DATA ACQUISITION And ANALYSIS CTR FOR BEHAVIORAL RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5U01HD033343-05 from National Institute Of Child Health And Human Development IRG: SRC
Abstract: This application, submitted by the Research Triangle Institute (RTI) in collaboration with the Frank Porter Graham Child Development Center at the University of North Carolina (FPG), is to serve as the Data Acquisition and Analysis Center (DAAC) for Phase II of the NICHD Study of Early Child Care (SECC) (RFAHD-95-004). The purpose of this collaborative study is to examine the relationship between child development and child care by conducting follow-up studies on a cohort of children who were recruited approximately five years ago in Phase I of this study. The broad roles of the DAAC in this study, are to have primary responsibility for collecting, editing, managing, storing and analyzing the study data collected at ten sites; to take an active role in refining and developing the study materials; to develop and implement data collection systems; to oversee quality control; to conduct training of site staff; to prepare periodic reports for the Steering Committee; to develop and implement communication systems between sites; to provide logistical support for the study; and to assist in the publication of study results. As the DAAC for the study, RTI/FPG will be involved in all phases of the project, working closely with the various study groups. During the first few months of the study, RTI/FPG will take an active role in refining the study materials (e.g., data forms) and will develop data collection systems (e.g., distributed data entry, computer assisted interviewing) in consultation with the Steering Committee. We will also pretest the data forms; train site personnel in all aspects of the study, including the data collection systems; and work with the sites to prepare for the start of data collection, including setting up the necessary quality control procedures. We will then implement computer systems to receive, process, edit, and store data received from the sites. We will also implement systems for monitoring completeness, accuracy, and timeliness of site data, and for timely communication to the Steering Committee. We will conduct site visits on a periodic basis to each site and will perform statistical analysis of the accumulating data and report the results of this analysis on a regular basis to the appropriate study groups. Upon conclusion of the studies data collection, the DAAC will assist sites with study closeout, continue to prepare appropriate reports to monitor all aspects of the study, prepare a final documented computer tape of study data and collaborate with study investigators in the preparation of manuscripts for publication and presentation. In addition, we will provide logistic support to the study in arranging meetings and telephone conferences, prepare agenda and minutes of these meeting and calls, and other related support functions as requested. We are also prepared to provide child development and economic input to all phases of the study including assuring that the necessary data are collected to address the study objectives. Our proposed data collection and data processing systems involve well developed data entry, communications and data management software used on many previous multisite studies. Training of site staff also follows well established methods used on several previous multisite studies. The proposed DAAC staff have extensive experience in cooperative multisite studies which we have been conducting for over 20 years and includes a strong interdisciplinary team with expertise in statistics, developmental psychology, economics, data management, site monitoring, study materials design, and coordination and administration of multisite studies.
Keywords: child (0-11), child care, computer data analysis, data collection methodology /evaluation, growth /development, child psychology, computer program /software, information system, language development, longitudinal human study, statistics /biometry, behavioral /social science research tag, human subject, interview, questionnaire, videotape /videodisc
Project start date: 1995-08-15
Project end date: 2000-02-29
5U01HD033343-05 (1999): $1393616
Sponsored Links Excellgen http://Excellgen.com
DATA ACQUISITION And ANALYSIS CENTER FOR BEHAVIORAL RESEAR
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5U01HD033343-09 from National Institute Of Child Health And Human Development IRG: ZHD1
Abstract: This competing continuation is submitted by the Research Triangle Institute (RTI) and the Frank Porter Graham Child Development Center at the University of North Carolina (FPG) to serve as the Data Acquisition and Analysis Center (DAAC) for the NICHD Phase III study of Early Child Care (SECC). Phases I and II (1990- 2000) of the study recruited and followed a cohort of infants through the second grade. Phase III (2000-2004) involves follow- up studies on the cohort of over 1,000 children through the sixth grade. The purpose of this collaborative study is to examine the relationships between child development and child care during infancy and childhood. A strong team of researchers led by Drs. T.D. Hartwell and Margaret Burchinal, the proposed PI and Co-PI, will provide senior statistical leadership and state-of-the-art data collection and data management to the study. An experienced staff of statisticians, data coordinators, developmental psychologists, statistical and database programmers, and support staff will support the study at the DAAC. The majority of this staff have been involved with the study for several years. As the DAAC for the study, RTI/FPG will work closely with the various SECC study groups and will assist in materials development (e.g., data forms, and manuals of operation), training and certification of research site staff, designing and implementing quality control procedures for data collection, developing and implementing data collection systems (e.g., remote data entry, web data entry, computer assisted interviewing), tracking and reporting on the progress of data collection, managing all study data, and conducting site visits to all research sites. The DAAC will work with the study investigators to analyze the accumulating study data and will assist in the preparation of manuscripts for publication and presentation. In addition, we will provide logistical support for the study in arranging meetings and telephone conferences, provide minutes of these meetings and calls, distribute study materials, and provide other related support functions as requested by the NICHD project scientist. We also propose to set up a project web site to assist with study communications and error resolution. Finally, we will document and provide SECC data to outside investigators as directed by NICHD and the study Steering Committee.
Keywords: child care, computer data analysis, data collection methodology /evaluation, growth /development, child psychology, computer program /software, information system, longitudinal human study, statistics /biometry, behavioral /social science research tag, child (0-11), human subject, interview, questionnaire, videotape /videodisc
Project start date: 1995-08-15
Project end date: 2004-12-31
5U01HD033343-09 (2003): $1791583
5U01HD033343-08 (2002): $1780513
DATA ACQUISITION And ANALYSIS CTR FOR BEHAVIORAL RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5U01HD033343-07 from National Institute Of Child Health And Human Development IRG: ZHD1
Abstract: This competing continuation is submitted by the Research Triangle Institute (RTI) and the Frank Porter Graham Child Development Center at the University of North Carolina (FPG) to serve as the Data Acquisition and Analysis Center (DAAC) for the NICHD Phase III study of Early Child Care (SECC). Phases I and II (1990- 2000) of the study recruited and followed a cohort of infants through the second grade. Phase III (2000-2004) involves follow- up studies on the cohort of over 1,000 children through the sixth grade. The purpose of this collaborative study is to examine the relationships between child development and child care during infancy and childhood. A strong team of researchers led by Drs. T.D. Hartwell and Margaret Burchinal, the proposed PI and Co-PI, will provide senior statistical leadership and state-of-the-art data collection and data management to the study. An experienced staff of statisticians, data coordinators, developmental psychologists, statistical and database programmers, and support staff will support the study at the DAAC. The majority of this staff have been involved with the study for several years. As the DAAC for the study, RTI/FPG will work closely with the various SECC study groups and will assist in materials development (e.g., data forms, and manuals of operation), training and certification of research site staff, designing and implementing quality control procedures for data collection, developing and implementing data collection systems (e.g., remote data entry, web data entry, computer assisted interviewing), tracking and reporting on the progress of data collection, managing all study data, and conducting site visits to all research sites. The DAAC will work with the study investigators to analyze the accumulating study data and will assist in the preparation of manuscripts for publication and presentation. In addition, we will provide logistical support for the study in arranging meetings and telephone conferences, provide minutes of these meetings and calls, distribute study materials, and provide other related support functions as requested by the NICHD project scientist. We also propose to set up a project web site to assist with study communications and error resolution. Finally, we will document and provide SECC data to outside investigators as directed by NICHD and the study Steering Committee.
Keywords: child care, computer data analysis, data collection methodology /evaluation, growth /development, child psychology, computer program /software, information system, longitudinal human study, statistics /biometry, behavioral /social science research tag, child (0-11), human subject, interview, questionnaire, videotape /videodisc
Project start date: 1995-08-15
Project end date: 2004-12-31
5U01HD033343-07 (2001): $1280062
5U01HD033343-04 (1998): $1144704
5U01HD033343-03 (1997): $1190536
5U01HD033343-02 (1996): $1030293
Grants awarded to Tyler D Hartwell
NIMH COLLABORATIVE HIV/STD PREVENTION TRIAL
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 3U10MH061537-04S1 from National Institute Of Mental Health IRG: ZMH1
Abstract: This proposal is submitted by Research Triangle Institute (RTI) to serve as the Data Coordinating Center (DCC) for the NIMH Collaborative HIV/STD Prevention Trial. A strong team of scientists led by Dr. T.D. Hartwell, the proposed PI, will provide overall study coordination, including study design, data management, and statistical analysis, materials development, biological specimen collection, and training in common procedures. An experienced staff of statisticians, programmers, ethnographers, data coordinators, biological specimen, laboratory, and international specialists have been assembled to support the trial. All of this staff have a great deal of experience in coordinating multicenter studies. We proposed to use ACASI to collect the majority of the data for the study. RTI has been a pioneer in the development and use of this method of data collection. Our communications network will be built around e-mail and a project web site which will be used to disseminate project reports and other information whenever possible. We propose to purchase all of the computer equipment for the trial, to coordinate training site staff in each country in assessment procedures and intervention delivery, to assist in tracking, training, and quality control for biological specimen collection to assist in coordinating and analyzing data for the ethnographic studies, to assist in materials development, to analyze the study data and to assist in manuscript preparation. In addition, RTI will provide logistic support for the entire study. This includes setting up conference calls and meetings, taking minutes at these meetings, and distributing study materials (e.g., protocols, data forms, and manuals of operation). We also will hire on-site data collection coordinators in each country and will use RTI regional specialists who are located throughout the world to assist with training and site visits.
Keywords: AIDS education /prevention, computer data analysis, data collection methodology /evaluation, disease /disorder prevention /control, information dissemination, sexually transmitted disease, statistics /biometry, Internet, clinical trial, cooperative study, culture, online computer, sex education, training, behavioral /social science research tag, clinical research, human data, human subject, meeting /conference /symposium, publication, sample collection
Project start date: 1999-09-30
Project end date: 2004-08-31
3U10MH061537-04S1 (2003): $611410
5U10MH061537-05 (2003): $2019024
5U10MH061537-03 (2001): $2127316
5U10MH061537-02 (2000): $2331454
1U10MH061537-01 (1999): $697317
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5U01HD040636-06 from National Institute Of Child Health And Human Development IRG: ZHD1
Abstract: This proposal is submitted by Research Triangle Institute (RTI) and the University of North Carolina (UNC) to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women s and Children s Health Research. A strong team of scientists including the proposed PI, Dr. T.D. Hartwell, and Co-PIs, Drs. Rao and Poole of RTI, and faculty from UNC will lead the project and will provide overall study coordination, including study design, data management, statistical analysis, materials development, biological specimen collection, training in common procedures, implementation of quality control procedures, and expertise in maternal and child health. An experienced staff of statisticians, programmers, data coordinators, epidemiologist, medical anthropologists and international and maternal and child health specialists have been assembled to support the Network. All of this staff have a great deal of experience in coordinating multicenter studies. We propose to have an Internal Management Committee oversee the DCC operations for the Network which will set up DCC Protocol Teams to work with Network Investigators on each protocol. We proposed to use computer assisted data collection methods to collect the majority of the data for the various Network protocols (e.g., Distributed Data Entry). We have used these methods in many multisite studies. Our communications network will be built around e-mail and a project web site which will be used to disseminate project reports and other information whenever possible. We propose to assist Research Units in purchasing computer equipment for the study, to coordinate training site staff in each country in assessment procedures and intervention delivery, to assist in tracking, training, and quality control for biological specimen collection, to assist in coordinating and analyzing data for qualitative studies, to assist in materials development, to analyze the study data and to assist in manuscript preparation. In addition, RTI/UNC will provide logistic support for the entire study. This includes setting up conference calls and meetings, taking minutes at these meetings, and distributing study materials. We also will hire on-site data collection coordinators in each country.
Keywords: mother /infant health care, statistical service /center, cooperative study, data collection, data management, experimental design, international health /scientific organization, clinical research, female, human data, women s health
Project start date: 2001-08-17
Project end date: 2007-04-30
5U01HD040636-06 (2006): $1185690
5U01HD040636-05 (2005): $3142459
5U01HD040636-04 (2004): $3058715
5U01HD040636-03 (2003): $3154471
GLOBAL NETWORK FOR WOMEN´S & CHILDREN´S HEALTH RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 1U01HD040636-01 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development IRG: ZHD1
Abstract: This proposal is submitted by Research Triangle Institute (RTI) and the University of North Carolina (UNC) to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women´s and Children´s Health Research. A strong team of scientists including the proposed PI, Dr. T.D. Hartwell, and Co-PIs, Drs. Rao and Poole of RTI, and faculty from UNC will lead the project and will provide overall study coordination, including study design, data management, statistical analysis, materials development, biological specimen collection, training in common procedures, implementation of quality control procedures, and expertise in maternal and child health. An experienced staff of statisticians, programmers, data coordinators, epidemiologist, medical anthropologists and international and maternal and child health specialists have been assembled to support the Network. All of this staff have a great deal of experience in coordinating multicenter studies. We propose to have an Internal Management Committee oversee the DCC operations for the Network which will set up DCC Protocol Teams to work with Network Investigators on each protocol. We proposed to use computer assisted data collection methods to collect the majority of the data for the various Network protocols (e.g., Distributed Data Entry). We have used these methods in many multisite studies. Our communications network will be built around e-mail and a project web site which will be used to disseminate project reports and other information whenever possible. We propose to assist Research Units in purchasing computer equipment for the study, to coordinate training site staff in each country in assessment procedures and intervention delivery, to assist in tracking, training, and quality control for biological specimen collection, to assist in coordinating and analyzing data for qualitative studies, to assist in materials development, to analyze the study data and to assist in manuscript preparation. In addition, RTI/UNC will provide logistic support for the entire study. This includes setting up conference calls and meetings, taking minutes at these meetings, and distributing study materials. We also will hire on-site data collection coordinators in each country
Keywords: mother /infant health care, statistical service /center cooperative study, data collection, data management, experimental design, international health /scientific organization clinical research, female, human data, women`s health
Project start date: 2001-08-17
Project end date: 2006-04-30
1U01HD040636-01 (2001): $2748884
Sponsored Links Excellgen http://Excellgen.com
DATA ACQUISITION & ANALYSIS CTR FOR BEHAVIORAL RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 2U01HD033343-06 from National Institute Of Child Health And Human Development IRG: ZHD1
Abstract: This competing continuation is submitted by the Research Triangle Institute (RTI) and the Frank Porter Graham Child Development Center at the University of North Carolina (FPG) to serve as the Data Acquisition and Analysis Center (DAAC) for the NICHD Phase III study of Early Child Care (SECC). Phases I and II (1990- 2000) of the study recruited and followed a cohort of infants through the second grade. Phase III (2000-2004) involves follow- up studies on the cohort of over 1,000 children through the sixth grade. The purpose of this collaborative study is to examine the relationships between child development and child care during infancy and childhood. A strong team of researchers led by Drs. T.D. Hartwell and Margaret Burchinal, the proposed PI and Co-PI, will provide senior statistical leadership and state-of-the-art data collection and data management to the study. An experienced staff of statisticians, data coordinators, developmental psychologists, statistical and database programmers, and support staff will support the study at the DAAC. The majority of this staff have been involved with the study for several years. As the DAAC for the study, RTI/FPG will work closely with the various SECC study groups and will assist in materials development (e.g., data forms, and manuals of operation), training and certification of research site staff, designing and implementing quality control procedures for data collection, developing and implementing data collection systems (e.g., remote data entry, web data entry, computer assisted interviewing), tracking and reporting on the progress of data collection, managing all study data, and conducting site visits to all research sites. The DAAC will work with the study investigators to analyze the accumulating study data and will assist in the preparation of manuscripts for publication and presentation. In addition, we will provide logistical support for the study in arranging meetings and telephone conferences, provide minutes of these meetings and calls, distribute study materials, and provide other related support functions as requested by the NICHD project scientist. We also propose to set up a project web site to assist with study communications and error resolution. Finally, we will document and provide SECC data to outside investigators as directed by NICHD and the study Steering Committee.
Keywords: child care, computer data analysis, data collection methodology /evaluation, growth /development, child psychology, computer program /software, information system, longitudinal human study, statistics /biometry, behavioral /social science research tag, child (0-11), human subject, interview, questionnaire, videotape /videodisc
Project start date: 1995-08-15
Project end date: 2004-12-31
2U01HD033343-06 (2000): $1699143
International Epi Databases To Evaluate AIDS (IEDEA) In Central Africa (Region 9)
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5U01AI069927-02 from National Institute Of Allergy And Infectious Diseases IRG: ZAI1
Abstract: This application proposes to establish an International Epidemiologic Database to Evaluate AIDS (IEDEA) Regional Center to harmonize HIV data and data collection in Region 9 - Central Africa. A Regional Data Center, backstopped by Research Triangle International (RTI), Research Triangle Park, North Carolina will be located in Kinshasa, Democratic Republic of Congo (DRC) at the University of North Carolina/DRC UNC/DRC) HIV/AIDS Clinical Research Unit at the Kinshasa School of Public Health. This multi-step research and capacity building process will occur through regional expansion/reinforcement of the existing partnership between the UNC s School of Public Health, the Kinshasa School of Public Health, RTI and the DR Congo s Programme National Multisectoriel de Lutte centre le SIDA (PNMLS). Additional international collaborators are (1) Institute of Tropical Medicine in Antwerp, Belgium; (2) Institut National d Etudes Demographiques Research Unites Mortalite Sante Epidemiologie et Population and Developpement, Paris, France; (3) Institut de Recherche pour le Developpement and Department of International Health, University of Montpellier, Montpellier France. Region 9 collaborators from Burundi, Cameroon, Central African Republic, Congo/Brazzaville, Democratic Republic of Congo, and Rwanda include HIV/AIDS clinicians /care providers, representatives of national HIV programs, and faculty from national medical schools. Our regional consortium has 20,200 patients currently on ARV s in a database and are following an additional 46,000 HIV-infected individuals who are not yet eligible to receive ART treatment. Harmonization of data across our region is the initial goal. When this is in place, our proposed research agenda will include (1) Identify new region-appropriate models of HIV care and systems for monitoring its efficacy; (2) Monitor sentinel populations for ARV resistance; (3) Determine the role the high rate of genetic diversity for HIV seen in this region plays on ARV resistance.
Keywords: AIDS, Africa, art, information system, Brazil, Europe, France, HIV infection, aging, alternative medicine, base, birth, cell, chemotherapy, children, choice, classification, community, conditioning, cost effectiveness, data collection, death, diagnosis, disease /disorder prevention /control, disease outbreak, drug resistance, drug screening /evaluation, emotion, experience, face, gait, genetics, gold, head, health, health care, human, infection, insight, lead, lighting, malaria, malnutrition, medical record, model, nucleotide, opportunistic infection, pharmacy, play, prevention, public health, quality of life, recombinant virus, reduction, reverse transcriptase inhibitor, role, school, sectioning, success, suppression, teacher, therapy, thinking, training, tropical medicine, tuberculosis, university, urban area, virus, vital statistics, clinical research
Project start date: 2006-07-01
Project end date: 2011-06-30
5U01AI069927-02 (2007): $1242247
1U01AI069927-01 (2006): $1032010
COMMUNITY CLINICAL TRIAL FOR HEAVY SMOKERS
Tyler D Hartwell
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 5N01CN064096-01087 from Division Of Cancer Prevention And Control
Abstract: The Smoking, Tobacco, and Cancer Program (STCP), Division Cancer Prevention and Control (DCPC), of the National Cancer Institute (NCI) is establishing the multi-cneter Community Clinical Trial for Heavy Smokers as cooperative research program to test strategies for heavy smokers (smoking 25 of more cigarettes per day) that (1) are effective in obtaining long term cessation; (2) are practical to implement on a large scale basis; and (3) employ a community intervention approach, working through major organizations and social institutions capable of influencing smoking behavior in large groups of people. The trial will involve eight Community Intervention Centers, (CIC) each contributing a matched pair of communities, with communities within each pair randomized to either the intervention or the control condition. The trial will be conducted in three phases Phase I, a 12-month planning and protocol development phase; Phase II, a 60-month intervention and evaluation phase; and Phase III, a 18-month analysis phase. Following the approval of the Phase I defined protocol by the STCP, DCPC, NCI, and its Board of Scientific counselors, Phases II and III will be initiated. Only those CIC who are able to fully implement the Phase II protocol will be continued into Phases II and III. These additional three alternate sites will be included in Phase I only as a technical safeguard against the loss of one of the 8 primary CICs on statistical reconsiderations that could require the expansion of the trial to more than 8 CICs.
Keywords: cancer information system, cancer prevention, cancer risk, community health service, tobacco abuse prevention, clinical study /trial, longitudinal human study, human clinical subject
MULTISITE TRIALS OF BEHAVIORAL STRATEGIE TO PREVENT HI
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 3U10MH048008-05S4 from National Institute Of Mental Health IRG: SRCM
Abstract: The purpose of this application, submitted by the Research Triangle Institute (RTI), is to participate i proposed (RFA MH-90-06) Cooperative Agreement for Multi-Site Trials of Behavioral Strategies to Preven Further Spread of BEIV Infection in the role of the Coordinating Center (CC). The purpose of the cooperative agreement is to generate critical information for the development of m of prevention that can be applied to diverse populations at risk for HIV infection. The CC in this study expected to provide overall study coordination, including data management and statistical analysis, traini common procedures, and distribution of necessary study materials to all study sites. A five year multi collaborative study, divided into three phases, is envisaged. As the CC for the study, RTI will be involved in several aspects of the project. During the first phase study (first 12 months), RTI will contribute to the development of the plans for the common research d through the participation of their investigators in a leadership role in the development of the statistical as of the study design(s), procedures for field data collection, data processing and data analysis, quality control coordination and management of the studies. During Phase II, expected to last for 24 months, RTI contribute to the development and testing of evaluation procedures (enrollment procedures, data colle instruments, data acquisition procedures, procedures for processing, analyzing and reporting of the results monitoring the conduct of the studies). During Phase III, expected to last another 2 years, RTI staff involved in monitoring the studies, developing and maintaining the common data repository, processin analyzing the data and reporting the results of the studylies) to the Steering Committee and the Monitoring Board. In addition RTI will provide logistic support to the NIMH Program Office and the Steering Committee in arranging meetings of the group, arranging for minutes of the Committee meetings and related staff support functions. These efforts will be carried out in close collaboration with the Steering Committee and the NIMH staff. The proposed data collection and data processing systems are based on a distributed data entry syste involves using well developed data entry, communications and data management software currently being on similar studies by RII staff. Training of Research Group staff to ensure standardization of procedures a sites will also follow well established methods used on several previous multi-site studies. The proposed CC staff have extensive experience in cooperative multi-site studies which the Institu been conducting for over eighteen years and includes a strong interdisciplinary team of biostatisticia psychologist, an epidemiologist, computer systems analysts, a health educator, and a data coordinator
Keywords: AIDS, AIDS education /prevention, HIV infection, behavior modification, data collection, health science research analysis /evaluation, information system communicable disease transmission, disease /disorder prevention /control, disease /disorder proneness /risk, homosexual, intravenous drug abuse, patient /disease registry behavioral /social science research tag, human subject, statistics /biometry
Project start date: 1990-09-30
Project end date: 1999-08-31
3U10MH048008-05S4 (1997): $640944
5U10MH048008-05 (1994): $670480
MULTI-SITE TRIALS OF BEHAVIORAL STRATEGIE TO PREVENT HI
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 5U10MH048008-04 from National Institute Of Mental Health IRG: SRCM
Abstract: The purpose of this application, submitted by the Research Triangle Institute (RTI), is to participate i proposed (RFA MH-90-06) Cooperative Agreement for Multi-Site Trials of Behavioral Strategies to Preven Further Spread of BEIV Infection in the role of the Coordinating Center (CC). The purpose of the cooperative agreement is to generate critical information for the development of m of prevention that can be applied to diverse populations at risk for HIV infection. The CC in this study expected to provide overall study coordination, including data management and statistical analysis, traini common procedures, and distribution of necessary study materials to all study sites. A five year multi collaborative study, divided into three phases, is envisaged. As the CC for the study, RTI will be involved in several aspects of the project. During the first phase study (first 12 months), RTI will contribute to the development of the plans for the common research d through the participation of their investigators in a leadership role in the development of the statistical as of the study design(s), procedures for field data collection, data processing and data analysis, quality control coordination and management of the studies. During Phase II, expected to last for 24 months, RTI contribute to the development and testing of evaluation procedures (enrollment procedures, data colle instruments, data acquisition procedures, procedures for processing, analyzing and reporting of the results monitoring the conduct of the studies). During Phase III, expected to last another 2 years, RTI staff involved in monitoring the studies, developing and maintaining the common data repository, processin analyzing the data and reporting the results of the studylies) to the Steering Committee and the Monitoring Board. In addition RTI will provide logistic support to the NIMH Program Office and the Steering Committee in arranging meetings of the group, arranging for minutes of the Committee meetings and related staff support functions. These efforts will be carried out in close collaboration with the Steering Committee and the NIMH staff. The proposed data collection and data processing systems are based on a distributed data entry syste involves using well developed data entry, communications and data management software currently being on similar studies by RII staff. Training of Research Group staff to ensure standardization of procedures a sites will also follow well established methods used on several previous multi-site studies. The proposed CC staff have extensive experience in cooperative multi-site studies which the Institu been conducting for over eighteen years and includes a strong interdisciplinary team of biostatisticia psychologist, an epidemiologist, computer systems analysts, a health educator, and a data coordinator
Project start date: 1990-09-30
Project end date: 1995-08-31
5U10MH048008-04 (1993): $656025
5U10MH048008-03 (1992): $666948
MULTISITE TRIALS OF BEHAVIORAL STRATEGIES TO PREVENT HIV
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 3U10MH048008-05S3 from National Institute Of Mental Health IRG: SRCM
Abstract: The purpose of this application, submitted by the Research Triangle Institute (RTI), is to participate i proposed (RFA MH-90-06) Cooperative Agreement for Multi-Site Trials of Behavioral Strategies to Preven Further Spread of BEIV Infection in the role of the Coordinating Center (CC). The purpose of the cooperative agreement is to generate critical information for the development of m of prevention that can be applied to diverse populations at risk for HIV infection. The CC in this study expected to provide overall study coordination, including data management and statistical analysis, traini common procedures, and distribution of necessary study materials to all study sites. A five year multi collaborative study, divided into three phases, is envisaged. As the CC for the study, RTI will be involved in several aspects of the project. During the first phase study (first 12 months), RTI will contribute to the development of the plans for the common research d through the participation of their investigators in a leadership role in the development of the statistical as of the study design(s), procedures for field data collection, data processing and data analysis, quality control coordination and management of the studies. During Phase II, expected to last for 24 months, RTI contribute to the development and testing of evaluation procedures (enrollment procedures, data colle instruments, data acquisition procedures, procedures for processing, analyzing and reporting of the results monitoring the conduct of the studies). During Phase III, expected to last another 2 years, RTI staff involved in monitoring the studies, developing and maintaining the common data repository, processin analyzing the data and reporting the results of the studylies) to the Steering Committee and the Monitoring Board. In addition RTI will provide logistic support to the NIMH Program Office and the Steering Committee in arranging meetings of the group, arranging for minutes of the Committee meetings and related staff support functions. These efforts will be carried out in close collaboration with the Steering Committee and the NIMH staff. The proposed data collection and data processing systems are based on a distributed data entry syste involves using well developed data entry, communications and data management software currently being on similar studies by RII staff. Training of Research Group staff to ensure standardization of procedures a sites will also follow well established methods used on several previous multi-site studies. The proposed CC staff have extensive experience in cooperative multi-site studies which the Institu been conducting for over eighteen years and includes a strong interdisciplinary team of biostatisticia psychologist, an epidemiologist, computer systems analysts, a health educator, and a data coordinator.
Keywords: AIDS, AIDS education /prevention, HIV infection, behavior modification, data collection, health science research analysis /evaluation, information system, communicable disease transmission, disease /disorder prevention /control, disease /disorder proneness /risk, homosexual, intravenous drug abuse, patient /disease registry, behavioral /social science research tag, human subject, statistics /biometry
Project start date: 1990-09-30
Project end date: 1999-08-31
3U10MH048008-05S3 (1996): $815512
MULTISITE TRIALS OF BEHAVIORAL STRATEGIE TO PREVENT HI
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 3U10MH048008-05S2 from National Institute Of Mental Health IRG: SRCM
Abstract: The purpose of this application, submitted by the Research Triangle Institute (RTI), is to participate i proposed (RFA MH-90-06) Cooperative Agreement for Multi-Site Trials of Behavioral Strategies to Preven Further Spread of BEIV Infection in the role of the Coordinating Center (CC). The purpose of the cooperative agreement is to generate critical information for the development of m of prevention that can be applied to diverse populations at risk for HIV infection. The CC in this study expected to provide overall study coordination, including data management and statistical analysis, traini common procedures, and distribution of necessary study materials to all study sites. A five year multi collaborative study, divided into three phases, is envisaged. As the CC for the study, RTI will be involved in several aspects of the project. During the first phase study (first 12 months), RTI will contribute to the development of the plans for the common research d through the participation of their investigators in a leadership role in the development of the statistical as of the study design(s), procedures for field data collection, data processing and data analysis, quality control coordination and management of the studies. During Phase II, expected to last for 24 months, RTI contribute to the development and testing of evaluation procedures (enrollment procedures, data colle instruments, data acquisition procedures, procedures for processing, analyzing and reporting of the results monitoring the conduct of the studies). During Phase III, expected to last another 2 years, RTI staff involved in monitoring the studies, developing and maintaining the common data repository, processin analyzing the data and reporting the results of the studylies) to the Steering Committee and the Monitoring Board. In addition RTI will provide logistic support to the NIMH Program Office and the Steering Committee in arranging meetings of the group, arranging for minutes of the Committee meetings and related staff support functions. These efforts will be carried out in close collaboration with the Steering Committee and the NIMH staff. The proposed data collection and data processing systems are based on a distributed data entry syste involves using well developed data entry, communications and data management software currently being on similar studies by RII staff. Training of Research Group staff to ensure standardization of procedures a sites will also follow well established methods used on several previous multi-site studies. The proposed CC staff have extensive experience in cooperative multi-site studies which the Institu been conducting for over eighteen years and includes a strong interdisciplinary team of biostatisticia psychologist, an epidemiologist, computer systems analysts, a health educator, and a data coordinator.
Keywords: AIDS, AIDS education /prevention, HIV infection, behavior modification, data collection, health science research analysis /evaluation, information system, communicable disease transmission, disease /disorder prevention /control, disease /disorder proneness /risk, homosexual, intravenous drug abuse, patient /disease registry, behavioral /social science research tag, human subject, statistics /biometry
Project start date: 1990-09-30
Project end date: 1999-08-31
3U10MH048008-05S2 (1995): $362561
Sponsored Links Excellgen http://Excellgen.com
3U10MH048008-05S1 (1994): $806385
NIMH Collaborative HIV/STD Prevention Trial
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 5U10MH061537-08 from National Institute Of Mental Health IRG: ZMH1
Abstract: RTI International (RTI) proposes to serve as the Data Coordinating Center (DCC) for the continuation of the NIHM-sponsored Collaborative HIV/STD Prevention Trial that is underway in five international sites. A strong team of scientists including the proposed PI, Dr. T.D. Hartwell, Co-PIs, Deborah McFadden and Lisa Strader, and faculty from Johns Hopkins (JH) and University of Arizona (AU) will lead the project and will provide overall study coordination, including study design, data collection and management, statistical analysis, materials development, biological specimen collection, training in common procedures, and implementation of quality control procedures. An experienced staff of statisticians, systems analysts and programmers, project managers, biological specimen experts, information technologists, and survey specialists who have been coordinating the trial for the past 4? years are available to continue to support the trial. All of these members have many years of experience in coordinating multicenter studies. We propose to continue to use computer-assisted personal interviews (CAPI) to collect the majority of the behavioral data for the study and to have Johns Hopkins University staff continue to oversee the collection of all biological data in the five sites. Our information technology network, which is based on a local area network (LAN) in each site consisting of a computer server, ethernet switch, a connection to the Internet and desktop and laptop computers, will continue to be used. We propose to continue to upgrade computer equipment as needed at each site, to coordinate training site staff in assessment procedures and intervention delivery, to develop new CAPI programs for the follow-up studies, to assist in tracking, to conduct training and quality control for biological specimen collection including periodic site visits, to assist in materials development, to analyze the study data and to report regularly to the Steering Committee and Data Safety and Monitoring Board on the results of these analyses, and to assist in manuscript preparation. In addition, as in the past, RTI will provide logistic support for the entire Trial. This includes setting up all conference calls and meetings, taking minutes at these meetings, and distributing study materials (e.g., protocols and study manuals) to all U.S. and international sites. We will also visit each international site each year to provide training and quality control
Keywords: AIDS education /prevention, computer data analysis, data collection, data management, disease /disorder prevention /control, human therapy evaluation, information dissemination, sexually transmitted disease, statistics /biometry Internet, clinical trial, cooperative study, culture, international cooperation, online computer, sex education, training behavioral /social science research tag, human data, human subject, meeting /conference /symposium, patient oriented research, publication, sample collection
Project start date: 1999-09-30
Project end date: 2008-08-31
5U10MH061537-08 (2006): $1702866
5U10MH061537-07 (2005): $2161813
2U10MH061537-06 (2004): $1818243
Global Network Data Coordinating Center
Tyler D Hartwell, Senior Program Director
Research Triangle Institute Box 12194, 3040 Cornwallis Rd Research Triangle Park, Nc 277092194
Grant 2U01HD040636-07 from National Institute Of Child Health And Human Development IRG: ZHD1
Abstract: Research Triangle Institute (RTI) proposes to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women s and Children s Health Research (GN). The strong, experienced team of scientists who have led the GN DCC for the past 5 years will continue this effort. Responsibilities of the DCC will include (1) coordinating overall study activities; (2) providing biostatistical and data management leadership; (3) participating in study design and protocol development; (4) developing data management systems (DMSs); (5) collaborating in developing study materials (e.g., data forms) and overseeing translation of these materials into appropriate languages; (6) developing and implementing quality control systems; (7) assisting in training Research Unit (RU) personnel in study procedures, including use of the DMSs; (8) developing capacity for research at the RUs by training RU staff in research methodology, data management, and statistical analysis and assisting them in writing DMSs and in publishing study results; (9) continuing to manage study-wide communications and logistics; (10) assisting RUs (if appropriate) in biological specimen collection; (11) organizing and coordinating Steering Committee (SC) and Data and Safety Monitoring Board (DSMB) meetings; (12) producing routine and special reports that meet the needs of the RUs, NICHD, the SC, and the DSMB; and (13) assisting in disseminating results of the GN studies through publication and presentations. All proposed RTI staff have been involved in carrying out the above responsibilities for the GN, including the PI, Tyler Hartwell, Ph.D., and Co-Pis Vijaya Rao, Ph.D., and Elizabeth McClure, M.Ed. Drs. Hartwell and Rao each have over 30 years of experience in leading DCCs for NIH multicenter studies, including international studies. We will use an Internal Management Committee to oversee the DCC operations and assign a DCC Protocol Team to work with GN investigators on each new protocol. We will use the existing IT structures, developed over the past 5 years, to collect and transmit study data to RTI from RU sites continuing in the Network, including hardware, software, and the on-site IT expert and data manager to assist in maintaining the systems. For new RUs, we will assist in purchasing the computer equipment required for data collection, management, and transmission and will help train new RU site staff to manage the systems developed. Our communications network will again be built around conference calls, e-mail, and the project website that disseminates project reports and study materials. During the first year of the project, RTI will collaborate with RU staff and NICHD to finish publications from single site protocols from the first phase of the study, complete data collection on the FIRST BREATH multicenter protocol, and begin developing additional common protocols for randomized clinical trials.
Project start date: 2001-08-17
Project end date: 2012-04-30
2U01HD040636-07 (2007): $2175573
3U01HD040636-09S2 (2010): $321534
5U01HD040636-10 (2010): $1373972
5U01HD040636-09 (2009): $1363038
3U01HD040636-09S1 (2009): $142436
PREVALENCE AND IMPACT OF EMPLOYEE ASSISTANCE PROGRAMS
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 5R01DA007250-04 from National Institute On Drug Abuse IRG: DAPA
Abstract: Research is needed to determine the prevalence of and to evaluate employee assistance programs (EAPs) for substance-abusing workers. This information will guide employers to establish the appropriate EAP for their work site. We propose a study to determine work site EAP prevalence and profiles and to evaluate EAP models. We will examine EAP costs and outcomes and compare EAP models across various industries and work sites. Our Methodology has three components a baseline national survey, case studies, and a follow-up national survey. The national surveys will focus on EAP prevalence, characteristics, use, costs, and outcomes. We will select a national probability sample of work sites from the Dun and Bradstreet sampling frame. The sample selection will be stratified by four work site sizes and six industry groups. We will use our Computer Assisted Telephone Interview (CATI) system to administer the questionnaire to 4,875 work sites with 50 or more employees. After collecting the baseline data, we will select 24 work sites for case study. We will gather cost and outcome information and estimate the cost-effectiveness of EAPs in several areas, including absenteeism, injuries, turnover, and accidents. To bolster information gathered from EAP administrators, we will conduct an employee survey to assess substance abuse and attitudes, and perceptions and use of the work site EAPs. We will also conduct a national follow-up survey (4,875 work sites) to determine changes in prevalence, administration, and use of substance abuse programs. The results of this study will provide insight into the design of EAPs and their impact on work site substance abuse. This composite EAP information will prove useful to both employers and policymakers
Keywords: counseling, occupational health /safety, substance abuse mental health epidemiology, questionnaire, work site human subject
Project start date: 1991-06-01
Project end date: 1995-12-31
5R01DA007250-04 (1994): $614773
Sponsored Links Excellgen http://Excellgen.com
5R01DA007250-03 (1993): $517565
5R01DA007250-02 (1992): $568227
MINORITY YOUTH HEALTH BEHAVIOR RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 5U01HD030118-06 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development IRG: SRC
Keywords: adolescence (12-18), behavior disorder, disease /disorder prevention /control, minority group, statistical service /center computer data analysis, computer program /software, computer system hardware, cooperative study, human morbidity, human mortality, human population study, injury prevention, sex behavior, training, violence behavioral /social science research tag, data collection methodology /evaluation, human subject, statistics /biometry
Project start date: 1992-09-30
Project end date: 2001-02-28
5U01HD030118-06 (1997): $642725
5U01HD030118-05 (1996): $612853
5U01HD030118-04 (1995): $587761
5U01HD030118-03 (1994): $246979
MULTISITE TRIALS--BEHAVIORAL STRATEGIES TO PREVENT HIV
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 3U10MH048008-04S1 from National Institute Of Mental Health IRG: SRCM
Project start date: 1990-09-30
Project end date: 1995-08-31
3U10MH048008-04S1 (1994): $146690
MINORITY YOUTH HEALTH BEHAVIOR RESEARCH
Tyler D Hartwell, Senior Program Director
Research Triangle Institute
box 12194, 3040 Cornwallis Rd
research Triangle Park, Nc 277092194
Grant 5U01HD030118-02 from National Institute Of Child Health And Human Development IRG: SRC
Keywords: adolescence (12-20), behavior disorder, disease prevention /control, minority group, statistical service /center computer data analysis, computer program /software, computer system hardware, cooperative study, human morbidity, human mortality, human population study, injury prevention, sex behavior, training, violence data collection methodology /evaluation, human subject, statistics /biometry
Project start date: 1992-09-30
Project end date: 1998-03-31
5U01HD030118-02 (1993): $594691
1U01HD030118-01 (1992): $299719