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Clinical Trials/NCT00183638
NCT00183638
Completed
Phase 2

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

University of Colorado, Denver1 site in 1 country1,870 target enrollmentStarted: June 2003Last updated:

Overview

Phase
Phase 2
Status
Completed
Enrollment
1,870
Locations
1
Primary Endpoint
Condom use with non main partners

Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Condom use with non main partners

Time Frame: Measured at Month 3

Secondary Outcomes

  • Self-efficacy for condom use and condom negotiation(Measured at Month 3)
  • Attitudes and norms towards condom use(Measured at Month 3)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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