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.

Demographic, behavioral, and clinical characteristics of men with nongonococcal urethritis differ by etiology: a case-comparison study.

BACKGROUND: Nongonococcal urethritis (NGU) is common, yet up to 50% of cases have no defined etiology. The extent to which risk profiles and clinical presentations of pathogen-associated and idiopathic cases differ is largely unknown. METHODS: Urethral swabs and urine specimens were collected from 370 NGU treatment trial participants who sought care at a sexually transmitted disease clinic in Seattle, WA from 2007 to 2009 and had a visible urethral discharge and/or microscopic evidence of urethral inflammation assessed by Gram-stain (≥5 polymorphonuclear leukocytes per high-powered field [PMNs/HPF]). Neisseria gonorrhoeae, Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Trichomonas vaginalis (TV), and Ureaplasma urealyticum (UU) were detected in urine, using nucleic acid amplification tests. Cases negative for all assessed pathogens were considered idiopathic. Bivariate and multivariate analyses identified clinical, sociodemographic, and behavioral factors associated with detection of specific pathogens. RESULTS: After excluding 3 participants with gonococcal infection, pathogens were detected in only 50.7% of the 367 eligible cases: CT in 22.3%, MG in 12.5%, TV in 2.5%, and UU in 24.0%, with multiple pathogens detected in 9.5%. In all, 3.5% of cases were negative for CT, MG, and TV but lacked speciated ureaplasma results. The remaining cases (45.8%) were considered idiopathic. Pathogen detection was associated with young age, black race, risky sexual behaviors, cloudy or purulent discharge, and visible discharge plus≥5 PMNs/HPF. In contrast, idiopathic cases were more likely to report prior NGU, were older and less likely to be black, or have an abnormal urethral discharge on examination, compared to all other cases. These cases were not associated with any high risk behaviors. CONCLUSIONS: NGU is a heterogeneous condition. Pathogen detection was associated with a variety of traditional risk factors and clinical features; whereas, idiopathic cases tended to be diagnosed among lower-risk men.

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.

Performance evaluation of four point-of-care HIV tests using unprocessed specimens.

BACKGROUND: The performance of recently approved point-of-care (POC) HIV tests should be assessed using unprocessed specimens. OBJECTIVE: To evaluate the sensitivity and specificity of four POC HIV tests using whole blood (WB) and two using oral fluid (OF) among persons recruited from health clinics in Seattle, Washington, during September 2015-September 2017. STUDY DESIGN: Participants were tested with the POC tests, additional plasma and serum were collected for laboratory testing, and participant- reported use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) was recorded. Participants testing negative on all tests could reenroll every 90 days. Specimens from persons previously diagnosed with HIV infection as well as from those who were newly diagnosed during the study were included in the sensitivity estimate. Sensitivity and specificity were calculated based on HIV status determined by laboratory testing. RESULTS: Of 1,256 visits, 179 were from persons with HIV infection; 120 of these were taking ART. Among 1,077 visits from participants not diagnosed with HIV, PrEP use was reported at 155 (14.4%) visits. Sensitivity was similar among POC WB tests (95.53%-97.21%; p>0.05). Among participants on ART, sensitivity was lower for the same test performed on OF compared to WB (p<0.003). Specificity was high for all tests (99.44%- 100.00%); we did not detect specificity differences with PrEP use. CONCLUSIONS: These POC tests displayed relatively high sensitivity and specificity using unprocessed specimens, suggesting their effectiveness in identifying HIV infections whenever laboratory-based testing is not feasible. Nonetheless, clients with recent risk should retest to rule out the possibility of a false-negative result.

Behavioral health needs and problem recognition by older adults receiving home-based aging services.

OBJECTIVE: Older adults' recognition of a behavioral health need is one of the strongest predictors of their use of behavioral health services. Thus, study aims were to examine behavioral health problems in a sample of older adults receiving home-based aging services, their recognition of behavioral health problems, and covariates of problem recognition. METHODS: The study design was cross-sectional. Older adults (n = 141) receiving home-based aging services completed interviews that included: Structured Clinical Interview for DSM-IV; Brief Symptom Inventory-18; attitudinal scales of stigma, expectations regarding aging, and thought suppression; behavioral health treatment experience; and questions about recognition of behavioral health problems. RESULTS: Thirty (21.9%) participants received an Axis I diagnosis (depressive, anxiety, or substance); another 17 (12.1%) were diagnosed with an adjustment disorder. Participants were more likely to recognize having a problem if they had an Axis I diagnosis, more distress on the BSI-18, family member or friend with a behavioral health problem, and greater thought suppression. In logistic regression, participants who identified a family member or friend with a behavioral health problem were more likely to identify having a behavioral health problem themselves. CONCLUSIONS: Findings suggest that older adults receiving home-based aging services who recognize behavioral health problems are more likely to have a psychiatric diagnosis or be experiencing significant distress, and they are more familiar with behavioral health problems in others. This familiarity may facilitate treatment planning; thus, older adults with behavioral health problems who do not report familiarity of problems in others likely require additional education.

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.

Usability and Acceptability of a Mobile Comprehensive HIV Prevention App for Men Who Have Sex With Men: A Pilot Study.

BACKGROUND: Men who have sex with men (MSM) are the group most impacted by the human immunodeficiency virus (HIV) epidemic and the only subgroup in the United States among which new HIV diagnoses are not decreasing. To achieve the US National HIV/AIDS (acquired immunodeficiency syndrome) Strategy goals of reducing new diagnoses by 25%, high (eg, 30-50%) coverage of multiple HIV prevention interventions is needed in both urban and rural areas. Mobile phone "apps" are an important channel through which prevention services could be provided at scale and at low marginal cost. OBJECTIVE: The aim of this study was to evaluate the usability and acceptability of a theory-based Android mobile phone app for HIV prevention. METHODS: The app included self-assessment tools; prevention recommendations; commodity (condoms, HIV self-tests) ordering; reminders to MSM for basic HIV prevention services, HIV testing, condom use, screening for preexposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP); and prevention and treatment provider locators. The study recruited HIV-negative, Android-using MSM in Atlanta and Seattle who were asked to use the app for 4 months and complete a post-use survey. We measured the use of the app and its features, ordering of commodities, self-report of establishing an HIV testing plan, being HIV tested in the community, and starting PrEP or using nPEP. Usability was assessed using the system usability scale (SUS). RESULTS: A total of 121 MSM were enrolled (59.5%, 72/121 from Atlanta; 40.5%, 49/121 from Seattle). Median age was 28. Nearly half (48.8%, 59/121) were nonwhite, and most (85.9%, 104/121) were gay-identified. Most had tested for HIV in the past (85.1%, 103/121), and 52 (43.0%, 52/121) had a plan to test for HIV regularly. Men used the app for an average of 17.7 minutes over the first 4 months. Over the 4-month period, over half ordered condoms (63.6%, 77/121) and HIV test kits (52.8%, 64/121) on the app. Eight of 86 (9%) PrEP-eligible MSM started PrEP during the 4-month period; of those, 6 of the 8 reported that the app influenced their decision to start PrEP. The mean SUS was 73 (above average). CONCLUSIONS: A theory-based mobile phone app was acceptable to MSM and was rated as having above-average usability. Most men used the commodity-ordering features of the app during the 4-month evaluation period, and nearly 1 in 10 PrEP-eligible men started PrEP, with most attributing their decision to start PrEP in part to the app. A broader, randomized controlled study of the impact of the app on uptake of prevention behaviors for MSM is warranted.

Building a Mobile HIV Prevention App for Men Who Have Sex With Men: An Iterative and Community-Driven Process.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM) account for a disproportionate burden of new HIV infections in the United States. Mobile technology presents an opportunity for innovative interventions for HIV prevention. Some HIV prevention apps currently exist; however, it is challenging to encourage users to download these apps and use them regularly. An iterative research process that centers on the community's needs and preferences may increase the uptake, adherence, and ultimate effectiveness of mobile apps for HIV prevention. OBJECTIVE: The aim of this paper is to provide a case study to illustrate how an iterative community approach to a mobile HIV prevention app can lead to changes in app content to appropriately address the needs and the desires of the target community. METHODS: In this three-phase study, we conducted focus group discussions (FGDs) with MSM and HIV testing counselors in Atlanta, Seattle, and US rural regions to learn preferences for building a mobile HIV prevention app. We used data from these groups to build a beta version of the app and theater tested it in additional FGDs. A thematic data analysis examined how this approach addressed preferences and concerns expressed by the participants. RESULTS: There was an increased willingness to use the app during theater testing than during the first phase of FGDs. Many concerns that were identified in phase one (eg, disagreements about reminders for HIV testing, concerns about app privacy) were considered in building the beta version. Participants perceived these features as strengths during theater testing. However, some disagreements were still present, especially regarding the tone and language of the app. CONCLUSIONS: These findings highlight the benefits of using an interactive and community-driven process to collect data on app preferences when building a mobile HIV prevention app. Through this process, we learned how to be inclusive of the larger MSM population without marginalizing some app users. Though some issues in phase one were able to be addressed, disagreements still occurred in theater testing. If the app is going to address a large and diverse risk group, we cannot include niche functionality that may offend some of the target population.

Preferences for a Mobile HIV Prevention App for Men Who Have Sex With Men.

BACKGROUND: The Centers for Disease Control and Prevention recommends that sexually active men who have sex with men (MSM) in the United States test for human immunodeficiency virus (HIV) at least three times per year, but actual testing frequency is much less frequent. Though mHealth is a popular vehicle for delivering HIV interventions, there are currently no mobile phone apps that target MSM with the specific aim of building an HIV testing plan, and none that focuses on developing a comprehensive prevention plan and link MSM to additional HIV prevention and treatment resources. Previous research has suggested a need for more iterative feedback from the target population to ensure use of these interventions. OBJECTIVE: The purpose of this study is to understand MSM's preferences for functionality, format, and design of a mobile phone-based HIV prevention app and to examine MSM's willingness to use an app for HIV prevention. METHODS: We conducted focus group discussions with 38 gay and bisexual men, with two in-person groups in Atlanta, two in Seattle, and one online focus group discussion with gay and bisexual men in rural US regions. These discussions addressed MSM's general preferences for apps, HIV testing barriers and facilitators for MSM, and ways that an HIV prevention app could address these barriers and facilitators to increase the frequency of HIV testing and prevention among MSM. During focus group discussions, participants were shown screenshots and provided feedback on potential app functions. RESULTS: Participants provided preferences on functionality of the app, including the type and delivery of educational content, the value of interactive engagement, and the importance of social networking as an app component. Participants also discussed preferences on how the language should be framed for the delivery of information, identifying that an app needs to be simultaneously fun and professional. Privacy and altruistic motivation were considered to be important factors in men's willingness to use a mobile HIV prevention app. Finally, men described the potential impact that a mobile HIV prevention app could have, identifying individual, interpersonal, and community-based benefits. CONCLUSIONS: In summary, participants described a comprehensive app that should incorporate innovative ideas to educate and engage men so that they would be motivated to use the app. In order for an app to be useful, it needs to feel safe and trustworthy, which is essential when considering the app's language and privacy. Participants provided a range of preferences for using an HIV prevention app, including what they felt MSM need with regards to HIV prevention and what they want in order to engage with an app. Making an HIV prevention app enjoyable and usable for MSM is a difficult challenge. However, the usability of the app is vital because no matter how great the intervention, if MSM do not use the app, then it will not be useful.

Non-occupational post-exposure prophylaxis for HIV: 10-year retrospective analysis in Seattle, Washington.

Despite treatment guidelines in place since 2005, non-occupational post-exposure HIV prophylaxis (nPEP) remains an underutilized prevention strategy. We conducted a retrospective chart review of patients presenting to a publicly-funded HIV clinic in Seattle, Washington for nPEP between 2000 and 2010 (N = 360). nPEP prescriptions were provided for 324 (90%) patients; 83% of prescription decisions were appropriate according to Centers for Disease Control and Prevention guidelines, but only 31% (N = 111/360) of patients were considered "high risk." In order to use limited resources most efficiently, public health agencies should target messaging for this high-cost intervention to individuals with high-risk HIV exposures.