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

Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Cancer
• Intervention / Treatment: Diagnostic test: HPV self-sampling kit; Behavioral: Interview; Behavioral: Culturally-targeted Fear Appeal Message; Behavioral: Fear Appeal Message

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33124
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Used and Returned Their Self-sampler Kit.	Number of participants that used and returned their self-sampler kit was evaluated.	2 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Susan E Morgan, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 17, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: HPV; self-sampling; culture; message design; health communication; Jamaica
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 20180033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes