Jeffrey T. Parsons - US grants

APPLICANT'S ABSTRACT: We propose an integrated behavioral intervention aimed at both the promotion of alcohol abstinence and the consistent use of safer sexual behaviors. This intervention will be evaluated with HIV seropositive (HIV+) men who have sex with men (MSM) who are alcohol abusers or alcohol dependent. The overall goal for the proposed study is to reduce the sexual transmission of HIV. The objectives are (1) to recruit and enroll a tri-ethnic (African-American, Latino and White) sample of 300 alcohol abusing/dependent HIV+ MSM in the New York City metropolitan area; (2) to test the efficacy and effectiveness of a theoretically-based alcohol-related HIV risk reduction intervention for eligible participants; (3) to promote two target behaviors (alcohol abstinence and safer sexual behaviors) among treatment group participants; (4) to prevent relapse and temptation to relapse from alcohol abstinence and safer sex behaviors among those participants currently in the maintenance stages for these behaviors; and (5) to impact decisional balance and improve self-efficacy for the target behaviors and to foster peer support for the target behaviors. The proposed intervention will utilize the Transtheoretical Model (TM). The TM recognizes that behavior change is not a dichotomous phenomenon, but instead proceeds through a series of stages of change (SOC). The intervention will consist of 10 weekly sessions designed to promote the two target behaviors. The first two individual counseling sessions will utilize Motivational Enhancement Therapy (MET) and focus on alcohol use. The next six sessions will utilize the TM and HIV risk reduction activities based on processes of change (POC) in a group therapy setting to promote safer sexual behaviors. Participants will then complete two additional individual MET sessions to focus on reinforcement for progression along the SOC and relapse prevention for the two target behaviors. Participants will be recruited through active and passive recruitment strategies from mainstream gay venues, alcohol treatment programs, and AIDS service organizations. Participants will be randomly assigned to the treatment or control conditions. Participants will complete assessment batteries at intake, and at 1-week, 3, 6, 9, and 12 month follow-ups in order to assess short-term and long-term effects.

DESCRIPTION (provided by applicant): We propose a theory-based intervention designed to improve HIV medication adherence and reduce alcohol use among an ethnically diverse sample of male and female HIV seropositive (HIV+) persons with alcohol-related problems. The intervention will be evaluated within existing HIV clinic settings in New York City. Eligible participants will be HIV+, have detectable viral loads at baseline, be on an HIV medication regimen, and demonstrate alcohol-related problems (e.g., dependence, abuse, problem drinking). The overall goal for the proposed study is to test an intervention with medically meaningful and behaviorally desirable outcomes, so that the intervention can be easily disseminated and integrated into other HIV clinics providing comprehensive care for HIV+ persons with alcohol problems. In addition, we will examine the mediating and moderating influences on intervention success. The proposed intervention utilizes Motivational Interviewing and Cognitive-Behavioral Skills Training and is delivered by a combination of a counselor and medical care provider and builds upon the previous work of the investigators who have conducted formative research on the adherence issues among HIV+ persons. Using the Information-Motivation-Behavioral Skills (IMB) model, the intervention is designed to impact knowledge and understanding of HIV medication regimens, motivation to adhere, and skills related to adherence. Further, the intervention aims to promote knowledge and understanding of the dangers of alcohol use for HIV+ persons, motivation to reduce drinking, and skills related to changing alcohol use behaviors. The intervention consists of eight sessions and will be compared to an attention control condition. Eligible participants will be referred by their clinic providers and will be randomized to one of two conditions: (1) treatment - the eight session theory-based intervention; or (2) comparison - eight sessions of standard care education. Participants will complete assessments t baseline, and at 3-, 6-, 9-, 12-, and 15-month follow-ups in order to assess short-term and long-term effects. We propose to use biological markers (viral load, CD4 count, and CDT testing for alcohol use) as primary outcome measures, supplemented with self-reported adherence, prescription refill data (via pharmacy records), adherence to medical appointments (via chart review), and self-reported alcohol use and alcohol related problems. Multivariate repeated measures analyses and growth curve modeling, using both continuous and dichotomous outcome variables, will be used to assess the impact of the intervention on both adherence and alcohol use.

DESCRIPTION (provided by applicant): We propose a theory-based intervention designed to improve HIV medication adherence and reduce alcohol use among an ethnically diverse sample of male and female HIV seropositive (HIV+) persons with alcohol-related problems. The intervention will be evaluated within existing HIV clinic settings in New York City. Eligible participants will be HIV+, have detectable viral loads at baseline, be on an HIV medication regimen, and demonstrate alcohol-related problems (e.g., dependence, abuse, problem drinking). The overall goal for the proposed study is to test an intervention with medically meaningful and behaviorally desirable outcomes, so that the intervention can be easily disseminated and integrated into other HIV clinics providing comprehensive care for HIV+ persons with alcohol problems. In addition, we will examine the mediating and moderating influences on intervention success. The proposed intervention utilizes Motivational Interviewing and Cognitive-Behavioral Skills Training and is delivered by a combination of a counselor and medical care provider and builds upon the previous work of the investigators who have conducted formative research on the adherence issues among HIV+ persons. Using the Information-Motivation-Behavioral Skills (IMB) model, the intervention is designed to impact knowledge and understanding of HIV medication regimens, motivation to adhere, and skills related to adherence. Further, the intervention aims to promote knowledge and understanding of the dangers of alcohol use for HIV+ persons, motivation to reduce drinking, and skills related to changing alcohol use behaviors. The intervention consists of eight sessions and will be compared to an attention control condition. Eligible participants will be referred by their clinic providers and will be randomized to one of two conditions: (1) treatment - the eight session theory-based intervention; or (2) comparison - eight sessions of standard care education. Participants will complete assessments t baseline, and at 3-, 6-, 9-, 12-, and 15-month follow-ups in order to assess short-term and long-term effects. We propose to use biological markers (viral load, CD4 count, and CDT testing for alcohol use) as primary outcome measures, supplemented with self-reported adherence, prescription refill data (via pharmacy records), adherence to medical appointments (via chart review), and self-reported alcohol use and alcohol related problems. Multivariate repeated measures analyses and growth curve modeling, using both continuous and dichotomous outcome variables, will be used to assess the impact of the intervention on both adherence and alcohol use.

DESCRIPTION (provided by applicant): The proposed investigation seeks to examine the use of "club drugs" among male and female young adults (ages 18-25) in New York City (NYC). We will undertake a longitudinal, prospective study, using qualitative and quantitative methods, guided by the following three aims: (1) To determine patterns of use, individual differences in use, and changes in club drug use among heterosexual and gay/bisexual male and female young adults (ages 18-25) in NYC over the course of one year; (2) To determine the extent to which antecedent person factors, social context factors, and constructs associated with the Theory of Reasoned Action (TRA) explain differences in year-long club drug use trajectories of young adults in NYC; and (3) To better understand how patterns of club drug use impact sexual risk taking behaviors among young adults in NYC. Our work will be guided by the TRA in order to determine how antecedents of club drug use influence the use of these substances, and how the interaction of these antecedents with actual use of club drugs leads to sexual risk taking behaviors. Our work will focus on six club drugs that our pilot work has shown to be used among young adults in NYC who frequent dance clubs: Cocaine, LSD, GFB, Ketamine, MDMA, and Methamphetamine. We will recruit 480 ethnically-diverse young adults into our study (stratified by gender and sexual orientation) using probability-based targeted sampling and conduct assessments of the antecedents, club drug use, and sexual risk-taking behaviors four times over the course of one year. Data analyses will utilize univariate and multivariate growth curve modeling to determine the relationships between these factors as a means of understanding patterns of club drug use and of evaluating the use of the TRA to explain club drug use. Quantitative assessments (administered via Audio-CASI) will be complemented by our use of qualitative techniques to provide us with episode-specific data to help realize the relationships that we are assessing as well as to further understand contextual aspects of club drug use (e.g., use of drugs in and out of dance club venues, reasons for using certain drugs, reasons for mixing multiple drugs, social context of club drug use, use of club drugs in conjunction with sexual behaviors). Mixed-methods strategies will be used to examine the qualitative and quantitative data together in order to further understand the data and potential implications for intervention development.

DESCRIPTION (provided by applicant): The use of club drugs, including cocaine, MDMA (ecstasy), methamphetamine, ketamine, and GHB, has increased dramatically among emerging adult males (ages 18-24), and particularly young men who have sex with men, in the past few years. These drugs pose a threat to the health and well-being of these highly vulnerable youth. The dangers associated with club drug use stem from the physical and psychological risks that are associated with use, as well as the risk of HIV infection through unsafe sexual behavior while under the influence. Research shows that these young men are reporting more sexual risk behavior than in previous years and there is significant concern that HIV infection rates may once again be on the rise. Currently there are no evidence-based interventions available that address club drug use and HIV sexual risk behaviors simultaneously among young men who have sex with men. We propose a brief intervention, based on the principles of Motivational Interviewing and using an adaptation of Motivational Enhancement Therapy, designed to reduce unsafe sexual practices and club drug use among non-treatment seeking emerging adult males who report engaging in both risk behaviors. The objectives of the project are to: (1) recruit and enroll an ethnically diverse sample of 300 young men (ages 18-24);(2) test the efficacy of a brief risk reduction intervention compared to an attention educational control intervention;(3) test whether baseline quantity/frequency of club drug use and unprotected sex, psychiatric severity, motivation, and self- efficacy are significant predictors of change over time, and (4) examine mediators that are hypothesized to be fundamental to motivational interviewing-based interventions. Participants will be randomized into either the proposed intervention or an attention control condition following the completion of an intake assessment. Follow-up assessments will occur at 3, 6, 9, and 12-months in order to assess short-term and longer-term effects. This research could help to reduce club drug use and unprotected sex among emerging adult males. If effective, the intervention will help minimize the negative physical and psychological effects associated with club drug use, and reduce HIV infections among emerging adult males.

DESCRIPTION (provided by applicant): The purpose of this proposal is to evaluate an intervention that can be readily disseminated and integrated into existing HIV clinics and other community-based organizations (CBOs) offering programs addressing the needs of HIV+ persons with methamphetamine problems. Broadly, this intervention aims to improve the health and quality of life of HIV+ methamphetamine-using men by developing a brief intervention designed to increase HIV medication adherence, decrease methamphetamine use, and positively impact other health related behaviors (sexual risk-taking, other drug use, etc.). Specifically, the proposed randomized clinical trial aims to test the efficacy of a brief, 8-session therapy condition against 8 sessions of education. Additionally, this intervention will test the applicability of Fisher &Fisher's (1992) Information-Motivation-Behavioral Skills (IMB) model to understand changes in adherence and substance use behaviors among HIV+ methamphetamine users. The proposed intervention will target HIV+ methamphetamine-using men in New York City who report less than 90% adherence to their HIV medication regimens. The treatment condition will receive 8 sessions of individually tailored motivational interviewing and cognitive behavioral skills training, while the education (comparison) condition will receive 8 sessions of education surrounding HIV medication adherence, methamphetamine use, and other health-related behaviors (sexual risk-taking, other drug use, etc.). Utilizing several measures of adherence (biological markers, objective, and self-report measures) and methamphetamine use (self-report and biological), this study will test the efficacy of the intervention at 3, 6, 9, and 12 months post-intervention to determine both any immediate and long-lasting effects of the intervention. Additionally, we will consider the mediating role of information, motivation, and behavioral skills to determine the most effective components of this theoretically-based intervention. The findings of this study could help to reduce methamphetamine use and increase HIV medication adherence among HIV+ men. Specifically if effective, the intervention will help minimize the negative physical and psychological effects associated with methamphetamine and improve HIV medication adherence, which has potential effects for survival and health as well as HIV transmission and HIV drug resistance.

DESCRIPTION (provided by applicant): Hunter College is a long existing urban university with a history of educating populations whose access to higher education has been historically limited. For decades, over 60% of Hunter College undergraduates have been underserved students and currently about 75% of our students are women. Throughout the years, we have demonstrated a strong commitment to educate our unique population of students, with a full range of academic programs, from undergraduate classes to doctoral dissertation research through the CUNY's Graduate Center. Moreover, the Department of Psychology has a core of researchers focused on drugs of abuse. NIDA recognized our didactic and scientific potential and awarded a MIDARP grant to Hunter in 1999. The goals of that grant were to develop the careers of junior faculty already involved in drug abuse research, engage a senior faculty member for the first time in drug abuse research, involve undergraduate and graduate students in drug abuse research, and improve the research infrastructure at the College. All goals were met and exceeded. The two junior faculty, both minority scholars, have developed their research programs and are becoming recognized as experts in their fields;our senior Distinguished Professor is now deeply involved in drug abuse research and has served as a consultant to NIDA. Undergraduate and graduate students have moved into top-notch Ph.D. programs and to postdoctoral fellowships in distinguished laboratories. We have improved facilities, obtained major equipment grants, and are in the process of expanding and updating our animal facility. This renewal application proposes to move the MIDARP program to the next stage: obtain independent NIH funding for our MIDARP faculty, include new faculty whose areas of interest include biobehavioral and psychosocial research allowing us to expand our success with student mentoring to include new cadres of students, and continue our efforts to improve research infrastructure and publicize drug abuse research. We do so with a highly experienced, well-funded, and successful Program Director who has substantial mentoring experience and is committed fully to the goals of MIDARP, and with well thought out plans for achieving these goals. We propose mechanisms for preparing NIH R01 applications, evaluating new projects from junior faculty, recruiting new students, including University Scholars who are undergraduates enrolled in the new CUNY Honors program, preparing those students to be highly competitive for the best Ph.D. programs in the Country, and continuing to obtain funding to improve our infrastructure.

Description (provided by the applicant): African Americans are disproportionately affected by HIV/AIDS, and this disparity is further evident among bisexually-active African American men (BAAM).Yet, there is insufficient knowledge regarding sexual risk behaviors of BAAM and the context in which they occur. To date, no interventions in the literature with demonstrated efficacy in reducing HIV-related sexual risk behaviors have been developed and evaluated for BAAM who do not inject drugs. The proposed study will develop and test the efficacy and acceptability of an innovative individually-tailored and culturally-sensitive 6-session online-delivered video intervention that simultaneously targets multiple domains of socio-cultural, structural-level factors, and contextual factors related to HIV risk behavior among BAAM, relative to an attention control (education) condition. This intervention is theoretically informed both in content (using the Information-Motivation-Behavior Skills model) and delivery (using tenets of Social Cognitive theory) and will feature peer BAAM. Both behavioral and biologic outcomes will be measured. Using respondent-driven sampling, a total of 120 BAAM will be enrolled and randomly assigned to either treatment or education-control conditions. They will be longitudinally tracked for six months (assessed at Baseline, month 3, and month 6). In addition to determining the prevalence of lifetime and recent HIV-associated risk behavior among BAAM, this study seeks to evaluate the impact of a brief intervention across three domains over time: (1) intentions/motivations to reduce HIV-associated risk behavior, (2) self-reported HIV-associated risk behavior, and (3) health/prevention knowledge and self-efficacy skills. The long term goal of the proposed project is to develop an empirically validated HIV/STI prevention program that can be delivered online BAAM. Consistent with the R34 mechanism, the final product will be the basis for an R01 application to conduct a large-scale efficacy study in this population. Should this intervention demonstrate effective, it will be a cost feasible approach to preventing HIV transmissions among BAAM, delivered via the medium where many men who have sex with men (including BAAM) actively meet sex partners (i.e., the Internet). Finally, the model for this intervention can easily be adopted by HIV service providers and delivered outside of traditional clinical setting with a variety of populations.

DESCRIPTION (provided by applicant): Sexual Compulsivity (SC) is characterized by sexual fantasies and behaviors that increase in frequency and intensity so as to interfere with personal, interpersonal, or vocational pursuits. Researchers have consistently identified strong links between SC and risky sexual behavior in a variety of populations, but particularly among men who have sex with men (MSM). Sexual behavior is not the only defining feature of SC;sexually compulsive men report a series of psychological symptoms (drug and alcohol abuse, mental health and affective comorbid disorders) associated with their sexual behavior. Research suggests that these psychological factors may exacerbate HIV risk for SC MSM. However, past research on SC MSM has not distinguished between the role of behavioral versus psychological factors in HIV risk among SC MSM. Most studies compare SC MSM with other MSM without controlling for general rates of sexual behavior. Our research suggests that there are significant numbers of MSM who are behaviorally similar to SC MSM (i.e. they have equivalent numbers of sexual partners and engage in sexual behaviors with equivalent frequency), but are psychologically very different from SC MSM (i.e. they do not report distress about their sexual behavior, loss of control, that their sexual behavior interferes with their personal and professional lives, or that they engage in sexual activity under the influence of drugs and alcohol as frequently). These men - highly sexually active, but non-SC MSM - will provide a critical window into the mechanisms by which SC is associated with greater HIV risk and sex under the influence of drugs and alcohol. Identifying factors that distinguish highly sexually active SC-MSM from highly sexually active non-SC MSM will allow us to identify psychological factors that make SC men more vulnerable to high-risk sexual behavior and inform the development of HIV prevention interventions for both populations Addressing these limitations and consistent with PA-07-409 "Health Research with Diverse Populations," this study will compare two samples of highly sexually active MSM, one cohort which exhibits SC symptoms and one which does not. By comparing highly sexually active SC and non-SC MSM, we can better understand both the connections between SC and HIV transmission, and the psychological, environmental, substance use, and contextual factors that make certain men vulnerable to SC and its negative consequences. We will use respondent-driven sampling to recruit 400 (n=200 SC, n=200 non-SC) highly sexually active MSM (>9 partners, <90 days) Participants will be followed longitudinally for 13 months and take part in a variety of assessments, capturing both antecedent conditions (neurocognitive deficits, and experienced stigma and abuse) and event-level triggers (drug and alcohol use, and affect). This study will determine the role of these factors in mediating and moderating the relationship between SC and HIV risk behavior. Our longitudinal approach will allow tracking of trajectories across groups and analysis of behaviors within individuals. Ultimately, this study will serve as the foundation for formative intervention development to reduce HIV associated risks among highly-sexually-active MSM. PUBLIC HEALTH RELEVANCE: The findings of this study will facilitate a more nuanced understanding of the association between sexual compulsivity (SC) and HIV-associated risk behaviors among men who have sex with men (MSM). Ultimately, this study will serve as the foundation to inform intervention development to reduce HIV associated risks among highly-sexually-active MSM, SC and non-SC alike.

DESCRIPTION (provided by applicant): The proposed investigation seeks to examine the relationship between alcohol consumption patterns and sexuality among male and female emerging adults (ages 18-29) in New York City (NYC). We will undertake a longitudinal, prospective, mixed methods study, guided by the following three aims: (1) Test a new theoretical model, Conflict-Motivation Theory (CMT), which focuses on the role of sexual conflict in predicting risk-taking among emerging adults in the context of alcohol use. (2) Examine the role of developmental and individual (e.g. neurocognitive maturation, decision-making ability), social (e.g. social norms, attitudes, personal beliefs and values), and contextual (e.g. partner characteristics, alcohol dose, and setting) factors in shaping both sexual conflict and the associations among conflict, alcohol consumption, and risk-taking outlined in CMT. (3) Examine and identify the specific roles of gender (including gender roles, and sexual double standards), sexual orientation (including sexual identity and internalized homophobia), and race/ethnicity in shaping both sexual conflict and the associations among conflict, alcohol consumption, and risk-taking outlined in CMT. To achieve these aims, we will recruit and enroll 400 emerging adults into our study (stratified by gender, sexual orientation, and race/ethnicity) using Respondent Driven Sampling and conduct assessments of conflict, alcohol consumption patterns, and sexual risk-taking behaviors three times over the course of two years. Data analyses will utilize structural equation modeling, path analyses, and univariate and multivariate growth curve modeling to determine the relationships between these factors as a means of understanding the relationship between alcohol and sexuality and of evaluating the use of CMT to explain this relationship. Quantitative assessments (administered via Audio-CASI) will be complemented by our use of qualitative techniques to provide us with episode-specific data to help realize the relationships that we are assessing as well as to further understand contextual aspects of the relationship (e.g., reasons for combining alcohol and sexual activity, social contexts of drinking and sexual activity, etc.). Mixed-methods strategies will be used to examine the qualitative and quantitative data together in order to further test the proposed theoretical framework (CMT) and to better understand and explicate potential implications for intervention development.

DESCRIPTION (provided by applicant): The number of HIV+ adults over age 50 is increasing steadily, and the CDC has estimated that by 2015 almost half of those living with HIV/AIDS will be age 50 or older. In spite of these rising rates, there are no published interventions targeting alcohol and/or substance use or medication adherence among older adults with HIV. This proposal is designed to test an adaptation of a proven intervention for HIV+ adults and tailor it to meet the unique needs of HIV+ older adults with alcohol and/or drug dependence. Specifically, this project will conduct an RCT to evaluate the efficacy of a 12-session intervention, Spiritual Self-Schema Therapy (3S+), compared to a 12-session education-based attentional control condition (ED), in improving HIV health outcomes, and reducing alcohol/drug use among alcohol and/or substance dependent HIV+ older adults. This project would be the first to extend a proven intervention tailored to meet the unique needs of this critical population. The proposed treatment, 3S+ therapy, is a fully manuallized and proven effective intervention which combines elements of cognitive therapy with non-sectarian Buddhist principles. We propose to extend 3S+ to a previously untested population: alcohol or drug dependent HIV+ older adults. The proposed intervention will target HIV+ older adults (age 50 and older, n = 240) with drug and/or alcohol dependence in New York City who report suboptimal HIV self care (less than 90% adherence to their HIV medication regimens). The treatment condition will receive 12 sessions of 3S+ therapy tailored to the specific needs of older HIV+ adults, while the education (comparison) condition will receive 12 sessions of education surrounding HIV medication adherence, drug and alcohol use, and sexual risk-taking. Utilizing several measures of drug and alcohol use (both self reported and biological measures) and HIV health (self reported medication adherence, HIV self care, and biological measures of HIV health), this study will test the efficacy of the intervention at 4, 8, and 12 months post-randomization to determine both immediate and long-lasting effects of the intervention. The significance and impact of this project is threefold: 1) the integration of spirituality into addiction treatment has shown great promise for HIV+ adults and older adults, 2) in addition to targeting addiction, the proposed intervention addresses multiple risk factors that impact HIV health, such as medication adherence, HIV self care, and sexual risk behavior;and 3) this treatment can be readily disseminated and integrated into existing HIV clinics and other community-based organizations offering programs addressing the needs of HIV+ older adults with drug and/or alcohol problems. Broadly, this intervention could help to reduce drug and alcohol abuse and increase HIV health and well-being among HIV+ older adults. If effective, the intervention will help minimize the negative physical and psychological effects associated with drug and alcohol use and improve HIV health and self care, which has potential effects for survival and health as well as reducing HIV transmission and HIV drug resistance. PUBLIC HEALTH RELEVANCE: The findings of this study will contribute to improved HIV treatment of a growing population: older HIV+ adults who are dependent on alcohol and/or drugs. The findings of this study will inform HIV preventions, interventions, and treatments designed to decrease alcohol and drug use and abuse, and increase HIV self care and overall health and wellbeing among those aged 50 and older.

DESCRIPTION (provided by applicant): The proposed investigation seeks to examine the relationship between alcohol consumption patterns and sexuality among male and female emerging adults (ages 18-29) in New York City (NYC). We will undertake a longitudinal, prospective, mixed methods study, guided by the following three aims: (1) Test a new theoretical model, Conflict-Motivation Theory (CMT), which focuses on the role of sexual conflict in predicting risk-taking among emerging adults in the context of alcohol use. (2) Examine the role of developmental and individual (e.g. neurocognitive maturation, decision-making ability), social (e.g. social norms, attitudes, personal beliefs and values), and contextual (e.g. partner characteristics, alcohol dose, and setting) factors in shaping both sexual conflict and the associations among conflict, alcohol consumption, and risk-taking outlined in CMT. (3) Examine and identify the specific roles of gender (including gender roles, and sexual double standards), sexual orientation (including sexual identity and internalized homophobia), and race/ethnicity in shaping both sexual conflict and the associations among conflict, alcohol consumption, and risk-taking outlined in CMT. To achieve these aims, we will recruit and enroll 400 emerging adults into our study (stratified by gender, sexual orientation, and race/ethnicity) using Respondent Driven Sampling and conduct assessments of conflict, alcohol consumption patterns, and sexual risk-taking behaviors three times over the course of two years. Data analyses will utilize structural equation modeling, path analyses, and univariate and multivariate growth curve modeling to determine the relationships between these factors as a means of understanding the relationship between alcohol and sexuality and of evaluating the use of CMT to explain this relationship. Quantitative assessments (administered via Audio-CASI) will be complemented by our use of qualitative techniques to provide us with episode-specific data to help realize the relationships that we are assessing as well as to further understand contextual aspects of the relationship (e.g., reasons for combining alcohol and sexual activity, social contexts of drinking and sexual activity, etc.). Mixed-methods strategies will be used to examine the qualitative and quantitative data together in order to further test the proposed theoretical framework (CMT) and to better understand and explicate potential implications for intervention development. PUBLIC HEALTH RELEVANCE: The findings of this study will facilitate a more nuanced understanding of the reciprocal relationship between alcohol consumption patterns and sexuality, which will, in turn, inform prevention and intervention efforts. Specifically, the findings will inform preventions, interventions, and treatments designed to decrease alcohol use, abuse, and the problems associated with alcohol consumption and also inform efforts to decrease risky sex practices, alcohol-related sexual victimization, and the negative consequences often associated with combining alcohol and sexual activity.

DESCRIPTION (provided by applicant): Project Summary Transgender women (TW) are at significant risk for HIV infection or transmission as a result of high levels of sexual risk behavirs and co-occurring substance use. Despite HIV and STI rates greater than those of men who have sex with men, there are currently no CDC-approved best evidence interventions to reduce HIV risk for TW. This project seeks to evaluate the efficacy of a peer-led innovative and scalable 7-session hybrid individual- and group-based HIV risk reduction intervention, based on Motivational Interviewing (MI) and Cognitive-Behavioral Skills Training (CBST) with TW in New York City (NYC). The intervention is based on promising findings from a CDC-funded pilot peer-led group intervention for TW, which was shown to be feasible, acceptable, and indicated preliminary efficacy in a short-term follow-up of a non-randomized design with no control group. We propose to expand and refine this intervention, in conjunction with TW and community partners who provide medical, social, and other services for TW, in order to evaluate the longer- term efficacy of a scalable 7-session intervention (two MI-based individual sessions, four MI and CBST-based group sessions, and one MI-based individually-tailored health navigation session) all delivered by TW peer- health navigators (PHN) to reduce risky sex and substance use among TW in NYC. The last session in both conditions will be followed by a phone call from the PHN regarding follow-through with accessing services and facilitation of any needed assistance, and a brief post-intervention assessment of primary outcomes. This randomized control trial (RCT) will examine short (immediate, and 4-months post-intervention) and longer-term (8 and 12-months post-intervention) outcomes between TW randomized to the intervention or an attention control education condition, both of which will include a booster session at 4-months post-intervention. Primary outcomes will be: (1) reductions in sexual risk (self-report and STI incidence), and (2) reductions in substance use (self-report, urine, and substance use related problems) and non-medically monitored hormone treatment and silicone injections. Secondary outcomes will be: (1) increases in resilience (e.g., engagement in care, self- esteem, positive coping), and (2) reductions in minority stress (e.g., internalized transphobia, stigma). In Phase I we will train four TW to be peer health navigators (PHNs) to deliver the 7-session intervention. We will also refine the intervention and develop a 7-session attention education condition based on feedback from PHNs and our community partners. In Phase II, we will recruit 20 TW to pilot both conditions. Participant and PHN feedback will be collected to fine-tune the intervention. In Phase III, 240 TW will be randomized to one of the two arms and outcomes will be assessed over 12-months post intervention. We will conduct biological testing (HIV, Chlamydia, gonorrhea, and syphilis) and collect self-report data to evaluate intervention efficacy. The proposed project will iteratively strengthen an existing promising intervention to provide much needed evidence-based support to reduce the syndemic of risk factors faced by TW, and test the efficacy of a 7- session intervention led by TW peers. This study will be the first in NYC and the US to formally evaluate the utility of a peer-delivered MI and CBST- based intervention tailored for TW, which can then be scalable and replicated in various communities to provide continuous support and protection for this underserved and marginalized vulnerable group. PUBLIC HEALTH RELEVANCE: Project Narrative This study will be the first in NYC to formally evaluate the utility of a scalable peer-delivered MI and CBST- based intervention aimed at reducing HIV-related sexual risk behaviors and substance use for transgender women, an underserved, vulnerable, and marginalized group. If efficacious, the intervention can generate content and clearly defined protocols that can be easily utilized by providers who do not operate in a research capacity, and be replicated in various communities to provide support and facilitate behavior change for transgender women. Findings from this study will support dissemination of relevant information on sexual risk reduction, substance use, and well-being for transgender women, as well as provide a model for implementing these preventive mechanisms at a low cost and with the benefits of peer-facilitated sessions.

DESCRIPTION (provided by applicant): Gay and bisexual men (GBM) and other men who have sex with men (MSM) accounted for 63% of all new HIV diagnoses in 2010 -they are among the only population in which infections are actually rising. The syndemics model has been applied to MSM finding considerable empirical support for a model in which several specific co-occurring psychosocial health problems (e.g., depression, substance use, trauma from childhood sexual abuse, intimate partner violence) compound risk for HIV. Yet this model does not account for resilience in the face of syndemic factors-there are GBM who experience syndemics and yet do not engage in hazardous (i.e., HIV risk) behavior. Yet, resilience too is not well understood among GBM. The proposed study builds from the syndemics framework by investigating patterns of resilience in a national US sample of GBM. We have partnered with Harris Interactive, Inc., a research firm that maintains the largest and most comprehensive database of GBM, to identify a national sample of 1,000 GBM to participate in a 3- year longitudinal study (Baseline, 12-, 24-, 36-months) investigating patterns and correlates of syndemic, protective, and resilient factors. We propose to collect behavioral and biological outcomes (at-home HIV and STI testing). We will: (1) Determine patterns and prevalence of syndemic factors and risk behavior in a national sample of GBM; (2) Conduct qualitative interviews with a subsample of participants to identify new/unmeasured mechanisms of resilience and to contextualize our quantitative data (Baseline and 36- months); and (3) Longitudinally track trajectories in resilience, syndemics, and HIV and STI incidence to identify psychosocial and behavioral factors associated with these changing trajectories. Our methodological design-including the use of a national sample, longitudinal assessments, biological testing for HIV and STIs-enhances this study's external validity and thus the impact of our findings. And by tracking patterns in syndemics and resilience, this study will inform (1) the development of the next generation of HIV prevention methods and (2) potential ways to improve established CDC DEBIs. Our application addresses an important problem and barrier to progress in the field (a strengths-based approach to HIV prevention among GBM that goes above and beyond general protective factors to examine resilient factors among men with high risk for hazardous behavior). It has potential to improve scientific knowledge regarding HIV prevention efforts with GBM. And understanding resilience in the face of syndemics can change the conceptual approach, treatments, services, and interventions for a population that remains in critical need.

DESCRIPTION (provided by applicant): Alcohol consumption at harmful or hazardous levels among HIV-positive (HIV+) persons exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) has been the single most important treatment for people living with HIV to optimize viral suppression and slow disease progression. Adherence to ART has considerable public health implications, particularly given that optimal adherence decreases morbidity and mortality, decreases the potential for the development of drug resistant strains of HIV, and reduces HIV infectiousness. Project PLUS (Positive Living through Understanding and Support) was the first (and to our knowledge only) theory-based behavioral intervention, which integrates motivational interviewing and cognitive-behavioral skills training, to demonstrate significant improvements in viral load, CD4 cell count, and self-reported adherence among a racially and ethnically diverse sample of HIV+ women and men enrolled in a randomized controlled trial, and the first intervention for hazardous drinkers to demonstrate any significant effects. A clinic-based replication is the crucial next step in studying the intervention's effectiveness in the real world when delivered by HIV clinic providers to their patients. In collaboration with medical providers at the Center for Comprehensive Care (CCC) at St. Luke's-Roosevelt Hospital Center, the largest provider of HIV medical care in the New York City area with over 5000 active HIV+ patients, our goals are to better understand alcohol-related outcomes among HIV+ persons over the lifespan and to conduct a multisite comparative effectiveness trial with three intensities of treatment-the PLUS intervention, an enhanced treatment as usual (eTAU) condition, and treatment as usual (TAU) condition-to test the clinical and cost-effectiveness of the PLUS intervention in reducing alcohol use and improving ART adherence, viral load, and CD4 counts among HIV+ hazardous drinkers. We will achieve our goals through four specific aims: 1) adapt the PLUS intervention for delivery in HIV clinic settings by mental health providers, and incorporate booster sessions to sustain longer-term effects; 2) test the effectiveness of the PLUS intervention relative to eTAU and TAU alone for HIV+ hazardous drinkers when delivered in a consortium of HIV clinics in New York City; 3) assess the cost-effectiveness of PLUS to an eTAU condition and TAU alone as estimated over 5- and 10-year windows; and 4) analyze retrospective cohort data and prospective natural history data via CCC's Electronic Medical Records. Working together with CCC experts will help to address practical problems at the frontline of medical service provision to pave the way for a comprehensive program in reducing alcohol use and improving ART adherence and health outcomes among HIV+ persons. Our project has the potential to exert a sustained and powerful impact not only on the effectiveness of ART interventions for HIV+ persons with problematic drinking, but also on the effective use of EMR data to examine the relationship among alcohol and HIV-related outcomes in a large urban and diverse cohort of HIV+ clinic patients.

Project Summary Young men who have sex with men (YMSM) remain a critical population in need of empirically supported approaches to improve self-management to promote reduced HIV sexual risk behaviors and substance use. The Young Men?s Health Project (YMHP), a structured and manualized 4-session intervention utilizing motivational interviewing, personalized feedback, and problem-solving skills building approaches for HIV- negative or untested youth was found to be efficacious in significantly reducing substance use and condomless anal sex (CAS) among YMSM ages 18-29. To date, this is the first and only RCT of any published trial or CDC DEBI with YMSM to show significant reductions in both substance use and sexual risk. The CDC recently rated YMHP as ?Best Evidence? and placed it on the compendium of Evidence Based Interventions and Best Practices for HIV Prevention. YMHP was tested through an efficacy trial in a research center environment with numerous inclusion and exclusion criteria, and thus, a real-world-based replication is the crucial next step in studying the intervention?s effectiveness in the real world when delivered by front-line staff to their clients. We will conduct a comparative effectiveness trial (CET) with two modalities of YMHP delivery ? clinic-based and telephone-based ? at three HIV clinic sites in Los Angeles, Philadelphia, and Miami. The Specific Aims are to: 1) adapt the YMHP intervention for clinic and phone delivery in HIV clinics by community health workers (CHWs); 2) compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the context of health care access, assessing the cost effectiveness of both modalities and the five components of the self- management model; and 3) test a sustainable model of YMHP implementation in real-world adolescent HIV clinics. The proposed study will be implemented over two phases. In Phase 1 we will conduct qualitative research with staff at our collaborating clinics (to understand implementation issues) and YMSM ages 15-17 (to adapt the efficacious YMHP intervention to be developmentally appropriate). In Phase 2 we will randomize 270 YMSM ages 15-24, to receive YMHP by phone or in person at the clinic. Assessments will include behavioral self-report measures, urine testing for substance use, and STI testing for sexual health outcomes. Working together with our clinic collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM. If effective, our program has the potential to exert a sustained and powerful influence on the effectiveness of behavioral interventions for YMSM.

Project Summary Ethnic and racial minority young men who have sex with men (MYMSM) remain a critical population at the nexus of substance use and HIV/AIDS: a 132% increase in new infections concentrated among African American and Hispanic YMSM has been observed since 2002. The Young Men's Health Project (YMHP), a 4- session intervention utilizing motivational interviewing designed for HIV-negative or untested YMSM ages 18- 29 was found to be efficacious in significantly reducing substance use and condomless anal sex (CAS). To date, this is the first and only RCT of any published trial or CDC DEBI with YMSM to show significant reductions in both substance use and sexual risk. The CDC recently rated YMHP as ?Best Evidence? and placed it on the compendium of Evidence Based Interventions and Best Practices for HIV Prevention. YMHP was tested through an efficacy trial in a research center environment with numerous inclusion and exclusion criteria, and thus, a community-based replication is the crucial next step in studying the intervention's effectiveness in the real world when delivered by staff to their clients. We will conduct a comparative effectiveness trial (CET) with two intensities of treatment offered following field-based HIV counseling and testing (C&T) ? the YMHP intervention and enhanced ?treatment as usual? (eTAU) HIV prevention services ? in two real-world community based organizations (CBOs) to test their relative effectiveness in reducing substance use and CAS among HIV-negative MYMSM. The Specific Aims are to: 1) adapt the YMHP intervention for delivery in CBOs by peer counselors; 2) test the effectiveness of the YMHP intervention when delivered by peer counselors at two CBOs situated in high HIV incidence neighborhoods in New York City; and 3) assess the cost-effectiveness of YMHP relative to TAU. The proposed study will be implemented over two phases. In Phase 1 we will conduct qualitative research with staff at our collaborating agencies to adapt the efficacious YMHP intervention to the unique needs of MYMSM and incorporate existing systems and approaches utilized by site collaborators to facilitate for delivery by peer counselors. In Phase 2 we will randomize 260 HIV-negative substance using MYMSM into the YMHP intervention or eTAU. Assessments will include behavioral self-report measures, urine testing for substance use, and HIV and STI testing for sexual health outcomes. Working together with our CBO collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and HIV infection among MYMSM. If effective, our program has the potential to exert a sustained and powerful influence on the effectiveness of behavioral interventions for economically disadvantaged, substance using MYMSM who are most at risk for HIV infection.

Abstract Despite the substantial declines in HIV transmission and increases in lifespan among those living with HIV achieved over the past decade, full benefits that should be possible based on the tools and interventions currently available have yet to be realized in youth, in large part because efficacious interventions for this age group have not been brought to scale. To be effective, youth must be fully engaged in interventions at every stage of the HIV care (treatment and prevention) cascades: HIV testing, linkage to care, timely initiation of care, persistence and adherence to antiretroviral care. At-risk HIV-negative youth need to be consistently engaged in prevention strategies such as PEP and/or PrEP as indicated, consistent safer sex practices and repeat HIV testing. Our U19 project - Scale It Up - specifically focuses on the process of improving self- management among youth including: 1) the identification of interventions that are efficacious and effective for improving self-management in YLH and at risk youth; 2) the multi-site implementation of an intervention shown to be efficacious in improving self-management; and 3) the assessment of the Five Components of Self- Management Model and how these vary over time, are directly improved by interventions, and mediate intervention effects. Our team has also been at the leading edge of implementation Science research related to HIV prevention and care. We are actively committed to aggressively moving beyond simple efficacy and effectiveness RCTs. The four Research Projects proposed in Scale It Up, all addressing self-management, will continue to develop the field of Implementation Science by employing three types of effectiveness- implementation hybrid designs. The studies further synergize by utilizing Aaron?s Exploration, Preparation, Implementation, Sustainment (EPIS) model to guide the proposed Implementation Science efforts. Our proposed Implementation Science Core, coupled with the cost effectiveness expertise of our Analytic Core, will be focused on the central notion of ?Scale It Up? ? taking efficacious self-management interventions and expeditiously moving them into practice while sustaining effectiveness. Scale It Up has assembled research teams who will develop, test, and bring to practice self-management interventions that positively impact the youth HIV prevention and care cascades. We will achieve these goals by: 1) Designing, conducting and evaluating self-management interventions grounded in the 5-component Self-Management Model and expeditiously moving effective programs into practice; 2) Developing, deploying and disseminating new methods for implementation and implementation analysis with a strong theoretical foundation; and 3) Engaging with the other funded U19s to identify additional opportunities to advance the implementation science and self- management science.

Project Summary Gay, bisexual and other men who have sex with men (GBMSM) remain a population in the U.S. for whom the burden of HIV is high and disproportionate, particularly among younger GBMSM and GBMSM of color, for whom HIV incidence continues to rise despite decades of HIV prevention research to curb the epidemic. However, even among these highest risk groups, risk for infection is not equivalent and the goal of this study is to better understand what factors differentiate levels of risk for HIV infection. Research to date suggests that this disproportionate burden is likely to be exacerbated by psychosocial disparities faced by this population in the form of syndemics and sexual minority stress. However, research on these factors has been limited by a focus on risk for HIV infection operationalized as risk behavior or cross-sectional prevalence of HIV, making actual vulnerability to infection and temporal associations difficult, if not impossible, to determine. We are submitting this application in response to RFA-AI-16-031 Limited Interaction Targeted Epidemiology (LITE) to Advance HIV Prevention (UG3/UH3). We propose to recruit and enroll a large and diverse cohort of approximately 8,000 GBMSM ages 16 and older in the U.S. and Puerto Rico who are at high risk for infection. We will utilize mobile sexual networking applications (?mobile apps?) to identify and enroll these men both to allow for rapid and efficient recruitment and because these apps rapidly increasing in popularity, with research demonstrating that men who use mobile apps are at higher levels of risk for HIV infection than GBMSM recruited through other means. Using this cohort, we will work to achieve three primary aims: (1) we will establish HIV prevalence as well as prevalence of rectal sexually transmitted infections (STIs; gonorrhea and chlamydia) at baseline and subsequently establish rates of HIV and rectal STI incidence among these men 12 months thereafter; (2) we will utilize baseline levels of syndemic, minority stress, and other relevant psychosocial risk factors to develop a model of those modifiable factors that contribute to increased risk for HIV seroconversion (i.e., incidence) as well as rectal STI infection; (3) we will utilize the model to target men in the highest quartile of risk for HIV seroconversion in the cohort and follow them every 6 months thereafter for an additional two years to examine the predictive utility in prospectively predicting HIV seroconversion as well as time to seroconversion. Developing a model of modifiable psychosocial risk factors for actual HIV seroconversion and subsequently testing its reliability and validity in a prospective design has high potential to improve the next generation of HIV prevention interventions aimed at reducing disparities for this population.