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Home > "H" Clinical Trials Conditions > HIV Prevention Preparedness Study in Russia, China, and India  HIV Prevention Preparedness Study in Russia, China, and India
HIV Prevention Preparedness Study in Russia, China, and India
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH)
Synopsis: The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world. In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.
Details: In order to realistically plan for future Phase III studies on HIV prevention, information must be obtained to characterize study population parameters at HTPN sites. Very different study designs may be required depending on these parameters, such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations. This study will be conducted at 4 HTPN sites to establish the necessary research knowledge and infrastructure. This study enrolls participants from St. Petersburg, Russia; Xinjiang and Guangxi, China; and Chennai, India who are at high risk for HIV infection due to sexual and/or drug use behaviors. Participants who meet the screening criteria then complete an HIV risk assessment interview, receive HIV pre-test and risk reduction counseling, and undergo phlebotomy for HIV antibody testing. Participants who test positive are referred to available services and studies. Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months. Participants complete "locator contacts" at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Participants may be eligible for this study if they: - Are 16 (Saint Petersburg) or 18 (Xinjiang, Guangxi, and Chennai) years of age or older. - Are HIV sero-negative. - Are available for 12 months of study participation. - Have written consent of parent or legal guardian if under age. - Are able and willing to provide information on where they can be located or contacted. - Meet specific risk-group requirements, for women at heterosexual risk, for men at heterosexual risk, and for injection drug users. Exclusion Criteria Participants will not be eligible for this study if they: - Have any mental disorders that would cause a problem with the informed consent or study participation. - Have any condition that, in the opinion of the doctor, would interfere with the study.
Total Enrollment: 2000
Location and Contact Information:
Overall Study Official:
RobertRyder, Study Chair,
Guangxi Centers for Disease Control, China
Nanning, , 532002I
China
Marybeth McCauley
Research Triangle Park, North Carolina, 27709
United States
Biomedical Ctr for AIDS, St. Petersburg Univ
St Petersburg, , 197110
Russian Federation
Xinjiang Uygar Autonomous Region, China
Xinjiang, ,
China
Yr Gaitonde Med and Research Foundation, India
Chennai, , 600017
India
Additional Information:
Study ID Numbers: HPTN 033;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021775
Other Hiv Infections Studies:
1. A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
2. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
3. Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
4. Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns
5. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
Related Studies:
Other HIV Infections Clinical Trials
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HIV Prevention Preparedness Study in Russia, China, and India
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