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Feasibility Pilot StudyNCT06764030

A Patient-Directed Computerized Intervention to Address Reproductive Coercion

A study testing Educational web-based application in people with Feasibility Pilot Study, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Feasibility Pilot Study
What is being tested?
Educational web-based application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteUnited States
Study dates
18 Nov 2024to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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.

Being tested
Educational web-based application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational web-based applicationOther

    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.

Study groups in NCT06764030
Study groupRoleWhat they receive
BRIDGES plus standard of careExperimentalNot described
Receives: Other: Educational web-based application
Standard of careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of agreement that the BRIDGES website was acceptable

    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.

    Measured: Up to five days after appointment

  2. Level of agreement that the user liked BRIDGES

    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.

    Measured: Up to five days after appointment

  3. Level of agreement that BRIDGES was helpful

    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.

    Measured: Up to five days after appointment

  4. Level of agreement that the user was comfortable using BRIDGES

    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.

    Measured: Up to five days after appointment

  5. Level of agreement that the user felt safe using BRIDGES

    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.

    Measured: Up to five days after appointment

  6. Level of agreement that BRIDGES was easy to use

    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.

    Measured: Up to five days after appointment

  7. Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their intimate relationships

    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.

    Measured: Up to five days after appointment

  8. Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their preferred birth control method

    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.

    Measured: Up to five days after appointment

  9. Level of agreement that the BRIDGES website helped them choose a birth control method that works best for them

    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.

    Measured: Up to five days after appointment

  10. Level of agreement that the BRIDGES website influenced their decision about which birth control method they wanted

    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.

    Measured: Up to five days after appointment

  11. Level of agreement that the BRIDGES website will help them talk to their friends and family about reproductive coercion

    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.

    Measured: Up to five days after appointment

  12. Level of agreement that the user would share the BRIDGES website with a friend or family member who needed support

    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.

    Measured: Up to five days after appointment

  13. Level of agreement that the user would use the BRIDGES website if the user were not in the study

    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.

    Measured: Up to five days after appointment

Secondary outcomes (8)
  1. Knowledge about which birth control methods can be kept private

    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.

    Measured: Pre-appointment

  2. Change in knowledge about which birth control methods can be kept private

    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.

    Measured: Three months after appointment

  3. Knowledge about what reproductive coercion is

    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.

    Measured: Pre-appointment

  4. Change in knowledge about what reproductive coercion is

    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.

    Measured: Three months after appointment

  5. Knowledge about the role of healthcare providers

    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.

    Measured: Pre-appointment

  6. Change in knowledge about the role of healthcare providers

    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.

    Measured: Three months after appointment

  7. Confidence in their ability to ask with their healthcare providers about issues related to reproductive coercion

    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.

    Measured: Three months after appointment

  8. Change in level of reproductive autonomy

    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.

    Measured: Three months after appointment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start18 Nov 2024
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Model description
The intervention group will interact with BRIDGES in addition to receiving standard of care while the control group will receive standard of care.
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764030
Sponsor's protocol ID
HUM00259457
Other IDs
R21HD107619
Status last verified
Dec 2025
First submitted
1 Dec 2024
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational web-based application in people with Feasibility Pilot Study, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of agreement that the BRIDGES website was acceptable (time frame: Up to five days after appointment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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