Back to resultsSalud en Mis Manos - Expansion 2 (SEMM2)
Primary Purpose
Breast Cancer, Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Navigation to clinic
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Cervical cancer screening, Breast cancer detection, HPV vaccination
Eligibility Criteria
Inclusion Criteria: Primarily residing in the Gulf Coast & Lower Rio Grande Valley county areas (or other counties in Texas) Women 40 years of age and older with no mammogram in the past 2 years Women 21-65 years, with no Pap test in the past 3 years Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals. Exclusion Criteria: Current pregnancy Have a current or prior cancer diagnosis
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Zoom Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Description
Community health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Outcomes
Primary Outcome Measures
Number of women 40 and older who complete mammogram screening
Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Number of women 21-65 years who complete Pap test screening
Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.
Secondary Outcome Measures
Number of women 18-26 years who receive dose 2 of HPV vaccine
Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.
Number of women 18-26 years who receive dose 3 of HPV vaccine
Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Full Information
NCT ID
NCT06082882
First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas
1. Study Identification
Unique Protocol Identification Number
NCT06082882
Brief Title
Salud en Mis Manos - Expansion 2
Acronym
SEMM2
Official Title
A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
July 30, 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
Cancer Prevention Research Institute of Texas
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 purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.
Detailed Description
This is an evaluation of the implementation of the Salud en Mis Manos program. We evaluate the effect of the program on increasing breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). We also describe the implementation of the program during a longer time period (2020-.2024).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Cervical cancer screening, Breast cancer detection, HPV vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Type
Experimental
Arm Description
Community health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Arm Title
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Type
Experimental
Arm Description
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Arm Title
Zoom Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Type
Experimental
Arm Description
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Education will be delivered in person in a group education setting or individually by phone. Group education will include a ~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Intervention Type
Behavioral
Intervention Name(s)
Navigation to clinic
Intervention Description
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
Primary Outcome Measure Information:
Title
Number of women 40 and older who complete mammogram screening
Description
Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Time Frame
Between baseline and end of study (about 9 months)
Title
Number of women 21-65 years who complete Pap test screening
Description
Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
Time Frame
Between baseline and end of study (about 9 months)
Title
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
Description
Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.
Time Frame
Between baseline and end of study (about 9 months)
Secondary Outcome Measure Information:
Title
Number of women 18-26 years who receive dose 2 of HPV vaccine
Description
Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.
Time Frame
between baseline and end of study (about 9 months)
Title
Number of women 18-26 years who receive dose 3 of HPV vaccine
Description
Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Time Frame
between baseline and end of study (about 9 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primarily residing in the Gulf Coast & Lower Rio Grande Valley county areas (or other counties in Texas)
Women 40 years of age and older with no mammogram in the past 2 years
Women 21-65 years, with no Pap test in the past 3 years
Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.
Exclusion Criteria:
Current pregnancy
Have a current or prior cancer diagnosis
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
Emily Adlparvar
Phone
713-500-9608
Email
Emily.M.Adlparvar@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
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
Individual Site Status
Recruiting
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
Emily Adlparvar
Phone
713-500-9608
Email
Emily.M.Adlparvar@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Salud en Mis Manos - Expansion 2
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