NCT00062634

Brief Summary

The female condom offers women a potentially important option for HIV prevention. This study will develop and evaluate a health education program to increase female condom use among ethnically diverse women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2004

First QC Date

June 9, 2003

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Female condom useMale condom useAIDS educationAIDS preventionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • percent of sex acts protected by female condoms

Secondary Outcomes (1)

  • percent of sex acts protected by male or female condoms

Interventions

Female condom skills trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African American, Asian American, Latina, or White
  • Two or more male sexual partners in the year prior to study entry
  • English speaking

You may not qualify if:

  • Commercial sex workers
  • Planning to move within 6 months of study entry
  • Allergic to polyurethane, latex, or lubricants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for AIDS Prevention Studies, University of California, San Francisco

San Francisco, California, 94105, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kyung-Hee Choi, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Hussey, MPH

CONTACT

415-597-9340whussey@psg.ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 9, 2003

First Posted

June 12, 2003

Study Start

June 1, 2003

Study Completion

August 1, 2005

Last Updated

June 24, 2005

Record last verified: 2004-10

Locations

US(1)