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.

The Testing Imperative: Why the US Ending the Human Immunodeficiency Virus (HIV) Epidemic Program Needs to Renew Efforts to Expand HIV Testing in Clinical and Community-Based Settings.

Data from several modeling studies demonstrate that large-scale increases in human immunodeficiency virus (HIV) testing across settings with a high burden of HIV may produce the largest incidence reductions to support the US Ending the HIV Epidemic (EHE) initiative's goal of reducing new HIV infections 90% by 2030. Despite US Centers for Disease Control and Prevention's recommendations for routine HIV screening within clinical settings and at least yearly screening for individuals most at risk of acquiring HIV, fewer than half of US adults report ever receiving an HIV test. Furthermore, total domestic funding for HIV prevention has remained unchanged between 2013 and 2019. The authors describe the evidence supporting the value of expanded HIV testing, identify challenges in implementation, and present recommendations to address these barriers through approaches at local and federal levels to reach EHE targets.

HIV Testing Services Outcomes in CDC-Funded Health Departments During COVID-19.

BACKGROUND: Organizations offering HIV prevention services have reported interruptions during the COVID-19 pandemic. The national extent of these interruptions and their public health impact remain largely unexplored. METHODS: Using data from 60 state and local health departments, we compared HIV testing services outcomes in calendar years 2019 and 2020, including the number of Centers for Disease Control and Prevention (CDC)-funded HIV tests conducted, the percentage of persons with newly diagnosed HIV infection (ie, HIV positivity), and the percentage linked to HIV medical care within 30 days after new diagnoses (ie, linkage to care) using χ2 and robust Poisson models. We also assessed the independent associations between the pandemic period (ie, March-December 2020) and the number of COVID-19 cases with monthly HIV testing services outcomes using multivariable robust Poisson models. RESULTS: There was a 46.0% (P < 0.001) reduction in the number of CDC-funded HIV tests conducted in 2020 (n = 1,255,895) compared with 2019 (n = 2,324,421). Although there were fewer persons with newly diagnosed HIV in 2020 (n = 5581 vs. n = 7739 in 2019), HIV positivity was greater in 2020 (0.4% vs. 0.3% in 2019; adjusted prevalence ratio [aPR] = 1.33, 95% confidence interval [CI]: 1.05 to 1.69). When adjusting for the monthly number of COVID-19 cases, the pandemic period was associated with a 56% reduction in the number of monthly CDC-funded HIV tests (adjusted rate ratio = 0.44, 95% CI: 0.37 to 0.52) but 28% higher monthly HIV positivity (aPR = 1.28 95% CI: 1.16 to 1.41) and 10% higher linkage to care (aPR = 1.10, 95% CI: 1.02 to 1.18). DISCUSSION: Despite increased HIV positivity, a drastic reduction in the number of CDC-funded HIV tests was observed in 2020, affecting the ability to identify persons with newly diagnosed HIV. CDC and health departments will need to expand testing strategies to cover tests not conducted in 2020 while adapting to the continuing pandemic.A visual abstract is available for this article at: http://links.lww.com/QAI/B941.

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.

HIV Testing Strategies for Health Departments to End the Epidemic in the U.S.

An important goal of the Ending the HIV Epidemic in the U.S. initiative is the timely diagnosis of all people with HIV as early as possible after infection. To end the HIV epidemic, health departments were encouraged to propose new and innovative HIV testing strategies and improve the reach of existing programs. These activities were divided into 3 core strategies: expansion of routine screening in healthcare settings, locally tailored HIV testing initiatives in nonhealthcare settings, and specific efforts to increase the frequency of testing for individuals with increased potential for acquiring HIV. Because HIV testing is such a crucial part of the core activities of the Centers for Disease Control and Prevention's HIV prevention programs, there are many examples of evidence-based programs and best practices for HIV testing in both clinical and nonclinical settings. This article reviews the evidence base for these strategies and some of the activities proposed under the Diagnose pillar to achieve the goal of diagnosing all HIV infections as early as possible. All other Ending the HIV Epidemic in the U.S. activities start with an awareness of HIV status, which is actually the indicator for which most health departments are closest to the proposed targets. There are both proven and emerging approaches to increasing HIV screening and increasing the frequency of HIV screening available. The Ending the HIV Epidemic in the U.S. initiative provides the motivation, the resources, and a coordinated plan to bring them to scale.

Increasing Access to HIV Testing Through Direct-to-Consumer HIV Self-Test Distribution - United States, March 31, 2020-March 30, 2021.

During 2019, approximately 34,800 new HIV infections occurred in the United States (1), and it is estimated that approximately 80% of HIV transmission occurs from persons who either do not know they have HIV infection or are not receiving regular care (2). Since 2006, CDC has recommended that persons who are disproportionately affected by HIV (including men who have sex with men [MSM]) should test for HIV at least annually (3,4). However, data from multiple sources indicate that these recommendations are not being fully implemented (5,6). TakeMeHome, a novel public-private partnership to deliver HIV self-testing kits to persons seeking HIV testing in the United States, was launched during March 2020 as home care options for testing became increasingly important during the COVID-19 pandemic. The initiation of the program coincided with the national COVID-19 Public Health Emergency declaration, issuance of stay-at-home orders, and other restrictions that led to disruption of traditional HIV testing services. During March 31, 2020-March 30, 2021, 17 state and local health departments participating in the program allowed residents of their jurisdictions to order test kits. Marketing for TakeMeHome focused on reaching gay, bisexual, and MSM through messages and embedded links in gay dating applications. Most participants in the program reported that they had either never tested for HIV (36%) or that they had last tested >1 year before receiving their self-test kit (56%). After receiving the self-test kit, >10% of respondents reported accessing additional prevention services. Health departments can increase options for HIV testing by distributing publicly funded self-test kits to persons without proximate access to clinic-based testing or who prefer to test at home. Increased and regular HIV testing among MSM will help meet annual testing goals.

Time From HIV Infection to Diagnosis in the U.S., 2014-2018.

INTRODUCTION: Understanding the role of sociologic, structural, and biomedical factors that influence the length of time from HIV infection to diagnosis and reducing the time from infection to diagnosis are critical for achieving the goals of the Ending the HIV Epidemic initiative. In a retrospective analysis, the length of time from HIV infection to diagnosis and its association with individual- and facility-level attributes are determined. METHODS: Data reported by December 2019 to the U.S. National HIV Surveillance System for people with HIV diagnosed during 2014-2018 were analyzed during December 2020. A CD4 depletion model was used to estimate the time from HIV infection to diagnosis. RESULTS: During 2018, the median time from HIV infection to diagnosis was shorter for those infections diagnosed using the rapid testing algorithm (30.3 months, 95% CI=25.5, 34.5) than those diagnosed using the recommended (41.0 months, 95% CI=39.5, 42.0), traditional (37.0 months, 95% CI=29.5, 43.5), or other (35.5 months, 95% CI=32.5, 38.0) diagnostic testing algorithms. From 2014 to 2018, the time from HIV infection to diagnosis remained stable overall for all testing methods except for the traditional diagnostic testing algorithm. In multivariate analyses, those more likely to have HIV diagnosed closer to the time of infection were younger, were White, had transmission risk factors of injection drug use or heterosexual contact (for female individuals) or male-to-male sexual contact and injection drug use, or had HIV diagnosed at a correctional or screening facility (p<0.01). CONCLUSIONS: Providing access to expanded testing, including rapid testing in nonclinical settings, is likely to result in a decrease in the length of time a person is unaware of their HIV infection and thus reduce onward transmission of HIV infection.

Estimating Gains in HIV Testing by Expanding HIV Screening at Routine Checkups.

Objectives. To estimate gains in the prevalence of individuals who had ever been tested for HIV overall and by subpopulations from increases in the percentage of persons who had a routine checkup and were tested. Methods. We used data from the 2019 Behavioral Risk Factor Surveillance System to determine the prevalence of individuals who were ever tested for HIV and the prevalence of missed opportunities for HIV testing among those never tested in the United States. We assessed the effect of absolute percentage increases in having ever been tested among those who had a past-year routine checkup on increasing the overall prevalence of having ever been tested. Results. In 2019, 49.5% of US adults had ever been tested for HIV; 34.5% had a missed opportunity. A 50% increase in testing at routine checkups would increase the prevalence of having ever been tested to 84.0%. Increases in the prevalence of having ever been tested (≥ 85%) was highest among persons aged 35 to 54 years, Black persons, persons who were female at birth, persons with health insurance, and persons reporting HIV risk behaviors. Conclusions. Fully incorporating HIV screening into primary care would greatly increase the proportion of US adults who have been tested for HIV. Public Health Implications. Continued efforts to promote HIV testing, including implementing routine screening in clinical settings, will help ensure that all US adults know their HIV status.

HIV Testing Trends at Visits to Physician Offices, Community Health Centers, and Emergency Departments - United States, 2009-2017.

In 2019, the U.S. Department of Health and Human Services launched the Ending the HIV Epidemic: A Plan for America (EHE) initiative to end the U.S. human immunodeficiency virus (HIV) epidemic by 2030. A critical component of the EHE initiative involves early diagnosis of HIV infection, along with prevention of new transmissions, treatment of infections, and response to HIV outbreaks (1). HIV testing is the first step in identifying persons with HIV infection who need to be engaged in treatment and care as well as persons with a negative HIV test result and who are at high risk for infection and can benefit from HIV preexposure prophylaxis (PrEP) and other prevention services. These opportunities are often missed for persons receiving clinical services in ambulatory care settings (2). Data from the 2009-2016 National Ambulatory Medical Care Survey (NAMCS) and 2009-2017 National Hospital Ambulatory Medical Care Survey (NHAMCS) were analyzed to estimate trends in HIV testing at visits by males and nonpregnant females to physician offices, community health centers (CHCs), and emergency departments (EDs) in the United States. HIV tests were performed at 0.63% of 516 million visits to physician offices, 2.65% of 37 million visits to CHCs, and 0.55% of 87 million visits to EDs. The percentage of visits with an HIV test did not increase at visits to physician offices during 2009-2016, increased at visits to CHC physicians during 2009-2014, and increased slightly at visits to EDs during 2009-2017. All adolescents and adults should have at least one HIV test in their lifetime (3). Strategies that reduce clinical barriers to HIV testing (e.g., clinical decision supports that use information in electronic health records [EHRs] to order an HIV test for persons who require one or standing orders for routine opt-out testing) are needed to increase HIV testing at ambulatory care visits.

Self-Reported Prevalence of HIV Testing Among Those Reporting Having Been Diagnosed With Selected STIs or HCV, United States, 2005-2016.

BACKGROUND: Persons with STIs or HCV infection often have indicators of HIV risk. We used weighted data from 6 cycles of the National Health and Nutrition Examination Survey (NHANES) to assess the proportion of persons who reported ever being diagnosed as having a selected STI or HCV infection and who reported that they were ever tested for HIV. METHODS: Persons aged 20 to 59 years with prior knowledge of HCV infection before receiving NHANES HCV RNA-positive results (2005-2012) or reporting ever being told by a doctor that they had HCV infection (2013-2016), or ever had genital herpes, or had chlamydia or gonorrhea in the past 12 months were categorized as having had a selected STI or HCV infection. Weighted proportions and 95% confidence intervals were estimated for reporting ever being tested for HIV for those who did and did not report a selected STI or HCV infection. RESULTS: A total of 19,102 respondents had nonmissing data for STI and HCV diagnoses and HIV testing history; 44.4% reported ever having been tested for HIV, and 5.2% reported being diagnosed as having a selected STI or HCV infection. The proportion reporting an HIV test was higher for the group that reported an STI or HCV infection than for the group that did not. CONCLUSION: Self-reported HIV testing remains low in the United States, even among those who reported a previous selected STI or HCV infection. Ensuring HIV tests are conducted routinely for those with overlapping risk factors can help facilitate the diagnosis of HIV infections.

HIV Testing and Linkage to Care Among Transgender Women Who Have Sex with Men: 23 U.S. Cities.

Transgender women face unique barriers to HIV testing and linkage to care. This article describes the results of a national testing initiative conducted by 36 community-based and other organizations using a variety of recruitment and linkage-to-care strategies. A total of 2191 HIV tests were conducted with an estimated 1877 unique transgender women, and 4.6% of the transgender women had confirmed positive results. Two thirds (66.3%) were linked to care within approximately three months of follow-up, and the median time to linkage was 7 days. Transgender women tested at clinical sites were linked to care faster than those tested at non-clinical sites (median: 0 vs. 12 days; P = .003). Despite the use of a variety of linkage-to-care strategies, the proportion of transgender women successfully linked to care was below national goals. Tailored programs and interventions are needed to increase HIV testing and improve timely linkage to care in this population.

Trends in HIV Testing Among US Adults, Aged 18-64 Years, 2011-2017.

In 2006, Centers for Disease Control and Prevention (CDC) recommended HIV screening in healthcare or clinical settings for all persons aged 13-64 years and annual rescreening for populations at high risk for HIV. We used the Behavioral Risk Factor Surveillance System to describe the prevalence and trends of ever tested for HIV and tested for HIV in the past 12 months among US adults. The percentage of ever tested increased from 42.9% in 2011 to 45.9% in 2017; testing in the past 12 months increased from 13.2% in 2011 to 14.8% in 2017. Despite these increases, less than half of US adults have ever been tested for HIV over ten years after CDC's recommendations. Increasing the prevalence of routine HIV screening and rescreening among individuals at high risk will reduce the number of undiagnosed persons with HIV infection and thus prevent new HIV infections-a key strategy in the Ending the HIV Epidemic initiative.

HIV Data to Care-Using Public Health Data to Improve HIV Care and Prevention.

BACKGROUND: "Data to Care" (D2C) is a public health strategy that uses surveillance and other data to improve continuity of HIV care for persons with HIV (PWH) by identifying those who are in need of medical care or other services and facilitating linkage to these services. The primary goal of D2C is to increase the number of PWH who are engaged in care and virally suppressed. METHODS: Data to Care can be implemented using several approaches. Surveillance-based D2C is usually initiated by health departments, using HIV surveillance and other data to identify those not in care. Health care providers may also initiate D2C by identifying patients who may have fallen out of care and working collaboratively with health departments to investigate, locate, and relink the patients to medical care or other needed services. RESULTS: Although D2C is a relatively new strategy, health department D2C programs have reported both promising results (eg, improved surveillance data quality and successful linkage to or re-engagement in care for PWH) and challenges (eg, incomplete or inaccurate data in surveillance systems, barriers to data sharing, and limitations of existing data systems). CONCLUSIONS: Data to Care is expected to enable health departments to move closer toward achieving national HIV prevention goals. However, additional information on appropriate implementation practices at each step of the D2C process is needed. This JAIDS Special Supplement explores how CDC funding to state health departments (eg, technical assistance and demonstration projects), and partnerships across federal agencies, are advancing our knowledge of D2C.

HIV Testing in 50 Local Jurisdictions Accounting for the Majority of New HIV Diagnoses and Seven States with Disproportionate Occurrence of HIV in Rural Areas, 2016-2017.

Since 2006, CDC has recommended universal screening for human immunodeficiency virus (HIV) infection at least once in health care settings and at least annual rescreening of persons at increased risk for infection (1,2), but data from national surveys and HIV surveillance demonstrate that these recommendations have not been fully implemented (3,4). The national Ending the HIV Epidemic initiative* is intended to reduce the number of new infections by 90% from 2020 to 2030. The initiative focuses first on 50 local jurisdictions (48 counties, the District of Columbia, and San Juan, Puerto Rico) where the majority of new diagnoses of HIV infection in 2016 and 2017 were concentrated and seven states with a disproportionate occurrence of HIV in rural areas relative to other states (i.e., states with at least 75 reported HIV diagnoses in rural areas that accounted for ≥10% of all diagnoses in the state).† This initial geographic focus will be followed by wider implementation of the initiative within the United States. An important goal of the initiative is the timely identification of all persons with HIV infection as soon as possible after infection (5). CDC analyzed data from the Behavioral Risk Factor Surveillance System (BRFSS)§ to assess the percentage of adults tested for HIV in the United States nationwide (38.9%), in the 50 local jurisdictions (46.9%), and in the seven states (35.5%). Testing percentages varied widely by jurisdiction but were suboptimal and generally low in jurisdictions with low rates of diagnosis of HIV infection. To achieve national goals and end the HIV epidemic in the United States, strategies must be tailored to meet local needs. Novel screening approaches might be needed to reach segments of the population that have never been tested for HIV.

Men Who Have Sex with Men (MSM) Who Have Not Previously Tested for HIV: Results from the MSM Testing Initiative, United States (2012-2015).

The Centers for Disease Control and Prevention recommends annual HIV tests for men who have sex with men (MSM), yet some have never tested. We analyzed data from the MSM Testing Initiative. Of 68,185 HIV tests, 8% were with MSM who never previously tested ("first-time testers"). Among tests with first-time testers, 70.7% were with MSM from racial or ethnic minorities; 66.5% were with MSM younger than 30 years. Tests with MSM who reported female partners only during the past year (compared to male partners only) or were recruited for at-home testing (compared to venue-based recruitment) were 4 times (prevalence ratio [PR] 3.62, 95% CI 3.15-4.15) and 5 times as likely (PR 4.69, 95% CI 4.22-5.21) to be associated with first-time testing. At-home testing and focusing on MSM who have sex with women may be effective methods for reaching MSM who are first-time testers.

Stigmatizing Attitudes Toward People Living with HIV Among Adults and Adolescents in the United States.

Stigmatizing attitudes toward people living with HIV (PLWH) cause psychological distress for PLWH and hinder HIV prevention efforts. We estimated the prevalence of stigmatizing attitudes among 6809 adults and 885 adolescents who responded to online surveys in 2015. Fear of casual contact with PLWH was reported by 17.5% [95% confidence interval (CI) 16.3-18.6%] of adults and 31.6% (CI 27.8-35.4%) of adolescents. Among adults, 12.5% (CI 11.6-13.5%) endorsed a measure of moral judgment toward PLWH. Stigmatizing attitudes toward PLWH persist in the United States. Continued monitoring of these attitudes and efforts to reduce associated stigma are warranted.

Interval Since Last HIV Test for Men and Women with Recent Risk for HIV Infection - United States, 2006-2016.

Since 2006, CDC has recommended routine screening of all persons aged 13-64 years for human immunodeficiency virus (HIV) and at least annual rescreening of persons at higher risk (1). However, national surveillance data indicate that many persons at higher risk for HIV infection are not screened annually, and delays in diagnosis persist (2). CDC analyzed 2006-2016 data from the General Social Survey (GSS)* and estimated that only 39.6% of noninstitutionalized U.S. adults had ever tested for HIV. Among persons ever tested, the estimated median interval since last test was 1,080 days or almost 3 years. Only 62.2% of persons who reported HIV-related risk behaviors in the past 12 months were ever tested for HIV, and the median interval since last test in this group was 512 days (1.4 years). The percentage of persons ever tested and the interval since last test remained largely unchanged during 2006-2016. More frequent screening of persons with ongoing HIV risk is needed to achieve full implementation of CDC's screening recommendations and to prevent new infections. Integration of routine screening as standard clinical practice through existing strategies, such as electronic medical record prompts (3), or through new, innovative strategies might be needed to increase repeat screening of persons with ongoing risk.

The Optimal Age for Screening Adolescents and Young Adults Without Identified Risk Factors for HIV.

PURPOSE: To assess the optimal age at which a one-time HIV screen should begin for adolescents and young adults (AYA) in the U.S. without identified HIV risk factors, incorporating clinical impact, costs, and cost-effectiveness. METHODS: We simulated HIV-uninfected 12-year-olds in the U.S. without identified risk factors who faced age-specific risks of HIV infection (.6-71.3/100,000PY). We modeled a one-time screen ($36) at age 15, 18, 21, 25, or 30, each in addition to current U.S. screening practices (30% screened by age 24). Outcomes included retention in care, virologic suppression, life expectancy, lifetime costs, and incremental cost-effectiveness ratios in $/year-of-life saved (YLS) from the health-care system perspective. In sensitivity analyses, we varied HIV incidence, screening and linkage rates, and costs. RESULTS: All one-time screens detected a small proportion of lifetime infections (.1%-10.3%). Compared with current U.S. screening practices, a screen at age 25 led to the most favorable care continuum outcomes at age 25: proportion diagnosed (77% vs. 51%), linked to care (71% vs. 51%), retained in care (68% vs. 44%), and virologically suppressed (49% vs. 32%). Compared with the next most effective screen, a screen at age 25 provided the greatest clinical benefit, and was cost-effective ($96,000/YLS) by U.S. standards (<$100,000/YLS). CONCLUSIONS: For U.S. AYA without identified risk factors, a one-time routine HIV screen at age 25, after the peak of incidence, would optimize clinical outcomes and be cost-effective compared with current U.S. screening practices. Focusing screening on AYA ages 18 or younger is a less efficient use of a one-time screen among AYA than screening at a later age.

Evaluating the Evidence for More Frequent Than Annual HIV Screening of Gay, Bisexual, and Other Men Who Have Sex With Men in the United States: Results From a Systematic Review and CDC Expert Consultation.

The Centers for Disease Control and Prevention (CDC) recommended in 2006 that sexually active gay, bisexual, and other men who have sex with men (MSM) be screened for human immunodeficiency virus (HIV) at least annually. A workgroup comprising CDC and external experts conducted a systematic review of the literature, including benefits, harms, acceptability, and feasibility of annual versus more frequent screening among MSM, to determine whether evidence was sufficient to change the current recommendation. Four consultations with managers of public and nonprofit HIV testing programs, clinics, and mathematical modeling experts were conducted to provide input on the programmatic and scientific evidence. Mathematical models predicted that more frequent than annual screening of MSM could prevent some new HIV infections and would be more cost-effective than annual screening, but this evidence was considered insufficient due to study design. Evidence supports CDC's current recommendation that sexually active MSM be screened at least annually. However, some MSM might benefit from more frequent screening. Future research should evaluate which MSM subpopulations would benefit most from more frequent HIV screening.