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

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ClinicalTrials.gov Identifier: NCT03713697
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Isabel Scarinci, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Pap testing Behavioral: Self-collection for HPV testing Behavioral: Choice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Self-Collection and HPV Testing in Unscreened Women: a Feasibility Study in Brazil
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713697


Locations
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Brazil
Universidade Estadual de Maringá
Maringá, Paraná, Brazil, 87080
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Isabel C Scarinci, PhD University of Alabama at Birmingham

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Responsible Party: Isabel Scarinci, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03713697     History of Changes
Other Study ID Numbers: X150303007
P30CA013148 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabel Scarinci, University of Alabama at Birmingham:
self-collection for HPV testing

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female