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HPTN 055
HIV Prevention Preparedness
Study
What is
HPTN 055?
Topical
microbicides are antimicrobial agents formulated for application to the
surface of the vagina and/or rectum for the prevention of HIV transmission
during sexual intercourse. This prevention strategy is urgently needed
throughout the world because many individuals at high risk of transmitting
or acquiring HIV infection cannot or will not use condoms with every act
of sexual intercourse. Reasons for lack of effective condom use include
power imbalances in relationships that result in the inability of the
receptive partner to negotiate condom use, physical discomfort and
decreased sexual pleasure.
HPTN
055 was a prospective cohort study that repared sites for implementation of
HPTN 035, a Phase III Safety and Effectiveness study of two vaginal microbicides for HIV prevention.
The study was conducted at HPTN study sites located in South
Africa (2 sites), Tanzania and Zambia.
Each study site targeted enrollment of 240 study participants
over the course of a six-month accrual period. The primary objective of
this study was to estimate rates of HIV seroincidence among women targeted
for inclusion in HPTN 035.
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HPTN 055 paper
published!
The HPTN 055 study paper was
published in the January 1, 2008 issue of the
Journal of AIDS.
This paper provides the
results from the HPTN 055 study. The study concluded that preparatory studies
provide accurate local estimates of HIV incidence, recruitment and retention
rates, and behavioral characteristics of targeted populations for large-scale
clinical trials. Determining these factors allows for better preparation for
design, sample size, and appropriate population for future selection of trial
sites. Because of the lower than expected HIV incidence observed at the Moshi,
Tanzania site, only the South African and Zambian sites were selected for the
phase 2/IIb trial.
Please find the reference
for the paper below. Click
on the title to view the paper's abstract and to gain access to the full text
version on the Journal of AIDS website.
Ramjee G, Kapiga S, Weiss S,
Peterson L, Leburg C, Kelly C, Masse B; the HPTN 055 Study Team.
The Value of Site Preparedness Studies for Future Implementation of Phase
2/IIb/III HIV Prevention Trials: Experience From the HPTN 055 Study.
Journal of AIDS.
2008 Jan 1; 47(1):93-100.
Protocol Status:
Concluded
Study
Summary
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
SDMC Protocol Specialist:
Corey Leburg
get info
Protocol Co-Chair:
Gita Ramjee
get info
Protocol Co-Chair:
Saidi Kapiga
get info
Protocol Co-Chair:
Stephen Weiss
get info
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