- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855489
Condom Use Attitudes, Beliefs, and Behaviors
Study Overview
Status
Conditions
Detailed Description
Theory allows researchers to systematically explain and predict health behavior by providing an organized framework to approach research questions; the importance of theory is particularly emphasized in meta-analyses demonstrating that interventions designed from the basis of health behavior theory are more successful than those that are not theory-based. The superiority of theory-based interventions has been established, but these meta-analyses do not answer the important questions of which theoretical constructs may be the "active ingredients" of change nor of how constructs in a particular theory may work separately versus in combination to produce the greatest amount of behavior change. Health interventions on the whole have only small to moderate effects on behavior change, and perhaps this is partly due to a lack of solid understanding of how key theoretical constructs influence each other to motivate behavior change. Often times when a theory is used as the basis for an intervention only a subset of the constructs seem to produce behavior change, which calls into question the sufficiency of our current theories for producing behavior change. One possible reason for this may be that current health behavior theories are really theories of behavioral prediction and not behavior change.
Health behavior theories are often used to inform intervention development-assuming that the same cognitive processes that successfully explain behavior are also the same processes that can be targeted to elicit behavior change. Past reviews show that theories like the Theory of Planned Behavior (TPB) explain 30%-50% of the variance in behavior, and when behavior change is the outcome the same predictors only produce small to moderate effects. However, it is unclear if the same predictors are working together in a similar way when using them to explain behavior versus creating behavior change. Currently, the same cognitive mechanisms are used to describe both processes, but those that explain behavior may not be the same ones that produce behavior change. There is very little literature that addresses how these processes may differ. A careful examination of the extent to which current theoretical constructs successfully produce behavior change individually or in combination may help clarify the optimal theoretical framework that should be utilized in behavior change interventions. Using the Theory of Planned Behavior (TPB) as the guiding theoretical framework, this study explores one way to experimentally determine how the constructs in the TPB influence each other and successfully produce health behavior change.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be 18 and older and must have had vaginal or anal intercourse at least once.
Exclusion Criteria:
- Prior research has indicated that the predictors of condom use are dramatically different in casual versus serious relationships and that condom use is extremely difficult to change among those in established long-term relationships. Thus, we will exclude participants if they indicate that they are in a relationship and they classify that relationship as someone they are "living with" or "married to".
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Attitudes Only
The attitudes condition targeted cognitive and affective attitudes by pairing attitudinal messages with pictures, and included an evaluative conditioning task.
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Experimental: Norms Only
The norms condition utilized a group-affirmation exercise, personalized feedback, and group norms in an attempt to greater condom use norms.
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Experimental: Perceived Behavioral Control Only
The PBC condition included a condom application video, lubrication instructions, condom negotiation videos, and a detailed description regarding purchasing condoms.
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Experimental: Intentions Only
The intentions condition utilized implementation intentions in order to create condom use intentions.
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Experimental: Three Constructs
A three construct condition, which included attitudes, norms, and perceived behavioral control represented the core components of the TPB that are thought to work through intentions to result in behavior change.
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Experimental: Four Constructs
A four construct condition (i.e., attitudes, norms, PBC, and intentions) was designed to represent the "full TPB model" intervention which we expected would be more successful than either the three-construct intervention or any of the single construct interventions.
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No Intervention: No-Treatment, Control
A no-treatment control condition, which solely consisted of pretest and posttest assessments, was included.
This allowed us to obtain important information about how the theoretical constructs in the TPB change over time (or do not) in the absence of an experimental manipulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risky Sexual Behavior
Time Frame: Three Months
|
Risky sexual behavior was a composite variable calculated using "how many times a participant had sex in the past 3 months" X "how many times they used a condom when having sex during those 3 months" (reverse coded).
Higher scores indicated riskier sexual behavior.
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Three Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Condom Use
Time Frame: Three Months
|
Condom use was measured by asking participants "In the past 3 months only, how much of the time have you used condoms when you've had sexual intercourse?" on a scale from 0% of the time to 100% of the time.
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Three Months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.
- Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
- Noar SM. Behavioral interventions to reduce HIV-related sexual risk behavior: review and synthesis of meta-analytic evidence. AIDS Behav. 2008 May;12(3):335-53. doi: 10.1007/s10461-007-9313-9. Epub 2007 Sep 21.
- Reid AE, Aiken LS. Integration of five health behaviour models: common strengths and unique contributions to understanding condom use. Psychol Health. 2011 Nov;26(11):1499-520. doi: 10.1080/08870446.2011.572259. Epub 2011 Jun 28.
- Glanz K, Maddock J. On judging models and theories: research and practice, psychology and public health. J Health Psychol. 2000 Mar;5(2):151-4. doi: 10.1177/135910530000500203. No abstract available.
- Webb TL, Sheeran P. Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. Psychol Bull. 2006 Mar;132(2):249-68. doi: 10.1037/0033-2909.132.2.249.
- Montanaro EA, Kershaw TS, Bryan AD. Dismantling the theory of planned behavior: evaluating the relative effectiveness of attempts to uniquely change attitudes, norms, and perceived behavioral control. J Behav Med. 2018 Dec;41(6):757-770. doi: 10.1007/s10865-018-9923-x. Epub 2018 Apr 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13-0558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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