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

NCT ID: NCT03713697

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-01-20

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Pap testing

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

Group Type: EXPERIMENTAL

Pap testing

Intervention Type: BEHAVIORAL

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

Self-Collection for HPV testing

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

Group Type: EXPERIMENTAL

Self-collection for HPV testing

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Choice

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Isabel Scarinci

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabel C Scarinci, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Universidade Estadual de Maringá

Maringá, Paraná, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30651294 (View on PubMed)

Other Identifiers

P30CA013148

Identifier Type: NIH

Identifier Source: secondary_id

View Link

X150303007

Identifier Type: -

Identifier Source: org_study_id