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

NCT03713697 | Completed

• 2 other identifiers: X150303007P30CA013148
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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

Keywords

self-collection for HPV testing

Outcome Measures

Primary Outcomes (1)

• Adherence to cervical cancer screening

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

  baseline to 30 days

Study Arms (3)

Pap testing

EXPERIMENTAL

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

Behavioral: Pap testing

Self-Collection for HPV testing

EXPERIMENTAL

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

Behavioral: Self-collection for HPV testing

Choice

EXPERIMENTAL

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

Interventions

Pap testing 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

Pap testing

Self-collection for HPV testing 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

Self-Collection for HPV testing

Choice 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

Choice

Eligibility Criteria

• Age: 25 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Universidade Estadual de Maringá

Maringá, Paraná, 87080, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30651294 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Vaginal Smears

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Isabel C Scarinci, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2016
• Primary Completion: November 30, 2016
• Study Completion: January 20, 2017
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)