A Serious Video Game Targeting HIV Testing and Counseling: A Randomized Controlled Trial.

PURPOSE: Adolescents are the age group that is least likely to know their HIV status and may unknowingly transmit the virus to others. A randomized controlled trial was conducted to evaluate the impact of the original video game intervention, PlayTest!, on behavioral antecedents for HIV testing and counseling (HTC). METHODS: Participants (N = 287 adolescents) were recruited between 2018 and 2020 and were 48% female, aged 14-18 years (mean age = 15.4 years), and 76% racial minorities. Participants were randomized 1:1 and assigned to either play PlayTest! or a set of control games, ∼one session per week for an hour per session over 4-6 weeks (gameplay) after school. The primary outcome measure was participants' attitudes around HTC at 6 months, with intentions, knowledge, self-efficacy, and behaviors assessed as secondary outcomes. RESULTS: Two hundred and ninety-six participants were enrolled/randomized; nine were withdrawn due to incomplete parental consent forms, leaving 287 participants: 145 were randomized to PlayTest! and 142 to the control condition. Mixed between-within subjects ANOVAs assessed the impact of the study conditions on outcomes. Improvements were seen in the PlayTest! group in HTC attitudes (p < .001), intentions (p < .001), knowledge (p < .001), and self-efficacy (p = .002) at all time-points. At 6 months, for those who had access to HTC (N = 134; prior to COVID-19) and for those who did not have access to HTC (N = 261; during COVID-19), there were no differences in self-reported HTC between the two groups (p = .289 and p = .074, respectively). DISCUSSION: PlayTest! impacted important behavioral antecedents related to HTC and has the potential to broadly increase HTC rates in adolescents.

Identifying Game-Based Digital Biomarkers of Cognitive Risk for Adolescent Substance Misuse: Protocol for a Proof-of-Concept Study.

BACKGROUND: Adolescents at risk for substance misuse are rarely identified early due to existing barriers to screening that include the lack of time and privacy in clinic settings. Games can be used for screening and thus mitigate these barriers. Performance in a game is influenced by cognitive processes such as working memory and inhibitory control. Deficits in these cognitive processes can increase the risk of substance use. Further, substance misuse affects these cognitive processes and may influence game performance, captured by in-game metrics such as reaction time or time for task completion. Digital biomarkers are measures generated from digital tools that explain underlying health processes and can be used to predict, identify, and monitor health outcomes. As such, in-game performance metrics may represent digital biomarkers of cognitive processes that can offer an objective method for assessing underlying risk for substance misuse. OBJECTIVE: This is a protocol for a proof-of-concept study to investigate the utility of in-game performance metrics as digital biomarkers of cognitive processes implicated in the development of substance misuse. METHODS: This study has 2 aims. In aim 1, using previously collected data from 166 adolescents aged 11-14 years, we extracted in-game performance metrics from a video game and are using machine learning methods to determine whether these metrics predict substance misuse. The extraction of in-game performance metrics was guided by literature review of in-game performance metrics and gameplay guidebooks provided by the game developers. In aim 2, using data from a new sample of 30 adolescents playing the same video game, we will test if metrics identified in aim 1 correlate with cognitive processes. Our hypothesis is that in-game performance metrics that are predictive of substance misuse in aim 1 will correlate with poor cognitive function in our second sample. RESULTS: This study was funded by National Institute on Drug Abuse through the Center for Technology and Behavioral Health Pilot Core in May 2022. To date, we have extracted 285 in-game performance metrics. We obtained institutional review board approval on October 11, 2022. Data collection for aim 2 is ongoing and projected to end in February 2024. Currently, we have enrolled 12 participants. Data analysis for aim 2 will begin once data collection is completed. The results from both aims will be reported in a subsequent publication, expected to be published in late 2024. CONCLUSIONS: Screening adolescents for substance use is not consistently done due to barriers that include the lack of time. Using games that provide an objective measure to identify adolescents at risk for substance misuse can increase screening rates, early identification, and intervention. The results will inform the utility of in-game performance metrics as digital biomarkers for identifying adolescents at high risk for substance misuse. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46990.

A Video Game Intervention to Prevent Opioid Misuse Among Older Adolescents: Development and Preimplementation Study.

BACKGROUND: Opioid misuse and mental disorders are highly comorbid conditions. The ongoing substance misuse and mental health crises among adolescents in the United States underscores the importance of widely scalable substance misuse preventive interventions that also address mental health risks. Serious video games offer an engaging, widely scalable method for delivering and implementing preventive interventions. However, there are no video game interventions that focus on preventing opioid misuse among older adolescents, and there are limited existing video game interventions that address mental health. OBJECTIVE: This study aims to develop and conduct a formative evaluation of a video game intervention to prevent opioid misuse and promote mental health among adolescents aged 16-19 years (PlaySmart). We conducted formative work in preparation for a subsequent randomized controlled trial. METHODS: We conducted development and formative evaluation of PlaySmart in 3 phases (development, playtesting, and preimplementation) through individual interviews and focus groups with multiple stakeholders (adolescents: n=103; school-based health care providers: n=51; and addiction treatment providers: n=6). PlaySmart content development was informed by the health belief model, the theory of planned behavior, and social cognitive theory. User-centered design principles informed the approach to development and play testing. The Exploration, Preparation, Implementation, and Sustainability framework informed preimplementation activities. Thematic analysis was used to identify themes from interviews and focus groups that informed PlaySmart game content and approaches to future implementation of PlaySmart. RESULTS: We developed a novel video game PlaySmart for older adolescents that addresses the risk and protective factors for opioid misuse and mental health. Nine themes emerged from the focus groups that provided information regarding game content. Playtesting revealed areas of the game that required improvement, which were modified for the final game. Preimplementation focus groups identified potential barriers and facilitators for implementing PlaySmart in school settings. CONCLUSIONS: PlaySmart offers a promising digital intervention to address the current opioid and mental health crises among adolescents in a scalable manner.

A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial.

Adolescents who engage in non-opioid substance misuse and/or experience mental health symptoms are at greater risk of misusing opioids and/or developing opioid use disorder. Adolescence is a critical developmental period to both prevent the initiation of opioid misuse and target mental health. To date, there are no digital health games targeting both conditions. We describe the protocol for a randomized controlled trial designed to assess the efficacy of an original digital health game, PlaySmart. Five hundred and thirty-two adolescents aged 16-19 years old, who are at greater risk for initiating opioid misuse are recruited from 10 Connecticut school-based health sites. Participants are randomized to PlaySmart or a set of time/attention control videogames. Randomization was stratified by sex at birth and school grade. Participants play their assigned game or games for up to six weeks (300 minutes) and complete assessment questions over a 12-month period (baseline, post-gameplay, 3, 6, and 12 months). The primary outcome is perception of risk of harm of opioid misuse at 3 months. Secondary outcome measures specific to opioid misuse include intentions, self-efficacy, attitudes, knowledge, and perceived norms. Mental health outcomes include measures of depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), help-seeking behaviors, stigma, measures of self-regulation, self-efficacy to seek professional help for mental health, and knowledge around coping skills. PlaySmart has the potential to significantly reduce the risk of initiation of opioid misuse, improve mental health outcomes, and given its high levels of engagement and accessibility, holds the promise for extensive reach, scale, and impact for adolescents. Trial registration: ClinicalTrials.gov: NCT04941950. Registered on 23 June 2021.

Evaluating the validity of game-based assessments measuring cognitive function among children and adolescents: A systematic review and meta-analysis.

Games offer advantages over traditional methods of assessing cognitive function among children and adolescents. However, the validity of game-based assessments has not been systematically evaluated. We conducted a systematic review and meta-analysis to assess the validity of game-based assessments measuring cognitive function among children and adolescents. We systematically searched several databases using pre-defined inclusion criteria. For papers that met the criteria, we extracted and analyzed the cognitive functions measured by each study, the correlation coefficients between game-based and traditional assessments, and factors that could influence the validity of game-based assessments. Our review identified 19 articles featuring 20 studies, 18 games, and 378 unique correlations between game-based and traditional assessments of cognitive function. Game-based assessments yielded significant correlations (n=282, 75%) with traditional assessments, over half of which were in the low to medium range in strength (r=0.3-0.69, n=227, 80%). Factors related to the child, such as age, gender, and prior gaming experience, may influence the validity of game-based assessments by modifying performance on game-based assessments. In addition, we found that game-based assessments that measured cognitive functions across more than one neurocognitive domain and used a prediction model for scoring were more likely to yield significant correlations. In contrast, including a narrative storyline in a game-based assessment was less likely to yield significant correlations. Most studies were of good quality, although the lack of sample size justification was a limiting factor. Further research is needed to elucidate the influence of identified factors on the validity of game-based assessment to justify the wide adoption of game-based assessments of cognitive function among children and adolescents.

Multidisciplinary Strategies for Preventing Opioid Misuse and Escalation by Targeting Mental Health Symptoms and Conditions.

We aim to review the association between childhood-onset mental health conditions and increased risk for early substance use including opioid misuse and opioid use disorders (OUD). The association between mental health conditions and opioid misuse suggests youth with mental health conditions may benefit from opioid prevention efforts that concurrently address mental health. To aid in the identification of youth with mental health conditions who could benefit from interventions, we will review opportunities and challenges associated with screening for mental health symptoms or substance use in settings where youth at high risk for mental health conditions present. We will also review how research projects within the National Institutes of Health's Helping to End Addiction Long-term (HEAL) Prevention Cooperative are addressing mental health within opioid misuse and OUD prevention interventions for youth.

Mixed methods evaluation of vaping and tobacco product use prevention interventions among youth in the Florida 4-H program.

INTRODUCTION: Novel prevention programs are developed to address the increase in e-cigarette use (vaping) among children. However, it remains paramount to test their feasibility in rural settings. This pilot study implemented and evaluated the feasibility and outcomes of two innovative programs, CATCH My Breath and smokeSCREEN, among youth in rural settings in Florida. METHODS: We conducted four focus groups with youth aged 11-17 recruited from 4-H rural clubs in Florida. In a subsequent randomized trial, we recruited 82 youth participants and assigned them to one of three arms: CATCH My Breath, smokeSCREEN, or control. CATCH My Breath and smokeSCREEN participants attended online group intervention sessions while the control group received educational material. Pre- and post-surveys were administered to all participants to assess knowledge, susceptibility, perceived positive outcomes and risk perceptions related to tobacco and e-cigarette use. Other feasibility parameters were also assessed. RESULTS: Focus group discussions provided insights about feasibility and informed the implementation of both interventions in terms of delivery format, scheduling of sessions and incentives. After the intervention, CATCH My Breath participants significantly improved their general tobacco-related knowledge (post-pre = 16.21-12.92 = 3.3, p <.01) and risk perceptions towards other flavored tobacco products (post-pre = 19.29-17.71 = 1.6, p <.05). smokeSCREEN participants significantly improved their general tobacco knowledge (post-pre = 18.77-13.77 = 5.0, p <.01), knowledge about e-cigarettes (post-pre = 9.08-6.31 = 2.8, p <.01) and risk perception towards e-cigarettes (post-pre = 24.69-21.92 = 2.8, p <.05). CONCLUSIONS: This study demonstrated feasibility of delivering the interventions via participant engagement, participants' willingness to be randomized, assessment of outcome measures, and exploration of different recruitment methods. Despite the potential positive influence of CATCH My Breath and smokeSCREEN on youth participants, further evaluation with larger samples is needed.

A Pilot Randomized Controlled Trial to Evaluate a Cognitive Behavioral Videogame Intervention: empowerED.

Objective: To design a cognitive behavioral videogame intervention and to evaluate its preliminary effect on improving youth's perceptions about themselves, their future, and their ability by incorporating skill development in cognitive reappraisal, an emotion regulation strategy to change perceptions. Materials and Methods: We conducted a pilot RCT to evaluate the preliminary efficacy of a videogame intervention, empowerED, in enhancing cognitive reappraisal skills. We also assessed beliefs/attitudes, self-efficacy, and emotional self-efficacy as well as user experience and feasibility. Youth (N = 100) aged 14-19 years from one school were enrolled in a pilot RCT assigned either to play empowerED or a control condition. Results: Improvements were noted in cognitive reappraisal in the empowerED group compared to the control group (LSM difference = 1.33, P = 0.01). There were no significant differences observed between treatment groups for beliefs/attitudes, self-efficacy, and emotional self-efficacy; however, the empowerED group reported improvements in beliefs/attitudes from pretest to posttest survey responses (M = 1.33, P = 0.01). Conclusion: Overall, the intervention was deemed easy to use and beneficial among youth, and feasibly delivered in a high school setting. Given the growing youth mental health needs in schools and the importance of school climate on healthy development, empowerED may offer an effective and innovative student-level approach to improve cognitive reappraisal and later empower youth to enact change in their school climate. Clinical Trials.gov Identifier: NCT04025294.

Methodological Strategies for Prospective Harmonization of Studies: Application to 10 Distinct Outcomes Studies of Preventive Interventions Targeting Opioid Misuse.

The Helping to End Addiction Long-Term (HEAL) Prevention Cooperative (HPC) is rapidly developing 10 distinct evidence-based interventions for implementation in a variety of settings to prevent opioid misuse and opioid use disorder. One HPC objective is to compare intervention impacts on opioid misuse initiation, escalation, severity, and disorder and identify whether any HPC interventions are more effective than others for types of individuals. It provides a rare opportunity to prospectively harmonize measures across distinct outcomes studies. This paper describes the needs, opportunities, strategies, and processes that were used to harmonize HPC data. They are illustrated with a strategy to measure opioid use that spans the spectrum of opioid use experiences (termed involvement) and is composed of common "anchor items" ranging from initiation to symptoms of opioid use disorder. The limitations and opportunities anticipated from this approach to data harmonization are reviewed. Lastly, implications for future research cooperatives and the broader HEAL data ecosystem are discussed.

Effectiveness of a web-based tobacco product use prevention videogame intervention on young adolescents' beliefs and knowledge.

BACKGROUND: Preventing tobacco product initiation in youth is a critical need. While cigarette smoking among youth has been on the decline, tobacco use in other forms, such as e-cigarettes and vaping, continue to be a major concern. The purpose of this study was to conduct a real-world, quasi-experimental test of the effectiveness of a web-based videogame, smokeSCREEN, aimed at developing healthy beliefs and knowledge associated with tobacco product use prevention, including electronic cigarettes. Methods: Adolescents (N = 560) aged 10-16 years were enrolled from schools and afterschool programs in a single-group pre-post study. Measures included a pre- and post-survey of beliefs and knowledge about tobacco product use. At post-survey, participants were asked questions regarding their gameplay experience. Paired responses for the tobacco product use in the beliefs and knowledge survey before and after the smokeSCREEN videogame intervention were compared using McNemar's test. Descriptive statistics were generated to assess overall participant gameplay experience. Results: McNemar's test showed significant differences in the proportions of correct answers before (pre-survey) and after (post-survey) the intervention in seven out of eight belief questions (p < . 0001). It also suggested significant differences in the proportions of correct answers before (pre-survey) and after (post-survey) the intervention in all six knowledge questions (p < . 0001). Several gender and age differences were noted for belief and knowledge questions related to e-cigarettes and vaping. There was no association between gameplay duration at post-survey or to the answers of the beliefs or knowledge questions. Overall, participants reported that they enjoyed playing the game. Conclusions: Findings suggest that the videogame intervention, smokeSCREEN, has a promising effect on participants' beliefs and knowledge about tobacco product use, including electronic cigarettes and vaping, and is well accepted by adolescents.

A quasi-experimental test of a virtual reality game prototype for adolescent E-Cigarette prevention.

OBJECTIVE: To test the preliminary impact and participant experience/satisfaction of Invite Only VR: A Vaping Prevention Game (Invite Only VR), an electronic cigarette (e-cigarette) prevention game prototype using virtual reality (VR) hardware. METHODS: Forty-seven adolescents (38 boys; mean age = 14.23 years, SD = 0.914) were enrolled to test the preliminary impact of Invite Only VR on knowledge, perceived likelihood of using e-cigarettes, perceptions of harm, attitudes, social norms, and self-efficacy to refuse e-cigarettes using a pre/post design. Experience/satisfaction was measured following gameplay. Paired-samples t-tests and associated effect sizes were used to assess changes in the dependent variables. Descriptive statistics were used to report on gameplay experience/satisfaction. RESULTS: From pre- to post-gameplay, players significantly increased in knowledge (t(34) = -5.594, p < .001, Cohen's d = 0.946) and perceptions of e-cigarette harm (t(34) = -3.370, p = .002, Cohen's d = 0.530) and decreased their perceived likelihood of using e-cigarettes in the future (t(35) = 2.140, p = .039, Cohen's d = 1.274). No significant change was found for attitudes towards e-cigarettes, social norm perceptions, nor refusal self-efficacy. Participants reported that they enjoyed playing the game (M = 3.00, SD = 0.99) and that they would tell their friends to play (M = 3.08, SD = 0.91). CONCLUSIONS: Invite Only VR may help players develop knowledge and correct harm perceptions regarding e-cigarettes while reducing their perceived likelihood of using them in the future. Participant enjoyment also provides an initial indication that the intervention may be acceptable for use with adolescents.

Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial.

BACKGROUND: At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and improve HIV-related outcomes in this population are lacking. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among PWH and at-risk alcohol use. METHODS: In this multi-site, randomized trial conducted between January 28, 2013 through July 14, 2017, we enrolled PWH and at-risk alcohol use [defined as alcohol consumption of ≥ 14 drinks per week or ≥ 4 drinks per occasion in men ≤ 65 years old or ≥ 7 drinks per week or ≥ 3 drinks per occasion in women or men > 65 years old]. ISAT (n = 46) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 47) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat principles. RESULTS: Despite a multi-pronged approach, we only recruited 37% of the target population (n = 93/254). Among ISAT participants, 50% advanced to Step 2, among whom 57% advanced to Step 3. Participants randomized to ISAT and TAU had no observed difference in drinks per week over the past 30 days at week 24 (primary outcome) [least square means (Ls mean) (95% CI) = 8.8 vs. 10.6; adjusted mean difference (AMD) (95% CI) = - 0.4 (- 3.9, 3.0)]. CONCLUSION: An insufficient number of patients were interested in participating in the trial. Efforts to enhance motivation of PWH with at-risk alcohol use to engage in alcohol-related research and build upon ISAT are needed. Trial registration Clinicaltrials.gov: NCT01410123, First posted August 4, 2011.

Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV.

INTRODUCTION: Infrequent use of and poor retention on evidence-based medications for alcohol use disorder (MAUD) represent a treatment gap, particularly among people living with HIV (PLWH). We examined predictors of MAUD initiation and retention across HIV status. METHODS: From Veterans Aging Cohort Study (VACS) data, we identified new alcohol use disorder (AUD) diagnoses from 1998 to 2015 among 163,339 individuals (50,826 PLWH and 112,573 uninfected, matched by age, sex, and facility). MAUD initiation was defined as a prescription fill for naltrexone, acamprosate or disulfiram within 30 days of a new diagnosis. Among those who initiated, retention was defined as filling medication for ≥80% of days over the following six months. We used multivariable logistic regression to assess patient- and facility-level predictors of AUD medication initiation across HIV status. RESULTS: Among 10,603 PLWH and 24,424 uninfected individuals with at least one AUD episode, 359 (1.0%) initiated MAUD and 49 (0.14%) were retained. The prevalence of initiation was lower among PLWH than those without HIV (adjusted odds ratio [AOR] 0.66, 95% confidence interval [CI] 0.51-0.85). Older age (for PLWH: AOR 0.78, 95% CI 0.61-0.99; for uninfected: AOR 0.70, 95% CI 0.61-0.80) and black race (for PLWH: AOR 0.63, 95% CI 0.0.49-0.1.00; for uninfected: AOR 0.63, 95% CI 0.48-0.83), were associated with decreased odds of initiation for both groups. The low frequency of retention precluded multivariable analyses for retention. CONCLUSIONS: For PLWH and uninfected individuals, targeted implementation strategies to expand MAUD are needed, particularly for specific subpopulations (e.g. black PLWH).

Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.

BACKGROUND: There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease. METHODS: In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat. RESULTS: Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU. CONCLUSION: ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.

Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial.

BACKGROUND: We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder. METHODS: In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123. FINDINGS: Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache). INTERPRETATION: ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care. FUNDING: US National Institute on Alcohol Abuse and Alcoholism.

One Night Stan: Feasibility Study of an HIV Prevention and Sexual Risk Reduction Social Card Game for Young Black Women.

OBJECTIVE: To develop and test the feasibility and preliminary impact of the social card game prototype, One Night Stan, a theory-driven and evidence-based human immunodeficiency virus (HIV) prevention intervention for young black women. MATERIALS AND METHODS: The study included the enrollment of 21 young, heterosexual black women (mean age 19) to test the feasibility and preliminary impact of the card game, using a pre/postdesign. Participant satisfaction and gameplay experience were assessed using quantitative and qualitative measures. Knowledge, self-efficacy, and intentions regarding condom use and HIV/sexually transmitted infection partner testing were assessed using standardized assessments. Effect sizes for the change in these outcome variables were calculated to determine the preliminary efficacy of the game. RESULTS: One hundred percent of participants reported that that they would play the game again, 95% liked the way the game looked, 100% enjoyed playing the game, and 100% reported that they would tell their friends to play. Effect sizes were large (ranged from 0.21 to 0.51) for all variables except perceived susceptibility (0.07) and suggest that playing the game can lead to increased self-efficacy and intentions to use condoms and insist that their partners get tested for HIV across time. CONCLUSIONS: One Night Stan is a feasible intervention approach and may be efficacious in helping players develop a pattern of cognitions and motivation that can protect them against the risk of HIV.

A videogame intervention for tobacco product use prevention in adolescents.

PURPOSE: This pilot study evaluated the short-term effects of an interactive videogame on changing adolescent knowledge, beliefs and risk perceptions, and intentions to use e-cigarettes, cigarettes, and other tobacco products. A secondary aim was to evaluate players' game experience. METHODS: Participants (N = 80 11-14 year olds) were recruited from 7 community-based afterschool programs in New Haven, Connecticut and Los Angeles, California. The design was a single group pre-post design with replication. A pre-test survey was administered that included demographic variables and knowledge, risk perceptions, beliefs, and intentions to use e-cigarettes, cigarettes, and other tobacco products. An interactive videogame focusing on risky tobacco use situations was subsequently played in four 60-min sessions over a four-week period, followed by a post-test survey. Analyses included paired t-tests of pre-post videogame change, regression analyses, and path analyses testing mediational effects of beliefs and risk perceptions on the relationship between knowledge and intentions. RESULTS: The videogame changed knowledge of e-cigarettes and other tobacco products (p's < 0.001), risk perceptions of cigarettes and e-cigarettes (p < .01 and p < .001, respectively), and beliefs about e-cigarettes and other tobacco products (p's < 0.05), but not intentions. Older adolescents reported greater e-cigarette knowledge and risk perceptions (p's < 0.05), and females reported greater risk perception of cigarettes (p < .05). Beliefs mediated the relationship between knowledge and intentions to use e-cigarettes (indirect effect p < .05). CONCLUSION: Results suggest that brief exposure (4 h over 4 weeks) to a videogame focused on changing knowledge and attitudes towards tobacco products may have a promising effect on preventing risk for early adolescent tobacco product use, particularly for e-cigarettes.

Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial.

We sought to test the efficacy of extended-release naltrexone (XR-NTX) on HIV-related and drinking outcomes. From April 2011-February 2015, we conducted a 4-site randomized double-blind placebo controlled clinical trial involving 51 HIV-positive patients with heavy drinking and < 95% antiretroviral (ART) adherence. All participants received counseling. The primary outcome was proportion with ≥ 95% ART adherence. Secondary outcomes included HIV biomarkers, VACS Index score, and past 30-day heavy drinking days. Based on receipt of ≥ 5 injections, 23 participants were retained at 24 weeks. We did not detect an effect of XR-NTX on ART adherence (p = 0.38); undetectable HIV viral load (p = 0.26); CD4 cell count (p = 0.75) or VACS Index score (p = 0.70). XR-NTX was associated with fewer heavy drinking days (p = 0.03). While XR-NTX decreases heavy drinking days, we did not detect improvements in ART adherence or HIV outcomes. Strategies to improve retention in alcohol treatment and HIV-related outcomes among heavy drinking HIV-positive patients are needed.

Development and Feasibility Testing of a Videogame Intervention to Reduce High-Risk Sexual Behavior in Black and Hispanic Adolescents.

Objective: Develop and test feasibility of a mobile videogame intervention to decrease high-risk sexual behavior in black and Hispanic adolescents. Materials and Methods: Iterative design to develop intervention in partnership with target audience. Feasibility and preliminary impact data collected at baseline, following 2-3 hours of gameplay and at 8-week follow-up. Results: Twenty-six 15-17-year-olds completed pilot testing: 16 (62%) were male, 20 (77%) black or Hispanic. Pilot testing demonstrated feasibility, including producing a usable videogame prototype, incorporating videogame testing within a high school, and participants' acceptability of the videogame. Participants' gameplay experience reflected that most would play the videogame again (77%), stated that they felt responsible for the choices they made in the videogame (73%), and would tell their friends to play the videogame (58%). Most suggested adding more videogame content to further engage participants. From baseline to follow-up, participants demonstrated improvements in condom and contraception self-efficacy (P = 0.003), risk perceptions (P = 0.009), and high-risk sexual behavior knowledge (P < 0.0001). Among black or Hispanic adolescents, we found improvements in summary measures of intentions (P = 0.04), self-efficacy (P = 0.003), risk perceptions (P = 0.002), and sexual knowledge (P = 0.0002). Adolescents with previous sexual experience showed similar improvements. Conclusion: Pilot testing of an innovative videogame, developed in partnership with the target audience, demonstrated feasibility and preliminary impact with this cohort of black or Hispanic adolescents. We developed a usable videogame prototype and gained important data about how to enhance the next videogame iteration. Future plans include targeting an older age group to maximize our ability to measure potential impact among sexually experienced adolescents.