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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00649701
Other study ID # CDC-URS PS000415
Secondary ID
Status Unknown status
Phase Phase 1
First received March 27, 2008
Last updated June 19, 2008
Start date April 2008
Est. completion date December 2008

Study information

Verified date June 2008
Source Public Health Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop and test the efficacy of online HIV risk reduction interventions among men who have sex with men.


Description:

This is an Internet-based, five-branch randomized controlled intervention, enrolling 3,000 adult MSM. The five branches include 1) a control condition receiving no intervention content, 2) a standard text-based prevention webpage, 3) an 8 minute dramatic video addressing sexual risk reduction within the context of alcohol use, 4) a 5 minute documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use, and 5) both videos. After completing the baseline survey, eligible participants who consent to participate in the intervention will be randomly assigned to the control condition or one of the four intervention conditions. The control condition will not include the delivery of any intervention content. All participants (branches 1-5) will be asked to complete a brief post-intervention survey (to measure intentions). All intervention participants will be invited to complete a final 60-day follow-up survey.


Recruitment information / eligibility

Status Unknown status
Enrollment 3097
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male;

- Age 18 and over;

- Ability to read and respond in English;

- Reside within the United States;

- Report oral or anal sex with any male (new partner or not) in the past 60 days AND report oral, anal or vaginal sex for the first time with any partner (male or female) in the past 60 days;

- Complete baseline survey

- Provide an email address;

Exclusion Criteria:

- Women and transgender persons

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard Text-Based Prevention Web Page
A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.
The Morning After
A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
Talking About HIV
A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
Both Videos
Morning After and Talking About HIV videos

Locations

Country Name City State
United States Public Health Solutions New York New York

Sponsors (2)

Lead Sponsor Collaborator
Public Health Solutions Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HIV disclosure, HIV testing, and condom use 60 days
Secondary drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks) 60 days
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