HIV Prevention Preparedness Study
1 other identifier
observational
1,200
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2002
CompletedFirst Posted
Study publicly available on registry
October 30, 2002
CompletedMay 14, 2010
January 1, 2006
October 29, 2002
May 13, 2010
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening).
- HIV-uninfected at screening.
- Able and willing to provide adequate locator information for study retention purposes.
You may not qualify if:
- History of adverse reaction to latex.
- Non-therapeutic injection drug use in the 12 months prior to screening.
- Vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening.
- Plans to travel away from the study site for more than 3 consecutive months in the next 12 months.
- Plans to relocate away from the study site in the next 12 months.
- Pregnancy or plans to become pregnant in the next 12 months.
- Pregnancy within 42 days prior to enrollment.
- Enrollment in any other study of a vaginally-applied product.
- Clinically apparent pelvic exam finding involving deep epithelial disruption.
- Diagnosis with a current STD and/or other reproductive tract infection requiring treatment.
- Conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
R.K. Khan Hospital
Chatsworth, South Africa
Unknown Facility
Durban, South Africa
Medical Research Council
Hlabisa, South Africa
Unknown Facility
Hlabisa, South Africa
Kilimanjaro Christian Med Ctr
Moshi, Tanzania
Unknown Facility
Moshi, Tanzania
Unknown Facility
Chililabombwe, Zambia
Chilenje Clinic, Lusaka, Sambia
Lusaka, Zambia
Kamwala Clinic
Lusaka, Zambia
Unknown Facility
Lusaka, Zambia
Related Publications (3)
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 Apr;36(4):199-206. doi: 10.1097/OLQ.0b013e318191ba01.
PMID: 19265734RESULTRamjee G, Kapiga S, Weiss S, Peterson L, Leburg C, Kelly C, Masse B; 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. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):93-100. doi: 10.1097/QAI.0b013e31815c71f7.
PMID: 17984760RESULTSchreiber 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 Feb 15;169(4):515-21. doi: 10.1093/aje/kwn345. Epub 2008 Dec 18.
PMID: 19095756RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Saidi Kapiga, MD, MPH, SCD
Harvard School of Public Health (HSPH)
- STUDY CHAIR
Gita Ramjee, PhD
South Africa Medical Research Council
- STUDY CHAIR
Stephen Weiss, PhD
University of Miami