Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening

Not Applicable

Recruiting

• Conditions: HPV
• Interventions: Behavioral: PRECEDE-PROCEED

• Registration Number: NCT06109870
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

Primary Objectives:

The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.

The specific aims of this protocol are to:

Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).

Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.

Secondary Objectives:

Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV.

Exploratory Aim 4: Evaluate contextual fit of the intervention.

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study Start: 2023-10-30
• Study First Posted: 2023-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2028-08-31
• Study Completion: 2030-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRECEDE-PROCEED	PRECEDE-PROCEED	To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Texas at Austin; 🇺🇸 Austin, Texas, United States