HIV Infections Clinical Trial
Official title:
HIV Prevention Preparedness Study
The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.
This study is designed to prepare for the implementation of a second study, HPTN 035: A
Phase II/III Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO
2000/5 Gel (P) for the Prevention of HIV Infection in Women. HPTN 035 requires an average
HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of
the present study is to estimate the rates of HIV seroincidence among women targeted for
inclusion in HPTN 035.
Women will be enrolled in this study for 6 to 12 months. Study visits will take place
monthly. At each visit, participants will complete a medical/menstrual history and undergo
pregnancy testing. Each quarter, participants will undergo a structured interview about
sexual practices and will receive HIV and STD tests, education, and counseling. Participants
will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis,
and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears
will be performed at sites with the capacity and expertise to prepare and interpret the
smears and provide appropriate follow-up care to participants with abnormal results.
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Time Perspective: Prospective
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