Condom UseNCT02855489
Condom Use Attitudes, Beliefs, and Behaviors
A study testing Attitudes Only, Norms Only and Intentions Only in people with Condom Use, run by University of Colorado, Boulder.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Condom Use
- What is being tested?
- Attitudes Only, Norms Only and Intentions Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be 18 and older and must have had vaginal or anal intercourse at least once.
Who cannot join
- 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".
About this study
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.
Read the 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.
- Conditions
- Condom Use
- Being tested
- Attitudes Only, Norms Only, Perceived Behavioral Control Only, Intentions Only, Three Constructs
- Keywords
- Condom Use, HIV/STD, Intervention, Theory of Planned Behavior, Dismantling Study Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attitudes OnlyBehavioural
Norms OnlyBehavioural
Perceived Behavioral Control OnlyBehavioural
Intentions OnlyBehavioural
Three ConstructsBehavioural
Four ConstructsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Attitudes Only | Experimental | The attitudes condition targeted cognitive and affective attitudes by pairing attitudinal messages with pictures, and included an evaluative conditioning task. Receives: Behavioral: Attitudes Only |
| Norms Only | Experimental | The norms condition utilized a group-affirmation exercise, personalized feedback, and group norms in an attempt to greater condom use norms. Receives: Behavioral: Norms Only |
| Perceived Behavioral Control Only | Experimental | The PBC condition included a condom application video, lubrication instructions, condom negotiation videos, and a detailed description regarding purchasing condoms. Receives: Behavioral: Perceived Behavioral Control Only |
| Intentions Only | Experimental | The intentions condition utilized implementation intentions in order to create condom use intentions. Receives: Behavioral: Intentions Only |
| Three Constructs | Experimental | 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. Receives: Behavioral: Three Constructs |
| Four Constructs | Experimental | 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. Receives: Behavioral: Four Constructs |
| No-Treatment, Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky Sexual Behavior
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.
Measured: Three Months
Secondary outcomes (1)
Condom Use
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.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Condom UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855489
- Sponsor's protocol ID
- 13-0558
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21678166Glanz 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.
PubMed 20070207Glanz 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.
PubMed 22049003Noar 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.
PubMed 17896176Godin 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.
PubMed 10163601Webb 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.
PubMed 16536643Montanaro 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.
PubMed 29671166
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condom Use Attitudes, Beliefs, and Behaviors
- ClinicalTrials.gov ID
- NCT02855489
- Acronym / sponsor ID
- 13-0558
- Conditions
- Condom Use
- Keywords
- Condom Use, HIV/STD, Intervention, Theory of Planned Behavior, Dismantling Study Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Attitudes Only | Experimental | Behavioral: Attitudes OnlyThe attitudes condition targeted cognitive and affective attitudes by pairing attitudinal messages with pictures, and included an evaluative conditioning task. |
| Norms Only | Experimental | Behavioral: Norms OnlyThe norms condition utilized a group-affirmation exercise, personalized feedback, and group norms in an attempt to greater condom use norms. |
| Perceived Behavioral Control Only | Experimental | Behavioral: Perceived Behavioral Control OnlyThe PBC condition included a condom application video, lubrication instructions, condom negotiation videos, and a detailed description regarding purchasing condoms. |
| Intentions Only | Experimental | Behavioral: Intentions OnlyThe intentions condition utilized implementation intentions in order to create condom use intentions. |
| Three Constructs | Experimental | Behavioral: Three ConstructsA 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. |
| Four Constructs | Experimental | Behavioral: Four ConstructsA 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. |
| No-Treatment, Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must be 18 and older and must have had vaginal or anal intercourse at least once.
Key exclusion criteria (1 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attitudes Only | Behavioural | Attitudes Only |
| Norms Only | Behavioural | Norms Only |
| Perceived Behavioral Control Only | Behavioural | Perceived Behavioral Control Only |
| Intentions Only | Behavioural | Intentions Only |
| Three Constructs | Behavioural | Three Constructs |
| Four Constructs | Behavioural | Four Constructs |
Primary outcome
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.
1 secondary outcome
Condom Use
Time frame: Three Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 21678166Reid 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.
- Background: PubMed 20070207Glanz 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.
- Background: PubMed 22049003Glanz 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.
- Background: PubMed 17896176Noar 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.
- Background: PubMed 10163601Godin 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.
- Background: PubMed 16536643Webb 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.
- Derived from this study: PubMed 29671166Montanaro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Attitudes Only, Norms Only and Intentions Only in people with Condom Use, run by University of Colorado, Boulder.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risky Sexual Behavior (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855489, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.