Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention
NCT ID: NCT05524480
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
2000 participants
INTERVENTIONAL
2024-10-02
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Salud en Mis Manos - Dissemination and Implementation Assistance
The multi-component and multi-faceted implementation strategy SEMM-DIA
Salud en Mis Manos - Dissemination and Implementation Assistance
The experimental arm will utilize the multi-component and multifaceted implementation strategy, SEMM-DIA. This includes elements like 1) A program orientation session (virtual or in-person), 2) Technical Assistance for implementers, such as SEMM Program Manager/ Coordinator and LHWs, 3) SEMM program materials (including LHW Training curriculum, in-reach/ outreach materials, patient tracking forms), and 4) Virtual community support (Project ECHO series).
Salud en Mis Manos - Usual Implementation Practice
The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.
Salud en Mis Manos- Usual Implementation Practice
The control arm will undertake SEMM- Usual Implementation Practice, which includes utilizing all existing SEMM program materials (MOPs, LHW Training Curriculum, etc.) which will be shared with clinic staff in PDF form.
Interventions
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Salud en Mis Manos - Dissemination and Implementation Assistance
The experimental arm will utilize the multi-component and multifaceted implementation strategy, SEMM-DIA. This includes elements like 1) A program orientation session (virtual or in-person), 2) Technical Assistance for implementers, such as SEMM Program Manager/ Coordinator and LHWs, 3) SEMM program materials (including LHW Training curriculum, in-reach/ outreach materials, patient tracking forms), and 4) Virtual community support (Project ECHO series).
Salud en Mis Manos- Usual Implementation Practice
The control arm will undertake SEMM- Usual Implementation Practice, which includes utilizing all existing SEMM program materials (MOPs, LHW Training Curriculum, etc.) which will be shared with clinic staff in PDF form.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expressed intent to participate in the implementation of SEMM.
* Serve low-income populations with low or no-cost screening and vaccination.
* Provide comprehensive primary health care services.
* Latinas who self-identify as Hispanic/Latina.
* Latinas who have at least one unmet breast or cervical cancer prevention need, following Electronic Clinical Quality Measures.
* (1) Latinas aged 21-64 years who have not had a Pap test in the past 3 years, and (2) Latinas aged 30-64 who have not had a HPV test in the past 5 years (CMS eCQM ID: CMS124v9).
* (3) Latinas aged 51-74 years who have not had a mammogram in the past 2 years (CMS eCQM ID: CMS125v9).
* (4) Latinas aged 18-26 years who have not initiated HPV vaccination.
* Note: Some women will have more than one unmet need (e.g., HPV vaccination and pap test), so they will be included in more than one non-adherent group.
Exclusion Criteria
\- Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.
18 Years
74 Years
FEMALE
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Lara Savas
Associate Professor
Principal Investigators
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Lara Savas, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Maria E Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-SPH-20-1117
Identifier Type: -
Identifier Source: org_study_id