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Clinical Trials/NCT06082505
NCT06082505
Completed
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 country8,262 target enrollmentNovember 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
8262
Locations
1
Primary Endpoint
Number of women 40 years and older who complete mammogram screening
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
May 29, 2019
Last Updated
2 years ago
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

  • 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

Outcomes

Primary Outcomes

Number of women 40 years and older who complete mammogram screening

Time Frame: 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

Time Frame: 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.

Time Frame: 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 Outcomes

  • Number of participants who received a clinical breast exam(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 the second dose of HPV vaccine(between baseline and end of study (about 9 months))

Study Sites (1)

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