Back to resultsAcceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Primary Purpose
Cervical Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV self-sampling kit
Culturally-targeted Fear Appeal Message
Fear Appeal Message
Interview
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring HPV, self-sampling, culture, message design, health communication, Jamaica
Eligibility 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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Experimental
Active Comparator
Arm Label
HPV self-sampling kit + Interview
Culturally-targeted Fear appeal message HPV self-sampling kit
Fear appeal message HPV self-sampling kit
HPV self-sampling kit
Arm Description
Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
Participants will receive an HPV self-sampling kit to screen for HPV
Outcomes
Primary Outcome Measures
Number of Participants That Used and Returned Their Self-sampler Kit.
Number of participants that used and returned their self-sampler kit was evaluated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03613493
Brief Title
Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Official Title
Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Budgetary and Timing Constraints
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
HPV, self-sampling, culture, message design, health communication, Jamaica
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV self-sampling kit + Interview
Arm Type
Other
Arm Description
Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.
Arm Title
Culturally-targeted Fear appeal message HPV self-sampling kit
Arm Type
Experimental
Arm Description
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
Arm Title
Fear appeal message HPV self-sampling kit
Arm Type
Experimental
Arm Description
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
Arm Title
HPV self-sampling kit
Arm Type
Active Comparator
Arm Description
Participants will receive an HPV self-sampling kit to screen for HPV
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV self-sampling kit
Intervention Description
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
Behavioral
Intervention Name(s)
Culturally-targeted Fear Appeal Message
Intervention Description
Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
Intervention Type
Behavioral
Intervention Name(s)
Fear Appeal Message
Intervention Description
Participants will receive fear appeal messages (only) in a graphically designed kit.
Intervention Type
Behavioral
Intervention Name(s)
Interview
Intervention Description
Participants will be interviewed about experiences using the self-sampling tool (qualitative).
Primary Outcome Measure Information:
Title
Number of Participants That Used and Returned Their Self-sampler Kit.
Description
Number of participants that used and returned their self-sampler kit was evaluated.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Morgan, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
We'll reach out to this number within 24 hrs