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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00649701
Recruitment Status : Unknown
Verified June 2008 by Public Health Solutions.
Recruitment status was:  Active, not recruiting
First Posted : April 1, 2008
Last Update Posted : June 20, 2008
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Public Health Solutions

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Standard Text-Based Prevention Web Page Behavioral: The Morning After Behavioral: Talking About HIV Behavioral: Both Videos Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3097 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men
Study Start Date : April 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HIV disclosure, HIV testing, and condom use [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks) [ Time Frame: 60 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649701


Locations
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United States, New York
Public Health Solutions
New York, New York, United States, 10013
Sponsors and Collaborators
Public Health Solutions
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Sabina Hirshfield, PhD Public Health Solutions
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sabina Hirshfield, PhD /Senior Research Scientist, Public Health Solutions
ClinicalTrials.gov Identifier: NCT00649701    
Other Study ID Numbers: CDC-URS PS000415
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008
Keywords provided by Public Health Solutions:
HIV
Internet
MSM
Condom Use
Disclosure
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases