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.
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
HPTN 055 Publications
Brahmi A, Reid C, Mass B, Kelly C. Meeting Retention Challenges in Lusaka Zambia. Research Practitioner. 2006, 7: 212-13
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. JAIDS. 2008, 47: 93-100.
Kapiga S, Kelly C, Weiss S, Daley T, Peterson L, Leburg C, Ramjee G. Risk factors for incidence of sexually transmitted infections among women in South Africa, Tanzania, and Zambia: results from HPTN 055 study. Sex Transm Dis. 2009, 36: 199-206 PMID:19265734
Kapina M, Reid C, Roman K, Cyrus-Cameron E, Kwiecien A, Weiss S, Vermund SH. HIV Incidence Rates and Risk Factors for Urban Women in Zambia: Preparing for a Microbicide Clinical Trial. Sex Transm Dis. 2009, 36: 129-33 PMCID: 2889146
Schreiber CA, Sammel M, Hillier SL, Barnhart KT. A Little Bit Pregnant: Modeling How the Accurate Detection of Pregnancy Can Improve HIV Prevention Trials. Am J Epidemiol. 2009, 169: 515-21 PMCID: 2732971