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TerminatedNCT00378885Updated Sep 21, 2006

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

An interventional study of Cognitive-behavioral tailored intervention in Sexual Risk Behavior for HIV-Infection, sponsored by Public Health Service of Amsterdam. Terminated at 1 site in Netherlands. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-09-21.

Sponsored by Public Health Service of Amsterdam · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
642
Allocation
Randomized
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Sexual Risk Behavior for HIV-Infection

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Keywords

  • HIV-prevention
  • Internet Prevention intervention
  • Online randomized controlled trial
  • Effect evaluation
  • MSM
  • Steady relationships
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 642 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Public Health Service of Amsterdam is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single
Enrollment
642 participants

Interventions

  • BehavioralCognitive-behavioral tailored intervention
06

What researchers measure

Primary outcomes

  1. Scores on the practice of safe sex with steady partners at a six-months follow-up

Secondary outcomes

  1. 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

07

Study locations

1 site
  • GGD Amsterdam- Amsterdam Health Services
    Amsterdam, 1018WT, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00378885
Lead sponsor
Public Health Service of Amsterdam
First posted
Sep 21, 2006
Start date
Jan 2003
Completion
Aug 2003
Last update
Sep 21, 2006

Study contacts

Udi Davidovich, Dr.
principal investigator · Public Health Service of Amsterdam
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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