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Online Peer Influence on IUD Behaviors and Attitudes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279043
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
William and Flora Hewlett Foundation
University of Pennsylvania
Information provided by (Responsible Party):
Christine Dehlendorf, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: Interaction with users of IUC and non-IUC users Behavioral: Interaction with non-IUC users only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Peer Influence on Intrauterine Contraceptive Behavior and Attitudes in an Online Social Community
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: 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. We will measure the attitudes and behaviors of those who do not have IUC before and after the intervention, considering social exposure to IUC users as a possible predictor of changes in knowledge, attitude and behavior.
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.

Placebo Comparator: 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. We will measure these participants' attitudes and behavior related to IUC use before and after the twelve-day study period, and compare results to those of participants in the intervention arm. There will be up to 35 control groups of 9 members each.
Behavioral: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Number of Participants Reporting IUC Use [ Time Frame: 12 days post-baseline ]
    Self-reported use of IUC in post-survey


Secondary Outcome Measures :
  1. Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey [ Time Frame: 12 days post-baseline ]
    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

  2. Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey [ Time Frame: 12 days post-baseline ]
    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

  3. Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey [ Time Frame: 12 days post-baseline ]
    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

  4. Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey [ Time Frame: 12 days post-baseline ]
    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

  5. Number of Participants With Responses Indicating Knowledge of IUC Safety [ Time Frame: 12 days post-baseline ]
    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.

  6. Number of Participants With Responses Indicating Knowledge of IUC Effectiveness [ Time Frame: 12 days post-baseline ]
    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.

  7. Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill [ Time Frame: 12 days post-baseline ]
    Correct response to post-survey item asking whether IUC is more, less, or as effective as the birth control pill (correct response: more effective).

  8. Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect) [ Time Frame: 12 days post-baseline ]
    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.

  9. Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like) [ Time Frame: 12 days post-baseline ]
    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.

  10. Number of Participants Reporting Information-seeking on Internet [ Time Frame: 12 days post-baseline ]
    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.

  11. Number of Participants Reporting Information-seeking From a Health Care Provider [ Time Frame: 12 days post-baseline ]
    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. Number of Participants Reporting Information-seeking From Peers [ Time Frame: 12 days post-baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279043


Locations
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United States, Pennsylvania
University of Pennsylvania, Annenberg School of Communication
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of California, San Francisco
William and Flora Hewlett Foundation
University of Pennsylvania
Investigators
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Principal Investigator: Damon Centola, PhD University of Pennsylvania, Annenberg School of Communication
Principal Investigator: Christine Dehlendorf, MD, MAS University of California, San Francisco

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Responsible Party: Christine Dehlendorf, Associate Professor, School of Medicine, Department of Family and Community Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02279043    
Other Study ID Numbers: 2014-9716
820383 ( Other Identifier: University of Pennsylvania Institutional Review Board )
14-14827 ( Other Identifier: UCSF Committee on Human Research )
First Posted: October 30, 2014    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified data will be shared with UCSF researchers through secure email.
Keywords provided by Christine Dehlendorf, University of California, San Francisco:
IUD
IUC
birth control
contraception
online