CDC-Funded HIV Testing Services Outcomes and Social Determinants of Health in Ending the HIV Epidemic in the U.S. Jurisdictions.

We performed an ecological analysis to examine associations between CDC-funded HIV testing services outcomes and social determinants of health (SDOH) among Ending the HIV Epidemic in the U.S. jurisdictions. Using National HIV Prevention Program Monitoring & Evaluation (2020) and American Community Survey (2016-2020) data, we ran robust Poisson models (adjusted for race/ethnicity). In healthcare settings, a 10% absolute increase in percentage without health insurance was associated with a 40% lower prevalence of newly diagnosed positivity (aPR = 0.60, 95% CI: 0.43-0.83); a $5,000 increase in median household income (aPR = 1.04, 95% CI: 1.03-1.06) and a 10% absolute increase in percentage unemployed (aPR = 1.80, 95% CI: 1.31-2.46) were associated with 4% and 80%, respectively, higher prevalence of percentage linked to HIV medical care within 30 days of diagnosis (i.e., linkage). In non-healthcare settings, a 10% absolute increase in percentage with less than high school diploma (aPR = 0.53, 95% CI: 0.29-0.96) was associated with a 47% lower prevalence of newly diagnosed positivity, whereas a 10% absolute increase in percentage without health insurance (aPR = 1.92, 95% CI: 1.29-2.88) was associated with a 92% higher prevalence of newly diagnosed positivity; a 10% absolute increase in percentage with less than high school diploma was associated with a 35% lower prevalence of linkage (aPR = 0.65, 95% CI: 0.43-0.97). Addressing SDOH in HIV prevention programs will play an important role in ending the HIV epidemic.

Seroconversion, seroreversion, and serowaffling among participants initiating antiretroviral therapy in Project DETECT.

BACKGROUND: Incomplete HIV seroconversion and seroreversion are increasingly documented by testing and pre-exposure prophylaxis programs more than previously recognized. This analysis reports on incomplete seroconversion and seroreversion by specimen and test type among Project DETECT participants. METHODS: Project DETECT included a longitudinal study of point-of-care tests. Participants were categorized as having "incomplete seroconversion" if all timepoints had ≥1 nonreactive test at study censoring. Among participants with incomplete seroconversion, we defined "seroreversion" as sustained regression to nonreactive for any test following a reactive result. We define "serowaffling" as any reactive result followed by a nonreactive and then reactive result. We used Fisher's exact tests to explore relationships between Fiebig stage at ART initiation and incomplete seroconversion, seroreversion, and serowaffling. RESULTS: Twenty of 1940 Project DETECT participants met criteria for this subset. Ten participants had complete seroconversion after a median of 23 (IQR 16-47) days following initial positive tests. Ten participants had incomplete seroconversion, eight of whom had seroreversion. Incomplete seroconversion with persistent nonreactive tests was seen only with oral fluid (OF). Of eight participants with seroreversion, all experienced seroreversion of OF tests if the test was ever reactive (n = 6); seroreversion occurred in fingerstick and venipuncture tests in two participants. Serowaffling occurred in nine (45%) participants. No associations were seen between Fiebig stage at ART start and complete seroconversion, seroregression, or serowaffling in our sample. CONCLUSIONS: OF tests may be particularly susceptible to providing false-negative results. Seroreversion and incomplete seroconversion among individuals on antiretroviral treatment may represent a growing problem for HIV testing and treatment programs.

Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT.

BACKGROUND: HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. OBJECTIVE: This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. METHODS: Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health-Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. RESULTS: Between September 2015 and March 2019, there were 14,990 Project DETECT-eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. CONCLUSIONS: Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/16332.

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.

Group Sex Events Among Cisgender Men Who Have Sex With Men: Cross-Sectional and Longitudinal Survey Study to Explore Participation and Risk-Taking Behaviors.

BACKGROUND: Group sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking platforms. However, collecting data on GSEs can be challenging, and many gaps exist in our knowledge about GSE participation among MSM. OBJECTIVE: The objective of this study was to develop survey questions addressing aggregate and partner-specific group sex behaviors to measure prevalence of GSEs and associated risks in persons participating in Project Diagnostic Evaluation To Expand Critical Testing Technologies (DETECT), including MSM seeking HIV and STD testing at a public clinic in Seattle, Washington. METHODS: We developed a computer self-assisted survey that included questions about participant demographics, sexual history, and risk behaviors, including group sex, as a part of Project DETECT, a Centers for Disease Control and Prevention-funded study evaluating point-of-care HIV tests. Aggregate and partner-specific questions asked about participation in all GSEs, threesomes, and four-or-more-somes including questions about number and HIV status of sex partners and condom use during the events. To evaluate question performance, we assessed the discrepancies in reporting between the aggregate and partner-specific questions, quantified question refusal rates, and calculated the additional time required to answer the GSE questions. Information about network density (number of partnerships of overlapping duration) was estimated and compared for MSM who did and did not report GSEs. RESULTS: Among 841 visits by 690 MSM who were asked any group sex survey question, participation in a GSE of any type in the past 3 months was reported at 293 visits (293/841, 34.8%). We found that 9.0% (76/841) of MSM in the sample reported ≥1 four-or-more-some in the partner-specific questions but did not report in the aggregate. The proportion of refusals on any given aggregate GSE-related question ranged from 0% (0/273) to 10.6% (15/141) (median 2.6%) and partner-specific questions ranged from 0% (0/143) to 22% (5/23) (median 3.0%), with questions about four-or-more-somes having the highest proportions of refusals. Completing the aggregate group sex questions added 1 to 2 minutes and the partner-specific questions added an additional 2 to 4 minutes per partner to the total survey length. As expected, the partner-specific GSE questions documented higher density of sexual networks that was not captured by asking about total partner counts and overlap of specific partnerships. CONCLUSIONS: We found that the Project DETECT survey was able to obtain nuanced information about GSEs. The question skip patterns and consistency checks were effective, and survey fatigue was minimal. More research is needed on GSEs, and our survey represents a promising data collection tool to help fill gaps in knowledge about the subject.

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.

Implementation of rapid HIV testing programs in community and outreach settings: perspectives from staff at eight community-based organizations in seven U.S. cities.

OBJECTIVES: The goals of this research were to evaluate perceptions of staff about the effectiveness of methods used by eight community-based organizations (CBOs) to implement human immunodeficiency virus (HIV) counseling and rapid testing in community and outreach settings in seven U.S. cities, and to identify operational challenges. METHODS: A survey was administered to CBO staff to determine their perceptions about the effectiveness of methods used to select testing venues, promote their testing programs, recruit people for testing, provide test results, and link HIV-positive people to health care. Using a Likert scale, respondents rated the effectiveness of methods, their agreement with statements about using mobile testing units (MTUs) and rapid HIV test kits, and operational challenges. RESULTS: Most respondents perceived the methods they used for selecting testing venues, and particularly using recommendations from people receiving testing, to be effective. Most respondents also thought their promotional activities were effective. Respondents believed that using MTUs improved their capacity to reach high-risk individuals, but that MTUs were associated with substantial challenges (e.g., costs to purchase and maintain them). Programmatic challenges included training staff to provide counseling and testing, locating and providing confirmatory test results to people with reactive rapid tests, and sustaining testing programs. CONCLUSIONS: CBO staff thought the methods used to select venues for HIV testing were effective and that using MTUs increased their ability to provide testing to high-risk individuals. However, using MTUs was expensive and posed logistical difficulties. CBOs planning to implement similar programs should take these findings into consideration and pay particular attention to training needs and program sustainability.

Cost-effectiveness of finding new HIV diagnoses using rapid HIV testing in community-based organizations.

OBJECTIVE: We assessed the cost-effectiveness of determining new human immunodeficiency virus (HIV) diagnoses using rapid HIV testing performed by community-based organizations (CBOs) in Kansas City, Missouri, and Detroit, Michigan. METHODS: The CBOs performed rapid HIV testing during April 2004 through March 2006. In Kansas City, testing was performed in a clinic and in outreach settings. In Detroit, testing was performed in outreach settings only. Both CBOs used mobile testing vans. Measures of effectiveness were the number of HIV tests performed and the number of people notified of new HIV diagnoses, based on rapid tests. We retrospectively collected program costs, including those for personnel, test kits, mobile vans, and facility space. RESULTS: The CBO in Kansas City tested a mean of 855 people a year in its clinic and 703 people a year in outreach settings. The number of people notified of new HIV diagnoses was 19 (2.2%) in the clinic and five (0.7%) in outreach settings. The CBO in Detroit tested 976 people a year in outreach settings, and the number notified of new HIV diagnoses was 15 (1.5%). In Kansas City, the cost per person notified of a new HIV diagnosis was $3,637 in the clinic and $16,985 in outreach settings. In the Detroit outreach settings, the cost per notification was $13,448. CONCLUSIONS: The cost of providing a new HIV diagnosis was considerably higher in the outreach settings than in the clinic. The variation can be largely explained by differences in the number of undiagnosed infections among the people tested and by the costs of purchasing and operating a mobile van.

Implementing rapid HIV testing in outreach and community settings: results from an advancing HIV prevention demonstration project conducted in seven U.S. cities.

OBJECTIVES: The goals of this project were to assess the feasibility of conducting rapid human immunodeficiency virus (HIV) testing in outreach and community settings to increase knowledge of HIV serostatus among groups disproportionately affected by HIV and to identify effective nonclinical venues for recruiting people in the targeted populations. METHODS: Community-based organizations (CBOs) in seven U.S. cities conducted rapid HIV testing in outreach and community settings, including public parks, homeless shelters, and bars. People with reactive preliminary positive test results received confirmatory testing, and people confirmed to be HIV-positive were referred to health-care and prevention services. RESULTS: A total of 23,900 people received rapid HIV testing. Of the 267 people (1.1%) with newly diagnosed HIV infection, 75% received their confirmatory test results and 64% were referred to care. Seventy-six percent were from racial/ethnic minority groups, and 58% identified themselves as men who have sex with men, 72% of whom reported having multiple sex partners in the past year. Venues with the highest proportion of new HIV diagnoses were bathhouses, social service organizations, and needle-exchange programs. The acceptance rate for testing was 60% among sites collecting this information. CONCLUSIONS: Findings from this demonstration project indicate that offering rapid HIV testing in outreach and community settings is a feasible approach for reaching members of minority groups and people at high risk for HIV infection. The project identified venues that would be important to target and offered lessons that could be used by other CBOs to design and implement similar programs in the future.