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In September 2022, CDC funded a nationwide program, Together TakeMeHome (TTMH), to expand distribution of HIV self-tests (HIVSTs) directly to consumers by mail through an online ordering portal. To publicize the availability of HIVSTs to priority audiences, particularly those disproportionately affected by HIV, CDC promoted this program through established partnerships and tailored resources from its Let's Stop HIV Together social marketing campaign. The online portal launched March 14, 2023, and through March 13, 2024, distributed 443,813 tests to 219,360 persons. Among 169,623 persons who answered at least one question on a postorder questionnaire, 67.9% of respondents were from priority audiences, 24.1% had never previously received testing for HIV, and 24.8% had not received testing in the past year. Among the subset of participants who initiated a follow-up survey, 88.3% used an HIVST themselves, 27.1% gave away an HIVST, 11.7% accessed additional preventive services, and 1.9% reported a new positive HIVST result. Mailed HIVST distribution can quickly reach large numbers of persons who have never received testing for HIV or have not received testing as often as is recommended. TTMH can help to achieve the goal of diagnosing HIV as early as possible and provides a path to other HIV prevention and care services. Clinicians, community organizations, and public health officials should be aware of HIVST programs, initiate discussions about HIV testing conducted outside their clinics or offices, and initiate follow-up services for persons who report a positive or negative HIVST result., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Robert Bole reports funding support from Emory University. Jennifer Hecht reports receipt of funding from OraSure Technologies for related work, not part of the current project. Patrick Sullivan reports institutional support from the National Institutes of Health, Merck, and Gilead Sciences, consulting fees from Merck and Gilead Sciences, honoraria from Gilead Sciences, and travel or meeting attendance support from Gilead Sciences. No other potential conflicts of interest were disclosed.

Background: Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP). This report describes a randomized clinical trial sponsored by the Centers for Disease Control and Prevention (CDC): "Ending the HIV Epidemic Through Point-of-Care Technologies" (EHPOC). The study's primary aim is to evaluate the use of a POC HIV VL test as part of a testing approach and assess the impact on time to linkage to ART or PrEP. The study will recruit people in Baltimore, Maryland, including patients attending a hospital emergency department, patients attending an infectious disease clinic, and people recruited via community outreach. The secondary aim is to evaluate the performance characteristics of two rapid HIV antibody tests approved by the United States Food and Drug Administration (FDA)., Methods: The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) HIV screening tests. Intervention arm participants will receive a POC HIV VL test in addition to the SOC HIV diagnostic screening tests. Follow up will consist of an interim phone survey conducted at week-4 and an in-person week-12 visit. Demographic and behavioral information, and oral fluid and blood specimens will be collected at enrollment and at week-12. Survey data will be captured in a Research Electronic Data Capture (REDCap) database. Participants in both arms will be referred for either ART or PrEP based on their HIV test results., Discussion: The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations., Trial Registration: NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Human immunodeficiency virus (HIV) self-testing has emerged as a tool to increase the proportion of people to know their status. Since the first HIV self-test was approved in 2012 by the US Food and Drug Administration (FDA), global access to HIV self-tests has been bolstered by public-private partnerships to ensure equitable access in low- and middle-income countries. However, no company has applied for FDA clearance in a decade. We highlight the potential benefits to reclassifying HIV self-tests from class III to class II., Competing Interests: Potential conflicts of interest. S. M. O. reports the following patent: Detection of HIV-1 nucleic acids by reverse-transcription loop-mediated isothermal amplification (patent no. 10697028; 30 June 2020); currently no money has been received for this patent, but it could be considered a diagnostic method. Y. C. M. reports consulting fees paid to the author from Abbott; a leadership or fiduciary role on the Infectious Diseases Institute board; and research grant support to Johns Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, and miDiagnostics. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Internet-recruited gay, bisexual, and other men who have sex with men (MSM) were offered HIV self-tests (HIVSTs) after completing baseline, 3-, 6-, and 9-month follow-up surveys. The surveys asked about the use and distribution of these HIVSTs. Among 995 who reported on their distribution of HIVSTs, 667 (67.0%) distributed HIVSTs to their social network associates (SNAs), which resulted in 34 newly identified HIV infections among 2301 SNAs (1.5%). The main reasons participants reported not distributing HIVSTs included: wanting to use the HIVSTs themselves (74.9%); thinking that their SNAs would get angry or upset if offered HIVSTs (12.5%); or not knowing that they could give the HIVSTs away (11.3%). Self-testing programs can provide multiple HIVSTs and encourage the distribution of HIVST by MSM to their SNAs to increase awareness of HIV status among persons disproportionately affected by HIV., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

To assess whether pressuring others to use HIV self-tests is prevalent among US men who have sex with men (MSM), we analyzed data from a randomized controlled trial of HIV self-testing. Among 752 online-recruited MSM who received HIV self-tests and responded to a 12-month survey, 8.5% (60/709) reported pressuring someone to use an HIV self-test: 29 pressured a friend, 28 pressured a sexual partner, and 1 pressured a family member. Conversely, 2.1% (15/715) reported being pressured to self-test: 12 by a sexual partner and 3 by a friend. No physical harm was reported. HIV prevention programs that use HIV self-tests to reach populations at risk for HIV may be reassured by our findings because, despite reports of pressure to use HIV self-tests, no physical abuse was reported between sex partners. These programs should, however, include messages emphasizing the voluntary use of HIV self-tests and be prepared to address concerns of persons who have been pressured to use HIV self-tests. This trial is registered at www.clinicaltrials.gov (NCT02067039) and the date of registration is February 5, 2014., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Introduction: This study aims to assess the public health impact of eliminating a longstanding routine HIV screening program and replacing it with targeted testing. In addition, costs, outcomes, and cost effectiveness of routine screening are compared with those of targeted testing in the Fulton County Jail, Atlanta, Georgia., Methods: A published mathematical model was used to assess the cost effectiveness and public health impact of routine screening (March 2013-February 2014) compared with those of targeted testing (January 2018-December 2018) from a health system perspective. Costs, outcomes, and other model inputs were derived from the testing programs and the published literature, and the cost effectiveness analysis was conducted from 2019 to 2020., Results: Routine screening identified 74 more new HIV infections over 1 year than targeted testing, resulting in an estimated 10 HIV transmissions averted and 45 quality-adjusted life-years saved, and was cost saving. The missed opportunity to diagnose infections because routine screening was eliminated resulted in an estimated 8.4 additional HIV transmissions and $3.7 million in additional costs to the healthcare system., Conclusions: Routine HIV screening in high-prevalence jails is cost effective and has a larger impact on public health than targeted testing. Prioritizing sustained funding for routine, jail-based HIV screening programs in high-prevalence areas may be important to realizing the national HIV prevention goals., (Published by Elsevier Inc.)

Background: In the US, one in six men who have sex with men (MSM) with HIV are unaware of their HIV infection. In certain circumstances, access to HIV testing and viral load (VL) monitoring is challenging. The objective of this study was to evaluate the feasibility of conducting laboratory-based HIV and antiretroviral (ARV) drug testing, and VL monitoring as part of two studies on self-collected dried blood spots (DBS)., Methods: Participants were instructed to collect DBS by self-fingerstick in studies that enrolled MSM online. DBS from the first study (N = 1444) were tested with HIV serological assays approved by the Food and Drug Administration (FDA). A subset was further tested with laboratory-modified serological and VL assays, and ARV levels were measured by mass spectrometry. DBS from the second study (N = 74) were only tested to assess VL monitoring., Results: In the first study, the mail back rate of self-collected DBS cards was 62.9%. Ninety percent of DBS cards were received at the laboratory within 2 weeks from the day of collection, and 98% of the cards had sufficient spots for one assay. Concordance between FDA-approved and laboratory-modified protocols was high. The samples with undetectable ARV had higher VL than samples with at least one ARV drug. In the second study, 70.3% participants returned self-collected DBS cards, and all had sufficient spots for VL assay. High VL was observed in samples from participants who reported low ARV adherence., Conclusions: In these studies, MSM were able to collect and provide adequate DBS for HIV testing. The FDA-approved and laboratory-modified testing algorithms performed similarly. DBS collected at home may be feasible for HIV testing, ARV measurement, and monitoring viral suppression.

Importance: Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM)., Objective: To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors., Design, Setting, and Participants: This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018., Interventions: All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit., Main Outcomes and Measures: Primary outcomes were HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting)., Results: Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests., Conclusions and Relevance: Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM., Trial Registration: ClinicalTrials.gov identifier: NCT02067039.

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., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

In the United States, an estimated 67% of new HIV diagnoses are among men who have sex with men (MSM), however 25% of HIV-positive MSM in the 2014 National HIV Behavioral Surveillance Survey were unaware of their infection. HIV self-testing (HIVST) with rapid diagnostic tests (RDTs) may facilitate access to HIV testing. We evaluated the ability of 22 MSM to conduct two HIV RDTs (OraQuick ® In-Home HIV Test and a home-use prototype of Sure Check ® HIV 1/2 Assay), interpret sample images of test results, and collect a dried blood spot (DBS) specimen. While some participants did not follow every direction, most participants were able to conduct HIVST and correctly interpret their results. Interpretation of panels of RDT images was especially difficult when the "control" line was missing, and 27% of DBS cards produced were rated as of bad quality. Modifications to the DBS instructions were necessary prior to evaluating the performance of these tests in real-world settings.

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.

Early diagnosis of human immunodeficiency virus (HIV) infection and initiation of antiretroviral treatment (ART) improves health outcomes and prevents HIV transmission. Before 2010, HIV testing was available to inmates in the California state prison system upon request. In 2010, the California Correctional Health Care Services (CCHCS) integrated HIV opt-out screening into the health assessment for inmates entering California state prisons. Under this system, a medical care provider informs the inmate that an HIV test is routinely done, along with screening for sexually transmitted, communicable, and vaccine-preventable diseases, unless the inmate specifically declines the test. During 2012-2013, CCHCS, the California Department of Public Health, and CDC evaluated HIV screening, rates of new diagnoses, linkage to and retention in care, ART response, and post-release linkage to care among California prison inmates. All prison inmates are processed through one of eight specialized reception center facilities, where they undergo a comprehensive evaluation of their medical needs, mental health, and custody requirements for placement in one of 35 state prisons. Among 17,436 inmates who entered a reception center during April-September 2012, 77% were screened for HIV infection; 135 (1%) tested positive, including 10 (0.1%) with newly diagnosed infections. Among the 135 HIV-positive patient-inmates, 134 (99%) were linked to care within 90 days of diagnosis, including 122 (91%) who initiated ART. Among 83 who initiated ART and remained incarcerated through July 2013, 81 (98%) continued ART; 71 (88%) achieved viral suppression (<200 HIV RNA copies/mL). Thirty-nine patient-inmates were released on ART; 12 of 14 who were linked to care within 30 days of release were virally suppressed at that time. Only one of nine persons with a viral load test conducted between 91 days and 1 year post-release had viral suppression. Although high rates of viral suppression were achieved in prison, continuity of care in the community remains a challenge. An infrastructure for post-release linkage to care is needed to help ensure sustained HIV disease control.

Emergency departments and jails provide medical services to persons at risk for HIV infection and are recommended venues for HIV screening. Our main objective in this study was to analyze the cost per new HIV diagnosis associated with the HIV screening program in these two venues. The emergency department's parallel testing program was conducted at Grady Memorial Hospital in Atlanta, Georgia starting in 2008; the jail's integrated testing program began at the Fulton County (GA) Jail in 2011. The two sites, four miles apart from one another, employed the same rapid HIV test. Ascertainment that cases were new differed by site; only the jail systematically checked identities against health department HIV registries. The program in the emergency department used dedicated HIV test counselors and made 242 diagnoses over a 40-month period at a cost of $2,981 per diagnosis. The jail program used staff nurses, and found 41 new HIV cases over 10.5 months at a cost of $6,688 per new diagnosis. Differences in methods for ascertainment of new diagnoses, previously undiagnosed HIV sero-positivity, and methodologies used for assessing program costs prevent concluding that one program was more economical than the other. Nonetheless, our findings show that testing in both venues yielded many new diagnoses, with the costs within the range reported in the literature.

People with HIV who are released from custody frequently do not maintain the viral suppression and other health benefits achieved while incarcerated. This study was conducted to provide preliminary evidence of efficacy of an intervention to reduce HIV risk behaviors and increase use of HIV medical services following release from custody. People with HIV were recruited from San Francisco County jails, San Quentin State Prison and the California Medical Facility (Vacaville, CA), and randomly assigned to the "standard of care" or POST intervention. POST consisted of 4 sessions pre-release and 2 sessions post-release, focusing on HIV prevention and access to care. Behavioral data were obtained for the 3 months before incarceration and 3 months after release. Although POST participants reported a statistically significant increase in receiving health care at HIV clinics (62.5-84.4 %), there were no significant differences between the POST and control participants with respect to any primary outcomes.

Thirty years into the human immunodeficiency virus (HIV) epidemic in the United States, an estimated 50,000 persons become infected each year: highest rates are in black and Hispanic populations and in men who have sex with men. Testing for HIV has become more widespread over time, with the highest rates of HIV testing in populations most affected by HIV. However, approximately 55% of adults in the United States have never received an HIV test. Because of the individual and community benefits of treatment for HIV, in 2006 the Centers for Disease Control and Prevention recommended routine screening for HIV infection in clinical settings. The adoption of this recommendation has been gradual owing to a variety of issues: lack of awareness and misconceptions related to HIV screening by physicians and patients, barriers at the facility and legislative levels, costs associated with testing, and conflicting recommendations concerning the value of routine screening. Reducing or eliminating these barriers is needed to increase the implementation of routine screening in clinical settings so that more people with unrecognized infection can be identified, linked to care, and provided treatment to improve their health and prevent new cases of HIV infection in the United States., (Copyright © 2012 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

We used Centers for Disease Control and Prevention HIV Counseling and Testing System data from 2007 to determine the percentage and characteristics of persons newly identified as HIV-positive in US correctional facilities. The newly identified HIV positivity was 0.7%, and 30% of detainees newly identified with HIV were categorized as having low-risk heterosexual contact or no acknowledged risk. Correctional facilities should provide detainees with routine opt-out HIV testing, unless the prevalence of previously undiagnosed HIV infection has been documented to be less than 0.1%.

Objectives: The objectives of this study were to describe preincarceration risk behaviors of young men and identify correlates of unprotected sex with multiple partners during the 3 months before incarceration., Study: Data on preincarceration risk behaviors were obtained from 550 men, aged 18 to 29 years, in state prisons in California, Mississippi, Rhode Island, and Wisconsin. Correlates of unprotected sex with multiple partners were determined by logistic regression., Results: Of 550 participants, 71% had multiple sex partners, 65.1% had sex with a partner they perceived as risky, and 45.3% engaged in unprotected sex with multiple partners. Men who drank heavily (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.11-2.54) or who had a risky partner (OR, 3.90; 95% CI, 2.60-5.85) were more likely to report unprotected sex with multiple partners. Men who attended religious gatherings (OR, 0.66; 95% CI, 0.46-0.96) or lived in stable housing (OR, 0.69; 95% CI, 0.48-1.00) were less likely to report unprotected sex with multiple partners., Conclusions: Most participants engaged in behaviors that could result in a sexually transmitted disease, including HIV. Prevention programs should address the relationship between heavy alcohol use and risky sexual behavior. Discharge planning should address housing needs. Faith-based community organizations may play an important role for some young men in their transition to the community.

There is wide variation in reported risk factors for HIV incidence among injecting drug users by community. Available HIV seroprevalence and incidence data indicate that nearly 60% of HIV infection is associated with injecting drug use in Connecticut and 48% in Massachusetts. Using 12-month follow-up data on 354 initially HIV-negative New England (Massachusetts and Connecticut) methadone treatment clients, we assessed the association between baseline drug use practices, sexual behavior, partner behaviors, and client-reported HIV infection during follow-up. Variables that predicted client-reported positive HIV antibody test results were modeled by Cox proportional hazards regression. HIV infection among those tested was 14.2 per 100 person years (PY) [95% Confidence interval (CI) = 9.5 to 21.3]. For each injection the relative risk (RR) was 1.1 (95% CI = 1.1 to 1.2), for males 3.0 (95% CI = 1.2 to 7.3), for blacks 5.0 (95% CI = 1.6 to 15.5), for Hispanics 3.6 (95% CI = 1.2 to 10.5). Men who used more than one unclean needle per day and had an HIV-infected steady partner had an RR of 28.4 (95% CI = 4.4 to 176.4). For women, using speedball (RR = 6.1, 95% CI = 1.2 to 38.8) and being black (RR = 4.4, 95% CI = 1.0 to 19.8) predicted self-reported HIV infection; having a steady partner who ever injected increased this risk substantially (RR = 65.3, 95% CI = 4.0 to 1046.5). These findings for IDUs in Massachusetts and Connecticut indicate that risk factors for HIV infection for men are consistent with expected transmission by unclean needles with an HIV-infected partner, but a preference for using speedball predicted HIV infection among women IDUs. [ABSTRACT FROM AUTHOR]

This article presents information on the demographic and behavioral factors associated with client-reported HIV infection among new enrollees in methadone maintenance treatment programs (MMTPs) in Massachusetts and Connecticut. It is informed that in the U.S., there are an estimated half million heroin addicts and approximately 115,000 addicts in 750 outpatient MMTPs. HIV has spread rapidly among injection drug users (IDUs) in the U.S. and in Europe. This rapid spread of HIV among IDUs has predominantly been the result of the sharing of contaminated needles, syringe, etc. Numerous factors associated with HIV infection among IDUs have been found within different geographic areas and communities. HIV infection is related to sexual behaviors, drug use behaviors, or both; however, specific factors related to these behaviors are not consistent between studies. One longitudinal study found that IDUs who reduced their HIV risk behaviors had a lower seroconversion rate than those who continued to engage in high-risk behaviors.