STAC Intervention for Health Equity

Overseen By Megan Knutson Sinaise, MS, ACSM-CEP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Antihypertensives

Disqualifiers: Heart disease, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on more than two blood pressure medications.

What data supports the effectiveness of the STAC treatment for health equity?

Research shows that interventions focusing on patient empowerment and cultural leverage can improve health outcomes and reduce disparities, especially in communities of color. These approaches have been effective in managing chronic conditions like diabetes and HIV by enhancing patient engagement and tailoring care to cultural needs. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Kara Hoppe, DO, PhD

Principal Investigator

University of Wisconsin, Madison

Andrew Garbacz, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for Black Women and Birthing Persons (WBP) who are dealing with high blood pressure during or after pregnancy. The study aims to adapt the STAC intervention specifically for this group to improve health equity.

Inclusion Criteria

I am pregnant and at least 24 weeks along or have recently given birth.

I can understand and sign the consent form in English.

Staff of CBO participating in PDSA cycle

Exclusion Criteria

I am experiencing bleeding in the later stages of my pregnancy.

I have a heart condition from birth that hasn't been surgically fixed.

I have heart failure and am pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation Interviews

Conduct interviews with STAC-CAB members and Lived Experience Group members to evaluate implementation factors and priorities for adaptation of STAC.

4 weeks

1-2 visits (in-person or virtual)

Focus Groups and PDSA Cycle 1

Conduct small focus groups and the first PDSA cycle with follow-up interviews and surveys for patients and CBO staff.

8 weeks

Multiple visits (in-person or virtual)

PDSA Cycle 2 and Finalization

Repeat PDSA cycle and incorporate usability data to refine and finalize the A-STAC intervention.

8 weeks

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for feedback on the finalized A-STAC intervention.

4 weeks

Treatment Details

Interventions

• STAC

Trial Overview The trial is testing the implementation of 'Staying Healthy After Childbirth' (STAC) using PDSA Cycles, which are steps taken to plan, do, study, and act on new strategies in community settings.

Participant Groups

Group I: PDSA Cycle Participants and CBO Staff Experimental Treatment 1 Intervention

Black pregnant or postpartum persons and Community Based Organization Staff

Group II: STAC-CAB Members Active Control 1 Intervention

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

Group III: Lived Experience Group Members Active Control 1 Intervention

Lived Experience Group members (8-12 members)

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

References

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

Early lessons from an initiative on Chicago's South Side to reduce disparities in diabetes care and outcomes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Establishing centers to address treatment effectiveness in diverse ethnic groups: the MEDTEP experience. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Activation of persons living with HIV for treatment, the great study. [2019]

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

Operationalizing Primary Outcomes to Achieve Reach, Effectiveness, and Equity in Multilevel Interventions. [2023]

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

Cultural leverage: interventions using culture to narrow racial disparities in health care. [2022]