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This revised competing continuation application of R01 DA14702-01 continues our behavioral interventions to reduce adolescent and young adult HIV sexual risks associated with non-injection methamphetamine use in northern Thailand. During the first five years of our grant, we characterized variation in MA use and sexual risks for HIV acquisition. In 2004, we started study procedures and enrollment was completed (n=987) in May 2006; data collection ends in July 2007. We have had excellent recruitment, participation and retention (>90%) in the trial and we now shift our focus to remote, rural areas. Ethnography shows MA and other non-injection drug use is pervasive among rural youth and associated with HIV risk. We seek to prevent MA abuse and HIV risk by promoting community-level structural interventions developed by and with the affected communities. Our specific aims are: (1) to follow the Connect to Protect (C2P) approach to promote community mobilization, community capacity building, and community involvement to forge structural changes leading to decreased MA and other non-injection drug use risks for HIV acquisition. (2) to conduct a cluster-randomized trial of C2P over 3 years in 5 community clusters of 25 villages and compare its efficacy in MA and sexual risk reduction compared to 25 villages in 5 nearby community clusters that offer referrals for HIV VCT referrals. HIV and STI incidence, drug and sex risks, and stigma will be assessed in cohorts before and for two 15 month intervals after C2P mobilization. Finally, (3) within experimental communities, to evaluate components of the C2P intervention that generate behavior change using qualitative process evaluation data. Ethnography in targeted communities will determine local priorities for mobilization, capacity building and involvement. We will recruit 40 randomly selected community dwellers aged 14-29 years of age from each of 50 selected communities to participate in a cohort study (n=2000) to systematically determine risk. We will conduct a statistical evaluation of process and ethnographic data on components of the interventions associated with reductions in community-level MA risk. The proposed study takes a successful theoretically grounded approach from the USA to confronting problems experienced by youth at the community level in Thailand, and it promotes this model in an international setting. This project proposes a community-level behavioral intervention to reduce adolescent and young adult HIV sexual risks associated with non-injection methamphetamine use in northern Thailand. We will use an approach to community mobilization, community capacity building, and community involvement to forge structural changes leading to decreased MA and other non-injection drug use risks for HIV acquisition that has been used in the USA to respond to community-identified youth drug problems.
Researchers
David Celentano
Jonathan Ellen
Susan Sherman
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Research into new prevention technologies, including vaccines, effective treatment regimens, and improved deployment of existing approaches, remains of central importance to eventual control of AIDS. However, the scientific and public health questions which require the most urgent answers are increasingly difficult to investigate in developed world settings. International collaborative HIV/AIDS research, and the training needed for developing country scientists to lead that research, remains an urgent global priority and a public health necessity.
From its inception the Hopkins AITRP has endeavored to provide training and research support to developing country partners in training relevant to the growing global HIV/AIDS research agenda. Our model has been to provide training in support of collaborative research between faculty of the Johns Hopkins Schools of Public Health and Medicine and their developing country partners, to foster lasting research partnerships, and to assist developing country scientists in establishing their own, and their countries’, capacity in independent HIV/AIDS research. We have measured our success through scientific contributions, competitive funding awards, the impact on country responses of returning fellows, and leadership in international HIV/AIDS research on the part of our trainees.
The Hopkins AITRP is located in the Department of Epidemiology in the Bloomberg School of Public Health; the Principal Investigator is Dr. Chris Beyrer. However, it is a campus-wide program involving faculty and trainees in departments in both the Bloomberg School of Public Health and the School of Medicine. Our international partners include institutions and investigators in Uganda, Malawi, Ethiopia, South Africa, Cameroon, Thailand, India, China, Laos, Russia, The Dominican Republic and Brazil. Primary departments participating in the program are: Biostatistics, Epidemiology, Health Policy & Management, International Health, Molecular Microbiology & Immunology and Population & Family Health Sciences in the Bloomberg School of Public Health and the Departments of Clinical Investigation, Medicine, Pathology, Pediatrics and OB/GYN in the School of Medicine. Campus-wide centers such as the Center for Immunization Research (CIR), the Center for Clinical Trials (CCT), the Center for Clinical Global Health Education (CCGHE), the Center for Public Health and Human Rights, the Center for TB Research, The Bioethics Institute, and the Center for Communications Programs (CCP) serve as resources for faculty and training programs. The Johns Hopkins University Fogarty AITRP is now in its fourth five-year funding cycle, Years 16-20. Year 19 began June 1, 2006.
For more information, visit the program''''''''s web site.
Researchers
Chris Beyrer
Robert Bollinger Jr.
Donald Burke
David Celentano
Karen Charron
Jacqueline Coberly
Vivian Go
Ronald Gray
Laura Guay
Clayton Harro
Deanna L. Kerrigan
Andrea Ruff
Hua Shan
Susan Sherman
Nicole Simmons
Michael Sweat
Taha E. Taha
Nathan Wolfe
Xiao-Fang Yu
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In this study, Phase III of a community-level randomized controlled study, 32 communities in Africa (Tanzania, Zimbabwe and South Africa) and 14 communities in Thailand will be randomized to either a community-based HIV voluntary counseling and testing (CBVCT) intervention or a clinic-based standard voluntary counseling and testing program (SCVT). The CBVCT intervention incorporates three components: increasing the availability of community setting VCT; recruiting early testers as community outreach workers; providing post-test support groups. It is the study’s hypothesis that increasing the proportion of people in communities who know their HIV status will change community norms and that changing community norms will reduce the risk of HIV infection for all members of the community, regardless of whether or not they have participated in the intervention. The efficacy of the CBVCT intervention will be measured by a comparison of rates of recent HIV infection (recent HIV incidence) among randomly selected 18 to 32 year old participants living in CBCVT and SCVT communities. These individuals will be evaluated at study baseline and post-intervention. Reports of HIV risk behavior, rates of HIV testing, social norms regarding HIV testing, frequency of discussions about HIV, frequency of disclosure of HIV status, amount of HIV stigma and HIV related social harm will also be compared between these participants. Study investigators from The Johns Hopkins Bloomberg School of Public Health include Dr. David Celentano, principal investigator, Dr. Chris Beyrer, co-principal investigator and Dr. Surinda Kawichai, Project Field Director. Drs. Suwat Chariyalertsak and Surasing Visrutaratana are Principal Investigators from Chiang Mai University in Thailand and Drs. Apinun Aramrattana, Namtip Srirak, and Cholticha Ruangyuttikarn are all Co- Principal Investigators from Chiang Mai University in Thailand. This study began in September of 2003 and runs through the end of June, 2008.
Researchers
Chris Beyrer
David Celentano
Surinda Kawichai
Carla Zelaya
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A Phase II/III safety and efficacy trial has been initiated by Centers for Disease Control and Prevention (CDC) at sites in Botswana an Thailand among to determine whether antiretroviral therapy with tenofovir disoproxil fumarate (TDF) taken as pre-exposure PrEP is safe on a long-term basis and whether it reduces the rate of acquisition of HIV infection among those exposed to HIV sexually or by injection drug use. The role of Hopkins investigators is to design nested pharmacologic studies within the conduct of the Botswana and Thailand study to establish models for intracellular and extracellular tenofivir pharmacokinetics and to build a pharmacodynamic model for HIV preventive efficacy as a function of tenofovir intracellular drug levels as explanatory variables in the study.
Researchers
Craig Hendrix
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HPTN 052 is a Phase III, two-arm, multi-site, randomized trial to determine the effectiveness of two treatment strategies in preventing the sexual transmission of HIV in HIV-serodiscordant couples.
Based on data collected in Africa and Thailand, there is a correlation between HIV viral load (blood levels) and HIV transmission. Specifically, the higher the viral load in the blood, the more likely the chance for transmission. Antiretroviral therapy (ART) reduces the viral load in the blood, as well as in genital secretions (for both men and women), and the drugs can be detected in semen and vaginal and cervical secretions. All of this information strongly suggests that ART may make HIV-infected people less contagious. HPTN 052 compares the HIV-infection rates of two groups of HIV-serodiscordant couples. The index case of the first group starts taking ART as soon as the couple is enrolled in the study, while the index case of the second group starts taking ART when his or her CD4+ cell count drops to 200 cells/mm3 or when he or she develops an AIDS-defining illness. Both groups will receive HIV primary care and couples counseling sessions to teach them how to reduce their risk of transmission.
Researchers
Robert Bollinger Jr.
David Celentano
Joel Gallant
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Develop capacity among epidemiologists at the Thai Ministry of Public Health to utilize new theoretical and computational tools in concert with traditional epidemiologic approaches to address issues surrounding avian influenza and potential influenza pandemics.
Researchers
Donald Burke
Derek Cummings
Justin Lessler
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The Center for Public Health and Human Rights (CPHHR) was established in April 2004 to examine the impact of human rights violations on the general health of populations through the application of epidemiological practices and other public health tools.
CPPHR uses critical evidence-based assessments of the role that repressive laws and social discord play in the health of populations. It is involved in a number of activities in three primary areas of effort—education, research, and advocacy.
Researchers
Chris Beyrer
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A map of tobacco industry strategies was developed using a structured conceptualization methodology known as concept mapping. The objective of the map was to develop a conceptual framework of tobacco industry tactics in four areas in Southeast Asia for the purpose of:
- Generating consensus on key areas of importance and feasibility for regional and cross-country tobacco industry monitoring and surveillance
- Developing measures to track and monitor the effects of the tobacco industry and to design counter strategies, and
- Building capacity to improve tobacco control planning in participating countries.
The map indicates areas of importance and feasibility for monitoring tobacco industry activities and serves as a basis for initial discussion about action planning.
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Researchers
Jonathan Samet
Frances Stillman
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The overall goal of this project is to build capacity in tracking and surveillance of tobacco control measures by development and use of data collection instruments for tracking and surveillance of tobacco control measures and industry activities that run counter to tobacco control. Four key priority areas for surveillance were chosen: second-hand smoke, point of purchase marketing, philanthropy; and product labeling and regulation.
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Researchers
Erika Avila-Tang
Jonathan Samet
Frances Stillman
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This is a randomized controlled study of a community-based model of HIV voluntary counseling and testing. It is conducted in Thailand, Tanzania, Zimbabwe, and South Africa.
Researchers
Katherine Fritz
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Co-Chair of WHO Multicountry Study of Violence Against Women & Health: Bengaladesh, Brazil, Peru, Namibia, Tanzania, Ethiopia, Thailand, Serbia, Japan, New Zealand
Researchers
Jacquelyn C. Campbell
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This project follows a similar methodology for developing measures of parental regulation of adolescent behaviors. Data come from five cultures: Thailand, Costa Rica and South Africa (black, white, colored).
Researchers
Clea McNeely
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This study examines infectious disease markers among blood donors in 6 cities in China.
Researchers
Kenrad Nelson
Paul Ness
Hua Shan
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This is a study of 642 couples in whom the man was identified to be HIV positive when he donated blood at the Blood bank at the Thai Red Cross or Chiang Mai University Blood bank in Chiang Mai , Thailand. We have evaluated the risk factors associated with transmission of HIV from the infected man to his wife—and the viral , host genetic , behavioral and other co-factors related to transmission of HIV and progression/natural history of HIV in this population.
Researchers
Kenrad Nelson
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This collaboration is with the Mae Tao Clinic in the Thai-Burma border region to establish a network of six standardized, locally staffed, mobile centers for capacity building and referral care within communities of internally displaced persons. Basic obstetric services and contraception will be provided through backpack health workers and maternity outcomes will be monitored and evaluated.
Researchers
Chris Beyrer
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Johns Hopkins University and its partners in Thailand and India are pleased to propose the JHU Southern Asia Clinical Trials Unit, David D. Celentano, Principal Investigator. This CTU focuses on recruiting injecting drug users (IDU) and high risk Asian populations affected by the HIV/AIDS epidemic, into phase IIb and III clinical trials investigating novel strategies to prevent HIV infection. We will address two of the high priority clinical research areas identified by DAIDS in its RFA-AI-05-002: Prevention of HIV Infection and Microbicides. For prevention of HIV infection we will affiliate with the proposed HIV Prevention Trials Network. The JHU Southern Asia CTU consists of an administrative component at Johns Hopkins and clinical research sites (CRS) in northern Thailand and southern India. In northern Thailand we are proposing a cluster of research sites led by the Research Institute for Health Sciences (RIHES) at Chiang Mai University (CMU) (Thira Sirisanthana, site leader). In southern India we propose a research site at the YR Gaitonde Center for Substance Abuse-related Research (YRG CSAR), Chennai (Suniti Solomon, site leader). We have longstanding research collaborations with both these units, and have been collaborators on past HPTN studies. Three HPTN studies are under way at the Chiang Mai site and will continue into the period this RFA. HPTN 037, a Phase III behavioral study of the efficacy of a social network intervention in preventing HIV infection among IDUs, began in Chiang Mai in March 2004; the site has a recruitment target of 1,740 volunteers; we propose expanding enrollment to the Chennai site. HPTN 043, a Phase III study of the effectiveness of community based voluntary counseling and testing to prevent HIV infection at a community level, is being carried out in 14 communities in northern Thailand. This study is largely supported by NIMH but was developed by the HPTN; the baseline survey began in January 2005, with interventions beginning in September 2005. HPTN 052, a Phase III IND clinical trial, of the efficacy of antiretroviral therapy in reducing sexual transmission of HIV among discordant couples, began in Chiang Mai in June 2005 with a site enrollment target of 243 couples. A fourth HPTN protocol under development, HPTN 058, is expected to begin in Chiang Mai, and expand to Chennai, in the next year. This is a Phase III IND clinical trial of the efficacy of opioid substitution therapy with buprenorphine/naloxone for prevention of HIV infection.
Researchers
Chris Beyrer
David Celentano
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The proposed study will explore the effects of a stringent new alcohol control bill in Thailand on HIV risk behaviors among high-risk, poly-drug-using youth. Thailand has one of the highest rates of alcohol consumption in the world, ranking 6th for spirits consumption. Youth (aged 15-20) are disproportionately represented among heavy drinkers. In response to these high levels of alcohol consumption and its associated harms, the Thai Government has recently prohibited all alcohol-related advertising and increased the legal drinking age in an alcohol control bill, enacted in December, 2006, to reduce alcohol availability to youth. Both quantitative and qualitative data collection measures will be utilized in examining the effects of this “natural experiment” on alcohol-related sexual risk among high-risk youth. The current study will occur in two phases each lasting one year: Phase I is qualitative in nature and Phase II is quantitative in nature. Phase I (Year 1) will include participant observations, key informant interviews with such individuals bar owners and law enforcement personnel, and in-depth interviews with 18-20 year olds who do and do not drink. Phase II (Year 2) will be comprised of a pre-law sample (n=943) of young high risk youth that we collected from our previously approved study of young methamphetamine (MA) users (IRB #H.34.01.09.14.B1) and a cross section study with 1000 18-20 year olds to examine the effects of a new, stringent alcohol control law on alcohol use, HIV/STIs and related risk behaviors among under-aged, (18-20 years old) in Chiang Mai, Thailand.
Researchers
David Celentano
Susan Sherman
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Study the impact of multiple types of immunity (long-term serotype specific immunity, short-term cross-serotype immunity, immune enhancement of secondary infection and dengue-specific, long-term cross-serotype immunity.
Funded by a Burroughs Wellcome Fund Career Award at the Scientific Interface
Researchers
Derek Cummings
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Detection of pneumococcal pneumonia and sepsis in low- and middle-income countries is limited by the poor sensitivity of blood culture, the existing “gold standard” diagnostic method. The objective of this project is to evaluate whether the Binax NOW® Immuno-Chromatographic Test and real-time Polymerase Chain Reaction for the pneumococcal LytA gene can enhance the diagnosis of pneumococcal pneumonia and sepsis, improve incidence estimates, and facilitate evaluation of pneumococcal vaccines in these settings. In addition, multiplex PCR testing for pneumococcal capsular serotypes will provide valuable data on the serotype distribution of blood culture-positive and culture-negative cases of pneumococcal pneumonia and sepsis.
Researchers
Jennifer Moisi
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An understanding of not only protein-protein but protein-glycan interactions are needed before we can completely dissect the molecular mechanisms involved in Plasmodium ookinete invasion of the mosquito midgut. Objectives: Functional analyses of
mosquito midgut glycoconjugates during Plasmodium invasion through RNAi knock-down of mosquito midgut and salivary gland glycosyl- and sulfo-transferases, and b) proteomic identification by mass spectrometry of mosquito core polypeptides to which the glycans are attached. Summary: An effective malaria vaccine remains elusive. The characterization of these mosquito ligands and parasite receptors offer us additional target antigens toward the development of malaria transmission-blocking vaccines and provide us critical insight into parasite and midgut cell biology and vector host-parasite interactions.
Researchers
Rhoel Dinglasan
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Johns Hopkins University (JHU) and its partners in Thailand and India are pleased to announce the funding of the JHU Southern Asia Clinical Trials Unit, David D. Celentano, Principal Investigator. This CTU is focused on recruiting injecting drug users and other high risk populations severely impacted by the HIV/AIDS epidemic, into phase IIb and III clinical trials investigating new strategies and methodologies to prevent HIV infection. In particular, we seek to address a high priority clinical research area identified by DAIDS in its RFA-AI-05-002: Prevention of HIV Infection and Microbicides. In the area of prevention of HIV infection we are affiliated with the proposal of the HPTN in response to the linked network RFA.
The JHU Southern Asia Clinical Trials Unit consists of an administrative component headquartered at the Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology and clinical research sites in northern Thailand and southern India. In northern Thailand we have a cluster of research sites led by the Research Institute for Health Sciences (RIHES) at Chiang Mai University (CMU) (Thira Sirisanthana, site leader). In southern India we propose the YR Gaitonde Centre for Substance Abuse-related Research (YRG CSAR), Chennai (Suniti Solomon, site leader). All 3 groups have been in the vanguard of HIV prevention research in Asia, with extensive experience dating to the early 1990s, near the beginning of the southern Asian epidemic, and have demonstrated success in recruiting and retaining large cohorts of volunteers and developing and testing innovative methods of prevention. They are led by scientists who are world leaders in HIV epidemiology, prevention, treatment and clinical trials design and include staff who are highly experienced in all key aspects required of clinical trials units and clinical research sites, including: community education, recruitment, retention, clinic coordination, GCP, human subjects protection, data management, specimen tracking and processing, laboratory science and research pharmacy. All 3 groups have previously conducted HIV research funded by the NIH and all have been approved as research sites for one or more DAIDS clinical trials networks. All are highly capable of meeting NIH financial and administrative management standards.
The JHU-CMU collaborators have played significant roles in the development of DAIDS network strategies. Dr. Celentano has served as Chair of the Behavioral Sciences Working Group for both the HIVNET and HPTN networks, who prioritized and promoted the establishment of sponsored protocols. Drs. Latkin, Sherman, Lucas, and Apinun Aramrattana are members of the Substance Use Working Group, and Celentano and Thira serve on the Prevention Sciences Committee of the AACTG and HPTN. In addition, Celentano has been a member of the PLG for the HPTN, and Beyrer serves a similar leadership role in the HVTN. Dr. Apinun will serve as the Co-Chair of the Substance Use Working Group for the new HPTN, and will thus be shaping the science agenda for that group for the next 5 years. In addition, Dr. Soloman of YRG CARE has played an active role in the formation of the HPTN.
Three HPTN studies are currently under way at the Chiang Mai site and are expect to continue into the period covered by this RFA. HPTN 037, a Phase III behavioral study of the efficacy of a social network intervention in preventing HIV infection among injection drug users, began in Chiang Mai in March 2004; the site has a recruitment target of 600 IDUs and their sexual and injection network members, for a total of 1,740 volunteers. This study was completed in 2006. HPTN 043, a Phase III study of the effectiveness of community based voluntary counseling and testing to prevent HIV infection at a community level, is being carried out in 14 communities in northern Thailand, 7 of which have been randomly assigned to receive the intervention. This study is supported by NIMH but was developed by the HPTN’s BSWG; the baseline survey began in January 2005 and is scheduled to be completed in 2011. HPTN 052, a Phase III clinical trial,conducted under an IND, of the efficacy of antiretroviral therapy in reducing sexual transmission of HIV among discordant couples, began enrollment in Chiang Mai in June 2005 with a site enrollment target of 243 couples. A fourth HPTN protocol under development, HPTN 058, began in Chiang Mai by March 2006 addressing the efficacy of opioid substitution therapy with buprenorphine/naloxone and counseling for prevention of HIV infection as compared to detoxification and counseling. Finally, HPTN 063, linking HIV positive heterosexual men and women and men who have sex with men to prevention and care services is to begin recruitment in June 2009.
Researchers
David Celentano
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This project is focused on identification of human waterborne protozoan pathogens in Chao Phraya River at the sites where the water is abstracted for drinking water production.
Researchers
Thaddeus Graczyk
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The Cochrane Eyes and Vision Group aims to prepare, maintain and promote access to systematic reviews of interventions used to prevent or treat eye diseases and/or visual impairment. The work of the CEVG is carried out by over 300 members in more than 30 countries. The CEVG editorial team is located in London, UK and the CEVG US Project (CEVG@US) is a US-based satellite at the Johns Hopkins Bloomberg School of Public Health.
The CEVG@US is funded by the National Eye Institute. The overall objective of CEVG@US is to develop a critical mass of US-based vision researchers and practitioners who are trained in preparing and using systematic reviews.
The CEVG@US aims to accomplish four main goals: 1) Expand awareness of evidence-based health care in general and in eyes and vision specifically, 2) Develop a critical mass of vision researchers who are able to perform and interpret systematic reviews, and train others to do the same; 3) Develop a critical mass of clinicians who use the results of systematic reviews as an evidence base to guide their practice, and to train others to do the same; 4) Generate an increased number of systematic reviews in priority vision research areas, published in The Cochrane Library and in the traditional vision research literature.
Researchers
Kay Dickersin
Ann-Margret Ervin
Barbara Hawkins
Roberta W. Scherer
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The PERCH project is a rigorous multi-country, case-control study of hospitalized pediatric patients with severe lower respiratory tract illnesses (hereafter referred to as pneumonia) to determine the etiology and risk factors associated with the syndrome. The project is going to be conducted with partner organizations in Kenya, New Caledonia, Bangladesh, Mali, South Africa, Zambia, Thailand and Gambia. Laboratory techniques that have remained vastly unchanged for more than a century have limited our understanding of pneumonia etiology. By applying modern tools with standardized methods, PERCH will contribute to new, precise information to guide the development of new vaccines and treatments.
Researchers
Orin Levine
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