HIV Prevention Preparedness Study

Completed

• Conditions: HIV Infections; HIV Seronegativity

• Registration Number: NCT00048282
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2002-10-29
• Study First Submitted QC: 2002-10-29
• Study First Posted: 2002-10-30
• Status Verified: 2006-01
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Kilimanjaro Christian Med Ctr; 🇹🇿 Moshi, Tanzania

R.K. Khan Hospital; 🇿🇦 Chatsworth, South Africa

Kamwala Clinic; 🇿🇲 Lusaka, Zambia

Chilenje Clinic, Lusaka, Sambia; 🇿🇲 Lusaka, Zambia

Medical Research Council; 🇿🇦 Hlabisa, South Africa