Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06689930

Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)

Led by University of Wisconsin, Madison · Updated on 2026-05-26

46

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

C

Centers for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are adapting the Staying Healthy After Childbirth (STAC) intervention to better serve Black women and birthing persons, focusing on preventing health complications related to hypertensive disorders of pregnancy during the critical postpartum period. This qualitative study aims to engage community members and stakeholders deeply to refine and prepare the adapted STAC (A-STAC) for wider use, addressing racial disparities in health outcomes. The study includes multiple steps: interviews and focus groups with community advisory board members and those with lived experiences to identify priorities and barriers; followed by Plan-Do-Study-Act (PDSA) cycles involving Black pregnant and postpartum persons and community organization staff to test implementation strategies. After each cycle, feedback is collected through interviews and surveys to refine the intervention, with up to three cycles planned before finalizing A-STAC. Participants will be involved in interviews, focus groups, and PDSA cycles, providing input on the intervention's usability and implementation. Researchers will collect qualitative data on barriers, facilitators, and adaptations to the intervention, as well as measures of acceptability, appropriateness, and feasibility. Study duration varies by participant engagement in these cycles, and findings will inform the final intervention for improving postpartum hypertension care.

CONDITIONS

Brief Title

Community-based Implementation of Adapted STAC

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Belong to the STAC-Community Advisory Board or Lived Experience Group
  • Aged 18 years or older
  • Staff of Community Based Organizations participating in PDSA cycles
  • Pregnant persons at 24 weeks gestation or more, or postpartum
  • Self-identify as African American or Black
  • Capable of providing informed consent in English
  • Able to use the M3care System and M3other App with a reliable smartphone
  • Interested in preventing or managing blood pressure during pregnancy
Not Eligible

You will not qualify if you...

  • Persistent second or third trimester bleeding at enrollment
  • Premature rupture of membranes during current pregnancy
  • Known unrepaired maternal congenital heart disease requiring surgery
  • Maternal heart failure
  • Chronic kidney disease requiring dialysis
  • Taking more than two antihypertensive medications at enrollment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Qualitative Data Collection

Duration - Up to 8 weeks

Participants provide qualitative data through semi-structured interviews and focus groups to evaluate implementation factors, priorities for adaptation, and usability of the intervention.

Multiple interviews and small focus groups over several weeks

PDSA Cycles

Duration - Up to 8 weeks per cycle, up to 3 cycles total

Participants engage in Plan-Do-Study-Act cycles with Community Based Organization partners, including follow-up interviews and surveys to gather feedback and refine the intervention.

Interviews and surveys after each PDSA cycle with 3-5 patients and CBO staff

Finalization of Intervention

Duration - Duration not specified

The intervention is refined and finalized based on data collected from PDSA cycles and participant feedback.

No participant visits; finalization is a study process

Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

M

Megan Knutson Sinaise, MS, ACSM-CEP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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