NCT07136402

Brief Summary

This research is being conducted to investigate how to increase primary care health care visits and screenings and treatment for hypertension and diabetes in residents of housing developments in Boston. The investigators are partnering with Boston Housing Authority (BHA) and Trinity housing management to randomize 12 housing developments (6 in intervention and 6 in control). 6 residents from the housing developments will become Community Health Ambassadors (CHA). The CHAs will be trained to conduct "workshops" within the intervention arm. These workshops will cover Diabetes Mellitus (DM) and Hypertension (HTN) information. Along with the workshops, CHAs will act as mentors for the residents and provide them with resources to connect them to primary care, Community Health Centers, food pantry resources, how to get insurance, and other needed services. CHAs will be part-time employees of the Massachusetts Community Engaged Alliance (MA-CEAL), so they will be paid for the work they are doing while simultaneously building their professional skill set. MA-CEAL's community engagement (CE) team will act as liaisons and mentors for the CHA's to help guide them and also connect them to opportunities for career/personal development.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
24mo left

Started Sep 2025

Typical duration for not_applicable hypertension

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Sep 2025May 2028

First Submitted

Initial submission to the registry

May 13, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

May 13, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Community health ambassadors (CHA)Community health centersWorkshops

Outcome Measures

Primary Outcomes (1)

  • Number of primary care visits

    Self-report primary care visits in the last 18 months will be obtained using selected items from the National Health Interview Survey (NHIS)

    Baseline, 6 months, 12 months, 18 months

Secondary Outcomes (2)

  • Number of screenings for diabetes

    Baseline, 6 months, 12 months, 18 months

  • Number of screenings for hypertension

    Baseline, 6 months, 12 months, 18 months

Study Arms (2)

Intervention (Phase A)

EXPERIMENTAL

Community health centers randomized into this arm will receive study interventions in the first 18 months of the study.

Other: Educating participants about healthcare resourcesOther: Healthcare appointmentsOther: Workshops

Control (Phase B)

EXPERIMENTAL

Community health centers randomized into this arm will be wait listed and will not receive study interventions during the first 18 months of the study. They will receive study interventions during the last 12 months of the study.

Other: Educating participants about healthcare resourcesOther: Healthcare appointmentsOther: Workshops

Interventions

MA-CEAL team members, including the community health ambassador (CHA), will assist in connecting residents with healthcare resources.

Control (Phase B)Intervention (Phase A)

MA-CEAL team members, including the community health ambassador (CHA), will assist residents in making physician appointments.

Control (Phase B)Intervention (Phase A)

Trained CHAs will provide workshops with information about diabetes and hypertension and how to be screened and get care.

Control (Phase B)Intervention (Phase A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current resident in selected Boston Health Authority (BHA) and Trinity housing developments
  • Speak and understand English and/or Spanish

You may not qualify if:

  • Does not speak English or Spanish
  • Not a resident of the development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes MellitusPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Benjamin Linas, MD MPH

    Boston Medical Center, Infectious Disease

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A waitlist-control trial design will be used for this study. 6 of the 12 participating housing developments will be randomized into the intervention arm and 6 into the control arm. At month 0 all participants will participate in baseline activities (surveys). At month 18 the control arm will begin the intervention. The whole study is projected to take 36 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

August 22, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share