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

NCT03613493 | Terminated Results FDA Device

• 1 other identifier: 20180033
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

HPV self-sampling kit + Interview

OTHER

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; Behavioral: Interview

Culturally-targeted Fear appeal message HPV self-sampling kit

EXPERIMENTAL

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; Behavioral: Culturally-targeted Fear Appeal Message

Fear appeal message HPV self-sampling kit

EXPERIMENTAL

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; Behavioral: Fear Appeal Message

HPV self-sampling kit

ACTIVE COMPARATOR

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

Diagnostic Test: HPV self-sampling kit

Interventions

HPV self-sampling kit DIAGNOSTIC_TEST

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.

Culturally-targeted Fear appeal message HPV self-sampling kit; Fear appeal message HPV self-sampling kit; HPV self-sampling kit; HPV self-sampling kit + Interview

Culturally-targeted Fear Appeal Message BEHAVIORAL

Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Culturally-targeted Fear appeal message HPV self-sampling kit

Fear Appeal Message BEHAVIORAL

Participants will receive fear appeal messages (only) in a graphically designed kit.

Fear appeal message HPV self-sampling kit

Interview BEHAVIORAL

Participants will be interviewed about experiences using the self-sampling tool (qualitative).

HPV self-sampling kit + Interview

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Jamaican women, aged 30 to 65.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33124, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Susan Morgan
• Organization: University of Miami

semorgan@miami.edu

7654094919

Study Officials

• Susan E Morgan, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Research Development and Strategy

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: August 3, 2018
• Study Start: July 10, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)