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BackgroundCisgender 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. ObjectiveWe 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). MethodsBetween 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. ResultsOverall, 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. ConclusionsIt 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. Trial RegistrationClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282

BackgroundHealthMindr 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. ObjectiveThe aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. MethodsIn 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. ResultsParticipant recruitment began in January 2020. ConclusionsThis trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial RegistrationClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID)PRR1-10.2196/16231

BackgroundHIV 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. ObjectiveThis paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. MethodsProject 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. ResultsBetween 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. ConclusionsStudies 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

BackgroundGroup 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. ObjectiveThe 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. MethodsWe 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. ResultsAmong 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. ConclusionsWe 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.

BackgroundMen 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. ObjectiveThe aim of this study was to evaluate the usability and acceptability of a theory-based Android mobile phone app for HIV prevention. MethodsThe 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). ResultsA 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). ConclusionsA 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.

BackgroundThe 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. ObjectiveThe 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. MethodsWe 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. ResultsParticipants 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. ConclusionsIn 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.

BackgroundHIV testing is the gateway to HIV treatment and prevention. HIV self-testing (HIVST) has potential to increase testing; however, the potential population-level impact of HIVST on the HIV epidemic and the best strategies for promoting HIVST are unknown. Our aim is to inform public health approaches for promoting HIVST as part of a comprehensive strategy to reduce HIV incidence.MethodsStochastic network-based HIV transmission models were used to estimate how different HIVST strategies would affect HIV incidence in Seattle and Atlanta over 10 years. We included four types of HIV testers and implemented nine replacement and eleven supplementation strategies for HIVST.ResultsReplacement of clinic-based tests with HIVST increased HIV incidence in Seattle and Atlanta. The benefits of supplementary strategies depended on the tester type using HIVST. Targeting non-testers averted the highest number of cases per test. In Seattle 2.2 (95%SI=-77, 100.4) and 4.7 (95%SI=-35.7, 60.1) infections were averted per 1000 HIVST when non-testers used HIVST once or twice per year respectively. In Atlanta the comparable rates were 8.0 (95%SI=-60.3 to 77.7) and 6.7 (95%SI=-37.7, 41.0). Paradoxically, increasing testing among risk-based testers using HIVST increased incidence.ConclusionsThe population-level impact of HIVST depends on who is reached with HIVST, how kits are used, and by characteristics of the underlying epidemic and HIV care infrastructure. Targeted HIVST can be an effective component of a comprehensive HIV testing strategy. More work is needed to understand how to identify and target non-testers for self-testing implementation.

BackgroundMaraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP).ObjectiveTo assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection.DesignPhase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114).Setting12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group.ParticipantsHIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days.InterventionMVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control).MeasurementsAt 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.ResultsAmong 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.LimitationsParticipants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy.ConclusionMaraviroc-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 sourceNational Institutes of Health.

BackgroundMaraviroc (MVC) is a candidate for human immunodeficiency virus (HIV) pre-exposure prophylaxis.MethodsPhase 2 48-week safety/tolerability study was conducted, comparing 4 regimens: MVC alone, MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. Eligible participants were HIV-uninfected men and transgender women reporting condomless anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. At each visit, assessments, laboratory testing, and counseling were done. Analyses were intention to treat.ResultsAmong 406 participants, 84% completed follow-up, 7% stopped early, and 9% were lost to follow-up; 9% discontinued their regimen early. The number discontinuing and the time to discontinuation did not differ among study regimens (P = .60). Rates of grade 3-4 adverse events did not differ among regimens (P = .37). In a randomly selected subset, 77% demonstrated detectable drug concentrations at week 48. Five participants acquired HIV infection (4 MVC alone, 1 MVC + TDF; overall annualized incidence, 1.4% [95% confidence interval, .5%-3.3%], without differences by regimen; P = .32); 2 had undetectable drug concentrations at every visit, 2 had low concentrations at the seroconversion visit, and 1 had variable concentrations.ConclusionsMVC-containing regimens were safe and well tolerated compared with TDF + FTC; this study was not powered for efficacy. Among those acquiring HIV infection, drug concentrations were absent, low, or variable. MVC-containing regimens may warrant further study for pre-exposure prophylaxis.Clinical trials registrationNCT01505114.

Transgender and gender nonbinary (TGNB) individuals are at high risk for HIV acquisition. However, TGNB individuals are often excluded from research and public health surveillance, both as participants and as reported sexual partners. This research study aimed to be inclusive, correctly classify TGNB participants, and accurately describe sex partners and sexual activity of participants to assess HIV risk while minimizing participant burden. The adaptation of survey questions designed for cisgender men to include TGNB participants and partners was feasible and relatively straightforward. However, additional work is still needed in this area to increase inclusivity and research participation by TGNB individuals. Clinical Trial Registration Number - NCT03584282. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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., Author(s): Joanne D. Stekler 1,*, Ross Milne 1,2, Rachel Payant 2, Ingrid Beck 2, Joshua Herbeck 1, Brandon Maust 1, Wenjie Deng 1, Kenneth Tapia 1, Sarah Holte 1,3, Janine [...]