A Pilot Trial of an Individualized Web-Based Condom Use Intervention

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.

Official Title
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A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Condom-HIM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are HIV-seropositive, Men who are having sex with men, engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown age 18 years and older, ability to read English have access to a computer and internet. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Web sites<br>Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use. | |
| Experimental: Condom-HIM<br>Individuals assigned to this arm must follow an on-line one session tailored intervention. | Behavioral: Condom-HIM<br>* The tailored on-line Condom-HIM intervention is composed of a single session involving activities to increase individuals self-efficacy and intention to use condoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention | The Self-Efficacy for condom use measure contains a set of items to rate participant's belief that they will be able to use condoms every time they have anal sex in a variety of situations. A four-point response scale, ranging from 'strongly agree' (0) to 'strongly disagree' (4) is used. The psychometric properties of the measure have been examined and have been shown to have good internal consistency with Cronbach's alpha coefficient of 0.96. | baseline and 2-weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in participants intention to use condoms at 2-weeks post-intervention | The intention to use condoms measure asks participants their intention to consistently use condoms. The psychometric properties of the measure have been examined and have shown to have good internal consistency with Cronbach's alpha coefficient of 0.89. | Baseline and 2-weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Condom Use, HIV+ gay males, Intervention, Tailored, On-line, Internet, Web-based