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BackgroundDespite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use. ObjectiveThis paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences. MethodsThis RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor’s-level and master’s-level therapist electronic coaches posting relevant content and responding to participants’ posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups. ResultsWe enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT. ConclusionsThe findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking. Trial RegistrationClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586. International Registered Report Identifier (IRRID)DERR1-10.2196/16688

BackgroundGay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest among young gay, bisexual, and other men who have sex with men (YGBMSM). ObjectiveWe describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually tailored, Web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). MethodsOutsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators and demographic and health-related characteristics as potential moderators of intervention effects. ResultsThe institutional review board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT began in fall 2019. ConclusionsIf shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Trial RegistrationClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106 International Registered Report Identifier (IRRID)PRR1-10.2196/16294

BackgroundMen 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. ObjectiveThe 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. MethodsMSM 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. ResultsM3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247 International Registered Report Identifier (IRRID)DERR1-10.2196/16439

BackgroundDespite ongoing prevention efforts, HIV and other sexually transmitted infections (HIV/STIs) and drug use remain public health concerns. Urban adolescents, many of whom are underserved and racial minorities, are disproportionately affected. Recent changes in policy, including the Affordable Care Act, and advances in technology provide HIV/STI and drug abuse prevention scientists with unique opportunities to deliver mobile health (mHealth) preventive interventions in primary care. ObjectivesThe purpose of this community-engaged study was to develop an mHealth version of the Storytelling for Empowerment preventive intervention for primary care (hereinafter referred to as “S4E”). MethodsA total of 29 adolescents were recruited from a youth-centered primary care clinic in Southeast, Michigan, to participate in qualitative interviews. Participants were predominantly African American (n=19, 65.5%) and female (n=21, 72.4%) with a mean age of 16.23 (SD 2.09). The principles of community-based participatory research (CBPR), in conjunction with agile software development and the recommended core prevention principles of the National Institute on Drug Abuse (NIDA) were employed during S4E development. CBPR principles are aimed at improving the effectiveness of research by addressing locally relevant health problems, working with community strengths, and translating basic science into applied research. Complementing this approach, the NIDA prevention principles are derived from decades of drug abuse prevention research aimed at increasing the effectiveness and uptake of programs, through the development of culturally specific interventions and ensuring the structure, content, and delivery of the intervention fit the needs of the community. Data were analyzed using thematic analysis. ResultsA total of 5 themes emerged from the data: (1) acceptability of the mHealth app to adolescents in primary care, (2) inclusion of a risk assessment to improve clinician-adolescent HIV/STI and drug use communication, (3) incorporation of culturally specific HIV/STI and drug use content, (4) incorporation of interactive aspects in the app to engage youth, and (5) perspectives on the appearance of the app. ConclusionsThere is a dearth of mHealth HIV/STI and drug abuse preventive interventions for primary care. Incorporating the principles of CBPR in conjunction with agile software development and NIDA-recommended core prevention principles may be helpful in developing culturally specific mHealth interventions. An important next step in this program of research is to examine the feasibility, acceptability, and efficacy of S4E on adolescent sexual risk and drug use behaviors, and HIV/STI testing. Implications for prevention research and primary care practice are discussed in the context of the Affordable Care Act and technological advances.

BackgroundWe lack a systematic portrait of the relationship between community involvement and how people interact with information. Young men who have sex with men (YMSM) are a population for which these relationships are especially salient: their gay community involvement varies and their information technology use is high. YMSM under age 24 are also one of the US populations with the highest risk of HIV/AIDS. ObjectiveTo develop, test, and refine a model of gay community involvement (GCI) factors in human-information interaction (HII) as applied to HIV/AIDS information among YMSM, specifically examining the role of Internet use in GCI and HII. MethodsMixed methods included: 1) online questionnaire with 194 YMSM; and 2) qualitative interviews with 19 YMSM with high GCI levels. Recruitment utilized social media, dating websites, health clinics, bars/clubs, and public postings. The survey included questions regarding HIV/AIDS–related information acquisition and use patterns, gay community involvement, risk behaviors, and technology use. For survey data, we tested multiple linear regression models using a series of community- and information-related variables as dependent variables. Independent variables included community- and information-related variables and demographic covariates. We then conducted a recursive path analysis in order to estimate a final model, which we refined through a grounded theory analysis of qualitative interview data. ResultsFour community-related variables significantly predicted how people interact with information (HII variables): 1) gay community involvement (GCI), 2) social costs of information seeking, 3) network expertise accessibility, and 4) community relevance. GCI was associated with significantly lower perceived social costs of HIV/AIDS information seeking (R2=0.07). GCI and social costs significantly predicted network expertise accessibility (R2=0.14). GCI predicted 14% of the variance in community relevance and 9% of the variance in information seeking frequency. Incidental HIV/AIDS information acquisition (IIA) was also significantly predicted by GCI (R2=0.16). 28% of the variance in HIV/AIDS information use was explained by community relevance, network expertise access, and both IIA and information seeking. The final path model showed good fit: the RSMEA was 0.054 (90% CI: .000-.101); the Chi-square was non-significant (χ2(11)=17.105; P=.105); and the CFI was 0.967. Qualitative findings suggest that the model may be enhanced by including information sharing: organizing events, disseminating messages, encouraging safety, and referring and recommending. Information sharing emerged under conditions of pro-social community value enactment and may have consequences for further HII. YMSM with greater GCI generally used the Internet more, although they chatted online less. ConclusionsHIV/AIDS–related HII and associated technology uses are community-embedded processes. The model provides theoretical mediators that may serve as a focus for intervention: 1) valuing HIV/AIDS information, through believing it is relevant to one’s group, and 2) supportive and knowledgeable network members with whom to talk about HIV/AIDS. Pro-social community value endorsement and information sharing may also be important theoretical mediators. Our model could open possibilities for considering how informatics interventions can also be designed as community-level interventions and vice versa.

Background: Mobile health platforms can facilitate social support and address HIV (human immunodeficiency virus) stigma but pose challenges for intervention design and participant engagement. Giddens's structuration theory, that individuals are shaped by--and shape--their communities through rules and resources that give them power to operate within these environments, provides a useful analytic framework for exploring these dynamic intervention spaces. Method: Data were drawn from an online randomized controlled trial intervention (HealthMpowerment) for young Black men who have sex with men to reduce condomless anal intercourse. We applied a conversational analysis informed by structuration theory to 65 user-generated conversations that included stigma content. We aimed to understand how the interdependent relationship between the intervention space and participants' contributions might contribute to behavior change. Results: Thirty five intervention participants contributed to the analyzed conversations. Our analysis identified three types of conversational processes that may underlie behavior change: (1) Through intervention engagement, participants established norms and expectations that shaped their discussions; (2) participants used anecdotes and anonymity to reinforce norms; and (3) intervention staff members sought to improve engagement and build knowledge by initiating discussions and correcting misinformation, thus playing an integral role in the online community. Conclusions: The lens of structuration theory usefully reveals potential behavior change mechanisms within the social interactions of an online intervention. Future design of these interventions to address HIV stigma should explicitly characterize the context in which individuals (study staff and participants) engage with one another in order to assess whether these processes are associated with improved intervention outcomes.

BackgroundDrug abuse and sexually transmitted infections (STIs), including the human immunodeficiency virus (HIV), remain significant public health concerns in the United States. Youth are at disproportionate risk of drug use and STIs/HIV, yet interventions aimed at improving STI and HIV testing and reducing STI/HIV risk behaviors through technology-based engagement in clinic settings are limited. The purpose of this study was to examine the feasibility and acceptability of Storytelling 4 Empowerment (S4E), a multilevel mobile-health drug abuse and STI/HIV preventive application (app) for clinic settings. We also explored uptake of STI/HIV testing among youth immediately post-intervention.MethodEmploying community-based participatory research principles and a multi-method research design, we developed a clinician-facing app, and examined the feasibility and acceptability of S4E among clinicians (n = 6) and youth (n = 20) in an urban youth-centered community health clinic. S4E aimed to improve clinician-youth risk communication and youths' drug use and STI/HIV knowledge, self-efficacy, and refusal skills. We also explored youths' uptake of STI and HIV testing. Quantitative data were analyzed by computing mean scores and proportions, and qualitative analyses followed the tenets of content analysis.ResultsAmong eligible participants, 86.9% of youth and 85.7% of clinicians enrolled in the study, suggesting the feasibility of recruiting participants from the targeted clinic. Most clinicians identified as non-Hispanic white (83%) and female (66.7%). Among the youth, 70% identified as non-Hispanic white, followed by 30% African American, and 50% identified as female with a mean age of 19.6 (SD = 1.5, Range = 16-21). The quantitative findings suggest that the acceptability of S4E is high, as indicated by the Client Satisfaction Questionnaire (mean score = 25.2, SD: 4.8). Immediately post-intervention, all youth who reported past 90-day condomless sex or having never been tested for STIs or HIV in their lifetime, were tested for both STIs and HIV. Qualitative themes revealed four overarching themes, including S4E: (1) faciliated timely, targeted, and tailored prevention and risk reduction strategies; (2) shaped clinician and youth communication and interaction during the clinic visit; (3) may have improved uptake of STI/HIV testing and increased STI/HIV knowledge and self-efficacy; and (4) had high feasibiliy and acceptability among youth and clninicans.ConclusionsFindings suggest the feasibility and acceptability of S4E in an urban community-based health clinic setting. A next important step is to examine the efficacy of S4E in a randomized controlled trial design.

Long-acting injectable cabotegravir (CAB-LA) was US Food and Drug Administration--approved in 2021. However, little is known about providers' CAB-LA knowledge, attitudes, challenges, and prescribing preferences for transgender women patients. Understanding this is critical to developing new pre-exposure prophylaxis (PrEP) interventions tailored to transgender women. We conducted 45-min, in-depth Zoom interviews (IDIs) with United States--based health care providers who prescribe PrEP to transgender women. IDIs focused on providers' CAB-LA knowledge/acceptability, willingness to prescribe CAB-LA to transgender women, potential challenges, and solutions to mitigate challenges. Providers (N517) had a mean age of 43 years, and 35.4% (n56) identified as people of color. Most (n = 12) had basic knowledge of CAB-LA but wanted additional training. All participants found CAB-LA acceptable and were willing to prescribe. Most (n = 11) anticipated minimal challenges to implementation. Others (n = 4) reported potential issues, including logistical/scheduling concerns that impede CAB-LA integration and staffing concerns. Many providers expressed support for self-injection (n = 13) and injections at "drop-in" clinics (n = 8) to overcome challenges. [ABSTRACT FROM AUTHOR]

ObjectiveTo assess the acceptability and feasibility of S2S, a newly adapted behavior intervention to address high-risk sexual behavior.DesignPilot randomized controlled trial.SettingThe Internet and text messages with no in-person interactions.ParticipantsEighty-eight Black women, ages 18 to 24 years, were randomly assigned to the intervention or control groups and self-enrolled in the respective text message program.MethodsParticipants in the intervention group were sent text messages about sexual health, whereas those in the control group were sent text messages about diet and/or exercise. Participants in each group received 24 text messages, including text-only messages, memes, and infopics. Participants in the intervention group also received videos links. All text messages were sent three times per week for 8 weeks. Quantitative methods were used to analyze data from the message and video platform reports. Quantitative and qualitative methods were used to analyze participants' responses to an acceptability and feasibility survey.ResultsOverall, the delivery of health promotion text messages was viewed as acceptable and feasible by participants in both groups. Most of the short answer responses from participants were favorable, and responses to the acceptability and feasibility survey yielded a total mean score of 4.01 on a 5-point scale.ConclusionResults from this study support the idea that evidence-based interventions can be adapted for delivery by text message. This delivery modality is acceptable to young adult Black women and may help decrease barriers that would otherwise prevent them from receiving health promotion messages.

Clinical trials often depend on participants receiving study product to meet objectives of the protocol. Vitally important are considerations for how sites receive and dispense study product during a study while ensuring appropriate handling, accountability and compliance. The process for provision of study product is detailed in Standard Operating Procedures (SOPs) which are adhered to by the research site throughout the trial. The COVID-19 pandemic unexpectedly affected the ability of study participants to receive study product. We report on the various methods implemented by trial sites to ensure timely provision of study product to participants during this unprecedented pandemic. In MTN-035, participants received 3 potential rectal microbicide formulations in randomized sequences to understand user preferences. Trial sites were permitted to revise dispensing methods to enable participants to continue to receive study product during COVID-19 restrictions. These actions mitigated disruption of study product administration and preserved the integrity of the trial. Out of the 78 participants expecting to receive study products on or after the onset of restrictions due to COVID-19, only four participants (5%) did not receive all three products. Adopting alternative methods to provide product to study participants in extraordinary circumstances was key to successful study completion and maintaining study integrity.

Youth bear a significant proportion of the sexually transmitted infection (STI)/HIV burden in the United States, CDC, 2010. Available at: http://www.cdc.gov/std/stats09/default.htm, with rates of some STIs increasing among youth of color and young men who have sex with men. Technology use among youth also continues to increase. The ubiquitous nature of technology use among youth offers a multitude of opportunities to promote youth sexual health and to prevent disease transmission and unplanned pregnancies. To date, there have been a handful of peer-reviewed articles published regarding the feasibility, acceptability, and effectiveness of using new media and technology for sexual health promotion. Despite recent publications, there is still a real need for high-quality research to understand the impact of different forms of new media use on youth sexual health, as well as to determine the best ways to harness technology to promote safer sex behaviors, both for the short- and long-term. In March 2011, Internet Sexuality Information Services (ISIS), National Institute of Mental Health (NIMH), and the Ford Foundation convened a meeting of scientists and technology experts to discuss how to effectively conduct sexual health promotion research using new forms of technology. The meeting was structured to cover the following topic areas: (i) research-community partnerships, (ii) institutional review board and ethical issues, (iii) theoretical frameworks, (iv) intervention approaches, (v) recruitment methods, and (vi) assessing impact. Presentations included case studies of successful technology-based HIV/STI prevention interventions for youth, which led to broader discussions on how to conduct research in this area. This article summarizes the meeting proceedings, highlights key points, offers recommendations, and outlines future directions.

Rates of HIV/STI transmission among Black men who have sex with men (BMSM) are alarmingly high and demand urgent public health attention. Stigma related concerns are a key barrier to accessing health care and prevention tools, yet limited research has been focused in this area. Experiences of stigma related to health care were evaluated among 151 BMSM residing in the Atlanta, GA area, both prior to and post HIV or STI diagnosis in a longitudinal study (data collected from 2014 to 2016). Findings demonstrated that inadequate health care engagement is associated with post-diagnosis anticipated stigma (b = - 0.38, SE = 0.17 p [less than or equal to] .05). Pre-diagnosis prejudice is a predictor of post-diagnosis enacted (b = 0.39, SE = 0.14, p < .01), anticipated (b = .28, SE = 0.14, p < .05), and internalized (b = .22, SE = 0.06, p < .001) stigmas. This study is the first of its kind to assess experiences of stigma among BMSM during a critical time (i.e., before and after diagnosis) for HIV/STI prevention and treatment. Results provide a novel understanding of how stigma unfolds over-time and provide direction for stigma intervention development., Author(s): Lisa A. Eaton [sup.1] , Valerie A. Earnshaw [sup.2] , Jessica L. Maksut [sup.1] , Katherine R. Thorson [sup.3] , Ryan J. Watson [sup.1] , Jose A. Bauermeister [sup.4] [...]

This study examined the latent structure and validity of inattention, hyperactivity-impulsivity, and sluggish cognitive tempo (SCT) symptomatology. We evaluated mother and teacher ratings of ADHD and SCT symptoms in 140 Puerto Rican children (55.7% males), ages 6 to 11 years, via factor and regression analyses. A three-factor model (inattention, hyperactivity-impulsivity, and SCT) provided the best fit for both sets of ratings. Inattention was the strongest correlate of lower scores on neuropsychological, achievement, and psychosocial measures. Externalizing problems were most strongly associated with hyperactivity-impulsivity, and internalizing problems were most strongly associated with parent-rated SCT and teacher-rated Inattention. SCT was not associated with executive function but was negatively associated with math. Inattention accounted for a disproportionate amount of ADHD-related impairment, which may explain the restricted discriminant validity of DSM-IV types. The distinct factors of hyperactivity-impulsivity and SCT had unique associations with impairing comorbidities and are roughly equivalent in predicting external correlates of ADHD-related impairment.

Objective: This study examined the impact of inattention, hyperactivity, and oppositional defiant disorder (ODD) behaviors and gender on family life. Method: We created scales for the Family Experiences Inventory (FEI) in a nonclinical sample of Spaniard families with children ages 6 to 12 years (N = 369) and analyzed the perceived impact of these three behavior dimensions on family experiences. Results: Multiple regression analyses indicated that ODD behaviors were uniquely correlated with Total FEI and its dimensions. Inattention was also uniquely related to higher negative Impact on School Relations and lower Positive Impact on Parents scales. Finally, gender-hyperactivity interactions indicated that boys with higher hyperactivity scores were more likely to score higher on the FEI Total, School Relations, and Siblings scales, and more likely to score lower on the Positive Impact on Parents scale than girls. Conclusions: These findings suggested that parents perceive greater child-related impact and place greater burden from having a male child with hyperactivity. Inattention, hyperactivity, and oppositional defiant behaviors are associated with global parent-child interactive stress but the pattern of associations will vary depending upon the behavior, child gender, and context of family life examined. (Contains 3 tables.)