NCT00164671

Brief Summary

The intent of this project is to replicate the POWER pilot campaign using a randomized controlled trial with neighborhoods as the unit of randomization and analysis. We plan to rigorously test the effects of the POWER campaign on women's knowledge of, attitudes toward and use of female and male condoms for the prevention of sexually transmitted disease (STD) and unintended pregnancy. We will work in 12 non-contiguous neighborhoods in four southwestern U.S. cities (four each in Oakland/Alameda County and Los Angeles and two each in San Diego and Las Vegas). We will complete a baseline assessment in all 12 neighborhoods to document knowledge of, attitudes toward and use of female and male condoms. We will then randomly assign six neighborhoods to intervention status and six neighborhoods to control status. We will adapt the campaign for each city, and implement it in six intervention neighborhoods for nine months, and will complete a follow-up assessment similar to the baseline assessment, with added questions regarding exposure to the POWER campaign. Study partners include Dr. Sheana Bull and research staff from the Colorado Health Outcomes Program (COHO) of the University of Colorado Health Sciences Center, Educational Message Services (EMS), and Centers for Disease Control and Prevention (CDC).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2003

Status
completed

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

November 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Condom Use

Keywords

Male condomsFemale condomsSelf-efficacy

Outcome Measures

Primary Outcomes (2)

  • Awareness of social marketing campaign to promote male and female condoms among sexually active young women

  • Increased positive outcome expectations for condom use

Secondary Outcomes (3)

  • Awareness of female condoms

  • Awareness of male condoms

  • Increased use of condoms among sexually active young women

Interventions

POWERBEHAVIORAL

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women 15 to 25, ability to communicate in English, living in recruitment neighborhoods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sheana Bull, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

November 1, 2003

Study Completion

August 1, 2005

Last Updated

September 14, 2005

Record last verified: 2005-09