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

This study has been terminated.

Sponsored by: Amsterdam Health Services
Information provided by: Amsterdam Health Services
ClinicalTrials.gov Identifier: NCT00378885
  Purpose

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 Intervention
Sexual Risk Behavior for HIV-Infection
Behavioral: Cognitive-behavioral tailored intervention

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
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

Further study details as provided by Amsterdam Health Services:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   642
Study Start Date:   January 2003
Estimated Study Completion Date:   August 2003

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.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378885

Locations
Netherlands
GGD Amsterdam- Amsterdam Health Services    
      Amsterdam, Netherlands, 1018WT

Sponsors and Collaborators
Amsterdam Health Services

Investigators
Principal Investigator:     Udi Davidovich, Dr.     Amsterdam Health Services    
  More Information

Study ID Numbers:   GGD 4013
First Received:   September 20, 2006
Last Updated:   September 20, 2006
ClinicalTrials.gov Identifier:   NCT00378885
Health Authority:   Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Amsterdam Health Services:
HIV-prevention  
Internet Prevention intervention  
Online randomized controlled trial  
Effect evaluation
MSM
Steady relationships

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 05, 2008




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