Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention

NCT ID: NCT03613493

Last Updated: 2019-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2018-10-01

Brief Summary

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The proposed study aims to increase HPV screening behaviors in Jamaican women by examining the acceptability of HPV Deoxyribonucleic Acid (DNA) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HPV self-sampling kit + Interview

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

Group Type OTHER

HPV self-sampling kit

Intervention Type DIAGNOSTIC_TEST

The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interview

Intervention Type BEHAVIORAL

Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Culturally-targeted Fear appeal message HPV self-sampling kit

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

Group Type EXPERIMENTAL

HPV self-sampling kit

Intervention Type DIAGNOSTIC_TEST

The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Culturally-targeted Fear Appeal Message

Intervention Type BEHAVIORAL

Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Fear appeal message HPV self-sampling kit

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

Group Type EXPERIMENTAL

HPV self-sampling kit

Intervention Type DIAGNOSTIC_TEST

The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Fear Appeal Message

Intervention Type BEHAVIORAL

Participants will receive fear appeal messages (only) in a graphically designed kit.

HPV self-sampling kit

Participants will receive an HPV self-sampling kit to screen for HPV

Group Type ACTIVE_COMPARATOR

HPV self-sampling kit

Intervention Type DIAGNOSTIC_TEST

The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interventions

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HPV self-sampling kit

The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Intervention Type DIAGNOSTIC_TEST

Culturally-targeted Fear Appeal Message

Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Intervention Type BEHAVIORAL

Fear Appeal Message

Participants will receive fear appeal messages (only) in a graphically designed kit.

Intervention Type BEHAVIORAL

Interview

Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Jamaican women, aged 30 to 65.

Exclusion Criteria

* Women who report having had a hysterectomy,
* have had a history of cervical cancer,
* Women who are currently up-to-date on cervical cancer screening (have had a Pap in the last 3 years or have had a Pap smear/HPV co-test within the past 5 years),
* Adults unable to consent, children, pregnant women and prisoners.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Susan Morgan

Associate Provost for Research Development and Strategy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan E Morgan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20180033

Identifier Type: -

Identifier Source: org_study_id

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