Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use.

Suboptimal adherence to oral PrEP medications, particularly among younger sexual minority men (SMM), continues to be a key barrier to achieving more substantial declines in new HIV infections. Although variety of interventions, including web and text-message-based applications, have successfully addressed PrEP adherence, very few have addressed the potential influence of alcohol. This pilot study explored whether the Game Plan for PrEP, a brief, web-based and text messaging intervention, helped promote PrEP persistence and adherence and reduced condomless sex and alcohol use. Seventy-three heavy-drinking SMM on PrEP were recruited online from states with Ending the HIV Epidemic jurisdictions and randomly assigned 1:1 to receive either the Game Plan for PrEP intervention or an attention-matched control. We collected online surveys assessing primary outcomes at one, three, and six months post-enrollment. As secondary outcomes, we also collected dried blood spot samples at baseline, three, and six months to analyze for biomarkers of PrEP and alcohol use. Our results showed that the odds of stopping PrEP or experiencing a clinically meaningful lapse in PrEP adherence (≥ 4 consecutive missed doses) were not different across the two conditions. We also did not find evidence of any differences in condomless sex or drinking outcomes across conditions, although participants in both conditions reported drinking less often over time. These findings were consistent across both self-reported outcomes and biomarkers. Overall, we did not find evidence that our brief, web and text messaging intervention encouraged more optimal PrEP coverage or moderate their alcohol use.

Efficacy of Behavioral Intervention, Text Messaging, and Extended Intervention to Address Alcohol Misuse in Sexual Minority Men with HIV: A Factorial Randomized Clinical Trial.

This clinical trial examined the individual and combined effects of three different approaches to reducing alcohol misuse among a sample of sexual minority men (SMM) with HIV. Specifically, we used a 2 × 2 × 2 randomized factorial design to compare: (a) behavioral intervention based in motivational interviewing (MI) vs. brief intervention (BI), (b) interactive text messaging (ITM) for alcohol use vs. no ITM, and (c) extended intervention (EI) length of nine months vs. a one-month intervention duration. Participants (N = 188) were SMM with HIV and alcohol misuse recruited in Miami, FL, and Boston, MA. Participants were randomized to one of eight intervention combinations and assessed at 6- and 12-month follow-ups. Large reductions of over 50% in drinks per week and heavy drinking days were observed in all conditions at follow-up. Those who received ITM, compared to those who did not, reported significantly lower drinks consumed per week at 6 and 12 months (incidence rate ratios = 0.73 [95% CI = 0.57, 0.90] and 0.72 [95% CI = 0.56, 0.87], respectively), and increased odds of cessation of alcohol misuse at 12 months, odds ratio = 1.46, 95% CI = 1.03, 2.08. Results provided no evidence of better alcohol use outcomes for either MI or EI relative to their comparison conditions, and no specific combination of intervention components demonstrated a notable benefit. This study suggests a two-session BI can effectuate substantial reductions in alcohol use in SMM with HIV and that adding one month of ITM can yield further improvements. Clinical Trials Number: NCT02709759.

Virtual reality (VR) treatments for anxiety disorders are unambiguously successful, so why are so few therapists using it? Barriers to adoption and potential solutions.

Anxiety disorders are a significant cause of disability globally, yet only one in ten sufferers receives adequate quality treatment. Exposure-based therapies are effective in reducing symptoms associated with a number of anxiety disorders. However, few therapists use exposure techniques to treat these conditions, even when they are adequately trained in them, often because of concerns about provoking distress, drop out, logistical barriers, and other concerns. Virtual reality exposure therapy (VRET) can address many of these concerns, and a large body of research decisively shows that VRET is as efficacious for treating these conditions as in vivo exposures. Yet, use of VRET remains low. In this article, we discuss several factors we believe are contributing to low VRET adoption among therapists and raise potential solutions to address them. We consider steps that VR experience developers and researchers might take, such as leading studies of VRET's real-world effectiveness and treatment optimization trials and continuing to improve the fit of platforms with clinicians' workflows. We also discuss steps to address therapist reservations using aligned implementation strategies, as well as barriers for clinics, and the roles that professional organizations and payers could have in improving care by encouraging adoption of VRET.

Gay, Bisexual, and Other Men Who Have Sex With Men Who Are Not on Oral PrEP may be Less Interested in Available Injectable Products than in Oral PrEP: Examining Individual-Level Determinants of Interest and Barriers Across Products.

Approval of the first injectable PrEP product (cabotegravir) provides an exciting addition to oral PrEP that could encourage those not currently on PrEP to use it. However, few studies have explored interest in injectable cabotegravir among those at increased risk who are not currently on PrEP. We conducted an online survey with 327 gay, bisexual, and other men who have sex with men (GBM) with limited PrEP history to explore their interest and intentions to use oral and injectable PrEP (cabotegravir), and examine barriers and individual-level predictors of both product types. Results showed that 17% of participants who reported being uninterested/neutral about oral PrEP expressed interest in injectable PrEP. Slightly more racial/ethnic minority GBM who were uninterested/neutral for oral PrEP expressed interest in injectable PrEP than White GBM (23% vs. 14%). Determinants were similar across PrEP types. Findings can directly inform interventions encouraging use of both PrEP products.

Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health.

Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators' awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.

Feasibility, Appropriateness, and Willingness to Use Virtual Reality as an Adjunct to Counseling among Addictions Counselors.

INTRODUCTION: Research suggests that virtual reality (VR) experiences can be helpful as adjunctive tools in psychotherapy for some mental health conditions. VR is a computer-generated experience that produces a feeling of being immersed in a different environment. VR experiences could be useful in the treatment of substance use disorders, and several are currently being tested. However, few psychotherapists report using VR experiences in their practices, even when doing so is well-supported. Understanding key barriers and concerns about using VR among drug/alcohol counselors is important to ultimately encouraging adoption. METHODS: Licensed counselors (N = 101) who provide treatment to clients with substance use disorders were recruited via email Listservs, professional organizations, and social media. Participants viewed a 15-minute educational video about VR and then completed a survey of their views about using it with their clients. RESULTS: Most clinicians (82%) believed they would be likely to use a VR experience in drug/alcohol counseling, and 81% believed it would be appropriate for most of their clients. A minority (19%) noted important concerns, including that their clients may be skeptical of it (15%), cost (14%), and space (10%). Those who had cost and space concerns were less likely to report high use intentions (OR = 0.29 and OR = 031, both p < .05, respectively). CONCLUSIONS: Findings suggest that addictions counselors are eager to use VR, but key barriers should be addressed. VR developers should incorporate features to encourage trust among users, design experiences for small spaces, and explore ways of supporting the purchase of VR systems for counselors.

Characteristics of Sex Events, Partners, and Motivations and Their Associations with HIV-Risk Behavior in a Daily Diary Study of High-Risk Men Who Have Sex with Men (MSM).

In the United States, men who have sex with men (MSM) continue to be at high-risk for HIV and other STIs, and condoms represent the most popular, affordable, and accessible method of prevention. Although a vast body of research has explored various factors associated with condom use in MSM, fewer studies have explored situation-level characteristics that affect their decisions about sex partners and condom use. Daily diary studies are well-suited to help improve our understanding of these event-level factors in detail, including the sex events themselves, partner characteristics, and motivations. As part of a larger study using ecological momentary assessment methods, high-risk MSM completed daily diary surveys about their sexual behavior on their smartphones each day for 30 days. This study explored detailed descriptive characteristics of sex events, partner characteristics, and motivations for sex and condom use, and examined whether specific aspects of these characteristics were associated with having condomless anal sex (CAS) with high-risk partners. High-risk CAS was common among MSM, with the majority of participants having met their partners online and many reporting sex the same day they met. Results showed that the odds of CAS were not higher with partners met online versus those met in other ways, but MSM were more likely to have asked online partners about their HIV status and testing history before sex. The odds of engaging in high-risk CAS was higher when MSM reported intimacy or self-assurance motives. Not having condoms readily available was a CAS motivation reported more commonly when MSM had sex with high-risk partners. Findings suggest that interventions should incorporate strategies that help MSM be safer specifically when meeting partners online and when having sex for intimacy or re-assurance. Interventions that remind MSM to carry condoms at opportune moments may also help reduce some HIV risk.

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.

Exploring the Use of Smartphone Geofencing to Study Characteristics of Alcohol Drinking Locations in High-Risk Gay and Bisexual Men.

BACKGROUND: Geofencing offers new opportunities to study how specific environments affect alcohol use and related behavior. In this study, we examined the feasibility of using geofencing to examine social/environmental factors related to alcohol use and sexual perceptions in a sample of gay and bisexual men (GBM) who engage in heavy drinking and high-risk sex. METHODS: HIV-negative GBM (N = 76) completed ecological momentary assessments for 30 days via a smartphone application and were prompted to complete surveys when inside general geofences set around popular bars and clubs. A subset (N = 45) were also asked to complete surveys when inside personal geofences, which participants set themselves by identifying locations where they typically drank heavily. RESULTS: Approximately 49% of participants received a survey prompted by a general geofence. Among those who identified at least 1 personal drinking location, 62.2% received a personal geofence-prompted survey. Of the 175 total location-based surveys, 40.2% occurred when participants were not at the location that was intended to be captured. Participants reported being most able to openly express themselves at gay bars/clubs and private residences, but these locations were also more "sexualized" than general bars/clubs. Participants did not drink more heavily at gay bars/clubs, but did when in locations with more intoxicated patrons or guests. CONCLUSIONS: Geofencing has the potential to improve the validity of studies exploring environmental influences on drinking. However, the high number of "false-positive" prompts we observed suggests that geofences should be used carefully until improvements in precision are more widely available.

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.

Causal Effects of Alcohol Intoxication on Sexual Risk Intentions and Condom Negotiation Skills Among High-Risk Men Who Have Sex with Men (MSM).

Alcohol use is a key risk factor for HIV infection among MSM, in part because intoxication may interfere with the use of prevention methods like condoms. However, few studies have examined whether this is due to alcohol's pharmacological or expectancy effects or explored the specific aspects of sexual decision-making that may be affected. In this study, high-risk, heavy drinking MSM (N = 121) were randomly assigned to receive either (1) alcohol beverages, (2) placebo beverages, or (3) control beverages, before navigating a video-based sexual risk scenario that assessed several aspects of sexual decision-making. Results showed that condom use intentions and negotiation behaviors were lower among alcohol and placebo participants compared with controls, but that few significant differences emerged between the alcohol and placebo groups. These findings contrast with similar past studies, and suggest that alcohol's expectancy effects may play a role in sexual decision-making.

Using Smartphone Survey Data and Machine Learning to Identify Situational and Contextual Risk Factors for HIV Risk Behavior Among Men Who Have Sex with Men Who Are Not on PrEP.

"Just-in-time" interventions (JITs) delivered via smartphones have considerable potential for reducing HIV risk behavior by providing pivotal support at key times prior to sex. However, these programs depend on a thorough understanding of when risk behavior is likely to occur to inform the timing of JITs. It is also critical to understand the most important momentary risk factors that may precede HIV risk behavior, so that interventions can be designed to address them. Applying machine learning (ML) methods to ecological momentary assessment data on HIV risk behaviors can help answer both questions. Eighty HIV-negative men who have sex with men (MSM) who were not on PrEP completed a daily diary survey each morning and an experience sampling survey up to six times per day via a smartphone application for 30 days. Random forest models achieved the highest area under the curve (AUC) values for classifying high-risk condomless anal sex (CAS). These models achieved 80% specificity at a sensitivity value of 74%. Unsurprisingly, the most important contextual risk factors that aided in classification were participants' plans and intentions for sex, sexual arousal, and positive affective states. Findings suggest that survey data collected throughout the day can be used to correctly classify about three of every four high-risk CAS events, while incorrectly classifying one of every five non-CAS days as involving high-risk CAS. A unique set of risk factors also often emerge prior to high-risk CAS events that may be useful targets for JITs.

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).

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.

HIV-related thought avoidance, sexual risk, and alcohol use among men who have sex with men.

HIV-related "cognitive escape" refers to a tendency to avoid thoughts associated with HIV, which may be particularly common among men who have sex with men (MSM) who are often inundated with HIV information, potentially to the point of fatigue. HIV-related cognitive escape is associated with increased sexual risk behaviors, such as condomless sex, and heavier alcohol use patterns. Other studies show that some MSM may use alcohol specifically to facilitate sex. These sexual motives for drinking (SMDs) could be one mechanism whereby cognitive escape leads to health risk behaviors. In this study, we tested models exploring whether cognitive escape was associated with markers of sex risk (condom use, number of sex partners) and alcohol use/problems, and examined whether SMDs mediated these associations. Heavy drinking, HIV-negative men (N = 196) aged ≥ 21 years who self-reported past year condomless anal sex with men completed assessments as part of a larger study. Results suggest that cognitive escape was associated with higher number of anal sex partners (incidence rate ratio [IRR] = 1.50, SE = 0.04, p < .001), decreased condom use (B = -0.30, SE = 0.14, p = .028), and increased alcohol-related problems (IRR = 1.28, SE = 0.07, p = .001) but not with drinking quantity. Sexual motives for drinking appeared to partially mediate the observed relationship between cognitive escape and alcohol-related problems, but other relationships did not show evidence of mediation. Findings suggest that those who tend to avoid HIV-related thoughts may be at increased risk for HIV and alcohol-related problems. Drinking to facilitate sex may partially account for the higher risk for alcohol-related problems conferred by cognitive escape. Alcohol interventions for MSM may be more effective if they address alcohol's role in coping with HIV threat and in facilitating sex under these circumstances.

Using Ecological Momentary Assessment (EMA) to Study Sex Events Among Very High-Risk Men Who Have Sex with Men (MSM).

MSM continue to represent the largest share of new HIV infections in the United States each year due to high infectivity associated with unprotected anal sex. Ecological momentary assessment (EMA) has the potential to provide a unique view of how high-risk sexual events occur in the real world and can impart detailed information about aspects of decision-making, antecedents, and consequences that accompany these events. EMA may also produce more accurate data on sexual behavior by assessing it soon after its occurrence. We conducted a study involving 12 high-risk MSM to explore the acceptability and feasibility of a 30 day, intensive EMA procedure. Results suggest this intensive assessment strategy was both acceptable and feasible to participants. All participants provided response rates to various assessments that approached or were in excess of their targets: 81.0 % of experience sampling assessments and 93.1 % of daily diary assessments were completed. However, comparing EMA reports with a Timeline Followback (TLFB) of the same 30 day period suggested that participants reported fewer sexual risk events on the TLFB compared to EMA, and reported a number of discrepancies about specific behaviors and partner characteristics across the two methods. Overall, results support the acceptability, feasibility, and utility of using EMA to understand sexual risk events among high-risk MSM. Findings also suggest that EMA and other intensive longitudinal assessment approaches could yield more accurate data about sex events.

Acute Effects of Intoxication and Arousal on Approach/Avoidance Biases Toward Sexual Risk Stimuli in Heterosexual Men.

This study tested the effects of alcohol intoxication and physiological arousal on cognitive biases toward erotic stimuli and condoms. Ninety-seven heterosexual men were randomized to 1 of 6 independent conditions in a 2 (high arousal or control) × 3 (alcohol target BAC = 0.08, placebo, or juice control) design and then completed a variant of the Approach-Avoidance Task (AAT). The AAT assessed reaction times toward approaching and avoiding erotic stimuli and condoms with a joystick. Consistent with hypotheses, the alcohol condition exhibited an approach bias toward erotic stimuli, whereas the control and placebo groups exhibited an approach bias toward condom stimuli. Similarly, the participants in the high arousal condition exhibited an approach bias toward erotic stimuli and the low arousal control condition exhibited an approach bias toward condoms. The results suggest that acute changes in intoxication and physiological arousal independently foster biased responding toward sexual stimuli and these biases are associated with sexual risk intentions.

Test-Retest Reliability and descriptive analyses of the Modified Important People and Activities (MIPA) Interview.

BACKGROUND: The Important People and Activities (IPA) instrument assesses network characteristics and social support for drinking and abstinence. The IPA has garnered widespread use in the alcohol treatment field. We modified the IPA to assess HIV status, drug of choice, and IV drug use among social network members. Further, we queried frequency of unprotected sex, between the participant and network members. AIM: Since this measure was modified, and the test-retest reliability of the IPA has only rarely been examined, we conducted a small substudy (n=26) to examine 1-week test-retest reliability of this measure. METHODS: Participants were individuals in a day treatment program with an SUD and/or AUD diagnosis. RESULTS: Drug of choice for the participants represented roughly equal thirds of heroin, cocaine, and alcohol. The sample was 62% female and 39% Latino/a. At pretest 198 persons were named on the MIPA (M=7.6 network members per subject). It was determined that 152 of the people were overlapping between the test and retest. CONCLUSIONS: Percent agreement, ICCs, and kappas for the items ranged from acceptable to excellent across the two time periods. Classification of network members as positive, negative, or neutral influences on sobriety also demonstrated good to excellent kappas.

Daily associations between alcohol use and unprotected anal sex among heavy drinking HIV-positive men who have sex with men.

Men who have sex with men (MSM) account for the largest proportion of new HIV infections in the United States. Alcohol may facilitate HIV transmission by increasing unprotected anal sex, but few studies have focused on transmission behaviors in HIV-positive MSM. This study explored daily associations between alcohol use and sexual behavior among heavy drinking HIV-positive MSM using a 30-day Timeline Followback interview. Results of generalized estimating equations indicated that greater alcohol consumption on a given day was associated with a linear increase in the odds of having unprotected anal sex with partners of any HIV status. However, the odds of reporting unprotected anal sex with HIV-negative or HIV-status unknown partners increased in a curvilinear fashion, occurring primarily at very heavy levels of use (12+ drinks). Results suggest that very heavy drinking increases the risk of engaging in sexual behavior that has the potential for transmitting HIV to other men.

Increasing the Value of an Alternative Monetary Reinforcer Reduces Cigarette Choice in Adolescents.

INTRODUCTION: Smoking can be conceptualized as an operant behavior maintained by the reinforcing effects of cigarettes. Changing the magnitude and availability of alternative reinforcers should shift behavior away from smoking. Adults' smoking behavior is sensitive to the magnitude and availability of alternative reinforcers; however, the extent to which the same is true for adolescents has not yet been shown in the laboratory. METHODS: To test the sensitivity of adolescent smoking behavior to changes in the magnitude of alternative reinforcement, we gave adolescents who abstained overnight the opportunity to make 20 choices between receiving two puffs of their usual-brand cigarette or money. The magnitude of the monetary reinforcer was varied across sessions in counterbalanced order ($0.00, $0.10, and $0.50). RESULTS: Results indicated that adolescents' choices for puffs decreased as a function of increasing monetary reinforcer magnitude, while money choices increased. This effect was moderated by baseline smoking level and by gender, such that heavier-smoking participants and males made more cigarette choices when the alternative monetary value was zero, and decreased their choices more steeply in response to increasing monetary value. CONCLUSIONS: The current study validates a laboratory choice procedure for studying smoking in adolescents, and demonstrates that adolescent smoking behavior is sensitive to changes in the magnitude of concurrently available monetary reinforcers. The current paradigm can be adapted and applied to explore the effects of other variables that may affect cigarette choice in adolescents.