Cervical CancerNCT02202109
Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
A study testing CHW and Self-sampling for Cervical Cancer and Mailed Self Sampler in people with Cervical Cancer, run by University of Miami at 1 site in United States.
Trial summary
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- CHW and Self-sampling for Cervical Cancer and Mailed Self Sampler
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Haitian, Hispanic, or African American
- Ages 30-65 years
- Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade
Who cannot join
- Women who report having had a hysterectomy
- Women who have a history of cervical cancer
- Women who plan to move outside of Miami-Dade county during the next six months
- Women who are enrolled in any other cancer prevention/outreach related study
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Cervical Cancer Disparity in South Florida: CBPR in Action
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.
- Conditions
- Cervical Cancer
- Being tested
- CHW and Self-sampling for Cervical Cancer, Mailed Self Sampler
- Keywords
- Screen, self-sampler, cervical, cancer, women, community health workers, Hispanic/ Latinas, Haitian, Focus of study is cervical cancer
- 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.
CHW and Self-sampling for Cervical CancerBehavioural
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
Mailed Self SamplerBehavioural
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
| Study group | Role | What they receive |
|---|---|---|
| CHWs facilitated Self-Sampling | Active comparator | CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test Receives: Behavioral: CHW and Self-sampling for Cervical Cancer |
| Mailed Self-Sampler | Active comparator | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone Receives: Behavioral: Mailed Self Sampler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing a Self-sampling Test
The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
Measured: 2 to 6 months
Secondary outcomes (2)
Proportion of Change in Cervical Cancer Knowledge Among Participants
Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.
Measured: Baseline, 6 months
Proportion of Participants With a Change in Access to Care
Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2017
- Study completionAug 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Health Choice Network, Center for Haitian Studies, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erin Kobetz-Kerman, University of Miami
- Investigators
- Erin Kobetz, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202109
- Sponsor's protocol ID
- 20140249
- Other IDs
- 1R01CA183612-01
- Status last verified
- Dec 2018
- First submitted
- 9 Jul 2014
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.
PubMed 28086983
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Cervical Cancer Disparity in South Florida: CBPR in Action
- ClinicalTrials.gov ID
- NCT02202109
- Acronym / sponsor ID
- 20140249
- Conditions
- Cervical Cancer
- Keywords
- Screen, self-sampler, cervical, cancer, women, community health workers, Hispanic/ Latinas, Haitian, Focus of study is cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Health Choice Network, Center for Haitian Studies, National Cancer Institute (NCI)
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHWs facilitated Self-Sampling | Active comparator | Behavioral: CHW and Self-sampling for Cervical CancerCHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test |
| Mailed Self-Sampler | Active comparator | Behavioral: Mailed Self SamplerMailed Self Sampler. Self sampler is mailed to participant; follow up by phone |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Haitian, Hispanic, or African American
- Ages 30-65 years
- Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade
Key exclusion criteria (8 listed)
- Women who report having had a hysterectomy
- Women who have a history of cervical cancer
- Women who plan to move outside of Miami-Dade county during the next six months
- Women who are enrolled in any other cancer prevention/outreach related study
- Adults unable to consent
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 |
|---|---|---|
| CHW and Self-sampling for Cervical CancerBehavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. | Behavioural | CHWs facilitated Self-Sampling |
| Mailed Self SamplerMailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; | Behavioural | Mailed Self-Sampler |
Primary outcome
Number of Participants Completing a Self-sampling Test
Time frame: 2 to 6 months
The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
2 secondary outcomes
Proportion of Change in Cervical Cancer Knowledge Among Participants
Time frame: Baseline, 6 months
Proportion of Participants With a Change in Access to Care
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28086983Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.
Related trials for Cervical Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Active, not recruiting
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Erin Kobetz, 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 CHW and Self-sampling for Cervical Cancer and Mailed Self Sampler 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2018. 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 19 Dec 2018). 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 Completing a Self-sampling Test (time frame: 2 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202109, which also lists 1 linked publication.
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 19 Dec 2018.