Community-based Implementation of Adapted STAC

NCT06689930 | Recruiting

• 3 other identifiers: 2024-1594Protocol Approved 4/11/25U48DP006793
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).

Conditions

Blood Pressure; Hypertension; Pregnancy Related; Health Equity

Keywords

Prenatal; Post Partum; Hypertensive Disorders of Pregnancy; Remote Patient Monitoring; Blood Pressure; Community-Based Participation

Outcome Measures

Primary Outcomes (6)

• Qualitative Summary of Barriers to Implementation of A-STAC

  Barriers to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding barriers will be coded for themes summarized by participant count.

  up to 4 weeks

• Qualitative Summary of Facilitators to Implementation of A-STAC

  Facilitators to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding facilitators will be coded for themes summarized by participant count.

  up to 4 weeks

• Qualitative Summary of Adaptations to STAC

  Adaptations to STAC will be analyzed from patient participant interviews and CBO staff participants post-PDSA cycles. Interviews will be coded for themes summarized by count.

  up to 8 weeks

• The Acceptability of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.

  up to 8 weeks

• The Intervention Appropriateness Measure (IAM)

  The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.

  up to 8 weeks

• The Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.

  up to 8 weeks

Study Arms (3)

STAC-CAB Members

NO INTERVENTION

Staying Healthy After Childbirth - Community Advisory Board members (8-12 members)

Lived Experience Group Members

NO INTERVENTION

Lived Experience Group members (8-12 members)

PDSA Cycle Participants and CBO Staff

EXPERIMENTAL

Black pregnant or postpartum persons and Community Based Organization Staff

Other: PDSA Cycles

Interventions

PDSA Cycles OTHER

Conduct PDSA cycle and follow-up interviews and surveys for patients (5 per cycle, 10 total) and CBO staff (no less than 2)

PDSA Cycle Participants and CBO Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Belong to the STAC-CAB or Lived Experience Group
• Aged 18 or older
• Staff of CBO participating in PDSA cycle
• Aged 18 years or older
• Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum
• Self-Identify as African American or Black
• Aged 18 years or older
• Capable of providing informed consent in English
• Can follow M•care System use instructions in English
• Have ownership of a functioning and reliable smartphone to upload and use the M•other App
• Interested in preventing or managing blood pressure during pregnancy

You may not qualify if:

• Persistent second or third trimester bleeding at time of enrollment
• Premature rupture of membranes in the current pregnancy at time of enrollment
• Known unrepaired maternal congenital heart disease requiring surgical correction
• Maternal heart failure
• Chronic kidney disease specifically requiring dialysis
• On greater than two antihypertensive medications at time of enrollment

Sponsors & Collaborators

• Centers for Disease Control and Prevention: collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

• STAC Web Page

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kara Hoppe, DO, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Andrew Garbacz, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Knutson Sinaise, MS, ACSM-CEP

CONTACT

608-556-9708; mknutson2@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is primarily a qualitative study designed to identify implementation strategies for the Adapted Staying Healthy After Childbirth (A-STAC). This pre-implementation phase includes 10 pilot participants and at least 2 CBO staff.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 15, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)