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

University of Miami

Status: Terminated

Conditions: Cervical Cancer

Treatments: Behavioral: Fear Appeal Message; Behavioral: Culturally-targeted Fear Appeal Message; Behavioral: Interview; Diagnostic Test: HPV self-sampling kit

Study type: Interventional

Funder types: Other

Identifiers

NCT03613493

20180033

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 4 patient groups

HPV self-sampling kit + Interview

Other group

Description:

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

Treatment:

Diagnostic Test: HPV self-sampling kit

Behavioral: Interview

Culturally-targeted Fear appeal message HPV self-sampling kit

Experimental group

Description:

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

Treatment:

Diagnostic Test: HPV self-sampling kit

Behavioral: Culturally-targeted Fear Appeal Message

Fear appeal message HPV self-sampling kit

Experimental group

Description:

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

Treatment:

Diagnostic Test: HPV self-sampling kit

Behavioral: Fear Appeal Message

HPV self-sampling kit

Active Comparator group

Description:

Participants will receive an HPV self-sampling kit to screen for HPV

Treatment:

Diagnostic Test: HPV self-sampling kit