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.

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Breast Cancer
• Intervention / Treatment: Behavioral: Education; Behavioral: Navigation to clinic

Detailed Description

This is an evaluation of the Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).

• Study Type: Interventional
• Enrollment (Actual): 8262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-Person Delivered Breast and Cervical Cancer Behavioral Intervention; 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.	Behavioral: Education; 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).; Behavioral: Navigation to clinic; 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.
Experimental: Telephone Delivered Breast and Cervical Cancer Behavioral Intervention; 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.	Behavioral: Education; 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).; Behavioral: Navigation to clinic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between baseline and end of study (about 9 months)
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.	between baseline and end of study (about 9 months)
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.	between baseline and end of study (about 9 months)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Lara Savas, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 29, 2019
• Study Completion (Actual): May 29, 2019

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer detection; HPV vaccination; Cervical cancer prevention
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: HSC-SPH-16-0159; PP160047 (Other Grant/Funding Number: Cancer Prevention and Research Institute of Texas)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No