HIV Prevention Preparedness Study
What was HPTN 055?
A prospective cohort study to prepare for implementation of 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
Who participated in the study?
Sexually active HIV-uninfected women from the study sites (240 participants per site)
What happened during the study?
No treatment regimen; however HIV/STD pre-test, risk reduction, and post-test counseling was provided each quarter, and STD treatment was provided as clinically indicated
Study Documents
Study Details
To prepare for implementation of 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
Prospective cohort study with a six-month accrual period and 6-12 months of follow-up for each enrolled participant
Sexually active HIV-uninfected women from the study sites
240 participants per site
Accrual will require six months. Each participant will be maintained in follow-up for a minimum of six months and a maximum of 12 months. At each site, the duration of follow-up will depend on the timing of initiation of HPTN 035.
None, however HIV/STD pre-test, risk reduction, and post-test counseling is provided each quarter, and STD treatment is provided as clinically indicated
To estimate rates of HIV seroincidence among women targeted for inclusion in HPTN 035.
To develop and describe the accrual process and estimate rates of accrual into a standardized HIV-related research study among women targeted for inclusion in HPTN 035.
To estimate rates of retention in a standardized HIV-related research study among women targeted for inclusion in HPTN 035.
To describe the demographic characteristics and HIV risk behaviors of women targeted for inclusion in HPTN 035.
To estimate prevalence and incidence rates of the following among women targeted for inclusion in HPTN 035: Genital lesions involving deep epithelial disruption; Genital ulcer disease; Other genital signs and symptoms; Bacterial vaginosis; Candidiasis; Chlamydia infection; Gonorrhea infection; Syphilis infection; Trichomoniasis