- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524480
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lara Savas, PhD
- Phone Number: (713) 500-9638
- Email: lara.staub@uth.tmc.edu
Study Contact Backup
- Name: Angelita Alaniz, MPH
- Email: angelita.alaniz@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Angelita Alaniz, MPH
- Email: angelita.alaniz@uth.tmc.edu
-
Contact:
- Lara Savas, PhD
- Phone Number: 713-500-9638
- Email: lara.staub@uth.tmc.edu
-
Principal Investigator:
- Maria E Fernandez, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Organization inclusion criteria:
- Clinic or community health center (CHC) with LHWs serving Latina populations.
- 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.
SEMM Participant Inclusion criteria:
- 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:
Organization exclusion criteria:
- Clinics/Community Health Centers not located in Texas.
SEMM Participant Exclusion criteria:
- Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salud en Mis Manos - Dissemination and Implementation Assistance
The multi-component and multi-faceted implementation strategy SEMM-DIA
|
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).
Other Names:
|
Active Comparator: Salud en Mis Manos - Usual Implementation Practice
The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach is measured by the proportion of women who participate in SEMM education sessions among those that are eligible in the clinic (among all eligible patients) & in the community (the number of participants that receive SEMM education).
Time Frame: 4-month follow up
|
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
|
4-month follow up
|
Reach is measured by the proportion of women who participate in SEMM education sessions among those that are eligible in the clinic (among all eligible patients) & in the community (the number of participants that receive SEMM education).
Time Frame: 8-month follow up
|
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
|
8-month follow up
|
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Time Frame: Baseline
|
Investigators will assess mammogram completion outcomes using EHR data collection.
All participants identified as eligible for a mammogram between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
Baseline
|
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Time Frame: 4-month follow-up
|
Investigators will assess mammogram completion outcomes using EHR data collection.
All participants identified as eligible for a mammogram between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
4-month follow-up
|
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Time Frame: 8-month follow-up
|
Investigators will assess mammogram completion outcomes using EHR data collection.
All participants identified as eligible for a mammogram between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
8-month follow-up
|
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Time Frame: Baseline
|
Investigators will assess Pap completion outcomes using EHR data collection.
All participants identified as eligible for a Pap or HPV screening test between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
Baseline
|
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Time Frame: 4-month follow-up
|
Investigators will assess Pap completion outcomes using EHR data collection.
All participants identified as eligible for a Pap or HPV screening test between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
4-month follow-up
|
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Time Frame: 8-month follow-up
|
Investigators will assess Pap completion outcomes using EHR data collection.
All participants identified as eligible for a Pap or HPV screening test between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
8-month follow-up
|
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Time Frame: Baseline
|
Investigators will assess HPV vaccination initiation or completion outcomes using EHR data collection.
All participants identified as eligible for an HPV vaccination between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
Baseline
|
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Time Frame: 4-month follow-up
|
Investigators will assess HPV vaccination initiation or completion outcomes using EHR data collection.
All participants identified as eligible for an HPV vaccination between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
4-month follow-up
|
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Time Frame: 8-month follow-up
|
Investigators will assess HPV vaccination initiation or completion outcomes using EHR data collection.
All participants identified as eligible for an HPV vaccination between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
|
8-month follow-up
|
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)
Time Frame: 8-month follow-up
|
Investigators will assess the level of implementation from baseline to 8-month follow-up using manager assessments.
|
8-month follow-up
|
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)
Time Frame: 8-month follow-up
|
Investigators will assess the level of implementation from baseline to 8-month follow-up using LHW assessments.
|
8-month follow-up
|
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)
Time Frame: 8-month follow-up
|
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with LHWs.
|
8-month follow-up
|
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)
Time Frame: 8-month follow-up
|
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with managers.
|
8-month follow-up
|
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
Time Frame: 4-month follow-up
|
Investigators will assess implementation fidelity using participant tracking forms (completed by LHWs) to understand their level of fidelity associated with implementing the program.
|
4-month follow-up
|
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
Time Frame: 8-month follow-up
|
Investigators will assess implementation fidelity using end-of-study in-depth interviews with LHWs to understand their level of fidelity associated with implementing the program.
|
8-month follow-up
|
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Time Frame: 4-month follow up
|
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
|
4-month follow up
|
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
Time Frame: 4-month follow up
|
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record # of navigation calls needed to overcome barriers to complete needed services (mammogram, Pap/HPV test, and HPV vaccination).
|
4-month follow up
|
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Time Frame: 8-month follow up
|
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
|
8-month follow up
|
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
Time Frame: 8-month follow up
|
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record # of navigation calls needed to overcome barriers to complete needed services (mammogram, Pap/HPV test, and HPV vaccination).
|
8-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost effectiveness of SEMM-DIA in community and clinic practice settings
Time Frame: 8-month follow up
|
The purpose of the economic analysis is to produce information on the cost-effectiveness of SEMM-DIA in community and clinic practice settings.
Investigators will determine the current market value of all ingredients associated with the planning and implementation of the dissemination interventions (from study start to 8-month follow-up), including training and other costs of adapting the intervention to specific sites.
|
8-month follow up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maria E Fernandez, PhD, The University of Texas Health Science Center, Houston
- Principal Investigator: Lara Savas, PhD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- HSC-SPH-20-1117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cancer Prevention
-
German Cancer Research CenterUniversity of Music, Drama, and Media HannoverNot yet recruiting
-
M.D. Anderson Cancer CenterActive, not recruitingCancer PreventionUnited States
-
IWK Health CentreLaval University; Canadian Association of Fire ChiefsRecruiting
-
AshtaYoga, LLCColumbia University; University Of Nigeria Teaching Hospital; Project PINKBLUE... and other collaboratorsNot yet recruitingStep up to Health, Nigeria! Impact of 2022 World Cancer Day Walk on Health Behaviors Among NigeriansCancer PreventionNigeria
-
HealthPartners InstituteCompleted
-
Case Comprehensive Cancer CenterActive, not recruiting
-
AshtaYoga, LLCColumbia University; University Of Nigeria Teaching Hospital; Project PINKBLUE... and other collaboratorsCompletedCancer PreventionNigeria
-
M.D. Anderson Cancer CenterWithdrawnCancer | Prevention Harmful Effects
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedTobacco Use Cessation | Cancer PreventionUnited States
-
University of California, DavisRecruitingCancer Awareness and Prevention EducationUnited States