NCT00649701

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,097

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 20, 2008

Status Verified

June 1, 2008

Enrollment Period

8 months

First QC Date

March 27, 2008

Last Update Submit

June 19, 2008

Conditions

Keywords

HIVInternetMSMCondom UseDisclosure

Outcome Measures

Primary Outcomes (1)

  • HIV disclosure, HIV testing, and condom use

    60 days

Secondary Outcomes (1)

  • drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)

    60 days

Study Arms (5)

1

NO INTERVENTION

2

EXPERIMENTAL

Text-based webpage

Behavioral: Standard Text-Based Prevention Web Page

3

EXPERIMENTAL

Talking about HIV video

Behavioral: Talking About HIV

4

EXPERIMENTAL

The Morning After video

Behavioral: The Morning After

5

EXPERIMENTAL

Both videos

Behavioral: Both Videos

Interventions

A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.

2

A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.

4

A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.

3
Both VideosBEHAVIORAL

Morning After and Talking About HIV videos

5

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Women and transgender persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Solutions

New York, New York, 10013, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sabina Hirshfield, PhD

    Public Health Solutions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 20, 2008

Record last verified: 2008-06

Locations