Publications by authors named "Kenneth H Mayer"

795 Publications

Higher colorectal tissue HIV infectivity in cisgender women compared with MSM before and during oral preexposure prophylaxis.

AIDS 2021 Apr 6. Epub 2021 Apr 6.

Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda University of Pittsburgh Medical School, Pittsburgh, Pennsylvania, USA Orion Biotechnology, Ottawa, Ontario, Canada Fred Hutchinson Cancer Research Center, Medical School, Pittsburgh, Pennsylvania Johns Hopkins University School of Medicine, Baltimore, Maryland University of Pennsylvania, Infectious Disease Division, Philadelphia, Pennsylvania University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of California Los Angeles, Center for Clinical AIDS Research and Education, Los Angeles, California, USA University of Barcelona, Barcelona, Spain University of Colorado, Denver, Colorado Fenway Health/Harvard Medical School, Boston, Massachusetts University of Michigan, School of Public Health, Ann Arbor, Michigan Weill Cornell Medicine, New York, New York, USA Prevention Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases FHI360.

Objective: The objective of this study was to compare HIV-negative cisgender women (CGW) with MSM for mucosal tissue differences in pharmacokinetics, HIV infectivity and cell phenotype.

Design: A substudy of HPTN 069/ACTG A5305, 48-week study of three oral candidate preexposure prophylaxis regimens: maraviroc, maraviroc/emtricitabine and maraviroc/tenofovir disoproxil fumarate (TDF) compared with a TDF/emtricitabine control group.

Methods: Plasma, peripheral blood mononuclear cells and cervical and colorectal tissue biopsies were collected at Baseline (no drug), Week 24 and 48 (on drug), and Week 49 (1-week postdrug). Drug concentrations were assessed in all matrices. HIV infectivity was assessed using tissue biopsy 'explants' challenged with HIV ex vivo followed by HIV p24 measurement. Flow cytometry evaluated colorectal cell phenotype.

Results: Thirty-seven CGW and 54 MSM participated. CGW's colorectal explant p24 was higher than MSM before (0.31 log10, P = 0.046), during (1.01-1.19 log10, P = 0.016) and one week after (0.61 log10, P = 0.011) study drug dosing. Pooling regimens, cervical explant p24 did not differ among visits. CGW had higher plasma maraviroc and colorectal tissue tenofovir diphosphate and lower colorectal tissue emtricitabine (all P < 0.005) compared with MSM. Each study drug's cervical tissue concentrations were more than 10-fold below paired colorectal concentrations (P < 0.001). Cell phenotype sex differences included 4% higher CD38+/CD8+ cells at baseline and 3-7% higher CD69+/CD8+ cells throughout Weeks 24-49 in CGW compared with MSM (P < 0.05).

Conclusion: Colorectal explants in CGW demonstrated greater HIV infectivity than MSM with and without study drugs. Small differences in adherence, drug concentration and colorectal tissue flow cytometry cannot fully explain this difference.
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http://dx.doi.org/10.1097/QAD.0000000000002907DOI Listing
April 2021

Longitudinal Associations between Police Harassment and Experiences of Violence among Black Men Who Have Sex with Men in Six US Cities: the HPTN 061 Study.

J Urban Health 2021 Apr 5. Epub 2021 Apr 5.

Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.

Interactions with the police may result in police brutality, particularly for people of color. Black men who have sex with men (BMSM) face disproportionate risk of police contact and may experience elevated violence risk. We measured longitudinal associations between discriminatory police harassment (DPH) and subsequent risk of a range of interpersonal violence experiences, including intimate partner violence (IPV). In this study, we estimated associations between DPH motivated by racism, homophobia, or both, and subsequent violent experiences (being physically harassed, hit, threatened with weapons, and intimate partner violence) among BMSM. Bivariate and multivariable regression analyses were used to control for demographic and behavioral factors. Among 1160 BMSM included at 12-month follow-up, experiencing DPH motivated by racism and homophobia was associated with over four times the odds of being threatened with violence (AOR 4.85, 95% CI 3.20, 7.33), four times the odds of or experiencing violence defined as being punched, kicked, or beaten, or having an object thrown at them (AOR 4.51, 95% CI 2.82, 7.19), and nearly three times the odds of physical partner abuse (AOR 3.49, 95% CI 1.69, 7.19). Findings suggest that for BMSM, DPH is associated with the threat and experience of violence, with a dose-response relationship between DPH motivated by one or more causes. Given that BMSM are a population particularly vulnerable to both police harassment related to race and sexual orientation and violence coupled with stigma, additional research evaluating mechanisms linking these associations is needed in order to develop additional supportive interventions.
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http://dx.doi.org/10.1007/s11524-021-00526-1DOI Listing
April 2021

COVID-19 Vaccine Acceptance among an Online Sample of Sexual and Gender Minority Men and Transgender Women.

Vaccines (Basel) 2021 Mar 1;9(3). Epub 2021 Mar 1.

Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA.

Sexual and gender minority (SGM) populations are particularly vulnerable to poor COVID-19 outcomes and are more likely to experience stigma and medical mistrust that may impact COVID-19 vaccine acceptance. This study examined the prevalence of COVID testing and diagnosis and assessed COVID-19 vaccine acceptance among a large sample of SGM. Participants were recruited as part of an online cross-sectional study focused on an HIV biomedical prevention technology willingness in the United States at increased risk for HIV sero-conversion. Multivariate linear analysis was conducted to examine COVID-19 vaccine acceptance. The study sample included 1350 predominately gay (61.6%), Black (57.9%), cis-gender (95.7%) males with a mean age of 32.9 years. Medical mistrust and social concern regarding COVID-19 vaccine stigma were significantly associated with decreased COVID-19 vaccine acceptance, and altruism was significantly associated with increased vaccine acceptance. Black participants were significantly less likely to accept a COVID-19 vaccine, and Asian participants were significantly more likely to accept a vaccine, compared to White peers. As the planning of COVID-19 vaccine rollout efforts is conceptualized and designed, these data may inform equitable implementation strategies and prevent worsening health inequities among SGM populations.
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http://dx.doi.org/10.3390/vaccines9030204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999863PMC
March 2021

Development and Evaluation of a Mobile App Designed to Increase HIV Testing and Pre-exposure Prophylaxis Use Among Young Men Who Have Sex With Men in the United States: Open Pilot Trial.

J Med Internet Res 2021 Mar 24;23(3):e25107. Epub 2021 Mar 24.

The Fenway Institute, Fenway Health, Boston, MA, United States.

Background: HIV disproportionately affects young men who have sex with men (YMSM) in the United States. Uptake of evidence-based prevention strategies, including routine HIV testing and use of pre-exposure prophylaxis (PrEP), is suboptimal in this population. Novel methods for reaching YMSM are required.

Objective: The aim of this study is to describe the development and evaluate the feasibility and acceptability of the MyChoices app, a mobile app designed to increase HIV testing and PrEP use among YMSM in the United States.

Methods: Informed by the social cognitive theory, the MyChoices app was developed using an iterative process to increase HIV testing and PrEP uptake among YMSM. In 2017, beta theater testing was conducted in two US cities to garner feedback (n=4 groups; n=28 YMSM). These findings were used to refine MyChoices, which was then tested for initial acceptability and usability in a technical pilot (N=11 YMSM). Baseline and 2-month postbaseline assessments and exit interviews were completed. Transcripts were coded using a deductive approach, and thematic analysis was used to synthesize data; app acceptability and use data were also reported.

Results: The MyChoices app includes personalized recommendations for HIV testing frequency and PrEP use; information on types of HIV tests and PrEP; ability to search for nearby HIV testing and PrEP care sites; and ability to order free home HIV and sexually transmitted infection test kits, condoms, and lube. In theater testing, YMSM described that MyChoices appears useful and that they would recommend it to peers. Participants liked the look and feel of the app and believed that the ability to search for and be pinged when near an HIV testing site would be beneficial. Some suggested that portions of the app felt repetitive and preferred using casual language rather than formal or medicalized terms. Following theater testing, the MyChoices app was refined, and participants in the technical pilot used the app, on average, 8 (SD 5.0; range 2-18) times over 2 months, with an average duration of 28 (SD 38.9) minutes per session. At the 2-month follow-up, the mean System Usability Scale (0-100) score was 71 (ie, above average; SD 11.8). Over 80% (9/11) of the participants reported that MyChoices was useful and 91% (10/11) said that they would recommend it to a friend. In exit interviews, there was a high level of acceptability for the content, interface, and features.

Conclusions: These data show the initial acceptability and user engagement of the MyChoices app. If future studies demonstrate efficacy in increasing HIV testing and PrEP uptake, the app is scalable to reach YMSM across the United States.

Trial Registration: Clinicaltrials.gov NCT03179319; https://clinicaltrials.gov/ct2/show/NCT03179319.

International Registered Report Identifier (irrid): RR2-10.2196/10694.
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http://dx.doi.org/10.2196/25107DOI Listing
March 2021

Strengthening resilience to reduce HIV risk in Indian MSM: a multicity, randomised, clinical efficacy trial.

Lancet Glob Health 2021 04;9(4):e446-e455

Fenway Institute, Fenway Health, Boston, MA, USA; Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioural Sciences, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.

Background: Men who have sex with men (MSM) in India are extremely marginalised and stigmatised, and therefore experience immense psychosocial stress. As current HIV prevention interventions in India do not address mental health or resilience to these stressors, we aimed to evaluate a resilience-based psychosocial intervention in the context of HIV and sexually transmitted infection (STI) prevention.

Methods: We did a multicity, randomised, clinical efficacy trial in Chennai (governmental tuberculosis research institute) and Mumbai (non-governmental organisation for MSM), India. Inclusion criteria were MSM, aged 18 years or older, who were at risk of HIV acquisition or transmission, defined as having any of the following in the 4 months before screening: anal sex with four or more male partners (protected or unprotected), diagnosis of an STI, history of transactional sex activity, or condomless anal sex with a man who was of unknown HIV status or serodiscordant. Participants were required to speak English, Tamil (in Chennai), or Hindi (in Mumbai) fluently. Eligible individuals were randomly assigned (1:1) to either a resilience-based psychosocial HIV prevention intervention, consisting of group (four sessions) and individual (six sessions) counselling alongside HIV and STI voluntary counselling and testing, or a standard-of-care control comprising voluntary counselling and testing alone. The primary outcomes were number of condomless anal sex acts with male partners during the past month (at baseline and 4 months, 8 months, and 12 months after randomisation), and incident bacterial STIs (at 12 months after randomisation). Resilience-related mediators included self-esteem, self-acceptance, and depression. Recruitment is now closed. This trial is registered with ClinicalTrials.gov, NCT02556294.

Findings: Between Sept 4, 2015, and June 28, 2018, we enrolled 608 participants; 305 (50%) were assigned to the psychosocial intervention condition and 303 (50%) were assigned to the control condition. 510 (84%) of 608 men completed an assessment at 4 months after randomisation, 483 (79%) at 8 months, and 515 (85%) at 12 months. 512 (99%) of 515 men had STI data from the 12-month assessment. The intervention condition had a 56% larger reduction in condomless anal sex acts (95% CI 35-71; p<0·0001) from baseline to 4-month follow-up, 72% larger reduction (56-82; p<0·0001) from baseline to 8-month follow-up, and 72% larger reduction (53-83; p<0·0001) from baseline to 12-month follow-up, compared with the standard-of-care control condition (condition by time interaction; χ=40·29, 3 df; p<0·0001). Improvements in self-esteem and depressive symptoms both mediated 9% of the intervention effect on condomless anal sex acts. Bacterial STI incidence did not differ between study conditions at 12-month follow-up.

Interpretation: A resilience-based psychosocial intervention for MSM at risk of HIV acquisition or transmission in India was efficacious in reducing condomless anal sex acts, with evidence for mediation effects in two key target resilience variables. HIV prevention programmes for MSM in India should address mental health resilience to augment reductions in the risk of sexually transmitted HIV.

Funding: National Institute of Mental Health.
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http://dx.doi.org/10.1016/S2214-109X(20)30547-7DOI Listing
April 2021

Autonomy-Supportive Healthcare Climate and HIV-Related Stigma Predict Linkage to HIV Care in Men Who Have Sex With Men in Ghana, West Africa.

J Int Assoc Provid AIDS Care 2021 Jan-Dec;20:2325958220978113

School of Nursing, 5755Yale University, New Haven, CT, USA.

In Ghana, the HIV prevalence among MSM is more than 10 times greater than the general population of adults, and rates of engagement in HIV medical care are low among MSM diagnosed with HIV. Using structured surveys, we investigated the impact of HIV-related stigma, same-sex behavior stigma, and gender nonconformity stigma on linkage to HIV care (LTC) in MSM ( = 225) living with HIV in Ghana. Autonomy-supportive healthcare climate ( = 1.63, < .01), vicarious HIV stigma ( = 2.73, < .01), and age ( = 1.06, p < .004) predicted LTC. Conversely, felt normative HIV stigma negatively predicted LTC ( = 0.65, < .05). Finally, we identified regional disparities, with MSM from Takoradi being 4 times and 5 times more likely to be LTC compared to Kumasi and Accra, respectively. Our findings highlight the nuanced roles of stigmas in shaping the HIV care continuum among MSM living with HIV, while revealing potential gaps in current measures of HIV-related stigma.
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http://dx.doi.org/10.1177/2325958220978113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983411PMC
March 2021

Estimating HIV transmissions in a large U.S. clinic-based sample: effects of time and syndemic conditions.

J Int AIDS Soc 2021 Mar;24(3):e25679

Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.

Introduction: Little is known about onward HIV transmissions from people living with HIV (PLWH) in care. Antiretroviral therapy (ART) has increased in potency, and treatment as prevention (TasP) is an important component of ending the epidemic. Syndemic theory has informed modelling of HIV risk but has yet to inform modelling of HIV transmissions.

Methods: Data were from 61,198 primary HIV care visits for 14,261 PLWH receiving care through the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) at seven United States (U.S.) sites from 2007 to 2017. Patient-reported outcomes and measures (PROs) of syndemic conditions - depressive symptoms, anxiety symptoms, drug use (opiates, amphetamines, crack/cocaine) and alcohol use - were collected approximately four to six months apart along with sexual behaviours (mean = 4.3 observations). Counts of syndemic conditions, HIV sexual risk group and time in care were modelled to predict estimated HIV transmissions resulting from sexual behaviour and viral suppression status (HIV RNA < 400/mL) using hierarchical linear modelling.

Results: Patients averaged 0.38 estimated HIV transmissions/100 patients/year for all visits with syndemic conditions measured (down from 0.83, first visit). The final multivariate model showed that per 100 patients, each care visit predicted 0.05 fewer estimated transmissions annually (95% confidence interval (CI): 0.03 to 0.06; p < 0.0005). Cisgender women, cisgender heterosexual men and cisgender men of undisclosed sexual orientation had, respectively, 0.47 (95% CI: 0.35 to 0.59; p < 0.0005), 0.34 (95% CI: 0.20 to 0.49; p < 0.0005) and 0.22 (95% CI: 0.09 to 0.35; p < 0.005) fewer estimated HIV transmissions/100 patients/year than cisgender men who have sex with men (MSM). Each within-patient syndemic condition predicted 0.18 estimated transmissions/100 patients/year (95% CI: 0.12 to 0.24; p < 0.0005). Each between-syndemic condition predicted 0.23 estimated HIV transmissions/100 patients/year (95% CI: 0.17 to 0.28; p < 0.0005).

Conclusions: Estimated HIV transmissions among PLWH receiving care in well-resourced U.S. clinical settings varied by HIV sexual risk group and decreased with time in care, highlighting the importance of TasP efforts. Syndemic conditions remained a significant predictor of estimated HIV transmissions notwithstanding the effects of HIV sexual risk group and time in care.
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http://dx.doi.org/10.1002/jia2.25679DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7962793PMC
March 2021

Police harassment and psychosocial vulnerability, distress, and depressive symptoms among black men who have sex with men in the U.S.: Longitudinal analysis of HPTN 061.

SSM Popul Health 2021 Mar 7;13:100753. Epub 2021 Feb 7.

Department of Population Health, New York University School of Medicine, New York, NY, USA.

The mental health impact of exposure to police harassment is understudied, particularly among Black men who have sex with men (BMSM), a group at elevated risk of exposure to such discrimination. This study aimed to identify the associations among BMSM between recent police harassment and psychosocial vulnerability, psychological distress, and depression measured six months later. Data come from the HIV Prevention Trials Network (HPTN) 061 Study, a cohort study of BMSM recruited in 6 U.S. cities (Atlanta, GA, Boston, MA, Los Angeles, CA, New York, NY, San Francisco, CA, and Washington DC). Participants completed baseline, 6-month follow-up, and 12-month follow-up interviews. A convenience sample of 1553 BMSM was recruited between July 2009 and October 2010 of whom 1155 returned for a follow-up interview 12 months later. Accounting for previous police interaction, poverty, psychopathology, drug use, and alcohol use, we estimated associations between recent police harassment reported at the 6 month follow-up interview and 12 month outcomes including psychosocial vulnerability (elevated racial/sexual identity incongruence), psychological distress (being distressed by experiences of racism and/or homophobia), and depression. About 60% of men reported experiencing police harassment between the baseline and 6-month interview due to their race and/or sexuality. Adjusted analyses suggested police harassment was independently associated with a 10.81 (95% CI: 7.97, 13.66) point increase and 8.68 (95% CI: 6.06, 11.30) point increase in distress due to experienced racism and distress due to experienced homophobia scores, respectively. Police harassment perceived to be dually motivated predicted disproportionate levels of distress. Police harassment is prevalent and associated with negative influences on psychosocial vulnerability and psychological distress among BMSM. Reducing exposure to police harassment may improve the psychosocial health of BMSM.
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http://dx.doi.org/10.1016/j.ssmph.2021.100753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7902537PMC
March 2021

Prioritising pleasure and correcting misinformation in the era of U=U.

Lancet HIV 2021 03;8(3):e175-e180

Department of Population Medicine, Harvard Medical School, Boston, MA, USA; The Fenway Institute, Fenway Health, Boston, MA, USA.

There is widespread unawareness and disbelief regarding the evidence-based conclusion that people who have a sustained undetectable HIV viral load cannot sexually transmit HIV-ie, undetectable=untransmittable (U=U). Long-standing, misguided fear about HIV transmission persists; consequently, so does the policing of sexual expression and the penalisation of pleasure faced by people with HIV. Many people with HIV with an undetectable viral load have unnecessarily abstained from condomless sex, avoided serodifferent partnering, and had anxiety about onward sexual transmission due to perceived HIV risk that is now known to be non-existent. Some health professionals have refrained from correcting this misinformation because of concerns that people with HIV will engage in more condomless sex or have more sexual partners upon learning of U=U. Withholding information about U=U is thus rooted in behavioural assumptions and is scientifically unfounded. Moreover, withholding such information violates medical ethics, perpetuates health inequities, and infringes on the sexual health and human rights of people with HIV. Health professionals and the broader public health community have an ethical responsibility to actively address misinformation about HIV transmission and disseminate the U=U message to all people.
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http://dx.doi.org/10.1016/S2352-3018(20)30341-6DOI Listing
March 2021

HIV Preexposure Prophylaxis and Sexual Satisfaction Among Men Who Have Sex with Men.

Sex Transm Dis 2021 Feb 19. Epub 2021 Feb 19.

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA The Fenway Institute, Fenway Health, Boston, MA Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA.

Abstract: In this large online survey of primarily men who have sex with men, those who used preexposure prophylaxis reported greater sexual satisfaction than non-users, including sexual sensations, sexual presence/awareness, and sexual exchange. Person-centered care and messaging may require acknowledging that some people use preexposure prophylaxis for reasons beyond HIV prevention.
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http://dx.doi.org/10.1097/OLQ.0000000000001361DOI Listing
February 2021

Longitudinal Cohort Study of Gender Affirmation and HIV-Related Health in Transgender and Gender Diverse Adults: The LEGACY Project Protocol.

JMIR Res Protoc 2021 Mar 1;10(3):e24198. Epub 2021 Mar 1.

Callen-Lorde Community Health Center, New York, NY, United States.

Background: Transgender and gender diverse (TGD) adults in the United States experience health disparities, especially in HIV infection. Medical gender affirmation (eg, hormone therapy and gender-affirming surgeries) is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effects of gender-affirming medical care on HIV-related outcomes.

Objective: This study aims to evaluate the effects of medical gender affirmation on HIV-related outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs.

Methods: LEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two federally qualified community health centers in the United States: Fenway Health in Boston, and Callen-Lorde Community Health Center in New York. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for 1 year of follow-up (baseline, 6-month, and 12-month assessments) with optional HIV and sexually transmitted infection (STI) testing. Biobehavioral data from the RDW, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and nonhormonal and nonsurgical interventions (eg, voice therapy).

Results: The contract began in April 2018. The cohort design was informed by focus groups with TGD patients (n=28) conducted between August-October 2018 and in collaboration with a community advisory board, scientific advisory board, and site-specific research support coalitions. Prospective cohort enrollment began in February 2019, with enrollment expected to continue through August 2020. As of April 2020, 7821 patients are enrolled in the LEGACY RDW and 1756 have completed a baseline survey. Participants have a median age of 29 years (IQR 11; range 18-82). More than one-third (39.7%) are racial or ethnic minorities (1070/7821, 13.68% Black; 475/7821, 6.07% multiracial; 439/7821, 5.61% Asian or Pacific Islander; 1120/7821, 14.32% other or missing) and 14.73% (1152/7821) are Hispanic or Latinx. By gender identity, participants identify as 33.79% (2643/7821) male, 37.07% (2900/7821) female, 21.74% (1700/7821) nonbinary, and 7.39% (578/7821) are unsure or have missing data. Approximately half (52.0%) of the cohort was assigned female sex at birth, and 5.4% (421/7821) are living with HIV infection.

Conclusions: LEGACY is an unprecedented opportunity to evaluate the impact of medical gender affirmation on HIV-related health. The study uses a comprehensive research methodology linking TGD patient biobehavioral longitudinal data from multiple sources. Patient-centeredness and scientific rigor are assured through the ongoing engagement of TGD communities, clinicians, scientists, and site clinical staff undergirded by epidemiological methodology. Findings will inform evidence-based clinical care for TGD patients, including optimal interventions to improve HIV-related outcomes.

International Registered Report Identifier (irrid): DERR1-10.2196/24198.
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http://dx.doi.org/10.2196/24198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7961399PMC
March 2021

Longitudinal Cohort Study of Gender Affirmation and HIV-Related Health in Transgender and Gender Diverse Adults: The LEGACY Project Protocol.

JMIR Res Protoc 2021 Mar 1;10(3):e24198. Epub 2021 Mar 1.

Callen-Lorde Community Health Center, New York, NY, United States.

Background: Transgender and gender diverse (TGD) adults in the United States experience health disparities, especially in HIV infection. Medical gender affirmation (eg, hormone therapy and gender-affirming surgeries) is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effects of gender-affirming medical care on HIV-related outcomes.

Objective: This study aims to evaluate the effects of medical gender affirmation on HIV-related outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs.

Methods: LEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two federally qualified community health centers in the United States: Fenway Health in Boston, and Callen-Lorde Community Health Center in New York. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for 1 year of follow-up (baseline, 6-month, and 12-month assessments) with optional HIV and sexually transmitted infection (STI) testing. Biobehavioral data from the RDW, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and nonhormonal and nonsurgical interventions (eg, voice therapy).

Results: The contract began in April 2018. The cohort design was informed by focus groups with TGD patients (n=28) conducted between August-October 2018 and in collaboration with a community advisory board, scientific advisory board, and site-specific research support coalitions. Prospective cohort enrollment began in February 2019, with enrollment expected to continue through August 2020. As of April 2020, 7821 patients are enrolled in the LEGACY RDW and 1756 have completed a baseline survey. Participants have a median age of 29 years (IQR 11; range 18-82). More than one-third (39.7%) are racial or ethnic minorities (1070/7821, 13.68% Black; 475/7821, 6.07% multiracial; 439/7821, 5.61% Asian or Pacific Islander; 1120/7821, 14.32% other or missing) and 14.73% (1152/7821) are Hispanic or Latinx. By gender identity, participants identify as 33.79% (2643/7821) male, 37.07% (2900/7821) female, 21.74% (1700/7821) nonbinary, and 7.39% (578/7821) are unsure or have missing data. Approximately half (52.0%) of the cohort was assigned female sex at birth, and 5.4% (421/7821) are living with HIV infection.

Conclusions: LEGACY is an unprecedented opportunity to evaluate the impact of medical gender affirmation on HIV-related health. The study uses a comprehensive research methodology linking TGD patient biobehavioral longitudinal data from multiple sources. Patient-centeredness and scientific rigor are assured through the ongoing engagement of TGD communities, clinicians, scientists, and site clinical staff undergirded by epidemiological methodology. Findings will inform evidence-based clinical care for TGD patients, including optimal interventions to improve HIV-related outcomes.

International Registered Report Identifier (irrid): DERR1-10.2196/24198.
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http://dx.doi.org/10.2196/24198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7961399PMC
March 2021

The potential effect of COVID-19-related disruptions on HIV incidence and HIV-related mortality among men who have sex with men in the USA: a modelling study.

Lancet HIV 2021 04 19;8(4):e206-e215. Epub 2021 Feb 19.

MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, UK; HIV Prevention Trials Network Modelling Centre, Imperial College London, London, UK; Abdul Latif Jameel Institute for Disease and Emergency Analytics, School of Public Health, Imperial College London, London, UK.

Background: During the COVID-19 pandemic, men who have sex with men (MSM) in the USA have reported similar or fewer sexual partners and reduced HIV testing and care access compared with before the pandemic. Pre-exposure prophylaxis (PrEP) use has also declined. We aimed to quantify the potential effect of COVID-19 on HIV incidence and HIV-related mortality among US MSM.

Methods: We used a calibrated, deterministic, compartmental HIV transmission model for MSM in Baltimore (MD, USA) and available data on COVID-19-related disruptions to HIV services to predict effects of reductions in sexual partners (0%, 25%, 50%), condom use (5%), HIV testing (20%), viral suppression (10%), PrEP initiations (72%), PrEP adherence (9%), and antiretroviral therapy (ART) initiations (50%). In our main analysis, we modelled disruptions due to COVID-19 starting Jan 1, 2020, and lasting 6 months. We estimated the median change in cumulative new HIV infections and HIV-related deaths among MSM over 1 and 5 years, compared with a base case scenario without COVID-19-related disruptions.

Findings: A 25% reduction in sexual partners for 6 months among MSM in Baltimore, without HIV service changes, could reduce new HIV infections by median 12·2% (95% credible interval 11·7 to 12·8) over 1 year and median 3·0% (2·6 to 3·4) over 5 years. In the absence of changes in sexual behaviour, the 6-month estimated reductions in condom use, HIV testing, viral suppression, PrEP initiations, PrEP adherence, and ART initiations combined are predicted to increase new HIV infections by median 10·5% (5·8 to 16·5) over 1 year, and by median 3·5% (2·1 to 5·4) over 5 years. Disruptions to ART initiations and viral suppression are estimated to substantially increase HIV-related deaths (ART initiations by median 1·7% [0·8 to 3·2], viral suppression by median 9·5% [5·2 to 15·9]) over 1 year, with smaller proportional increases over 5 years. The other individual disruptions (to HIV testing, PrEP and condom use, PrEP initiation, and partner numbers) were estimated to have little effect on HIV-related deaths (<1% change over 1 or 5 years). A 25% reduction in sexual partnerships is estimated to offset the effect of the combined service disruptions on new HIV infections (change over 1 year: median -3·9% [-7·4 to 1·0]; over 5 years: median 0·0% [-0·9 to 1·4]), but not on HIV deaths (change over 1 year: 11·0% [6·2 to 17·7]; over 5 years: 2·6% [1·5 to 4·3]).

Interpretation: Maintaining access to ART and adherence support is of the utmost importance to maintain viral suppression and minimise excess HIV-related mortality due to COVID-19 restrictions in the USA, even if disruptions to services are accompanied by reductions in sexual partnerships.

Funding: National Institutes of Health.
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http://dx.doi.org/10.1016/S2352-3018(21)00022-9DOI Listing
April 2021

Epidemiology of HIV in the USA: epidemic burden, inequities, contexts, and responses.

Lancet 2021 Mar 19;397(10279):1095-1106. Epub 2021 Feb 19.

Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.

The HIV epidemic in the USA began as a bicoastal epidemic focused in large cities but, over nearly four decades, the epidemiology of HIV has changed. Public health surveillance data can inform an understanding of the evolution of the HIV epidemic in terms of the populations and geographical areas most affected. We analysed publicly available HIV surveillance data and census data to describe: current HIV prevalence and new HIV diagnoses by region, race or ethnicity, and age; trends in HIV diagnoses over time by HIV acquisition risk and age; and the distribution of HIV prevalence by geographical area. We reviewed published literature to explore the reasons for the current distribution of HIV cases and important disparities in HIV prevalence. We identified opportunities to improve public health surveillance systems and uses of data for planning and monitoring public health responses. The current US HIV epidemic is marked by geographical concentration in the US South and profound disparities between regions and by race or ethnicity. Rural areas vary in HIV prevalence; rural areas in the South are more likely to have a high HIV prevalence than rural areas in other US Census regions. Ongoing disparities in HIV in the South are probably driven by the restricted expansion of Medicaid, health-care provider shortages, low health literacy, and HIV stigma. HIV diagnoses overall declined in 2009-18, but HIV diagnoses among individuals aged 25-34 years increased during the same period. HIV diagnoses decreased for all risk groups in 2009-18; among men who have sex with men (MSM), new diagnoses decreased overall and for White MSM, remained stable for Black MSM, and increased for Hispanic or Latino MSM. Surveillance data indicate profound and ongoing disparities in HIV cases, with disproportionate impact among people in the South, racial or ethnic minorities, and MSM.
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http://dx.doi.org/10.1016/S0140-6736(21)00395-0DOI Listing
March 2021

The persistent and evolving HIV epidemic in American men who have sex with men.

Lancet 2021 Mar 19;397(10279):1116-1126. Epub 2021 Feb 19.

Rollins School of Public Health, Emory University, Atlanta, GA, USA.

Men who have sex with men (MSM) in the USA were the first population to be identified with AIDS and continue to be at very high risk of HIV acquisition. We did a systematic literature search to identify the factors that explain the reasons for the ongoing epidemic in this population, using a social-ecological perspective. Common features of the HIV epidemic in American MSM include role versatility and biological, individual, and social and structural factors. The high-prevalence networks of some racial and ethnic minority men are further concentrated because of assortative mixing, adverse life experiences (including high rates of incarceration), and avoidant behaviour because of negative interactions with the health-care system. Young MSM have additional risks for HIV because their impulse control is less developed and they are less familiar with serostatus and other risk mitigation discussions. They might benefit from prevention efforts that use digital technologies, which they often use to meet partners and obtain health-related information. Older MSM remain at risk of HIV and are the largest population of US residents with chronic HIV, requiring culturally responsive programmes that address longer-term comorbidities. Transgender MSM are an understudied population, but emerging data suggest that some are at great risk of HIV and require specifically tailored information on HIV prevention. In the current era of pre-exposure prophylaxis and the undetectable equals untransmittable campaign, training of health-care providers to create culturally competent programmes for all MSM is crucial, since the use of antiretrovirals is foundational to optimising HIV care and prevention. Effective control of the HIV epidemic among all American MSM will require scaling up programmes that address their common vulnerabilities, but are sufficiently nuanced to address the specific sociocultural, structural, and behavioural issues of diverse subgroups.
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http://dx.doi.org/10.1016/S0140-6736(21)00321-4DOI Listing
March 2021

Call to action: how can the US Ending the HIV Epidemic initiative succeed?

Lancet 2021 03 19;397(10279):1151-1156. Epub 2021 Feb 19.

Beth Israel Deaconess Medical Center, Harvard Medical School, Fenway Health, Boston, MA, USA.

With more than 1·2 million people living with HIV in the USA, a complex epidemic across the large and diverse country, and a fragmented health-care system marked by widening health disparities, the US HIV epidemic requires sustained scientific and public health attention. The epidemic has been stubbornly persistent; high incidence densities have been sustained over decades and the epidemic is increasingly concentrated among racial, ethnic, and sexual and gender minority communities. This fact remains true despite extraordinary scientific advances in prevention, treatment, and care-advances that have been led, to a substantial degree, by US-supported science and researchers. In this watershed year of 2021 and in the face of the COVID-19 pandemic, it is clear that the USA will not meet the stated goals of the National HIV/AIDS Strategy, particularly those goals relating to reductions in new infections, decreases in morbidity, and reductions in HIV stigma. The six papers in the Lancet Series on HIV in the USA have each examined the underlying causes of these challenges and laid out paths forward for an invigorated, sustained, and more equitable response to the US HIV epidemic than has been seen to date. The sciences of HIV surveillance, prevention, treatment, and implementation all suggest that the visionary goals of the Ending the HIV Epidemic initiative in the USA might be achievable. However, fundamental barriers and challenges need to be addressed and the research effort sustained if we are to succeed.
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http://dx.doi.org/10.1016/S0140-6736(21)00390-1DOI Listing
March 2021

DoDoxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men who have Sex with Men: A Randomized Controlled Trial.

Clin Infect Dis 2021 Feb 19. Epub 2021 Feb 19.

Fenway Health, Boston, MA, USA.

Background: Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective.

Methods: This randomized, double-blind, placebo-controlled trial compared azithromycin (single one-gram dose) vs. doxycycline (100mg twice daily for seven days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment, two weeks, and four weeks post-enrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at four weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants.

Results: Among 177 participants enrolled, 135 (76%) met CC population criteria for the four-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population [100% (70 of 70) vs. 74% (48 of 65); absolute difference 26% (95% CI: 16-36%; p<0.001)] and the ITT population [91% (80 of 88) vs. 71% (63 of 89); absolute difference 20% (95% CI: 9-31%; p<0.001)].

Conclusions: A one-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM. (Funded by National Institute of Allergy & Infectious Diseases contract HHSN272201300014I, Protocol 17-0092).
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http://dx.doi.org/10.1093/cid/ciab153DOI Listing
February 2021

To Disclose, Not Disclose, or Conceal: A Qualitative Study of HIV-Positive Men with Multiple Concealable Stigmatized Identities.

AIDS Patient Care STDS 2021 02;35(2):47-55

The Fenway Institute, Fenway Health, Boston, Massachusetts, USA.

People living with HIV (PLHW) and other concealable stigmatized identities (CSIs) face continual decisions about the degree of openness they are willing to allow for their identities in different social contexts. Disclosing or concealment of CSIs describes potential stigma management strategies that may have distinct psychosocial consequences. This study aimed to examine disclosure processes in a sample of sexual minority men (SMM) with intersecting CSIs, who use substances and were suboptimally engaged in HIV care. Interviews ( = 33) were initially double coded following thematic analysis, which identified disclosure as a theme. Subsequently, content analysis and additional selective double coding were used to iteratively identify and refine subthemes related to disclosure decisions. Illustrative quotes and frequencies of the invoked subthemes and identities were recorded for each participant. The majority of participants discussed experiences of disclosure and nondisclosure ( = 31, 94%). Among these, a spectrum of related behaviors and preferences emerged, including active disclosure, passive disclosure, passive nondisclosure, and concealment. Across disclosure-related content, in addition to HIV status, the majority of participants also described navigating decisions about disclosure of sexual orientation (71%), substance use (61%), and multiple identities at once (55%). Findings from this study highlight the fluid and multi-dimensional nature of identity-related disclosure processes in SMM with multiple CSIs. Participants in this study possessed interlocking stigmatized identities and described being varying degrees of "out" across identities and time. Moreover, these findings challenge common beliefs that disclosure is a binary construct associated with positive gain.
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http://dx.doi.org/10.1089/apc.2020.0205DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885899PMC
February 2021

The Pre-Exposure Prophylaxis Cascade in At-Risk Transgender Men Who Have Sex with Men in the United States.

LGBT Health 2021 Feb-Mar;8(2):116-124. Epub 2021 Feb 9.

The Fenway Institute, Fenway Health, Boston, Massachusetts, USA.

This analysis was designed to characterize the pre-exposure prophylaxis (PrEP) cascade in a U.S. national sample of transgender men and trans masculine adults who have sex with cisgender men (trans MSM) at-risk for HIV acquisition. From November to December 2017, 843 HIV-negative trans MSM self-reporting past-6-month receptive sex with a cisgender man were recruited via peer referrals, dating apps, listservs, and social media. A computer-assisted self-interview assessed demographics, health care, and the PrEP cascade. Descriptive statistics and multivariable regression models evaluated factors associated with PrEP uptake and persistence. Mean age was 28.1 years (standard deviation = 7.1); 4.8% were Black, 21.7% Latinx, and 25.6% another race/ethnicity. A total of 84.1% had heard of PrEP, with 67.3% reporting interest. More than half (55.2%) were PrEP indicated, of which 50.8% were PrEP naive. Approximately 1/4 (28.0%) reported PrEP use, of which 65.3% were PrEP persistent. PrEP modality preferences were injectable (51.2%), daily oral pill (22.1%), and anal gel/lube (14.6%). Reasons for PrEP noninterest were no HIV risk (68.5%), cost (24.2%), and side effects (20.1%). Surgical gender affirmation, no health care discrimination, and social media as a primary health information source were associated with increased odds of PrEP uptake and persistence (all  < 0.05). PrEP adherence difficulties were reported by 52.6%, due to busy/inconsistent schedule (53.1%), side effects (27.4%), and too many medical visits (11.6%). PrEP uptake was modest among the trans MSM sampled, given prevalent HIV risk behaviors. The limited PrEP uptake in at-risk trans MSM suggests the need to develop culturally tailored community education and interventions.
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http://dx.doi.org/10.1089/lgbt.2020.0232DOI Listing
February 2021

Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial.

PLoS Med 2021 Feb 3;18(2):e1003495. Epub 2021 Feb 3.

Boston University School of Medicine, Department of Medicine, Boston, Massachusetts, United States of America.

Background: MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally.

Methods And Findings: The clinical trial enrolled healthy reproductive-aged, sexually abstinent women. In Segment A, 9 women received a single MB66 film which was inserted into the vaginal posterior fornix by a clinician. In Segment B, 29 women were randomly assigned to MB66 (Active) or Placebo film groups and were instructed to insert 1 film vaginally for 7 consecutive days. Visits and clinical sampling occurred predose and at various time points after single and repeated film doses. The primary endpoint was number of adverse events (AEs) Grade 2 or higher related to product use. Secondary endpoints included film dissolution rate, Nugent score (a Gram stain scoring system to diagnose bacterial vaginosis), vaginal pH, post-use survey results, cytokine concentrations in cervicovaginal lavage (CVL) specimens (assessed by Luminex assay), mAb concentrations in vaginal fluid collected from 4 sites (assessed by ELISA), and HIV and HSV neutralization activity of CVL samples ex vivo (assessed by TZM-bl and plaque reduction assay, respectively). The product was generally safe and well tolerated, with no serious AEs recorded in either segment. The AEs in this study were primarily genitourinary in nature with the most commonly reported AE being asymptomatic microscopic hematuria. There were no differences in vaginal pH or Nugent scores or significant increases in levels of proinflammatory cytokines for up to 7 days after film insertion in either segment or between Active and Placebo groups. Acceptability and willingness to use the product were judged to be high by post-use surveys. Concentrations of VRC01-N and HSV8-N in vaginal secretions were assessed over time to generate pharmacokinetic curves. Antibody levels peaked 1 hour postdosing with Active film (median: 35 μg/mL) and remained significantly elevated at 24 hours post first and seventh film (median: 1.8 μg/mL). Correcting for sample dilution (1:20), VRC01-N concentrations ranged from 36 to 700 μg/mL at the 24-hour time point, greater than 100-fold the IC50 for VRC01 (0.32 μg/mL); HSV8-N concentrations ranged from 80 to 601 μg/mL, well above the IC50 of 0.1 μg/m. CVL samples collected 24 hours after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. Study limitations include the small size of the study cohort, and the fact that no samples were collected between 24 hours and 7 days for pharmacokinetic evaluation.

Conclusions: Single and repeated intravaginal applications of MB66 film were safe, well tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and thus could provide protection for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to provide protection against other sexually transmitted infections (STIs) and contraception.

Trial Registration: ClinicalTrials.gov NCT02579083.
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http://dx.doi.org/10.1371/journal.pmed.1003495DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857576PMC
February 2021

Differences in mental health symptom severity and care engagement among transgender and gender diverse individuals: Findings from a large community health center.

PLoS One 2021 25;16(1):e0245872. Epub 2021 Jan 25.

Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, United States of America.

Mental health disparities among transgender and gender diverse (TGD) populations have been documented. However, few studies have assessed differences in mental health symptom severity, substance use behavior severity, and engagement in care across TGD subgroups. Using data from the electronic health record of a community health center specializing in sexual and gender minority health, we compared the (1) severity of self-reported depression, anxiety, alcohol use, and other substance use symptoms; (2) likelihood of meeting clinical thresholds for these disorders; and (3) number of behavioral health and substance use appointments attended among cisgender, transgender, and non-binary patients. Participants were 29,988 patients aged ≥18 who attended a medical appointment between 2015 and 2018. Depression symptom severity (F = 200.6, p < .001), anxiety symptom severity (F = 102.8, p < .001), alcohol use (F = 58.8, p < .001), and substance use (F = 49.6, p < .001) differed significantly by gender. Relative to cisgender and transgender individuals, non-binary individuals are at elevated risk for depression, anxiety, and substance use disorders. Gender was also associated with differences in the number of behavioral health (χ2 = 51.5, p < .001) and substance use appointments (χ2 = 39.3, p < .001) attended. Engagement in treatment among certain gender groups is poor; cisgender women and non-binary patients assigned male at birth were the least likely to have attended a behavioral health appointment, whereas transgender men and cisgender women had attended the lowest number of substance use appointments. These data demonstrate the importance of (1) assessing gender diversity and (2) addressing the barriers that prevent TGD patients from receiving affirming care.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245872PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833136PMC
January 2021

Drug and alcohol use among people living with HIV in care in the United States by geographic region.

AIDS Care 2021 Jan 23:1-8. Epub 2021 Jan 23.

Department of Epidemiology, University of Washington, Seattle, WA, USA.

Substance use in the U.S. varies by geographic region. Opioid prescribing practices and marijuana, heroin, and methamphetamine availability are evolving differently across regions. We examined self-reported substance use among people living with HIV (PLWH) in care at seven sites from 2017-2019 to understand current regional substance use patterns. We calculated the percentage and standardized percentage of PLWH reporting current drug use and at-risk and binge alcohol use by U.S. Census Bureau geographic region and examined associations in adjusted logistic regression analyses. Among 7,686 PLWH, marijuana use was the most prevalent drug (30%), followed by methamphetamine/crystal (8%), cocaine/crack (7%), and illicit opioids (3%). One-third reported binge alcohol use (32%). Differences in percent of current use by region were seen for marijuana (24-41%) and methamphetamine/crystal (2-15%), with more use in the West and Northeast, and binge alcohol use (26-40%). In adjusted analyses, PLWH in the Midwest were significantly less likely to use methamphetamine/crystal (aOR: 0.13;0.06-0.25) or illicit opioids (aOR:0.16;0.05-0.53), and PLWH in the Northeast were more likely to use cocaine/crack (aOR:1.59;1.16-2.17), compared to PLWH in the West. Understanding differences in substance use patterns in the current era, as policies continue to evolve, will enable more targeted interventions in clinical settings among PLWH.
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http://dx.doi.org/10.1080/09540121.2021.1874274DOI Listing
January 2021

The target/perpetrator brief-implicit association test (B-IAT): an implicit instrument for efficiently measuring discrimination based on race/ethnicity, sex, gender identity, sexual orientation, weight, and age.

BMC Public Health 2021 Jan 19;21(1):158. Epub 2021 Jan 19.

Harvard T.H. Chan School of Public Health, Boston, MA, USA.

Background: To date, research assessing discrimination has employed primarily explicit measures (i.e., self-reports), which can be subject to intentional and social desirability processes. Only a few studies, focusing on sex and race/ethnicity discrimination, have relied on implicit measures (i.e., Implicit Association Test, IAT), which permit assessing mental representations that are outside of conscious control. This study aims to advance measurement of discrimination by extending the application of implicit measures to multiple types of discrimination and optimizing the time required for the administration of these instruments.

Methods: Between September 27th 2019 and February 9th 2020, we conducted six experiments (984 participants) to assess implicit and explicit discrimination based on race/ethnicity, sex, gender identity, sexual orientation, weight, and age. Implicit discrimination was measured by using the Brief-Implicit Association Test (B-IAT), a new validated version of the IAT developed to shorten the time needed (from ≈15 to ≈2 min) to assess implicit mental representations, while explicit discrimination was assessed using self-reported items.

Results: Among participants (mean age = 37.8), 68.6% were White Non-Hispanic; 69% were females; 76.1% were heterosexual; 90.7% were gender conforming; 52.8% were medium weight; and 41.5% had an advanced level of education. Overall, we found implicit and explicit recognition of discrimination towards all the target groups (stronger for members of the target than dominant groups). Some exceptions emerged in experiments investigating race/ethnicity and weight discrimination. In the racism experiment, only people of Color showed an implicit recognition of discrimination towards the target group, while White people were neutral. In the fatphobia experiment, participants who were not heavy showed a slight implicit recognition of discrimination towards the dominant group, while heavy participants were neutral.

Conclusions: This study provides evidence that the B-IAT is a valuable tool for quickly assessing multiple types of implicit discrimination. It shows also that implicit and explicit measures can display diverging results, thus indicating that research would benefit from the use of both these instruments. These results have important implications for the assessment of discrimination in health research as well as in social and psychological science.
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http://dx.doi.org/10.1186/s12889-021-10171-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7814653PMC
January 2021

Incidence and time-varying predictors of HIV and sexually transmitted infections among male sex workers in Mexico City.

Infect Dis Poverty 2021 Jan 19;10(1). Epub 2021 Jan 19.

Department of Health Services, Policy, and Practice, School of Public Health, Brown University, 121 South Main Street, Box G-121S-2, Providence, RI, 02912, USA.

Background: Male sex workers are at high-risk for acquisition of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). We quantified incidence rates of STIs and identified their time-varying predictors among male sex workers in Mexico City.

Methods: From January 2012 to May 2014, male sex workers recruited from the largest HIV clinic and community sites in Mexico City were tested for chlamydia, gonorrhea, syphilis, hepatitis, and HIV at baseline, 6-months, and 12-months. Incidence rates with 95% bootstrapped confidence limits were calculated. We examined potential time-varying predictors using generalized estimating equations for a population averaged model.

Results: Among 227 male sex workers, median age was 24 and baseline HIV prevalence was 32%. Incidence rates (per 100 person-years) were as follows: HIV [5.23; 95% confidence interval (CI): 2.15-10.31], chlamydia (5.15; 95% CI: 2.58-9.34), gonorrhea (3.93; 95% CI: 1.88-7.83), syphilis (13.04; 95% CI: 8.24-19.94), hepatitis B (2.11; 95% CI: 0.53-4.89), hepatitis C (0.95; 95% CI: 0.00-3.16), any STI except HIV (30.99; 95% CI: 21.73-40.26), and any STI including HIV (50.08; 95% CI: 37.60-62.55). In the multivariable-adjusted model, incident STI (excluding HIV) were lower among those who reported consistently using condoms during anal and vaginal intercourse (odds ratio = 0.03, 95% CI: 0.00-0.68) compared to those who reported inconsistently using condoms during anal and vaginal intercourse.

Conclusions: Incidence of STIs is high among male sex workers in Mexico City. Consistent condom use is an important protective factor for STIs, and should be an important component of interventions to prevent incident infections.
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http://dx.doi.org/10.1186/s40249-020-00792-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7814587PMC
January 2021

Research Priorities to End the Adolescent HIV Epidemic in the United States: Viewpoint.

JMIR Res Protoc 2021 Jan 4;10(1):e22279. Epub 2021 Jan 4.

Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.

Youth represent 21% of new HIV diagnoses in the United States. Gay, bisexual, and transgender (GBT) youth, particularly those from communities of color, and youth who are homeless, incarcerated, in institutional settings, or engaging in transactional sex are most greatly impacted. Compared with adults, youth have lower levels of HIV serostatus awareness, uptake of antiretroviral therapy (ART), and adherence. Widespread availability of ART has revolutionized prevention and treatment for both youth at high risk for HIV acquisition and youth living with HIV, increasing the need to integrate behavioral interventions with biomedical strategies. The investigators of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) completed a research prioritization process in 2019, focusing on research gaps to be addressed to effectively control HIV spread among American youth. The investigators prioritized research in the following areas: (1) innovative interventions for youth to increase screening, uptake, engagement, and retention in HIV prevention (eg, pre-exposure prophylaxis) and treatment services; (2) structural changes in health systems to facilitate routine delivery of HIV services; (3) biomedical strategies to increase ART impact, prevent HIV transmission, and cure HIV; (4) mobile technologies to reduce implementation costs and increase acceptability of HIV interventions; and (5) data-informed policies to reduce HIV-related disparities and increase support and services for GBT youth and youth living with HIV. ATN's research priorities provide a roadmap for addressing the HIV epidemic among youth. To reach this goal, researchers, policy makers, and health care providers must work together to develop, test, and disseminate novel biobehavioral interventions for youth.
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http://dx.doi.org/10.2196/22279DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813632PMC
January 2021

TransPrEP: Results from the Pilot Study of a Social Network-Based Intervention to Support PrEP Adherence Among Transgender Women in Lima, Peru.

AIDS Behav 2021 Jan 1. Epub 2021 Jan 1.

Asociacion Civil Impacta Salud y Educacion, Lima, Peru.

We conducted a pilot randomized controlled trial of a social network-based intervention to promote PrEP adherence among transgender women (TW) in Lima, Peru. We enrolled 89 TW from six social networks and cluster-randomized them 1:1 to standard of care (n = 44) or the TransPrEP intervention (n = 45). Core workshops discussed strategies to support PrEP adherence and defined group adherence objectives. Maintenance workshops discussed participants' experiences taking PrEP and collective adherence goals. At 3-month follow-up, we evaluated 40 participants and obtained 29 hair samples for tenofovir level measurements. Though no significant differences were observed, 36.4% (4/11) of participants of TransPrEP participants and 10.0% (1/10) of control participants had tenofovir levels > 0.023 ng/mg, consistent with ≥ 4 doses per week. 81.8% (9/11) of intervention and 40.0% (4/10) of control participants had any detectable tenofovir in their hair. Pilot assessment of our network-based intervention suggested a trend towards improved PrEP adherence, measured objectively, for TW in Peru.
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http://dx.doi.org/10.1007/s10461-020-03117-4DOI Listing
January 2021

The HIV Index: Using a Patient-Reported Outcome on Engagement in HIV Care to Explain Sub-Optimal Retention in Care and Virologic Control.

Clin Infect Dis 2020 Dec 29. Epub 2020 Dec 29.

Department of Medicine, University of California, San Francisco, San Francisco, CA.

Background: We investigated the prospective association between a brief self-report measure of engagement in HIV care (the Index) and suboptimal retention and viral suppression (VS) outcomes.

Methods: The CNICS cohort study combines medical record data with patient-reported outcomes from eight HIV clinics in the United States, which from April 2016-March 2017 included the 10-item Index. Multivariable logistic regression (LR) was used to estimate the risk and odds ratios of mean Index score on two outcomes in the subsequent year: 1) not keeping at least 75% of scheduled HIV care appointments, and; 2) for those with VS at Index, having viral load >200 copies/mL on at least one measurement. We also employed generalized linear mixed models (GLMM) to estimate the risk and odds ratios of appointment non-attendance or unsuppressed viral load at any given observation. We generated receiver-operator characteristic (ROC) curves for the full models overlaid with Index as a sole predictor.

Results: Mean Index score was 4.5 (SD 0.6). Higher Index scores were associated with lower relative risk of suboptimal retention (N=2,576; LR aRR 0.88, 95% CI 0.87 - 0.88; GLMM aRR 0.85, 95% CI 0.83 - 0.87 and lack of sustained VS (N=2,499; LR aRR 0.75, 95% CI 0.68 - 0.83; GLMM aRR 0.74, 95% CI 0.68 - 0.80. Areas under the ROC curve for the full models were 0.69 (95% CI = 0.67 - 0.71) for suboptimal retention and 0.76 (95% CI = 0.72 - 0.79) for lack of sustained VS.

Conclusions: Index scores are significantly associated with suboptimal retention and VS outcomes.
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http://dx.doi.org/10.1093/cid/ciaa1892DOI Listing
December 2020

HPTN 078: High Prevalence of HCV Antibodies Among Urban U.S. Men Who Have Sex with Men (MSM) Independent of HIV Status.

Clin Infect Dis 2020 Dec 21. Epub 2020 Dec 21.

Johns Hopkins University, Baltimore, MD, USA.

Background: Sexual transmission of hepatitis C virus (HCV) is uncommon, yet documented among men who have sex with men (MSM), primarily among those with HIV.

Methods: In HPTN 078, which assessed an integrated strategy to achieve HIV viral suppression, 1305 MSM were screened across four geographically diverse US cities. At screening, demographic/behavioral/psychosocial questionnaires were completed, along with HIV and HCV testing. Multivariable logistic regression was used to evaluate associations with HCV antibody positivity.

Results: Of the 1287 (99%) MSM with HCV antibody results, median age was 41, 69% were Black, 85% had a high school diploma or more, 35% were employed, 70% had HIV, and 21% had undergone substance use counseling. The median lifetime number of male sexual partners was 17 (IQR: 6, 50) and 246 (19%) were HCV antibody positive. HCV antibody positivity was high in MSM with HIV (20%) and MSM without HIV (17%) (P=0.12) and was higher in those receiving substance use counseling (36%) than those that had not (15%)(P=<0.01). Substance use counseling [OR 2.51, 95% CI 1.80-3.51] and unstable housing [OR 2.16, 95% CI 1.40-3.33] were associated with HCV antibody positivity.

Conclusion: Nearly 1 in 5 MSM screened for HPTN 078 have been infected with HCV. The prevalence is high regardless of HIV status and is high even in those who did not undergo substance use counseling. In HIV burden networks, high HCV infection prevalence may occur in MSM without HIV. As PrEP implementation expands and condom use declines, routine HCV counseling and screening among MSM is important.
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http://dx.doi.org/10.1093/cid/ciaa1869DOI Listing
December 2020

HPTN 078: High Prevalence of HCV Antibodies Among Urban U.S. Men Who Have Sex with Men (MSM) Independent of HIV Status.

Clin Infect Dis 2020 Dec 21. Epub 2020 Dec 21.

Johns Hopkins University, Baltimore, MD, USA.

Background: Sexual transmission of hepatitis C virus (HCV) is uncommon, yet documented among men who have sex with men (MSM), primarily among those with HIV.

Methods: In HPTN 078, which assessed an integrated strategy to achieve HIV viral suppression, 1305 MSM were screened across four geographically diverse US cities. At screening, demographic/behavioral/psychosocial questionnaires were completed, along with HIV and HCV testing. Multivariable logistic regression was used to evaluate associations with HCV antibody positivity.

Results: Of the 1287 (99%) MSM with HCV antibody results, median age was 41, 69% were Black, 85% had a high school diploma or more, 35% were employed, 70% had HIV, and 21% had undergone substance use counseling. The median lifetime number of male sexual partners was 17 (IQR: 6, 50) and 246 (19%) were HCV antibody positive. HCV antibody positivity was high in MSM with HIV (20%) and MSM without HIV (17%) (P=0.12) and was higher in those receiving substance use counseling (36%) than those that had not (15%)(P=<0.01). Substance use counseling [OR 2.51, 95% CI 1.80-3.51] and unstable housing [OR 2.16, 95% CI 1.40-3.33] were associated with HCV antibody positivity.

Conclusion: Nearly 1 in 5 MSM screened for HPTN 078 have been infected with HCV. The prevalence is high regardless of HIV status and is high even in those who did not undergo substance use counseling. In HIV burden networks, high HCV infection prevalence may occur in MSM without HIV. As PrEP implementation expands and condom use declines, routine HCV counseling and screening among MSM is important.
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http://dx.doi.org/10.1093/cid/ciaa1869DOI Listing
December 2020

NIH Workshop on HIV-Associated Comorbidities, Coinfections, and Complications: Summary and Recommendation for Future Research.

J Acquir Immune Defic Syndr 2021 Jan;86(1):11-18

Regional Alliance Sustainable Development, Kigali, Rwanda.

Background: With potent antiretroviral therapy and simplified regimens, people living with HIV (PWH) are achieving near-normal lifespans but not necessarily a normal health span or healthy aging. PWH have a higher than expected risk of developing a number of non-AIDS comorbidities, coinfections, and complications (CCC), often against a background of stigma, poverty, and isolation.

Setting: To gain a better understanding of research needs for HIV-associated CCC, the NIH convened a 2-day workshop (HIV-associated CCC, or HIV ACTION).

Methods: A cross-institute NIH planning committee identified 6 key research areas: epidemiology and population research, pathogenesis and basic science research, clinical research, implementation science research, syndemics research and international research in low and middle income countries. Investigators were selected to lead working groups (WGs) to assess the state-of-the-art and identify 3-5 priority areas in each field before the workshop. A 2-day program at the NIH was developed which included presentations by invited experts and WG members.

Results: Over 400 participants attended the workshop. After general and individual WG discussions, the most pressing gaps, questions, or proposed action items were identified. Priority lists of pressing research issues were presented by cochairs of each WG. A detailed report is posted at the NHLBI website. This article reports the streamlined priority list and a summary of WG discussions to inform investigators of current priorities in the field.

Conclusion: Collaborative efforts of many disciplines are needed to improve the health and wellbeing of PWH. Several common themes emerged across WG representing potential priorities for investigators and recommendations for the NIH.
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http://dx.doi.org/10.1097/QAI.0000000000002528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982002PMC
January 2021