Findings from the First Year of a Federally Funded, Direct-to-Consumer HIV Self-Test Distribution Program - United States, March 2023-March 2024.

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.

Accelerating Human Immunodeficiency Virus Self-Testing in the United States: A Call to Action.

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.

Distribution of HIV Self-tests by Men Who have Sex with Men (MSM) to Social Network Associates.

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.

RESUMEN: Hombres gais, bisexuales y otros hombres que indicaron tener contacto sexual con hombres (MSM, por sus siglas en inglés) fueron reclutados por el Internet y se les ofreció autopruebas del VIH (HIVST, por sus siglas en inglés) después de completar una encuestas inicial y encuestas de seguimiento a los 3, 6 y 9 meses. Las encuestas recogieron datos sobre el uso y distribución de estas autopruebas del VIH. De los 995 MSM que indicaron distribuir las autopruebas, 667 (67.0%) distribuyeron las autopruebas a personas en sus redes sociales (SNA, por sus siglas en inglés), resultando en 34 nuevas infecciones por el VIH identificadas entre 2,301 SNA (1.5%). Las razones principales por las que algunos participantes no distribuyeron las autopruebas del VIH incluyen: el deseo de utilizar las autopruebas del VIH para sí mismos (74.9%); pensar que las SNA se enfadarían o molestarían si se les ofreciesen autopruebas del VIH (12.5%); o no saber que podían distribuir las autopruebas del VIH (11.3%). Los programas que proporcionen múltiples autopruebas del VIH podrían alentar la distribución de las autopruebas por parte de los MSM a las SNA para aumentar el conocimento sobre el estado del VIH entre personas afectadas de manera desproporcionada por el VIH.

Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial.

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.

HIV Testing Before and During the COVID-19 Pandemic - United States, 2019-2020.

HIV testing is a core strategy for the Ending the HIV Epidemic in the U.S. (EHE) initiative, which has the aim of reducing new HIV infections by at least 90% by 2030.* During 2016-2017, jurisdictions with the highest HIV diagnosis rates were those with higher prevalences of HIV testing; past-year HIV testing was higher among persons who reported recent HIV risk behaviors compared with those who did not report these risks (1). During 2020-2021, the COVID-19 pandemic disrupted health care delivery, including HIV testing in part because many persons avoided services to comply with COVID-19 risk mitigation efforts (2). In addition, public health departments redirected some sexual health services to COVID-19-related activities.† CDC analyzed data from four national data collection systems to assess the numbers of HIV tests performed and HIV infections diagnosed in the United States in the years before (2019) and during (2020) the COVID-19 pandemic. In 2020, HIV diagnoses reported to CDC decreased by 17% compared with those reported in 2019. This decrease was preceded by decreases in HIV testing during the same period, particularly among priority populations including Black or African American (Black) gay men, Hispanic or Latino (Hispanic) gay men, bisexual men, other men who have sex with men (MSM), and transgender persons in CDC-funded jurisdictions. To compensate for testing and diagnoses missed during the COVID-19 pandemic and to accelerate the EHE initiative, CDC encourages partnerships among federal organizations, state and local health departments, community-based organizations, and health care systems to increase access to HIV testing services, including strategies such as self-testing and routine opt-out screening in health care settings.

Pressure to Use HIV Self-Tests Among Men Who Have Sex With Men, United States, 2015-2016.

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.

RESUMEN: Analizamos los datos de un ensayo controlado aleatorio (ECA) de 12 meses para evaluar si presionar a alguien a que utilice la autoprueba del VIH es una ocurrencia frecuente entre hombres estadounidenses que tienen sexo con hombres (HSH) reclutados via el internet. Entre 752 HSH que recibieron por correo autopruebas del VIH y que respondieron a una encuesta a los 12 meses del ECA, el 8.5% (60/709) informó haber presionado a alguien a que usara una autoprueba del VIH: 29 presionaron a un amigo, 28 presionaron a una pareja sexual y uno presionó a un miembro de su familia. Por el contrario, el 2.1% (15/715) informó haber sido presionado a usar la autoprueba: 12 por una pareja sexual y 3 por un amigo. Ningun participante reporto daños físicos. Los programas de prevención del VIH que utilizan autopruebas del VIH para alcanzar a poblaciones a riesgo de contraer el VIH, pueden sentirse tranquilizados por nuestros hallazgos porque, a pesar de los reportes de presión para usar las autopruebas del VIH, no se reporto abuso físico entre parejas sexuales. Sin embargo, los programas deben incluir mensajes que enfaticen el uso voluntario de las autopruebas del VIH y estar preparados para calmar las preocupaciones de las personas que han sido presionadas a usar las autopruebas del VIH. El ensayo está registrado en www.clinicaltrials.gov (NCT02067039) y la fecha de registro es el 5 de febrero de 2014.

The feasibility of modified HIV and antiretroviral drug testing using self-collected dried blood spots from men who have sex with men.

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.

Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.

We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.

Distribution of HIV Self-tests by HIV-Positive Men Who Have Sex with Men to Social and Sexual Contacts.

HIV-positive men who have sex with men (MSM) were recruited on www.Facebook.com and www.Poz.com to give HIV self-tests to their contacts. Study participants completed a baseline survey, were given two self-tests, and completed a survey 2 months later. Of 133 eligible men, 40 (30%) completed both surveys. Most participants were 30-54 years old and non-Hispanic white. Some had a detectable viral load (n = 4), had condomless anal sex with male partners of negative or unknown status (n = 17), and had met anal sex partners at gay dating websites (n = 23). Of 80 self-tests given to participants, 59 (74%) were distributed, primarily to non-Hispanic white MSM, 30-54 years old who were friends. Participants reported results from 31 distributed tests; 2 sex partners of participants had positive results. Participants indicated these two persons were unaware of their infections. Expanding recruitment websites might reach non-white MSM. Unrecognized infections were identified through online recruitment and self-test distribution via HIV-positive persons.

Pilot Evaluation of the Ability of Men Who Have Sex with Men to Self-Administer Rapid HIV Tests, Prepare Dried Blood Spot Cards, and Interpret Test Results, Atlanta, Georgia, 2013.

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.

Willingness to distribute free rapid home HIV test kits and to test with social or sexual network associates among men who have sex with men in the United States.

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.

Evaluation of Routine HIV Opt-Out Screening and Continuum of Care Services Following Entry into Eight Prison Reception Centers--California, 2012.

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.

Positive Transitions (POST): Evaluation of an HIV Prevention Intervention for HIV-Positive Persons Releasing from Correctional Facilities.

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.

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial.

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. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.

Newly identified HIV infections in correctional facilities, United States, 2007.

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%.

Sexually transmitted infections and hepatitis in men with a history of incarceration.

BACKGROUND: Men entering correctional facilities have high rates of human immunodeficiency virus, sexually transmitted infections (STI), and hepatitis. Many prisons offer screening, treatment, and vaccination services; however, little is known about the rates of these infections in men after release to the community. METHODS: Young men were recruited from prisons in Mississippi, Rhode Island, and Wisconsin as part of a human immunodeficiency virus/STI/hepatitis intervention study. Participants were offered screening for Neisseria gonorrhoeae (GC), Chlamydia trachomatis, trichomoniasis, syphilis, hepatitis B (HBV) and C (HCV) 6 months after release. Logistic regression was performed to identify associations with prevalent infections. RESULTS: Of 248 eligible men, 178 (71.8%) participated. Their mean age was 22.5 years, and 92% reported multiple lifetime incarcerations. At 6-month postrelease, 79% reported unprotected vaginal or anal sex, and 26% tested positive for 1 or more infections (GC, 1%; C. trachomatis, 12%; trichomoniasis, 8%; syphilis, 0%; HCV, 6%; HBV, 1%). Of all, 55% were susceptible to HBV infection. Active STI (GC, C. trachomatis, or trichomoniasis) was associated with less education (odds ratios [OR], 2.25; P < 0.05). HCV infection was associated with injection drug use (OR, 69.70; P < 0.05) and being white (OR, 7.54; P < 0.05). HBV susceptibility was associated with older age (OR, 3.02; P < 0.05), more education (OR, 2.39; P < 0.05), or incarceration in Mississippi (OR, 6.69; P < 0.05) or Rhode Island (OR, 2.84; P < 0.05). CONCLUSIONS: Effective screening and prevention programs are needed for this population before and after release from custody to prevent acquisition and further transmission of these infections.

Costs and Consequences of Eliminating a Routine, Point-Of-Care HIV Screening Program in a High-Prevalence Jail.

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.

Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial.

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.

Estimating the costs and cost-effectiveness of HIV self-testing among men who have sex with men, United States.

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.

Voluntary rapid human immunodeficiency virus (HIV) testing in jails.

OBJECTIVES: To provide human immunodeficiency virus (HIV) rapid testing to persons in jails, identify previously undiagnosed cases of HIV infection, and refer HIV-infected inmates to care, treatment, and prevention services. DESIGN: Four state health departments (Florida, Louisiana, New York, and Wisconsin) collaborated with jails to implement stand-alone voluntary rapid HIV testing programs. Inmates requested or were referred by medical staff for rapid HIV testing. HIV testing was provided by the health department, correctional facility, or a community-based organization. Inmates whose rapid test was reactive were offered confirmatory testing, medical evaluation, prevention services, and discharge planning. RESULTS: From December 2003 through May 2006, rapid HIV testing was provided to 33,211 inmates, more than 99.9% of whom received their test results. Most of the inmates tested were male (79%), black (58%), and less than 35 years of age (60%). A total of 440 (1.3%) rapid HIV tests were reactive, and 409 (1.2%) of the results were confirmed positive. The testing programs identified 269 (0.8%) previously undiagnosed cases of HIV infection. In the multivariate analyses, new HIV diagnoses were associated with race/ethnicity, report of risky behaviors, and with no report of HIV risk behavior. Almost 40% of diagnoses were for inmates whose only reported risk was heterosexual contact. CONCLUSIONS: Rapid HIV testing in jails identified a considerable number of previously undiagnosed cases of HIV infection. Rapid HIV testing should be available to all inmates, regardless of whether inmates reported HIV risky behaviors.