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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Pap testing
* Behavioral: Self-collection for HPV testing
* Behavioral: Choice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No personal history of cervical cancer Not have engaged in cervical cancer screening for the past 4 years Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pap testing<br>Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit | Behavioral: Pap testing<br>* 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<br>|
| Experimental: Self-Collection for HPV testing<br>Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing | Behavioral: Self-collection for HPV testing<br>* 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<br>|
| Experimental: Choice<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-collection for HPV testing