Research in Ethno-Medicine and Education (REMED)

Study Overview
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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.

Official Title
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Intervention to Promote Cervical Cancer Prevention and Early Detection, and Understand the Role of Plants in HPV. (Research in Ethno-Medicine and Education)

Conditions
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Cervical Cancer, Human Papilloma Virus, HPV, Human Papillomavirus Infection

Intervention / Treatment
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* Behavioral: Cervical Cancer Prevention Education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twalet Deba Group<br>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. | Behavioral: Cervical Cancer Prevention Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twalet Deba