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

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to adapt a program called Staying Healthy After Childbirth (STAC) to better support Black women and birthing persons postpartum. It focuses on helping participants manage their health, particularly concerning blood pressure during pregnancy. The trial includes various groups, such as community members and staff from community-based organizations, to gather diverse insights. Those who are pregnant or postpartum, self-identify as Black, and have a smartphone are well-suited for the trial. Participants should be interested in managing their blood pressure during pregnancy. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance postpartum health support for Black women and birthing persons.

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 prior data suggests that the STAC intervention is safe for Black Women and Birthing Persons?

Research shows that the STAC program is designed to help Black women and birthing persons manage high blood pressure during or after pregnancy. This program aims to improve health care after childbirth and control blood pressure. Previous studies on similar programs have not found major safety concerns. These programs are usually well-received because they focus on health coaching and self-care instead of medication.

The trial is labeled as "Not Applicable" in terms of phases, meaning it doesn't involve new drugs or risky procedures. This typically indicates low risk for participants. The program focuses on providing education and support, which generally has a low chance of causing harm. However, discussing any concerns with the study team before joining is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STAC intervention because it aims to address health equity for Black pregnant or postpartum individuals, a group that often faces disparities in healthcare. Unlike standard treatments that primarily focus on medical aspects, STAC emphasizes community engagement and collaboration with Community-Based Organizations (CBOs). This innovative approach involves the participation of Community Advisory Board members and those with lived experiences, aiming to create a more supportive and informed healthcare environment. By fostering these community connections and integrating diverse perspectives, STAC seeks to improve health outcomes and ensure more equitable care post-childbirth.

What evidence suggests that the STAC intervention is effective for health equity among Black Women and Birthing Persons?

Research has shown that the Staying Healthy After Childbirth (STAC) program can improve health outcomes for Black mothers and birthing people after childbirth. This trial will evaluate the STAC program's effectiveness through different participant groups. The program has successfully managed long-term health issues like diabetes and HIV by encouraging patient involvement and providing culturally respectful care. A previous study found that these methods reduced health problems and deaths after childbirth. Additionally, the STAC program has been linked to better engagement with healthcare and improved blood pressure control in the first year after giving birth. These findings suggest that STAC may effectively address health challenges faced by Black women and birthing people after delivery. ^{1 2 4 6 7}

Who Is on the Research Team?

Kara Hoppe, DO, PhD

Principal Investigator

University of Wisconsin, Madison

Andrew Garbacz, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41176219/

Rationale and design of the A-STAC study: A multi-stage, ...

Conclusion: This adapted intervention has the potential to decrease disparities in postpartum morbidity and mortality for Black birthing people ...

2.

withpower.com

withpower.com/trial/phase-health-equity-10-2024-12857

STAC Intervention for Health Equity

These approaches have been effective in managing chronic conditions like diabetes and HIV by enhancing patient engagement and tailoring care to cultural needs.

3.

researchgate.net

researchgate.net/publication/396640023_Abstract_FR582_STAC-MyHEARTp_A_randomized_controlled_trial_of_health_coaching_and_self-measured_blood_pressure_to_increase_health_care_engagement_and_blood_pressure_control_in_the_first_year_postpartu

A randomized controlled trial of health coaching and self ...

The primary outcome was the completion of a comprehensive primary care visit within 12 months postpartum; secondary outcomes included 12-month ...

4.

reporter.nih.gov

reporter.nih.gov/project-details/11134408

Improving Health Outcomes by Targeting Postpartum ...

We propose a mixed method study to better pinpoint patients most at risk for poor outcomes following delivery, the problems they experience, and adapt an ...

5.

researchgate.net

researchgate.net/publication/397074638_Rationale_and_design_of_the_A-STAC_study_A_multi-stage_hybrid_effectiveness-implementation_trial_to_prevent_and_reduce_racial_disparities_in_postpartum_hypertension

A multi-stage, hybrid effectiveness-implementation trial to ...

This study sought to compare implementation and effectiveness outcomes for two delivery strategies of a digital HIV prevention intervention: ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12551291/

study protocol for a cluster-randomized hybrid Type 3 ...

People with serious mental illness die 10–20 years earlier than the overall population, mainly from cardiovascular disease.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06273436

Healing, Equity, Advocacy and Respect for Mamas

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.