Linda B. Cottler, PhD, MPH – Grants and Contracts
Indo-US Training Program in Behavioral Health Across the Lifespan
D43TW009120 (September 1, 2011 – July 31, 2016)
Director: Cottler, Co-Director: Gold
The Indo-US training program in behavioral health across the lifespan at the University of Florida focuses on three locations in India that are experiencing acute, detrimental effects of urbanization: Northeast India (Assam and Sikkim) and South Central India (Karnataka). The goals of this Fogarty program align with the Fogarty Strategic Plan to reduce the training gap and increase research capacity for CNCDs, and focuses on behavioral conditions that receive little attention even though they are increasingly contributing to the burden of disease in Lower and Middle Income Countries (LMICs). This program addresses exposure to violence, addiction (prescribed and illicit drugs, alcohol and nicotine), and the most impairing mental symptoms (psychosis, suicidal ideation and dementia). It also emphasizes training in the social determinants of illness (environmental and social factors), as well as epigenetic determinants, across the lifespan. This new program will enhance and expand the work conducted through a sunsetted Fogarty ICOHRTA Program, funded since 2001, directed by Dr. Linda Cottler (formerly at Washington University) and Major Foreign Collaborator Dr. Sanjeev Jain from the National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore, Karnataka, India. Under the CNCD mechanism, we have added two new institutions, specifically, Lokopriya Gopinath Bordoloi (LGBRIMH) Regional Institute of Mental Health in Tezpur, Assam and the Voluntary Health Association of Gangtok, Sikkim (VHAS). These institutions are added to increase the public health and policy emphasis of our training collaborating with premier NGO institutions. This new Fogarty gives University of Florida and NIMHANS the opportunity to continue building needed public health relevant research capacity while also bridging to Northeast areas of Sikkim and Assam-areas that have critical need for sustainable research capacity building and outreach mentoring. We will train 4 long term post doc trainees every year for 5 years. Trainee selection and progress will be evaluated by the Training Advisory Group (TAG), who will give feedback to the Director and Major Foreign Collaborator on issues relating to the focus of training workshops in India and ideas for more collaborative grants between and across the institutions. Trainees in this program will have the opportunity to take formal courses, attend seminars and tutorials and work with their mentors in apprenticeship style. Training in the responsible conduct of research is a major emphasis of this program. Through our expanded program with three Indian sites, one with increased capacity, and two in critical need of infrastructure building, and our new networks of focus at the University of Florida, we will develop sustainable partnerships to intervene with some of the most burdensome CNCDs in the world.
Transformative Approach to Reduce Disparities Towards Drug Users
R01DA027951 (September 1, 2009 – May 31, 2016)
PI: Cottler, Co PI: Striley
Although individual researchers and projects have focused on underrepresented populations and populations critically in need of services, drug users remain excluded from research studies and unlinked to services. This study is changing the research landscape through the CTSA. This new NIDA initiative is extending our successful NIDA model to actively recruit and enroll multi-generational underrepresented populations, specifically drug users, into research studies and will link them to needed health and social services. This project will recruit, enroll and follow up participants to achieve these specific aims: 1.) Conduct a Needs Assessments among investigators, coordinators, IRB members and Human Research Protection Office (HRPO) staff to understand attitudes toward excluding, enrolling and retaining underrepresented populations, including drug users, in research; 2.) Evaluate the findings from the Needs Assessment to formulate educational guidelines and recommendations to make research more inclusive. These two aims were completed at Washington University. 3a.) Extend the CTSA street-based outreach model to target persons with recent illicit drug use and link them to the CCBR, where they will be referred to health services, assessed for medical and psychiatric history, and invited to participate in University of Florida research studies; 3b.) Randomize 200 study-eligible participants to either the newly established navigator model of referral to a relevant study, or to an enhanced navigation model where a “study ambassador” guides the participant through all research stages. Effectiveness will be assessed at 30 days, 2 months and 3 months after randomization; 3c.) Evaluate the effectiveness of the model to refer participants to primary care homes and other needed services, to increase satisfaction with navigation, to reduce perceived discrimination, and to report fewer barriers to participation. This grant will provide the opportunity to further translate and disseminate evidence- based practices across all arenas of public health for drug users. This project will enhance public health by increasing the generalizability of medical research studies by developing, using and evaluating innovative methods to recruit and enroll multi- generational underrepresented populations, including drug users, into relevant research studies. These community-based research services will reduce researchers’ perceptions that enrolling and retaining underrepresented populations is difficult, provide a catalyst to revise stringent inclusion/exclusion criteria to include these underrepresented populations, and link participants with critical and previously unattainable services.
University of Florida Clinical and Translational Science Institute – Community Engagement and Sentinel Network to Increase Community Participation in Research
UL1RR029890 (April, 2009 – March, 2014)
PI of CTSI: Nelson, Co-Director of Community Engagement, and Director of the Sentinel Network: Cottler
There are over 80,000 clinical trials conducted each year in the US, and yet, less than 1% of the population participates in them. The so-called “leaky pipe” of research participation must be fixed to include more women, older adults, racial, ethnic and rural populations in research studies so that findings will fully account for all genetic, cultural, linguistic, race, ethnic, gender, and age factors. Two reasons for poor participation might be some communities’ reluctance to participate in research and a university’s lack of engagement in the community. Six CTSA Community Engagement Resource Development Workgroup members have joined efforts on a CTSA Supplement creating a Sentinel Network to:
1. Develop procedures to increase community participation in research which ensure more generalizable and representative research findings.
2. Build capacity for Community Health Workers and to expand their role in research.
3. Increase the thoroughness of community health evaluations and research.
4. Build trust and connections with the community.
5. Detect emerging community issues regarding participation of underrepresented populations in health research.
6. Utilize existing nationally developed education curricula to address clinical trial participation and pertinent health and social service needs.
Community Health Workers at all Sentinel Network sites will engage community members, collect demographic data and top health and neighborhood concerns, and determine barriers to research participation. They will also collect data on education, family life, physical and mental health history, medication and drug use. This information will be used to link community members to medical and social services (including a medical care “home”) and research opportunities. A 30-day follow-up will be conducted with each community member to ascertain whether the services and opportunities were useful to them. Core data from each site will be compiled regularly and shared with the National Institutes of Health (NIH) research communities and their community at large to meet the study aims.
Afghanistan National Drug Use Survey
JMJ Technologies/Dept. of State (October 15, 2011 – December 31,2013)
Conflicting reports exist about the extent and nature of Afghan drug abuse. A 2005 UN Drug Abuse Survey estimated that 3.8% of the population in Afghanistan used illicit drugs, and suggested that these rates are likely underestimates. Additionally, they suggest that rates of illicit drug use are increasing. Based on this report, the most commonly abused drugs in Afghanistan are hashish and opium; injection drug use is common, while safer injecting behaviors are not. According to the UN Drug Abuse Report (2005), HIV, syphilis and Hepatitis B & C have been detected among Afghan drug users. Poppy eradication strategies in Afghanistan are among the highest priorities of the US government. Afghanistan supplies over 90% of world’s opium supply. Understanding the patterns and prevalence of opium use, and evaluating the need for treatment among the Afghan population is critical to the goal of poppy eradication. This project will be the first of its kind to randomly to test households in Afghanistan for exposure to drugs and alcohol while also simultaneously assessing self-reported drug use. The study aims to define the nature of Afghan drug abuse through the use of household surveys linked to biological measures. Field work was carried out by credible, well-trained Afghanistan team of doctors and professionals who conducted the field work using a well-designed survey based on questions that had been tested for cultural acceptability and previously psychometrically tested. This combination of methods is critical in order to ascertain the prevalence and patterns of drug use in this population. The Afghanistan National Drug Abuse Survey was conducted with 2187 households from 11 provinces in Afghanistan. The provinces were selected by the Spectre Group International, LLC, in accordance with on the ground conditions. For safety, most of the southeastern provinces were not selected. The female head of the household is the informant and selected by the male head of the household. Biological samples (hair, saliva and urine) were obtained from three members of each household: the female respondent, the eldest male, and the youngest child age 4 or older. This topic is one of international public health concern and while the UN has collected data in specific provinces in Afghanistan, this study would be the first of its kind on drug abuse in Afghanistan based on a general population.
Evolution of Psychopathology in the Population
R01DA026652 (April 01, 1992 – November 30, 2013)
PI: Eaton – Johns Hopkins, PI of Subcontract: Cottler
The Epidemiologic Catchment Area (ECA) cohorts, interviewed from 1979-1983, are the earliest in the nation to include a wide range of psychopathology according to operational diagnostic criteria. Follow-up of the ECA cohorts after 25 years provides unprecedented opportunity to study consequences of common mental disorders in community samples. The research strategy will enrich ECA data via linkage to available record systems. The 11,519 individuals interviewed in the first three ECA sites (New Haven, Baltimore, and St. Louis) will be linked to the National Death Index Plus (NDI+) from 1979-2008, generating more than 260,000 person years of risk. The NDI+ identifies respondents who have died and provides the contents of the death certificate, including causes of death according to ICD codes. One consequence is mortality. The literature on mortality and mental disorder has focused on psychiatric treatment, including only scant data on mortality among persons with common mental disorders in the general population. A second consequence is costs. There are extensive data in the Baltimore ECA site interviews in 1981, 1982, 1993, and 2004 on reports by the respondent of use of health care facilities. The 1920 subjects from the 1993 Baltimore ECA site follow-up will be linked to Medicare and Medicaid records for the years 1995-2004 to improve estimates of direct costs. Extensive reports of employment, marital, and socioeconomic status, as well as of disability and functioning, will help estimate indirect costs. Data on mortality will be incorporated into estimates of indirect costs. These data will be enriched by linking Baltimore ECA respondents to records of the Maryland Department of Motor Vehicles and the Maryland Criminal Justice System. There are no similar estimates of costs of common mental disorders available. A third type of consequence is non-monetary, involving social functioning and psychological well being. The population-based sample in Baltimore, diagnostically-oriented interviews at baseline, and follow-up interviews one and two decades after baseline, with a wide range of measures of mental and social functioning, facilitate documentation of these consequences. Mortality, costs, and non-monetary costs of mental disorders are affected by treatment. Data on treatments received reported in the Baltimore cohort will facilitate exploration in a community setting of the long-term consequences of receiving, or not receiving, treatment for common mental disorders. This project will provide the most accurate estimates available in the United States of the long-term consequences of common mental disorders for mortality, direct and indirect costs, social functioning, and psychological well-being. It will show the consequences of receiving, and not receiving, treatment for common mental disorders. Documentation of mortality, costs, and consequences provides basic information for the public health approach to mental disorders.
Those with * have available data for secondary analysis.
National Monitoring of Adolescent Prescription Stimulants Study *
Pinney Associates (May 01, 2008 – April 30, 2013)
N-MAPSS is an innovative national study of youth 10 to 18 years to evaluate their ability to identify prescription stimulants, detect recent use and patterns of use and monitor trends in their consumption and risk factors over time. The study is fielded in 10 cities: Boston, Cincinnati, Denver, Houston, Los Angeles, New York City, Philadelphia, Seattle, St. Louis and Tampa in four terms of two full school years (2008-2009, 2010-2011). The cities were chosen based on their level of prescribing patterns of stimulants according to the IMS database. An entertainment venue intercept method was used to recruit 11,048 youth at malls, other shopping areas, parks and playgrounds, libraries, coffee shops, ball parks, arcades, cinemas, skate parks, recreation centers and other youth friendly venues to provide an alternative to school-based sampling. The Cottler group developed an instrument, the N-MAPSS survey, to measure youth knowledge and use of prescription stimulants. The aims of this youth surveillance program are: 1) Evaluate the ability of pre-teens and adolescents 10 to 18 years old to recognize and identify prescription stimulants by name, 2) Detect and evaluate past 12-month use (prevalence) and potential signals of misuse, abuse and diversion of specific stimulants by name, 3) Evaluate sources, patterns of, and reasons for stimulant use, 4) Identify demographic (age, region, etc.) variation in use, misuse and recognition patterns, and 5) Monitor trends over time. Because the N-MAPSS survey focuses on prescription stimulants, it increases the ability to report brand level data, where hot spots are for misuse and diversion, subtypes of diversion and other risk factor analyses that would be unavailable in national studies focused on multiple substances and other topics. N-MAPSS also has qualitative data on what teens think we should be done to reduce the misuse of prescription drug abuse among youth and teens.
Websystem to Increase Research Participation of Underrepresented Populations
RC2HL101838 (September 30, 2009 – December 31, 2012)
The ultimate goal of this 2 year NIH-NHLBI RC2 GO Grant (RFA-OD-09-004), “Comparative Effectiveness”, is to develop a web system that facilitates Community Based Participatory Research (CBPR) to identify populations underrepresented in research. This effort builds on our 20 year community based model. Recently scaled up for the Washington University’s Clinical & Translational Science Award (CTSA), our community based model called Health Street is a one-stop portal of entry for navigating underrepresented populations (URPs) to social, medical and psychiatric services, and to research opportunities. Health Street relies on Community Health Workers (CHWs) for engagement and is complementary to planned national self-guided participant registries. The deliverables will be the model, its protocols and manuals, and its concomitant web system that automates its work flow; they would be made available for replication nationally. The system will be an important component of the recruitment armamentarium to boost URPs in research. A web system to track and facilitate all functions of this approach, along with all decision logic, is mandatory to scale up the effort for better efficiency of field-based recruitment on a local and national level. The study aims to i) Refine the workflow of the novel Health Street model, to reduce disparities in research participation, and make it complementary to both local and national registry based efforts, ii) Design and develop a sophisticated web system that automates all of the work flow and allows CHWs to capture individual data from underrepresented populations, from portal of entry forward. It will also longitudinally track need for services, health priorities and concerns, risk factors, referrals made, Health Street services provided, and community recruitment, navigation, and enrollment rates, iii) Test the web system for relevance locally with the input of the CHWs, the Recruitment Enhancement and Bio-Informatics Cores, and the local Community Advisory Board; and nationally with the input of the Program Advisory Board and CTSA Community Engagement Cores ,iv) Make the web system available nationally; begin a Sentinel Network for ongoing multi-site monitoring of increased enrollment of URPs into relevant research studies , v)Plan a collaborative comparative effectiveness study of the web system vs current models to longitudinally monitor recruitment, navigation, enrollment and retention yields among URPs. This work will have a substantial transformative and sustainable impact as it brings research from the bench and bedside to the “curbside”. The public health impact of the Health Street approach to recruit more underrepresented populations into research and link them to needed services is significant. When samples enrolled for research studies are comprised of diverse populations, there is greater generalizability and applicability of the findings to the larger population to which they relate. This increases the effectiveness and speedy approval of treatments and interventions that are tested in various research studies, thereby positively impacting public health outcomes. Thus, the use of a comprehensive web system, deployed by Community Health Workers, and based on the principles of community based participatory research, is pioneering.
Indo-US Fogarty Training Program in Behavioral Disorders
D43TW005811 (September 1, 2001 – April 30, 2013)
This is a joint training program between India and US investigators in the areas of epidemiology, nosology, services research, and genetics to study major psychiatric public health problems affecting people in the Indian sub-continent. The program has gained considerable momentum; trainees from the program are fulfilling the vision of solid, evidence-based psychiatric research in India. Re-entry grants have allowed trainees the opportunity to gain state of the art research experience and bring that experience back to their home country to address major global health problems. Our program is multidisciplinary and holistic, reflecting the wide range of expertise required for understanding the complex etiology of psychiatric and behavioral disorders which contribute significantly to the global burden of disease. Additionally, this program has recruited, enrolled, and retained predominately MD scientists, a significant challenge facing all training programs. Stateside mentors, paired with those from the National Institute of Mental Health and Neurosciences (NIMHANS) Bangalore, India, provided an excellent environment for collaborative and multidisciplinary training in all aspects of clinical psychiatry research, epidemiology, nosology, services research, and genetics. In this program we trained outstanding postdoctoral trainees in India for long-term multidisciplinary training in psychiatric epidemiology, nosology, services research, and human genetics; strengthened and enriched academic programs at NIMHANS and simultaneously at Washington University, where the training was predominantly, by providing: (i) short and intermediate term fellowships (ii) Didactic training courses offered in School of Medicine or local School of Public Health (iii) Conducting visits of US faculty to NIMHANS and vice versa; Implemented strategies to increase the national and international research structure by:(i) Recruitment of trainees from multiple sites who returned to their home institutions, (ii) Continued growth of individual and multidisciplinary research studies at NIMHANS. (iii) Expansion of training and research facilities at NIMHANS. (iv) Providing training in the responsible conduct of research that is culturally relevant that also meets the guidelines of 45CFR46 of the US Government and development of a bioethics incubator to address the issues of conflict, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects; Interacted with other Fogarty Training Programs via satellite and other web based electronic communication efforts to share curriculum and training experiences in a “virtual collaboratory” to enhance our programs.
*Survey of Retired Professional NFL Football Players
ESPN and NIDA (2010 – 2011)
The Survey of Retired Professional NFL Football Players is a research project, sponsored by ESPN and NIDA, whose purpose was to obtain data on the health concerns and pain levels of retired NFL players and their use and misuse of prescription medications, especially prescription opioids. Specifically, this study 1) assessed the extent of current pain attributable to prior NFL injuries; 2) determined the amount of prescription pain medications used medically and non-medically to manage pain from prior NFL injuries; and 3) determined lifetime use and source of prescription pain medications to manage pain. Data was obtained through a telephone survey of approximately 644 former NFL players.
*Prescription Drug Misuse, Abuse, and Dependence
R01DA20791 (September 30, 2006 – April 30, 2011
Prescription drug abuse is among the nation’s most important drug problems due to its physical, social and psychiatric consequences. Increases in non-medical use and presumably the consequences of these drugs have been found especially among younger and older adults. NIDA’s PA 04-110, Prescription Drug Abuse, was an attempt to stimulate research in this area, and to understand the populations most at risk for abuse and its consequences. While publications have recently focused on the prevalence of this misuse, methodological efforts aimed at assessing the associated problems have been lacking. As the field has moved forward with prevalence studies, the foundation on which these rates have been built requires attention. With our team’s years of experience in assessment development and nosological science, we addressed this critical need to aid in the interpretation of findings. This team proposed methodological aims among 400 individuals who used prescription drugs, primarily stimulants, sedatives, or opioids non-medically, such as when they were not prescribed for them, in larger amounts than prescribed, more often than prescribed, or for longer than prescribed. A community based sample of younger and older users was enrolled. The aims of this proposal were to: 1) Conduct qualitative research on prescription drug users and health professionals to understand contextual factors related to prescription drug (stimulants, sedatives and opioids) misuse and its consequences. The data informed revisions to the Substance Abuse Module (SAM) and Risk Behavior Assessment (RBA) for the quantitative study. Focus group topics for user groups (n=4) and health professional groups (n=2) included those salient to the field. An ethnographic sub-study was also conducted (n=40) to explain the findings of the quantitative study. 2) Evaluate the inter-rater reliability and validity of the SAM questions, criteria, and abuse of and dependence on each category of prescription drugs. Compare the reliability and validity of these drugs to that for other illicit drugs assessed in the SAM. 3) Understand reasons for poor reliability and misunderstood questions through the use of our computerized Discrepancy Interview Protocol (DIP) and Debriefing Interview, to “perfect” assessments. 4) Evaluate nosological issues about prescription drug abuse, and dependence.
2009-2011 Principal Investigator – Prescription Drug Misuse, Abuse and Dependence – Research Supplement for Retired Professional NFL Football Players
2008-2010 Principal Investigator – Prescription Drug Misuse, Abuse and Dependence – Research Supplement to Promote Diversity in Health-Related Research Program for Dr. Simone Cummings
2008-2009 Principal Investigator – Prescription Drug Misuse, Abuse and Dependence-Research Supplement for Impaired Professionals.
*Enrolling and Retaining Female Offenders in HIV Trials (STOP)
R01NR09180 (September 15, 2004 – June 30, 2010)
This project responded to PAS-03-168 which sought to recruit and retain women and minorities for HIV/AIDS research trials. The Sisters Teaching Options for Prevention project (STOP) had two goals: it enrolled and retained a severely difficult to reach population of women–poor, inner city, female arrestees–who, despite their high risk, have been largely overlooked for HIV/AIDS research to date. Secondly, it initiated strategies to correct barriers to participation in research, a recent goal of NIAID. The methods for recruitment, retention and intervention were based on this team’s decade and a half of community based behavioral interventions aimed at reducing high risk behaviors. Grounded in the Health Belief Model, the proposed peer-delivered case management intervention provided the tools to facilitate self-directed change. Our community-based research consistently shows four key barriers to high risk women’s participation in research: lack of transportation, fear and distrust, misperceptions of and risks for disease, and a research community that favors healthier populations perceived to be “more compliant”. Because the rate of HIV risky behaviors is highest among this group of women both locally and nationally, interventions for them at this critical juncture are imperative. The aims of the STOP project were to: 1. Adapt a culturally-relevant, gender-specific, community-based, theoretically-driven Peer Partnered behavioral intervention for a randomized clinical trial (RCT) to reduce HIV risk behaviors, and facilitate access to needed services and research protocols. 2. Reach a difficult to recruit population of women–female offenders–in need of HIV/STD testing, counseling, and medical and behavioral interventions. 3. Enroll these women into this RCT, and retain them with high response rates, comparing a standard intervention to a Peer Partnered Case Management Intervention (PPCMI). 4. Assess the effectiveness of the Peer Partnered Case Management Intervention at 3 and 6 months to facilitate access to needed services, to reduce barriers to service access, to reduce high risk behaviors, to increase knowledge of HIV and other STDs, and to improve trust in and understanding of research involvement. 5. Disseminate the PPCMI model and findings locally, nationally and internationally.
*Deconstructing HIV Interventions for Female Offenders
R21DA19199 (September 30, 2004 – July 31, 2007)
HIV prevention interventions have not delivered the desired level of behavior change to female offenders for several reasons: the women may not perceive any need for interventions; the interventions may not appear relevant to their specific needs, or there may be client, setting, and environmental factors precluding enrollment, engagement and retention. Responding to RFA-DA-04-015, this project explored factors related to engagement in prevention efforts to develop behavioral interventions adapted specifically to female, drug-abusing offenders. Deconstructing HIV Interventions Among Female Offenders aimed to understand what components of an intervention developed for drug using women are particularly relevant for female offenders sentenced to community-based Court supervision. With this insight, we restructured existing HIV prevention interventions for these women. To deconstruct aspects of the intervention that hold the greatest likelihood for success for this specific at-risk population, our team: 1. Conducted secondary analyses of a recently recruited sample of women in the St. Louis Female Drug Court to determine: a. Differences in the characteristics of women (including demographic, sexual behavior, and medical, psychiatric and substance use) enrolled from the Drug Court compared with non-offending women recruited from an HIV prevention study (DA11622); b. The client-level, environmental and intervention process factors associated with intervention participation and compliance, as well as attrition at the 4 and 12-month follow-up among both female drug-using offenders and Non-offenders. 2. Re-interviewed a subset of female offenders using a combination of qualitative and quantitative methods to ascertain the most salient factors predicting participation and compliance. 3. Synthesized the results of aims 1 and 2 to revise our intervention specifically for female drug using offenders at high risk for HIV/AIDS, for a future study of behavior change.
*Collaborative MDMA and Other Club Drug Study in Taiwan
NIDA HHSN 271200477521C (September 1, 2004 – August 31, 2006)
According to the UN Office on Drugs and Crime, people around the world do not perceive harm from club drugs due to lack of information on their consequences. Thus, the worldwide community is unprepared to assess, treat, and prevent club drug abuse and dependence. Using focus groups (Phase I), diagnostic assessment (Phase II), clinical validation (Phase III), and testing (Imaging and Biological Markers) (Phase IV), this study in Taiwan aimed to mirror studies of specific types of club drugs conducted in the US and Sydney, with a few additions. Specifically, we:
1) Described the nature and extent of self-reported dependence on and abuse of specific types of club drugs, (Ecstasy, GHB, rohypnol, ketamine and methamphetamine);
2) Administered a modified Risk Behavior Assessment (RBA) to understand the risk factors related to club drug use, abuse and dependence for cross-cultural comparisons with the other sites. Components of the interview included, among others, use of over-the-counter booster drugs, spiritual factors, concomitant high risk sexual behaviors, cultural issues related to use, parental monitoring, and users’ perceptions of harm;
3) Evaluated depression and other major co-occurring psychiatric disorders among users;
4) Conducted qualitative (ethnographic) research on the unique contextual factors that relate to club drug and methamphetamine use in Taiwan to help interpret the data from the epidemiological study;
5) Enrolled respondents simultaneously into studies evaluating biological and neurobiological vulnerabilities using PET scans and blood chemistries.
*Community Based HIV Prevention Among Females at Risk in Bangalore, India (WAF)
World Aids Foundation (2003 – 2007)
This study, funded by the World AIDS Foundation (WAF) was an Indo-US collaborative project conducted in a slum in Bangalore, India. The significance of this community based HIV prevention project for women is immense. Most HIV prevention studies in India predominantly targeted high risk groups such as sex workers, substance using populations and truck drivers, among others. However, HIV rates in India show high prevalence rates among women who are married and in monogamous relationships due to the risk behaviors of their spouses. Very few efforts have been made to talk to married women to educate them about HIV infection and the ways to protect themselves from HIV and other sexually transmitted infections. Therefore, in this project we: 1. Adapted and pilot tested a community-based intervention being used in the US for an HIV prevention study of women at high risk in India; 2. a) Evaluated lifetime substance use, psychiatric and health risk histories of women with heavy drinking partners; and b) understood the extent of risk by determining comorbid STIs; 3. a) Developed a culturally relevant community-based HIV prevention intervention that centers on the Health Belief Model to increase women’s knowledge of HIV risk factors; and b) tested its short term (2-month) effectiveness in increasing women’s knowledge of risk; 4.Tested the feasibility of applying unique tracking and locating strategies to achieve follow-up rates never achieved in community-based studies in India and; 5. Fostered the development of Indo-US collaborative efforts based on results of the pilot and disseminated feasibility findings. Although there were structural barriers to initiating the study, eventually, the barriers were lifted and the teams carried out the project with complete follow-up of every woman. The study was deemed feasible by the women and the interviewers. Numerous tangible and intangible outcomes have been realized, with more to come in the future.
*Tri-City Study of Club Drug Use, Abuse and Dependence (Club Drug)
R01DA-14854 (September 30, 2001 – July 31, 2005)
Surveillance data from the field’s best monitoring systems are detecting alarming increases in the rates of “club drug use” among young adults; yet, we know little about club drug abuse and dependence. Such information is essential to a relevant public health response. The proposed “Tri-City Study” was the first study of the applicability, reliability and validity of abuse and dependence concepts as they apply to specific “club drugs.” Specifically, a multisite study was proposed among 450 recent Ecstasy and other club drug users, 15 to 30 years of age, in areas indicated by NIDA’s Community Epidemiology Workgroup (CEWG) as emerging or current areas of high risk — St. Louis, Seattle and Miami — to: 1) Describe the nature and extent of self-reported dependence on and abuse of Ecstasy, GHB, rohypnol and ketamine. This was accomplished by determining whether “cookie cutter” diagnostic criteria used for other illicit drugs (such as described in DSM-IV, III-R, III, and ICD-10 and the Edwards-Gross Dependence Syndrome) are generalizable to individual club drugs, and to what extent users report the hallmark symptoms of dependence and abuse such as tolerance, withdrawal, craving, loss of control and social consequences; 2) a) Expand the Substance Abuse Module (SAM) to assess abuse of and dependence on specific club drugs and b) determine the psychometric properties (reliability and validity) of these disorders; 3) Understand the reasons for inconsistent answers and misunderstood questions; 4) Develop and test a Risk Behavior Assessment to facilitate the collection of risk factor data relevant to club drug use, abuse and dependence; 5) Conduct qualitative research on the unique contextual factors that relate to club drug use, in each site, to help inform revisions to the SAM and the RBA; 6) Disseminate the aggregate findings to the drug abuse field. Such efforts, considered mundane to many in the drug abuse field, are critical at this early stage of the club drug epidemic.
2002-2003 Principal Investigator – Supplement to Bi-City Study of Club Drug Use, Abuse and Dependence Project for STD testing
2002-2004 Principal Investigator – Supplement to Tri-City Study of Club Drug Use, Abuse and Dependence Project, for Sydney Australia sub-study
*Prevention of HIV and STDs in Drug Using Women (Women Teaching Women)
R01DA011622 (January 1, 2000 – December 31, 2006)
Women Teaching Women (WTW) was proposed by a team of Washington University investigators who have focused on HIV prevention efforts among out-of-treatment injecting drug users (IDUs) and crack cocaine users since 1988. Our peer-delivered prevention model was successful in reducing cocaine use among men. We believe no differences were found in drug and sexual risk behaviors for women because the intervention lacked gender-specificity. Thus, we proposed to tailor our previous intervention to women’s needs to determine the shorter and intermediate term effectiveness of a gender-specific model on reducing drug use and sexual risks. This was the last time we could submit WTW and we were hopeful that our revisions strengthened the science of this protocol. The urgency for women-focused interventions was highlighted by increasing HIV/STD rates among women nationwide. The revised intervention was designed to bring the HIV prevention message to women in a public health environment. The three-arm intervention, which targeted out-of-treatment drug-using women, assessed the differential impact of a woman-centered standard intervention alone, the same standard intervention plus a well-woman exam, and those plus the addition of 4 educational sessions. This proposal responded to two NIDA PAs: 95-083 (Women’s HIV Risk and Protective Behaviors) and 96-018 (Drug Abuse Prevention Intervention for Women and Minorities). Aims included: 1. Recruit of out-of-treatment female drug injectors, heroin, crack/cocaine and methamphetamine users into an intervention aimed at reducing high risk sexual and drug use behaviors. Street outreach, bars and clubs, shelters, health fairs and daycare facilities were used to reach these vulnerable women at risk. 2. Administer a modified theory-based, peer-delivered, gender and culture-specific intervention that encourages women to reduce their high risk drug and sexual behaviors. 3. Assess the effectiveness of the interventions in reducing drug and sexual risk at 3 and 8 months post-intervention, controlling for baseline characteristics. 4. Evaluate the relative cost- effectiveness of each intervention. 5. Assess: a) incidence of HIV, Hepatitis B and C, syphilis, chlamydia and gonorrhea at 8 monthspost-intervention; b) change in HIVrisk and drug and alcohol use at 3 and 8 months post-intervention; c) the effect of psychopathology on behavior change at 8 months post-intervention; d) lifetime history of substance abuse and service utilization for mental and physical problems at baseline. 6. Disseminate findings to the scientific community, practitioners and community members.
*Peer Interventions to Reduce HIV Among Female Heavy Drinkers (Sister to Sister)
R01AA012111 (August 1, 1999 – April 30, 2006)
Previous work has demonstrated that alcohol use is associated with high-risk sexual activity and other substance abuse. The aims of this project were: (1) Recruit 720 out-of-treatment female problem drinkers, 18 to 40 years of age, for a randomized intervention trial aimed at reducing alcohol-related high risk sexual behaviors. (2) Administer a theory based peer-delivered gender and culturally-relevant intervention that is a modification of an earlier successful intervention used by these investigators with injectors and crack cocaine users. Women were randomly assigned to a standard intervention (HIV testing plus counseling), or to a standard intervention plus 4 2-hour risk reduction interventions conducted by both peers and allied health professionals. (3) Assess the effectiveness of the interventions in reducing high risk behaviors at 4 and 8 months. Cost effectiveness was also evaluated. The characteristics of those who maintained a low risk, maintained a high risk, stopped their risky behavior, increased their risk, or reduced their risk were assessed, where risk is defined as problem drinking, drinking in situations that could be hazardous (e.g. before or during sexual activity), unprotected sexual activity, and use of other substances. Other measures that affect behavior change and HIV incidence were evaluated such as symptoms of depression, PTSD, gambling, and antisocial personality disorder. (4) The intervention and findings were disseminated to the community.
2002-2003 Principal Investigator – Supplement to Women’s Alcohol/HIV Peer Intervention Project for STD testing
*Inhalant Abuse and Dependence (St. Louis sub-contract)
R01DA015984-04 (September 22, 2002 – June 30, 2005
PI: Ridenour, I: Cottler
Ongoing surveillance studies consistent suggest that inhalants are the fourth most prevalently used psychoactive substance. Inhalants are unique among drugs of abuse because they are legal for all ages, easily accessible, and inexpensive. Moreover, the immediate medical consequences of inhalant use, including respiratory problems, damage to the liver, heart, or brain, and even death, can be much more severe than the more prevalently used substances: tobacco, alcohol, and marijuana. Surveillance data indicate that inhalants generally are first used at a young age (consistently nearly 20% of 8th graders surveyed in the Monitoring the Future study report having used inhalants), suggesting that inhalant use may play a developmental role in use of other substances such as cocaine or opiates. Relative to other substances, however, very little is known about inhalant use and even less is known about inhalant abuse and dependence. Such data are critical to a relevant public health response and prevention efforts directed at inhalant misuse. For illustration, although a withdrawal syndrome for inhalants is absent from the DSM-IV, preliminary data collected in our laboratory suggest that inhalant withdrawal is experienced by some inhalant users. We proposed to develop Substance Abuse Module (SAM) questions specifically for the different types of inhalants (solvents, aerosols, gases, and nitrites) and to quantitatively estimate the psychometrics of a general inhalants category of abuse and dependence diagnoses, preliminarily study separate diagnoses for the different types of inhalants, investigate the occurrence of inhalant use-related abuse and dependence among users of inhalants, qualitatively explore the experiences of inhalant users relevant to their inhalant use (e.g., how did they learn about inhalants, did their inhalant use lead to trying other drugs), and to explore qualitatively parents’ and health care professionals’ knowledge of inhalants, consequences of use, and efforts to warn children of this danger. We also studied the comorbidity and age-of-onset of other substance use-related disorders among inhalant users. We proposed to address these issues by reanalyzing the WHO/NIDA/NIAAA Reliability and Validity of Substance Use Disorders data, conducting focus groups, and conducting a test-retest-validity study of abuse and dependence disorders in older adolescent and young adult inhalant users with questions regarding specific types of inhalants.
*Reliability of DSM-III-R and ICD-10 Substance Use Disorders
R01DA05585 (September 30, 1988 – February 28, 2003)
The proposed study determined the interrater reliability of and diagnostic agreements between DSM-III-R and ICD-10 psychoactive substance use disorders through personal interviews using the WHO/ADAMHA Composite International Diagnostic Interview Substance Abuse Module (CIDI-AM). A pilot study conducted by the applicant found good to excellent agreement for most DSM-III-R substance use disorders. In the proposed study a sample of 125 clinical and community substance abusers were interviewed with a test re-test design of two interviews per subject. After the second interview the interviews determined the reason for discrepant information. The analysis evaluated interrater reliability of DSM-III-R, and ICD-10 psychoactive substance disorders. The two systems were compared with respect to the dependence syndrome and hazardous use and abuse. Key indicators of dependence criteria such as loss of control, craving, salience and narrowing of repertoire were examined. Kappa statistics and 95% confidence intervals were calculated for all comparisons. It is expected that the findings from this study influenced future decisions about the diagnostic criteria for substance abuse and dependence.
Missouri Child and Adolescent Project (MOCAP), UNOCCAP Cooperative Agreement
U01MH54293 (September 30, 1994 – August 31, 1999)
In response to RFA MH 94009, UNO-CAP, this application proposed a 5-year study of 3900 4 to 17 year olds–3000 from the general population and 900 identified as in need of psychological assessment or treatment from six service sectors (mental health, juvenile justice, child welfare, education, general health, and substance abuse). The study determined rates of mental disorders and impairments, availability and use of mental health services, impediments to service usage, costs of service use, and outcomes of use or lack of use. The research, entitled Missouri Child and Adolescent Project (MOCAP), was conducted in the “Heartland of America” in areas with above average rates of mental illness risk indicators. The three specific target sampling areas selected were: the racially mixed rural Bootheel area of Missouri, and two areas in St. Louis City–one comprising the St. Louis proposed Federal Empowerment Zone (which meant a major infusion of resources to the City) and one outside the Zone. The methods built upon those of the NIMH-funded MECA studies. Suggested were a number of new methods and interests for a multisite study of children and adolescents such as: assessing mental disorder among 4 to 8 year olds with direct interviews; evaluating changes in mental health status over time; determining the cost of mental health services provided to children and adolescents; describing the patterns of referral to mental health services, barriers to care and satisfaction with services, and evaluating whether use is associated with perceived need. In addition, the MOCAP team proposed a study of the role of exposure to violence at home, in the media, and in neighborhoods on changes in mental health status; an investigation of the association between an adult informant’s mental health status with their report about the child, and a parallel study in Ontario where the health payment system is different. A 2-year followup assessment was proposed with another wave envisioned as part of a continuation. This study extended the research of an investigative team with great experience and interest in conducting large-scale, multisite epidemiologic studies, in developing psychiatric assessments, in nosological issues of psychiatric disorders, in assessing the reliability and validity of assessments, and in health services research. In addition, collectively, the team had the essential local and statewide networks needed for this exciting endeavor.
*EachOneTeachOne: St. Louis’ HIV Risk Reduction Study, Cooperative Agreement
U01DA008324-01 (August 1, 1993 – May 31, 1999)
With 16 Cooperative Agreement sites presently funded, America’s Midwest population remains underserved in HIV prevention efforts even though CDC data indicate significant rates of HIV/AIDS in Midwest cities. St. Louis, a metropolitan area with 15.3 AIDS cases per 100,000 and high rates of HIV risk behaviors, lacks intervention services which makes it fertile ground for an intervention study. Building upon established city-wide collaborations, the investigators proposed surveillance of the spread of HIV among out-of-treatment drug users and the implementation and evaluation of a peer-oriented program aimed at reducing HIV risk. The proposed new study, called EachOneTeachOne, followed the guidelines of the NIDA Cooperative Agreement. The Epidemiological Aims included assessing among out-of-treatment IDU and crack cocaine users recruited from two target areas: a) HIV seroprevalence; b) prevalence of HIV risk behaviors; c) prevalence of tuberculosis, hepatitis B and syphilis which have similar risk factors as HIV and are markers for the spread of HIV; d) stages of change; e) characteristics of peer networks, and f) symptoms of depression and antisocial personality disorder. The Evaluation Aims involved testing the efficacy of an enhanced peer-oriented intervention compared to a standard intervention for reducing HIV risk behaviors at a six month follow-up. Analyses included: a) a contrast of the enhanced intervention to the standard on reduction of HIV high-risk behaviors, peer network characteristics and stages of change, controlling for race and gender, and b) the association of depression and antisocial personality with these behaviors. To accomplish these aims the investigators: a) defined two areas of St. Louis which were at highest risk for IDU and AIDS as evidenced by DUF, DAWN, police arrest data, and public health reports of the prevalence of hepatitis B, syphilis, tuberculosis, HIV infection and AIDS; b) recruited 50 out-of-treatment IDU and crack cocaine users per month for 24 months through street outreach orchestrated from two St- Louis City Health Department satellite health centers, known as HealthStreet, which are located at the centers of the two areas; c) provided a standard HIV risk reduction intervention to 35 eligible subjects per month out of the 50 recruited; d) provided the enhanced intervention, in addition to the standard, to a minimum of 21 subjects per month randomly selected from the 35 recruited subjects; the enhanced program, which was designed to consist of a 4-week series called “Structured Chemical Free Experiences”, was cofacilitated by drug treatment program graduates and community professionals, and e) conducted a six-month follow-up assessment similar to the baseline on at least 85% of the randomized subjects. Outcome measures included changes in HIV risk behaviors, alcohol and drug use and problems from drug use, incidence of HIV, stages of change, peer network characteristics, and symptoms of depression and antisocial personality disorder.
1997-1999 Principal Investigator – Supplement for the Study of Drug Abuse and HIV/AIDS: Supplement to EachOneTeachOne Project
1994-1996 Principal Investigator – Women’s Prevention Study: Supplement to the EachOneTeachOne Project – from the Office of Research on Women’s Health (ORWH)
*St. Louis’ Efforts to Reduce the Spread of AIDS in IVDUs (ERSA)
R18DA06163 (September 30, 1989 – August 31, 1994)
The primary objective of this four and one half year city-wide research demonstration project was to attract an increased number of intravenous drug users (IVDUs) to enter treatment; to improve drug free and methadone maintenance treatment programs and to educate persons about how to reduce behaviors associated with the spread of HIV infection. In an effort to reach IVDUs not in treatment, a community street outreach program was also initiated. This research was conducted in St. Louis, an area with currently low prevalence of reported AIDS cases, and high prevalence of intravenous drug use (IVDU). Specifically, we proposed: (1) To establish new treatment slots for a methadone treatment and drug free treatment program located in the inner-city St. Louis area and to implement changes in their existing treatment protocols. (2) To recruit index subjects for a longitudinal study which (a) evaluated improvements in the programs, (b) compared the efficacy of drug free treatment vs. methadone maintenance, a culturally-specific program vs. a racially generic program, and aftercare vs. no aftercare. The outcomes assessed included: relapse to drug use, needle sharing and high risk sexual behaviors, program retention rate, employment, criminal activities and HIV seropositivity rates. (3) To identify individual characteristics which predict changes in outcomes among individuals regardless of treatment program. Specifically, through the use of standardized interviews, we evaluated family history, and pre-admission and follow-up characteristics such as past and current psychiatric symptoms, lifetime abuse of and dependence on drugs and alcohol, high risk sexual behaviors, knowledge of HIV transmission, and needle sharing behavior. (4) To develop a community street outreach program to reduce high risk behaviors among high risk substance abusers not in treatment and their sexual partners. We: (a) mapped areas of our city and county which are at high risk for illicit drug use and high risk sexual behaviors by imputation of data from the St. Louis Epidemiological Catchment Area survey; (b) collaborated with the Public Health Department to initiate a community street outreach program which operated in the identified high risk areas to distribute vouchers for drug treatment, to provide crisis intervention for addicts who become HIV positive, and provide educational materials concerning prevention of HIV infection and drug abuse, and (c) evaluated the efficacy of this outreach program. (5) To disseminate information gathered from this study to drug treatment programs and health officials in the Metropolitan St. Louis area. (6) To further improve drug treatment services by conducting ethnographic interviews with clients concerning reasons for staying in or dropping out of their programs; and to raise awareness by having Junior High School students produce rap music about preventing drug abuse. (7) To recruit the subjects from this study for participation in other Washington University AIDS research studies and clinical trials.
*Risk Factors for HIV Infection in Drug Users and Partners (SARA)
R01DA05619 (April 1, 1989 – September 28, 1994)
The objective of this project were (1) to study the prevalence of human immunodeficiency virus (HIV) infection among persons vulnerable for drug use in an area with relatively low prevalence of reported AIDS cases but with high prevalence of intravenous drug use (IVDU), (2) to evaluate the co-occurrence of behavioral and psychiatric factors, high risk drug use and sexual activity to better target public education efforts aimed at reducing HIV risk behaviors and (3) educate persons who are vulnerable to HIV infection on ways to change these behaviors. Specifically we proposed two studies: Study 1 1) Recruited index subjects for a longitudinal study of the prevalence of HIV infection among persons vulnerable to HIV infection. The sample included persons who were at varying risk such as prisoners, reforming female prostitutes, heroin and other intravenous drug users in methadone, drug free and other treatment, and non-parenteral drug users; 2) Recruited sexual partners to determine (a) HIV seropositivity rates among partners, (b) whether the substance use patterns of sexual partners were similar to those of the subjects, and (c) whether the psychiatric risk factors of sexual partners were similar to those of the subjects; 3) Evaluated the co-occurrence of the following HIV risk factors: DSM-III, III-R, and ICD-10 substance abuse and dependence, presence and severity of DSM-III and III-R past and current psychiatric symptoms; risk- taking personality traits; high risk sexual behaviors; knowledge of HIV transmission; and sociodemographic factors; 4) Identified (from #3 above) risk factors for, and protective factors against, IVDU and needle sharing; 5) Followed study subjects every twelve months through 04 to determine (a) seroconversion and (b) changes in risk behaviors; 6) Educated persons who were vulnerable to HIV infection on ways to change these behaviors or reduce their risk; 7a) Offered the subjects from this study the opportunity to participate in other Washington University AIDS research; 7b) Cross-analyzed the data from this proposed study with data collected from an eight-year follow-up of a subset of general population subjects (who have not sought treatment but have abused drugs) from the St. louis Epidemiologic Catchment Area (ECA) survey. Study 2 simultaneously conducted an in-depth longitudinal ethnographic study of needle sharing, high risk sexual behavior, and IV drug use among a subset of Study 1 subjects.
*Epidemiologic Catchment Area Program (ECA)
U01MH33883 (1980 – 1986)
PI: Robins, Co-PI: Helzer, Project Coordinator: Cottler
The Epidemiologic Catchment Area (ECA) program of research was initiated in response to the 1977 report of the President’s Commission on Mental Health. The purpose was to collect data on the prevalence and incidence of mental disorders and on the use of and need for services by the mentally ill. Independent research teams at five universities (Yale University, Johns Hopkins University, Washington University, Duke University, and University of California at Los Angeles), in collaboration with the National Institute for Mental Health, conducted the studies with a core of common questions and sample characteristics. The sites were areas that had previously been designated as Community Mental Health Center catchment areas: New Haven, Connecticut, Baltimore, Maryland, St. Louis, Missouri, Durham, North Carolina, and Los Angeles, California. Each site sampled over 3,000 community residents and 500 residents of institutions, yielding 20,861 respondents overall. The longitudinal ECA design incorporated two waves of personal interviews administered one year apart and a brief telephone interview in between (for the household sample). The diagnostic interview used in the ECA was the NIMH Diagnostic Interview Schedule (DIS), Version III (with the exception of the Yale Wave I survey, which used Version II). Diagnoses were categorized according to the Diagnostic And Statistical Manual Of Mental Disorders, 3rd Edition (DSM-III). Diagnoses derived from the DIS include manic episode, dysthymia, bipolar disorder, single episode major depression, recurrent major depression, atypical bipolar disorder, alcohol abuse or dependence, drug abuse or dependence, schizophrenia, schizophreniform, obsessive compulsive disorder, phobia, somatization, panic, antisocial personality, and anorexia nervosa. The DIS uses the Mini-Mental State Examination (MMSE), which measures cognitive functioning, as an indirect measure of the DSM-III Organic Mental Disorders. In the ECA survey, this diagnosis is called cognitive impairment.