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Trial Title:
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
NCT ID:
NCT06082882
Condition:
Breast Cancer
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical cancer screening
Breast cancer detection
HPV vaccination
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Education
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).
Arm group label:
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Arm group label:
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Arm group label:
Zoom Delivered Breast and Cervical Cancer Behavioral Intervention
Intervention type:
Behavioral
Intervention name:
Navigation to clinic
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.
Arm group label:
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Arm group label:
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Arm group label:
Zoom Delivered Breast and Cervical Cancer Behavioral Intervention
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. The
investigators evaluate the effect of the program on increasing participant breast and
cervical cancer screening and HPV vaccination using a one-group pre-post study design
(2022-2024). The investigators also describe the implementation of the program during a
longer time period (2020-.2024).
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The University of Texas Health Science Center at Houston
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lara Savas, PhD
Phone:
713-500-9638
Email:
lara.staub@uth.tmc.edu
Contact backup:
Last name:
Emily Adlparvar
Phone:
713-500-9608
Email:
Emily.M.Adlparvar@uth.tmc.edu
Start date:
February 20, 2020
Completion date:
July 30, 2024
Lead sponsor:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
Cancer Prevention Research Institute of Texas
Agency class:
Other
Source:
The University of Texas Health Science Center, Houston
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082882
