Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices

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. Identifier: NCT00378885
Recruitment Status : Terminated
First Posted : September 21, 2006
Last Update Posted : September 21, 2006
Information provided by:
Public Health Service of Amsterdam

Brief Summary:
The purpose of this study is to examine the efficacy of a theory based, online tailored intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our hypothesis was that a tailored internet intervention would be more effective in stimulating safe-sex practices of gay men than a non-tailored internet intervention when compared to a waiting-list control group.

Condition or disease Intervention/treatment
Sexual Risk Behavior for HIV-Infection Behavioral: Cognitive-behavioral tailored intervention

Detailed Description:

Relationships are a high-risk setting for HIV-infection. This trial aimed at testing the efficacy of an online theory-based tailored intervention for preparing single MSM to practice safe sex with future steady partners—labeling it the ‘cognitive vaccine approach’.

The target was the promotion of negotiated safety (NS): steady partners testing for HIV and reaching agreements to either be monogamous or to only have safe sex outside the relationship in order to have safe unprotected anal intercourse with each other. The intervention content was based on the information, motivation, behavioral-skills model and the intervention was tailored according to knowledge, motivation, and skill-related deficiencies of each participant. Condom use was promoted as the default alternative for NS. Using an online randomized controlled trial we examined the effects of a tailored versus non-tailored version of the intervention. The cognitive effect (i.e. response efficacy, intentions, and perceived behavioral control (PBC) was measured directly after the intervention and, after 6-months, the behavioral effect (i.e. NS and condom use) via e-mail follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: The Effect of a Theory Based Tailored Intervention Online on the Reduction of Risk Behavior for HIV Transmission Among Men Who Have Sex With Men - a Randomized, Single-Blind, Active (Waiting-List) Controlled Trial
Study Start Date : January 2003
Estimated Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. Scores on the practice of safe sex with steady partners at a six-months follow-up

Secondary Outcome Measures :
  1. Scores on response efficacy, intentions and perceived behavioral control regarding the practice of safe sex with steady partners directly after the administration of the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men who have sex with men of all ages, HIV-negative or of unknown serostatus, single, and open to a steady relationship with a man in the future

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 identifier (NCT number): NCT00378885

GGD Amsterdam- Amsterdam Health Services
Amsterdam, Netherlands, 1018WT
Sponsors and Collaborators
Public Health Service of Amsterdam
Principal Investigator: Udi Davidovich, Dr. Public Health Service of Amsterdam Identifier: NCT00378885     History of Changes
Other Study ID Numbers: GGD 4013
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: September 21, 2006
Last Verified: September 2006

Keywords provided by Public Health Service of Amsterdam:
Internet Prevention intervention
Online randomized controlled trial
Effect evaluation
Steady relationships

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