A Tailored Interactive Website for Promoting Condom Use Among Young Adults (Youthnet)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | September 19, 2008 | ||||
| Start Date ICMJE | June 2003 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Condom use with non main partners [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Efficacy of intervention to increase condom use with non main partners among study participants; measured at Months 1 and 3 | ||||
| Change History | Complete list of historical versions of study NCT00183638 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Efficacy of intervention to increase self-efficacy for condom use and condom negotiation; to improve attitudes towards condom use; to increase norms regarding condom use; measured at Months 1 and 3 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Tailored Interactive Website for Promoting Condom Use Among Young Adults | ||||
| Official Title ICMJE | Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25 | ||||
| Brief Summary | This study will develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among young adults. |
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| Detailed Description | Adolescents and young adults are at the greatest risk for acquiring an 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, CO 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1870 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 25 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00183638 | ||||
| Other Study ID Numbers ICMJE | R01 MH63690-02, DAHBR 9A-ASI | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sheana Bull, PhD, MPH, Associate Professor, University of Colorado at Denver and Health Sciences Center | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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