Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
2 other identifiers
interventional
920
1 country
2
Brief Summary
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
March 4, 2026
March 1, 2026
4.8 years
October 25, 2023
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average 1 year.
Study Arms (1)
PRECEDE-PROCEED
EXPERIMENTALTo identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.
Interventions
delivered self-sampling (CHWSS) to increase screening participation.
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Currently resident in RGV or other low-resource community in Texas
- Stated willingness to comply with all study procedures
- Females; Age ≥25 years
- Have no history of hysterectomy with removal of the cervix
- Have no history of cervical cancer or high-grade dysplasia
- Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to communicate in English or Spanish
- Lack valid telephone contact information
- Report being currently pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Texas at Austin
Austin, Texas, 78712, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Fallah PN, Bowman P, Tran C, Chen V, Pippin M, Varon ML, Baker E, Milan J, Parker SL, Lezama-Sierra J, Munsell MF, Desravines N, Lavie I, Batman S, Montealegre J, Schmeler KM, Williams-Brown MY, Salcedo MP. Implementation of Human Papillomavirus Self-Collection and Barriers to Follow-Up Among Unhoused Individuals in Texas: The EMPOWER Study. Obstet Gynecol. 2025 Nov 1;146(5):710-717. doi: 10.1097/AOG.0000000000006003. Epub 2025 Jul 17.
PMID: 40674748DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Montealegre, M D
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
October 31, 2023
Study Start
October 30, 2023
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2030
Last Updated
March 4, 2026
Record last verified: 2026-03