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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03372369
Enrollment
990
Registered
2017-12-13
Start date
2018-01-26
Completion date
2018-02-13
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Knowledge, Attitudes, Practice

Keywords

contraceptive knowledge, contraceptive use, educational intervention, poster, online survey

Brief 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) 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.

Interventions

OTHERView CDC Poster

The poster designed by the CDC to explain contraceptive effectiveness.

OTHERView Patient-Centered Poster

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.

Sponsors

North Carolina Translational and Clinical Sciences Institute
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* Speak and read English * Have had vaginal intercourse in the past three months

Exclusion criteria

* Are pregnant * Are trying to conceive

Design outcomes

Primary

MeasureTime frameDescription
Change in Contraceptive Knowledge Assessment (CKA) ScoreBaseline 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 ScoreBaseline 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 ScoreBaseline 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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled between January 26 and February 13, 2018. They were enrolled and participated in the study through a survey distributed on Amazon Mechanical Turk.

Participants by arm

ArmCount
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. View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.
469
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. View Patient-Centered Poster: 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.
473
Total942

Withdrawals & dropouts

PeriodReasonFG000FG001
Intervention and Follow-Up PeriodWithdrawal by Subject33
Qualification PeriodInconsistent Eligibility Results109
Qualification PeriodWithdrawal by Subject1613

Baseline characteristics

CharacteristicPatient-Centered PosterTotalCDC Poster
Age, Continuous32 years32 years32 years
Race/Ethnicity, Customized
Race or Ethnicity
Black or African American
36 Participants81 Participants45 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Hispanic or Latina
21 Participants38 Participants17 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Multiracial
31 Participants57 Participants26 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Some Other Race
34 Participants62 Participants28 Participants
Race/Ethnicity, Customized
Race or Ethnicity
White
351 Participants704 Participants353 Participants
Region of Enrollment
United States
473 Participants942 Participants469 Participants
Sex: Female, Male
Female
473 Participants942 Participants469 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 4950 / 495
other
Total, other adverse events
0 / 4950 / 495
serious
Total, serious adverse events
0 / 4950 / 495

Outcome results

Primary

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.

Time frame: Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)

ArmMeasureValue (MEAN)
CDC PosterChange in Contraceptive Knowledge Assessment (CKA) Score0.90 scores on a scale
Patient-Centered PosterChange in Contraceptive Knowledge Assessment (CKA) Score1.6 scores on a scale
Comparison: The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.p-value: <0.0001t-test, 1 sided
Comparison: The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.p-value: <0.0001t-test, 1 sided
Comparison: The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.p-value: <0.0001t-test, 1 sided
Primary

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.

Time frame: Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)

ArmMeasureValue (MEAN)
CDC PosterChange in Effective Contraception Preference Score0.09 scores on a scale
Patient-Centered PosterChange in Effective Contraception Preference Score0.09 scores on a scale
Comparison: The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.p-value: >0.01t-test, 1 sided
Comparison: The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.p-value: <0.01t-test, 1 sided
Primary

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.

Time frame: Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)

ArmMeasureValue (MEAN)
CDC PosterChange in Perceived Pregnancy Risk Score0.002 scores on a scale
Patient-Centered PosterChange in Perceived Pregnancy Risk Score0.03 scores on a scale
Comparison: The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.p-value: >0.01t-test, 1 sided
Comparison: The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.p-value: >0.01t-test, 1 sided
Comparison: The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.p-value: >0.01t-test, 1 sided
Post Hoc

Change in Mean Accuracy of Perceived Pregnancy Risk Score

Women are asked what their chances of getting pregnant this year are (very high, high, moderate, low, very low). This response is compared to the most effective contraceptive method women reported using in the past three months using the same categories of effectiveness as in the change in effective contraception preference score outcome. Women received a score of 1 if their perceived pregnancy risk was accurate based on their current contraceptive method and a score of 0 if it was inaccurate. Women's perceived pregnancy risk was accurate if: they used a highly effective method and they said they were at very low risk; if they used an effective method and they said they were at low or moderate risk; if they used a less effective method and said they were at moderate or high risk; or if they used no method and said they were at very high risk. A good outcome would be increased accuracy of perceived pregnancy risk as reflected by a higher score.

Time frame: Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)

ArmMeasureValue (MEAN)
CDC PosterChange in Mean Accuracy of Perceived Pregnancy Risk Score0 scores on a scale
Patient-Centered PosterChange in Mean Accuracy of Perceived Pregnancy Risk Score0.013 scores on a scale
Comparison: The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.p-value: >0.01t-test, 1 sided
Comparison: The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.p-value: >0.01t-test, 1 sided
Comparison: The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.p-value: >0.01t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026