Video selection and assessment for an app-based HIV prevention messaging intervention: formative research.

Background: Gay, bisexual, and other men who have sex with men (GBMSM) continue to be overrepresented in human immunodeficiency virus (HIV) infection in the United States. HIV prevention and care interventions that are tailored to an individual's serostatus have the potential to lower the rate of new infections among GBMSM. Mobile technology is a critical tool for disseminating targeted messaging and increasing uptake of basic prevention services including HIV testing, sexually transmitted infection (STI) testing, and pre-exposure prophylaxis (PrEP). Mobile Messaging for Men (M-Cubed) is a mobile health HIV prevention intervention designed to deliver video- and text-based prevention messages, provide STI and HIV information, and link GBMSM to prevention and healthcare resources. The current report describes an iterative process of identifying and selecting publicly available videos to be used as part of the M-Cubed intervention. We also conducted interviews with GBMSM to assess the acceptability, comprehension, and potential audience reach of the selected video messages. Methods: The selection of videos included balancing of specific criteria [e.g., accuracy of scientific information, video length, prevention domains: HIV/STI testing, antiretroviral therapy (ART), PrEP, engagement in care, and condom use] to ensure that they were intended for our GBMSM audiences: HIV-negative men who engage in condomless anal sex, HIV-negative men who do not engage in condomless anal sex, and men living with HIV. This formative study included in-person interviews with 26 GBMSM from three U.S. cities heavily impacted by the HIV epidemic-New York City, Detroit, and Atlanta. Results: Following a qualitative content analysis, the study team identified five themes across the interviews: participant reactions to the video messages, message comprehension, PrEP concerns, targeting of video messaging, and prompted action. Conclusions: Study results informed a final selection of 12 video messages for inclusion in a randomized controlled trial of M-Cubed. Findings may serve as a guide for researchers who plan to develop HIV prevention interventions that utilize publicly available videos to promote behavioral change. Further, the findings presented here suggest the importance of developing videos with broad age and gender diversity for use in interventions such as M-Cubed, and in other health promotion settings.

Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM. OBJECTIVE: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM. METHODS: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period. RESULTS: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups. CONCLUSIONS: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16439.

The feasibility of modified HIV and antiretroviral drug testing using self-collected dried blood spots from men who have sex with men.

BACKGROUND: In the US, one in six men who have sex with men (MSM) with HIV are unaware of their HIV infection. In certain circumstances, access to HIV testing and viral load (VL) monitoring is challenging. The objective of this study was to evaluate the feasibility of conducting laboratory-based HIV and antiretroviral (ARV) drug testing, and VL monitoring as part of two studies on self-collected dried blood spots (DBS). METHODS: Participants were instructed to collect DBS by self-fingerstick in studies that enrolled MSM online. DBS from the first study (N = 1444) were tested with HIV serological assays approved by the Food and Drug Administration (FDA). A subset was further tested with laboratory-modified serological and VL assays, and ARV levels were measured by mass spectrometry. DBS from the second study (N = 74) were only tested to assess VL monitoring. RESULTS: In the first study, the mail back rate of self-collected DBS cards was 62.9%. Ninety percent of DBS cards were received at the laboratory within 2 weeks from the day of collection, and 98% of the cards had sufficient spots for one assay. Concordance between FDA-approved and laboratory-modified protocols was high. The samples with undetectable ARV had higher VL than samples with at least one ARV drug. In the second study, 70.3% participants returned self-collected DBS cards, and all had sufficient spots for VL assay. High VL was observed in samples from participants who reported low ARV adherence. CONCLUSIONS: In these studies, MSM were able to collect and provide adequate DBS for HIV testing. The FDA-approved and laboratory-modified testing algorithms performed similarly. DBS collected at home may be feasible for HIV testing, ARV measurement, and monitoring viral suppression.

The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: Key Indicators Report 2018.

The American Men's Internet Survey (AMIS) is an annual web-based behavioral survey conducted in the United States of men who have sex with men (MSM). This rapid surveillance report describes the sixth cycle of data collection (September-December 2018; AMIS 2018). The key indicators were the same as those previously reported for past AMIS cycles. The AMIS methodology has not substantively changed since AMIS 2017. MSM were recruited from a variety of websites using banner advertisements and email blasts. In addition, participants from AMIS 2017 who agreed to be recontacted for future research were emailed a link to AMIS 2018. Men were eligible to participate if they were aged ≥15 years, resided in the United States, provided a valid US ZIP code, and reported ever having sex with a man or identified as gay or bisexual. The analysis was limited to those who reported having oral or anal sex with a male partner in the past 12 months. We examined demographic and recruitment characteristics using multivariable regression modeling (P<.05) stratified by the participants' self-reported HIV status. The AMIS 2018 round of data collection resulted in 10,129 completed surveys from MSM representing every US state, Puerto Rico, and Guam. Most participants were non-Hispanic White, aged between 15 and 24 years, living in urban areas in the southern United States, and recruited from general social networking websites. The plurality (4230/10,129, 41.76%) of participants was in the youngest age group, 15-24 years, followed by the 40 years and older age group (3088/10,129, 30.49%). The self-reported HIV prevalence was 6.08% (616/10,129). Compared with HIV-negative or unknown status participants, HIV-positive participants were more likely to have had anal sex without a condom with a male partner in the past 12 months (adjusted odds ratio [aOR] 2.02, 95% CI 1.63-2.50) and more likely to have had anal sex without a condom with a serodiscordant or an unknown status partner (aOR 3.90, 95% CI 3.27-4.66). The reported use of marijuana in the past 12 months was higher among HIV-positive participants than among HIV-negative or unknown status participants (aOR 1.39, 95% CI 1.15-1.68). The reported use of methamphetamines and other illicit substances in the past 12 months was higher among HIV-positive participants than among HIV-negative or unknown status participants (aOR 3.42, 95% CI 2.41-4.87 and aOR 1.90, 95% CI 1.56-2.32, respectively). Most HIV-negative or unknown status participants (6838/9513, 71.88%) reported ever taking an HIV test previously, and 52.51% (4995/9513) of the participants reported undergoing HIV testing in the past 12 months. HIV-positive participants were more likely to report testing and diagnosis of sexually transmitted infections than HIV-negative or unknown status participants (aOR 3.50, 95% CI 2.89-4.24 and aOR 2.61, 95% CI 2.10-3.25, respectively).

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions.

Stigma regarding HIV pre-exposure prophylaxis (PrEP) is commonly implicated as a factor limiting the scale-up of this highly effective HIV prevention modality. To quantify and characterize PrEP stigma, we developed and validated a brief HIV PrEP Stigma Scale (HPSS) among a group of 279 men who have sex with men (MSM). Scale development was informed by a theoretical model to enhance content validity. We assessed two scale versions, Semantic Differential and Likert, randomizing the order in which scales were presented to participants. Both scales demonstrated high internal consistency. The Likert scale had substantially better construct validity and was selected as the preferred option. Scale scores demonstrated construct validity through association with constructs of interest: healthcare distrust, HIV knowledge, perceived proportion of friends/partners on PrEP, perceived community evaluation of PrEP, and perceived effectiveness of PrEP. The scale accounted for 25% of the total variance in reported willingness to be on PrEP, indicating the substantial role PrEP stigma may have on decisions to initiate PrEP. Given increased efforts to roll-out PrEP, having a valid tool to determine the level and types of PrEP stigma in individuals, groups, and communities can help direct implementation plans, identify goals for stigma reduction, and monitor progress over time.

HIV Prevention Via Mobile Messaging for Men Who Have Sex With Men (M-Cubed): Protocol for a Randomized Controlled Trial.

BACKGROUND: Men who have sex with men (MSM) continue to be the predominately impacted risk group in the United States HIV epidemic and are a priority group for risk reduction in national strategic goals for HIV prevention. Modeling studies have demonstrated that a comprehensive package of status-tailored HIV prevention and care interventions have the potential to substantially reduce new infections among MSM. However, uptake of basic prevention services, including HIV testing, sexually transmitted infection (STI) testing, condom distribution, condom-compatible lubricant distribution, and preexposure prophylaxis (PrEP), is suboptimal. Further, stronger public health strategies are needed to promote engagement in HIV care and viral load suppression among MSM living with HIV. Mobile health (mHealth) tools can help inform and encourage MSM regarding HIV prevention, care, and treatment, especially among men who lack access to conventional medical services. This protocol details the design and procedures of a randomized controlled trial (RCT) of a novel mHealth intervention that comprises a comprehensive HIV prevention app and brief, tailored text- and video-based messages that are systematically presented to participants based on the participants' HIV status and level of HIV acquisition risk. OBJECTIVE: The objective of the RCT was to test the efficacy of the Mobile Messaging for Men (M-Cubed, or M3) app among at least 1200 MSM in Atlanta, Detroit, and New York. The goal was to determine its ability to increase HIV testing (HIV-negative men), STI testing (all men), condom use for anal sex (all men), evaluation for PrEP eligibility, uptake of PrEP (higher risk HIV-negative men), engagement in HIV care (men living with HIV), and uptake of and adherence to antiretroviral medications (men living with HIV). A unique benefit of this approach is the HIV serostatus-inclusiveness of the intervention, which includes both HIV-negative and HIV-positive MSM. METHODS: MSM were recruited through online and venue-based approaches in Atlanta, Detroit, and New York City. Men who were eligible and consented were randomized to the intervention (immediate access to the M3 app for a period of three months) or to the waitlist-control (delayed access) group. Outcomes were evaluated immediately postintervention or control period, and again three and six months after the intervention period. Main outcomes will be reported as period prevalence ratios or hazards, depending on the outcome. Where appropriate, serostatus/risk-specific outcomes will be evaluated in relevant subgroups. Men randomized to the control condition were offered the opportunity to use (and evaluate) the M3 app for a three-month period after the final RCT outcome assessment. RESULTS: M3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. CONCLUSIONS: This RCT of the M3 mobile app seeks to determine the effects of an HIV serostatus-inclusive intervention on the use of multiple HIV prevention and care-related outcomes among MSM. A strength of the design is that it incorporates a large sample and broad range of MSM with differing prevention needs in three cities with high prevalence of HIV among MSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16439.

Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program.

We piloted PrEP@Home, a preexposure prophylaxis system of remote laboratory and behavioral monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden. The system was highly acceptable and in-demand for future use, and more than one-third of participants reported greater likelihood of persisting in care if available.