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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613493
Recruitment Status : Terminated (Budgetary and Timing Constraints)
First Posted : August 3, 2018
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Morgan, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Diagnostic Test: HPV self-sampling kit Behavioral: Culturally-targeted Fear Appeal Message Behavioral: Fear Appeal Message Behavioral: Interview Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.
Diagnostic Test: 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.

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

Experimental: 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
Diagnostic Test: 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.

Behavioral: Culturally-targeted Fear Appeal Message
Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Experimental: 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
Diagnostic Test: 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.

Behavioral: Fear Appeal Message
Participants will receive fear appeal messages (only) in a graphically designed kit.

Active Comparator: HPV self-sampling kit
Participants will receive an HPV self-sampling kit to screen for HPV
Diagnostic Test: 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.




Primary Outcome Measures :
  1. Number of Participants That Used and Returned Their Self-sampler Kit. [ Time Frame: 2 weeks ]
    Number of participants that used and returned their self-sampler kit was evaluated.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613493


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Susan E Morgan, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Susan Morgan, University of Miami:

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Responsible Party: Susan Morgan, Associate Provost for Research Development and Strategy, University of Miami
ClinicalTrials.gov Identifier: NCT03613493     History of Changes
Other Study ID Numbers: 20180033
First Posted: August 3, 2018    Key Record Dates
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Susan Morgan, University of Miami:
HPV
self-sampling
culture
message design
health communication
Jamaica
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female