Back to resultsEffect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
Primary Purpose
Sexual Risk Behavior for HIV-Infection
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive-behavioral tailored intervention
Sponsored by
About this trial
This is an interventional prevention trial for Sexual Risk Behavior for HIV-Infection focused on measuring HIV-prevention, Internet Prevention intervention, Online randomized controlled trial, Effect evaluation, MSM, Steady relationships
Eligibility 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
Sites / Locations
- GGD Amsterdam- Amsterdam Health Services
Outcomes
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
Full Information
NCT ID
NCT00378885
First Posted
September 20, 2006
Last Updated
September 20, 2006
Sponsor
Public Health Service of Amsterdam
1. Study Identification
Unique Protocol Identification Number
NCT00378885
Brief Title
Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
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 Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Public Health Service of Amsterdam
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Risk Behavior for HIV-Infection
Keywords
HIV-prevention, Internet Prevention intervention, Online randomized controlled trial, Effect evaluation, MSM, Steady relationships
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
642 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral tailored intervention
Primary Outcome Measure Information:
Title
Scores on the practice of safe sex with steady partners at a six-months follow-up
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udi Davidovich, Dr.
Organizational Affiliation
Public Health Service of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGD Amsterdam- Amsterdam Health Services
City
Amsterdam
ZIP/Postal Code
1018WT
Country
Netherlands
12. IPD Sharing Statement
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Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
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