Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1

Not Applicable

Completed

• Conditions: Cervical Cancer; Breast Cancer
• Interventions: Behavioral: Education; Behavioral: Navigation to clinic

• Registration Number: NCT06082505
• Lead Sponsor: The University of Texas Health Science Center, Houston

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. 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 Timeline

• Study Start: 2016-11-01
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-29
• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention	Education	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.
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention	Education	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.
In-Person Delivered Breast and Cervical Cancer Behavioral Intervention	Navigation to clinic	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.
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention	Navigation to clinic	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.

Primary Outcome Measures

Name	Time	Method
Number of women 40 years and older who complete mammogram screening	Between baseline and end of study (about 9 months)	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	Between baseline and end of study (about 9 months)	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.	between baseline and end of study (about 9 months)	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

Name	Time	Method
Number of participants who received a clinical breast exam	between baseline and end of study (about 9 months)	Among women that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Number of participants who received the third dose of HPV vaccine	between baseline and end of study (about 9 months)	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 the second dose of HPV vaccine	between baseline and end of study (about 9 months)	Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States