A Patient-Directed Computerized Intervention to Address Reproductive Coercion

December 7, 2025 updated by: Yasamin Yoko Kusunoki, University of Michigan

A Pilot Feasibility Study of a Patient-Directed Computerized Intervention to Address Reproductive Coercion

The goal of this clinical trial is to evaluate the feasibility and acceptability of "BRIDGES" (Building Reproductive Decision-Making, Empowerment, & Support), a new patient-directed educational website (bridges4support.org). BRIDGES aims to improve family planning (FP) patients' understanding of reproductive coercion (RC) and harm-reduction strategies, as well as their ability to discuss RC-related issues with healthcare providers if they so choose. Designed to be integrated into routine FP clinical care and pre-visit materials, this brief (5-10 minute) educational website includes 1) education on reproductive coercion and (un)healthy relationships, 2) harm-reduction and safety planning strategies, and 3) patient activation messages to encourage patients to actively engage with their healthcare provider. Four study clinics were selected from Planned Parenthood of Michigan (PPMI) clinics based on patient volume and number of clinics. Two of the four chosen clinics will be randomly assigned to receive BRIDGES, with 40 participants per clinic, and the other two clinics will be randomly assigned to receive the standard of care, also with 40 participants per clinic. Control clinics will receive the standard of care, which includes the typical support and counseling provided at these centers for FP patients, and the intervention clinics will receive BRIDGES plus standard of care. Research staff will recruit FP patients ages 18-29 (N=160) through patient portal messages. Participants will complete online, self-directed Qualtrics surveys at three time points: pre-appointment, post-appointment, and 3-months. Survey data will be used to assess differences in patient knowledge, self-efficacy, and behavior between patients attending intervention clinics and patients attending control FP clinics (i.e., receiving standard-of-care FP services). Feasibility, implementation, and pilot outcome data will be used to further refine the intervention towards the goal of conducting a future larger-scale study of BRIDGES within FP clinics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Family planning patients at study clinics, including women, transgender men, non-binary, and other gender-diverse people
  • Ages 18-29
  • Able to participate in English
  • Has an upcoming birth control appointment (telemedicine or in-clinic) scheduled at a study clinic during the enrollment period (November 2024-June 2025). Appointments must be scheduled for at least 24 hours after study enrollment.
  • Has access to PPMI MyChart (i.e., study clinic patient portal)
  • Participants who complete the Pre-Appointment Survey and attend the scheduled birth control appointment or a rescheduled (up to 3x) appointment are eligible for the Post-Appointment Survey
  • Participants who complete the Pre-Appointment Survey are eligible for the 3-Month Survey, regardless of whether they complete the Post-Appointment Survey

Exclusion Criteria:

  • Previously exposed to the intervention (e.g., participated in user testing during September and October 2024)
  • Does not have a valid email address

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of care
Experimental: BRIDGES plus standard of care
Other: Educational web-based application
BRIDGES is a patient-directed computerized universal education on RC that is delivered within the FP setting, and that does not require the patient to disclose RC experiences to learn about RC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of agreement that the BRIDGES website was acceptable
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statements: The BRIDGES website is an acceptable way to learn about each of the following (reproductive coercion, birth control methods that other people are less able to control, things to discuss with a healthcare provider, resources, and use of the patient portal for the invitation to the study). Reponse options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the user liked BRIDGES
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I like the bridges website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that BRIDGES was helpful
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: Overall, the BRIDGES website helped me. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the user was comfortable using BRIDGES
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I felt uncomfortable when viewing the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the user felt safe using BRIDGES
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I felt unsafe when viewing the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that BRIDGES was easy to use
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website was easy to use. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their intimate relationships
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me talk to my healthcare provider about my intimate relationships. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their preferred birth control method
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me talk to my healthcare provider about my preferred birth control method. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the BRIDGES website helped them choose a birth control method that works best for them
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me choose a birth control method that works best for me. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the BRIDGES website influenced their decision about which birth control method they wanted
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website influenced my decision about which birth control method I wanted. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the BRIDGES website will help them talk to their friends and family about reproductive coercion
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website will help me talk to my friends and family about reproductive coercion. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the user would share the BRIDGES website with a friend or family member who needed support
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I would share the BRIDGES website with a friend or family member who needed support. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment
Level of agreement that the user would use the BRIDGES website if the user were not in the study
Time Frame: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: If I was not in this research study, I would use the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Up to five days after appointment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge about which birth control methods can be kept private
Time Frame: Pre-appointment
In a self-administered survey, all patients are asked: Imagine you wanted to keep your birth control private. Which of the following birth control methods are more difficult for other people (like a partner) to mess with or control? (select all that apply). Seven types of birth control methods are provided. The correct answers include birth control implant, injectable birth control, intrauterine device, and sterilization. Incorrect answers include birth control pills, condoms, and withdrawal.
Pre-appointment
Change in knowledge about which birth control methods can be kept private
Time Frame: Three months after appointment
In a self-administered survey, all patients are asked: Imagine you wanted to keep your birth control private. Which of the following birth control methods are more difficult for other people (like a partner) to mess with or control? (select all that apply). Seven types of birth control methods are provided. The correct answers include birth control implant, injectable birth control, intrauterine device, and sterilization. Incorrect answers include birth control pills, condoms, and withdrawal. A measure of change will be created by subtracting the number of correct methods 3 months after interacting with BRIDGES minus the number of correct methods before interacting with BRIDGES. A value of 0 will signify that knowledge remained the same; a positive value will signify that knowledge increased; a negative value will signify that knowledge decreased.
Three months after appointment
Knowledge about what reproductive coercion is
Time Frame: Pre-appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Pressuring a partner to become pregnant when they don't want to be can be a sign of an unhealthy relationship. The correct answer is true.
Pre-appointment
Change in knowledge about what reproductive coercion is
Time Frame: Three months after appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Pressuring a partner to become pregnant when they don't want to be can be a sign of an unhealthy relationship. The correct answer is true. A measure of change will be created that compares the answer to this question before and three months after interacting with BRIDGES. If the response is true at both time points or was false before and true after, it would signify an improvement in knowledge.
Three months after appointment
Knowledge about the role of healthcare providers
Time Frame: Pre-appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Healthcare providers can support people who feel controlled in their reproductive decisions. The correct answer is true.
Pre-appointment
Change in knowledge about the role of healthcare providers
Time Frame: Three months after appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Healthcare providers can support people who feel controlled in their reproductive decisions. The correct answer is true. A measure of change will be created that compares the answer to this question before and three months after their appointment. If the response is false before and true after, it would signify an improvement in knowledge.
Three months after appointment
Confidence in their ability to ask with their healthcare providers about issues related to reproductive coercion
Time Frame: Three months after appointment
In a self-administered survey, all patients are asked the extent to which they agree with being confident in asking their healthcare provider about issues related to reproductive coercion. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement. The responses to this question will be compared between the treatment and control.
Three months after appointment
Change in level of reproductive autonomy
Time Frame: Three months after appointment
In a self-administered survey, all patients are asked about their level of reproductive autonomy based on a validated 14-item measure which included three subscales that encompass reproductive autonomy including communication, freedom from coercion, and decision-making. Mean scores were calculated for each subscale by adding the value of the response choice for each item on the subscale and dividing this value by the number of items on the subscale. Higher scores on each subscale represented higher levels of RA (score ranges from 0 to 14). A measure of change will be created that compares the answer to this question before and three months after their appointment.
Three months after appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00259457
  • R21HD107619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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