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Research in Ethno-Medicine and Education (REMED) (REMED)

Primary Purpose

Cervical Cancer, Human Papilloma Virus, HPV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical Cancer Prevention Education
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Twalet Deba

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Are adults unwilling or unable to provide consent Individuals less than 18 years of age Pregnant women Prisoners

Sites / Locations

  • Martine Poitevien

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Twalet Deba Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
University of Miami
Collaborators
Cigna Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05907187
Brief Title
Research in Ethno-Medicine and Education (REMED)
Acronym
REMED
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Cigna Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Human Papilloma Virus, HPV, Human Papillomavirus Infection
Keywords
Twalet Deba

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twalet Deba Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cervical Cancer Prevention Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plant products used for intravaginal twalet deba.
Description
Identification of the most commonly used plant products for intravaginal twalet deba as measured by the Research in Ethno-Medicine and Education (REMED) tool.
Time Frame
Up to 30 days
Title
Methods of using plant products for intravaginal twalet deba.
Description
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.
Time Frame
Up to 30 days
Title
Cultural beliefs surrounding the practice of intravaginal twalet deba.
Description
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.
Time Frame
Up to 30 days
Title
Health access for cervical cancer screening as measured by REMED tool
Description
The REMED tool will collect information regarding early detection and prevention of cervical cancer among underserved communities.
Time Frame
Up to 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Are adults unwilling or unable to provide consent Individuals less than 18 years of age Pregnant women Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Kobetz-Kerman, PhD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martine Poitevien
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Research in Ethno-Medicine and Education (REMED)

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