Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1
SEMM1
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.
2 other identifiers
interventional
8,262
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedDecember 1, 2023
October 1, 2023
2.6 years
October 9, 2023
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Between baseline and end of study (about 9 months)
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.
Between baseline and end of study (about 9 months)
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.
between baseline and end of study (about 9 months)
Secondary Outcomes (3)
Number of participants who received the second dose of HPV vaccine
between baseline and end of study (about 9 months)
Number of participants who received the third dose of HPV vaccine
between baseline and end of study (about 9 months)
Number of participants who received a clinical breast exam
between baseline and end of study (about 9 months)
Study Arms (2)
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
EXPERIMENTALCommunity 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.
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
EXPERIMENTALCommunity 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current pregnancy
- Current or prior cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Savas, PhD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 9, 2023
First Posted
October 13, 2023
Study Start
November 1, 2016
Primary Completion
May 29, 2019
Study Completion
May 29, 2019
Last Updated
December 1, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share