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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Public Health Solutions.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Public Health Solutions
ClinicalTrials.gov Identifier:
NCT00649701
First received: March 27, 2008
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Public Health Solutions:

Primary Outcome Measures:
  • HIV disclosure, HIV testing, and condom use [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks) [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 3097
Study Start Date: April 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649701

Locations
United States, New York
Public Health Solutions
New York, New York, United States, 10013
Sponsors and Collaborators
Public Health Solutions
Investigators
Principal Investigator: Sabina Hirshfield, PhD Public Health Solutions
  More Information

No publications provided by Public Health Solutions

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sabina Hirshfield, PhD /Senior Research Scientist, Public Health Solutions
ClinicalTrials.gov Identifier: NCT00649701     History of Changes
Other Study ID Numbers: CDC-URS PS000415
Study First Received: March 27, 2008
Last Updated: June 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Public Health Solutions:
HIV
Internet
MSM
Condom Use
Disclosure

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2014