search
Back to results

Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention

Primary Purpose

Cancer Prevention

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salud en Mis Manos - Dissemination and Implementation Assistance
Salud en Mis Manos- Usual Implementation Practice
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Prevention focused on measuring Implementation Intervention, Cervical Cancer, Breast Cancer, HPV Vaccination

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 the US Prevention Services Task Force Guidelines.
  • Latinas aged 21-65 years who have not had a Pap test in the past 3 years.
  • Latinas aged 50-75 years who have not had a mammogram in the past 2 years.
  • Latinas aged 21-26 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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Salud en Mis Manos - Dissemination and Implementation Assistance

Salud en Mis Manos - Usual Implementation Practice

Arm Description

The multi-component and multi-faceted implementation strategy SEMM-DIA

The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.

Outcomes

Primary Outcome Measures

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).
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
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).
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
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.
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
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.
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
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.
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
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.
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
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.
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
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.
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
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.
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
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.
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
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.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)
Investigators will assess the level of implementation from baseline to 8-month follow-up using manager assessments.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)
Investigators will assess the level of implementation from baseline to 8-month follow-up using LHW assessments.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with LHWs.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with managers.
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
Investigators will assess implementation fidelity using participant tracking forms (completed by LHWs) to understand their level of fidelity associated with implementing the program.
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
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.
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
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).
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
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).

Secondary Outcome Measures

Cost effectiveness of SEMM-DIA in community and clinic practice settings
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.

Full Information

First Posted
August 23, 2022
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT05524480
Brief Title
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention
Official Title
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 4, 2023 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and HPV vaccination program for Latinas (SEMM).
Detailed Description
This study tests a multicomponent and multifaceted implementation strategy, SEMM-DIA and serves as a model for developing other implementation strategies designed to build the capacity of clinic leadership, intervention champions, and LHWs to plan, manage, and deliver SEMM. Investigators will examine the effect of SEMM-DIA program implementation in a randomized group trial comparing the impact of SEMM-DIA vs. SEMM- Usual Implementation Practice on the reach, effectiveness, implementation, and cost-effectiveness of SEMM in safety-net clinics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Prevention
Keywords
Implementation Intervention, Cervical Cancer, Breast Cancer, HPV Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Twenty community health centers (CHCs) will be recruited and randomized to either the SEMM-Dissemination and Implementation Assistance arm or the SEMM-Usual Implementation Practice arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salud en Mis Manos - Dissemination and Implementation Assistance
Arm Type
Experimental
Arm Description
The multi-component and multi-faceted implementation strategy SEMM-DIA
Arm Title
Salud en Mis Manos - Usual Implementation Practice
Arm Type
Active Comparator
Arm Description
The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.
Intervention Type
Behavioral
Intervention Name(s)
Salud en Mis Manos - Dissemination and Implementation Assistance
Other Intervention Name(s)
SEMM-DIA
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Salud en Mis Manos- Usual Implementation Practice
Other Intervention Name(s)
SEMM
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
Time Frame
4-month follow up
Title
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).
Description
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
Time Frame
8-month follow up
Title
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Description
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.
Time Frame
Baseline
Title
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Description
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.
Time Frame
4-month follow-up
Title
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
Description
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.
Time Frame
8-month follow-up
Title
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Description
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.
Time Frame
Baseline
Title
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Description
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.
Time Frame
4-month follow-up
Title
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
Description
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.
Time Frame
8-month follow-up
Title
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Description
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.
Time Frame
Baseline
Title
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Description
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.
Time Frame
4-month follow-up
Title
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
Description
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.
Time Frame
8-month follow-up
Title
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)
Description
Investigators will assess the level of implementation from baseline to 8-month follow-up using manager assessments.
Time Frame
8-month follow-up
Title
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)
Description
Investigators will assess the level of implementation from baseline to 8-month follow-up using LHW assessments.
Time Frame
8-month follow-up
Title
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)
Description
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with LHWs.
Time Frame
8-month follow-up
Title
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)
Description
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with managers.
Time Frame
8-month follow-up
Title
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
Description
Investigators will assess implementation fidelity using participant tracking forms (completed by LHWs) to understand their level of fidelity associated with implementing the program.
Time Frame
4-month follow-up
Title
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
Description
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.
Time Frame
8-month follow-up
Title
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Description
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
Time Frame
4-month follow up
Title
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
Description
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).
Time Frame
4-month follow up
Title
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
Description
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
Time Frame
8-month follow up
Title
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
Description
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).
Time Frame
8-month follow up
Secondary Outcome Measure Information:
Title
Cost effectiveness of SEMM-DIA in community and clinic practice settings
Description
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.
Time Frame
8-month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 the US Prevention Services Task Force Guidelines. Latinas aged 21-65 years who have not had a Pap test in the past 3 years. Latinas aged 50-75 years who have not had a mammogram in the past 2 years. Latinas aged 21-26 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Savas, PhD
Phone
(713) 500-9638
Email
lara.staub@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angelita Alaniz, MPH
Email
angelita.alaniz@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Savas, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Savas, PhD
Phone
713-500-9638
Email
lara.staub@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Angelita Alaniz, MPH
Email
angelita.alaniz@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention

We'll reach out to this number within 24 hrs