Recruiting

STAC

Sponsor:

University of Wisconsin, Madison

Code:

NCT06689930

Conditions

Blood Pressure

Hypertension

Pregnancy Related

Health Equity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PDSA Cycles

Study Details

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

Study ID

NCT06689930

Start date

May 22, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (Interviews and Focus Groups):

  • Belong to the STAC-CAB or Lived Experience Group
  • Aged 18 or older

Inclusion Criteria (CBO Staff):

  • Staff of CBO participating in PDSA cycle
  • Aged 18 years or older

Inclusion Criteria (PDSA-Cycles):

  • 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

Exclusion Criteria (PDSA-Cycles):

  • 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

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: STAC-CAB Members

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

no intervention: Lived Experience Group Members

Lived Experience Group members (8-12 members)

experimental: PDSA Cycle Participants and CBO Staff

Black pregnant or postpartum persons and Community Based Organization Staff

Interventions

PDSA Cycles

Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2)

Primary outcome measure

  • Qualitative Summary of Barriers to Implementation of A-STAC [ Time Frame: up to 4 weeks ]
  • Qualitative Summary of Facilitators to Implementation of A-STAC [ Time Frame: up to 4 weeks ]
  • Qualitative Summary of Adaptations to STAC [ Time Frame: up to 8 weeks ]
  • The Acceptability of Intervention Measure (AIM) [ Time Frame: up to 8 weeks ]
  • The Intervention Appropriateness Measure (IAM) [ Time Frame: up to 8 weeks ]
  • The Feasibility of Intervention Measure (FIM) [ Time Frame: up to 8 weeks ]

Central Contacts and Locations

Central contacts

Krissy Buchholz Alaniz, PhD, MPH

608-334-7710prccoreproject_obgyn@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-11.