HIV Prevention Preparedness Study

This study has been completed.

First Received on October 29, 2002. Last Updated on May 13, 2010 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00048282

Purpose

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.

Condition
HIV Infections HIV Seronegativity

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	HIV Prevention Preparedness Study

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

1200

Detailed Description:

This study is designed to prepare for the implementation of a second study, 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. HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035.

Women will be enrolled in this study for 6 to 12 months. Study visits will take place monthly. At each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. Each quarter, participants will undergo a structured interview about sexual practices and will receive HIV and STD tests, education, and counseling. Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048282

Locations

South Africa
R.K. Khan Hospital
Chatsworth, South Africa

Durban, South Africa

Hlabisa, South Africa
Medical Research Council
Hlabisa, South Africa
Tanzania

Moshi, Tanzania
Kilimanjaro Christian Med Ctr
Moshi, Tanzania
Zambia

Chililabombwe, Zambia

Lusaka, Zambia
Chilenje Clinic, Lusaka, Sambia
Lusaka, Zambia
Kamwala Clinic
Lusaka, Zambia

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institute on Drug Abuse (NIDA)

Investigators

Study Chair:	Saidi Kapiga, MD, MPH, SCD	Harvard School of Public Health
Study Chair:	Gita Ramjee, PhD	South Africa Medical Research Council
Study Chair:	Stephen Weiss, PhD	University of Miami

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

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.

Ramjee 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.

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 Feb 15;169(4):515-21. Epub 2008 Dec 18.

ClinicalTrials.gov Identifier:	NCT00048282 History of Changes
Other Study ID Numbers:	HIVNET/HPTN 055
Study First Received:	October 29, 2002
Last Updated:	May 13, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Incidence
HIV Seroprevalence
Vagina
Anti-Infective Agents

Administration, Topical
Gels
HIV Seronegativity

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012