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Completed

NCT Number: NCT05907187

Research in Ethno-Medicine and Education (REMED)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Martine Poitevien

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Plant products used for intravaginal twalet deba.

    Time frame: 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.

  2. Methods of using plant products for intravaginal twalet deba.

    Time frame: 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.

  3. Cultural beliefs surrounding the practice of intravaginal twalet deba.

    Time frame: 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.

  4. Health access for cervical cancer screening as measured by REMED tool

    Time frame: Up to 30 days

    The REMED tool will collect information regarding early detection and prevention of cervical cancer among underserved communities.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Cigna Foundation

Registry information

Official study title

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

Acronym: REMED

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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