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BackgroundHIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. ObjectiveThis paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. MethodsProject DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. ResultsBetween September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. ConclusionsStudies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. International Registered Report Identifier (IRRID)RR1-10.2196/16332

BackgroundGroup sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking platforms. However, collecting data on GSEs can be challenging, and many gaps exist in our knowledge about GSE participation among MSM. ObjectiveThe objective of this study was to develop survey questions addressing aggregate and partner-specific group sex behaviors to measure prevalence of GSEs and associated risks in persons participating in Project Diagnostic Evaluation To Expand Critical Testing Technologies (DETECT), including MSM seeking HIV and STD testing at a public clinic in Seattle, Washington. MethodsWe developed a computer self-assisted survey that included questions about participant demographics, sexual history, and risk behaviors, including group sex, as a part of Project DETECT, a Centers for Disease Control and Prevention–funded study evaluating point-of-care HIV tests. Aggregate and partner-specific questions asked about participation in all GSEs, threesomes, and four-or-more-somes including questions about number and HIV status of sex partners and condom use during the events. To evaluate question performance, we assessed the discrepancies in reporting between the aggregate and partner-specific questions, quantified question refusal rates, and calculated the additional time required to answer the GSE questions. Information about network density (number of partnerships of overlapping duration) was estimated and compared for MSM who did and did not report GSEs. ResultsAmong 841 visits by 690 MSM who were asked any group sex survey question, participation in a GSE of any type in the past 3 months was reported at 293 visits (293/841, 34.8%). We found that 9.0% (76/841) of MSM in the sample reported ≥1 four-or-more-some in the partner-specific questions but did not report in the aggregate. The proportion of refusals on any given aggregate GSE-related question ranged from 0% (0/273) to 10.6% (15/141) (median 2.6%) and partner-specific questions ranged from 0% (0/143) to 22% (5/23) (median 3.0%), with questions about four-or-more-somes having the highest proportions of refusals. Completing the aggregate group sex questions added 1 to 2 minutes and the partner-specific questions added an additional 2 to 4 minutes per partner to the total survey length. As expected, the partner-specific GSE questions documented higher density of sexual networks that was not captured by asking about total partner counts and overlap of specific partnerships. ConclusionsWe found that the Project DETECT survey was able to obtain nuanced information about GSEs. The question skip patterns and consistency checks were effective, and survey fatigue was minimal. More research is needed on GSEs, and our survey represents a promising data collection tool to help fill gaps in knowledge about the subject.

Introduction: HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness of a self-testing programme. Methods: Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States. Participants were randomly assigned either to the self-testing arm or the control arm. All participants received information on HIV testing services and locations in their community. Self-testing participants received up to four self-tests each quarter, which they could use themselves or distribute to their social network associates. Quarterly follow-up surveys collected testing outcomes, including number of tests used and new HIV diagnoses. Using trial expenditure data, we estimated the cost of implementing a self-testing programme. Primary outcomes of this analysis included total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved. Results: A total of 2665 men were assigned either to the self-testing arm (n = 1325) or the control arm (n = 1340). HIV testing was reported by 971 self-testing participants who completed a total of 5368 tests. In the control arm, 619 participants completed 1463 HIV tests. The self-testing participants additionally distributed 2864 self-tests to 2152 social network associates. Testing during the trial identified 59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV. The implementation cost of the HIV self-testing programme was $449,510. The cost per self-test completed, cost per person tested at least once, and incremental cost per new HIV diagnosis was $61, $145 and $9365 respectively. We estimated that self-testing programme potentially averted 3.34 transmissions, saved 14.86 QALYs and nearly $1.6 million lifetime HIV treatment costs. Conclusions: The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving. Keywords: HIV self-testing; social networks; costs and cost-effectiveness; costing methods; clinical trial expenditures; United States, 1 | INTRODUCTION An estimated 1.1 million people in the United States are living with HIV, and 14% are unaware of their HIV-positive status [1]. Gay, bisexual and other men [...]

Background: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. Objective: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. Methods: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. Results: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. Conclusions: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. [ABSTRACT FROM AUTHOR]

More than one-quarter of the adults living with diagnosed HIV infection in the US are women. Binge drinking (i.e., ≥4 alcoholic drinks per occasion for women) is associated with poor HIV treatment compliance, HIV incidence, and unplanned pregnancy. However, little is known about the prevalence of binge drinking among women of childbearing age who are living with HIV (WLWH) and health risk behaviours among those who binge drink. Using the 2013–2014 data cycles of Medical Monitoring Project, we assessed the weighted prevalence of drinking patterns by socio-demographic, clinical and reproductive characteristics of 946 WLWH. Logistic regression was used to calculate unadjusted and adjusted prevalence ratios and 95% confidence intervals. Overall, 39% of WLWH reported current drinking and 10% reported binge drinking. Compared to non-drinkers, binge drinkers were less likely to adhere to antiretroviral therapy (ART) or be virally suppressed. In multivariate analyses, binge drinking among WLWH was associated with smoking, drug use, and reduced ART adherence compared to non-drinkers, increasing the likelihood of negative clinical outcomes. WLWH may benefit from a comprehensive approach to reducing binge drinking including alcohol screening and brief interventions and evidence-based policy strategies that could potentially improve adherence to HIV treatment. [ABSTRACT FROM AUTHOR]

Background. Human immunodeficiency virus (HIV) testing is critical for both HIV treatment and prevention. Expanding testing in hospital settings can identify undiagnosed HIV infections. Methods. To evaluate the feasibility of universally offering HIV testing during emergency department (ED) visits and inpatient admissions, 9 hospitals in the Bronx, New York and 7 in Washington, District of Columbia (DC) undertook efforts to offer HIV testing routinely. Outcomes included the percentage of encounters with an HIV test, the change from year 1 to year 3, and the percentages of tests that were HIV-positive and new diagnoses. Results. From 1 February 2011 to 31 January 2014, HIV tests were conducted during 6.5% of 1 621 016 ED visits and 13.0% of 361 745 inpatient admissions in Bronx hospitals and 13.8% of 729 172 ED visits and 22.0% of 150 655 inpatient admissions in DC. From year 1 to year 3, testing was stable in the Bronx (ED visits: 6.6% to 6.9%; inpatient admissions: 13.0% to 13.6%), but increased in DC (ED visits: 11.9% to 15.8%; inpatient admissions: 19.0% to 23.9%). In the Bronx, 0.4% (408) of ED HIV tests were positive and 0.3% (277) were new diagnoses; 1.8% (828) of inpatient tests were positive and 0.5% (244) were new diagnoses. In DC, 0.6% (618) of ED tests were positive and 0.4% (404) were new diagnoses; 4.9% (1349) of inpatient tests were positive and 0.7% (189) were new diagnoses. Conclusions. Hospitals consistently identified previously undiagnosed HIV infections, but universal offer of HIV testing proved elusive. [ABSTRACT FROM AUTHOR]

HIV testing is the gateway into both prevention and treatment services. It is important to understand how men who have sex with men (MSM) perceive HIV self-tests. We conducted focus groups and individual interviews to collect feedback on two HIV self-tests, and on a dried blood spot (DBS) specimen collection kit. Perceptions and attitudes around HIV self-testing (HIVST), and willingness to distribute HIV self-tests to others were assessed. MSM reported HIVST to be complementary to facility-based testing, and liked this approach because it offers privacy and convenience, does not require counseling, and could lead to linkage to care. However, they also had concerns around the accuracy of HIV self-tests, their cost, and receiving a positive test result without immediate access to follow-up services. Despite these issues, they perceived HIVST as a positive addition to their HIV prevention toolbox. [ABSTRACT FROM AUTHOR]

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Peer-driven HIV prevention strategies can be effective in identifying high-risk persons with undiagnosed infections. Besides individual self-testing, other potential uses of rapid home HIV test kits include distributing them, and testing with others within one's social or sexual networks. We sought to identify factors associated with the willingness to engage in these alternative activities among men who have sex with men (MSM) in the United States. From May to October 2014, we surveyed 828 HIV-negative or unknown status MSM about multiple aspects of rapid home HIV testing. A greater proportion indicated being likely to distribute free oral fluid (OF) tests compared to free finger-stick blood (FSB) tests (91% versus 79%), and almost three-fourths (72%) reported being likely to test with their friends or sex partners in the future. MSM not identifying as homosexual/gay were less willing to distribute OF tests, and those with lower educational attainment were more willing to distribute FSB tests. MSM unaware of their HIV status were less likely to report potentially testing with others using free rapid home HIV tests compared to those who were HIV-negative. Finally, MSM willing to self-test were more likely to report future test kit distribution, and those willing to distribute kits were more likely to report potentially testing with others. Engaging individuals with positive attitudes towards these strategies in prevention efforts could help increase HIV testing levels among MSM. A greater understanding of the potential public health impact of rapid home HIV test kits is necessary. [ABSTRACT FROM PUBLISHER]

Background: Men who have sex with men (MSM) are disproportionately at risk of contracting HIV and other sexually transmissible infections (STIs). Correct and consistent condom use is the most effective method to prevent HIV and other STIs among sexually active MSM.Methods: Using data from the 2002, 2006-10, 2011-13 cycles of the National Survey of Family Growth (NSFG), the overall prevalence of condom use at last sex and by sexual risk behaviours (sex with ≥2 same-sex partners, sex with ≥2 opposite sex partners, sex with a person who injects drugs, sex with an HIV-positive person and exchanged sex for money or drugs) among sexually active MSM (reported oral or anal sex with a male in the preceding 12 months) was estimated. The association between condom use at last sex and demographic and sexual behaviour variables was also evaluated.Results: Approximately 31% of all respondents (n=618; weighted n=1596702) reported condom use at last sex. Among MSM who reported ≥1 sexual risk behaviour in the past year, prevalence of condom use at last sex ranged from 30 to 38%. After adjusting for covariates, Hispanic MSM [adjusted prevalence ratio (APR)=1.81, 95%CI=1.27-2.58] were more likely than White MSM to report condom use at last sex; MSM with a recently diagnosed STI (APR=1.71, 95%CI=1.04-2.80) were more likely than MSM without a recently diagnosed STI to report condom use at last sex; and married or cohabitating MSM (APR=0.29, 95%CI=0.13-0.66) were less likely than unmarried and not cohabitating MSM to report condom use at last sex. There was no difference in temporal trends in condom use at last sex across the three NSFG cycles [2002 (33.8%); 2006-10 (25.6%); 2011-13 (40.6%), P=0.926].Conclusions: This study data suggest that prevalence of condom use among MSM is low, even among MSM who report sexual risk behaviours. The continued promotion of consistent condom use as an effective primary HIV/STI risk-reduction strategy is important because it mitigates HIV and STI risk and also complements the effectiveness of newer HIV prevention approaches such as pre-exposure prophylaxis. [ABSTRACT FROM AUTHOR]

Introduction: While there is much information about the burden of influenza A(H1N1)pdm09 in North America, little data exist on its burden in South America. Methods: During April to December 2009, we actively searched for persons with severe acute respiratory infection and influenza-like illness (ILI) in three sentinel cities. A proportion of case-patients provided swabs for influenza testing. We estimated the number of case-patients that would have tested positive for influenza by multiplying the number of untested case-patients by the proportion who tested positive. We estimated rates by dividing the estimated number of case-patients by the census population after adjusting for the proportion of case-patients with missing illness onset information and ILI case-patients who visited physicians multiple times for one illness event. Results: We estimated that the influenza A(H1N1)pdm09 mortality rate per 100,000 person-years (py) ranged from 1.5 among persons aged 5-44 years to 5.6 among persons aged ≥65 years. A(H1N1)pdm09 hospitalization rates per 100,000 py ranged between 26.9 among children aged < 5 years to 41.8 among persons aged ≥65 years. Influenza A(H1N1)pdm09 ILI rates per 100 py ranged between 1.6 among children aged < 5 to 17.1 among persons aged 45-64 years. While 9 (53%) of 17 influenza A(H1N1)pdm09 decedents with available data had obesity and 7 (17%) of 40 had diabetes, less than 4% of surviving influenza A(H1N1)pdm09 case-patients had these pre-existing conditions (p ≤ 0.001). Conclusion: Influenza A(H1N1)pdm09 caused a similar burden of disease in Argentina as in other countries. Such disease burden suggests the potential value of timely influenza vaccinations. [ABSTRACT FROM AUTHOR]

Summary: This report reviews U.S. guidelines for the identification of persons exposed to rubella during air travel. In response to an individual with rubella who traveled on multiple flights, CDC conducted an airline contact investigation that was expanded beyond customary protocol to assess if current operating procedures are adequate. Of 250 potentially exposed airline passengers, 215 (86%) were contacted and none developed a rubella-like rash, arguing against the need to notify passengers beyond the standard protocol in most cases. [Copyright &y& Elsevier]

Background: Binge drinking accounts for more than half of the 79,000 deaths due to excessive drinking in the U.S. each year. In 2006, the Behavioral Risk Factor Surveillance System (BRFSS) lowered the threshold for defining binge drinking among women from ≥5 drinks to ≥4 drinks per occasion, in accordance with national recommendations.Purpose: To assess changes in binge-drinking prevalence among women.Methods: The relative and absolute change in binge drinking among U.S. adult women was assessed using pooled BRFSS data from the 2 years before (2004-2005) and after (2006-2007) the implementation of the new gender-specific definition. Analyses were conducted in 2008-2009.Results: Binge-drinking prevalence among women increased 2.6 percentage points (from 7.3% in 2004-2005 to 9.9% in 2006-2007), a 35.6% relative increase. The percentage of women who reported consuming exactly 4 drinks in 2006 (3.6%) was similar to the increase in the prevalence of binge drinking among women that was observed from 2005 to 2006 (absolute change=2.9 percentage points).Conclusions: The new gender-specific definition of binge drinking significantly increased the identification of women drinking at dangerous levels. The change in prevalence among women was primarily due to the change in the definition and not to actual changes in drinking behavior. The new gender-specific definition of binge drinking can increase the usefulness of this measure for public health surveillance and support the planning and implementation of effective prevention strategies (e.g., increasing alcohol excise taxes). [ABSTRACT FROM AUTHOR]

Presents information on a study which investigated the effect of retinoic acid on the protein kinase signaling pathways in the liver tissue of rats fed with ethanol. Results; Discussion; Methodology.

Background Condom-less sex can increase the risk of acquiring or transmitting HIV. Aim To characterize the prevalence of condom use at the most recent sex act and identify factors associated with use of a condom at the most recent sex act in adults in the United States. Methods Data from the cross-sectional National Survey of Family Growth from cycles 2006 through 2010 and 2011 through 2013 were analyzed for sexually active men and women 18 to 44 years old who reported having sex (vaginal, anal, or oral) with an opposite-sex partner in the past 12 months. HIV-related sexual risk behaviors (SRBs) in the past 12 months included sex with at least four opposite-sex partners; exchanging sex for money or drugs; sex with an injection drug user; sex with an HIV-positive person; sex with a man who previously had sex with a man (women only); sex with a man (men only); or sex with a partner who had sex with other partners. Outcomes The outcome for this analysis was condom use at the most recent anal or vaginal sex act. Results Overall prevalence of condom use was 24.8%; only 33.8% of adults with at least one SRB reported the use of a condom. Only 46.4% of unmarried or single men (vs 14.7% married or cohabitating men) and 32.3% unmarried or single women (vs 14.1% married or cohabitating women) with SRBs reported using a condom at the most recent sexual encounter and were less likely to use a condom at the most recent sexual encounter compared with those who did not report SRBs. We did not find a significant relation between using a condom and SRBs in married or cohabitating men and women. Strengths and Limitations Our analysis adds to the literature on how condom use varies by marital status. We measured the use of condoms at the most recent sexual act, which might not reflect an individual's previous behavior of condom use. Nonetheless, condom use at the most recent sexual act has been documented in previous studies as a valid proxy of condom use over time. Conclusion Continued efforts are needed to promote condom use in heterosexual adults in the United States, particularly those at high risk for HIV, namely individuals engaging in anal sexual acts and with multiple sex partners. Nasrullah M, Oraka E, Chavez PR, et al. Factors Associated With Condom Use Among Sexually Active US Adults, National Survey of Family Growth, 2006–2010 and 2011–2013. J Sex Med 2017;14:541–550. [ABSTRACT FROM AUTHOR]

Abstract: Background: Worldwide, many countries test for HIV infection using combination assays that simultaneously detect p24 antigen and HIV antibodies. One such assay, the ARCHITECT® HIV Ag/Ab Combo Assay (ARCHITECT), has recently been approved by the Food and Drug Administration (FDA) for use in the United States. Objective: To evaluate the performance of ARCHITECT on well-characterized specimens from four CDC-funded studies. Study design: We evaluated 3386 HIV-infected, 7551 HIV-uninfected, and 58 acute HIV infection (AHI) specimens. HIV-infected specimens were repeatedly reactive by enzyme immunoassay (EIA) and Western blot (WB) or positive by nucleic acid amplification testing (NAAT). HIV-uninfected specimens were EIA- and NAAT-negative. AHI specimens were seronegative or indeterminate (using antibody-based EIAs, rapid tests or WB) and NAAT-positive. All specimens were de-identified and sent to Abbott Diagnostics for testing with ARCHITECT. ARCHITECT test results were compared to original study characterizations and were used to assess overall sensitivity and specificity and also sensitivity for AHI. ARCHITECT false-positive specimens with sufficient quantity were retested. Results: Based on results from the initial ARCHITECT test, sensitivity was 99.94% (95% confidence interval [CI]: 99.79, 99.99) and specificity was 98.78% (95% CI: 98.51–99.01). Repeat testing resulted in corrected specificity of 99.50% (95% CI: 99.31, 99.64). Also, 48 AHI specimens (83%) were detected by this screening assay. Conclusion: The sensitivity and specificity of the ARCHITECT combination assay are very high and most AHIs were detected by the assay. Use of Ag/Ab combination assays may improve the number of AHIs identified relative to existing FDA-approved HIV-antibody only based serologic assays, particularly in high incidence populations. [Copyright &y& Elsevier]

Abstract: Background: An alternate HIV testing algorithm has been proposed which includes a fourth-generation immunoassay followed by an HIV-1/HIV-2 antibody differentiation supplemental test for reactive specimens and a nucleic acid test (NAT) for specimens with discordant results. Objective: To evaluate the performance of five rapid tests (Alere Clearview, Bio-Rad Multispot, OraSure OraQuick, MedMira Reveal, and Trinity Biotech Unigold) as the supplemental antibody assay in the algorithm. Study design: A total of 3273 serum and plasma specimens that were third-generation immunoassay repeatedly reactive and Western blot (WB) negative or indeterminate were tested with rapid tests and NAT. Specimens were classified by NAT: (1) HIV-1 infected (NAT-reactive; n =184, 5.6%), (2) HIV-status unknown (NAT nonreactive; n =3078, 94.2%) or by Multispot, (3) HIV-2 positive (n =5), and (4) HIV-1 and HIV-2 positive (n =6). Excluding HIV-2 positive specimens, we calculated the proportion of reactive rapid tests among specimens with reactive and nonreactive NAT. Results: The proportion of infected specimens with reactive rapid test results and negative or indeterminate WB ranged from 30.4% (56) to 47.8% (88) depending on the rapid test. From 1% to 2% of NAT-negative specimens had reactive rapid test results. Conclusions: In these diagnostically challenging specimens, all rapid tests identified infections that were missed by the Western blot, but only Multispot could differentiate HIV-1 from HIV-2. Regardless of which rapid test is used as a supplemental test in the alternative algorithm, false-positive algorithm results (i.e., reactive screening and rapid test in uninfected person) may occur, which will need to be resolved during the baseline medical evaluation. [Copyright &y& Elsevier]

Introduction: We evaluated internet platforms for distributing HIV self-tests (HIVSTs) to Black or African American (Black) and Hispanic or Latino men who have sex with men (MSM) and transgender women (TGW)., Methods: We recruited MSM and TGW from general interest, dating, and lesbian, gay, bisexual, and transgender platforms. Two HIVSTs were mailed to all MSM and TGW. Surveys (screening, baseline, 4-month, and results reporting) were completed online. After 4 months, participants were mailed another HIVST and a dried blood spot card. All HIVST interpretations and images of HIVST devices were reported online., Results: Of 2093 MSM and 102 TGW, most were recruited through general interest and dating platforms. Over 50% were 18-29 years old, most identified as gay or bisexual. Overall, 45% had not tested for HIV in the past 12 months, and 9.1% of MSM reported a positive (reactive for HIV antibodies) HIVST result, with the highest percentage among Black MSM (11.5%). Dating platforms recruited higher percentages of MSM who recorded positive results compared with MSM from general interest platforms during the intervention period (11.9% vs 5.5% (P < 0.0001)), and MSM who had never tested for HIV reported a greater percentage of positive HIVST results compared with MSM who had been tested for HIV before enrollment (16.1% vs. 7.1%; P < 0.0001). MSM were able to correctly interpret and report HIVST results. Of TGW, 7% reported a positive HIVST result., Conclusions: Internet dating and general interest platforms can be key to increasing awareness of infection among BMSM, HMSM, and TGW persons, including those who do not use existing HIV services., Trial Registration: www.clinicaltrials.gov Identifier: NCT04219878., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US., Methods: From June 2018-March 2019, we conducted a cross-sectional evaluation of the Simple Amplification-Based Assay version II (SAMBA II) POC NAT. People with HIV (PWH) and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naive, and SAMBA II Semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared with Abbott RealTime HIV-1 polymerase chain reaction results on plasma. We calculated sensitivity, specificity, and concordance between tests., Results: SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naive participants was 91.4% [32/35, 95% confidence interval (CI): 77.6% to 97.0%] using VP WB and 100% (27/27, 95% CI: 87.5% to 100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1% to 99.4%) and 100% (30/30, 95% CI: 88.7% to 100%) using VP and FS WB, respectively., Conclusions: The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US., Competing Interests: S.M.A., A.R., N.G. and H.L. are employed by Diagnostics for the Real World (DRW), the creators of the SAMBA II test. DRW provided 2 SAMBA II machines for investigational use. The remaining authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)