Cervical CancerREMEDNCT05907187
Research in Ethno-Medicine and Education (REMED)
A study testing Cervical Cancer Prevention Education in people with Cervical Cancer and Human Papilloma Virus, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to gain information about intravaginal practices, like intravaginal "twalet deba", among Haitian women living in South Florida. Intravaginal "twalet deba" may include douching, cleaning inside the vagina with different kinds of products, or using steam/vapor that enter the vagina. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Human Papilloma Virus, HPV
- What is being tested?
- Cervical Cancer Prevention Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Self-identifies as Haitian or Haitian-American
- Resident of Miami-Dade, Broward or Palm Beach County
- Currently engages in regular intravaginal cleansing practices that involve more than just water alone
- No history of hysterectomy
- Speaks Creole or English
Who cannot join
- Are adults unwilling or unable to provide consent
- Individuals less than 18 years of age
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention to Promote Cervical Cancer Prevention and Early Detection, and Understand the Role of Plants in HPV. (Research in Ethno-Medicine and Education)
The purpose of this study is to gain information about intravaginal practices, like intravaginal "twalet deba", among Haitian women living in South Florida. Intravaginal "twalet deba" may include douching, cleaning inside the vagina with different kinds of products, or using steam/vapor that enter the vagina. The investigators want to help learn the best way to increase early detection and/or prevention for cervical cancer. The investigators would like to know what plants, herbs, commercial products and medicines are used in these practices, how these products are prepared, applied, why these products are used, and how these products affect the vagina and cervix.
- Being tested
- Cervical Cancer Prevention Education
- Keywords
- Twalet Deba
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Cancer Prevention EducationBehavioural
Participants will receive in-person, one-time health education on the importance of cervical cancer screening using a short intervention/educational script; and motivation to encourage women to have human papillomavirus (HPV) screening. Participants will also be informed of the nature and risks of HPV infection, and the importance of seeing a doctor including having a gynecologic exam.
| Study group | Role | What they receive |
|---|---|---|
| Twalet Deba Group | Experimental | Participants will receive cervical cancer prevention education, and provide self-administered vaginal or cervical specimens and provide specimens of plants, plant-products or herbs most commonly used in the intravaginal cleansing practice of twalet deba. Total expected participation is about 30 days. Receives: Behavioral: Cervical Cancer Prevention Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plant products used for intravaginal twalet deba.
Identification of the most commonly used plant products for intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Measured: Up to 30 days
Methods of using plant products for intravaginal twalet deba.
Identification of the most commonly used methods of using plant products for intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Measured: Up to 30 days
Cultural beliefs surrounding the practice of intravaginal twalet deba.
Identification of the most commonly held cultural beliefs surrounding the practice of intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Measured: Up to 30 days
Health access for cervical cancer screening as measured by REMED tool
The REMED tool will collect information regarding early detection and prevention of cervical cancer among underserved communities.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start7 Nov 2017
- Primary completion21 Nov 2018
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Cigna Foundation
- Responsible party
- Principal investigator, Erin Kobetz-Kerman, PhD, MPH, University of Miami
- Investigators
- Erin Kobetz-Kerman, PhD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907187
- Sponsor's protocol ID
- 20170445
- Other IDs
- NCI-2023-00177
- Acronym
- REMED
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Cervical Cancer Prevention and Early Detection, and Understand the Role of Plants in HPV. (Research in Ethno-Medicine and Education)
- ClinicalTrials.gov ID
- NCT05907187
- Acronym / sponsor ID
- REMED / 20170445
- Keywords
- Twalet Deba
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Cigna Foundation
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gain information about intravaginal practices, like intravaginal "twalet deba", among Haitian women living in South Florida. Intravaginal "twalet deba" may include douching, cleaning inside the vagina with different kinds of products, or using steam/vapor that enter the vagina. The investigators want to help learn the best way to increase early detection and/or prevention for cervical cancer. The investigators would like to know what plants, herbs, commercial products and medicines are used in these practices, how these products are prepared, applied, why these products are used, and how these products affect the vagina and cervix.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twalet Deba Group | Experimental | Behavioral: Cervical Cancer Prevention EducationParticipants will receive cervical cancer prevention education, and provide self-administered vaginal or cervical specimens and provide specimens of plants, plant-products or herbs most commonly used in the intravaginal cleansing practice of twalet deba. Total expected participation is about 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Self-identifies as Haitian or Haitian-American
- Resident of Miami-Dade, Broward or Palm Beach County
- Currently engages in regular intravaginal cleansing practices that involve more than just water alone
- No history of hysterectomy
Key exclusion criteria (4 listed)
- Are adults unwilling or unable to provide consent
- Individuals less than 18 years of age
- Pregnant women
- 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 |
|---|---|---|
| Cervical Cancer Prevention EducationParticipants will receive in-person, one-time health education on the importance of cervical cancer screening using a short intervention/educational script; and motivation to encourage women to have human papillomavirus (HPV) screening. Participants will also be informed of the nature and risks of HPV infection, and the importance of seeing a doctor including having a gynecologic exam. | Behavioural | Twalet Deba Group |
Primary outcome
Plant products used for intravaginal twalet deba.
Time frame: Up to 30 days
Identification of the most commonly used plant products for intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Methods of using plant products for intravaginal twalet deba.
Time frame: Up to 30 days
Identification of the most commonly used methods of using plant products for intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Cultural beliefs surrounding the practice of intravaginal twalet deba.
Time frame: Up to 30 days
Identification of the most commonly held cultural beliefs surrounding the practice of intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Health access for cervical cancer screening as measured by REMED tool
Time frame: Up to 30 days
The REMED tool will collect information regarding early detection and prevention of cervical cancer among underserved communities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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.
Erin Kobetz-Kerman, PhD, MPH 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 Cervical Cancer Prevention Education in people with Cervical Cancer and Human Papilloma Virus, 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 6 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: finished, as of the sponsor's last update on 18 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plant products used for intravaginal twalet deba. (time frame: Up to 30 days). The study lists 4 primary outcomes in all. 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 18 Jun 2023.