NCT06082882

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

5.5 years

First QC Date

October 9, 2023

Last Update Submit

December 6, 2024

Conditions

Breast CancerCervical Cancer

Keywords

Cervical cancer screeningBreast cancer detectionHPV vaccination

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    Between baseline and end of study (about 9 months)

Secondary Outcomes (2)

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

    between baseline and end of study (about 9 months)

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

    between baseline and end of study (about 9 months)

Study Arms (3)

In-Person Delivered Breast and Cervical Cancer Behavioral Intervention

EXPERIMENTAL

Community health worker delivered behavioral education and referrals to low-cost services. Delivered 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.

Behavioral: EducationBehavioral: Navigation to clinic

Telephone Delivered Breast and Cervical Cancer Behavioral Intervention

EXPERIMENTAL

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Behavioral: EducationBehavioral: Navigation to clinic

Zoom Delivered Breast and Cervical Cancer Behavioral Intervention

EXPERIMENTAL

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Behavioral: EducationBehavioral: Navigation to clinic

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).

In-Person Delivered Breast and Cervical Cancer Behavioral InterventionTelephone Delivered Breast and Cervical Cancer Behavioral InterventionZoom Delivered Breast and Cervical Cancer Behavioral Intervention
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.

In-Person Delivered Breast and Cervical Cancer Behavioral InterventionTelephone Delivered Breast and Cervical Cancer Behavioral InterventionZoom Delivered Breast and Cervical Cancer Behavioral Intervention

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current pregnancy
  • Have a current or prior cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Lara Savas, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

February 20, 2020

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)