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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2030-08-31

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.

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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 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.

Conditions

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HPV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PRECEDE-PROCEED

Intervention Type BEHAVIORAL

delivered self-sampling (CHWSS) to increase screening participation.

Interventions

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PRECEDE-PROCEED

delivered self-sampling (CHWSS) to increase screening participation.

Intervention Type BEHAVIORAL

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No