Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men - Full Text View

Sponsors and Collaborators:	Public Health Solutions Centers for Disease Control and Prevention
Information provided by:	Public Health Solutions
ClinicalTrials.gov Identifier:	NCT00649701

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 I

MedlinePlus related topics: AIDS

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men

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
1: No Intervention
2: Experimental 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.
3: Experimental 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.
4: Experimental 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.
5: Experimental 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

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

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Sabina Hirshfield, PhD

Public Health Solutions

More Information

Responsible Party:	Public Health Solutions ( Sabina Hirshfield, PhD /Senior Research Scientist )
Study ID Numbers:	CDC-URS PS000415
Study First Received:	March 27, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00649701
Health Authority:	United States: Institutional Review Board

Keywords provided by Public Health Solutions:

HIV
Internet
MSM
Condom Use
Disclosure

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Ethanol

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009