Online Peer Influence on IUD Behaviors and Attitudes

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279043
• Other study ID #: 2014-9716
• Secondary ID: 82038314-14827
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Interaction 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.
• Interaction 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania, Annenberg School of Communication	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Pennsylvania, William and Flora Hewlett Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting IUC Use	Self-reported use of IUC in post-survey	12 days post-baseline
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	12 days post-baseline
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	12 days post-baseline
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	12 days post-baseline
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	12 days post-baseline
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.	12 days post-baseline
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.	12 days post-baseline
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).	12 days post-baseline
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.	12 days post-baseline
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.	12 days post-baseline
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.	12 days post-baseline
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.	12 days post-baseline
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.	12 days post-baseline