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

The University of Alabama at Birmingham

Status: Completed

Conditions: Cervical Cancer

Treatments: Behavioral: Choice; Behavioral: Self-collection for HPV testing; Behavioral: Pap testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03713697

X150303007

P30CA013148 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 484 patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 3 patient groups

Pap testing

Experimental group

Description:

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

Treatment:

Behavioral: Pap testing

Self-Collection for HPV testing

Experimental group

Description:

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

Treatment:

Behavioral: Self-collection for HPV testing

Choice

Experimental group

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

Treatment:

Behavioral: Choice