Research in Ethno-Medicine and Education (REMED)

NCT05907187 | Completed DMC

• 2 other identifiers: 20170445NCI-2023-00177
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Human Papilloma Virus; HPV; Human Papillomavirus Infection

Keywords

Twalet Deba

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Behavioral: Cervical Cancer Prevention Education

Interventions

Cervical Cancer Prevention Education 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.

Twalet Deba Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Are adults unwilling or unable to provide consent
• Individuals less than 18 years of age
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Miami: lead
• Cigna Foundation: collaborator

Study Sites (1)

Martine Poitevien

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Kobetz-Kerman, PhD, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: November 7, 2017
• Primary Completion: November 21, 2018
• Study Completion: June 9, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)