Are persons living with diagnosed HIV capable of mounting a strong inflammatory response to the new coronavirus?

BACKGROUND: The impact of COVID-19 on persons living with diagnosed HIV (PLWDH) remains incompletely understood. It's unclear whether an impaired immune system offers protection against mounting cytokine storm. METHODS: Retrospective matched cohort study of COVID-19 hospitalized individuals in New York State (NYS). Medical records were abstracted and analyzed for 853 PLWDH hospitalized with COVID-19 in NYS and 1621 HIV-negative controls. Preexisting comorbidities and inflammatory markers measured within 24 h of hospital admission were abstracted. RESULTS: PLWDH were significantly less likely to have elevated inflammatory markers compared to matched controls. Elevated WBC occurred in 23.3% of PLWDH vs 30.1% of controls (p = .0002), elevated CRP in 37.4% of PLWDH vs 43.2% of controls (p = .03), elevated ferritin in 73.4% of PLWDH vs 78.9% of controls (p = .004). There was an inverse but not statistically significant relationship between the frequency of elevated inflammatory markers and HIV disease stage, with greatest percent of PLWDH with elevated WBC, LDH, CRP, and ferritin among PLWDH with HIV disease stage 1. CONCLUSION: PLWDH had lower inflammatory marker elevation during COVID-19 infection compared to matched controls. PLWDH with low CD4 were less likely to mount a cytokine storm in the setting of impaired immune function.

Development of a Mission-Driven Research Agenda to Support Efforts to End Epidemics.

CONTEXT: New York State continues efforts to end the AIDS and hepatitis C epidemics and reduce new infections of sexually transmitted infections. PROGRAM: In 2022, the New York State Department of Health AIDS Institute released its first-ever Research Agenda. This Research Agenda was systematically developed following input from internal and external research and community stakeholders. We used a participatory and iterative process to prioritize research knowledge gaps related to HIV/AIDS; sexual health and sexually transmitted infections; hepatitis C; lesbian, gay, bisexual, transgender health; drug user health; health equity; and emerging issues such as COVID-19. Questions were prioritized on the basis of the alignment with the following 5 criteria: magnitude of impact; funding and resources; feasibility of conducting research; translatability; and addresses an internal priority area. Findings are anticipated to generate actionable results that can be readily translatable into programs, policies, and practices. IMPLEMENTATION: This Research Agenda includes 79 research and program evaluation questions prioritized for internally led and collaborative research. Efforts on 35 of the 61 internally led questions and funding of 11 collaborative research projects related to Research Agenda priorities began in 2022. EVALUATION: An evaluation survey was conducted among all stakeholders involved in the prioritization process. All were satisfied or very satisfied with the process, and results yielded recommendations for future processes including weighting of questions relative to one another within each focus area and other suggestions to streamline the process. In year 1, 10 of the 35 questions were completed. DISCUSSION: Lessons learned include use of a participatory process to facilitate support and completion of Research Agenda, prioritize research questions to maximize impact and translatability, streamline the prioritization process by restricting proposed questions to those with clear potential for innovative research, emphasize anticipated resources necessary to implement the Research Agenda to set a realistic and actionable plan, and adaptability toward shifting priorities.

COVID-19 Vaccination and Hospitalization Among Persons Living With Diagnosed HIV in New York State.

BACKGROUND: Persons living with diagnosed HIV (PLWDH) have higher COVID-19 diagnoses rates and poorer COVID-19-related outcomes than persons living without diagnosed HIV. The intersection of COVID-19 vaccination status and likelihood of severe COVID-19 outcomes has not been fully investigated for PLWDH. SETTING: New York State (NYS). METHODS: We matched HIV surveillance, immunization, and hospitalization databases to compare COVID-19 vaccination and COVID-19-related hospitalizations among PLWDH during B.1.617.2 (Delta) and B.1.1.529 (Omicron) predominance. RESULTS: Through March 4, 2022, 69,137 of the 101,205 (68%) PLWDH were fully vaccinated or boosted for COVID-19. PLWDH who were virally suppressed or in care were more often to be fully vaccinated or boosted compared with PLWDH who were not virally suppressed (77% vs. 44%) or without evidence of care (74% vs. 33%). Overall hospitalization rates were lower among virally suppressed PLWDH. During Delta predominance, PLWDH with any vaccination history who were in care had lower hospitalization rates compared with those not in care; during Omicron predominance, this was the case only for boosted PLWDH. CONCLUSIONS: Approximately 28% (28,255) of PLWDH in NYS remained unvaccinated for COVID-19, a rate roughly double of that observed in the overall adult NYS population. PLWDH of color were more often than non-Hispanic White persons to be unvaccinated, as were the virally unsuppressed and those without evidence of HIV-related care, threatening to expand existing disparities in COVID-19-related outcomes. Vaccination was protective against COVID-19-related hospitalizations for PLWDH; however, differences in hospitalization rates between fully vaccinated and unvaccinated PLWDH were smaller than those among all New Yorkers.

Geospatial Prioritization to Reach Hispanic or Latino and Other Priority Populations Through HIV Home Testing Services.

CONTEXT: Hispanic or Latino men who have sex with men (HLMSM) are disproportionately affected by the HIV/AIDS epidemic in New York State (NYS) and nationally. In 2019, HLMSM comprised 13% of all new diagnoses and 21% of new diagnoses among men who have sex with men (MSM) in NYS excluding New York City. HIV home testing programs are effective methods for increasing HIV testing. OBJECTIVE: This pilot sought to determine whether the NYS HIV Home Test Giveaway (HHTG) can effectively reach priority populations, specifically HLMSM/transgender/gender nonconforming persons who have sex with men, to increase uptake of HIV home testing services and identify new HIV infections. DESIGN/SETTING: We recruited participants using media campaigns linked to a brief self-administered eligibility survey. Eligible participants provided their e-mail address to receive a code for a free HIV home test and were sent a self-administered follow-up survey 4 to 11 weeks after eligibility survey completion. PARTICIPANTS: The 2018 and 2019 NYS HHTG reached 1214 and 1340 participants, respectively. A total of 606 participants in 2018 and 736 participants in 2019 were eligible to receive the HHTG home test kit. MAIN OUTCOME MEASURES: HHTG utilization and test results. RESULTS: Hispanic or Latino persons participated at higher rates (34.8% and 25.4% in 2018 and 2019, respectively) than the percentage of Hispanic men in prioritized zip codes (15.7% and 15.6% in 2018 and 2019, respectively). The majority of participants who received HHTG test kits used them to test themselves (87.5% in 2018 and 90.6% in 2019). Across both rounds, 4 participants reported new HIV-positive results, for a seropositivity rate of approximately 1%. CONCLUSION: Geospatial prioritization was successful in reaching Hispanic or Latino priority populations for HIV testing. HIV self-testing programs such as the HHTG are beneficial methods to reach priority populations for state and national Ending the HIV Epidemic initiatives.

Factors associated with SARS-CoV-2-related hospital outcomes among and between persons living with and without diagnosed HIV infection in New York State.

BACKGROUND: Persons living with diagnosed HIV (PLWDH) are at increased risk for severe illness due to COVID-19. The degree to which this due to HIV infection, comorbidities, or other factors remains unclear. METHODS: We conducted a retrospective matched cohort study of individuals hospitalized with COVID-19 in New York State between March and June 2020, during the first wave of the pandemic, to compare outcomes among 853 PLWDH and 1,621 persons without diagnosed HIV (controls). We reviewed medical records to compare sociodemographic and clinical characteristics at admission, comorbidities, and clinical outcomes between PLWDH and controls. HIV-related characteristics were evaluated among PLWDH. RESULTS: PLWDH were significantly more likely to have cardiovascular (matched prevalence-ratio [mPR], 1.22 [95% CI, 1.07-1.40]), chronic liver (mPR, 6.71 [95% CI, 4.75-9.48]), chronic lung (mPR, 1.76 [95% CI, 1.40-2.21]), and renal diseases (mPR, 1.77 [95% CI, 1.50-2.09]). PLWDH were less likely to have elevated inflammatory markers upon hospitalization. Relative to controls, PLWDH were 15% less likely to require mechanical ventilation or extracorporeal membrane oxygenation (ECMO) and 15% less likely to require admission to the intensive care unit. No significant differences were found in in-hospital mortality. PLWDH on tenofovir-containing regimens were significantly less likely to require mechanical ventilation or ECMO (risk-ratio [RR], 0.73 [95% CI, 0.55-0.96]) and to die (RR, 0.74 [95% CI, 0.57-0.96]) than PLWDH on non-tenofovir-containing regimens. CONCLUSIONS: While hospitalized PLWDH and controls had similar likelihood of in-hospital death, chronic disease profiles and degree of inflammation upon hospitalization differed. This may signal different mechanisms leading to severe COVID-19.

Effects of Condom Use on Human Immunodeficiency Virus Transmission Among Adolescent Sexual Minority Males in the United States: A Mixed Epidemiology and Epidemic Modeling Study.

BACKGROUND: We examined condom use patterns and potential population-level effects of a hypothetical condom intervention on human immunodeficiency virus (HIV) transmission among adolescent sexual minority males (ASMM). METHODS: Using 3 data sets: national Youth Risk Behavior Survey 2015 to 2017 (YRBS-National), local YRBS data from 8 jurisdictions with sex of partner questions from 2011 to 2017 (YRBS-Trends), and American Men's Internet Survey (AMIS) 2014 to 2017, we assessed associations of condom use with year, age, and race/ethnicity among sexually active ASMM. Using a stochastic agent-based network epidemic model, structured and parameterized based on the above analyses, we calculated the percent of HIV infections averted over 10 years among ASMM ages 13 to 18 years by an intervention that increased condom use by 37% for 5 years and was delivered to 62% of ASMM at age 14 years. RESULTS: In YRBS, 51.8% (95% confidence interval [CI], 41.3-62.3%) and 37.9% (95% CI, 32.7-42.3%) reported condom use at last sexual intercourse in national and trend data sets, respectively. In AMIS, 47.3% (95% CI, 44.6-49.9%) reported condom use at last anal sex with a male partner. Temporal trends were not observed in any data set (P > 0.1). Condom use varied significantly by age in YRBS-National (P < 0.0001) and YRBS-Trends (P = 0.032) with 13- to 15-year-olds reporting the lowest use in both; age differences were not significant in AMIS (P = 0.919). Our hypothetical intervention averted a mean of 9.0% (95% simulation interval, -5.4% to 21.2%) of infections among ASMM. CONCLUSIONS: Condom use among ASMM is low and appears to have remained stable during 2011 to 2017. Modeling suggests that condom use increases, consistent with previous interventions, have potential to avert 1 in 11 new HIV infections among ASMM.

Impacts of Changing Sexual Behavior on Chlamydia and Gonorrhea Burden Among US High School Students, 2007 to 2017.

BACKGROUND: Rates of adolescent sexual activity have long been declining in the United States. We sought to estimate the number of cases of gonorrhea and chlamydia averted over 1 decade associated with these declines and associated costs saved. METHODS: We analyzed data from the Centers for Disease Control and Prevention's Youth Risk Behavior Survey of US high school students from 2007 to 2017 and combined it with epidemiological estimates drawn from the literature to parameterize a dynamic population transmission model. We compared transmissions from observed behavioral trends with a counterfactual scenario that assumed sexual behaviors from 2007 remained constant for 10 years. We calculated outcomes by age and for 3 racial/ethnic groups (Hispanic, non-Hispanic Black, and non-Hispanic White adolescents) who vary on underlying burden and amount of behavioral change. RESULTS: We estimated 1,118,483 cases of chlamydia and 214,762 cases of gonorrhea were averted (19.5% of burden across all ages). This yielded $474 million (2017 dollars) savings in medical costs over the decade. The largest number of averted cases (767,543) was among Black adolescents, but the largest proportion (28.7%) was among Hispanic adolescents. CONCLUSIONS: Whatever its origins, changing sexual behavior among adolescents results in large estimated reductions in STI burden and medical costs relative to previous cohorts. Although diagnoses among adolescents have not declined at this rate, multiple explanations could make these apparently divergent trends consistent. Efforts to continue supporting effective sex education in and out of school along with STI screening for adolescents should reinforce these gains.

Monitoring Coronavirus Disease 2019 (COVID-19) Through Trends in Influenza-like Illness, Laboratory-confirmed Influenza, and COVID-19-New York State, Excluding New York City, 1 January 2020-12 April 2020.

Innovative monitoring approaches are needed to track the coronavirus disease 2019 (COVID-19) epidemic and potentially assess the impact of community mitigation interventions. We present temporal data on influenza-like illness, influenza diagnosis, and COVID-19 cases for all 4 regions of New York State through the first 6 weeks of the outbreak.

Assessing the cost-utility of preferentially administering Heplisav-B vaccine to certain populations.

Vaccination is the primary strategy to prevent hepatitis B virus (HBV) infection in the United States. Prior to 2017, most standard hepatitis B vaccine schedules required 3 doses over 6 months. Heplisav-B, approved in 2017, is administered in 2 doses over a 1 month time period but has a higher per-dose cost ($115.75 per dose compared to $57.25 per Engerix-B dose, costs as of June 1, 2019). We aimed to assess the cost-utility of providing the two-dose Heplisav-B vaccine compared to a three-dose Engerix-B vaccine among adult populations currently recommended for vaccination against hepatitis B. We used a decision-tree model with microsimulation and a Markov disease progression process to assess the cost-utility separately for the following populations: adults with diabetes, obesity, chronic kidney disease, HIV; non-responders to previous hepatitis B vaccination; older adults; and persons who inject drugs (PWID). We modeled epidemiologic outcomes (incident HBV infections, sequelae and related deaths), costs (2019 USD) and benefits (quality-adjusted life years, QALYs) and compared them across strategies. Sensitivity analyses assessed the cost-utility at varying estimates of Heplisav-B efficacy. In the base case scenario for each population, vaccination with Heplisav-B resulted in fewer HBV infections (37.5-59.8% averted), sequelae, and HBV-related deaths (36.3-71.4% averted). Heplisav-B resulted in decreased costs and increased benefits compared to Engerix-B for all populations except non-responders. Incremental costs from the baseline strategy ranged from $4746.78 saved (PWID) to $14.15 added cost (non-responders). Incremental benefits per person ranged from 0.00005 QALYs (older adults) to 0.7 QALYs (PWID). For persons with HIV and PWID, Heplisav-B resulted in lower costs and increased benefits in all scenarios in which Heplisav-B series efficacy was at least 80%. Vaccination using Heplisav-B is a cost-saving strategy compared to Engerix-B for adults with diabetes, chronic kidney disease, obesity, and HIV; older adults; and PWID.

Use of Population-Based Surveys for Estimating the Population Size of Persons Who Inject Drugs in the United States.

BACKGROUND: In the United States, injection is an increasingly common route of administration for opioids and other substances. Estimates of the number of persons who inject drugs (PWID) are needed for monitoring risk-specific infectious disease rates and health services coverage. METHODS: We reviewed design and instruments for 4 national household surveys, 2012-2016, for their ability to produce unbiased injection drug use (IDU) prevalence estimates. We explored potential analytic adjustments for reducing biases through use of external data on (1) arrest, (2) narcotic overdose mortality, and (3) biomarker-based sensitivity of self-reported illicit drug use. RESULTS: Estimated national past 12 months IDU prevalence ranged from 0.24% to 0.59% across surveys. All surveys excluded unstably housed and incarcerated persons, and estimates were based on <60 respondents reporting IDU behavior in 3 surveys. No surveys asked participants about nonmedical injection of prescription drugs. Analytic adjustments did not appreciably change IDU prevalence estimates due to suboptimal specificity of data points. CONCLUSIONS: PWID population size estimates in the United States are based on small numbers and are likely biased by undercoverage of key populations and self-report. Novel methods as discussed in this article may improve our understanding of PWID population size and their health needs.

Predicting the impact of sexual behavior change on adolescent STI in the US and New York State: a case study of the teen-SPARC tool.

PURPOSE: Adolescents aged 13-18 years bear a large burden of sexually transmitted infections (STIs) and changing adolescent sexual risk behavior is a key component of reducing this burden. We demonstrate a novel publicly available modeling tool (teen-SPARC) to help state and local health departments predict the impact of behavioral change on gonorrhea, chlamydia, and HIV burden among adolescents. METHODS: Teen-SPARC is built in Excel for familiarity and ease and parameterized using data from CDC's Youth Risk Behavior Surveillance System. We present teen-SPARC's methods, including derivation of national parameters and instructions to obtain local parameters. We model multiple scenarios of increasing condom use and estimate the impact on gonorrhea, chlamydia, and HIV incidence, comparing national and New York State (NYS) results. RESULTS: A 1% annual increase in condom use (consistent with Healthy People 2020 goals) could prevent nearly 10,000 cases of STIs nationwide. Increases in condom use of 17.1%, 2.2%, and 25.5% in NYS would be necessary to avert 1000 cases of gonorrhea, 1000 cases of chlamydia, and 10 cases of HIV infection, respectively. Additional results disaggregate outcomes by age, sex, partner sex, jurisdiction, and pathogen. CONCLUSION: Teen-SPARC may be able to assist health departments aiming to tailor behavioral interventions for STI prevention among adolescents.

Cumulative incidence and diagnosis of SARS-CoV-2 infection in New York.

PURPOSE: New York State (NYS) is an epicenter of the SARS-CoV-2 pandemic in the United States. Reliable estimates of cumulative incidence in the population are critical to tracking the extent of transmission and informing policies. METHODS: We conducted a statewide seroprevalence study in a 15,101 patron convenience sample at 99 grocery stores in 26 counties throughout NYS. SARS-CoV-2 cumulative incidence was estimated from antibody reactivity by first poststratification weighting and then adjusting by antibody test characteristics. The percent diagnosed was estimated by dividing the number of diagnoses by the number of estimated infection-experienced adults. RESULTS: Based on 1887 of 15,101 (12.5%) reactive results, estimated cumulative incidence through March 29 was 14.0% (95% confidence interval [CI]: 13.3%-14.7%), corresponding to 2,139,300 (95% CI: 2,035,800-2,242,800) infection-experienced adults. Cumulative incidence was highest in New York City 22.7% (95% CI: 21.5%-24.0%) and higher among Hispanic/Latino (29.2%), non-Hispanic black/African American (20.2%), and non-Hispanic Asian (12.4%) than non-Hispanic white adults (8.1%, P < .0001). An estimated 8.9% (95% CI: 8.4%-9.3%) of infections in NYS were diagnosed, with diagnosis highest among adults aged 55 years or older (11.3%, 95% CI: 10.4%-12.2%). CONCLUSIONS: From the largest U.S. serosurvey to date, we estimated >2 million adult New York residents were infected through late March, with substantial disparities, although cumulative incidence remained less than herd immunity thresholds. Monitoring, testing, and contact tracing remain essential public health strategies.

Multisystem Inflammatory Syndrome in Children in New York State.

BACKGROUND: A multisystem inflammatory syndrome in children (MIS-C) is associated with coronavirus disease 2019. The New York State Department of Health (NYSDOH) established active, statewide surveillance to describe hospitalized patients with the syndrome. METHODS: Hospitals in New York State reported cases of Kawasaki's disease, toxic shock syndrome, myocarditis, and potential MIS-C in hospitalized patients younger than 21 years of age and sent medical records to the NYSDOH. We carried out descriptive analyses that summarized the clinical presentation, complications, and outcomes of patients who met the NYSDOH case definition for MIS-C between March 1 and May 10, 2020. RESULTS: As of May 10, 2020, a total of 191 potential cases were reported to the NYSDOH. Of 95 patients with confirmed MIS-C (laboratory-confirmed acute or recent severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection) and 4 with suspected MIS-C (met clinical and epidemiologic criteria), 53 (54%) were male; 31 of 78 (40%) were black, and 31 of 85 (36%) were Hispanic. A total of 31 patients (31%) were 0 to 5 years of age, 42 (42%) were 6 to 12 years of age, and 26 (26%) were 13 to 20 years of age. All presented with subjective fever or chills; 97% had tachycardia, 80% had gastrointestinal symptoms, 60% had rash, 56% had conjunctival injection, and 27% had mucosal changes. Elevated levels of C-reactive protein, d-dimer, and troponin were found in 100%, 91%, and 71% of the patients, respectively; 62% received vasopressor support, 53% had evidence of myocarditis, 80% were admitted to an intensive care unit, and 2 died. The median length of hospital stay was 6 days. CONCLUSIONS: The emergence of multisystem inflammatory syndrome in children in New York State coincided with widespread SARS-CoV-2 transmission; this hyperinflammatory syndrome with dermatologic, mucocutaneous, and gastrointestinal manifestations was associated with cardiac dysfunction.

Hepatitis C Virus Prevalence in 50 U.S. States and D.C. by Sex, Birth Cohort, and Race: 2013-2016.

Hepatitis C virus (HCV) infection is a leading cause of liver-related morbidity and mortality, and more than 2 million adults in the United States are estimated to be currently infected. Reducing HCV burden will require an understanding of demographic disparities and targeted efforts to reduce prevalence in populations with disproportionate disease rates. We modeled state-level estimates of hepatitis C prevalence among U.S. adults by sex, birth cohort, and race during 2013-2016. National Health and Nutrition Examination Survey data were used in combination with state-level HCV-related and narcotic overdose-related mortality data from the National Vital Statistics System and estimates from external literature review on populations not sampled in the National Health and Nutrition Examination Survey. Nationally, estimated hepatitis C prevalence was 1.3% among males and 0.6% among females (prevalence ratio [PR] = 2.3). Among persons born during 1945 to 1969, prevalence was 1.6% compared with 0.5% among persons born after 1969 (PR = 3.2). Among persons born during 1945 to 1969, prevalence ranged from 0.7% in North Dakota to 3.6% in Oklahoma and 6.8% in the District of Columbia. Among persons born after 1969, prevalence was more than twice as high in Kentucky, New Mexico, Oklahoma, and West Virginia compared with the national average. Hepatitis C prevalence was 1.8% among non-Hispanic black persons and 0.8% among persons of other races (PR = 2.2), and the magnitude of this disparity varied widely across jurisdictions (PR range: 1.3-7.8). Overall, 23% of prevalent HCV infections occurred among non-Hispanic black persons, whereas 12% of the population was represented by this racial group. These estimates provide information on prevalent HCV infections that jurisdictions can use for understanding and monitoring local disease patterns and racial disparities in burden of disease.

Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex.

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.

Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data.

BACKGROUND: Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse. OBJECTIVE: The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial. METHODS: This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference. RESULTS: The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months. CONCLUSIONS: This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12205.

Levels of clinical condom failure for anal sex: A randomized cross-over trial.

BACKGROUND: Men who have sex with men (MSM) face a 28-fold higher risk of HIV acquisition than men who have sex with women (MSW). Condoms are the most accessible prevention method, with billions produced annually. Due to potentially high clinical failure, international regulatory agencies do not approve condoms for anal sex. This trial sought to provide data regarding approval of condoms for anal sex. METHODS: We conducted a blinded, crossover randomized trial among MSM and MSW in Atlanta, Georgia, USA. Crossover conditions were standard condoms, thin condoms, and condoms fitted to each user's penile dimensions. The primary outcome was total clinical failure (slippage and/or breakage), assessed using an intention-to-treat analysis. A mixed methods model assessed differences in odds of failure. The study is registered with ClinicalTrials.gov, NCT02753842, and is completed. FINDINGS: We enrolled 252 MSM and 252 MSW between May 19, 2016 and May 2, 2017. Participants reported a total of 4884 anal or vaginal sex acts using study-provided condoms. For all crossover conditions, clinical failure was lower for anal sex (0•7%, 16/2351) than for vaginal sex (1•9%, 48/2533), (odds ratio 0•40, 95% confidence interval 0•21, 0•75, p < â€¢001)00. There was no difference in odds of failure for anal sex acts between the different types of condoms. Due to study design, nearly all anal sex acts used condom-compatible lubricant (98•3%), yet only a minority of vaginal sex acts (41•6%) used lubricant. Sex acts for which lubricant was used had lower failure for both anal and vaginal sex, with no difference in odds of failure between them. INTERPRETATION: In the largest trial of effectiveness of condoms for anal sex to date, we found remarkably low levels of failure. Condoms should be approved by regulatory agencies for anal sex. Clinicians may recommend condoms as a highly efficacious HIV and STD prevention tool for anal sex. Differences between failure for anal and vaginal sex were likely due to differential use of lubricant. Condom promotion programs should consider providing additional lubricant for all condoms distributed.