Research in Ethno-Medicine and Education (REMED)

Not Applicable

Completed

• Conditions: HPV; Human Papilloma Virus; Human Papillomavirus Infection; Cervical Cancer
• Interventions: Behavioral: Cervical Cancer Prevention Education

• Registration Number: NCT05907187
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-07
• Primary Completion: 2018-11-21
• Study Completion: 2020-06-09
• Status Verified: 2023-06
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Twalet Deba Group	Cervical Cancer Prevention Education	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.

Primary Outcome Measures

Name	Time	Method
Methods of using plant products for intravaginal twalet deba.	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.
Plant products used for intravaginal twalet deba.	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.
Cultural beliefs surrounding the practice of intravaginal twalet deba.	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	Up to 30 days	The REMED tool will collect information regarding early detection and prevention of cervical cancer among underserved communities.

Trial Locations

Locations (1)

Martine Poitevien; 🇺🇸 Miami, Florida, United States