NCT02279043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

October 27, 2014

Results QC Date

November 15, 2018

Last Update Submit

March 11, 2019

Conditions

Contraception

Keywords

IUDIUCbirth controlcontraceptiononline

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting IUC Use

    Self-reported use of IUC in post-survey

    12 days post-baseline

Secondary Outcomes (12)

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

    12 days post-baseline

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

    12 days post-baseline

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

    12 days post-baseline

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

    12 days post-baseline

  • Number of Participants With Responses Indicating Knowledge of IUC Safety

    12 days post-baseline

  • +7 more secondary outcomes

Study Arms (3)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

IUC users

NO INTERVENTION

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.

Interventions

Interaction with users of IUC and non-IUC usersBEHAVIORAL

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.

Intervention
Interaction with non-IUC users onlyBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania, Annenberg School of Communication

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Results Point of Contact

Title
Edith Fox
Organization
University of California, San Francisco
edith.fox@ucsf.edu
4152062544

Study Officials

  • Damon Centola, PhD

    University of Pennsylvania, Annenberg School of Communication

    PRINCIPAL INVESTIGATOR

  • Christine Dehlendorf, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine, Department of Family and Community Medicine

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 30, 2014

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 19, 2019

Results First Posted

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Deidentified data will be shared with UCSF researchers through secure email.

Locations

US(1)