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A Patient-Directed Computerized Intervention to Address Reproductive Coercion

NCT ID: NCT06764030

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Feasibility Pilot Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The intervention group will interact with BRIDGES in addition to receiving standard of care while the control group will receive standard of care.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BRIDGES plus standard of care

Group Type EXPERIMENTAL

Educational web-based application

Intervention Type OTHER

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.

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Yasamin Yoko Kusunoki

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R21HD107619

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00259457

Identifier Type: -

Identifier Source: org_study_id