STD CONTROL FOR MATERNAL INFANT HEALTH--SUPPLEMENT
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 3R01AI034826-03S1 from National Institute Of Allergy And Infectious Diseases IRG: ARRB
Project start date: 1994-03-01
Project end date: 1999-02-28
3R01AI034826-03S1 (1996): $498787
Sponsored Links Excellgen http://Excellgen.com
STD CONTROL FOR AIDS PREVENTION
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 3R01AI034826-05S1 from National Institute Of Allergy And Infectious Diseases IRG: ARRD
Abstract: Improved strategies to control the epidemic of human immunodeficiency virus (HIV) type l are urgently needed. Research suggests that other sexually transmitted diseases (STDs) facilitate HIV transmission and may contribute substantially to the spread of AIDS. It is difficult, however, to establish the causal nature of the STD/HIV interaction in clinic based studies, due to potential confounding. In order to avoid this problem and to assess the impact of reduced STD levels on HIV incidence, we propose to conduct a prospective community based trial of intensive STD treatment and control. Twenty five randomly selected villages in Rakai District, Uganda, will receive the STD intervention, including a modified mass treatment strategy, serological surveillance, active case finding and intensive health education/condom distribution. An equal number of randomly chosen villages will serve as control communities, with equivalent data collection and preventive activities; however, instead of mass treatment, control subjects will be referred for STD treatment if warranted by symptomatology or serological results. The proposed study will build upon a large cohort study in the district. Cohort data indicate that the populations of the villages to be included have very high rates of HIV prevalence (range 10% - 58% for all adults), substantial HIV seroincidence (2.6% per 100 person years for adults aged 15-59), over 10% positive syphilis RPR, and over 10% of adults reporting genital ulcer or discharge on an annual basis. Cumulative follow-up rates have exceeded 80% over the 3 years of the current cohort study. We estimate that HIV and STD rates in this population are sufficiently high to detect a 35% reduction in HIV incidence in response to STD control, with 80% statistical power. Rakai District represents a unique setting for the proposed research, as no other study we know of is based in a similarly large number of villages with such high documented rates of both HIV and STDs. In the proposed modified mass STD treatment, we will use safe and effective drugs, administered as single dose oral regimens to both symptomatic and asymptomatic persons, and additional selected therapeutics provided on the basis of symptomatology, physical or laboratory diagnosis. This approach represents the optimum feasible strategy to ensure compliance, good population coverage and therapeutic efficacy in an underserviced area such as Rakai. The study will permit the testing of the mass treatment approach, a strategy of great potential value in other underserviced settings in the world. Due to the research nature of this project, the mass treatment will be backed up by intensive follow-up, surveillance and evaluation.
Keywords: AIDS, AIDS education /prevention, Africa, communicable disease control, human immunodeficiency virus 1, microorganism interaction, sexually transmitted disease, antibiotic, condom, health behavior, human therapy evaluation, microorganism disease chemotherapy, penicillin, sex behavior, African, human subject, serology /serodiagnosis
Project start date: 1994-03-01
Project end date: 2000-03-31
3R01AI034826-05S1 (1999): $362746
3R01AI034826-02S1 (1996): $143178
3R01AI034826-03S2 (1996): $140029
Grants awarded to Maria J Wawer
Maria J Wawer, Professor Of Public Health
Population And Family Healthcolumbia Univ New York Morningside
research Administration
new York, Ny 100277003
Grant 5R01HD028886-03 from National Institute Of Child Health And Human Development IRG: ARRD
Abstract: The Ugandan Ministry of Health and Columbia University are collaborating in a longitudinal population-based HIV cohort study in rural Rakai District, southwestern Uganda. Preliminary behavioral and HIV-1 serological data from the cohort suggest that geographic location, mobility and related variables influence sexual behavior and the structure of sexual networks in the study population, contributing in turn to the rapid spread of HIV infection. In 1990, adult HIV-1 prevalence in the cohort was 20.1%; extrapolated district level HIV prevalence was 13.9% (95%CI = 9.7% - 17.7%, design effect 3.5). Between 1989-1990, one year incidence among all cohort adults was 2.6%; in men 20 to 24, it was 5.9%, and in women in the same age group, 6.4%. Substantial gradations in HIV prevalence and in reported behavioral variables (mobility, travel to urban areas, numbers of partners) were noted between Rakai´s three geographic strata main road trading centers, small trading villages on secondary roads and rural agricultural villages. We propose to collect detailed qualitative and quantitative data in Rakai District to define sexual networks and behaviors critical to the transmission of HIV infection, and to elucidate their determinants, including place of residence, geographic mobility and social/ethnic status. A specific objective will be to determine whether there are potential behavioral barriers to HIV spread from high to low prevalence areas, and whether certain communities act as bridging populations facilitating HIV transmission into lower prevalence villages. Additional data will be collected in neighborhoods known to be hubs of travel and migration in the regional capital of Masaka and the national capital of Kampala. Movement of persons between all study sites, and its effects on sexual behavior, will be examined. In Rakai, subjects for the behavioral research will be drawn in part from the cohort study, which is collecting serological health status and knowledge, attitudes and behavior data on a random sample of the population. For those subjects from Rakai who are not enrolled in the existing cohort, as well as for respondents in Masaka and Kampala, we will collect filter paper serological samples for ELISA and Western blot testing, in order to match serostatus with reported behaviors. The behavioral study will provide information critical to the development of more effective preventive strategies for Rakai and Uganda as a whole. Improved prevention programs are needed since HIV transmission remains elevated despite high levels of knowledge regarding AMS, the existence of educational programs, and condom distribution. The data will also permit more exact modelling of the HIV epidemic
Keywords: AIDS, AIDS education /prevention, African, HIV infection, human immunodeficiency virus communicable disease transmission, longitudinal human study, sex behavior
Project start date: 1992-06-01
Project end date: 1995-05-31
5R01HD028886-03 (1994): $398173
5R01HD028886-02 (1993): $388613
1R01HD028886-01A1 (1992): $403907
HIV PREVENTION TRIALS UNIT, RAKAI, UGANDA
Maria J Wawer, Professor Of Public Health
Population And Family Healthcolumbia University Health Sciences
columbia University Medical Center
new York, Ny 100323702
Grant 1U01AI047974-01 from National Institute Of Allergy And Infectious Diseases IRG: ZAI1
Abstract: The Rakai Project, a collaboration between the Uganda Ministry of Health, and Makerere, Columbia and Johns Hopkins Universities, has conducted HIV/TD epidemiologic and behavioral research and randomized trials of HIV prevention of HIV prevention in rural Rakai District, Uganda since 1988. (The randomized trials addresses addressed STD control for HIV prevention and the treatment of chorioamnionitis to prevent mother-to-child (MTC) transmission). We currently have a representative cohort of 12,000 subjects aged 15-59 under surveillance in collaboration with the Walter Reed Army Institute of Research (WRAIR). The Rakai cohort provides a pluripotential population allowing us to address most HPTN agenda priorities for HIV prevention research either as a single site, or in multi-site studies to developed by HPTN. The HPTN priority agenda items that can be addressed include perinatal lactational MTC HIV transmission, microbicide trials, community- randomized STD control by a hybrid of presumptive and syndromic treatment in low HIV prevalence settings, behavioral interventions and antiretroviral therapy in discordant couples. We have demonstrated the ability to enroll subjects (90% in the general population, 95% in pregnant women), to obtain high compliance with provision of samples and acceptance of treatment (greater than or equal to 90%), and to retain subjects for prolonged periods of time (general population 80% follow up 30 months, pregnant women 95% postpartum follow up). We have laboratory and data management facilities, and experienced field personnel, and have established innovative methods of sample collection in the respondent´s homes to maximize coverage and compliance. The population can readily be expanded to meet HPTN requirements, and selective recruitment can target priority subgroups such as high risk "core groups", pregnant women 95% postpartum follow up). We have laboratory and data management facilities, and experienced field personnel, and have established innovative methods of sample collection in the respondent´s homes to maximize coverage and compliance. The population can readily be expanded to meet HPTN requirements, and selective recruitment can target priority subgroups such as high risk "core groups", pregnant and lactating women, or discordant couples, and we propose such expansion in the current application. We have support from the Minister of Health and relevant collaborators in-country (e.g., Ugandan PIs include the Dean of Medicine and Director of the Institute of Public Health, Makerere University), as well as in the US (e.g., Drs. Jackson and Quin who direct the HPTN Core Laboratory Facility). In summary, Rakai is the largest established population-based HIV/STD cohort in Africa and is ideally suited for HPTN agenda priorities
Keywords: AIDS, AIDS education /prevention, AIDS therapy, HIV infection, antiAIDS agent, antibiotic, behavior therapy, human immunodeficiency virus 1, human therapy evaluation, sexually transmitted disease, vertical transmission breast feeding, clinical trial phase II /III /IV, combination chemotherapy, cooperative study, sex partner Africa, African, behavioral /social science research tag, clinical research, human subject
Project start date: 2000-07-01
Project end date: 2001-12-31
1U01AI047974-01 (2000): $1000101
COMMUNITY OPINION LEADER INTERVENTION TRIAL RAKAI-UGANDA
Maria J Wawer, Professor Of Public Health
Ctr/population & Family Hlthcolumbia University Health Sciences
columbia University Medical Center
new York, Ny 100323702
Grant 5U10MH061538-03 from National Institute Of Mental Health IRG: ZMH1
Abstract: The Rakai Project Research Group (RPRG) proposes to collaborate with the NIMH/ACTs/DCC by implementing a randomized, community-based trial of the Opinion Leaders (OL) intervention in rural Rakai District, Uganda. Rakai provides a unique setting for the trial we have conducted multiple behavioral, epidemiological, and intervention studies in the district since 1989, resulting in detailed demographic, behavioral and STD/HIV data needed or trial design. We have extensive experience in combining behavioral data and biological specimen collection in the community, and have achieved high enrolment compliance and extended follow up greater than 75 percent. Over 80 percent of the African population is rural, and faces substantial risk of HIV. In Rakai, approximately 13 percent of all adults greater than or equal to age 13 years are HIV+. We propose to target and enrol all consenting persons aged 12-49 resident in 30 communities and to randomly assign communities to an intervention and control arm. Prior to implementing the intervention, we will conduct ethnographic and social networks research in the intervention arm to identify opinion leaders and develop intervention messages, including promotion of consistent condom use and reductions in numbers of sexual partners. Given that sexual behavior change and condom use in Rakai are constrained by lack of communication about sexual matters between partners, marriage between HIV discordant individuals, fertility desires, transactional factors governing sexual relations between young girls and older men, alcohol use and coercive sex, we propose to address such factors in the OL intervention messages, as guided by the ethnographic research. The OL intervention will be evaluated via a baseline and two follow up surveys at 12 and 24 months, conducted in the home in all study communities. We will measure intermediate behavioral variables (condom use, reported numbers of partners, other behaviors) and STD/HIV endpoints, including trichomonas prevalence and incidence, and HIV and HSV-2 prevalence and incidence. We will also compare the results of ethnographic research to network surveys as a means of identifying OLs, monitor OL turnover, and assess whether the intensity of message provision remains stable over time. Such data will assist in future programmatic replications of the OL intervention. The research design, target population and messages can be modified (ex to include bars in Rakai trading centers) if desirable for the design of the overall OL collaborative study or for metanalysis of data from multiple sites
Keywords: AIDS education /prevention, Africa, HIV infection, behavior modification, education evaluation /planning, human therapy evaluation, public opinion, sexually transmitted disease Trichomonas, clinical trial, communicable disease transmission, community, condom, cooperative study, herpes simplex virus 2, human immunodeficiency virus, longitudinal human study, safe sex African, adolescence (12-18), behavioral /social science research tag, clinical research, human middle age (35-64), human subject, young adult human (19-34)
Project start date: 1999-09-30
Project end date: 2004-08-31
5U10MH061538-03 (2001): $527247
5U10MH061538-02 (2000): $1033606
COMMUNITY OPINION LEADER INTERVENTION TRIAL--RAKAI UGAND
Maria J Wawer, Professor Of Public Health
Population And Family Healthcolumbia University Health Sciences
columbia University Medical Center
new York, Ny 100323702
Grant 1U10MH061538-01 from National Institute Of Mental Health IRG: ZMH1
Abstract: The Rakai Project Research Group (RPRG) proposes to collaborate with the NIMH/ACTs/DCC by implementing a randomized, community-based trial of the Opinion Leaders (OL) intervention in rural Rakai District, Uganda. Rakai provides a unique setting for the trial we have conducted multiple behavioral, epidemiological, and intervention studies in the district since 1989, resulting in detailed demographic, behavioral and STD/HIV data needed or trial design. We have extensive experience in combining behavioral data and biological specimen collection in the community, and have achieved high enrolment compliance and extended follow up greater than 75 percent. Over 80 percent of the African population is rural, and faces substantial risk of HIV. In Rakai, approximately 13 percent of all adults greater than or equal to age 13 years are HIV+. We propose to target and enrol all consenting persons aged 12-49 resident in 30 communities and to randomly assign communities to an intervention and control arm. Prior to implementing the intervention, we will conduct ethnographic and social networks research in the intervention arm to identify opinion leaders and develop intervention messages, including promotion of consistent condom use and reductions in numbers of sexual partners. Given that sexual behavior change and condom use in Rakai are constrained by lack of communication about sexual matters between partners, marriage between HIV discordant individuals, fertility desires, transactional factors governing sexual relations between young girls and older men, alcohol use and coercive sex, we propose to address such factors in the OL intervention messages, as guided by the ethnographic research. The OL intervention will be evaluated via a baseline and two follow up surveys at 12 and 24 months, conducted in the home in all study communities. We will measure intermediate behavioral variables (condom use, reported numbers of partners, other behaviors) and STD/HIV endpoints, including trichomonas prevalence and incidence, and HIV and HSV-2 prevalence and incidence. We will also compare the results of ethnographic research to network surveys as a means of identifying OLs, monitor OL turnover, and assess whether the intensity of message provision remains stable over time. Such data will assist in future programmatic replications of the OL intervention. The research design, target population and messages can be modified (ex to include bars in Rakai trading centers) if desirable for the design of the overall OL collaborative study or for metanalysis of data from multiple sites
Keywords: AIDS education /prevention, Africa, HIV infection, behavior modification, education evaluation /planning, human therapy evaluation, public opinion, sexually transmitted disease Trichomonas, clinical trial, communicable disease transmission, community, condom, cooperative study, herpes simplex virus 2, human immunodeficiency virus, longitudinal human study, safe sex African, adolescence (12-18), behavioral /social science research tag, clinical research, human middle age (35-64), human subject, young adult human (19-34)
Project start date: 1999-09-30
Project end date: 2004-08-31
1U10MH061538-01 (1999): $613362
ARV EFFECTS ON HIV EPIDEMIOLOGY AND BEHAVIORS IN RAKAI, UGANDA
Maria J Wawer
Johns Hopkins University, 3400 N Charles St, Baltimore, Md 21218
Grant 5R01HD050180-06 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development
Abstract: The provision of HIV antiretroviral (ARV) therapy in Africa will have beneficial health and social effects, but will present many challenges. Since the drugs are now being initiated in Uganda, we have a narrow window of opportunity to assess the population-level impact of ARVs on HIV transmission and epidemiology, on behaviors in both HIV+ and HIV uninfected persons, and on sociodemographic indicators. Information is also needed on the emergence and transmission of drug resistance mutations, the effects of prior maternal nevirapine use on subsequent ARV effectiveness, and on barriers to ARV acceptance and adherence. The Rakai Health Sciences Program has received PEPFAR funds to initiate an ARV program in rural Rakai District, Uganda. Since 1994, we have conducted the Rakai Community Cohort Study (RCCS) and have longitudinal population-based information on HIV epidemiology, and on community risk behaviors, health and sociodemographic characteristics. These data provide a baseline for the assessment of ARV effects. Rakai has a mature, generalized epidemic, with a prevalence of 15% and an incidence of approximately 1.4/100 py. Under the proposed R01 (complementary to PEPFAR), we plan to conduct integrated quantitative and qualitative research in RCCS communities (n= 12,000 adults and approximately 600 children) and in non-RCCS comparison communities (n = 1,000 adults). We propose to examine epidemiological effects of ARVs (HIV incidence and prevalence; emergence and transmission of drug-resistant HIV, treatment acceptance and effectiveness, mother-to-child HIV transmission by subtype [A, D, AD recombinant]; as well as behavioral, social and demographic effects (behavioral disinhibition, use of HIV counseling and testing, use of other prevention services, contraceptive use, mortality, fertility, marital stability and orphanhood). We will also examine knowledge and attitudes towards ARVs, and the effects of stigma on ARV use. The study will provide unique data to guide HIV care in Africa and for projecting the course of the epidemic in the ARV era
Keywords: 0-11 years old; 21+ years old; 6H-Dipyrido(3, 2-b[{..}]2`, 3`-e)(1, 4)diazepin-6-one, 11-cyclopropyl-5, 11-dihydro-4-methyl-; ACT2; AIDS Virus; AIDS prevention; AIDS/HIV prevention; ARV resistance; ARV resistant; AT744.1; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Act-2; Active Follow-up; Address; Adherence; Adherence (attribute); Adult; Affect; Africa; Alcohol Drinking; Alcohol consumption; Analysis, Data; Anti-Retroviral Agents; Antiretroviral Agents; Antiretroviral resistance; Antiretroviral resistant; Attitude; Behavior; Behavioral; Belief; Birth; Breast Milk; CCL4; CCL4 gene; Caring; Censuses; Cessation of life; Characteristics; Child; Child Youth; Children (0-21); Clinical; Cohort Studies; Communities; Community Surveys; Complex; Concurrent Studies; Consent; Contraceptive Usage; Counseling; Couples; Data; Data Analyses; Death; Developed Countries; Developed Nations; Disinhibition; Divorce; Drug resistance; Drugs; ELIG; Effectiveness; Eligibility; Eligibility Determination; Epidemic; Epidemiology; Equilibrium; EtOH drinking; FLR; Failure (biologic function); Family; Fertility, Marital; Focus Groups; Fostering; Funding; General Population; General Public; Generalized Growth; Genetic Alteration; Genetic Change; Genetic defect; Grant; Growth; HIV; HIV Infections; HIV Prevention; HIV diagnosis; HIV drug resistance; HIV drug resistant; HIV/AIDS prevention; HTLV-III; HTLV-III Infections; HTLV-III-LAV Infections; Health; Health Sciences; Hemoglobin; Home; Home environment; Household; Human Immunodeficiency Viruses; Human Milk; Human Mother`s Milk; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Human, Adult; Human, Child; Incidence; Individual; Industrialized Countries; Industrialized Nations; Infant; Infection; Interview; Investigators; Knowledge; LAG1; LAV-HTLV-III; Laboratories; Liver; Lymphadenopathy-Associated Virus; MIP-1-beta; MIP1B; Mammary Gland Milk; Marital Fertility; Marital Status; Maritally Unattached; Medication; Milk Substitutes; Milk, Human; Monitor; Mortality; Mortality Vital Statistics; Mothers; Mutation; Nevirapine; Observational Study; Orphan; Out-Migrations; Parturition; Patients; Perception; Persons; Pharmaceutic Preparations; Pharmaceutical Preparations; Population; Pregnancy Rate; Pregnancy loss; Prevalence; Prevention; Prevention education; Principal Investigator; Programs (PT); Programs [Publication Type]; Protocol Screening; Qualitative Research; Recombinants; Renal function; Reporting; Research; Research Personnel; Researchers; Resistance; Risk Behaviors; Risky Behavior; Rural; SCYA4; SUBGP; Sample Size; Screening procedure; Services; Single Person; Social support; Stigmata; Structure; Subgroup; Survey Instrument; Surveys; Surveys, Community; T-Lymphotropic Virus Type III Infections, Human; Testing; Time; Tissue Growth; Transmission; Uganda; Unmarried person; Vertical Disease Transmission; Vertical Transmission; Viral Burden; Viral Load; Viral Load result; Viramune; Virus-HIV; Woman; adult human (21+); aged; alcohol ingestion; alcohol intake; alcohol product use; alcohol use; alcoholic beverage consumption; alcoholic drink intake; anti-retroviral; anti-retroviral resistance; anti-retroviral resistant; antiretroviral; antiretroviral therapy; at risk behavior; balance; balance function; base; behavioral disinhibition; behavioral health; body system, hepatic; children; contraceptive use; cost; drug resistant; drug/agent; ethanol consumption; ethanol drinking; ethanol ingestion; ethanol intake; ethanol product use; ethanol use; etoh use; experience; failure; follow-up; genome mutation; high risk behavior; kidney function; marital violence; meetings; mother to child transmission; novel; ontogeny; organ system, hepatic; population based; prevention service; programs; resistance mutation; resistance to ARV; resistance to Drug; resistance to HIV drug; resistance to anti-retroviral; resistance to antiretroviral; resistant; resistant to ARV; resistant to Drug; resistant to HIV drug; resistant to anti-retroviral; resistant to antiretroviral; response; screening; screenings; service utilization; sex risk; social; social stigma; social support network; stigma; transmission process; treatment response; trend; youngster
Project start date: 2005-07-15
Project end date: 2011-05-31
Budget start date: 1-JUN-2009
Budget end date: 31-MAY-2011
5R01HD050180-06 (2009): $1822150
ARV Effects On HIV Epidemiology And Behaviors Rakai Uganda
Maria J Wawer, Professor Of Public Health
Johns Hopkins University W400 Wyman Park Building Baltimore, Md 212182680
Grant 5R01HD050180-04 from National Institute Of Child Health And Human Development IRG: ACE
Abstract: The provision of HIV antiretroviral (ARV) therapy in Africa will have beneficial health and social effects, but will present many challenges. Since the drugs are now being initiated in Uganda, we have a narrow window of opportunity to assess the population-level impact of ARVs on HIV transmission and epidemiology, on behaviors in both HIV+ and HIV uninfected persons, and on sociodemographic indicators. Information is also needed on the emergence and transmission of drug resistance mutations, the effects of prior maternal nevirapine use on subsequent ARV effectiveness, and on barriers to ARV acceptance and adherence. The Rakai Health Sciences Program has received PEPFAR funds to initiate an ARV program in rural Rakai District, Uganda. Since 1994, we have conducted the Rakai Community Cohort Study (RCCS) and have longitudinal population-based information on HIV epidemiology, and on community risk behaviors, health and sociodemographic characteristics. These data provide a baseline for the assessment of ARV effects. Rakai has a mature, generalized epidemic, with a prevalence of 15% and an incidence of approximately 1.4/100 py. Under the proposed R01 (complementary to PEPFAR), we plan to conduct integrated quantitative and qualitative research in RCCS communities (n= 12,000 adults and approximately 600 children) and in non-RCCS comparison communities (n = 1,000 adults). We propose to examine epidemiological effects of ARVs (HIV incidence and prevalence; emergence and transmission of drug-resistant HIV, treatment acceptance and effectiveness, mother-to-child HIV transmission by subtype [A, D, AD recombinant]; as well as behavioral, social and demographic effects (behavioral disinhibition, use of HIV counseling and testing, use of other prevention services, contraceptive use, mortality, fertility, marital stability and orphanhood). We will also examine knowledge and attitudes towards ARVs, and the effects of stigma on ARV use. The study will provide unique data to guide HIV care in Africa and for projecting the course of the epidemic in the ARV era.
Keywords: HIV infection, communicable disease transmission, epidemiology, health behavior, AIDS education /prevention, AIDS therapy, antiAIDS agent, combination chemotherapy, drug resistance, gene mutation, health care service evaluation, health care service utilization, human therapy evaluation, rural health, vertical transmission, Africa, behavioral /social science research tag, clinical research, human subject
Project start date: 2005-07-15
Project end date: 2010-05-31
5R01HD050180-04 (2007): $1647344
ARV Effects On HIV Epidemiology & Behaviors Rakai Uganda
Maria J Wawer, Professor Of Public Health
Johns Hopkins University W400 Wyman Park Building Baltimore, Md 212182680
Grant 7R01HD050180-03 from National Institute Of Child Health And Human Development IRG: ACE
Abstract: The provision of HIV antiretroviral (ARV) therapy in Africa will have beneficial health and social effects, but will present many challenges. Since the drugs are now being initiated in Uganda, we have a narrow window of opportunity to assess the population-level impact of ARVs on HIV transmission and epidemiology, on behaviors in both HIV+ and HIV uninfected persons, and on sociodemographic indicators. Information is also needed on the emergence and transmission of drug resistance mutations, the effects of prior maternal nevirapine use on subsequent ARV effectiveness, and on barriers to ARV acceptance and adherence. The Rakai Health Sciences Program has received PEPFAR funds to initiate an ARV program in rural Rakai District, Uganda. Since 1994, we have conducted the Rakai Community Cohort Study (RCCS) and have longitudinal population-based information on HIV epidemiology, and on community risk behaviors, health and sociodemographic characteristics. These data provide a baseline for the assessment of ARV effects. Rakai has a mature, generalized epidemic, with a prevalence of 15% and an incidence of approximately 1.4/100 py. Under the proposed R01 (complementary to PEPFAR), we plan to conduct integrated quantitative and qualitative research in RCCS communities (n= 12,000 adults and approximately 600 children) and in non-RCCS comparison communities (n = 1,000 adults). We propose to examine epidemiological effects of ARVs (HIV incidence and prevalence; emergence and transmission of drug-resistant HIV, treatment acceptance and effectiveness, mother-to-child HIV transmission by subtype [A, D, AD recombinant]; as well as behavioral, social and demographic effects (behavioral disinhibition, use of HIV counseling and testing, use of other prevention services, contraceptive use, mortality, fertility, marital stability and orphanhood). We will also examine knowledge and attitudes towards ARVs, and the effects of stigma on ARV use. The study will provide unique data to guide HIV care in Africa and for projecting the course of the epidemic in the ARV era.
Keywords: HIV infection, communicable disease transmission, epidemiology, health behavior, AIDS education /prevention, AIDS therapy, antiAIDS agent, combination chemotherapy, drug resistance, gene mutation, health care service evaluation, health care service utilization, human therapy evaluation, rural health, vertical transmission, Africa, behavioral /social science research tag, clinical research, human subject
Project start date: 2005-07-15
Project end date: 2010-05-31
Sponsored Links Excellgen http://Excellgen.com
1R01HD050180-01 (2005): $1400001
BV ETIOLOGY, NATURAL HISTORY, AND SEXUAL TRANSMISSION
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 5R01AI047608-05 from National Institute Of Allergy And Infectious Diseases IRG: ZRG1
Abstract: The proposed study will test hypotheses regarding microbiological, virological and behavioral risk factors for the development of bacterial vaginosis (BV), a common vaginal condition which is increasingly recognized as having serious health sequelae, including adverse pregnancy outcomes, pelvic inflammatory disease, and increased risk of HIV infection. The etiology and natural history of BV are poorly understood. The study will be conducted in Rakai District, Uganda, where approximately 50 percent in the general population of women of reproductive age have BV. We propose to conduct two complementary research activities I, a BV natural history study in a cohort of 250 women (with and without BV, HIV and prior sexual experience), and II, a study in 50 polygamous family units which will enrol the husband, his wives and other women residing in the household. Repeated interview and sample collection in the two studies will be used to assess transition probabilities of BV onset, persistence, regression and recurrence in relation to a) detailed sociodemographic, behavioral and health data; b) vaginal microflora, particularly Lactobacillus species (which will be characterized using DNA homology and assessed for H2O2 production) and c) the potential presence of lactobacillus bacteriophages, whose possible role in Lactobacillus depletion will be explored. In the polygamous household study, we will determine whether factors associated with normal vaginal flora or with BV (including lactobacilli, anaerobes and phages) may be transmitted sexually or via close household contact such as through the sharing of bathing utensils or water, by comparing women with a polygamous sexual network to other women within the household. The Rakai population offers a unique opportunity to assess BV. We previously enrolled and followed approximately 7,000 women in a population-based trial of STD control for AIDS prevention, have documented increased risk of HIV and adverse birth outcomes in women with BV, and have evidence of improved pregnancy outcomes with STD/BV treatment. The proposed study will provide unique epidemiological, microbiological and virological data regarding normal vaginal flora in this rural African population, the natural history of BV, and on potential causes of this prevalent condition. Such information will be critical for the design of future BV prevention, treatment and control trials, including selection of interventions to be tested, sample size requirements and definition of study end points.
Keywords: bacteria, communicable disease transmission, disease /disorder etiology, epidemiology, vaginitis, HIV infection, Lactobacillus, bacterial virus, disease /disorder onset, health behavior, hydrogen peroxide, marriage /marital status, metronidazole, microorganism disease chemotherapy, relapse /recurrence, sex behavior, African, adolescence (12-20), clinical research, female, human subject, young adult human (21-34)
Project start date: 2000-09-01
Project end date: 2006-05-31
5R01AI047608-05 (2004): $411282
5R01AI047608-04 (2003): $497363
5R01AI047608-02 (2001): $630193
1R01AI047608-01 (2000): $563926
HIV DYNAMICS AND PREVENTION, RAKAI DISTRICT UGANDA
Maria J Wawer, Professor Of Public Health
Columbia Univ New York Morningside Research Administration New York, Ny 100277003
Grant 5R01AI029314-03 from National Institute Of Allergy And Infectious Diseases IRG: ARR
Abstract: The proposed study will expand and continue an existing rural, community based cohort in Rakai District, southwestern Uganda. Project goals are to obtain descriptive epidemiological data on HIV-1 prevalence, annual seroconversion rates, patterns of transmission (including sexual and perinatal), progression to clinical disease, cofactors and coinfections, and behavioral risk factors. Knowledge, attitudes and behaviors (KAB) will be examined over time to evaluate the effects of health education and condom distribution programs. Increased access to STD treatment for the population of the district will also be implemented. As new barrier methods, therapies, and immunizations become available and are adequately tested, they may be incorporated into the project, contingent on approval by Ugandan authorities. In a preliminary study, all residents (adults and children) in 840 households in 21 randomly selected cluster (9 roadside trading center, and 12 rural villages) were enumerated. KAB and serological data were collected on all consenting residents. Serologic results on the 1133 consenting adults in the first 18 clusters indicate that, overall, 19.2% were HIV positive (34% in the roadside stratum, 11% in the rural stratum). Women aged 20 to 24 had the highest prevalence (52%). The pregnancy rate among HIV positive and HIV negative was 12%. Current or previous symptoms of genital ulcer disease (GUD) and STD, and number of reported sexual partners were associated with serostatus. Knowledge of condoms was low and use was below 2%. It is proposed that the project population be doubled to approximately 6800 in order to increase the power for statistical analysis of epidemiologic parameters and effects of preventive interventions (seroconversion, vertical transmission, risk factors, knowledge and behaviors) and that follow up be extended for 4 additional years. Scope of work will include annual KAB/serologic and health surveys, a vertical transmission study with 6-monthly follow up, social science research (indepth interviews and focus groups) and evaluation of preventive strategies (health education, condom distribution, referral for treatment of STDs).
Keywords: HIV infection, communicable disease control, epidemiology, health attitude, human immunodeficiency virus 1, African, adult human (21+), child (0-11), condom, congenital infection, disease proneness /risk, health education, interview, longitudinal human study, questionnaire, sex behavior, sex partner, sexually transmitted disease, female, human clinical subject, human pregnant subject, serology /serodiagnosis
Project start date: 1990-02-01
Project end date: 1993-01-31
5R01AI029314-03 (1992): $532001
BEHAVIORAL RESEARCH FOR AIDS PREVENTION IN THAILAND
Maria J Wawer, Professor Of Public Health
Columbia Univ New York Morningside
research Administration
new York, Ny 100277003
Grant 5R01HD028306-04 from National Institute Of Child Health And Human Development IRG: ARRF
Abstract: The Columbia University Center for Population and Family Health and the Institute for Population and Social Research of Mahidol University, Bangkok, propose to conduct a research project to study patterns of sexual activity and AIDS/STD related knowledge, attitudes and practices, in low income (slum) areas in three cities of Thailand. The project, to be conducted in Bangkok in central Thailand, Chiang Rai in the north, and Hadyai in the south, will collect quantitative and qualitative behavioral data in brothels (included in the study will be brothel owners, and manager, commercial sex workers, and clients); and from patients in STD clinic, long distance truck and bus drivers at their place of work, and low income neighborhood youth contacted at typical social gathering places. IAP data will also be collected from the adult and adolescent male population via random household surveys in the study communities. The three cities have been selected because they are important foci in the domestic and international commercial sex industry. The study populations are themselves potentially at high risk of acquiring HIV, particularly through sexual channels, and may act as sources of infection to wider segments of the Thai population. Contextual, intermediate and proximate determinants of high risk behavior, and their interrelations, will be examined. Methods of modifying such determinants and the resulting effects on behavior will be postulated using the conceptual framework of the AIDS Risk Reduction Model. The project will also be the first in Thailand to investigate migration and travel patterns as a factor in the transmission of HIV infection. Data will be analyzed to indicate networks of social and sexual interactions between the study populations, to project the potential for the transmission of HIV infection between these groups and from them to other segments of the Thai population, and to serve as a basis for developing effective strategies for the prevention of high risk behavior. Selected behavioral interventions which the project proposes to test include peer counseling and condom distribution in the brothels, involvement of brothel owners and managers in safe sex programs for their employees, and AIDS education and condom distribution through trucking companies. In large part, the project´s support of interventions will occur through existing implementing agencies in Thailand
Keywords: AIDS, AIDS education /prevention, HIV infection, behavior modification, disease proneness /risk, sexually transmitted disease, southeast Asia high risk life style, nondrug contraceptive, peer group, sex behavior AIDS test
Project start date: 1990-09-30
Project end date: 1994-08-31
5R01HD028306-04 (1993): $203971
5R01HD028306-03 (1992): $195628
STD CONTROL FOR AIDS PREVENTION
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 5R01AI034826-02 from National Institute Of Allergy And Infectious Diseases IRG: ARRD
Abstract: Improved strategies to control the epidemic of human immunodeficiency virus (HIV) type l are urgently needed. Research suggests that other sexually transmitted diseases (STDs) facilitate HIV transmission and may contribute substantially to the spread of AIDS. It is difficult, however, to establish the causal nature of the STD/HIV interaction in clinic based studies, due to potential confounding. In order to avoid this problem and to assess the impact of reduced STD levels on HIV incidence, we propose to conduct a prospective community based trial of intensive STD treatment and control. Twenty five randomly selected villages in Rakai District, Uganda, will receive the STD intervention, including a modified mass treatment strategy, serological surveillance, active case finding and intensive health education/condom distribution. An equal number of randomly chosen villages will serve as control communities, with equivalent data collection and preventive activities; however, instead of mass treatment, control subjects will be referred for STD treatment if warranted by symptomatology or serological results. The proposed study will build upon a large cohort study in the district. Cohort data indicate that the populations of the villages to be included have very high rates of HIV prevalence (range 10% - 58% for all adults), substantial HIV seroincidence (2.6% per 100 person years for adults aged 15-59), over 10% positive syphilis RPR, and over 10% of adults reporting genital ulcer or discharge on an annual basis. Cumulative follow-up rates have exceeded 80% over the 3 years of the current cohort study. We estimate that HIV and STD rates in this population are sufficiently high to detect a 35% reduction in HIV incidence in response to STD control, with 80% statistical power. Rakai District represents a unique setting for the proposed research, as no other study we know of is based in a similarly large number of villages with such high documented rates of both HIV and STDs. In the proposed modified mass STD treatment, we will use safe and effective drugs, administered as single dose oral regimens to both symptomatic and asymptomatic persons, and additional selected therapeutics provided on the basis of symptomatology, physical or laboratory diagnosis. This approach represents the optimum feasible strategy to ensure compliance, good population coverage and therapeutic efficacy in an underserviced area such as Rakai. The study will permit the testing of the mass treatment approach, a strategy of great potential value in other underserviced settings in the world. Due to the research nature of this project, the mass treatment will be backed up by intensive follow-up, surveillance and evaluation.
Keywords: AIDS, AIDS education /prevention, Africa, communicable disease control, human immunodeficiency virus 1, microorganism interaction, sexually transmitted disease, antibiotic, communicable disease chemotherapy, condom, health behavior, human therapy evaluation, penicillin, sex behavior, African, human subject, serology /serodiagnosis
Project start date: 1994-03-01
Project end date: 1999-02-28
5R01AI034826-02 (1995): $1350640
1R01AI034826-01A1 (1994): $1647905
Sponsored Links Excellgen http://Excellgen.com
5R01AI034826-05 (1998): $1411967
5R01AI034826-04 (1997): $2251229
ARV Effects On HIV Epidemiology & Behaviors Rakai Uganda
Maria J Wawer
Columbia University Health Sciences
5R01HD050180-02 (2006): $1166833
COMMUNITY OPINION LEADER INTERVENTION TRIAL RAKAI-UGANDA
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 5R01MH061538-05 from National Institute Of Mental Health IRG: ZMH1
Project start date: 1999-09-30
Project end date: 2004-08-31
5R01MH061538-05 (2003): $69111
STD CONTROL FOR AIDS PREVENTION
Maria J Wawer, Professor Of Public Health
Columbia University Health Sciences Columbia University Medical Center New York, Ny 100323702
Grant 5R01AI034826-03 from National Institute Of Allergy And Infectious Diseases IRG: ARRD
Project start date: 1994-03-01
Project end date: 1999-02-28
5R01AI034826-03 (1996): $1274745