Clinical trial NCT02855489: Condom Use Attitudes, Beliefs, and Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Condom Use
Keywords: Condom Use
HIV/STD
Intervention
Theory of Planned Behavior
Dismantling Study Design
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study has three primary goals. First, to design distinct interventions that target the three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and perceived behavioral control (PBC)). The second goal is to determine which combination of the Theory of Planned Behavior constructs is more successful at changing condom use behavior among college students. Finally, the investigators will examine the impact change in targeted constructs has on those not targeted by an intervention. The current study intends to empirically test how the constructs (i.e., attitudes, norms, PBC) in the Theory of Planned Behavior influence each other to increase condom use with college students.

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.

Eligibility criteria: 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".

Primary outcomes:
measure: Risky Sexual Behavior
timeFrame: Three Months
Secondary outcomes:
measure: Condom Use
timeFrame: Three Months
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.