- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378885
Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands, 1018WT
- GGD Amsterdam- Amsterdam Health Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Scores on the practice of safe sex with steady partners at a six-months follow-up
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Udi Davidovich, Dr., Public Health Service of Amsterdam
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GGD 4013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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