Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men (5Part)
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Text-Based Prevention Web Page
The Morning After
Talking About HIV
Both Videos
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, Internet, MSM, Condom Use, Disclosure
Eligibility 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
Sites / Locations
- Public Health Solutions
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
Text-based webpage
Talking about HIV video
The Morning After video
Both videos
Outcomes
Primary Outcome Measures
HIV disclosure, HIV testing, and condom use
Secondary Outcome Measures
drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
Full Information
NCT ID
NCT00649701
First Posted
March 27, 2008
Last Updated
June 19, 2008
Sponsor
Public Health Solutions
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00649701
Brief Title
Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men
Acronym
5Part
Official Title
Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Public Health Solutions
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Internet, MSM, Condom Use, Disclosure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3097 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Text-based webpage
Arm Title
3
Arm Type
Experimental
Arm Description
Talking about HIV video
Arm Title
4
Arm Type
Experimental
Arm Description
The Morning After video
Arm Title
5
Arm Type
Experimental
Arm Description
Both videos
Intervention Type
Behavioral
Intervention Name(s)
Standard Text-Based Prevention Web Page
Intervention Description
A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.
Intervention Type
Behavioral
Intervention Name(s)
The Morning After
Intervention Description
A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
Intervention Type
Behavioral
Intervention Name(s)
Talking About HIV
Intervention Description
A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
Intervention Type
Behavioral
Intervention Name(s)
Both Videos
Intervention Description
Morning After and Talking About HIV videos
Primary Outcome Measure Information:
Title
HIV disclosure, HIV testing, and condom use
Time Frame
60 days
Secondary Outcome Measure Information:
Title
drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
Time Frame
60 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabina Hirshfield, PhD
Organizational Affiliation
Public Health Solutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Solutions
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23071551
Citation
Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. Epub 2012 Oct 2.
Results Reference
derived
Learn more about this trial
Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men
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