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

Study Overview
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Brief Summary
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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
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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, a lowresource community in Texas. The specific aims of this protocol are to: Specific Aim 1: Determine the feasibility of CHW-SS in the RGV (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. 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.

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

Conditions
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HPV

Intervention / Treatment
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* Behavioral: PRECEDE-PROCEED


Participation Criteria
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Eligibility Criteria
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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 Stated willingness to comply with all study procedures Females; Age ≥30 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. 4.3 Vulnerable Populations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRECEDE-PROCEED<br>To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up. | Behavioral: PRECEDE-PROCEED<br>* delivered self-sampling (CHWSS) to increase screening participation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |