employee compensation that in some cases may include equity awards. In addition to his role at Roche, Dr. Baron has a part-time research faculty position at the Massachusetts General Hospital; Dr. Baron worked on this paper solely in his capacity as a Roche employee. Drs. Yao, Mayer, Kuritzkes, and Patel had previously received consulting honoraria from Roche but were not paid for work on this study. Dr. Yao has also received research support from Roche not connected to this study. Additional disclosures are as follows. Dr. Mayer: research support paid to institution from Gilead Sciences, Merck Inc., GlaxoSmithKlein, and Moderna and scientific advisory boards for Gilead Sciences and Merck Inc. Dr. Patel: ViiV Healthcare. Dr. Kuritzkes: consulting honoraria and/or research support from AbbVie, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, and ViiV. All other authors report no potential conflicts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Little is known about biopsychosocial factors relating to pre-exposure prophylaxis (PrEP) awareness among people with either heterosexual or injection drug use HIV risk behaviors. Participants engaged in vaginal/anal sex with a person of the opposite sex ( N = 515) or were people who injected drugs (PWID; N = 451) in the past 12 months from 2018-2019 in Boston, MA. We examined associations between PrEP awareness and: homelessness; perceived HIV-related stigma; country of birth; bacterial STDs, chlamydia, and/or gonorrhea in the past 12 months, lifetime hepatitis C virus (HCV) infection, sexual orientation, and poverty. More PWID (36.8%) were aware of PrEP than people with heterosexual HIV risk (28%; p = .001). Among people with heterosexual risk, homelessness (aOR = 1.99, p = .003), and among PWID: homelessness (aOR = 2.11, p = .032); bacterial STD (aOR = 2.96, p = .012); chlamydia (aOR = 6.14, p = .008); and HCV (aOR = 2.40, p < .001) were associated with increased likelihood of PrEP awareness. In the combined sample: homelessness (aOR = 2.25, p < .001); HCV (aOR = 2.18, p < .001); identifying as homosexual (aOR = 3.71, p = .036); and bisexual (aOR = 1.55, p = .016) were each associated with PrEP awareness. Although having an STD, HCV, identifying as homosexual or bisexual, and experiencing homelessness were associated with increased PrEP awareness, most participants were unaware of PrEP. Efforts to increase PrEP awareness could engage PWID and heterosexual HIV risk behavior.

The 2022 mpox (formerly monkeypox) outbreak affected predominantly men who have sex with men (MSM), likely through sexual transmission, which resulted in institutions specializing in sexual health being at the frontlines of the mpox outbreak. Fenway Health in Boston serves close to 10 000 MSM annually, which includes more than 2400 MSM who are living with HIV and 3320 MSM with active HIV preexposure prophylaxis (PrEP) prescriptions. We report on the programs implemented and changes to clinical practice at Fenway Health during the mpox outbreak. Fenway Health diagnosed its first case of mpox in June 2022 and treated this patient with tecovirimat. In early July 2022, Fenway Health administered its first dose of the Jynneos vaccine under the Emergency Use Authorization for protection against mpox. As of October 6, 2022, 69 people had tested positive for the mpox virus at Fenway Health. Among the 69 people who tested positive, 43 (62.3%) self-identified as male, with the remaining not reporting a sex or gender identity, and 40 (58.0%) reported their sexual orientation as gay or bisexual. Twenty-five people (36.2%) were treated with tecovirimat. As of October 30, 2022, Fenway Health had administered 6376 doses of the Jynneos vaccine. The programmatic changes involved in rollout and scale-up of vaccination, treatment, and community outreach services at Fenway Health during the 2022 mpox outbreak that we describe here could inform strategies to address subsequent outbreaks., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

In a nationwide sample of cisgender Black women in the US, we assessed the associations between social and structural factors and interest in using HIV preexposure prophylaxis (PrEP). Among 315 respondents, 62.2% were interested in PrEP if it were provided for free. Positive social norms surrounding PrEP, including injunctive norms (perceived social acceptability of PrEP use) and descriptive norms (perceived commonality of PrEP use), were positively associated with interest in using PrEP. Concerns about HIV infection, recently visiting a health care provider, and comfort discussing PrEP with a provider were also positively associated with interest in using PrEP. Anticipating PrEP disapproval from others was negatively associated with interest in PrEP. Although PrEP can promote autonomy and personal discretion, Black women's PrEP-related decisions occur in a complex social environment. Black women may benefit from interventions to promote positive norms and attitudes surrounding PrEP at the community level and empower them in discussions with their providers about PrEP.

Alcohol use was associated with elevated COVID-19 risk in the general population. People with HIV (PWH) have high prevalences of alcohol use. To evaluate the effect of alcohol use on COVID-19 risks among PWH, we estimated the risk of COVID-19 diagnosis and COVID-19-related hospitalization among PWH in routine care at 8 HIV primary care centers that contributed data to the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort according to their alcohol use just prior to the COVID-19 pandemic. The CNICS data repository includes demographic characteristics, clinical diagnoses, and laboratory test results from electronic medical records and other sources. Alcohol use, substance use, and mental health symptoms were self-reported on tablet-based standardized surveys. Alcohol use was categorized according to standard, sex-specific Alcohol Use Disorder Identification Test-Consumption instrument cut-offs. We followed 5,496 PWH (79% male, 48% Black race, median age = 53 years) from March 1, 2020 to December 31, 2020. Relative to PWH with no baseline alcohol use, the adjusted hazard ratio (aHR) of COVID-19 diagnosis was 1.09 (95% confidence interval [CI]: 0.78, 1.51) for lower-risk drinking and 1.19 (95%CI: 0.81, 1.73) for unhealthy drinking. The aHR of COVID-19-related hospitalization was 0.82 (95%CI: 0.33, 1.99) for lower-risk drinking and 1.25 (95%CI: 0.50, 3.09) for unhealthy drinking. Results were not modified by recent cocaine or non-prescribed opioid use, depressive symptoms, or diagnoses of alcohol use disorder. The study suggested a slightly increased, but not statistically significant risk of COVID-19 diagnosis and hospitalization associated with unhealthy alcohol use., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Transgender and gender diverse (TGD) adults in the U.S. experience health disparities, including in anogenital sexually transmitted infections (STI). Gender-affirming hormone therapy (GAHT) is known to be medically necessary and improve health. Few studies have assessed the effect of GAHT on STI diagnoses., Objective: To evaluate the effect of GAHT delivered in primary care as an intervention to improve STI outcomes for TGD adults., Design: LEGACY is a longitudinal, multisite cohort study of adult TGD primary care patients from two federally qualified community health centers in Boston, MA, and New York, NY., Participants: Electronic health record data for eligible adult TGD patients contributed to the LEGACY research data warehouse (RDW). A total of 6330 LEGACY RDW patients were followed from 2016 to 2019, with 2555 patients providing STI testing data., Main Measures: GAHT exposure was being prescribed hormones, and the clinical outcome was anogenital gonorrhea or chlamydia diagnoses. Log-Poisson generalized estimating equations assessed the effect of prescription GAHT on primary outcomes, adjusting for age, race, ethnicity, gender identity, poverty level, health insurance, clinical site, and cohort years., Key Results: The median age was 28 years (IQR = 13); the racial breakdown was 20.4% Black, 8.1% Multiracial, 6.9% Asian/Pacific Islander, 1.8% Other; 62.8% White; 21.3% Hispanic/Latinx; 47.0% were assigned female at birth, and 16.0% identified as nonbinary. 86.3% were prescribed hormones. Among those tested, the percentage of patients with a positive anogenital STI diagnosis ranged annually from 10.0 to 12.5% between 2016 and 2019. GAHT prescription was associated with a significant reduction in the risk of anogenital STI diagnosis (aRR = 0.75; 95% CI = 0.59-0.96) over follow-up., Conclusions: GAHT delivered in primary care was associated with less STI morbidity in this TGD cohort over follow-up. Patients may benefit from individualized and tailored clinical care alongside GAHT to optimize STI outcomes., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: An effective HIV vaccine will most likely need to have potent immunogenicity and broad cross-subtype coverage. The aim of the HIV Vaccine Trials Network (HVTN) 124 was to evaluate safety and immunogenicity of a unique polyvalent DNA-protein HIV vaccine with matching envelope (Env) immunogens., Methods: HVTN 124 was a randomised, phase 1, placebo-controlled, double-blind study, including participants who were HIV seronegative and aged 18-50 years at low risk for infection. The DNA vaccine comprised five plasmids: four copies expressing Env gp120 (clades A, B, C, and AE) and one gag p55 (clade C). The protein vaccine included four DNA vaccine-matched GLA-SE-adjuvanted recombinant gp120 proteins. Participants were enrolled across six clinical sites in the USA and were randomly assigned to placebo or one of two vaccine groups (ie, prime-boost or coadministration) in a 5:1 ratio in part A and a 7:1 ratio in part B. Vaccines were delivered via intramuscular needle injection. The primary outcomes were safety and tolerability, assessed via frequency, severity, and attributability of local and systemic reactogenicity and adverse events, laboratory safety measures, and early discontinuations. Part A evaluated safety. Part B evaluated safety and immunogenicity of two regimens: DNA prime (administered at months 0, 1, and 3) with protein boost (months 6 and 8), and DNA-protein coadministration (months 0, 1, 3, 6, and 8). All randomly assigned participants who received at least one dose were included in the safety analysis. The study is registered with ClinicalTrials.gov (NCT03409276) and is closed to new participants., Findings: Between April 19, 2018 and Feb 13, 2019, 60 participants (12 in part A [five men and seven women] and 48 in part B [21 men and 27 women]) were enrolled. All 60 participants received at least one dose, and 14 did not complete follow-up (six of 21 in the prime-boost group and eight of 21 in the coadminstration group). 11 clinical adverse events deemed by investigators as study-related occurred in seven of 48 participants in part B (eight of 21 in the prime-boost group and three of 21 in the coadministration group). Local reactogenicity in the vaccine groups was common, but the frequency and severity of reactogenicity signs or symptoms did not differ between the prime-boost and coadministration groups (eg, 20 [95%] of 21 in the prime-boost group vs 21 [100%] of 21 in the coadministration group had either local pain or tenderness of any severity [p=1·00], and seven [33%] vs nine [43%] had either erythema or induration [p=0·97]), nor did laboratory safety measures. There were no delayed-type hypersensitivity reactions or vasculitis or any severe clinical adverse events related to vaccination. The most frequently reported systemic reactogenicity symptoms in the active vaccine groups were malaise or fatigue (five [50%] of ten in part A and 17 [81%] of 21 in the prime-boost group vs 15 [71%] of 21 in the coadministration group in part B), headache (five [50%] and 18 [86%] vs 12 [57%]), and myalgia (four [40%] and 13 [62%] vs ten [48%]), mostly of mild or moderate severity., Interpretation: Both vaccine regimens were safe, warranting evaluation in larger trials., Funding: US National Institutes of Health and US National Institute of Allergy and Infectious Diseases., Competing Interests: Declaration of interests IF, NG, KES, JRH, SE, SCDR, DEM, DCM, GDT, LC, and SL report support for the present manuscript from National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS, and the HIV Vaccine Trials Network (HVTN) paid to their institutions. SCDR and DEM report support for the present manuscript from the Bill & Melinda Gates Foundation, and grants or contracts outside of the submitted work from Janssen, Sanofi, and Moderna. IF reports grants or contracts outside of the submitted work from Janssen, Gilead, Moderna, Pfizer, and Sanofi paid to his institution, consulting fees from Gilead and ViiV, and participation or payment from Janssen for participation on a data safety monitoring board or advisory board. JRH reports support for attending meetings or travel from the HVTN. MCK reports grants or contracts from NIAID outside of the submitted work and participation on a data safety monitoring board or advisory board for the Worcester HIV Vaccine. SL reports royalties or licences from Cosmic Bliss Sciences related to polyvalent DNA–protein HIV vaccine IP from the University of Massachusetts Medical School, Worcester, MA, USA, and reports stock ownership of Cosmic Bliss Sciences since 2023. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Substance use in people with HIV (PWH) negatively impacts antiretroviral therapy (ART) adherence. However, less is known about this in the current treatment era and the impact of specific substances or severity of substance use. We examined the associations of alcohol, marijuana, and illicit drug use (methamphetamine/crystal, cocaine/crack, illicit opioids/heroin) and their severity of use with adherence using multivariable linear regression in adult PWH in care between 2016 and 2020 at 8 sites across the US. PWH completed assessments of alcohol use severity (AUDIT-C), drug use severity (modified ASSIST), and ART adherence (visual analogue scale). Among 9400 PWH, 16% reported current hazardous alcohol use, 31% current marijuana use, and 15% current use of ≥1 illicit drugs. In multivariable analysis, current methamphetamine/crystal use, particularly common among men who had sex with men, was associated with 10.1% lower mean ART adherence ( p  < 0.001) and 2.6% lower adherence per 5-point higher severity of use (ASSIST score) ( p  < 0.001). Current and more severe use of alcohol, marijuana, and other illicit drugs were also associated with lower adherence in a dose-dependent manner. In the current HIV treatment era, individualized substance use treatment, especially for methamphetamine/crystal, and ART adherence should be prioritized.

Background: Black sexual minority men and Black transgender women (BSMM/BTW) experience disproportionate levels of HIV/STI-related risk factors as well as police harassment (PH). PH is linked to psychiatric risk and could play a role in substance use, sexual risk behavior, and HIV/STI risk., Methods: We used data from the HIV Prevention Trials Network 061(HPTN 061) study to examine associations between PH and HIV/STI-related outcomes. Using PH exposure measured at baseline and 6-month study visits, we examined an ordinal exposure (PH reported at both visits, PH reported at either visit, versus PH reported at neither baseline nor 6 months) and a binary exposure of persistent PH reported at both visits (yes versus no). We estimate risk ratios (RR) for associations between PH and depression, use of alcohol and methamphetamine, multiple partnerships, condomless sex, and syphilis., Results: Persistent PH (binary) was associated with a 20% or greater increase in the risk of depression (RR, 1.26 (1.07, 1.47)) and multiple partnerships (RR, 1.20 (1.05, 1.39)). There was evidence that ordinal PH was associated with elevated risk of alcohol use (RR, 1.17 (1.00, 1.36)); the point estimate for the association between persistent PH and alcohol use was similar but the imprecision was greater (RR, 1.16 (0.95, 1.42))., Conclusion: PH may influence not only mental health but also behavioral risks that contribute to HIV/STI among BSMM/BTW, highlighting the potential wide-ranging and downstream effects of PH on health. Further research is required to confirm associations and elucidate pathways through which PH may influence HIV/STI among BSMM/BTW., (© 2024. W. Montague Cobb-NMA Health Institute.)

We examined changes in the proportion of people with human immunodeficiency virus (PWH) with virologic suppression (VS) in a multisite US cohort before and since the coronavirus disease 2019 (COVID-19) pandemic. Overall, prior gains in VS slowed during COVID-19, with disproportionate impacts on Black PWH and PWH who inject drugs., Competing Interests: Potential conflicts of interest. M. A. S., D. V. G., M. O. J., K. A. C., K. H. M., A. E. S., M. G., and G. B. report institutional funding from the NIH during conduct of the study. M. A. S. and K. H. M. report investigator-initiated grant support from Gilead Sciences. E. R. C. reports institutional grants or contracts from Gilead Science for unrelated research and consulting fees from Theratechnologies for 1-time advisory board participation. K. A. C. and K. H. M. report serving as medical advisory board members for Gilead Sciences. K. A. C. reports payment or honoraria for educational events as a workshop participant from Janssen. D. V. G. reports personal consulting fees from Gilead Sciences outside the submitted work. H. M. C. reports institutional grants from the Agency for Healthcare Research and Quality and ViiV; consulting fees on patient-reported outcomes from ViiV (not relevant to this work); previous participation on a Gilead advisory board; and a previous, unpaid position on the NIH’s Office of AIDS Research Advisory Council. A. E. S. reports institutional funding grants for coronavirus disease 2019 therapy clinical trials from Vir Biotechnology; travel support from the Infectious Diseases Society of America Foundation; and participation on a data and safety monitoring board for Datura Trial with French National Agency for Research on AIDS and Viral Hepatitis/European and Developing Countries Clinical Trials Partnership. M. A. S. reports royalties or licenses for a chapter on human immunodeficiency virus Current Medical Diagnosis and Treatment chapter from McGraw Hill and payment or honoraria for role as editor for the Johns Hopkins eHIV Review. 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.)

Background: Black sexual minority men (BSMM) are disproportionately vulnerable to HIV acquisition; the MPowerment model is one community-based framework for preventing HIV in this population. It focuses on developing a supportive network of peers to promote health messaging, reduce stigma, and improve resilience. While these interventions have demonstrated general success, there are important challenges related to race, sexuality, and internalized stigma. Our study aimed to explore these experiences among BSMM in MPowerment models focused on HIV prevention., Method: We conducted 24 qualitative interviews of BSMM attending HIV prevention-related MPowerment events in the greater D.C. Metropolitan area. In-depth interviews were conducted via phone, and interviews were analyzed using thematic analysis., Results: We identified four themes from the transcript analysis process: Black queer intersectional social support and community, HIV-related information and destigmatization, social status, and sexuality. Within each of these themes, we identified relationships with overall HIV prevention messaging, including barriers to PrEP use. Barriers related to social status were especially prevalent and described as unique to the D.C. metropolitan area., Conclusion: Overall, MPowerment event spaces provide a forum for BSMM to feel safe and supported while gaining important HIV-related knowledge and prevention access. Challenges related to social status and destigmatization of sexuality are important considerations in designing and implementing this model, especially related to PrEP promotion., (© 2024. The Author(s).)

Objective: There is limited real-world evidence about the effectiveness of semaglutide for weight loss among people with HIV (PWH). We aimed to investigate weight change in a US cohort of PWH who initiated semaglutide treatment., Design: Observational study using the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort., Methods: We identified adult PWH who initiated semaglutide between 2018 and 2022 and with at least two weight measurements. The primary outcome was within-person bodyweight change in kilograms at 1 year. The secondary outcome was within-person Hemoglobin A1c percentage (HbA1c) change. Both outcomes were estimated using multivariable linear mixed model., Results: In total, 222 new users of semaglutide met inclusion criteria. Mean follow-up was 1.1 years. Approximately 75% of new semaglutide users were men, and at baseline, mean age was 53 years [standard deviation (SD): 10], average weight was 108 kg (SD: 23), mean BMI was 35.5 kg/m 2 , mean HbA1c was 7.7% and 77% had clinically recognized diabetes. At baseline, 97% were on ART and 89% were virally suppressed (viral load < 50 copies/ml). In the adjusted mixed model analysis, treatment with semaglutide was associated with an average weight loss of 6.47 kg at 1 year (95% CI -7.67 to -5.18) and with a reduction in HbA1c of 1.07% at 1 year (95% CI -1.64 to -0.50) among the 157 PWH with a postindex HbA1c value., Conclusion: Semaglutide was associated with significant weight loss and HbA1c reduction among PWH, comparable to results of previous studies from the general population., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings., Methods: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies., Results: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports., Conclusions: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Objectives: The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers., Design: The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing., Methods: The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP., Results: Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs., Conclusion: Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Sexually transmitted infections (STIs) are commonly encountered in primary care. The Centers for Disease Control and Prevention and the US Preventive Services Task Force have both issued guidelines about screening for chlamydia, gonorrhea, syphilis, and HIV. By eliciting a sexual history, understanding their patients' anatomy, and considering factors which may increase the likelihood of STIs and their sequelae, clinicians can implement a practical, evidence-based approach to STI screening., Competing Interests: Disclosure Dr K.L. Ard has received in-kind research support from Binx Health. Dr K.H. Mayer has received unrestricted research grants from Gilead Sciences, United States, ViiV Healthcare, United Kingdom, and Merck, United States and is on the Scientific Advisory Boards of Gilead Sciences and Merck, Inc related to HIV., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how adherence is communicated by the study staff to trial participants. Increasingly, clinical trials investigating PrEP are creating and implementing 'participant-centered' approaches that discuss potential non-adherence neutrally (without negative judgement) and support efforts to adhere versus insisting on perfect adherence. In the HPTN069/ACTG A5305 study, we evaluated participant experiences of potentially negative adherence-related interactions with study teams using ten items to characterize the frequency of such experiences. We related these individual items and a combined set of seven negative experience items (total negative experience score) to drug concentrations (detectable or consistent with daily-dosing). The exploratory analyses used logistic regression for each experience item on the full sample and disaggregated by sex. Several experiences were related to drug detection and to daily-dosing, although more so for participants identifying as men than women. Total negative experience scores associated with not having detection drug concentrations for the full sample, and remained significant even when controlling for sex, age, and race. Daily dosing was associated with total negative experience score for men in the sample. Additional investigations into adherence-related interactions with study teams that are most problematic or helpful in general and uniquely for men and women are warranted., (© 2023. The Author(s).)

Competing Interests: Conflict of Interest and Sources of Funding: J.S. is a member of Merck KGaA's Ethics Advisory Panel and Stem Cell Research Oversight Committee, a member of IQVIA's Ethics Advisory Panel, and a member of Aspen Neurosciences' Clinical Advisory Panel He was previously a member of a Merck Data Monitoring Committee and a consultant to Biogen. None of these activities are related to the material discussed in this manuscript. Fenway Health is a subrecipient of a grant to Mpact: Global Action for Gay Men's Health and Rights from Glaxo Smith Kline for a research project on knowledge of and attitudes toward hepatitis A and B vaccination among gay and bisexual men and transgender people in the United States and Mexico. S.C. is the principal investigator of this project. S.C. is on the Patient Advocate Steering Committee for Prostate Cancer Clinical Trials for Janssen Global Services representing gay and bisexual men and transgender women. None of these activities are related to the material discussed in this article. C.C. has served as an advisory board member to Gilead Sciences, Merck, and Viiv and an expert witness for Gilead Sciences. None of these activities are related to the material discussed in this article. Stephanie E. Cohen has received laboratory support from Cepheid and Hologic and medication donation from Mayne Pharma, to support the conduct of the DoxyPEP study. A.F.L. has received laboratory support from Cepheid and Hologic and medication donation from Mayne Pharma, to support the conduct of the DoxyPEP study. She has received grant support from Gilead, Merck, and Viiv to UCSF, unrelated to this work. Fenway Health is the recipient of funding from the Centers for Disease Control and Prevention through a subcontract with National Association of County and City Health Officials to assess the roll-out of DoxyPEP. K.H.M. is the subcontract principal investigator. Fenway Health has also received unrestricted research grants from Gilead Sciences and Merck, Inc., and K.H.M. is the principal investigator for those grants. K.H.M. is on scientific advisory boards for Gilead Sciences and Merck, Inc., focusing on HIV prevention. H.A.T.'s effort is funded by the National Institutes of Health Clinical Center, Department of Bioethics.

The prevalence and correlates of food insecurity-the unavailability of food and limited access to it-have not been adequately considered among transgender women (TW), particularly alongside other health-related conditions burdening this population, such as HIV infection. This study examined the prevalence and correlates of food insecurity among TW. Between 2018 and 2020, 1590 TW in the Eastern and Southern U.S. completed a multi-site baseline assessment (socio-behavioral survey and HIV testing). Descriptive statistics were calculated and multivariable Poisson models with robust error variance were used to estimate prevalence ratios and 95% confidence intervals for correlates of food insecurity (dichotomized as sometimes-to-always vs. seldom-to-never running out of food). Eighteen percent of TW were living with HIV and nearly half of participants (44%) reported food insecurity. Correlates of food insecurity included being Black, multiracial, or another race/ethnicity; having < college education, low income, unstable housing, and high anticipated discrimination; and a history of sex work and sexual violence (all p < 0.05). Food insecurity was highly prevalent among TW. Current programs to provide food support do not adequately meet the needs of TW. HIV pr evention and care programs may benefit from addressing food insecurity., Competing Interests: The authors declare no conflicts of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Once-daily oral HIV pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV, but is highly dependent on adherence. Men who have sex with men (MSM) who use substances face unique challenges maintaining PrEP adherence. Digital pill systems (DPS) allow for real-time adherence measurement through ingestible sensors. Integration of DPS technology with other digital health tools, such as digital phenotyping, may improve understanding of nonadherence triggers and development of personalized adherence interventions based on ingestion behavior. This study explored the willingness of MSM with substance use to share digital phenotypic data and interact with ancillary systems in the context of DPS-measured PrEP adherence. Adult MSM on PrEP with substance use were recruited through a social networking app. Participants were introduced to DPS technology and completed an assessment to measure willingness to participate in DPS-based PrEP adherence research, contribute digital phenotyping data, and interact with ancillary systems in the context of DPS-based research. Medical mistrust, daily worry about PrEP adherence, and substance use were also assessed. Participants who identified as cisgender male and were willing to participate in DPS-based research (N = 131) were included in this subsample analysis. Most were White (76.3%) and non-Hispanic (77.9%). Participants who reported daily PrEP adherence worry had 3.7 times greater odds (95% CI: 1.03, 13.4) of willingness to share biometric data via a wearable device paired to the DPS. Participants with daily PrEP adherence worry were more likely to be willing to share smartphone data (p = 0.006) and receive text messages surrounding their daily activities (p = 0.003), compared to those with less worry. MSM with substance use disorder, who worried about PrEP adherence, were willing to use DPS technology and share data required for digital phenotyping in the context of PrEP adherence measurement. Efforts to address medical mistrust can increase advantages of this technology for HIV prevention., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Albrechta 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.)

Background: An increasing number of studies have described new and persistent symptoms and conditions as potential post-acute sequelae of SARS-CoV-2 infection (PASC). However, it remains unclear whether certain symptoms or conditions occur more frequently among persons with SARS-CoV-2 infection compared with those never infected with SARS-CoV-2. We compared the occurrence of specific COVID-associated symptoms and conditions as potential PASC 31- to 150-day following a SARS-CoV-2 test among adults and children with positive and negative test results., Methods: We conducted a retrospective cohort study using electronic health record (EHR) data from 43 PCORnet sites participating in a national COVID-19 surveillance program. This study included 3,091,580 adults (316,249 SARS-CoV-2 positive; 2,775,331 negative) and 675,643 children (62,131 positive; 613,512 negative) who had a SARS-CoV-2 laboratory test during March 1, 2020-May 31, 2021 documented in their EHR. We used logistic regression to calculate the odds of having a symptom and Cox models to calculate the risk of having a newly diagnosed condition associated with a SARS-CoV-2 positive test., Results: After adjustment for baseline covariates, hospitalized adults and children with a positive test had increased odds of being diagnosed with ≥ 1 symptom (adults: adjusted odds ratio[aOR], 1.17[95% CI, 1.11-1.23]; children: aOR, 1.18[95% CI, 1.08-1.28]) or shortness of breath (adults: aOR, 1.50[95% CI, 1.38-1.63]; children: aOR, 1.40[95% CI, 1.15-1.70]) 31-150 days following a SARS-CoV-2 test compared with hospitalized individuals with a negative test. Hospitalized adults with a positive test also had increased odds of being diagnosed with ≥ 3 symptoms or fatigue compared with those testing negative. The risks of being newly diagnosed with type 1 or type 2 diabetes (adjusted hazard ratio[aHR], 1.25[95% CI, 1.17-1.33]), hematologic disorders (aHR, 1.19[95% CI, 1.11-1.28]), or respiratory disease (aHR, 1.44[95% CI, 1.30-1.60]) were higher among hospitalized adults with a positive test compared with those with a negative test. Non-hospitalized adults with a positive test also had higher odds or increased risk of being diagnosed with certain symptoms or conditions., Conclusions: Patients with SARS-CoV-2 infection, especially those who were hospitalized, were at higher risk of being diagnosed with certain symptoms and conditions after acute infection., (© 2024. The Author(s).)

The nationwide scale-up of evidence-based and evidence-informed interventions has been widely recognized as a crucial step in ending the HIV epidemic. Although the successful delivery of interventions may involve intensive expert training, technical assistance (TA), and dedicated funding, most organizations attempt to replicate interventions without access to focused expert guidance. Thus, there is a grave need for initiatives that meaningfully address HIV health disparities while addressing these inherent limitations. Here, the Health Resources and Services Administration HIV/AIDS Bureau (HRSA HAB) initiative Using Evidence-Informed Interventions to Improve HIV Health Outcomes among People Living with HIV (E2i) piloted an alternative approach to implementation that de-emphasized expert training to naturalistically simulate the experience of future HIV service organizations with limited access to TA. The E2i approach combined the HAB-adapted Institute for Healthcare Improvement's Breakthrough Series Collaborative Learning Model with HRSA HAB's Implementation Science Framework, to create an innovative multi-tiered system of peer-to-peer learning that was piloted across 11 evidence-informed interventions at 25 Ryan White HIV/AIDS Program sites. Four key types of peer-to-peer learning exchanges (i.e., intervention, site, staff role, and organization specific) took place at biannual peer learning sessions, while quarterly intervention cohort calls and E2i monthly calls with site staff occurred during the action periods between learning sessions. Peer-to-peer learning fostered both experiential learning and community building and allowed site staff to formulate robust site-specific action plans for rapid cycle testing between learning sessions. Strategies that increase the effectiveness of interventions while decreasing TA could provide a blueprint for the rapid uptake and integration of HIV interventions nationwide., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: The study was designed to evaluate whether an educational intervention to train the health center (HC) staff to optimize care for sexual and gender minority (SGM) patients could improve documentation of sexual orientation and gender identity (SOGI) and increase preventive screenings. Methods: Twelve HCs were matched and randomized to either receive a tailored, multicomponent educational intervention or a 1-hour prerecorded webinar. Documentation of SGM status and clinical testing was measured through analysis of data that HCs report annually. Nonparametric statistics were used to assess associations between baseline HC characteristics and outcome measures. Results: The HCs were geographically, racially, and ethnically diverse. In all but one HC, <10% of the patients were identified as SGM. Intervention HCs underwent between 3 and 10 trainings, which were highly acceptable. In 2018, 9 of 12 HCs documented SO and 11 of 12 documented GI for at least 50% of their patients. Five of 6 intervention HCs increased SO documentation by 2020, compared to 3 of 6 control HCs (nonsignificant, NS). Five intervention HCs increased GI documentation, although generally by less than 10%, compared to 2 of the controls (NS). Intervention HCs tended to increase documentation of preventive services more than control HCs, but the changes were NS. Conclusions: An educational intervention designed to train the HC staff to provide culturally responsive services for SGM patients was found to be acceptable, with favorable, but nonsignificant changes. Further refinement of the intervention using a larger sample of HCs might demonstrate the effectiveness of this approach. Clinical trial registration #: NCT03554785.

Background: Transgender women (TW) experience significant inequities in healthcare access and health disparities compared to cisgender populations. Access to non-transition related healthcare is understudied among TW. We aimed to assess the association between access to care and gender minority stress and resilience factors among TW living with and without HIV in eastern and southern United States., Methods: This study was a cross-sectional analysis of baseline data drawn from a cohort of 1613 adult TW from the LITE Study. The cohort permitted participation through two modes: a site-based, technology-enhanced mode and an exclusively online (remote) mode. Exploratory and confirmatory factor analyses determined measurement models for gender minority stress, resilience, and healthcare access. Structural equation modeling was used to assess the relationships between these constructs. Models were evaluated within the overall sample and separately by mode and HIV status., Results: Higher levels of gender minority stress, as measured by anticipated discrimination and non-affirmation were associated with decreased access to healthcare. Among TW living with HIV, higher levels of anticipated discrimination, non-affirmation, and social support were associated with decreased healthcare access. Among TW living without HIV in the site-based mode, resilience was positively associated with positive healthcare experiences and inversely associated with barriers to healthcare access. Among TW living without HIV in the online mode, anticipated discrimination was associated with barriers to healthcare access; resilience was positively associated with positive healthcare experiences and inversely associated with barriers to healthcare access., Conclusions: Gender minority stress was associated with increased barriers to healthcare access among TW in the US, regardless of HIV status. Resilience factors did not mediate this effect. Interventions aiming to increase healthcare access among TW can be aided by efforts to mitigate drivers of gender minority stress and improve patient experiences in healthcare facilities., (© 2024. The Author(s).)

Antiretroviral preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection, but uptake has been limited and inequitable. Although interventions to increase PrEP uptake are being evaluated in clinical trials among men who have sex with men (MSM), those trials cannot evaluate effects on HIV incidence. Estimates from observational studies of the causal effects of PrEP-uptake interventions on HIV incidence can inform decisions about intervention scale-up. We used longitudinal electronic health record data from HIV-negative MSM accessing care at Fenway Health, a community health center in Boston, Massachusetts, from January 2012 through February 2018, with 2 years of follow-up. We considered stochastic interventions that increased the chance of initiating PrEP in several high-priority subgroups. We estimated the effects of these interventions on population-level HIV incidence using a novel inverse-probability weighted estimator of the generalized g-formula, adjusting for baseline and time-varying confounders. Our results suggest that even modest increases in PrEP initiation in high-priority subgroups of MSM could meaningfully reduce HIV incidence in the overall population of MSM. Interventions tailored to Black and Latino MSM should be prioritized to maximize equity and impact., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)

Black men and people belonging to sexual minority groups are disproportionately impacted by criminal legal involvement and sexually transmitted infections (STIs). Traumatic experiences are often associated with later criminal legal involvement, depression symptoms, sexual risk behavior, and STIs. Research on the joint influence of trauma and incarceration on STI risk among racial and/or sexual minority people is limited. This study tested the association between post-traumatic stress disorder (PTSD) symptoms and incarceration on sexual risk behavior and STI among Black sexual minority men, a population that may be at higher risk for contracting STIs. Using data from the HIV Prevention Trials Network 061 Study, a longitudinal study of adult Black sexual minority men in six U.S. cities ( N = 855), we tested associations between past six-month incarceration and subsequent sexual risk behavior, STI, and depression symptoms, for those with and without pre-incarceration PTSD symptoms. PTSD symptoms were elevated among participants who reported Hispanic ethnicity, having sex with both men and women, and previous incarceration. Although there were not significant differences between recent incarceration and sexual risk for those with and without PTSD, incarceration was linked to some sexual risk behaviors regardless of PTSD symptoms. Among people with PTSD symptoms, there was a higher prevalence of sexual risk and depression symptoms, regardless of incarceration. These findings suggest a potentially compounding influence of PTSD symptoms and incarceration on sexual risk and infection among Black sexual minority men.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but its efficacy is dependent on adherence, which can be challenging for men who have sex with men (MSM) with substance use. Digital pill systems (DPS) represent a novel tool for directly measuring adherence through ingestible radiofrequency sensors that confirm ingestions in real-time. We examined operational challenges across two studies involving DPS to measure PrEP adherence. While most participants successfully operated the system, a number of technological and sociobehavioral challenges requiring intervention were identified across both studies. Technological issues were both system- and participant-related, and were primarily addressed with technical updates and participant re-education, while sociobehavioral issues, including health and housing changes and issues with technology access, warranted innovative solutions. Future research leveraging DPS technology should develop robust supportive infrastructure and mitigation procedures to promptly identify and resolve operational issues to optimize the potential benefits of DPS use.

Introduction: Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring., Design/methods: Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress)., Results: The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW., Conclusion: Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts., Clinical Relevance: This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities., (© 2023 The Authors. Journal of Nursing Scholarship published by Wiley Periodicals LLC on behalf of Sigma Theta Tau International.)

Abstract: "Sick quitting," a phenomenon describing reductions in alcohol consumption following poor health, may explain observations that alcohol appears protective for frailty risk. We examined associations between frailty and reductions in drinking frequency among people with HIV (PWH). At six Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) sites between January 2012 and August 2021, we assessed whether frailty, measured through validated modified frailty phenotype, precedes reductions in drinking frequency. We associated time-updated frailty with quitting and reducing frequency of any drinking and heavy episodic drinking (HED), adjusted for demographic and clinical characteristics in Cox models. Among 5,654 PWH reporting drinking, 60% reported >monthly drinking and 18% reported ≥monthly HED. Over an average of 5.4 years, frail PWH had greater probabilities of quitting (HR: 1.56, 95% confidence interval [95% CI] [1.13-2.15]) and reducing (HR: 1.35, 95% CI [1.13-1.62]) drinking frequency, as well as reducing HED frequency (HR: 1.58, 95% CI [1.20-2.09]) versus robust PWH. Sick quitting likely confounds the association between alcohol use and frailty risk, requiring investigation for control., (Copyright © 2024 Association of Nurses in AIDS Care.)

Background: The COVID-19 pandemic has created substantial and profound barriers to several forms of health care engagement. For Black sexual minority men, this may include engagement with pre-exposure prophylaxis (PrEP) to prevent HIV infection, with significant implications for HIV disparities. Our study explored how the COVID-19 pandemic affected Black sexual minority men, with a focus on relationships between COVID-19 and PrEP engagement., Setting: We sampled 24 Black sexual minority men attending HIV prevention-related events in the greater D.C. Metropolitan area (D.C., Maryland, Virginia)., Methods: We conducted qualitative phone interviews among our sample. Questions were primarily focused on the COVID-19 pandemic and how it affected engagement and considerations of PrEP use. Interviews were transcribed and qualitatively analyzed using the 6 stages of thematic analysis., Results: We identified 3 major themes from our thematic analysis: Changes in the health care system, changes in sexual and relationship contexts, and COVID-19 vaccine hesitancy and misinformation. Relationships between COVID-19 vaccine hesitancy and PrEP hesitancy were especially prevalent, with participants describing that COVID-19 hesitancy can directly deter PrEP use through eroding medical trust further., Conclusions: We identified changes in the health care system, sexual and relationship contexts, and COVID-19 vaccine hesitancy as important issues driven by COVID-19 with significant implications for PrEP use. The COVID-19 pandemic has changed the health care and social landscape in profound ways that affect PrEP access, sexual networks, and associated HIV vulnerability. Future research further exploring relationships between specific pandemic stressors and HIV prevention among Black sexual minority men is recommended ., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Transgender women in the United States experience high HIV incidence and suboptimal Pre-exposure prophylaxis (PrEP) engagement. We sought to estimate PrEP initiation and discontinuation rates and characterize PrEP discontinuation experiences among a prospective cohort of transgender women., Methods: Using a sequential, explanatory, mixed-methods design, 1312 transgender women at risk for HIV acquisition were enrolled from March 2018 to August 2020 and followed through July 2022 (median follow-up 24 months; interquartile range 15-36). Cox regression models assessed predictors of initiation and discontinuation. In-depth interviews were conducted among 18 participants, including life history calendars to explore key events and experiences surrounding discontinuations. Qualitative and quantitative data were integrated to generate typologies of discontinuation, inform meta-inferences and facilitate the interpretation of findings., Results: 21.8% (n = 286) of participants reported taking PrEP at one or more study visits while under observation. We observed 139 PrEP initiations over 2127 person-years (6.5 initiations/100 person-years, 95% CI: 5.5-7.7). Predictors of initiation included identifying as Black and PrEP indication. The rate of initiation among those who were PrEP-indicated was 9.6 initiations/100 person-years (132/1372 person-years; 95% CI: 8.1-11.4). We observed 138 PrEP discontinuations over 368 person-years (37.5 discontinuations/100 person-years, 95% CI: 31.7-44.3). Predictors of discontinuation included high school education or less and initiating PrEP for the first time while under observation. Four discontinuation typologies emerged: (1) seroconversion following discontinuation; (2) ongoing HIV acquisition risk following discontinuation; (3) reassessment of HIV/STI prevention strategy following discontinuation; and (4) dynamic PrEP use coinciding with changes in HIV acquisition risk., Conclusions: PrEP initiation rates were low and discontinuation rates were high. Complex motivations to stop using PrEP did not consistently correspond with HIV acquisition risk reduction. Evidence-based interventions to increase PrEP persistence among transgender women with ongoing acquisition risk and provide HIV prevention support for those who discontinue PrEP are necessary to reduce HIV incidence in this population., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Enhanced provider training could improve PrEP access and equity. We conducted a pilot randomized controlled trial comparing (a) a one-hour, group-based provider intervention integrating PrEP and Cultural Competence (PCC) training with (b) a standard HIV continuing medical education session (n = 56). PCC participants favorably rated the intervention and reported increased PrEP knowledge. The PCC intervention increased their confidence performing PrEP-related clinical activities and intention to prescribe PrEP. The percentage of participants discussing PrEP with patients increased marginally in both study conditions. The percentage of participants who prescribed PrEP and self-rated cultural competence did not change in either study condition., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Post-exposure prophylaxis (PEP) to prevent HIV acquisition has been recommended for over three decades, but remains underutilised. Over the past decade, clinical trials have established the safety and tolerability of newer PEP regimens, particularly those containing integrase strand transfer inhibitors (INSTIs) combined with a tenofovir and lamivudine or emtricitabine backbone. Several of these regimens were better tolerated than historical controls. Studies in macaques found that shorter courses of PEP with INSTIs were effective, particularly if dosing occurred close to the time of retroviral exposure. Despite the increase in well tolerated options, PEP seems to be underused globally and links to other prevention services are suboptimal. Interventions to increase provider and community awareness of PEP are needed., Competing Interests: Declaration of interests KHM has previously received unrestricted research grants to his institution from Merck and Gilead Sciences to conduct PEP studies, which are now completed. L-TA-B declares no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Despite their dynamic, socially constructed, and imprecise nature, both race and gender are included in common risk calculators used for clinical decision-making about statin therapy for atherosclerotic cardiovascular disease (ASCVD) prevention., Methods and Materials: We assessed the effect of manipulating six different race-gender categories on ASCVD risk scores among 90 Black transgender women., Results: Risk scores varied by operationalization of race and gender and affected the proportion for whom statins were recommended., Discussion: Race and gender are social constructs underpinning racialized and gendered health inequities. Their rote use in ASCVD risk calculators may reinforce and perpetuate existing inequities., Competing Interests: T.P. and A.L.W. receive research funding from ViiV Healthcare to their research institutes unrelated to this work. C.G.S. receives consulting fees from EverlyWell, L'Oreal, and the Texas Health Institute unrelated to this work., (© Tonia Poteat et al., 2023; Published by Mary Ann Liebert, Inc.)

Intimate partner violence (IPV) can constraint Black women's ability to prioritize and access Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP) services. Recent research has called for the development of trauma-informed PrEP implementation programs to improve the delivery of PrEP to Black cisgender women; however, many PrEP-prescribing settings do not reflect this recommendation. The current study sought to identify key components to develop a trauma-informed PrEP implementation program for Black cisgender women and clinical staff. We conducted focus groups with PrEP-eligible Black cisgender women (February-June 2019), and semi-structured interviews with clinical staff offering HIV prevention and treatment services (October-November 2020) in community healthcare clinics in Mississippi. Seven themes were identified as needed to facilitate integration of trauma-informed approaches into existing PrEP programs, including defining intimate partner violence (IPV), appropriate IPV screening and response, HIV prevention in abusive relationships, staff training needs, and creating supportive clinic environments. PrEP-eligible Black women and clinical staff generally agreed on how to best operationalize IPV screening and response, the importance of trauma-informed staff training, and the need for Black women-specific informational campaigns. However, Black women highlighted the need for providers to discuss HIV prevention in controlling relationships, and to respond to IPV disclosure. HIV pre-exposure prophylaxis has yet to achieve the potential impact observed in trials. Ultimately, realizing the HIV prevention potential of PrEP in the US necessitates centering the perspectives of Black cisgender women and staff to better integrate trauma-informed approaches., Competing Interests: 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., (© 2023 The Authors. Published by Elsevier Inc.)

Background: There is a limited understanding about the impact of spiritual beliefs and activities on HIV seroconversion among black men who have sex with men (BMSM), which we investigate in this study., Setting: United States., Methods: The HIV Prevention Trials Network Study 061 collected demographic and biomedical assessments among BMSM across 6 United States cities for longitudinal analysis. Spiritual beliefs and spiritual activities are constructed composite scales. Bivariate analyses among 894 who provided data at 12-month follow-up compared men who seroconverted to HIV between baseline and 6 months with those who remained uninfected with HIV at 12 months. Cox proportional hazard regression among 944 men tested spiritual beliefs and activities on the longitudinal risk of HIV seroconversion adjusting for age and any sexually transmitted infection (STI)., Results: Among this sample, HIV incidence between baseline and 6 months was 1.69%, (95% confidence intervals [CI]: 1.04 to 2.77). Men who seroconverted to HIV were significantly younger than those who remained uninfected at the 12-month follow-up: (mean age 27, SD = 11 vs 37, SD = 12) and a higher proportion reported any STI (46.67% vs 11.39%, P < 0.01). A one-unit increase in spiritual beliefs was associated with lower hazard rate of seroconverting to HIV at follow-up [adjusted hazard ratio (aHR) = 0.37, 95% CI: = (0.16 to 0.87)]. Religious service attendance and spiritual activities were unrelated to seroconverting., Conclusions: Spirituality is important in the lives of BMSM. Biomedical and behavioral HIV prevention interventions should consider assessing spiritual beliefs in HIV care among BMSM., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Evidence suggests adverse health effects from vaporized nicotine (VN) use, such as electronic "e" cigarettes, and limited efficacy to aid tobacco cessation. People with HIV (PWH) smoke tobacco at higher rates than the general population, with greater morbidity, highlighting the necessity of effective tobacco cessation tools. PWH may be more vulnerable to adverse effects of VN. Using semi-structured 1:1 interviews, we examined health beliefs regarding VN, patterns of use, and perceived effectiveness for tobacco cessation among PWH in HIV care at three geographically diverse U.S. sites. PWH ( n  = 24) had limited understanding of VN product content or health effects, presuming VN less harmful than tobacco cigarettes (TC). VN failed to adequately replicate the psychoactive effects or desired ritual of smoking TC. Concurrent TC use, and continuous VN use throughout the day, was common. Satiety using VN was elusive, and consumption quantity was difficult to track. VN had limited desirability and durability as a TC cessation tool among the interviewed PWH.

Incarceration can lead to different risk behaviors often due to increased distress and disruption of social networks. It is not well known, however, how these associations may differ by age. In this study, we measure age differences in longitudinal associations between incarceration and substance use, sex risk, and sexually transmitted infection (STI) among Black sexual minority men and Black transgender women (BSMM/BTW). We recruited BSMM/BTW from 2009 to 2011 that were part of the HIV Prevention Trials Network 061 study. We compared those less than 30 years old ( n = 375) to those 30 years old or greater ( n = 794) examining substance use, sex risk, and STI infection stratified by age. Logistic regression with inverse probability weighting was used for the statistical analysis. Approximately 59% of the sample reported incarceration history. In adjusted analysis, incarceration was more strongly associated with alcohol use and stimulant use among older individuals as was sexual risk behaviors including buying and selling sex. Concurrent partnerships were associated with the younger age groups. STI incidence was associated with younger individuals while associations with HIV infection were similar for the two age groups. Understanding differences in substance use and STI risk among age cohorts is imperative to the design and implementation of re-entry programs. Younger BSMM/BTW participating in re-entry support programs may benefit in particular from HIV/STI prevention and care efforts, while post-release substance abuse treatment and harm reduction programs should target older individuals with continued substance abuse., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The prevalence of alcohol misuse is high among people with HIV (PWH); however, access to and utilization of evidence-based alcohol misuse interventions remain limited. Telehealth is one treatment approach with the potential for enhancing substance use disorder treatment utilization for PWH served by Federally Qualified Health Centers (FQHCs). However, questions remain regarding barriers to alcohol-focused telehealth service integration and telehealth research in FQHCs. This study employed qualitative methods, guided by the Dynamic Sustainability Framework, to evaluate barriers and cultural factors impacting FQHC telehealth integration. Eighteen qualitative interviews were completed with staff and leaders across four FQHCs. Interviews were analyzed using directed content analysis, and codes were organized into a priori and emergent themes. Key themes included the presence of common workflows for referring clients to substance use disorder treatment; existing research workflows and preferences for active project staff involvement; telehealth barriers including exacerbation of healthcare disparities and high provider turnover; and the importance of cultural humility and telehealth adaptations for sexual, gender, racial and ethnic minority clients. Findings from this study will inform the development of an alcohol-focused telehealth implementation strategy for a Hybrid Type 1 implementation effectiveness trial to enhance FQHC substance use disorder treatment. Trial registration: ClinicalTrials.gov identifier: NCT02563574..

Objectives: The focus of this study was to calculate and contextualize response rates for a community-based study conducted during the COVID-19 pandemic, a topic on which scant data exist, and to share lessons learned from recruiting and enrolling for implementation of future studies., Design: The Life+Health Study, a cross-sectional population-based study designed to advance novel methods to measure and analyze multiple forms of discrimination for population health research., Setting: The study recruited participants from 3 community health centers in Boston, Massachusetts, between May 2020 and July 2022., Participants: A total of 699 adult participants between the ages of 25 and 64 years who were born in the United States and had visited one of the health centers within the last 2 years., Main Outcome Measures: The response rate was calculated as follows: (number of completions + number of dropouts)/(dropouts + enrollments). To contextualize this response rate, we synthesized evidence pertaining to local COVID-19 case counts, sociopolitical events, pandemic-related restrictions and project protocol adjustments, and examples of interactions with patients., Results: Our study had a lower-than-expected response rate (48.4%), with the lowest rates from the community health centers serving primarily low-income patients of color. Completion rates were lower during periods of higher COVID-19 case counts. We describe contextual factors that led to challenges and lessons learned from recruiting during the pandemic, including the impact of US sociopolitical events., Conclusions: The Life+Health Study concluded recruitment during the pandemic with a lower-than-expected response rate, as also reported in 4 other US publications focused on the impact of COVID-19 on response rates in community-based studies. Our results provide an example of the impact of the pandemic and related US sociopolitical events on response rates that can serve as a framework for contextualizing other research conducted during the pandemic and highlight the importance of best practices in research recruitment with underserved populations., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc.)

Introduction: More than 70% of new HIV diagnoses in the United States were among men who have sex with men (MSM) in 2019. Pre-exposure prophylaxis (PrEP) is a transformative innovation for reducing human immunodeficiency virus (HIV) infections. Structural stigma against sexual minorities, including in the form of state-level policies, may affect PrEP implementation. We evaluated whether lower structural stigma reflected by earlier year of state same-sex marriage legalization was associated with increased male PrEP prescriptions and male PrEP-to-need ratio (PnR), a ratio of PrEP prescriptions to new HIV diagnoses., Methods: We used 2012-2019 AIDSVu data on male PrEP prescriptions and male PnR in each US state and year. We used generalized estimating equations to evaluate the relationship between the timing of implementing state same-sex marriage policies and the outcomes of male PrEP prescriptions per 100,000 people and the male PnR. We adjusted for calendar year, Medicaid expansion and the political party of the governor in each state., Results: State implementation of same-sex marriage policies in earlier, relative to later, periods was associated with increases in the rate of male PrEP prescriptions and in the male PnR. Specifically, implementing state same-sex marriage policies between 2004 and 2011 and between 2012 and 2013 were each associated with greater rates of male PrEP prescriptions relative to implementing same-sex marriage policies between 2014 and 2015. Implementing state same-sex marriage policies between 2004 and 2011 as well as between 2012 and 2013 were both significantly associated with a greater male PnR relative to implementing same-sex marriage policies between 2014 and 2015. By 2019, the difference in male PrEP prescriptions was 137.9 (97.3-175.5) per 100,000 in states that implemented same-sex marriage in 2004-2011 and 27.2 (23.3-30.5) per 100,000 in states that implemented same-sex marriage from 2012 to 2013, relative to states that implemented same-sex marriage in 2014-2015., Conclusions: Earlier implementation of state same-sex marriage policies was associated with greater rates of male PrEP prescriptions. Reducing state-level structural stigma may improve HIV prevention among MSM in the United States., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Hepatitis delta virus (HDV) infection increases the risk of liver complications compared to hepatitis B virus (HBV) alone, particularly among persons with human immunodeficiency virus (HIV). However, no studies have evaluated the prevalence or determinants of HDV infection among people with HIV/HBV in the US. We performed a cross-sectional study among adults with HIV/HBV coinfection receiving care at eight sites within the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) between 1996 and 2019. Among patients with available serum/plasma specimens, we selected the first specimen on or after their initial HBV qualifying test. All samples were tested for HDV IgG antibody and HDV RNA. Multivariable log-binomial generalized linear models were used to estimate prevalence ratios (PRs) with 95% CIs of HDV IgG antibody-positivity associated with determinants of interest (age, injection drug use [IDU], high-risk sexual behaviour). Among 597 adults with HIV/HBV coinfection in CNICS and available serum/plasma samples (median age, 43 years; 89.9% male; 52.8% Black; 42.4% White), 24/597 (4.0%; 95% CI, 2.4%-5.6%) were HDV IgG antibody-positive, and 10/596 (1.7%; 95% CI, 0.6%-2.7%) had detectable HDV RNA. In multivariable analysis, IDU was associated with exposure to HDV infection (adjusted PR = 2.50; 95% CI, 1.09-5.74). In conclusion, among a sample of adults with HIV/HBV coinfection in care in the US, 4.0% were HDV IgG antibody-positive, among whom 41.7% had detectable HDV RNA. History of IDU was associated with exposure to HDV infection. These findings emphasize the importance of HDV testing among persons with HIV/HBV coinfection, especially those with a history of IDU., (© 2023 John Wiley & Sons Ltd.)

Objectives: Gender-affirming hormonal therapies (GAHT) and HIV increase cardiovascular risk for transgender women (TW), yet there is a paucity of data quantifying cardiometabolic changes following GAHT initiation, particularly among TW with HIV., Methods: The Féminas study enrolled TW from October 2016 to March 2017 in Lima, Peru. Participants reported sexual activity that was high risk for HIV acquisition or transmission. All were tested for HIV/ sexually transmitted infection and were given access to GAHT (oestradiol valerate and spironolactone), HIV pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) for 12 months. Biomarker measurement was done on stored serum, whereas fasting glucose and lipids were measured in real time., Results: In all, 170 TW (32 with HIV, 138 without HIV) had median age 27 years and 70% prior GAHT use. At baseline, PCSK9, sCD14, sCD163, IL-6, sTNFRI/II, CRP and EN-RAGE levels were significantly higher in TW with HIV than in TW without HIV. High-density lipoprotein and total cholesterol were lower and insulin and glucose parameters were similar. All TW with HIV started ART, but only five achieved virological suppression at any time. No TW without HIV initiated PrEP. Over 6 months, all participants initiated GAHT and had worsening insulin, glucose and HOMA-IR. Large d-dimer decreases also occurred. Similar changes occurred in TW with and without HIV., Conclusions: In this unique cohort of TW, GAHT decreased d-dimer but worsened insulin sensitivity. Because PrEP uptake and ART adherence were very low, observed effects are primarily attributed to GAHT use. Further study is needed to better understand cardiometabolic changes in TW by HIV serostatus., (© 2023 British HIV Association.)

Background: The prevalence of substance use in people with HIV (PWH) in the United States is higher than in the general population and is an important driver of HIV-related outcomes. We sought to assess if previously identified genetic associations that contribute to substance use are also observed in a population of PWH., Methods: We performed genome-wide association studies (GWAS) of alcohol, smoking, and cannabis use phenotypes in a multi-ancestry population of 7,542 PWH from the Center for AIDS Research Network of Integrated Clinical Systems (CNICS). We conducted multi-ancestry GWAS for individuals of African (n = 3,748), Admixed American (n = 1,334), and European (n = 2,460) ancestry. Phenotype data were self-reported and collected using patient reported outcomes (PROs) and three questions from AUDIT-C, an alcohol screening tool. We analyzed nine phenotypes: 1) frequency of alcohol consumption, 2) typical number of drinks on a day when drinking alcohol, 3) frequency of five or more alcoholic drinks in a 30-day period, 4) smoking initiation, 5) smoking cessation, 6) cigarettes per day, 7) cannabis use initiation, 8) cannabis use cessation, 9) frequency of cannabis use during the previous 30 days. For each phenotype we considered a) variants previously identified as associated with a substance use trait and b) novel associations., Results: We observed evidence for effects of previously reported single nucleotide polymorphisms (SNPs) related to alcohol (rs1229984, p = 0.001), tobacco (rs11783093, p = 2.22E-4), and cannabis use (rs2875907, p = 0.005). We also report two novel loci (19p13.2, p = 1.3E-8; and 20p11.21, p = 2.1E-8) associated with cannabis use cessation., Conclusions: Our analyses contribute to understanding the genetic bases of substance use in a population with relatively higher rates of use compared to the general population., Competing Interests: KMJ was employed by Bristol-Myers Squibb during the drafting of this manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors report no conflicts of interest to disclose., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Benefits of pre-exposure prophylaxis (PrEP) extend beyond HIV risk reduction. Users report a range of physical, emotional, and social effects, including reduced anxiety, increased intimacy, and greater sexual satisfaction. For some people, these benefits are the primary motivation for using PrEP. To successfully engage in shared decision making about HIV prevention methods, clinicians need to be able to discuss all potential risks and benefits of PrEP. These risks and benefits include not only those related to HIV risk reduction and other clinical outcomes, but also those related to experiences and relationships that people value. However, national and international clinical resources on the provision of PrEP do not include user-reported outcomes that are values-based or reflect positive effects on personal, social, or sexual wellbeing. To better integrate the values of potential users into discussions about PrEP, clinician training programmes and clinical guidelines need to be guided by community-driven frameworks and expanded to include user-reported outcomes of PrEP use, including beneficial effects. Achieving PrEP uptake and equity goals will require an approach to PrEP provision that centres the values and desired experiences of potential users, particularly those from populations with the greatest unmet need for PrEP., Competing Interests: Declaration of interests MWT reports speaker's honoraria, consultancy fees, and investigator-initiated research funding from Gilead Sciences. DSK has been co-investigator and study physician on studies at The Fenway Institute funded by grants from Merck and Gilead Sciences, has received funds from Virology Education and UpToDate for developing medical education content, and has received funds as a consultant to Loma Linda, University of North Texas Health Science Centre, and University of Alabama at Birmingham. KHM has received unrestricted research grants from, and has served on scientific advisory boards for, Gilead Sciences and Merck, and has received funds from UpToDate for developing medical education content. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention ("PrEPare-for-Work") to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)