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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: Pap testing; Behavioral: Choice; Behavioral: Self-collection for HPV testing

• Registration Number: NCT03713697
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-11-30
• Study Completion: 2017-01-20
• Status Verified: 2018-10
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 484

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pap testing	Pap testing	Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit
Choice	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
Self-Collection for HPV testing	Self-collection for HPV testing	Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing

Primary Outcome Measures

Name	Time	Method
Adherence to cervical cancer screening	baseline to 30 days	Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)

Trial Locations

Locations (1)

Universidade Estadual de Maringá; 🇧🇷 Maringá, Paraná, Brazil