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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: HPV

Treatments: Behavioral: PRECEDE-PROCEED

Study type: Interventional

Funder types: Other

Identifiers

NCT06109870

2023-0529

NCI-2023-09607 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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920 participants in 1 patient group

PRECEDE-PROCEED

Experimental group

Description:

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

Treatment:

Behavioral: PRECEDE-PROCEED