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

This study has been terminated.
Sponsor:
Information provided by:
Public Health Service of Amsterdam
ClinicalTrials.gov Identifier:
NCT00378885
First received: September 20, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Public Health Service of Amsterdam:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
GGD Amsterdam- Amsterdam Health Services
Amsterdam, Netherlands, 1018WT
Sponsors and Collaborators
Public Health Service of Amsterdam
Investigators
Principal Investigator: Udi Davidovich, Dr. Public Health Service of Amsterdam
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on September 18, 2014