A Tailored Interactive Website for Promoting Condom Use Among Young Adults (Youthnet)
Primary Purpose
HIV Infections, Sexually Transmitted Diseases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Internet-based tailored prevention messages
Non-tailored messages
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Internet, Interactive Computer Program, HIV Prevention
Eligibility Criteria
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
Sites / Locations
- University of Colorado Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive Internet-based tailored prevention messages
Participants will receive non-tailored messages containing information on reproductive health
Outcomes
Primary Outcome Measures
Condom use with non main partners
Secondary Outcome Measures
Self-efficacy for condom use and condom negotiation
Attitudes and norms towards condom use
Full Information
NCT ID
NCT00183638
First Posted
September 13, 2005
Last Updated
November 26, 2013
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00183638
Brief Title
A Tailored Interactive Website for Promoting Condom Use Among Young Adults
Acronym
Youthnet
Official Title
Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
Internet, Interactive Computer Program, HIV Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1870 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive Internet-based tailored prevention messages
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive non-tailored messages containing information on reproductive health
Intervention Type
Behavioral
Intervention Name(s)
Internet-based tailored prevention messages
Other Intervention Name(s)
Youthnet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-tailored messages
Intervention Description
The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.
Primary Outcome Measure Information:
Title
Condom use with non main partners
Time Frame
Measured at Month 3
Secondary Outcome Measure Information:
Title
Self-efficacy for condom use and condom negotiation
Time Frame
Measured at Month 3
Title
Attitudes and norms towards condom use
Time Frame
Measured at Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheana S. Bull, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0508
Country
United States
12. IPD Sharing Statement
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A Tailored Interactive Website for Promoting Condom Use Among Young Adults
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