A Tailored Interactive Website for Promoting Condom Use Among Young Adults (Youthnet)

November 26, 2013 updated by: University of Colorado, Denver

Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25

This study will develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among young adults.

Study Overview

Detailed Description

Adolescents and young adults are at the greatest risk for acquiring a sexually transmitted disease (STD). Approximately 3 million people between the ages of 18 and 24 become infected with an STD each year. Education about the risks and consequences of unprotected sex is a powerful tool that can be used to prevent or reduce the risk of infection. The program in this study will deliver messages to educate participants about condom use and the risk of STD infection. The study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of STD infection in young adults.

Participants in this open-label study will be recruited from one of two clinics in the Denver, Colorado area: Denver Metropolitan Health Clinic or Planned Parenthood of the Rocky Mountains. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program while filling out a risk assessment survey. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage. The control program will deliver 5 general, non-tailored messages containing information on reproductive health not specific to condoms or STDs. Participants will be assessed at baseline and a follow-up session 3 months after enrollment. Frequency of condom use and attitudes toward condom use will be assessed using behavioral scales.

Study Type

Interventional

Enrollment (Actual)

1870

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045-0508
        • University of Colorado Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Client of Denver Metropolitan Health Clinic or Planned Parenthood
  • English-speaking
  • Access to a computer and an existing e-mail account
  • Will be in Denver for at least 4 months

Exclusion Criteria:

  • Not a resident of the Denver metropolitan area
  • No existing e-mail address
  • No access to a computer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive Internet-based tailored prevention messages
Participants will receive five 30-second flash clips promoting condom norms, positive attitudes, self-efficacy, and risk awareness. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage.
Other Names:
  • Youthnet
Active Comparator: 2
Participants will receive non-tailored messages containing information on reproductive health
The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Condom use with non main partners
Time Frame: Measured at Month 3
Measured at Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-efficacy for condom use and condom negotiation
Time Frame: Measured at Month 3
Measured at Month 3
Attitudes and norms towards condom use
Time Frame: Measured at Month 3
Measured at Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sheana S. Bull, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 02-0764a
  • DAHBR 9A-ASI
  • R01MH063690 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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