Community Gateway to Health Study
2 other identifiers
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 18, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
July 1, 2029
May 18, 2026
May 1, 2026
2 years
May 4, 2026
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Patients Screened for Colorectal Cancer
% 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
% 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
% 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
% patients offered pharmacotherapy from EMR
change from baseline to end of intervention period, an average of 1 year
Secondary Outcomes (2)
Acceptability of the intervention
Post intervention, 1 year follow up
Feasibility of the intervention
Post intervention, 1 year follow up
Study Arms (2)
Multilevel Intervention
EXPERIMENTALUsual Care
NO INTERVENTIONIn 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Community health center staff or community partners
- Age 18 or older
You may not qualify if:
- Under 18
- Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard School of Public Health (HSPH)lead
- National Cancer Institute (NCI)collaborator
- Caring Health Centercollaborator
- Massachusetts League of Community Health Centerscollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer on Social and Behavioral Sciences
Study Record Dates
First Submitted
May 4, 2026
First Posted
May 18, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
July 1, 2029
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be stored for 7 years.
- 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.
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).