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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

Brazil

Universidade Estadual de Maringá

Maringá, Paraná, Brazil, 87080

Sponsors and Collaborators

University of Alabama at Birmingham

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Isabel C Scarinci, PhD; University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Isabel Scarinci, Primary Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03713697
• Other Study ID Numbers: X150303007; P30CA013148 ( U.S. NIH Grant/Contract )
• First Posted: October 22, 2018
• Last Update Posted: October 22, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases