Research in Ethno-Medicine and Education (REMED)

NCT ID: NCT05907187

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2020-06-09

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer Human Papilloma Virus HPV Human Papillomavirus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Twalet Deba Group

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.

Group Type EXPERIMENTAL

Cervical Cancer Prevention Education

Intervention Type BEHAVIORAL

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.

Interventions

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Cervical Cancer Prevention Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cigna Foundation

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Erin Kobetz-Kerman, PhD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erin Kobetz-Kerman, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Martine Poitevien

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2023-00177

Identifier Type: REGISTRY

Identifier Source: secondary_id

20170445

Identifier Type: -

Identifier Source: org_study_id

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