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Could home human immunodeficiency virus (HIV) self-testing make a major difference in identifying persons with undiagnosed HIV in the United States? We argue that approval of new self-test assays for home use would help but must be combined with extensive investment in community outreach and linkage to care to make an impact.

HIV PrEP (pre-exposure prophylaxis) is underutilized among Latinx and Black men who have sex with men (MSM) in the United States. Although peer navigation approaches may increase PrEP uptake and adherence, it remains unclear what strategies work best for MSM of color.From July 2017 to August 2018, we conducted semi-structured in-depth interviews with 25 purposively sampled Latinx and Black cisgender MSM to evaluate how the intersectionality of race/ethnicity, sexual orientation, and other identities influenced men's views on PrEP in general and on peer navigation specifically. Thematic analysis was used to identify and analyze emergent themes.Emergent themes included: (1) awareness of vulnerability in intimate relationships; (2) barriers to PrEP initiation including perceived side effects, stigma, and financial concerns; (3) a wish to connect with other Latinx and Black MSM in a health and prevention space; and (4) the desire for peer matching based on identity considerations and lived experience. Younger men and Spanish-speaking Latinx men were most interested in peer navigation to access PrEP, while bisexual men had confidentiality concerns.In our study, Latinx and Black MSM viewed peer navigation services favorably, especially if they addressed men's desire to connect with other MSM of color.Developing culturally-congruent peer navigation programming could help improve PrEP uptake and care engagement for Latinx and Black MSM. Programs should recruit peers from the racial/ethnic minority communities most impacted by HIV and prioritize matching peers to clients based on identity concerns, needs, and preferences.

Direct-acting antivirals (DAAs) offer an unprecedented opportunity to eliminate hepatitis C virus (HCV) infection, yet barriers among people who inject drugs (PWID) remain. Having pharmacists provide care through collaborative drug therapy agreements (CDTAs) offers a promising solution. We developed and piloted a Pharmacist, Physician, and Patient Navigator-Collaborative Care Model (PPP-CCM) which utilized pharmacists to directly deliver HCV care at community organizations serving PWID. We conducted formative evaluation of the PPP-CCM pilot to characterize implementation experiences.The PPP-CCM was implemented from November of 2020 through July of 2022. Formative evaluation team members observed implementation-related meetings and conducted multiple site visits, taking detailed fieldnotes. Fieldnotes were iteratively reviewed to identify barriers and facilitators to implementation and used to inform 7 key informant interviews conducted with programmatic staff at the end of the pilot. All data were analyzed using a Rapid Assessment Process (RAP) guided by the Consolidated Framework for Implementation Research (CFIR). The formative evaluation team shared results with program stakeholders (pharmacists, physicians, and other site staff) to verify and expand on learnings.Evaluation of PPP-CCM revealed 5 themes, encompassing all CFIR domains: 1) PPP-CCM was feasible but challenging to deliver efficiently; 2) the pharmacist role and characteristics (e.g., being flexible, available, and patient-centered) were key to PPP-CCM successes; 3) the PPP-CCM team met challenges engaging patients over time, but some team-based strategies helped; 4) community site characteristics (e.g., existing trusting relationships with PWID and physical space that enabled program visibility) were important contributors; and 5) financial barriers may limit PPP-CCM scale-up and sustainability.PPP-CCM is a novel and promising approach to HCV care delivery for PWID who may previously lack engagement in traditional care models, but careful attention needs to be paid to financial barriers to ensure scalability and sustainability.

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.

Background In the United States, cisgender men who have sex with men (MSM) who use methamphetamine are at substantial risk for HIV and can benefit from pre-exposure prophylaxis (PrEP). Methods We used data from the National HIV Behavioral Surveillance 2017 survey from Seattle, WA; Portland, OR; and Denver, CO, to estimate PrEP awareness and use in the past 12 months among MSM who use methamphetamine. We then compared these estimates with participants who do not use methamphetamine but meet other criteria for PrEP use (i.e., condomless anal sex or a bacterial sexually transmitted infection). We explored reasons for not using PrEP and challenges using PrEP. Results Of the 1602 MSM who participated in the 2017 National HIV Behavioral Surveillance survey in Seattle, WA; Portland, OR; and Denver, CO, 881 met the inclusion criteria for this study, of whom 88 (10%) reported methamphetamine use in the past 12 months. Most (95%) participants had heard of PrEP, and 35% had used it in the past 12 months. Pre-exposure prophylaxis awareness was lower among MSM who used methamphetamine (P = 0.01), but use was not different (P = 0.26). Among those who had not used PrEP, the most common reason for not using it was not thinking one's HIV risk was high enough (51%). Men who have sex with men who used methamphetamine were more likely to report that they were not sure PrEP would prevent them from getting HIV (38% vs. 19%, P = 0.002). Conclusions These results highlight the need for continued efforts to educate and promote PrEP uptake among MSM, particularly those who use methamphetamine.

Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US.From June 2018-March 2019, we conducted a cross-sectional evaluation of the Simple Amplification-Based Assay version II (SAMBA II) POC NAT. People with HIV (PWH) and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naive, and SAMBA II Semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared with Abbott RealTime HIV-1 polymerase chain reaction results on plasma. We calculated sensitivity, specificity, and concordance between tests.SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naive participants was 91.4% [32/35, 95% confidence interval (CI): 77.6% to 97.0%] using VP WB and 100% (27/27, 95% CI: 87.5% to 100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1% to 99.4%) and 100% (30/30, 95% CI: 88.7% to 100%) using VP and FS WB, respectively.The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US.

Aims To evaluate provider perspectives on the use of a point-of-care nucleic acid test (POC NAT) and preferential opinions for motivational interviewing (MI) or problem-solving counseling (PSC) as an ultra-brief intervention for patients experiencing challenges to antiretroviral therapy (ART) adherence. Methods A qualitative study was conducted among providers at an HIV care clinic in Seattle, Washington. Ten in-depth interviews with HIV care providers were completed, which explored determinants of acceptability, feasibility and preferences for a combined adherence counseling and POC NAT intervention for patients living with HIV. Interviews were analyzed through consensus coding and the Five A’s Framework to inform thematic analysis. Results Providers favored the use of a combined adherence counseling technique and POC NAT for their non-adherent patients living with HIV. Providers believed the intervention was an improvement on current assessment and advising practices. However, concerns about extended wait times for the POC NAT results influenced perceptions about feasibility around clinic flow and incorporation into clinic practice. Providers believed that acceptability of POC NAT implementation would be enhanced by including a subset of patient populations whom tend to be in the clinic for longer periods, and in tandem face greater ART adherence challenges. Conclusion The GAIN Study will be the first project to evaluate the implementation of POC NAT in the U.S. Continued formative work is ongoing and may illustrate how best to address feasibility and concern around the two-hour time to result. The planned GAIN study will incorporate some of the findings found in this qualitative study and pilot this intervention, including a time-in-motion analyses of clinic flow, which may help reduce perceived wide-scale adaptation of POC NAT and ART adherence counselling among PLHW. Future work, including a shorter time to results and/or lower limit detection could make a significant improvement in the provision of HIV care.

BACKGROUND Cisgender men who have sex with men (MSM) and transgender people (TGP) who use methamphetamine are disproportionately impacted by HIV acquisition. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV, and interventions that support PrEP persistence and adherence should be evaluated among MSM and TGP who use methamphetamine. OBJECTIVE We conducted formative work to inform the development of text messaging and peer navigation interventions to support PrEP persistence and adherence among MSM and TGP who use methamphetamine. In this paper, we describe how the findings from these focus groups and interviews were used to refine the study interventions and protocol for the Hit Me Up! study (HMU!; HIV Prevention in Methamphetamine Users). METHODS Between October 2017 and March 2018, we conducted two focus groups and three in-depth interviews with MSM and TGP who use methamphetamine or who have worked with people who use methamphetamine. During these formative activities, we asked participants about their opinions on the proposed interventions, education and recruitment materials, and study design. We focused on how we could develop peer navigation and text messaging interventions that would be culturally appropriate and acceptable to MSM and TGP who use methamphetamine. Transcripts were reviewed by two authors who performed a retrospective content analysis to describe which specific opinions and recommendations influenced protocol development and the refinement of the interventions. RESULTS Overall, participants thought that MSM and TGP would be interested in participating in the study, although they expected recruitment and retention to be challenging. Participants thought that the peer navigator should be someone who is nonjudgmental, has experience with people who use methamphetamine, and is patient and flexible. There was consensus that three text messages per day were appropriate, adherence reminders should be straightforward, all messages should be nonjudgmental, and participants should be able to tailor the timing and content of the text messages. These suggestions were incorporated into the study interventions via the hiring and training process and into the development of the text library, platform selection, and customizability of messages. CONCLUSIONS It is important to include the opinions and insights of populations most impacted by HIV to develop PrEP interventions with the greatest chance of success. Our formative work generated several recommendations that were incorporated into the interventions and protocol development for our ongoing study. CLINICALTRIAL ClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282

We examined adherence, medication-taking practices, and preferences to inform development of a wrist-worn adherence system. Two convenience samples of persons taking antiretroviral therapy and HIV pre-exposure prophylaxis completed a survey. Additional online questions asked about willingness to use a wrist-worn device and reminder and feedback preferences. Among 225 participants, 13% reported adherence < 90% this was associated with younger age and clinic sample. Compared to pill bottle–using participants, mediset users less commonly reported adherence < 90% (aOR = 0.16, p = .02), and blister pack users (aOR = 6.3, p = .02) and pill roll users (aOR = 3.3, p = .04) more commonly reported adherence < 90%. Sixty-two percent of the online participants reporting adherence (< 100%) had some interest in receiving adherence reminders, including 42% with interest in receiving reminders by smartwatch notifications. Although confounders are likely, formative work identified potential users and interest in using a wrist-worn adherence system. Future work will determine its acceptability and efficacy.

Objectives High medication adherence is important for HIV suppression (antiretroviral therapy) and pre-exposure prophylaxis efficacy. We are developing sensor-based technologies to detect pill-taking gestures, trigger reminders, and generate adherence reports. Materials and Methods We collected interview, observation, and questionnaire data from individuals with and at-risk for HIV (N = 17). We assessed their medication-taking practices and physical actions, and feedback on our initial design. Results While participants displayed diverse medication taking practices and physical actions, most (67%) wanted to use the system to receive real-time and summative feedback, and most (69%) wanted to share data with their physicians. Participants preferred reminders via the wrist-worn device or mobile app, and summative feedback via mobile app or email. Discussion Adoption of these systems is promising if designs accommodate diverse behaviors and preferences. Conclusion Our findings may help improve the accuracy and adoption of the system by accounting for user behaviors, physical actions, and preferences.

Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status, but there is concern that absence of counseling may result in increased HIV risk.Seattle, Washington.We randomly assigned 230 high-risk HIV-negative men who have sex with men to have access to oral fluid HIV self-tests at no cost versus testing as usual for 15 months. The primary outcome was self-reported number of HIV tests during follow-up. To evaluate self-testing's impact on sexual behavior, we compared the following between arms: non-HIV-concordant condomless anal intercourse and number of male condomless anal intercourse partners in the last 3 months (measured at 9 and 15 months) and diagnosis with a bacterial sexually transmitted infection (STI: early syphilis, gonorrhea, and chlamydial infection) at the final study visit (15 months). A post hoc analysis compared the number of STI tests reported during follow-up.Men randomized to self-testing reported significantly more HIV tests during follow-up (mean = 5.3, 95% confidence interval = 4.7 to 6.0) than those randomized to testing as usual (3.6, 3.2 to 4.0; P0.0001), representing an average increase of 1.7 tests per participant over 15 months. Men randomized to self-testing reported using an average of 3.9 self-tests. Self-testing was noninferior with respect to all markers of HIV risk. Men in the self-testing arm reported significantly fewer STI tests during follow-up (mean = 2.3, 95% confidence interval = 1.9 to 2.7) than men in the control arm (3.2, 2.8 to 3.6; P = 0.0038).Access to free HIV self-testing increased testing frequency among high-risk men who have sex with men and did not impact sexual behavior or STI acquisition.

BACKGROUND We aimed to assess HIV preexposure prophylaxis (PrEP) awareness and prescribing practices among Washington State medical providers from diverse professional disciplines and practice types. METHODS In May 2016, we administered an anonymous online survey to licensed medical practitioners who provide primary, longitudinal, walk-in, emergency, obstetric, gynecologic, sexually transmitted infection, or family planning care. RESULTS Of 735 eligible providers, 64.8% had heard of PrEP. Younger providers and providers with a doctor of medicine degree were more likely to be aware of PrEP compared with older providers (P = 0.0001) and providers of other training backgrounds (advanced registered nurse practitioner, doctor of osteopathic medicine, or physician assistant; P = 0.04). Among providers aware of PrEP, most frequent reported concerns about prescribing were adherence (46.0%) and costs (42.9%). Providers felt very (20.1%) or somewhat (33.8%) comfortable discussing PrEP overall, but very (26.8%) or somewhat (44.7%) uncomfortable discussing cost and insurance issues. The 124 PrEP prescribers reported a median of 2 (range, 1-175; total, 1142) patients prescribed PrEP. Prior authorizations and insurance denials had prevented prescriptions for 28.7% and 12.1% of prescribers, respectively. CONCLUSIONS Interventions to improve PrEP access should include education to inform medical providers about PrEP, with particular attention to provider types less likely to be aware. Continued efforts to eliminate cost and insurance barriers and educate providers regarding financial resources would help improve PrEP access.

Background HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. Objective To assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. Methods In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Results Participant recruitment is expected to begin in January 2020. Conclusions This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial Registration ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID) PRR1-10.2196/16231

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

One barrier to human immunodeficiency virus preexposure prophylaxis (PrEP) is lack or perceived lack of health insurance or financial assistance. We performed a medical records review at a safety-net PrEP clinic in Seattle, Washington, and found that barriers to obtaining financial assistance were commonly recorded in association with initiation and persistence on PrEP.

The performance of recently approved point-of-care (POC) HIV tests should be assessed using unprocessed specimens.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.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.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%; p0.05). Among participants on ART, sensitivity was lower for the same test performed on OF compared to WB (p0.003). Specificity was high for all tests (99.44%- 100.00%); we did not detect specificity differences with PrEP use.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.

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 RR1-10.2196/16332

Summary Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are used for HIV treatment and prevention. Previously, we found that topical rectal tenofovir gel caused immunological changes in the mucosa. Here, we assess the effect of oral TDF/FTC in three HIV pre-exposure prophylaxis trials, two with gastrointestinal and one with cervicovaginal biopsies. TDF/FTC induces type I/III interferon-related (IFN I/III) genes in the gastrointestinal tract, but not blood, with strong correlations between the two independent rectal biopsy groups (Spearman r = 0.91) and between the rectum and duodenum (r = 0.81). Gene set testing also indicates stimulation of the type I/III pathways in the ectocervix and of cellular proliferation in the duodenum. mRNA sequencing, digital droplet PCR, proteomics, and immunofluorescence confirm IFN I/III pathway stimulation in the gastrointestinal tract. Thus, oral TDF/FTC stimulates an IFN I/III signature throughout the gut, which could increase antiviral efficacy but also cause chronic immune activation in HIV prevention and treatment settings., Graphical Abstract, Highlights Tenofovir (TDF) and emtricitabine (FTC) are used for HIV treatment and prevention TDF/FTC induce a type I/III interferon-associated signature throughout the gut IFN I/III induction is confirmed in independent clinical cohorts and 5 assay types IFN I/III induction may contribute to anti-HIV efficacy and chronic immune activation, Many people take the antiretroviral drugs tenofovir and emtricitabine to prevent and treat HIV infection. Hughes et al. show that these medications induce genes and proteins associated with type I/III interferon pathways in the gut. This effect may contribute to HIV inhibition but could also cause chronic immune activation.

These recommendations and resources can help make HIV pre-exposure prophylaxis an essential part of your work.

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.

Background HIV disproportionately affects cisgender men and transgender people who have sex with men (MSM/TG) and use methamphetamine. Pre-exposure prophylaxis (PrEP) uptake has been slow in this group. It is important to understand perceptions about PrEP and barriers to its use among MSM/TG who use methamphetamine to reduce new HIV infections. Methods: We conducted four focus groups with peer educators of a harm reduction program. We assessed their perspectives of PrEP and barriers across the PrEP continuum among MSM/TG who use methamphetamine. Results: Notably, stigma related to the multiple marginalised identities of MSM/TG who use methamphetamine (e.g. MSM/TG-related stigma, methamphetamine-related stigma) was a barrier at each step. We developed a framework that combined the PrEP continuum and a stigma-based treatment cascade to explore these themes and describe the effects of stigma on PrEP engagement. Methamphetamine-related barriers were also identified. Conclusions: The findings of this study emphasise the importance of incorporating stigma reduction into PrEP delivery for MSM/TG who use methamphetamine.

This study explores the impacts of HIV pre-exposure prophylaxis (PrEP) use on the sexual health of men who have sex with men (MSM). The authors conducted in-depth interviews with MSM who use PrEP (n = 14). Data was analyzed using interpretative phenomenological analysis. PrEP use reduced fear and shame associated with sex and facilitated greater sexual satisfaction and intimacy. Although participants generally viewed PrEP as empowering and beneficial, they also experienced PrEP-related stigma. The authors’ analysis emphasizes the importance of understanding the reasons MSM use PrEP and highlights opportunities for reducing harm and fostering sexual health among MSM who are using or considering PrEP.

Background and objective The rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection. Study design Men and transgender persons reporting sex with men in the prior year were recruited at the Public Health—Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected. Results Between February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component ( p =.008) and Combo overall ( p =.004), and there was a trend when compared to INSTI ( p =.06). The Determine Combo specificity was 98.99%. Conclusions As reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.

We evaluated detection of HIV-1 RNA from dried blood spots (DBS) and oral fluid specimens. Between February 2010 and August 2014, HIV-1 was newly diagnosed in eight (2.6%) study participants who had median blood HIV-1 RNA of 61 500 copies/ml (interquartile range 7500-146 000). RNA was detected in seven (87.5%) DBS and three (37.5%) oral fluid swabs but was not detected in either specimen from one participant. DBS may be a reasonable specimen collection method to detect acute infection.

Background Methamphetamine use is increasing, and opioid use remains elevated in the US. Understanding interest in reducing/stopping substance use among people who inject drugs (PWID), as well as types of help wanted, can inform interventions. Methods Data from the 2019 Washington State Syringe Exchange Survey were used in logistic regression analyses to assess if demographics, substance use, and concern about anxiety or depression were associated with interest in reducing/stopping substance use among people whose main drug was methamphetamine or opioids. Types of help wanted to reduce/stop use are reported. Results Of 583 participants included, 76 % reported opioids were their main drug, of whom 82 % were interested in reducing/stopping their opioid use. 24 % reported methamphetamine as their main drug, of whom 46 % were interested in reducing/stopping their methamphetamine use. Among those whose main drug was an opioid, female gender (AOR:2.19, p = .023) and concern about depression (AOR:3.04, p = .002) were associated with interest in reducing/stopping opioid use. Among participants whose main drug was methamphetamine, being in jail in the past year and having an infection likely related to injection (e.g., abscess) in the past year were associated with over twice the odds of interest in reducing/stopping methamphetamine use (AOR:2.14, p = .056 and 2.43, p = .052, respectively); however, these findings were not significant. Several types of help to reduce/stop use were endorsed. Conclusion There were high, though differing, levels of interest in reducing/stopping opioid or methamphetamine use and in a range of support services. PWID should be asked about interest in reducing/stopping use and provided appropriate support.

Regular HIV testing is required to ensure the safety of HIV pre-exposure prophylaxis (PrEP). We describe and discuss a series of false-positive HIV test results from an individual receiving PrEP. The expansion of PrEP will likely result in greater numbers of false-positive test results that may pose challenges for interpretation.

There has been increasing recognition of the importance of diagnosing individuals during the earliest stages of human immunodeficiency virus (HIV) infection. Sera from individuals referred to a primary HIV infection research program were screened using the IgG-sensitive Vironostika HIV-1 Microelisa System, IgG/IgM-sensitive GS HIV-1/HIV-2 Plus O antibody enzyme immunoassay (EIA), or Abbott ARCHITECT HIV antigen (Ag)/antibody (Ab) Combo assay and confirmed by the Bio-Rad Multispot and Western blot. A subset of participants was co-enrolled in a study designed to compare the ability of point-of-care tests to detect early infection. We calculated time within primary infection laboratory stages using actual observed transitions and with an expectation-maximization algorithm. Three hundred and sixty participants contributed data to this analysis. Of 123 persons referred with EIA-negative/RNA-positive test results (Fiebig stage I-II) or for concern for symptoms, 24 (20%) were still in stages I-II, and 99 (80%) were in stages III or later at their screening visit. Participants were estimated to spend a median of 13.5 days in stages I and II, 2.3 days in stage III, and 7.8 days in stage IV. OraQuick performed on oral fluids detected 53% of 17 participants in stage V. The durations of stages we observed are consistent with previous publications. Most persons referred for research no longer had acute infection at their first visit. Programs wishing to identify persons in the very earliest stages of infection need to expedite referrals or develop targeted screening programs.

Background Cisgender men and transgender individuals who have sex with men (MSM/TG) and use methamphetamine are at elevated risk for HIV and have had limited pre-exposure prophylaxis (PrEP) uptake. The aim of this study was to quantify the knowledge and use of PrEP, identify barriers to PrEP use, and develop a targeted educational campaign to promote PrEP among MSM/TG who use methamphetamine. Methods: We conducted three consultations with peer educators of Project Needle and Sex Education Outreach Network (NEON) to develop and disseminate educational materials. We surveyed the peers’ HIV-negative contacts before and after this work to explore knowledge and opinions about PrEP and to assess the effect of our materials. Results: There were 221 respondents at baseline (August 2016) and 100 at follow-up (April–May 2017). At baseline, nearly all participants had ‘heard of PrEP’ (96%) and were insured (97%). However, only 3% had ever used PrEP. Peers suggested educational cards that included a definition of PrEP, adherence tips and that PrEP does not prevent other sexually transmissible infections. Peers distributed approximately 2560 educational cards. At follow-up, approximately half the respondents (53%) had seen the cards, and those who did reported significantly more agreement with the majority of the card messages about PrEP. Significantly more participants reported ever receiving PrEP at follow-up (21%; P

Availability of integrase strand transfer inhibitors created interest in determining whether their use would decrease persistently infected cell numbers. This study hypothesized that adding raltegravir (RAL) to standard antiretroviral therapy (ART) would decrease human immunodeficiency virus (HIV)-infected CD4+ T cells more than standard combination ART. This was a pilot, randomized study comparing open-label standard triple ART to standard triple ART plus RAL over 96 weeks in ART-naive adults with early HIV infection. The primary objective was to compare quantity and trajectory of HIV DNA. Eighty-two persons were referred. A diverse set of reasons precluded the enrollment of all but 10. Those who enrolled and completed the study had an estimated median duration of HIV infection of 74 days at ART start. The groups had similar baseline characteristics. The RAL group had more rapid first phase plasma HIV RNA decay (0.67 log10 copies/mL/day) than with combination ART (0.34 log10copies/mL/day), p = 0.037. Second phase HIV RNA decay, residual viremia, cell-associated RNA, HIV DNA, CD4+ T-cells with replication-competent virus, and 2LTR circle levels did not differ between groups. Among those with entry plasma HIV RNA levels above the median, 2LTR circles were significantly lower over time than in those with lower entry HIV RNA levels (p = 0.02). Our results suggest homogeneity of responses in cell-associated RNA, HIV DNA, CD4+ T-cells with replication-competent virus, and 2LTR circles with early HIV in both ART groups. The kinetics of 2LTR DNA did not reflect the kinetics of plasma HIV RNA decline following ART initiation.

Background US guidelines recommend genotyping for persons newly diagnosed with HIV infection to identify transmitted drug resistance mutations associated with decreased susceptibility to nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors. To date, testing for integrase strand transfer inhibitor (INSTI) mutations has not been routinely recommended. We aimed to evaluate the prevalence of transmitted INSTI mutations among persons with primary HIV-1 infection in Seattle, WA, USA. Methods Persons with primary HIV-1 infection have enrolled in an observational cohort at the University of Washington Primary Infection Clinic since 1992. We performed a retrospective analysis of plasma specimens collected prospectively from the 82 antiretroviral-naive subjects who were enrolled from 2007–2013, after FDA-approval of the first INSTI. Resistance testing was performed by consensus sequencing. Results Specimens for analysis had been obtained a median of 24 (IQR 18–41, range 8–108) days after the estimated date of HIV-1 infection. All subjects were infected with HIV-1 subtype B except for one subject infected with subtype C. Consensus sequencing identified no subjects with major INSTI mutations (T66I, E92Q, G140S, Y143C/H/R, S147G, Q148H/K/R, N155H). Using exact binomial CIs, the upper bound of the 95% CI was 4.4%. Conclusions Although our sample size was small, this study does not support the need at this time to evaluate integrase mutations as part of routine consensus sequencing among persons newly diagnosed with HIV-1 infection. However, it is likely that the prevalence of transmitted INSTI mutations may increase with the recent commercial introduction of additional INSTIs and presumably greater INSTI use among persons living with HIV-1.

Background Maraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP). Objective To assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection. Design Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114). Setting 12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. Participants HIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days. Intervention MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). Measurements At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to their original assignment. Results Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants; rates did not differ among regimens. One death (by suicide) occurred in the MVC-TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred. Limitations Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy. Conclusion Maraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF-FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study. Primary Funding Source National Institutes of Health.

Background Transmission of human immunodeficiency virus type 1 (HIV-1) drug resistance mutations, particularly that of minority drug-resistant variants, remains poorly understood. Population-based studies suggest that drug-resistant HIV-1 is less transmissible than drug-susceptible viruses. We compared HIV-1 drug-resistant genotypes among partner-pairs in order to assess the likelihood of transmission of drug resistance mutations and investigate the role of minority variants in HIV transmission. Methods and findings From 1992–2010, 340 persons with primary HIV-1 infection and their partners were enrolled into observational research studies at the University of Washington Primary Infection Clinic (UWPIC). Out of 50 partner-pairs enrolled, 36 (72%) transmission relationships were confirmed by phylogenetic distance analysis of HIV-1 envelope (env) sequences, and 31 partner-pairs enrolled after 1995 met criteria for this study. Drug resistance mutations in the region of the HIV-1 polymerase gene (pol) that encodes protease and reverse transcriptase were assessed by 454-pyrosequencing. In 25 partner-pairs where the transmission direction could be determined, 12 (48%) transmitters had 1–4 drug resistance mutations (23 total) detected in their HIV-1 populations at a median frequency of 6.0% (IQR 1.5%–98.7%, range 1.0%–99.6%). Of 10 major mutations detected in five transmitters at a frequency >95%, 100% (95% CI 69.2%–100%) were detected in recipients. All of these transmitters were antiretroviral (ARV)-naïve at the time of specimen collection. Fourteen mutations (eight major mutations and six accessory mutations) were detected in nine transmitters at low frequencies (1.0%–11.8%); four of these transmitters had previously received ARV therapy. Two (14% [95% CI 1.8%–42.8%]) G73S accessory mutations were detected in both transmitter and recipient. This number is not significantly different from the number expected based on the observed frequencies of drug-resistant viruses in transmitting partners. Limitations of this study include the small sample size and uncertainties in determining the timing of virus transmission and mutation history. Conclusions Drug-resistant majority variants appeared to be commonly transmitted by ARV-naïve participants in our analysis and may contribute significantly to transmitted drug resistance on a population level. When present at low frequency, no major mutation was observed to be shared between partner-pairs; identification of accessory mutations shared within a pair could be due to transmission, laboratory artifact, or apolipoprotein B mRNA-editing enzyme, catalytic polypeptides (APOBECs), and warrants further study., In a cross-sectional study, Joanne Stekler and colleagues investigate transmission of HIV drug-resistance mutations between serodiscordant partners., Author summary Why was this study done? Previous studies have shown that virus factors like replication capacity (the ability of a virus to multiply) can impact the likelihood of HIV-1 transmission. Little is known about whether HIV-1 drug-resistance mutations impact the likelihood of HIV transmission. What did the researchers do and find? We identified 31 participants with primary HIV-1 infection and their partners. We found that five transmitting partners, none of whom had taken antiretroviral (ARV) therapy at the time of specimen collection, had 10 drug resistance mutations that made up more than 95% of the transmitter’s viral population; all of these mutations were found in their recipient partners. We identified another 14 mutations at low frequencies (1.0%–11.8%) in nine transmitting partners; two of these low frequency mutations were also detected in two recipient partners. What do these findings mean? Our findings suggest that HIV-1 drug resistance may be spread to and by people who have never taken ARV medications. Although we identified low-frequency mutations that were in both the transmitter and recipient in two partner-pairs, the mutation that we detected is considered an “accessory” mutation that does not have a significant impact on the effectiveness of HIV treatment. We are uncertain if these this mutation was transmitted within the two partner-pairs where it was identified or was a result of cellular restriction factors like APOBECs that acted independently in both members of the partner-pairs. Because of its small size, this study was not able to definitively address whether HIV-1 drug resistance mutations reduce the likelihood of HIV-1 transmission.

Background :The U.S. HIV staging system is being revised to more comprehensively track early and acute HIV infection (AHI). We evaluated our ability to identify known cases of AHI using King County (KC) HIV surveillance data.Methodology :AHI cases were men who have sex with men (MSM) with negative antibody and positive pooled nucleic acid amplification (NAAT) tests identified through KC testing sites. We used KC surveillance data to calculate inter-test intervals (ITI, time from last negative to first positive test) and the serologic algorithm for recent HIV seroconversion (STARHS). For surveillance data, AHI was defined as an ITI of ≤ 30 days and early infection as an ITI ≤ 180 days or STARHS recent result. Dates of last negative HIV tests were obtained from lab reports in the HIV surveillance system or data collected for HIV Incidence Surveillance.Results :Between 2005 and 2011, 47 MSM with AHI were identified by pooled NAAT. Of the 47 cases, 36% had ITI < 1 day, 60% had an ITI < 30 days, and 70% (95% CI=55-82%) had an ITI ≤ 6 months and would have been identified as early HIV infection. Of the 47, 38% had STARHS testing and 94% were STARHS recent.Conclusion :MSM with known AHI were not identified by proposed definitions of AHI and early infection. These known AHI cases were frequently missed by HIV surveillance because concurrent negative antibody tests were not reported. Successful implementation of the revisions to the HIV staging system will require more comprehensive reporting.

Approximately 60% of human immunodeficiency virus (HIV)-infected individuals are unaware of their infection, and stigma and discrimination continue to threaten acceptance of HIV testing services worldwide. Self-testing for HIV has garnered controversy for years and the debate reignited with the approval of a point-of-care test for over-the-counter sale in the US in 2012. Here, we present arguments for and against HIV self-testing. The case in support of HIV self-testing contends that: the modality is highly acceptable, especially among the most at-risk individuals; self-testing empowers users, thus helping to normalize testing; and mutual partner testing has the potential to increase awareness of risk and avert condomless sex between discordant partners. Arguments against HIV self-testing include: cost limits access to those who need testing most; false-negative results, especially during the window period, may lead to false reassurance and could promote sex between discordant partners at the time of highest infectivity; opportunities for counseling, linkage to care, and diagnosis of other sexually transmitted infections may be missed; and self-testing leads to potential for coercion between partners. Research is needed to better define the risks of self-testing, especially as performance of the assays improves, and to delineate the benefits of programs designed to improve access to self-test kits, because this testing modality has numerous potential advantages and drawbacks.

In the United States, of the 1.1 million persons infected with human immunodeficiency virus (HIV) and the 2.7 million infected with hepatitis C virus (HCV), approximately 16% and 50%, respectively, are unaware of their infection. Highly effective treatments have turned both diseases into manageable conditions, and in the case of hepatitis C, a disease that can be cured. Early diagnosis is imperative so that infected persons can take measures to stay healthy, get into care, benefit from therapy, and reduce the risk of transmission. In this report, we review current recommendations provided by the Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force on whom to screen for HIV and HCV infections, and recommendations from the CDC, the Association of Public Health Laboratories, and the Clinical and Laboratory Standards Institute on how to test for these infections.

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.

BackgroundAfrican-born individuals in the U.S. are disproportionately affected by HIV yet have low HIV testing rates. We conducted a mixed methods study to assess the uptake and feasibility of a novel strategy for integrating HIV testing into residential health fairs among African-born individuals in Seattle, WA.MethodsFrom April to May 2018, we held six health fairs at three apartment complexes with high numbers of African-born residents. Fairs included free point-of-care screening for glucose, cholesterol, body mass index, blood pressure, and HIV, as well as social services and health education. The health fairs were hosted in apartment complex common areas with HIV testing conducted in private rooms. Health fair participants completed a series of questionnaires to evaluate demographics, access to health services, and HIV testing history. We conducted 18 key informant interviews (KIIs) with health fair participants and community leaders to identify barriers to HIV testing among African-born individuals.ResultsOf the 111 adults who accessed at least one service at a health fair, 92 completed questionnaires. Fifty-five (61%) were female, 48 (52%) were born in Africa, and 55 (63%) had health insurance. Half of African-born participants accepted HIV testing; all tested negative. The most common reasons for declining testing were lack of perceived risk for HIV and knowledge of HIV status. We identified a high prevalence of non-communicable diseases (NCDs) among health fair participants; among those tested, 77% (55/71) were overweight/obese, 39% (31/79) had blood pressure > 140/90 mmHg, and 30% (22/73) had total cholesterol > 200 mg/dL. KIIs identified community stigma and misinformation as major barriers to HIV testing among African-born individuals.ConclusionsResidential health fairs are a feasible method to increase HIV testing among African-born individuals in Seattle. The high prevalence of NCDs highlights the importance of integrating general preventive services within HIV testing programs in this population.

The ARCHITECT HIV Ag/Ab Combo assay has a wide dynamic range for determining the sample-to-cutoff ratio (S/CO) values compared to other diagnostic HIV antibody assays.Determine the performance of an HIV testing algorithm that uses the ARCHITECT combo assay in the clinical setting and explore the utility of the signal-to-cutoff (S/CO) ratio to predict acute HIV-1 infection status.A retrospective analysis of clinical samples from a hospital and referral population screened for HIV-1 infection between May 2011 and March 2013. Repeatedly reactive samples were tested using the Multispot HIV-1/HIV-2 rapid test and depending on that result, confirmatory orthogonal testing used the Western blot (WB) for HIV-1, Immunoblot for HIV-2 and nucleic acid amplification testing (NAAT) for HIV RNA.A total of 21,317 test results were evaluated of which 509 were ARCHITECT repeatedly reactive; of these, 422 were Multispot-reactive only for HIV-1 (413 WB-positive; 9 indeterminate), 4 were Multispot-reactive for both HIV-1 and HIV-2 (one HIV-2 immunoblot-positive with 17 HIV-2 RNA copies/mL) and 83 were Multispot-non-reactive of which 15 were HIV-1 RNA positive and represented acute HIV-1 infection. There was an association among the ARCHITECT S/CO (median; IQR) values for antibody-negative (0.14; 0.11-0.16), acute infection (33; 2.1-76) and established HIV-1 infection (794; 494-1,029) (Kruskal-Wallis, p0.0001).The ARCHITECT combo assay with Multispot confirmation and reserved use of HIV-1 WB, HIV-2 Immunoblot and HIV NAAT for Multispot dual HIV-1/2 infection, and NAAT alone for Multispot-negative specimens, had a suitable test performance for detecting acute and established HIV infection.

Background Point-of-care (POC) rapid HIV tests have sensitivity during the “window period” comparable only to earliest generation EIAs. To date, it is unclear whether any POC test performs significantly better than others. Objective Compare abilities of POC tests to detect early infection in real time. Study design Men who have sex with men (MSM) were recruited into a prospective, cross-sectional study at two HIV testing sites and a research clinic. Procedures compared four POC tests: one performed on oral fluids and three on fingerstick whole blood specimens. Specimens from participants with negative POC results were tested by EIA and pooled nucleic acid amplification testing (NAAT). McNemar's exact tests compared numbers of HIV-infected participants detected. Results Between February 2010 and May 2013, 104 men tested HIV-positive during 2479 visits. Eighty-two participants had concordant reactive POC results, 3 participants had concordant non-reactive POC tests but reactive EIAs, and 8 participants had acute infection. Of 12 participants with discordant POC results, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids identified fewer infections than OraQuick performed on fingerstick ( p = .005), Uni-Gold Recombigen HIV test ( p = .01), and determine HIV-1/2 Ag/Ab combo ( p = .005). Conclusions These data confirm that oral fluid POC testing detects fewer infections than other methods and is best reserved for circumstances precluding fingerstick or venipuncture. Regardless of specimen type, POC tests failed to identify many HIV-infected MSM in Seattle. In populations with high HIV incidence, the currently approved POC antibody tests are inadequate unless supplemented with p24 antigen tests or NAAT.

The Centers for Disease Control and Prevention recommends at least annual HIV testing for men who have sex with men (MSM), but motivations for testing are not well understood.We evaluated data from MSM testing for HIV at a community-based program in King County, Washington. Correlates of regular testing were examined using generalized estimating equation regression models.Between February 2004 and June 2011, 7176 MSM attended 12,109 HIV testing visits. When asked reasons for testing, 49% reported that it was time for their regular test, 27% reported unprotected sex, 24% were starting relationships, 21% reported sex with someone new, 21% sought sexually transmitted infection/hepatitis screening, 12% reported sex with an HIV-infected partner, 2% suspected primary HIV infection, and 16% reported other reasons. In multivariable analysis, factors associated with regular testing included having a regular health care provider and the following in the previous year: having only male partners, having 10 or more male partners, inhaled nitrite use, not injecting drugs, and not having unprotected anal intercourse with a partner of unknown/discordant status (P ≤ 0.001 for all). Men reporting regular testing reported shorter intertest intervals than men who did not (median of 233 vs. 322 days, respectively; P0.001).Regular testing, sexual risk, and new partnerships were important drivers of HIV testing among MSM, and regular testing was associated with increased testing frequency. Promoting regular testing may reduce the time that HIV-infected MSM are unaware of their status, particularly among those who have sex with men and women or inject drugs.