Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples.

BACKGROUND: The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses. OBJECTIVE: We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology. METHODS: Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens. RESULTS: The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants. CONCLUSIONS: Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic.

The Prevalence of Sexual Behavior Stigma Affecting Gay Men and Other Men Who Have Sex with Men Across Sub-Saharan Africa and in the United States.

BACKGROUND: There has been increased attention for the need to reduce stigma related to sexual behaviors among gay men and other men who have sex with men (MSM) as part of comprehensive human immunodeficiency virus (HIV) prevention and treatment programming. However, most studies focused on measuring and mitigating stigma have been in high-income settings, challenging the ability to characterize the transferability of these findings because of lack of consistent metrics across settings. OBJECTIVE: The objective of these analyses is to describe the prevalence of sexual behavior stigma in the United States, and to compare the prevalence of sexual behavior stigma between MSM in Southern and Western Africa and in the United States using consistent metrics. METHODS: The same 13 sexual behavior stigma items were administered in face-to-face interviews to 4285 MSM recruited in multiple studies from 2013 to 2016 from 7 Sub-Saharan African countries and to 2590 MSM from the 2015 American Men's Internet Survey (AMIS), an anonymous Web-based behavioral survey. We limited the study sample to men who reported anal sex with a man at least once in the past 12 months and men who were aged 18 years and older. Unadjusted and adjusted prevalence ratios were used to compare the prevalence of stigma between groups. RESULTS: Within the United States, prevalence of sexual behavior stigma did not vary substantially by race/ethnicity or geographic region except in a few instances. Feeling afraid to seek health care, avoiding health care, feeling like police refused to protect, being blackmailed, and being raped were more commonly reported in rural versus urban settings in the United States (P<.05 for all). In the United States, West Africa, and Southern Africa, MSM reported verbal harassment as the most common form of stigma. Disclosure of same-sex practices to family members increased prevalence of reported stigma from family members within all geographic settings (P<.001 for all). After adjusting for potential confounders and nesting of participants within countries, AMIS-2015 participants reported a higher prevalence of family exclusion (P=.02) and poor health care treatment (P=.009) as compared with participants in West Africa. However, participants in both West Africa (P<.001) and Southern Africa (P<.001) reported a higher prevalence of blackmail. The prevalence of all other types of stigma was not found to be statistically significantly different across settings. CONCLUSIONS: The prevalence of sexual behavior stigma among MSM in the United States appears to have a high absolute burden and similar pattern as the same forms of stigma reported by MSM in Sub-Saharan Africa, although results may be influenced by differences in sampling methodology across regions. The disproportionate burden of HIV is consistent among MSM across Sub-Saharan Africa and the United States, suggesting the need in all contexts for stigma mitigation interventions to optimize existing evidence-based and human-rights affirming HIV prevention and treatment interventions.

Rates of Prevalent HIV Infection, Prevalent Diagnoses, and New Diagnoses Among Men Who Have Sex With Men in US States, Metropolitan Statistical Areas, and Counties, 2012-2013.

BACKGROUND: In the United States, men who have sex with men (MSM) increasingly represent the majority of people living with and acquiring human immunodeficiency virus (HIV) infection. Local and federal surveillance programs estimate the number of persons living with an HIV diagnosis, persons living with HIV infection, and new diagnoses. Given the absence of population-based estimates of the number of MSM for US states, metropolitan statistical areas (MSAs), or counties, it is not possible to accurately estimate rates using these indicators at these levels, inhibiting the ability to understand HIV burden and to direct prevention efforts. OBJECTIVE: To synthesize recently published estimates of MSM population size with publicly available HIV surveillance data, in order to estimate the prevalence of HIV diagnosis and infection and the rate of new diagnoses, at the national, state, MSA, and county levels. METHODS: The number of MSM living with HIV infection in 2012 (prevalence), living with an HIV diagnosis in 2012 (diagnosed prevalence), and newly diagnosed with HIV infection in 2013 (new diagnosis), at state, MSA, and county levels, were obtained from publicly available data from AIDSVu.org and the US Centers for Disease Control and Prevention. The estimated number of MSM living in every US county was calculated using recently published methodology that utilized data from the National Health and Nutrition Examination Survey and American Community Survey. Estimated county-level MSM counts were aggregated to form MSA- and state-level totals. From this, we estimated HIV prevalence, diagnosed prevalence, and new diagnosis rates. RESULTS: The estimated HIV prevalence among MSM in the United States in 2012 was 15.0% (666,900/4,452,772), the diagnosed HIV prevalence in 2012 was 11.1% (493,453/4,452,772), and the new diagnosis rate for 2013 was 0.7 per 100 MSM. For diagnosed prevalence at the state level, 6 states had both <15,000 cases and diagnosed prevalence rates of ≥15%, all in the South. Five highly populated states had ≥15,000 cases and rates between 10% and 15%. Georgia was the only state with ≥15,000 cases and ≥15% diagnosed prevalence rate. Of the 25 MSAs with the highest diagnosed prevalence rates in the United States, 21 were in the South and 6 had diagnosed prevalence of ≥25%. County-level data showed high diagnosed prevalence rates in both urban and rural counties of the South. CONCLUSIONS: HIV infection is hyperendemic among MSM in many areas of the United States, particularly in the South. Our data emphasize the priorities for HIV prevention and care set forth in the United States National HIV/AIDS Strategy (NHAS) and provide updatable local estimates of NHAS indicators. Jurisdictions can use these results to direct resources, programs, and policies to optimally benefit the health of MSM.

The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: Protocol and Key Indicators Report 2013.

BACKGROUND: Men who have sex with men (MSM) are disproportionately affected by human immunodeficiency virus (HIV) and there is evidence that this population is participating in increasingly risky sexual behavior. These changes are occurring in the context of new modes of online social interaction-many MSM now report first meeting their sex partners on the Internet. Better monitoring of key behavioral indicators among MSM requires the use of surveillance strategies that capitalize on these new modes of interaction. Therefore, we developed an annual cross-sectional behavioral survey of MSM in the United States, the American Men's Internet Survey (AMIS). OBJECTIVE: The purpose of this paper was to provide a description of AMIS methods. In addition we report on the first cycle of data collection (December 2013 through May 2014; AMIS-2013) on the same key indicators used for national HIV behavioral surveillance. METHODS: AMIS-2013 recruited MSM from a variety of websites using banner advertisements or email blasts. Adult men currently residing in the United States were eligible to participate if they had ever had sex with a man. We examined demographic and recruitment characteristics using multivariable regression modeling (P<.05) stratified by the participants' self-reported HIV status. RESULTS: In the AMIS-2013 round, 79,635 persons landed on the study page and 14,899 were eligible, resulting in 10,377 completed surveys from MSM representing every US state. Participants were mainly white, 40 years or older, living in the US South, living in urban areas, and recruited from a general social networking website. Self-reported HIV prevalence was 10.73% (n=1113). Compared to HIV-negative/unknown status participants, HIV-positive participants were more likely to have had anal sex without a condom with any male partner in the past 12 months (72.24% versus 61.24%, respectively; P<.001) and more likely to have had anal sex without a condom with their last male sex partner who was discordant/unknown HIV status (42.95% versus 13.62%, respectively; P<.001). Illicit substance use in the past 12 months was more likely to be reported by HIV-positive participants than HIV-negative/unknown status participants (39.17% versus 26.85%, respectively; P<.001). The vast majority of HIV-negative/unknown status participants (84.05%) had been previously HIV tested, but less than half (44.20%) had been tested in the past 12 months. Participants 18-24 years of age were more likely than those 40 years or older to have had anal sex without a condom with a discordant/unknown HIV status partner, were more likely to report substance use, and were less likely to have been HIV tested. Compared to general social networking, those from a geospatial social networking website were more likely to have reported all risk behaviors but were more likely to have been HIV tested. CONCLUSIONS: The first round of AMIS generated useful behavioral measures from more than 10,000 MSM Internet users. Preliminary findings identified some subgroups of MSM Internet users that are at potentially higher risk of HIV acquisition/transmission. AMIS will provide an ongoing data source for examining trends in sexual risk behavior of MSM. This will help to plan and monitor the impact of programs to improve this population's health.