HIV Infections Clinical Trial
Official title:
HIV Prevention Preparedness Study
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.
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.
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N/A
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