Back to resultsSalud en Mis Manos - Expansion 1 (SEMM1)
Primary Purpose
Cervical Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Navigation to clinic
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring Cervical cancer prevention, Breast cancer detection, HPV vaccination
Eligibility Criteria
Inclusion Criteria: Self identifies as Hispanic or Latina Lives in Texas Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series Age limit for breast cancer screening group: 40 years and older Age limit for cervical cancer screening group (Pap test): 21 years and older Age limit for HPV vaccination group: 21-26 years Exclusion Criteria: Current pregnancy Current or prior cancer diagnosis
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Description
Community health worker deliver behavioral education and referrals to low-cost services. Deliver 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 deliver behavioral education and referrals to low-cost services. 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 years and older who complete mammogram screening
Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-65 years old who complete Pap test screening
Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-26 years old who initiate their HPV vaccination series.
Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.
Secondary Outcome Measures
Number of participants who received the second dose of HPV vaccine
Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Number of participants who received the third dose of HPV vaccine
Among women that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Number of participants who received a clinical breast exam
Among women that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Full Information
NCT ID
NCT06082505
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
NCT06082505
Brief Title
Salud en Mis Manos - Expansion 1
Acronym
SEMM1
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
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
May 29, 2019 (Actual)
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 is to evaluate implementation of a community-based prevention project aimed at increasing 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 Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). We also describe the implementation of the program during a longer time period (November 2016 - May 2019).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Breast Cancer
Keywords
Cervical cancer prevention, Breast cancer detection, HPV vaccination
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Arm Type
Experimental
Arm Description
Community health worker deliver behavioral education and referrals to low-cost services. Deliver 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 deliver behavioral education and referrals to low-cost services. 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 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed 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 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 years and older who complete mammogram screening
Description
Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Time Frame
Between baseline and end of study (about 9 months)
Title
Number of women 21-65 years old who complete Pap test screening
Description
Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
Time Frame
Between baseline and end of study (about 9 months)
Title
Number of women 21-26 years old who initiate their HPV vaccination series.
Description
Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.
Time Frame
between baseline and end of study (about 9 months)
Secondary Outcome Measure Information:
Title
Number of participants who received the second dose of HPV vaccine
Description
Among women that have not had their second 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)
Title
Number of participants who received the third dose of HPV vaccine
Description
Among women 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)
Title
Number of participants who received a clinical breast exam
Description
Among women that have not had a mammogram in the past two years, 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
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self identifies as Hispanic or Latina
Lives in Texas
Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
Age limit for breast cancer screening group: 40 years and older
Age limit for cervical cancer screening group (Pap test): 21 years and older
Age limit for HPV vaccination group: 21-26 years
Exclusion Criteria:
Current pregnancy
Current or prior cancer diagnosis
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Salud en Mis Manos - Expansion 1
We'll reach out to this number within 24 hrs