eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men.

BACKGROUND: HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. HIV self-testing (HST) may be an important tool for increasing rates and frequency of testing. HST may be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. METHODS: We developed a mobile health platform (eTest) that monitors when HST users open their tests in real time, allowing us to provide timely, "active" follow-up counseling and referral over the phone. In this study, 900 high-risk MSM (with targets of 40% AA, 35% H/L) who have not tested in the last year will be recruited from social media and other gay-oriented websites in several major cities. Over 12 months, participants will be randomly assigned to receive (1) HST with post-test phone counseling and referral (eTest condition), (2) HST without active follow-up (standard condition), or (3) reminders to get tested for HIV at a local clinic (control) every 3 months. Primary outcomes include rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation verified by clinical medical records. DISCUSSION: This study tests whether providing more active counseling and referral after HST encourages more regular HIV testing and engagement with other prevention services among MSM, compared to more passive approaches or clinic-based testing alone. It will also explore the cost-effectiveness and emotional/behavioral effects of these two strategies. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03654690 . Registered on 31 August 2018.

Longitudinal effects of home-based HIV self-testing on well-being and health empowerment among men who have sex with men (MSM) in the United States.

HIV self-test (HST) kits have been available for purchase directly by consumers since 2012. However, public health and prevention programs have been slow to adopt self-testing as a strategy for improving testing rates and regularity, in part due to concerns about its effects on the well-being of users and lack of follow-up. This study explored whether there were differences in several constructs related to well-being, including health-related quality of life, social support, health empowerment, and emotional distress, across those who used HSTs versus tested at a clinic over time. Data were drawn from a longitudinal randomized controlled trial exploring methods of encouraging HIV testing (clinic-based, regular home delivery of HSTs) and providing follow-up afterward. Results showed that using HST in a given month was not associated with changes in either distress or well-being that same month. Although social support was lower in months when HST was used (versus clinic-based testing), participants reported that engaging in other health behaviors (e.g., Healthy diet, exercise) were more important in months they used HST compared to testing in a clinic, suggesting that HST may empower MSM to begin making other lifestyle changes that could improve their health.

A Preliminary Randomized Controlled Trial of Game Plan, A Web Application to Help Men Who Have Sex with Men Reduce Their HIV Risk and Alcohol Use.

Alcohol use is a key risk factor for HIV infection among men who have sex with men (MSM). Past studies show that brief motivational interventions (BMI) can increase the use of prevention methods (e.g., condoms), reduce alcohol use, and can be adapted for web-based delivery. However, few studies have explored these interventions' effects in MSM. Forty high-risk, heavy drinking MSM who sought rapid HIV testing were randomly assigned to receive either (1) standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP), a tablet tablet-based BMI for alcohol use and HIV risk. Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls. GP participants also reported fewer high-risk condomless anal sex events than controls, but these differences were not significant. These initial results suggest that web-based BMIs may be promising tools to help MSM reduce health risk behaviors.

Timeline: A web application for assessing the timing and details of health behaviors.

BACKGROUND: Timeline Followback (TLFB) interview methods are used to assess a variety of health behaviors, including alcohol use, drug use, and sexual behavior. While several online TLFBs have been developed, most focus on single behaviors, and few studies have explored their validity in assessing multiple risk behaviors using a single online TLFB. OBJECTIVE: To examine the validity of a customizable web application (Timeline) for assessing alcohol use, drug use, and sexual behavior among high-risk men who have sex with men. METHODS: Participants (N = 15 men) completed standardized survey instruments before undergoing a 30-day daily diary procedure where they submitted daily reports of health risk behaviors via smartphone. They then completed a Timeline at the end of the 30-day period covering the same time interval. RESULTS: Comparing a baseline administration of Timeline with popular surveys of health risk behaviors supported Timeline's validity (r = 0.41-0.59 for alcohol use, r = 0.83 for drug use, and r = 0.34-0.52) for sexual behaviors. While participants reported similar amounts of each behavior via daily diary as they did on a follow-up Timeline (r = 0.55-0.88 for alcohol use, r = 0.69 for drug use, and r = 0.87-0.92 for sexual behaviors), results provided evidence of underreporting on the Timeline. Timing of behaviors also frequently disagreed across these methods. CONCLUSIONS: Timeline is valid for assessing overall engagement in alcohol use, drug use, and sexual behavior over a 30-day window. However, researchers interested in the specific timing of behaviors within assessment intervals should use smaller follow-up intervals (e.g., 7 days, 14 days) or more intensive reporting methods (e.g., daily diary).

User-centered, interaction design research approaches to inform the development of health risk behavior intervention technologies.

BACKGROUND: Computers have tremendous potential for helping people change behaviors that put their health at risk. This potential has led to the development of a variety of health behavior intervention technologies (BITs) in recent years. While many of these BITs have been informed by scientific theories on behavior change, poor design can fail to engage intended users. User-centered, interaction design (IxD) research can help BIT developers create tools that are intuitive and enjoyable and that align with intended users' goals. In this manuscript, we describe an IxD research process we used to inform the development of a tablet-optimized web application designed to help heavy drinking gay and bisexual men reduce their risk for HIV when they seek HIV testing. METHODS: We conducted focus groups with subject matter experts (SMEs, N = 10) and intended users (N = 25). In the SME group, HIV test counselors were recruited to provide an understanding of the priorities and challenges of post-test counseling. In focus groups with intended users, participants created detailed, personalized models of two "typical" users of the proposed app ("personas") that could be used to guide design decisions. RESULTS: SMEs emphasized the importance of putting patients at ease, and suggested that interventions should prioritize identifying personal risks and provide options for change. Personas created by intended users provided important details about users' attitudinal and emotional contexts, and their possible motivations and goals for using the app. These suggested that users might be most motivated to use the app in order to understand their personal risks, compare their behavior with others like them, help them decide whether they want to change to reduce their risk, and see all their options for doing so. Personas also provided insights about the aesthetic experience that might be most appealing to users. CONCLUSIONS: Interaction design research can provide BIT development teams with personal models of likely users to help guide decisions about the allocation of design resources and the overall form and spirit of the software. These insights can help teams build BITs that are more engaging and interesting to intended users.

Vulnerable Periods: Characterizing Patterns of Sexual Risk and Substance Use During Lapses in Adherence to HIV Pre-exposure Prophylaxis Among Men Who Have Sex With Men.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly efficacious, but some groups of men who have sex with men may have difficulty adhering to daily dosing. Prevention-effective adherence suggests that PrEP's efficacy depends on adherence at the time of HIV exposure; yet, few studies have examined how exposures (ie, high-risk sex) overlap with periods of consecutive missed PrEP doses. Substance use may also play a role in these vulnerable periods. METHODS: We used digital pill bottles to monitor the daily adherence of 40 PrEP-experienced patients recruited from an outpatient clinic in the Northeastern US over a six-month period. Participants also completed detailed online diaries every 2 weeks during this time that surveyed their sexual behavior and substance use each day. RESULTS: Daily adherence was high overall (M = 83.9%, SD = 18.0%), but 53% (N = 21) had a lapse of > 3 consecutive daily PrEP doses over 6 months. Participants' rate of engaging in high-risk condomless anal sex (CAS) did not differ across lapse days versus continuously adherent days. Alcohol use was not associated with engaging in CAS during a PrEP lapse. However, participants reported engaging in CAS significantly more often during a PrEP adherence lapse on days when they also used stimulant drugs. CONCLUSIONS: Men who have sex with men may have periodic difficulty adhering to PrEP at the specific times when they are at risk. Stimulant drug use could play an important role in increasing HIV risk specifically during adherence lapses.

Game Plan: Development of a Web App Designed to Help Men Who Have Sex With Men Reduce Their HIV Risk and Alcohol Use.

BACKGROUND: Men who have sex with men (MSM) are at high risk for HIV, and alcohol use is a major risk factor for HIV infection. Internet-facilitated brief interventions have been shown to reduce alcohol use and HIV-risk behavior in other at-risk populations, but have so far incorporated limited content and have not been tested among MSM. OBJECTIVE: This manuscript describes Game Plan, an interactive, tablet-optimized web application designed to help heavy drinking, high-risk MSM consider reducing their alcohol use and sexual risk behavior. In this paper, we discuss the rationale, goals, and flow for each of Game Plan's components, which were modelled after common in-person and web-based brief motivational interventions for these behaviors. METHODS: The development of Game Plan was informed by a thorough user-focused design research process that included (1) audits of existing interventions, (2) focus groups with stakeholders and (3) intended users (high-risk, heavy drinking MSM), and (4) usability testing. The aesthetic, features, and content of the app were designed iteratively throughout this process. RESULTS: The fully-functional Game Plan app provides (1) specific and personal feedback to users about their level of risk, (2) exercises to help prompt users to reflect on whether their current behavior aligns with other important life goals and values, and for those open to change, (3) exercises to help users understand factors that contribute to risk, and (4) a change planning module. In general, this flow was constructed to roughly align with the two phases described in early accounts of motivational interviewing (MI): (1) Content intended to elicit intrinsic motivation for change, and when/if sufficient motivation is present, (2) content intended to translate that motivation into specific goals and plans for change. This sequence first focuses on the user's HIV risk behavior, followed by their alcohol use and the connection between the two. The app's overall aesthetic (eg, branding, color palettes, icons/graphics) and its onboarding sequence was also designed to align with the "spirit" of MI by conveying respect for autonomy, open-mindedness (ie, avoiding judgment), and empathy. CONCLUSIONS: Should future research support its efficacy in facilitating behavior change, Game Plan could represent a wide-reaching and scalable tool that is well-suited for use in settings where delivering evidence-based, in-person interventions would be difficult or cost-prohibitive.

HIV Testing Among Men Who Have Sex with Men in the Northeastern United States.

Men who have sex with men (MSM) continue to be at especially high risk for HIV in the United States. Past studies have shown that rates of HIV testing differ across a number of demographic and behavioral factors, and this research may be helpful for targeting efforts to increase testing among certain subgroups of MSM. In this study, MSM were recruited from several online sources to complete a questionnaire on HIV testing. Generalized ordered logit models suggested that the odds of having tested within the last 12 months were higher among racial/ethnic minority MSM, those with a college degree, and those who engaged in more recent HIV-risk behavior. The odds of having tested within the last 12 months were also higher among those who reported having sex with a partner they met online in the last 12 months. Conversely, the odds of having tested in the last 12 months were lower among those who reported drinking alcohol heavily, when compared with more moderate drinkers, highlighting yet another potential impact of alcohol on HIV outcomes.