Clinical trial NCT02279043: Online Peer Influence on IUD Behaviors and Attitudes
Official title: Peer Influence on Intrauterine Contraceptive Behavior and Attitudes in an Online Social Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: IUD
IUC
birth control
contraception
online
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: William and Flora Hewlett Foundation
name: University of Pennsylvania
First posted: 2014-10-30
Enrollment: 630
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting IUC Use
timeFrame: 12 days post-baseline
Secondary outcomes:
measure: Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey
timeFrame: 12 days post-baseline
measure: Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey
timeFrame: 12 days post-baseline
measure: Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey
timeFrame: 12 days post-baseline
measure: Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey
timeFrame: 12 days post-baseline
measure: Number of Participants With Responses Indicating Knowledge of IUC Safety
timeFrame: 12 days post-baseline
measure: Number of Participants With Responses Indicating Knowledge of IUC Effectiveness
timeFrame: 12 days post-baseline
measure: Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill
timeFrame: 12 days post-baseline
measure: Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)
timeFrame: 12 days post-baseline
measure: Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)
timeFrame: 12 days post-baseline
measure: Number of Participants Reporting Information-seeking on Internet
timeFrame: 12 days post-baseline
measure: Number of Participants Reporting Information-seeking From a Health Care Provider
timeFrame: 12 days post-baseline
measure: Number of Participants Reporting Information-seeking From Peers
timeFrame: 12 days post-baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Annenberg School of Communication
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Annenberg School of Communication
name: Damon Centola, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: