Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil (HPV)

October 19, 2018 updated by: Isabel Scarinci, University of Alabama at Birmingham

Self-Collection and HPV Testing in Unscreened Women: a Feasibility Study in Brazil

Our long-term goal is to decrease cervical cancer incidence and mortality among women in low- and middle-income countries (LMICs) by using the most efficacious and acceptable screening method, particularly among women who do not come to the clinic for their regular Pap testing. The purpose of this feasibility study is to compare three cervical cancer screening modalities (self-collection and HPV testing, Pap testing at the public health clinic, and choice between self-collection and HPV testing and Pap testing) among women who have not undergone cervical cancer screening within the past four years using a theory-based, culturally relevant intervention implemented by Community Health Workers (CHWs) via door-to-door visits. Three Basic Health Units (BHUs) within the public health system will be randomly assigned to one of the three screening modalities/conditions (self-collection and HPV testing, Pap testing at the local public health clinic, and choice between self-collection and HPV testing and Pap testing). CHWs will invite women who report not having been screened for cervical cancer in the past four years to participate in the study, and deliver a brief educational/behavioral session on cervical cancer and screening using a door-to-door approach under of one of the three conditions. The primary outcome will be adherence to cervical cancer screening. We hypothesize that (1) Women in the "choice" and "self-collection" groups will be more likely to engage in cervical cancer screening and display higher satisfaction with their screening than women assigned to the "Pap" with women assigned to the "choice" group having the highest adherence of the three groups; and (2) Within the "choice" group, more women will choose and complete self-collection than Pap test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Maringá, Paraná, Brazil, 87080
        • Universidade Estadual de Maringá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • No personal history of cervical cancer
  • Not have engaged in cervical cancer screening for the past 4 years

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pap testing
Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit
Behavioral: Pap testing
Un/underscreened women received a home visit by a Community Health Worker and were scheduled an appointment for a Pap testing at the Basic Health Unit
Experimental: Self-Collection for HPV testing
Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing
Behavioral: Self-collection for HPV testing
Un/underscreened women received a home visit by a Community Health Worker and were given a kit to self-collect their own sampling for HPV testing at home
Experimental: Choice
Women assigned to this arm were given a choice between a Pap testing at the local Basic Health Unit or self-collection for HPV testing
Behavioral: Choice
Un/underscreened women received a home visit by a Community Health Worker and were given a choice between scheduling an appointment for a Pap testing at the Basic Health Unit or self-collect their own sampling for HPV testing at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to cervical cancer screening
Time Frame: baseline to 30 days
Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)
baseline to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X150303007
  • P30CA013148 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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