Effect of Screening and Treatment for Gonorrhea and Chlamydia on HIV Incidence Among Men Who Have Sex With Men in the United States: A Modeling Analysis.

BACKGROUND: Previous models have estimated the total population attributable fraction of Neisseria gonorrhoeae and Chlamydia trachomatis (NG/CT) on HIV incidence among men who have sex with men (MSM), but this does not represent realistic intervention effects. We estimated the potential impact of screening for NG/CT on downstream incidence of HIV among MSM. METHODS: Using a network model, we estimated the effects of varying coverage levels for sexually transmitted infection screening among different priority populations: all sexually active MSM regardless of HIV serostatus, MSM with multiple recent (past 6 months) sex partners regardless of serostatus, MSM without HIV, and MSM with HIV. Under the assumption that all screening events included a urethral test, we also examined the effect of increasing the proportion of screening events that include rectal screening for NG/CT on HIV incidence. RESULTS: Increasing annual NG/CT screening among sexually active MSM by 60% averted 4.9% of HIV infections over a 10-year period (interquartile range, 2.8%-6.8%). More HIV infections were averted when screening was focused on MSM with multiple recent sex partners: 60% coverage among MSM with multiple recent sex partners averted 9.8% of HIV infections (interquartile range, 8.1%-11.6%). Increased sexually transmitted infection screening among MSM without HIV averted more new HIV infections compared with the transmissions averted because of screening MSM with HIV, but fewer NG/CT tests were needed among MSM with HIV to avert a single new HIV infection. CONCLUSIONS: Screening of NG/CT among MSM is expected to lead to modest but clinically relevant reductions in HIV incidence among MSM.

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.

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.

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.

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.

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.

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.

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.

Recommendations for HIV Screening of Gay, Bisexual, and Other Men Who Have Sex with Men - United States, 2017.

CDC's 2006 recommendations for human immunodeficiency virus (HIV) testing state that all persons aged 13-64 years should be screened for HIV at least once, and that persons at higher risk for HIV infection, including sexually active gay, bisexual, and other men who have sex with men (MSM), should be rescreened at least annually (1). Authors of reports published since 2006, including CDC (2), suggested that MSM, a group that is at highest risk for HIV infection, might benefit from being screened more frequently than once each year. In 2013, the U.S. Preventive Services Task Force (USPSTF) found insufficient evidence to specify an HIV rescreening interval but recommended annual screening for MSM as a reasonable approach (3). However, some HIV providers have begun to offer more frequent screening, such as once every 3 or 6 months, to some MSM. A CDC work group conducted a systematic literature review and held four expert consultations to review programmatic experience to determine whether there was sufficient evidence to change the 2006 CDC recommendation (i.e., at least annual HIV screening of MSM in clinical settings). The CDC work group concluded that the evidence remains insufficient to recommend screening more frequently than at least once each year. CDC continues to recommend that clinicians screen asymptomatic sexually active MSM at least annually. Each clinician can consider the benefits of offering more frequent screening (e.g., once every 3 or 6 months) to individual MSM at increased risk for acquiring HIV infection, weighing their patients' individual risk factors, local HIV epidemiology, and local testing policies.

Highlights from the 2016 HIV diagnostics conference: The new landscape of HIV testing in laboratories, public health programs and clinical practice.

The 2016 HIV Diagnostics Conference, held in Atlanta, Georgia, was attended by public health officials, laboratorians, HIV testing program managers, surveillance coordinators and industry representatives. The conference addressed test performance data, the implementation of new testing algorithms, quality assurance, and the application of new tests in a variety of settings. With regard to the recommended Centers for Disease Control and Prevention/Association of Public Health Laboratories HIV laboratory testing algorithm, the conference featured performance data, implementation challenges such as a lack of test options for the second and third steps, as well as data needs for new tests that may be used as part of the algorithm. There are delays when nucleic acid testing is needed with the algorithm. Novel tests such as point of care nucleic acid tests are needed on the U.S. market to readily identify acute infection. Multiplex tests are being developed which allow for the simultaneous detection of multiple pathogens. CDC staff highlighted new guidance for testing in non-clinical settings. Innovative approaches to linking testing and care in some settings have led to identification of early infections, improved receipt of test results and expedited initiation of therapy. Work continues to optimize testing so that infections are accurately identified as early as possible and time to treatment is minimized to improve health outcomes and prevent transmission.

Using a Multitest Algorithm to Improve the Positive Predictive Value of Rapid HIV Testing and Linkage to HIV Care in Nonclinical HIV Test Sites.

BACKGROUND: Use of a rapid HIV testing algorithm (RTA) in which all tests are conducted within one client appointment could eliminate off-site confirmatory testing and reduce the number of persons not receiving confirmed results. METHODS: An RTA was implemented in 9 sites in Los Angeles and San Francisco; results of testing at these sites were compared with 23 sites conducting rapid HIV testing with off-site confirmation. RTA clients with reactive results on more than 1 rapid test were considered HIV+ and immediately referred for HIV care. The positive predictive values (PPVs) of a single rapid HIV test and the RTA were calculated compared with laboratory-based confirmatory testing. A Poisson risk regression model was used to assess the effect of RTA on the proportion of HIV+ persons linked to HIV care within 90 days of a reactive rapid test. RESULTS: The PPV of the RTA was 100% compared with 86.4% for a single rapid test. The time between testing and receipt of RTA results was on average 8 days shorter than laboratory-based confirmatory testing. For risk groups other than men who had sex with men, the RTA increased the probability of being in care within 90 days compared with standard testing practice. CONCLUSIONS: The RTA increased the PPV of rapid testing to 100%, giving providers, clients, and HIV counselors timely information about a client's HIV-positive serostatus. Use of RTA could reduce loss to follow-up between testing positive and confirmation and increase the proportion of HIV-infected persons receiving HIV care.

First population-level effectiveness evaluation of a national programme to prevent HIV transmission from mother to child, South Africa.

BACKGROUND: There is a paucity of data on the national population-level effectiveness of preventing mother-to-child transmission (PMTCT) programmes in high-HIV-prevalence, resource-limited settings. We assessed national PMTCT impact in South Africa (SA), 2010. METHODS: A facility-based survey was conducted using a stratified multistage, cluster sampling design. A nationally representative sample of 10 178 infants aged 4-8 weeks was recruited from 565 clinics. Data collection included caregiver interviews, record reviews and infant dried blood spots to identify HIV-exposed infants (HEI) and HIV-infected infants. During analysis, self-reported antiretroviral (ARV) use was categorised: 1a: triple ARV treatment; 1b: azidothymidine >10 weeks; 2a: azidothymidine ≤10 weeks; 2b: incomplete ARV prophylaxis; 3a: no antenatal ARV and 3b: missing ARV information. Findings were adjusted for non-response, survey design and weighted for live-birth distributions. RESULTS: Nationally, 32% of live infants were HEI; early mother-to-child transmission (MTCT) was 3.5% (95% CI 2.9% to 4.1%). In total 29.4% HEI were born to mothers on triple ARV treatment (category 1a) 55.6% on prophylaxis (1b, 2a, 2b), 9.5% received no antenatal ARV (3a) and 5.5% had missing ARV information (3b). Controlling for other factors groups, 1b and 2a had similar MTCT to 1a (Ref; adjusted OR (AOR) for 1b, 0.98, 0.52 to 1.83; and 2a, 1.31, 0.69 to 2.48). MTCT was higher in group 2b (AOR 3.68, 1.69 to 7.97). Within group 3a, early MTCT was highest among breastfeeding mothers 11.50% (4.67% to 18.33%) for exclusive breast feeding, 11.90% (7.45% to 16.35%) for mixed breast feeding, and 3.45% (0.53% to 6.35%) for no breast feeding). Antiretroviral therapy or >10 weeks prophylaxis negated this difference (MTCT 3.94%, 1.98% to 5.90%; 2.07%, 0.55% to 3.60% and 2.11%, 1.28% to 2.95%, respectively). CONCLUSIONS: SA, a high-HIV-prevalence middle income country achieved <5% MTCT by 4-8 weeks post partum. The long-term impact on PMTCT on HIV-free survival needs urgent assessment.

Quality of nonmydriatic digital fundus photography obtained by nurse practitioners in the emergency department: the FOTO-ED study.

OBJECTIVE: Nonmydriatic fundus photography by non-ophthalmic-trained personnel has recently been shown to be a potential alternative to direct ophthalmoscopy in the emergency department (ED). We evaluated the reliability of a novel quality rating scale and applied this scale to nonmydriatic fundus photographs taken during routine ED patient encounters to determine factors associated with diminished photograph quality. DESIGN: Prospective, cross-sectional study. PARTICIPANTS: We included 350 patients enrolled in the Fundus photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department study who were photographed by nurse practitioners after <30 minutes of training followed by supervision. METHODS: Photographs of both eyes were graded for quality on 2 occasions by 2 neuro-ophthalmologists. Four regions were independently evaluated for quality: Optic disc, macula, and superior and inferior vascular arcades. Quality as a function of the number of photographs taken was evaluated by Kaplan-Meier analysis. Mixed effects ordinal logistic regression was used to evaluate for predictors of image quality while accounting for the repeated measures design. MAIN OUTCOME MEASURES: Overall photographic quality (1-5 scale; 5 best). RESULTS: We evaluated 1734 photographs. Inter- and intraobserver agreements between neuro-ophthalmologists were very good (weighted kappa, 0.84-0.87). Quality of the optic disc area was better than those of other retinal areas (P<0.002). Kaplan-Meier analysis showed that if a high-quality photograph of an eye was not obtained by the third attempt, it was unlikely that one would be obtained at all. A 10-second increase in the interphotograph interval before a total of 40 seconds increased the odds of a 1-unit higher quality rating by 1.81 times (95% confidence interval [CI], 1.68-1.98), and a 10-year increase in age decreased the odds by 0.76 times (95% CI, 0.69-0.85). Black patients had 0.42 times (95% CI, 0.28-0.63) the odds of a 1-unit higher quality rating compared with whites. CONCLUSIONS: Our 5-point scale is a reliable measure of nonmydriatic photograph quality. The region of interest, interphotograph interval, and patient age and race are significant predictors of image quality for nonmydriatic photographs taken by nurse practitioners in the ED. Addressing these factors may have a direct impact on the successful implementation of nonmydriatic fundus photography into the ED.

Performance of an alternative laboratory-based algorithm for HIV diagnosis in a high-risk population.

BACKGROUND: An immunoassay (IA) followed by Western blot (WB) or immunofluorescence assay has been the primary algorithm used to provide laboratory confirmation of the diagnosis of HIV infection in the US for more than 20 years. Recently, an alternative diagnostic algorithm was proposed to more accurately identify early HIV-1 infection and differentiate between HIV-1 and HIV-2 infection. OBJECTIVES: Evaluate a sequential alternative algorithm in which reactive IAs are followed by a rapid HIV test and, if negative, a nucleic acid amplification test (NAAT). STUDY DESIGN: Specimens from high-risk persons were tested with 4 HIV IAs, 6 rapid HIV tests and NAAT (APTIMA(®)), which are approved by the United States Food and Drug Administration. IAs were repeated in duplicate if specimen volumes were sufficient. The performance of the alternative algorithm was compared to HIV WB and NAAT. RESULTS: The original study classified 377 specimens as HIV-positive and 3070 as HIV-negative. All 4 IAs correctly identified >99.5% of HIV-positive specimens and, on initial screening, >95.8% of HIV-negative specimens. When repeated, specificity of IAs improved to >99%. Between 6.7% and 12.4% of IA-repeatedly reactive specimens required APTIMA for resolution. The alternative algorithm led to the correct classification of all IA-reactive specimens. CONCLUSIONS: Regardless of screening IA and rapid test used, the alternative algorithm correctly classified the infection status of all persons with reactive screening IA results. Few specimens required NAAT for resolution, and the proportion requiring NAAT was lower when repeat IA test results were considered.

False-positive human immunodeficiency virus enzyme immunoassay results in pregnant women.

OBJECTIVE: Examine whether false-positive HIV enzyme immunoassay (EIA) test results occur more frequently among pregnant women than among women who are not pregnant and men (others). DESIGN: To obtain a large number of pregnant women and others tested for HIV, we identified specimens tested at a national laboratory using Genetic Systems HIV-1/HIV-2 Plus O EIA from July 2007 to June 2008. METHODS: Specimens with EIA repeatedly reactive and Western blot-negative or indeterminate results were considered EIA false-positive. We compared the false-positive rate among uninfected pregnant women and others, adjusting for HIV prevalence. Among all reactive EIAs, we evaluated the proportion of false-positives, positive predictive value (PPV), and Western blot bands among indeterminates, by pregnancy status. RESULTS: HIV prevalence was 0.06% among 921,438 pregnant women and 1.34% among 1,103,961 others. The false-positive rate was lower for pregnant women than others (0.14% vs. 0.21%, odds ratio 0.65 [95% confidence interval 0.61, 0.70]). Pregnant women with reactive EIAs were more likely than others (p<0.01) to have Western blot-negative (52.9% vs. 9.8%) and indeterminate results (17.0% vs. 3.7%) and lower PPV (30% vs. 87%). The p24 band was detected more often among pregnant women (p<0.01). CONCLUSIONS: False-positive HIV EIA results were rare and occurred less frequently among pregnant women than others. Pregnant women with reactive EIAs were more likely to have negative and indeterminate Western blot results due to lower HIV prevalence and higher p24 reactivity, respectively. Indeterminate results may complicate clinical management during pregnancy. Alternative methods are needed to rule out infection in persons with reactive EIAs from low prevalence populations.