HPTN 055

HIV Prevention Preparedness Study

Study Summary
Study Documents - Study Details* - Key Study Personnel* - Study SitesPublications
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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

Protocol Status: Concluded
Study Purpose:

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

Study Design:

Prospective cohort study with a six-month accrual period and 6-12 months of follow-up for each enrolled participant

Study Population:

Sexually active HIV-uninfected women from the study sites

Study Size:

240 participants per site

Study Duration:

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.

Treatment Regimen:

None, however HIV/STD pre-test, risk reduction, and post-test counseling is provided each quarter, and STD treatment is provided as clinically indicated

Primary Objectives:

To estimate rates of HIV seroincidence among women targeted for inclusion in HPTN 035.

Secondary Objectives:

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

Key Study Personnel

Gita Ramjee, Protocol Co-Chair
Stephen Weiss, Protocol Co-Chair