Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2

N/AActive Not RecruitingNCT06082882

The University of Texas Health Science Center, Houston8,000 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

8,000

Conditions

Breast Cancer Cervical Cancer

Interventions

EducationBEHAVIORAL

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).

Navigation to clinicBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of women 40 and older who complete mammogram screening

Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys

Time frame: Between baseline and end of study (about 9 months)

Number of women 21-65 years who complete Pap test screening

Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.

Time frame: Between baseline and end of study (about 9 months)

Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine

Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.

Time frame: Between baseline and end of study (about 9 months)

Secondary Outcomes

Number of women 18-26 years who receive dose 2 of HPV vaccine

Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.

Time frame: between baseline and end of study (about 9 months)

Number of women 18-26 years who receive dose 3 of HPV vaccine

Among women 18-26 years 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.