ContraceptionNCT03372369
Testing the Impact of Two Posters on Contraceptive Knowledge, Contraceptive Preferences, and Perceived Pregnancy Risk
A study testing View CDC Poster and View Patient-Centered Poster in people with Contraception and Knowledge, Attitudes, Practice, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Knowledge, Attitudes, Practice
- What is being tested?
- View CDC Poster and View Patient-Centered Poster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 13 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speak and read English
- Have had vaginal intercourse in the past three months
Who cannot join
- Are pregnant
- Are trying to conceive
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception, Knowledge, Attitudes, Practice
- Being tested
- View CDC Poster, View Patient-Centered Poster
- Keywords
- contraceptive knowledge, contraceptive use, educational intervention, poster, online survey
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
View CDC PosterOther
The poster designed by the CDC to explain contraceptive effectiveness.
View Patient-Centered PosterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CDC Poster | Active comparator | 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. Receives: Other: View CDC Poster |
| Patient-Centered Poster | Experimental | 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. Receives: Other: View Patient-Centered Poster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Contraceptive Knowledge Assessment (CKA) Score
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.
Measured: Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)
Change in Effective Contraception Preference Score
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.
Measured: Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)
Change in Perceived Pregnancy Risk Score
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.
Measured: Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start26 Jan 2018
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Seri AL Anderson, MPH, Principal investigator, University of North Carolina, Chapel HillKristen H Lich, PHD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372369
- Sponsor's protocol ID
- 17-2955
- Other IDs
- UL1TR001111
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of individual participant data with other researchers
Publications
Anderson S, Frerichs L, Kaysin A, Wheeler SB, Halpern CT, Lich KH. Effects of Two Educational Posters on Contraceptive Knowledge and Intentions: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jan;133(1):53-62. doi: 10.1097/AOG.0000000000003012.
PubMed 30531560
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of the Effectiveness of Risk Communication in Two Contraceptive Fact Sheets
- ClinicalTrials.gov ID
- NCT03372369
- Acronym / sponsor ID
- 17-2955
- Conditions
- Contraception, Knowledge, Attitudes, Practice
- Keywords
- contraceptive knowledge, contraceptive use, educational intervention, poster, online survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDC Poster | Active comparator | Other: View CDC PosterAfter 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. |
| Patient-Centered Poster | Experimental | Other: View Patient-Centered PosterAfter 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Speak and read English
- Have had vaginal intercourse in the past three months
Key exclusion criteria (2 listed)
- Are pregnant
- Are trying to conceive
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 |
|---|---|---|
| View CDC PosterThe poster designed by the CDC to explain contraceptive effectiveness. | Other | CDC Poster |
| View Patient-Centered PosterThe 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. | Other | Patient-Centered Poster |
Primary outcome
Change in Contraceptive Knowledge Assessment (CKA) Score
Time frame: Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)
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.
Change in Effective Contraception Preference Score
Time frame: Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)
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.
Change in Perceived Pregnancy Risk Score
Time frame: Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30531560Anderson S, Frerichs L, Kaysin A, Wheeler SB, Halpern CT, Lich KH. Effects of Two Educational Posters on Contraceptive Knowledge and Intentions: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jan;133(1):53-62. doi: 10.1097/AOG.0000000000003012.
- Individual participant dataSharing planned: No. No sharing of individual participant data with other researchers
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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.
Seri AL Anderson, MPH principal investigator
University of North Carolina, Chapel Hill
Kristen H Lich, PHD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing View CDC Poster and View Patient-Centered Poster in people with Contraception and Knowledge, Attitudes, Practice, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 2 inclusion and 2 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Contraceptive Knowledge Assessment (CKA) Score (time frame: Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)). The study lists 3 primary outcomes in all. 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 NCT03372369, which also lists 1 linked publication.
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 20 Aug 2019.