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

Sexual Risk Behavior for HIV-Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00378885
• Other study ID #: GGD 4013
• Status: Terminated
• Phase: N/A
• First received: September 20, 2006
• Last updated: September 20, 2006
• Start date: January 2003
• Est. completion date: August 2003

Study information

• Verified date: September 2006
• Source: Public Health Service of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 642
• Est. completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexual Risk Behavior for HIV-Infection

Intervention

Behavioral:
• Cognitive-behavioral tailored intervention

Locations

Country	Name	City	State
Netherlands	GGD Amsterdam- Amsterdam Health Services	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Public Health Service of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the practice of safe sex with steady partners at a six-months follow-up
Secondary	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