Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
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ClinicalTrials.gov Identifier: NCT00378885 |
Recruitment Status
:
Terminated
First Posted
: September 21, 2006
Last Update Posted
: September 21, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexual Risk Behavior for HIV-Infection | Behavioral: Cognitive-behavioral tailored intervention | Not Applicable |
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 : | Interventional (Clinical Trial) |
Enrollment : | 642 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single |
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 |
Study Start Date : | January 2003 |
Study Completion Date : | August 2003 |

- Scores on the practice of safe sex with steady partners at a six-months follow-up
- 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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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378885
Netherlands | |
GGD Amsterdam- Amsterdam Health Services | |
Amsterdam, Netherlands, 1018WT |
Principal Investigator: | Udi Davidovich, Dr. | Public Health Service of Amsterdam |
ClinicalTrials.gov Identifier: | NCT00378885 History of Changes |
Other Study ID Numbers: |
GGD 4013 |
First Posted: | September 21, 2006 Key Record Dates |
Last Update Posted: | September 21, 2006 |
Last Verified: | September 2006 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |