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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713697
Acronym
HPV
Enrollment
484
Registered
2018-10-22
Start date
2016-01-01
Completion date
2017-01-20
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

self-collection for HPV testing

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.

Interventions

BEHAVIORALPap 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

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

BEHAVIORALChoice

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Adherence to cervical cancer screeningbaseline to 30 daysAdherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026