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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00021775 |
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.
Condition |
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HIV Infections |
Study Type: | Observational |
Official Title: | HIV Prevention Preparedness Study |
Estimated Enrollment: | 2000 |
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 HPTN 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. In a substudy of this trial in China, participants will be interviewed about their drug use, social networks, needs, and perceptions about HIV/AIDS. These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Participants may be eligible for this study if they:
Exclusion Criteria
Participants will not be eligible for this study if they:
United States, North Carolina | |
Marybeth McCauley | |
Research Triangle Park, North Carolina, United States, 27709 | |
China | |
Guangxi Centers for Disease Control, China | |
Nanning, China, 532002I | |
Xinjiang Uygar Autonomous Region, China | |
Xinjiang, China | |
India | |
Yr Gaitonde Med and Research Foundation, India | |
Chennai, India, 600017 | |
Russian Federation | |
Biomedical Ctr for AIDS, St. Petersburg Univ | |
St. Petersburg, Russian Federation, 197110 |
Study Chair: | Robert Ryder |
Study ID Numbers: | HPTN 033 |
Study First Received: | August 4, 2001 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00021775 |
Health Authority: | United States: Federal Government |
Risk Factors Incidence Patient Selection HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |