Research in Ethno-Medicine and Education (REMED)

Cervical Cancer Clinical Trial

— REMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907187
• Other study ID #: 20170445
• Secondary ID: NCI-2023-00177
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: June 9, 2020

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 9, 2020
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HPV
• Human Papilloma Virus
• Human Papillomavirus Infection
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Martine Poitevien	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Cigna Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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