- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372369
Testing the Impact of Two Posters on Contraceptive Knowledge, Contraceptive Preferences, and Perceived Pregnancy Risk
A Randomized Control Trial of the Effectiveness of Risk Communication in Two Contraceptive Fact Sheets
This study tests two posters that teach people about contraception: one designed by the Centers for Disease Control (CDC), and one designed by the researchers. The investigators hypothesize that the new poster will have more increased (1) contraceptive knowledge, (2) willingness to use effective contraception, and (3) perceived pregnancy risk than the CDC poster. This study will expand useful knowledge because contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk have been shown to affect women's likelihood of using contraception. If the investigators learn how to increase these factors, the investigators could theoretically reduce women's risk of unplanned pregnancy.
The investigators will test this hypothesis by recruiting N=1000 women to complete an online survey using Amazon Mechanical Turk. These women will complete a survey that will first measure their initial contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk. Then women will randomly be shown one of the two posters. Then, the investigators will measure their contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk again. The investigators will use statistical tests (a t-test) to find out whether there are significant changes in these three outcomes for either of the posters, and whether one poster does a better job of changing these outcomes than the other.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: To evaluate the effectiveness of two posters' ability to improve contraceptive knowledge, willingness to use effective contraception, and pregnancy risk perceptions. One of these posters was developed by the CDC. The other was developed by the research team in a previous study using cognitive interviews with N=26 women. The new poster is designed to meet the informational needs of women with low numeracy (i.e. low facility with math) and women who do not use contraception.
Participants: The investigators will recruit N=1020 women aged 18-44 who can speak and read English, have been sexually active in the last three months, and who are not pregnant or trying to get pregnant.
Procedures (methods): The investigators will use Amazon Mechanical Turk to recruit participants. Participants will take one survey. The survey will first ask baseline questions to assess contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk. Participants will then be randomly shown one of the two posters. Then post-exposure questions on the three outcomes will be asked.
The investigators test the hypotheses that before compared to after exposure, the mean scores for (1) contraceptive knowledge, (2) willingness to use effective contraception, and (3) perceived pregnancy risk will increase more for the new fact sheet than for the CDC sheet.
The investigators also collect the following covariates: age, race/ethnicity, education, income, insurance type, insurance coverage of contraception, numeracy (facility with math), health and safety contraindications to contraceptive use, sexual orientation, parenthood, years since first sex, relationship status, prior exposure to CDC sheet, and pregnancy avoidance intensity. The investigators will compare whether the covariates are balanced between the randomized groups and the US population using two-sample t-tests, chi-squared, or nonparametric tests as appropriate. If the unbalance is statistically significant, the investigators will include the covariate in the regression to compare the adjusted difference between treatments. The investigators use two-sample t-tests to test our hypotheses. The investigators will also test for subgroup differences in our outcomes based on our covariates using a Chow test.
The investigators will first test survey mechanics (correct coding, correct links) on N=20 women. The investigators will survey N=1000 women for data analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27510
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Speak and read English
- Have had vaginal intercourse in the past three months
Exclusion Criteria:
- Are pregnant
- Are trying to conceive
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CDC Poster
After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.
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The poster designed by the CDC to explain contraceptive effectiveness.
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Experimental: Patient-Centered Poster
After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.
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The poster designed by the research team to explain contraceptive effectiveness.
This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Contraceptive Knowledge Assessment (CKA) Score
Time Frame: Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)
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The CKA is a 25-item tool covering knowledge gaps like long-acting reversible contraceptives, emergency contraception, common myths, and efficacy rates which will be used to determine contraception knowledge.
One point is added for each correctly answered question for a total possible score of 25.
Higher scores reflect greater contraceptive knowledge.
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Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)
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Change in Effective Contraception Preference Score
Time Frame: Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)
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Women will be asked whether they are planning on switching contraceptive methods in the next year and which methods of contraception they would hypothetically consider using if they were to switch contraceptive methods within the next year.
They are then asked to rank the methods in order of how likely they would be to use each method.
A woman's "contraceptive preference" is the method that she says she would be most likely to use.
Methods will be scored from 0-3: '0' for no method, '1' for ineffective methods like condoms, '2' for effective methods like the Pill, and '3' for highly effective methods like Intrauterine Devices (IUDs).
Positive scores reflect improvements in the effectiveness of the contraceptive method that women say they are likely to use.
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Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)
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Change in Perceived Pregnancy Risk Score
Time Frame: Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)
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Women are asked what their chances of getting pregnant this year are (very high=4, high=3, moderate=2, low=1, very low=0).
A good outcome in terms of reducing the risk of unprotected sex and unplanned pregnancy would be increased perceived pregnancy risk as reflected in a higher score.
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Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)
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Collaborators and Investigators
Investigators
- Principal Investigator: Seri AL Anderson, MPH, University of North Carolina, Chapel Hill
- Principal Investigator: Kristen H Lich, PHD, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 17-2955
- UL1TR001111 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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