A Tailored Interactive Website for Promoting Condom Use Among Young Adults

HIV Infections Clinical Trial

— Youthnet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183638
• Other study ID #: 02-0764a
• Secondary ID: R01MH063690DAHBR
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 26, 2013
• Start date: June 2003
• Est. completion date: December 2008

Study information

• Verified date: November 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1870
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

Behavioral:
• 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.
• Non-tailored messages
The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condom use with non main partners		Measured at Month 3	No
Secondary	Self-efficacy for condom use and condom negotiation		Measured at Month 3	No
Secondary	Attitudes and norms towards condom use		Measured at Month 3	No