Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso

May 17, 2020 updated by: Maria E Fernandez, The University of Texas Health Science Center, Houston
The purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • overdue for a repeat mammogram
  • overdue for repeat cervical screening

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Unidas por Vida y Salud prevention program
Unidas por Vida y Salud (United for Life and Health) prevention program
Behavioral: Unidas por Vida y Salud prevention program
The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.
NO_INTERVENTION: No intervention control
The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who uptake clinical breast exam (CBE)
Time Frame: 6 months
6 months
Number of participants who uptake mammography
Time Frame: 6 months
6 months
Number of participants who uptake pap test
Time Frame: 6 months
6 months
Number of participants who repeat mammography
Time Frame: 6 months
6 months
Number of participants who repeat pap test
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Cancer Prevention Research Institute of Texas

Investigators

  • Principal Investigator: Maria E Fernandez, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2015

Primary Completion (ACTUAL)

October 17, 2017

Study Completion (ACTUAL)

October 17, 2017

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (ACTUAL)

May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-12-0677

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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