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Online Peer Influence on IUD Behaviors and Attitudes

Peer Influence on Intrauterine Contraceptive Behavior and Attitudes in an Online Social Community

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02279043
Enrollment
630
Registered
2014-10-30
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2019-03-19

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

Conditions

Contraception

Keywords

IUD, IUC, birth control, contraception, online

Brief summary

This study will look at women's social communication about IUDs (intrauterine devices) and their attitudes and behavior related to IUD use. The researchers will design an online community where women can talk to each other about their experiences with birth control. We will examine whether social exposure to IUD users in this setting is associated with change in attitudes and behavior among women who have never had an IUD.

Detailed description

Study Design: University of Pennsylvania researchers will conduct a randomized controlled trial to examine whether there is an association between social exposure to women who use intrauterine contraception (IUC) as their method of birth control and change in IUC attitudes and behavior among women who have never used IUC. The intervention used to test this association will be an online social community, designed by the researchers, in which women will be invited to share their personal experiences with birth control methods they have used. Non-IUC user participants will be randomized to either the intervention or control conditions. The intervention condition will consist of small online social groups in which non-IUC user participants will interact with IUC user participants. The control condition will consist of online groups identical to intervention groups, except that no IUC user participants will be in these groups. Participants will interact within small groups for twelve days each. Non-IUC user participants will complete surveys before and after the twelve-day intervention that measure IUC attitudes and behavior. UCSF researchers will conduct analysis on deidentified data obtained from this study. Hypothesis: It is hypothesized that among women who have never used IUC, there is an association between social exposure to IUC users and change in attitudes and behavior related to IUC use. It is also hypothesized that exposure to IUC users is associated with positive change in knowledge of IUC use and efficacy and positive change in IUC-related information-seeking. Aims: The study has three aims: Aim 1: To determine whether exposure to IUC users in an online community is associated with change in women's attitudes and behavior related to IUC use. Aim 2: To determine whether an association between exposure to IUC users and change in women's IUC attitudes and behavior varies by women's race/ethnicity. Aim 3: To observe the content of women's interactions about IUC and other birth control methods in an online social community. Data analysis: In order to address Aim 1, we will first conduct univariate analysis and obtain descriptive statistics (including mean, median, mode, variance, and range) on demographic characteristics and IUC attitudes and behaviors among participants in the intervention and control groups. In bivariate analysis, we will use chi-square tests to examine the relationship between study condition and IUC-related behaviors, as measured on the post-survey. We will use t-tests to examine relationships between condition and post-survey IUC attitudes, and matched t-tests to examine the relationships between conditions and changes in IUC attitudes. If data on attitudes is not normally distributed, we will use the appropriate non-parametric tests instead of t-tests. We will conduct multivariate analyses for those outcomes associated with intervention condition in bivariate tests. Multivariate analysis for Aim 1 will include mixed-effects regression to examine associations at both the individual and cluster levels. We will use multiple linear regression for continuous outcomes and multiple logistic regression for binary outcomes. Regression models will test associations between intervention and control conditions and outcome IUC attitude and behavior variables. We will obtain regression coefficients from linear regression models and odds ratios from logistic regression models in order to describe the associations between study arms and outcomes. In order to address Aim 2, we will examine bivariate relationships between the racial/ethnic categories of participants and outcome attitude and behavior variables, using chi-square tests for binary outcomes and t-tests or appropriate non-parametric tests for continuous outcomes. We will use multiple linear and/or logistic regression to test possible associations between race/ethnicity and outcome variables, controlling for other background variables. Resulting regression coefficients and odds ratios will describe whether the effect of the intervention was greater for women in some racial/ethnic groups as compared to others. In order to address Aim 3, we will perform qualitative analysis of conversations that take place among group members in the online social groups, using grounded theory methodology. We will examine qualitative data from both the intervention and control groups. Privacy: Recruitment and participation in the study will occur online. Participants will only interact with the study from remote locations, so they will not be seen entering or leaving any location affiliated with the study, or interacting with any study personnel. Once registered in the study, participants will only be contacted via secure email that does not indicate the nature of the study in the subject line. The study website will be password-protected to prohibit access to Internet users not participating in the study. Participants' screen names on the site will not contain their real names, and they will not be identifiable to other study participants. There is minimal risk of privacy loss. Study participants may not want others to know about their interest in or use of birth control, and may have feelings of embarrassment or shame in the event of a loss of study privacy. Additionally, birth control use may be a sensitive topic in the personal relationships of some study participants, and a loss of privacy could lead to strain or conflict in these personal relationships. Confidentiality: Data collected by researchers at the University of Pennsylvania will be stored on a secure network at their site. Only University of Pennsylvania study staff will have access to data on this network. University of PEnnsylvania staff will remove all identifiers from the data and export the data to researchers at UCSF via secure email. Deidentified data will be stored at on a secure UCSF server. Only the study staff will have access to the data, and we will not have access to the key.

Interventions

BEHAVIORALInteraction with users of IUC and non-IUC users

Birth Control Connect is an online community where women will be invited to share their personal experiences with birth control. Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.

BEHAVIORALInteraction with non-IUC users only

Birth Control Connect is an online community where women will be invited to share their personal experiences with birth control. Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions.

Sponsors

William and Flora Hewlett Foundation
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Non-IUC users: * Women * Age 18 - 45 * Sexually active with men * Do not want to get pregnant in the next year * Want to learn more about different birth control methods IUC users * Women * Age 18-45 * Currently uses IUC (Paragard, Mirena, or Skyla)

Exclusion criteria

Non-IUC users * Previous IUC use * Not able to become pregnant IUC users -Using IUC for other reason, and not pregnancy prevention

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting IUC Use12 days post-baselineSelf-reported use of IUC in post-survey

Secondary

MeasureTime frameDescription
Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey12 days post-baselineResponses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method
Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey12 days post-baselineResponses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method
Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey12 days post-baselineResponses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method
Number of Participants With Responses Indicating Knowledge of IUC Safety12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on IUC safety. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Number of Participants With Responses Indicating Knowledge of IUC Effectiveness12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on IUC effectiveness. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey12 days post-baselineMean difference of responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method
Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect group gave participants information on IUC they didn't have before. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect gave them a better idea of what using IUC would be like. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Number of Participants Reporting Information-seeking on Internet12 days post-baselineReport (Yes/No) in post-survey of whether participant had looked on the Internet (outside of Birth Control Connect) for information on IUC since study start. Outcome is count of participants reporting yes.
Number of Participants Reporting Information-seeking From a Health Care Provider12 days post-baselineReport (Yes/No) in post-survey of whether participant had consulted a health care provider about IUC since study start. Outcome is count of participants reporting yes.
Number of Participants Reporting Information-seeking From Peers12 days post-baselineReport (Yes/No) in post-survey of whether participant had talked to women they know about IUC since study start. Outcome is count of participants reporting yes.
Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill12 days post-baselineCorrect response to post-survey item asking whether IUC is more, less, or as effective as the birth control pill (correct response: more effective).

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users. Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
174
Control
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each. Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
314
IUC Users
IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
0
Total488

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up46880
Overall StudyPost-rand. exclusion - not eligible110

Baseline characteristics

CharacteristicControlTotalIntervention
Age, Customized
18-24
159 Participants249 Participants90 Participants
Age, Customized
25-34
137 Participants216 Participants79 Participants
Age, Customized
35-45
17 Participants22 Participants5 Participants
Age, Customized
Missing
1 Participants1 Participants0 Participants
Birth control method used at baseline
Arm implant
29 Participants46 Participants17 Participants
Birth control method used at baseline
Condoms
110 Participants174 Participants64 Participants
Birth control method used at baseline
Female sterilization
4 Participants8 Participants4 Participants
Birth control method used at baseline
Male sterilization
7 Participants9 Participants2 Participants
Birth control method used at baseline
None
16 Participants23 Participants7 Participants
Birth control method used at baseline
Other
6 Participants8 Participants2 Participants
Birth control method used at baseline
Patch
11 Participants13 Participants2 Participants
Birth control method used at baseline
Pill
171 Participants266 Participants95 Participants
Birth control method used at baseline
Ring
13 Participants23 Participants10 Participants
Birth control method used at baseline
Shot
12 Participants24 Participants12 Participants
Birth control method used at baseline
Withdrawal
70 Participants107 Participants37 Participants
Number of children
0 children
282 Participants436 Participants154 Participants
Number of children
1 or more children
31 Participants51 Participants20 Participants
Number of children
Missing
1 Participants1 Participants0 Participants
Number of pregnancies
0 pregnancies
159 Participants241 Participants82 Participants
Number of pregnancies
1 or more pregnancies
29 Participants50 Participants21 Participants
Number of pregnancies
Missing
126 Participants197 Participants71 Participants
Parental education
High school graduate or less
51 Participants82 Participants31 Participants
Parental education
Missing
88 Participants134 Participants46 Participants
Parental education
More than 4-year college graduate
53 Participants94 Participants41 Participants
Parental education
Some college or 4-year college graduate
122 Participants178 Participants56 Participants
Race/Ethnicity, Customized
Asian
24 Participants36 Participants12 Participants
Race/Ethnicity, Customized
Black/African American
38 Participants60 Participants22 Participants
Race/Ethnicity, Customized
Hispanic/Latina
36 Participants47 Participants11 Participants
Race/Ethnicity, Customized
Missing
13 Participants17 Participants4 Participants
Race/Ethnicity, Customized
Other
18 Participants27 Participants9 Participants
Race/Ethnicity, Customized
White
185 Participants301 Participants116 Participants
Sex: Female, Male
Female
314 Participants488 Participants174 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 / 1750 / 315
other
Total, other adverse events
0 / 1750 / 315
serious
Total, serious adverse events
0 / 1750 / 315

Outcome results

Primary

Number of Participants Reporting IUC Use

Self-reported use of IUC in post-survey

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting IUC Use2 Participants
ControlNumber of Participants Reporting IUC Use4 Participants
p-value: 0.8995% CI: [0.16, 4.88]Regression, Logistic
Secondary

Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey

Mean difference of responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method

Time frame: 12 days post-baseline

Population: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.

ArmMeasureValue (MEAN)
InterventionMean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey0.50 units on a scale
ControlMean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey0.16 units on a scale
p-value: 0.28t-test, 2 sided
Secondary

Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey

Responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method

Time frame: 12 days post-baseline

Population: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.

ArmMeasureValue (MEAN)
InterventionMean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey0.65 units on a scale
ControlMean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey0.05 units on a scale
p-value: 0.03t-test, 2 sided
Comparison: Multivariate analysis adjusting for cluster, as association was significant in bivariate test.p-value: 0.0295% CI: [0.08, 1.11]Regression, Linear
Secondary

Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey

Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method

Time frame: 12 days post-baseline

Population: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.

ArmMeasureValue (MEAN)
InterventionMean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey0.22 units on a scale
ControlMean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey0.04 units on a scale
p-value: 0.59t-test, 2 sided
Secondary

Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey

Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method

Time frame: 12 days post-baseline

Population: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.

ArmMeasureValue (MEAN)
InterventionMean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey0.50 units on a scale
ControlMean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey0 units on a scale
p-value: 0.08t-test, 2 sided
Secondary

Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)

Response on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect gave them a better idea of what using IUC would be like. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)90 Participants
ControlNumber of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)116 Participants
p-value: <0.0195% CI: [1.42, 3.56]Regression, Logistic
Comparison: Multivariate analysis adjusting for cluster, as association was significant in bivariate test.p-value: <0.0195% CI: [0.33, 1.35]Mixed Models Analysis
Secondary

Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)

Response on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect group gave participants information on IUC they didn't have before. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)81 Participants
ControlNumber of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)116 Participants
p-value: 0.0395% CI: [1.05, 2.58]Regression, Logistic
Comparison: Multivariate analysis adjusting for cluster, as association was significant in bivariate test.p-value: 0.0395% CI: [0.04, 0.97]Mixed Models Analysis
Secondary

Number of Participants Reporting Information-seeking From a Health Care Provider

Report (Yes/No) in post-survey of whether participant had consulted a health care provider about IUC since study start. Outcome is count of participants reporting yes.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting Information-seeking From a Health Care Provider10 Participants
ControlNumber of Participants Reporting Information-seeking From a Health Care Provider15 Participants
p-value: 0.6895% CI: [0.52, 2.74]Regression, Logistic
Secondary

Number of Participants Reporting Information-seeking From Peers

Report (Yes/No) in post-survey of whether participant had talked to women they know about IUC since study start. Outcome is count of participants reporting yes.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting Information-seeking From Peers56 Participants
ControlNumber of Participants Reporting Information-seeking From Peers87 Participants
p-value: 0.3395% CI: [0.08, 1.93]Regression, Logistic
Secondary

Number of Participants Reporting Information-seeking on Internet

Report (Yes/No) in post-survey of whether participant had looked on the Internet (outside of Birth Control Connect) for information on IUC since study start. Outcome is count of participants reporting yes.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Reporting Information-seeking on Internet59 Participants
ControlNumber of Participants Reporting Information-seeking on Internet103 Participants
p-value: 0.9395% CI: [0.52, 2.74]Regression, Logistic
Secondary

Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill

Correct response to post-survey item asking whether IUC is more, less, or as effective as the birth control pill (correct response: more effective).

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill72 Participants
ControlNumber of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill105 Participants
p-value: 0.0895% CI: [0.95, 2.29]Regression, Logistic
Secondary

Number of Participants With Responses Indicating Knowledge of IUC Effectiveness

Response on 5-point Likert scale of agreement in post-survey on IUC effectiveness. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Responses Indicating Knowledge of IUC Effectiveness115 Participants
ControlNumber of Participants With Responses Indicating Knowledge of IUC Effectiveness203 Participants
p-value: 0.9995% CI: [0.49, 2.05]Regression, Logistic
Secondary

Number of Participants With Responses Indicating Knowledge of IUC Safety

Response on 5-point Likert scale of agreement in post-survey on IUC safety. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.

Time frame: 12 days post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Responses Indicating Knowledge of IUC Safety103 Participants
ControlNumber of Participants With Responses Indicating Knowledge of IUC Safety172 Participants
p-value: 0.3495% CI: [0.75, 2.2]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026