Community Health Worker Support for Preeclampsia

(AW2H Trial)

Recruiting at 1 trial location

Overseen By Rachel Sinkey, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English speakers, Incarceration, Previous P3OPPY

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Community Health Worker Intervention for preeclampsia?

Research shows that community health workers can play a crucial role in managing preeclampsia by engaging with communities, facilitating early diagnosis, and referring women for further care, which can help reduce maternal and perinatal mortality. ^{1 2 3 4 5}

Is the Community Health Worker Support for Preeclampsia generally safe for humans?

The research suggests that community health worker programs, including those using mobile health applications, are generally well-received and safe, as they improve interactions and support maternal health without reported safety concerns. ^{1 2 3 6 7}

How does the Community Health Worker Intervention treatment for preeclampsia differ from other treatments?

The Community Health Worker Intervention for preeclampsia is unique because it involves community health workers who engage with the community to provide early diagnosis, stabilization, and referral for women with preeclampsia, especially in low-resource settings. This approach focuses on task-sharing and building trust-based relationships, which is different from traditional medical treatments that rely solely on healthcare facilities and professionals. ^{1 2 4 6 8}

What is the purpose of this trial?

United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.

Research Team

Jesse E Rattan

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for Black individuals between the ages of 16-56 who are experiencing adverse pregnancy outcomes like preeclampsia, preterm birth, and others. Participants must be planning to deliver at UAB Hospital, speak and write English, and not be due for delivery at enrollment.

Inclusion Criteria

I am between 16 and 56 years old.

Self Identifies as Black

Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant

Exclusion Criteria

I choose not to be randomly assigned to a treatment group.

Speaks or writes in languages other than English

Currently incarcerated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive cardiovascular disease prevention education and community health worker support

12 weeks

Regular visits with community health workers

Follow-up

Participants are monitored for satisfaction and health outcomes, including blood pressure and primary care visit scheduling

6-12 weeks postpartum

Treatment Details

Interventions

• Community Health Worker Intervention

Trial Overview The study is testing if adding a community health worker intervention to usual postpartum care can better control blood pressure after childbirth and help prevent heart disease later on in Black patients with adverse pregnancy outcomes.

Participant Groups

Group I: Usual care and community health worker intervention Experimental Treatment 2 Interventions

Usual postpartum care and community health worker visits and support

Group II: Usual Care Experimental Treatment 1 Intervention

Usual postpartum care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The CLIP trial, involving 39,446 women, aimed to reduce maternal and perinatal mortality through community engagement by Lady Health Workers, but did not show a significant difference in overall adverse outcomes between intervention and control groups.

While the intervention did lead to a reduction in stillbirths, it had no significant impact on maternal deaths or morbidity, suggesting that improvements in community outreach need to be paired with enhanced healthcare facility support for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial. Qureshi, RN., Sheikh, S., Hoodbhoy, Z., et al.[2021]

Community health care workers in northern Karnataka, India, have limited understanding of the causes of pre-eclampsia and eclampsia, often attributing hypertension to psychological factors rather than medical ones.

Despite some misconceptions, these workers possess basic knowledge of managing hypertensive disorders in pregnancy, such as recommending rest and dietary changes, but require further training to effectively administer treatments like magnesium sulfate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India. Ramadurg, U., Vidler, M., Charanthimath, U., et al.[2018]

The PIERS on the Move (POM) mobile health application was found to be easy to use and well-received by community health workers (CHWs) in rural India, enhancing their interactions with women and families, even among those with limited smartphone experience.

While POM did not significantly increase CHWs' knowledge or self-efficacy regarding pre-eclampsia care, it effectively strengthened their roles as essential members of the antenatal healthcare system, highlighting the potential of mHealth technologies to improve healthcare access in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India. Charanthimath, U., Katageri, G., Kinshella, MW., et al.[2021]

Community health workers in Mozambique can effectively screen for pre-eclampsia and eclampsia, indicating that task-sharing initial care at the community level is feasible and acceptable.

However, significant barriers exist in healthcare facilities, such as lack of necessary equipment and surgical capacity, which could hinder the management of obstetric emergencies and the referral process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of task-sharing with community health workers for the identification, emergency management and referral of women with pre-eclampsia, in Mozambique. Sevene, E., Boene, H., Vidler, M., et al.[2021]

Community health workers in Nigeria demonstrated a good understanding of pre-eclampsia, including its symptoms and risk factors, and were capable of initiating care and referrals for affected women.

Despite their knowledge, some community health workers felt limited in their ability to manage pre-eclampsia due to restrictive guidelines, highlighting the need for regular training and clearer protocols to enhance maternal health care in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers' knowledge and practice in relation to pre-eclampsia in Ogun State, Nigeria: an essential bridge to maternal survival. Sotunsa, JO., Vidler, M., Akeju, DO., et al.[2022]

Community health workers (CHWs) foster trust-based relationships with perinatal women, which significantly enhance their prenatal care experience and health outcomes, as reported by 39 clients in focus groups and interviews.

These relationships provide essential emotional, informational, and instrumental support, leading to improved engagement with healthcare, better health behaviors, and reduced stress, highlighting the importance of trust-building in community health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features and Impact of Trust-Based Relationships Between Community Health Workers and Low-Resource Perinatal Women with Chronic Health Conditions. Boyd, LM., Mehra, R., Thomas, J., et al.[2021]

Community Health Workers (CHWs) who received enhanced training and support were 15% more likely to fully immunize their clients and 14% more likely to ensure that clients completed four or more antenatal care visits, indicating the effectiveness of the intervention in improving health outcomes.

The study found that recent training and experience with pregnant women significantly increased CHW knowledge, while education and literacy showed mixed associations with competency, suggesting that these factors may not be the best criteria for selecting CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. Rogers, A., Goore, LL., Wamae, J., et al.[2023]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial. [2021]

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

Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of task-sharing with community health workers for the identification, emergency management and referral of women with pre-eclampsia, in Mozambique. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Community health workers' knowledge and practice in relation to pre-eclampsia in Ogun State, Nigeria: an essential bridge to maternal survival. [2022]

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

Features and Impact of Trust-Based Relationships Between Community Health Workers and Low-Resource Perinatal Women with Chronic Health Conditions. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. [2022]