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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

Tracking Information
First Submitted Date  ICMJE June 17, 2018
First Posted Date  ICMJE August 3, 2018
Results First Submitted Date  ICMJE July 10, 2019
Results First Posted Date  ICMJE August 2, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE July 10, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
Differences in uptake of the self-sampler tool measured by instrument developed by researcher [ Time Frame: 8 weeks ]
The experiment (between-group differences in surveys administered) will gauge culturally appropriate message design for HPV self-sampling kits for cervical cancer prevention by comparing participants in three message conditions: culturally targeted fear appeals, fear appeal only and plain packaging (standard of care). The instrument includes multiple scales, but mainly focuses on a fear appeal measure developed by Kim Witte (1994), a 7-point likert scale (from strongly agree to strongly disagree).
Change History Complete list of historical versions of study NCT03613493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Official Title  ICMJE Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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.
  • Behavioral: Fear Appeal Message
    Participants will receive fear appeal messages (only) in a graphically designed kit.
  • Behavioral: Interview
    Participants will be interviewed about experiences using the self-sampling tool (qualitative).
Study Arms  ICMJE
  • 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.
    Interventions:
    • Diagnostic Test: HPV self-sampling kit
    • Behavioral: Interview
  • 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
    Interventions:
    • Diagnostic Test: HPV self-sampling kit
    • Behavioral: Culturally-targeted Fear Appeal Message
  • 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
    Interventions:
    • Diagnostic Test: HPV self-sampling kit
    • Behavioral: Fear Appeal Message
  • Active Comparator: HPV self-sampling kit
    Participants will receive an HPV self-sampling kit to screen for HPV
    Intervention: Diagnostic Test: HPV self-sampling kit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
175
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
360
Actual Study Completion Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03613493
Other Study ID Numbers  ICMJE 20180033
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Susan Morgan, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan E Morgan, PhD University of Miami
PRS Account University of Miami
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP