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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pap testing
Self-collection for HPV testing
Choice
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring self-collection for HPV testing

Eligibility Criteria

25 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Universidade Estadual de Maringá

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pap testing

Self-Collection for HPV testing

Choice

Arm Description

Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit

Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing

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

Outcomes

Primary Outcome Measures

Adherence to cervical cancer screening
Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)

Secondary Outcome Measures

Full Information

First Posted
October 18, 2018
Last Updated
October 19, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03713697
Brief Title
Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil
Acronym
HPV
Official Title
Self-Collection and HPV Testing in Unscreened Women: a Feasibility Study in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
January 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
self-collection for HPV testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pap testing
Arm Type
Experimental
Arm Description
Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit
Arm Title
Self-Collection for HPV testing
Arm Type
Experimental
Arm Description
Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing
Arm Title
Choice
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Pap testing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Self-collection for HPV testing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Choice
Intervention Description
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 Measure Information:
Title
Adherence to cervical cancer screening
Description
Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)
Time Frame
baseline to 30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No personal history of cervical cancer Not have engaged in cervical cancer screening for the past 4 years Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel C Scarinci, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual de Maringá
City
Maringá
State/Province
Paraná
ZIP/Postal Code
87080
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30651294
Citation
Castle PE, Silva VRS, Consolaro MEL, Kienen N, Bittencourt L, Pelloso SM, Partridge EE, Pierz A, Dartibale CB, Uchimura NS, Scarinci IC. Participation in Cervical Screening by Self-collection, Pap, or a Choice of Either in Brazil. Cancer Prev Res (Phila). 2019 Mar;12(3):159-170. doi: 10.1158/1940-6207.CAPR-18-0419. Epub 2019 Jan 16.
Results Reference
derived

Learn more about this trial

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

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