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

Cervical Cancer Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713697
• Other study ID #: X150303007
• Secondary ID: P30CA013148
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 20, 2017

Study information

• Verified date: October 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: January 20, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

• No personal history of cervical cancer

• Not have engaged in cervical cancer screening for the past 4 years

Exclusion Criteria:

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Maringá	Maringá	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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