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

• ClinicalTrials.gov Identifier: NCT03613493
• Recruitment Status: Terminated
• First Posted: August 3, 2018
• Results First Posted: August 2, 2019
• Last Update Posted: August 2, 2019
• Sponsor: University of Miami
• Information provided by (Responsible Party): Susan Morgan, University of Miami

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33124

Sponsors and Collaborators

University of Miami

Investigators

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

  Study Documents (Full-Text)

Documents provided by Susan Morgan, University of Miami:

Study Protocol and Statistical Analysis Plan  [PDF] April 27, 2018

More Information

• Responsible Party: Susan Morgan, Associate Provost for Research Development and Strategy, University of Miami
• ClinicalTrials.gov Identifier: NCT03613493
• Other Study ID Numbers: 20180033
• First Posted: August 3, 2018
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Susan Morgan, University of Miami:

HPV; self-sampling; culture; message design; health communication; Jamaica

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases