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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03613493
Enrollment
175
Registered
2018-08-03
Start date
2018-07-10
Completion date
2018-10-01
Last updated
2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTHPV 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.

BEHAVIORALCulturally-targeted Fear Appeal Message

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

BEHAVIORALFear Appeal Message

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

BEHAVIORALInterview

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

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants That Used and Returned Their Self-sampler Kit.2 weeksNumber of participants that used and returned their self-sampler kit was evaluated.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).
10
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 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. Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
74
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 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. Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.
0
HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV 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.
89
Total173

Baseline characteristics

CharacteristicHPV Self-sampling Kit + InterviewCulturally-targeted Fear Appeal Message HPV Self-sampling KitHPV Self-sampling KitTotalFear Appeal Message HPV Self-sampling Kit
Age, Continuous47.40 Years
STANDARD_DEVIATION 9.442
45.01 Years
STANDARD_DEVIATION 9.099
41.09 Years
STANDARD_DEVIATION 10.222
44.50 Years
STANDARD_DEVIATION 9.587
—
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants74 Participants89 Participants173 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Prior pap test experience7 participants64 participants72 participants143 participants—
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants74 Participants89 Participants173 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
10 Participants74 Participants89 Participants173 Participants0 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 740 / 89
other
Total, other adverse events
0 / 100 / 740 / 89
serious
Total, serious adverse events
0 / 100 / 740 / 89

Outcome results

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.

Time frame: 2 weeks

Population: Data was not collected for the fear appeal message HPV self-sampling condition due to lack of funding.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Culturally-targeted Fear Appeal Message HPV Self-sampling KitNumber of Participants That Used and Returned Their Self-sampler Kit.73 Participants
HPV Self-sampling KitNumber of Participants That Used and Returned Their Self-sampler Kit.83 Participants
HPV Self-sampling Kit + InterviewNumber of Participants That Used and Returned Their Self-sampler Kit.10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026