- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183638
A Tailored Interactive Website for Promoting Condom Use Among Young Adults (Youthnet)
Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045-0508
- University of Colorado Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheana S. Bull, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-0764a
- DAHBR 9A-ASI
- R01MH063690 (U.S. NIH Grant/Contract)
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