Community Gateway to Health Study

May 11, 2026 updated by: Rebekka Lee, Harvard School of Public Health (HSPH)
The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes. This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and participation in cancer control care. The system-level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation. These interventions will be delivered via usual care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Study participants include community health center and community partner staff participating in surveys and interviews about the implementation of the intervention.

Inclusion Criteria:

  • Community health center staff or community partners
  • Age 18 or older

Exclusion Criteria:

  • Under 18

Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multilevel Intervention
Behavioral: Tools and Training for Cancer Control
This system level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation.
Behavioral: Enhancing Social Capital and Civic Engagement
This community level intervention consists of a patient referral from a community health center to a community organization focused on building social capital and civic engagement to test the impact of connecting clinical and community resources explicitly for patients.
No Intervention: Usual Care
In this stepped wedge design, all sites have a period of being in usual care. Six sites then have periods of providing the intervention and six sites remain comparison sites (i.e. usual care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Screened for Colorectal Cancer
Time Frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on colorectal cancer screening from EMR
change from baseline to end of intervention period, an average of 1 year
Patients Screened for Breast Cancer
Time Frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on breast cancer screening from EMR
change from baseline to end of intervention period, an average of 1 year
Patients Screened for Cervical Cancer
Time Frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on cervical cancer screening from EMR
change from baseline to end of intervention period, an average of 1 year
Patients Offered Pharmacotherapy for Smoking Cessation
Time Frame: change from baseline to end of intervention period, an average of 1 year
% patients offered pharmacotherapy from EMR
change from baseline to end of intervention period, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention
Time Frame: Post intervention, 1 year follow up
Self reported via staff survey
Post intervention, 1 year follow up
Feasibility of the intervention
Time Frame: Post intervention, 1 year follow up
Self-reported via staff survey
Post intervention, 1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Cancer Institute (NCI)
Massachusetts League of Community Health Centers
Caring Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241740
  • U19CA291431 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data that underlie the results reported here, after de-identification. Individual staff/partner data on implementation will be made publicly available.

Patient data can be made available upon request and appropriate approvals (see below).

IPD Sharing Time Frame

Data will be stored for 7 years.

IPD Sharing Access Criteria

Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance from the study's analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are available. Requests should be directed to jdaly@hsph.harvard.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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