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

Purpose

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.

Condition	Intervention
Sexual Risk Behavior for HIV-Infection	Behavioral: Cognitive-behavioral tailored intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Public Health Service of Amsterdam:

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


Estimated Enrollment:	642
Study Start Date:	January 2003
Estimated Study Completion Date:	August 2003

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378885

Locations


Netherlands
GGD Amsterdam- Amsterdam Health Services
Amsterdam, Netherlands, 1018WT

Sponsors and Collaborators

Public Health Service of Amsterdam

Investigators


Principal Investigator:	Udi Davidovich, Dr.	Public Health Service of Amsterdam

More Information


ClinicalTrials.gov Identifier:	NCT00378885 History of Changes
Other Study ID Numbers:	GGD 4013
Study First Received:	September 20, 2006
Last Updated:	September 20, 2006
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on September 27, 2016