Educational Website for Reproductive Coercion

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Previous exposure, No valid email

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational content rather than medication changes.

What data supports the effectiveness of the treatment BRIDGES for reproductive coercion?

Research suggests that provider scripts can help address reproductive coercion and increase contraceptive use, as seen in a study where these scripts led to reduced coercion and higher contraceptive uptake. ^{1 2 3 4 5}

How does the BRIDGES treatment differ from other treatments for reproductive coercion?

The BRIDGES treatment is unique because it involves an educational website specifically designed to address reproductive coercion, a form of abuse that interferes with a person's reproductive choices. Unlike other treatments that may focus on physical or medical interventions, BRIDGES aims to empower individuals through information and support, helping them recognize and resist coercive behaviors. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for family planning patients aged 18-29 at Planned Parenthood of Michigan clinics. It's designed to help them understand and address reproductive coercion (RC). Participants must be willing to use a web-based educational tool and complete surveys. There are no specific exclusion criteria provided.

Inclusion Criteria

I completed the survey and attended my birth control appointment.

I am seeking family planning services and identify as a woman, transgender man, non-binary, or gender-diverse.

Able to participate in English

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the BRIDGES educational website intervention or standard of care

5-10 minutes

1 visit (in-person)

Follow-up

Participants complete surveys to assess knowledge, self-efficacy, and behavior changes

3 months

3 surveys (pre-appointment, post-appointment, 3-months)

Treatment Details

Interventions

• BRIDGES

Trial Overview The 'BRIDGES' website, an educational tool aimed at improving understanding of RC and promoting healthy relationships, is being tested against standard care. The study involves random assignment of clinics to either integrate BRIDGES into patient care or continue with their usual support services.

Participant Groups

Group I: BRIDGES plus standard of care Experimental Treatment 1 Intervention

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychometric properties and refinement of the Reproductive Coercion Scale. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Follow-Up Findings from an Implementation Randomized Controlled Trial Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Screening and intervening: evaluating a training program on intimate partner violence and reproductive coercion for family planning and home visiting providers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Justice-involved women's preferences for an internet-based Sexual Health Empowerment curriculum. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Women's perceptions and experiences of reproductive coercion and abuse: a qualitative evidence synthesis. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Reproductive coercion and abuse in Australia: what do we need to know? [2022]

8. England pubmed.ncbi.nlm.nih.gov

Coerced Abortion - The Neglected Face of Reproductive Coercion. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Reproductive Coercion: A Systematic Review. [2023]