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

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: HPV self-sampling kit
* Behavioral: Culturally-targeted Fear Appeal Message
* Behavioral: Fear Appeal Message
* Behavioral: Interview


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HPV self-sampling kit + Interview<br>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<br>* 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.<br>Behavioral: Interview<br>* Participants will be interviewed about experiences using the self-sampling tool (qualitative).<br>|
| Experimental: Culturally-targeted Fear appeal message HPV self-sampling kit<br>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<br>* 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.<br>Behavioral: Culturally-targeted Fear Appeal Message<br>* Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.<br>|
| Experimental: Fear appeal message HPV self-sampling kit<br>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<br>* 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.<br>Behavioral: Fear Appeal Message<br>* Participants will receive fear appeal messages (only) in a graphically designed kit.<br>|
| Active Comparator: HPV self-sampling kit<br>Participants will receive an HPV self-sampling kit to screen for HPV | Diagnostic Test: HPV self-sampling kit<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, self-sampling, culture, message design, health communication, Jamaica