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Clinical Trials/NCT06082882
NCT06082882
Active, Not Recruiting
N/A

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 University of Texas Health Science Center, Houston1 site in 1 country8,000 target enrollmentFebruary 20, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
8000
Locations
1
Primary Endpoint
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
February 20, 2020
End Date
August 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Savas

Associate Professor

The University of Texas Health Science Center, Houston

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

Outcomes

Primary Outcomes

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

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

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.

Number of women 40 and older who complete mammogram screening

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

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

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

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

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.

Secondary Outcomes

  • Number of women 18-26 years who receive dose 3 of HPV vaccine(between baseline and end of study (about 9 months))
  • Number of women 18-26 years who receive dose 2 of HPV vaccine(between baseline and end of study (about 9 months))

Study Sites (1)

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