Cervical CancerNCT03613493
Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
A study testing HPV self-sampling kit, Culturally-targeted Fear Appeal Message and Fear Appeal Message in people with Cervical Cancer, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV self-sampling kit, Culturally-targeted Fear Appeal Message and Fear Appeal Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Jamaican women, aged 30 to 65.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
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
- Being tested
- HPV self-sampling kit, Culturally-targeted Fear Appeal Message, Fear Appeal Message, Interview
- Keywords
- HPV, self-sampling, culture, message design, health communication, Jamaica
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-sampling kitDiagnostic 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 MessageBehavioural
Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
Fear Appeal MessageBehavioural
Participants will receive fear appeal messages (only) in a graphically designed kit.
InterviewBehavioural
Participants will be interviewed about experiences using the self-sampling tool (qualitative).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: HPV self-sampling kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Used and Returned Their Self-sampler Kit.
Number of participants that used and returned their self-sampler kit was evaluated.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start10 Jul 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Why it stopped: Budgetary and Timing Constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Morgan, University of Miami
- Investigators
- Susan E Morgan, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613493
- Sponsor's protocol ID
- 20180033
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2018
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
- ClinicalTrials.gov ID
- NCT03613493
- Acronym / sponsor ID
- 20180033
- Conditions
- Cervical Cancer
- Keywords
- HPV, self-sampling, culture, message design, health communication, Jamaica
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budgetary and Timing Constraints
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HPV self-sampling kit + Interview | Other | Diagnostic Test: HPV self-sampling kit, Behavioral: InterviewParticipants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. |
| Culturally-targeted Fear appeal message HPV self-sampling kit | Experimental | Diagnostic Test: HPV self-sampling kit, Behavioral: Culturally-targeted Fear Appeal MessageParticipants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message |
| Fear appeal message HPV self-sampling kit | Experimental | Diagnostic Test: HPV self-sampling kit, Behavioral: Fear Appeal MessageParticipants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message |
| HPV self-sampling kit | Active comparator | Diagnostic Test: HPV self-sampling kitParticipants will receive an HPV self-sampling kit to screen for HPV |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Jamaican women, aged 30 to 65.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV self-sampling kitThe 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. | Diagnostic test | 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 MessageParticipants will receive culturally-targeted and fear appeal messages in a graphically designed kit. | Behavioural | Culturally-targeted Fear appeal message HPV self-sampling kit |
| Fear Appeal MessageParticipants will receive fear appeal messages (only) in a graphically designed kit. | Behavioural | Fear appeal message HPV self-sampling kit |
| InterviewParticipants will be interviewed about experiences using the self-sampling tool (qualitative). | Behavioural | HPV self-sampling kit + Interview |
Primary outcome
Number of Participants That Used and Returned Their Self-sampler Kit.
Time frame: 2 weeks
Number of participants that used and returned their self-sampler kit was evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Morgan, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self-sampling kit, Culturally-targeted Fear Appeal Message and Fear Appeal Message in people with Cervical Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Used and Returned Their Self-sampler Kit. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.