Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men (5Part)

June 19, 2008 updated by: Public Health Solutions

Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3097

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Public Health Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Experimental: 2
Text-based webpage
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.
Experimental: 3
Talking about HIV video
Behavioral: Talking About HIV
A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
Experimental: 4
The Morning After video
Behavioral: The Morning After
A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
Experimental: 5
Both videos
Behavioral: Both Videos
Morning After and Talking About HIV videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV disclosure, HIV testing, and condom use
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Solutions

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Sabina Hirshfield, PhD, Public Health Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2008

Last Update Submitted That Met QC Criteria

June 19, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-URS PS000415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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