Background Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States.Methods In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs.Results The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination.Conclusion Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications.

INTRODUCTION: Pharmacy-based HIV and hepatitis C virus (HCV) screening services developed in conjunction with state and local health departments can improve public health through increased access to testing and a linkage-to-care strategy. The objective of this study was to evaluate the impact of implementing HIV and HCV screening in community pharmacies. METHODS: This prospective, multicenter implementation project was conducted from July 2015 through August 2018. Sixty-one pharmacies participated in 3 US regions. We assessed the effectiveness of point-of-care testing, counseling, and disease education for populations at increased risk for HIV and HCV infection through screening programs offered in community pharmacies. Pharmacy customers were offered screening with point-of-care HIV and/or HCV tests. Reactive test results were reported to state or local health departments for disease surveillance. RESULTS: A total of 1,164 patients were screened for HIV, HCV, or both at the 61 participating pharmacies; the average number of patients screened per pharmacy was 19. Pharmacists conducted 1,479 HIV or HCV tests among the 1,164 patients. Five of 612 (0.8%) HIV tests yielded a reactive result, and 181 of 867 (20.9%) of HCV tests yielded a reactive result. CONCLUSION: Patients at increased risk of HIV or HCV can benefit from screening for infection at community pharmacies. Ease of accessibility to testing coupled with a strategy for linkage to care designed for the local community can improve patient care and improve the course of treatment for HIV and HCV.

High prevalences of HIV and other sexually transmitted infections (STIs) have been reported in the current global monkeypox outbreak, which has affected primarily gay, bisexual, and other men who have sex with men (MSM) (1-5). In previous monkeypox outbreaks in Nigeria, concurrent HIV infection was associated with poor monkeypox clinical outcomes (6,7). Monkeypox, HIV, and STI surveillance data from eight U.S. jurisdictions* were matched and analyzed to examine HIV and STI diagnoses among persons with monkeypox and assess differences in monkeypox clinical features according to HIV infection status. Among 1,969 persons with monkeypox during May 17-July 22, 2022, HIV prevalence was 38%, and 41% had received a diagnosis of one or more other reportable STIs in the preceding year. Among persons with monkeypox and diagnosed HIV infection, 94% had received HIV care in the preceding year, and 82% had an HIV viral load of <200 copies/mL, indicating HIV viral suppression. Compared with persons without HIV infection, a higher proportion of persons with HIV infection were hospitalized (8% versus 3%). Persons with HIV infection or STIs are disproportionately represented among persons with monkeypox. It is important that public health officials leverage systems for delivering HIV and STI care and prevention to reduce monkeypox incidence in this population. Consideration should be given to prioritizing persons with HIV infection and STIs for vaccination against monkeypox. HIV and STI screening and other recommended preventive care should be routinely offered to persons evaluated for monkeypox, with linkage to HIV care or HIV preexposure prophylaxis (PrEP) as appropriate.

BACKGROUND: Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States. METHODS: In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs. RESULTS: The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination. CONCLUSION: Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications.

The Centers for Disease Control and Prevention (CDC) and state, territorial, and local health departments have expanded efforts to detect and respond to HIV clusters and outbreaks in the United States. In July 2017, CDC created the HIV Outbreak Coordination Unit (OCU) to ensure consistent and collaborative assessment of requests from health departments for consultation or support on possible HIV clusters and outbreaks of elevated concern. The HIV OCU is a multidisciplinary, cross-organization functional unit within CDC's Division of HIV/AIDS Prevention. HIV OCU members have expertise in areas such as outbreak detection and investigation, prevention, laboratory services, surveillance and epidemiology, policy, communication, and operations. HIV OCU discussions facilitate problem solving, coordination, and situational awareness. Between HIV OCU meetings, designated CDC staff members communicate regularly with health departments to provide support and assessment. During July 2017-December 2019, the HIV OCU reviewed 31 possible HIV clusters and outbreaks (ie, events) in 22 states that were detected by CDC, health departments, or local partners; 17 events involved HIV transmission associated with injection drug use, and other events typically involved sexual transmission or overall increases in HIV diagnoses. CDC supported health departments remotely or on site with planning and prioritization; data collection, management, and analysis; communications; laboratory support; multistate coordination; and expansion of HIV prevention services. The HIV OCU has augmented CDC's support of HIV cluster and outbreak assessment and response at health departments and had important internal organizational benefits. Health departments may benefit from developing or strengthening similar units to coordinate detection and response efforts within and across public health agencies and advance the national Ending the HIV Epidemic initiative.

BACKGROUND: Black and Hispanic men have the highest rates of HIV diagnoses. To decrease the number of U.S. men who are unaware of their HIV status, they should be tested at least once. Our objective was to estimate the increases needed in HIV testing rates at ambulatory healthcare visits to achieve universal coverage. METHODS: We analyzed nationally representative medical record abstraction data to estimate the number of visits per person to physician offices, emergency departments, and outpatient clinics among men aged 18-39 years during 2009-2016, and the percentage of visits with an HIV test. We calculated the increase in the percentage of visits with an HIV test needed to achieve universal testing coverage of men by age 39 years. RESULTS: Men had a mean of 75.3 million ambulatory visits per year and 1.67 visits per person. An HIV test was performed at 0.9% of the ambulatory visits made by white men, 2.5% by black men, and 2.4% by Hispanic men. A 3-fold increase in the percentage of visits with an HIV test would result in coverage of 46.2% of white, 100% of black, and 100% of Hispanic men; an 11-fold increase would be needed to result in coverage of 100% of white men. CONCLUSIONS: HIV testing rates of men at ambulatory healthcare visits were too low to provide HIV testing coverage of all men by aged 39 years. A 3-fold increase in the percentage of visits with an HIV test would result in universal testing coverage of black and Hispanic men by age 39 years.

OBJECTIVES: Hepatitis C virus (HCV) and HIV transmission in the United States may increase as a result of increasing rates of opioid use disorder (OUD) and associated injection drug use (IDU). Epidemiologic trends among American Indian/Alaska Native (AI/AN) persons are not well known. METHODS: We analyzed 2010-2014 Indian Health Service data on health care encounters to assess regional and temporal trends in IDU indicators among adults aged >/=18 years. IDU indicators included acute or chronic HCV infection (only among adults aged 18-35 years), arm cellulitis and abscess, OUD, and opioid-related overdose. We calculated rates per 10 000 AI/AN adults for each IDU indicator overall and stratified by sex, age group, and region and evaluated rate ratios and trends by using Poisson regression analysis. RESULTS: Rates of HCV infection among adults aged 18-35 increased 9.4% per year, and rates of OUD among all adults increased 13.3% per year from 2010 to 2014. The rate of HCV infection among young women was approximately 1.3 times that among young men. Rates of opioid-related overdose among adults aged <50 years were approximately 1.4 times the rates among adults aged >/=50 years. Among young adults with HCV infection, 25.6% had concurrent OUD. Among all adults with arm cellulitis and abscess, 5.6% had concurrent OUD. CONCLUSIONS: Rates of HCV infection and OUD increased significantly in the AI/AN population. Strengthened public health efforts could ensure that AI/AN communities can address increasing needs for culturally appropriate interventions, including comprehensive syringe services programs, medication-assisted treatment, and opioid-related overdose prevention and can meet the growing need for treatment of HCV infection.

In January 2015, the Indiana State Health Department detected an alarming number of new HIV diagnoses in Scott County, a rural community in southeastern Indiana. A disease intervention specialist identified a cluster of 11 newly diagnosed HIV infections in a county where just five infections had been diagnosed from 2004 to 2014.1 The first three cases were detected through routine HIV screening. Following initial contact tracing, eight additional cases were diagnosed in the syringe-sharing partners of the three patients. All 11 individuals reported having injected the prescription opioid oxymorphone.

BACKGROUND: Infective endocarditis (IE) is a life-threatening bacterial infection of the heart valves, most often diagnosed in older persons and persons with prior cardiac surgery. It is also associated with injection drug use, a behavior that has increased in recent years along with the U.S. opioid crisis. METHODS: We conducted a retrospective cohort analysis of commercial and Medicaid health insurance databases to estimate incident cases of IE in the United States in 2017, stratified by HIV, HCV infection and opioid use disorder (OUD). We also estimated annual percentage changes (EAPCs) in IE from 2007-2017 among persons with commercial insurance. RESULTS: The weighted incidence rate of IE was 13.8 cases per 100,000 persons among persons with commercial insurance, and 78.7 among those with Medicaid. The incidence rate of IE among commercially insured persons increased slightly from 2007-2017 (EAPC 1.0%). It decreased among commercially insured persons with HIV from 148.0 in 2007 to 112.1 in 2017 (EAPC -4.3%) and increased among those with HCV infection from 172.4 to 238.6 in 2017 (EAPC 3.2%). Among persons aged 18-29 years with HCV infection, IE increased from 337.6 in 2007 to 1028.7 in 2017 (EAPC 15.3%), and among those with OUD it increased from 156.4 in 2007 to 642.9 in 2017 (EAPC 13.8%). CONCLUSIONS: The incidence rate of IE increased markedly among young persons with HCV infection or OUD. This increase appears to parallel the ongoing national opioid crisis. Harm reduction with syringe services programs, medications for opioid use disorder, and safe injection practices can prevent HIV, HCV, and IE.

INTRODUCTION: In April 2017, the Tennessee Department of Health (TDH) was notified of an increase in the number of persons newly diagnosed with HIV in eastern Tennessee in the same month. Two were identified as persons with a history of injection drug use (IDU) and named each other as syringe-sharing partners, prompting an investigation into a possible HIV cluster among persons with a history of IDU. MATERIALS AND METHODS: TDH and public health staff members in eastern Tennessee collaborated to implement procedures outlined in TDH's HIV/hepatitis C virus (HCV) Outbreak Response Plan, including conducting enhanced interviewing and using a preestablished database for data collection and management. To complement contact tracing and enhanced interviewing, TDH partnered with the Centers for Disease Control and Prevention to conduct molecular HIV analyses. RESULTS: By June 27, 2017, the investigation had identified 31 persons newly diagnosed with HIV infection; 8 (26%) self-reported IDU, 4 of whom were also men who have sex with men (MSM). Of the remaining 23 persons newly diagnosed with HIV infection, 10 were MSM who did not report IDU, 9 reported high-risk heterosexual contact, and 4 had other or unknown risk factors. Molecular analysis of the 14 HIV-1 polymerase genes (including 7 of the 8 persons self-reporting IDU) revealed 3 distinct molecular clusters, one of which included 3 persons self-reporting IDU. PRACTICE IMPLICATIONS: This investigation highlights the importance of implementing an established Outbreak Response Plan and using HIV molecular analyses in the event of a transmission cluster or outbreak investigations. Future HIV outbreak surveillance will include using Global Hepatitis Outbreak Surveillance Technology to identify HCV gene sequences as a potential harbinger for HIV transmission networks.

Tailoring public health responses to growing HIV transmission clusters depends on accurately mapping the risk network through which it spreads and identifying acute infections that represent the leading edge of cluster growth. HIV transmission links, especially those involving persons with acute HIV infection (AHI), can be difficult to uncover, or confirm during partner services investigations. We integrated molecular, epidemiologic, serologic and behavioral data to infer and evaluate transmission linkages between participants of a prospective study of AHI conducted in North Carolina, New York City and San Francisco from 2011-2013. Among the 547 participants with newly diagnosed HIV with polymerase sequences, 465 sex partners were reported, of whom only 35 (7.5%) had HIV sequences. Among these 35 contacts, 23 (65.7%) links were genetically supported and 12 (34.3%) were not. Only five links were reported between participants with AHI but none were genetically supported. In contrast, phylodynamic inference identified 102 unreported transmission links, including 12 between persons with AHI. Importantly, all putative transmission links between persons with AHI were found among large clusters with more than five members. Taken together, the presence of putative links between acute participants who did not name each other as contacts that are found only among large clusters underscores the potential for unobserved or undiagnosed intermediaries. Phylodynamics identified many more links than partner services alone and, if routinely and rapidly integrated, can illuminate transmission patterns not readily captured by partner services investigations.

Objectives. To describe and control an outbreak of HIV infection among people who inject drugs (PWID).Methods. The investigation included people diagnosed with HIV infection during 2015 to 2018 linked to 2 cities in northeastern Massachusetts epidemiologically or through molecular analysis. Field activities included qualitative interviews regarding service availability and HIV risk behaviors.Results. We identified 129 people meeting the case definition; 116 (90%) reported injection drug use. Molecular surveillance added 36 cases to the outbreak not otherwise linked. The 2 largest molecular groups contained 56 and 23 cases. Most interviewed PWID were homeless. Control measures, including enhanced field epidemiology, syringe services programming, and community outreach, resulted in a significant decline in new HIV diagnoses.Conclusions. We illustrate difficulties with identification and characterization of an outbreak of HIV infection among a population of PWID and the value of an intensive response.Public Health Implications. Responding to and preventing outbreaks requires ongoing surveillance, with timely detection of increases in HIV diagnoses, community partnerships, and coordinated services, all critical to achieving the goal of the national Ending the HIV Epidemic initiative. (Am J Public Health. Published online ahead of print November 14, 2019: e1-e8. doi:10.2105/AJPH.2019.305366).

A syringe services program (SSP) was established following the Indiana HIV outbreak among persons who inject drugs (PWID) in Scott County. Among Indiana-based PWID, we examined injection behaviors associated with HIV status, SSP use after its establishment, and changes in injection behaviors after the outbreak response. During 2016, we interviewed 200 PWID and assessed injection behaviors before the response by HIV status. We reported injection behaviors prior to the response and used Fisher's exact Chi square tests (P < 0.05) to assess differences by HIV status. Next, among persons who injected both before (July-December 2014) and after (past 30 days) the response, we (1) reported the proportion of persons who used the SSP to obtain sterile syringes, and assessed differences in SSP use by HIV status using Fisher's exact Chi square tests; and (2) compared distributive and receptive sharing of injection equipment and disposal of syringes before and after the outbreak response, and assessed statistical differences using McNemar's test. We also compared injection behaviors before and after the response by HIV status. Injecting extended release oxymorphone (Opana(R) ER); receptive sharing of syringes and cookers; and distributive sharing of cookers, filters, or water before the response were associated with HIV infection. SSP use was high (86%), particularly among HIV-positive compared with HIV-negative persons (98% vs. 84%). Injection equipment sharing decreased and safe disposal of used syringes increased after the response, especially among HIV-positive persons. Injection equipment sharing contributed to the outbreak. High SSP use following the response, particularly among HIV-positive persons, contributed to decreased high-risk injection practices.

From 2000 to 2014, the number of annual diagnoses of human immunodeficiency virus (HIV) infection in Massachusetts declined 47% (1). In August 2016, however, the Massachusetts Department of Public Health (MDPH) received reports of five new HIV cases among persons who inject drugs from a single community health center in the City of Lawrence (2). On average, less than one case per month among persons who inject drugs had been reported in Lawrence during 2014–2015 from all providers. Surveillance identified additional cases of HIV infection among such persons linked to Lawrence and Lowell, in northeastern Massachusetts, during 2016–2017. In 2018, MDPH and CDC conducted an investigation to characterize the outbreak and recommend control measures.

BACKGROUND: Syphilis transmission can be prevented by prompt diagnosis and treatment of primary and secondary infection. We evaluated the performance of a point-of-care rapid syphilis treponemal test (RST) in an emergency department (ED) setting. METHODS: Between June 2015 and April 2016, men aged 18-34 years seeking services in a Detroit ED, and with no history of syphilis, were screened for syphilis with the RST, rapid plasma reagin (RPR) test, and Treponema pallidum particle agglutination assay (TP-PA). A positive reference standard was both a reactive RPR and a reactive TP-PA. We compared test results in self-reported MSM to non-MSM. RESULTS: Among 965 participants, 10.9% of RSTs were reactive in MSM and only 1.5% in non-MSM (p<0.001). Sensitivity of the RST was 76.9% and specificity was 99.0% (PPV 50.0%) compared to the positive reference standard. Three discordant specimens found negative with the RST but positive with the reference standard had an RPR titer of 1:1, compared with 10 specimens with concordant positive results that had a median RPR titer of 1:16. The RST sensitivity was 50.0% (PPV 68.4%) compared to the TP-PA test alone. Among men seeking care in an ED, the RST detected 76.9% of participants with a reactive RPR and TP-PA. CONCLUSIONS: The RST detected all of the participants with an RPR titer > 1:2 but less than 20% of participants with a positive TP-PA and negative RPR. The RST was useful to detect a high proportion of participants with an active syphilis in an urban ED.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

BACKGROUND: Laboratory assays for determining recent HIV-1 infection are an important public health tool for aiding in the estimation of HIV incidence. Some incidence assay analytes are remarkably predictive of time since seroconversion and may be useful for additional applications, such as predicting recent transmission events during HIV outbreaks and informing prevention strategies. METHODS: Plasma samples (n= 154) from a recent HIV-1 outbreak in a rural community in Indiana were tested with the customized HIV-1 Multiplex assay, based on the Bio-Rad Bio-Plex platform, which measures antibody response to HIV envelope antigens, gp120, gp160, and gp41. Assay cutoffs for each analyte were established to determine whether an individual seroconverted within 30, 60, or 90 days of the sample collection date. Additionally, a novel bioinformatics method was implemented to infer infection dates of persons newly diagnosed with HIV during the outbreak. RESULTS: Sensitivity/specificity of the HIV-1 Multiplex assay for predicting seroconversion within 30, 60, 90 days, based on a training data set, was 90.5%/95.4%, 94.1%/90%, 89.4%/82.9%, respectively. Of 154 new diagnoses in Indiana between December 2014 and August 2016, the majority (71%) of recent infections (</=3 months since seroconversion) were identified between February and May 2016. The epidemiologic curve derived from the bioinformatics analysis indicated HIV transmission began as early as 2010, grew exponentially in 2014, and leveled off in April 2015. CONCLUSION: The HIV-1 Multiplex assay has the potential to identify and monitor trends in recent infection during an epidemic to assess the efficacy of programmatic or treatment interventions.

BACKGROUND: In the US, the HIV diagnostic algorithm for laboratory settings recommends the use of an HIV-1/HIV-2 differentiation supplemental assay after an initial reactive antigen/antibody (Ag/Ab) assay result. Since the discontinuation of the Multispot HIV-1/HIV-2 Rapid Test (MS), the Geenius HIV-1/2 Supplemental assay (Geenius) is the only FDA-approved supplemental differentiation test. OBJECTIVE: We compared the performance of Geenius to MS and Western Blot (WB). STUDY DESIGN: The relative seroconversion plasma reactivity of Geenius and MS was assessed using a 50% cumulative frequency analysis from 17 HIV-1 seroconverters. In addition, previously characterized plasma specimens, 186 HIV-1 positive, 100 HIV-2 positive, and 93 Ag/Ab-positive/HIV-1 RNA-negative, were tested with Geenius v1.1 software. McNemar's test was used for paired comparison analysis. A subset of 48 specimens were retested with the upgraded Geenius v1.3 software. RESULTS: In HIV-1 seroconverters, the relative seroconversion reactivity was 2.5 and 2 days before the first positive HIV-1 WB for Geenius and MS, respectively. In HIV-1 positive samples, Geenius performed similarly to HIV-1 WB (p=0.1687) and MS (p=0.8312). In HIV-2 positive samples, Geenius underperformed compared to HIV-2 WB (p=0.0005) and MS (p=0.0012). When using the upgraded software among the HIV-1 positive and Ag/Ab-reactive/HIV-1 RNA-negative samples, gp140 reactivity decreased without affecting characterization of HIV-2 samples. CONCLUSIONS: With HIV-1 samples, Geenius, WB and MS performance was similar as supplemental tests. The updated Geenius software reduced false gp140 reactivity, but had no impact on identifying true HIV-2 infections. Further evaluation will assess the impact of the Geenius software update on final diagnostic interpretations.

In October 2013, Detroit’s only sexually transmitted disease (STD) clinic, at the Herman Kiefer Health Complex, was closed, which decreased access to HIV testing for many persons at substantial risk for acquiring infection [1]. Emergency departments (EDs), like STD clinics, often serve as a safety net for underinsured individuals but integrating additional services can be difficult given time and space constraints. This journal previously published an evaluation of a rapid point-of-care (POC) HIV antigen/antibody (Ag/Ab) test using stored specimens [2] and here we present an evaluation of this test to identify undiagnosed HIV infection in young men who sought emergency care.

BACKGROUND: Misuse of prescription opioid analgesics (POA) has increased dramatically in the US, particularly in non-urban areas. We examined injection practices among persons who inject POA in a rural area that experienced a large HIV outbreak in 2015. METHODS: Between August-September 2015, 25 persons who injected drugs within the past 12 months were recruited in Scott County, Indiana for a qualitative study. Data from in-depth, semi-structured interviews were analyzed. RESULTS: All 25 participants were non-Hispanic white and the median age was 33 years (range: 19-57). All had ever injected extended-release oxymorphone (Opana((R)) ER) and most (n=20) described preparing Opana((R)) ER for multiple injections per injection episode (MIPIE). MIPIE comprised 2-4 injections during an injection episode resulting from needing >1mL water to prepare Opana((R)) ER solution using 1mL syringes and the frequent use of "rinse shots." MIPIE occurred up to 10 times/day (totaling 35 injections/day), often in the context of sharing drug and injection equipment. CONCLUSIONS: We describe a high-risk injection practice that may have contributed to the rapid spread of HIV in this community. Efforts to prevent bloodborne infections among people who inject POA need to assess for MIPIE so that provision of sterile injection equipment and safer injection education addresses the MIPIE risk environment.

Identifying patients at-risk for HIV infection, such as men who have sex with men (MSM), is an important step in providing HIV testing and prevention interventions. It is unknown how primary care providers (PCPs) assess MSM status and related HIV-risk factors. We analyzed data from a panel-derived web-based survey for healthcare providers conducted in 2014 to describe how PCPs in the U.S. determined their patients' MSM status. We calculated adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) to describe PCP characteristics associated with systematically determining MSM status (i.e., PCP used "a patient-completed questionnaire" or "routine verbal review of sex history"). Among the 1008 PCPs, 56% determined MSM status by routine verbal review of sexual history; 41% by patient disclosure; 39% by questions driven by symptoms/history; 23% by using a patient-completed questionnaire, and 9% didn't determine MSM status. PCPs who systematically determined MSM status (n=665; 66%) were more likely to be female (aPR=1.16, CI=1.06-1.26), to be affiliated with a teaching hospital (aPR=1.15, CI=1.06-1.25), to routinely screen all patients aged 13-64 for HIV (aPR=1.29, CI=1.18-1.41), and to estimate that 6% or more of their male patients are MSM (aPR=1.14, CI=1.01-1.30). The majority of PCPs assessed MSM status and HIV risk factors through routine verbal reviews of sexual history. Implementing a systematic approach to identify MSM status and assess risk may allow PCPs to identify more patients needing frequent HIV testing and other preventive services, while mitigating socio-cultural barriers to obtaining such information.

Background: Anal sex is a common sexual behavior among women that increases their risk of acquiring rectal infection with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Methods: We estimated the frequency and positivity of rectal CT and GC tests for women aged 15-60 years performed by a large U.S. commercial laboratory between November 2012 and September 2015. We also estimated the frequency and positivity of pharyngeal and genital specimens also performed on the same date. Among women with a positive CT or GC result, we estimated the frequency and positivity of recommended repeat testing within 12 months. Results: Of 5,499 women who had rectal CT and GC tests, positivity was 10.8%. On the same date, approximately 80% also had genital CT tests, genital GC tests, and pharyngeal GC tests, while 40% had pharyngeal CT tests. Rectal CT or GC infection was associated with genital CT or GC infection, but 46.5% of rectal CT and GC infections would not have been identified with genital testing alone. Among women with a rectal CT or GC infection, only 20.0% had a recommended repeat rectal test. Of those who had a repeat test, 17.7% were positive. Conclusions: Testing women for rectal CT and GC was infrequent but positive tests were often found in women with negative genital tests. Most women with positive rectal tests were not retested. Interventions are needed to increase extragenital CT and GC testing of at-risk women.

In January 2015, an outbreak of undiagnosed human immunodeficiency virus (HIV) infections among persons who inject drugs (PWID) was recognized in rural Indiana. By September 2016, 205 persons in this community of approximately 4400 had received a diagnosis of HIV infection. We report results of new approaches to analyzing epidemiologic and laboratory data to understand transmission during this outbreak. HIV genetic distances were calculated using the polymerase region. Networks were generated using data about reported high-risk contacts, viral genetic similarity, and their most parsimonious combinations. Sample collection dates and recency assay results were used to infer dates of infection. Epidemiologic and laboratory data each generated large and dense networks. Integration of these data revealed subgroups with epidemiologic and genetic commonalities, one of which appeared to contain the earliest infections. Predicted infection dates suggest that transmission began in 2011, underwent explosive growth in mid-2014, and slowed after the declaration of a public health emergency. Results from this phylodynamic analysis suggest that the majority of infections had likely already occurred when the investigation began and that early transmission may have been associated with sexual activity and injection drug use. Early and sustained efforts are needed to detect infections and prevent or interrupt rapid transmission within networks of uninfected PWID.

OBJECTIVES: To estimate the number of men in the U.S. military who are gay, bisexual, or other men who have sex with men (MSM) to inform the development of military and other federal policies. STUDY DESIGN: We analyzed data from the National Surveys of Family Growth to estimate the number of U.S. men who were gay, bisexual, or MSM, and who had served in the military, compared to those who did not serve. We stratified using hierarchical categories of gay, bisexual, and other MSM to compare proportions in the military and general population. RESULTS: We found that 4.23% of men self-reported as gay, bisexual, or other MSM among men who served in the military, compared to 4.14% among men who had not served (p = 0.93). When stratified, we found that 0.78% self-reported as gay among men who served in the military, compared to 2.12% among men who had not served (p<0.001). CONCLUSIONS: The proportion of men who identified as a gay was lower in the military than in the general population. This finding might have been influenced by historical military policies related to sexual orientation.

BACKGROUND: Our medical center laboratory recently adapted its 24/7, two-hourly testing program to use an ARCHITECT-Multispot-viral load (AR-MS-VL) algorithm in place of a previous rapid test-immunofluorescence (RT-IF) algorithm. OBJECTIVES: We evaluated screening test performance, acute case detection, turnaround time and ability to resolve HIV status under the new algorithm. STUDY DESIGN: We considered consecutive HIV tests from January to November 2015. AR-MS-VL results at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) were compared with RT-IF results at ZSFG and also with AR-MS-VL results in the recently completed CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM at publicly funded testing sites in San Francisco. RESULTS: Among 21,985 HIV tests performed at ZSFG, 16,467 were tested by RT-IF and 5518 by AR-MS-VL. There were 321 HIV infections detected, of which 274 (84%) were known HIV+ cases, and 47 were newly identified HIV infections. Considering only patients of HIV-negative or -unknown status, prevalence was 0.22%. Under the AR-MS-VL algorithm, turnaround times for screening results and full algorithm results were 3 and 21h; status-unresolved cases were reduced (from 47% to 22%) compared with the RT-IF algorithm. The positive predictive value (PPV) of a new-positive AR screening test was low (0.44) at ZSFG, where no acute infections were detected. At STOP Study sites where HIV prevalence was higher and acute infection was more common, the AR PPV was higher (0.93). All 24 false-positive AR screening tests at ZSFG had a signal/cutoff (S/CO) ratio of <15 and all 88 true-positive tests had S/CO ratio >15. Of 62 acute infections in the STOP Study, 23 (37%) had an S/CO<15. DISCUSSION: An AR-MS-VL algorithm is feasible and can return rapid results in a large medical center. In this setting, reactive 4th generation assay tests that are negative for HIV antibodies are typically false-positive with low S/CO ratios.

BACKGROUND: The Determine HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens. OBJECTIVES: We compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens. STUDY DESIGN: We tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar's and Wilcoxon signed rank tests were used for statistical analysis. RESULTS: Of 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p<0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or -undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p<0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p=0.008). CONCLUSIONS: In plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion.

BACKGROUND: The flow-through INSTI HIV-1/HIV-2 Rapid Antibody (INSTI) test is a 60s FDA-approved test for HIV-1 and HIV-2 antibody testing using whole blood and plasma. OBJECTIVE: We evaluated the performance of INSTI using plasma and simulated whole blood specimens. STUDY DESIGN: INSTI's performance in plasma specimens from commercial seroconversion panels was assessed by estimating the relative sensitivity using a 50% cumulative frequency analysis and by comparing its performance with other FDA-approved rapid tests (RTs). INSTI was further evaluated using 320 HIV-1 plasma specimens collected during a cross-sectional study and with 107 HIV-1 and 24 HIV-2 simulated whole blood specimens. Sensitivity and specificity were calculated using 615 known HIV-1 group M/O and 80 HIV-2 (Western blot (WB)-positive), and 497 HIV-negative plasma specimens, respectively. RESULTS: In HIV-1 seroconversion panels, INSTI became reactive 9days before a positive WB. When compared to FDA-approved antibody-based lateral flow RTs, INSTI detected significantly more early infections. Among HIV-1-infected cross-sectional plasma samples, INSTI detected 23 (27%) of 85 Architect-positive/Multispot-negative or indeterminate specimens. For plasma specimens, the sensitivity was 99.84% for HIV-1 and 100% for HIV-2, and the specificity was 99.80%. Using simulated whole blood from seroconverters, INSTI performed similarly to plasma. CONCLUSIONS: INSTI performed significantly better than antibody-based lateral flow RTs during early stages of seroconversion. Sensitivity and specificity were within the manufacturer's reported ranges. Considering the observed test performance and the almost immediate results, INSTI is an accurate option to detect HIV-1/HIV-2 antibodies in point-of-care settings where lab testing is not feasible.

New recommendations for laboratory diagnosis of HIV infection in the United States were published in 2014. The updated testing algorithm includes a qualitative HIV-1 RNA assay to resolve discordant immunoassay results and to identify acute HIV-1 infection (AHI). The qualitative HIV-1 RNA assay is not widely available; therefore, we evaluated the performance of a more widely available quantitative HIV-1 RNA assay, viral load, for diagnosing AHI. We determined that quantitative viral loads consistently distinguished AHI from a false-positive immunoassay result. Among 100 study participants with AHI and a viral load result, the estimated geometric mean viral load was 1,377,793 copies/mL.

Background In January 2015, a total of 11 new diagnoses of human immunodeficiency virus (HIV) infection were reported in a small community in Indiana. We investigated the extent and cause of the outbreak and implemented control measures. Methods We identified an outbreak-related case as laboratory-confirmed HIV infection newly diagnosed after October 1, 2014, in a person who either resided in Scott County, Indiana, or was named by another case patient as a syringe-sharing or sexual partner. HIV polymerase (pol) sequences from case patients were phylogenetically analyzed, and potential risk factors associated with HIV infection were ascertained. Results From November 18, 2014, to November 1, 2015, HIV infection was diagnosed in 181 case patients. Most of these patients (87.8%) reported having injected the extended-release formulation of the prescription opioid oxymorphone, and 92.3% were coinfected with hepatitis C virus. Among 159 case patients who had an HIV type 1 pol gene sequence, 157 (98.7%) had sequences that were highly related, as determined by phylogenetic analyses. Contact tracing investigations led to the identification of 536 persons who were named as contacts of case patients; 468 of these contacts (87.3%) were located, assessed for risk, tested for HIV, and, if infected, linked to care. The number of times a contact was named as a syringe-sharing partner by a case patient was significantly associated with the risk of HIV infection (adjusted risk ratio for each time named, 1.9; P<0.001). In response to this outbreak, a public health emergency was declared on March 26, 2015, and a syringe-service program in Indiana was established for the first time. Conclusions Injection-drug use of extended-release oxymorphone within a network of persons who inject drugs in Indiana led to the introduction and rapid transmission of HIV. (Funded by the state government of Indiana and others.).

Zika virus has been identified as a cause of congenital microcephaly and other serious brain defects. CDC issued interim guidance for the prevention of sexual transmission of Zika virus on February 5, 2016, with an initial update on April 1, 2016 (2). The following recommendations apply to all men and women who have traveled to or reside in areas with active Zika virus transmission and their sex partners. The recommendations in this report replace those previously issued and are now updated to reduce the risk for sexual transmission of Zika virus from both men and women to their sex partners. This guidance defines potential sexual exposure to Zika virus as having had sex with a person who has traveled to or lives in an area with active Zika virus transmission when the sexual contact did not include a barrier to protect against infection. Such barriers include male or female condoms for vaginal or anal sex and other barriers for oral sex. Sexual exposure includes vaginal sex, anal sex, oral sex, or other activities that might expose a sex partner to genital secretions. This guidance will be updated as more information becomes available.

In 2014, 81% of new human immunodeficiency virus (HIV) infection diagnoses in the United States were in males, with the highest number of cases among those aged 20-29 years. Racial and ethnic minorities continue to be disproportionately affected by HIV; there are 13 new diagnoses each year per 100,000 white males, 94 per 100,000 black males, and 42 per 100,000 Hispanic males. Despite the recommendation by CDC for HIV testing of adults and adolescents, in 2014, only 36% of U.S. males aged ≥18 years reported ever having an HIV test, and in 2012, an estimated 15% of males living with HIV had undiagnosed HIV infection. To identify opportunities for HIV diagnosis in young males, CDC analyzed data from the 2009-2012 National Ambulatory Medical Care Survey (NAMCS) and U.S. Census data to estimate rates of health care use at U.S. physicians' offices and HIV testing at these encounters. During 2009-2012, white males visited physicians' offices more often (average annual rate of 1.6 visits per person) than black males (0.9 visits per person) and Hispanic males (0.8 visits per person). Overall, an HIV test was performed at 1.0% of visits made by young males to physicians' offices, with higher testing rates among black males (2.7%) and Hispanic males (1.4%), compared with white males (0.7%). Although higher proportions of black and Hispanic males received HIV testing at health care visits compared with white males, this benefit is likely attenuated by a lower rate of health care visits. Interventions to routinize HIV testing at U.S physicians' offices could be implemented to improve HIV testing coverage.