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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03613493
• Other study ID #: 20180033
• Status: Terminated
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: July 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• Fear Appeal Message
Participants will receive fear appeal messages (only) in a graphically designed kit.
• Interview
Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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