Research in Ethno-Medicine and Education (REMED)

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT05907187

Collaborator

Cigna Foundation (Other)

100

Enrollment

Location

Arm

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Human Papilloma Virus HPV Human Papillomavirus Infection	Behavioral: Cervical Cancer Prevention Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Nov 7, 2017

Actual Primary Completion Date :

Nov 21, 2018

Actual Study Completion Date :

Jun 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Twalet Deba Group 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 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.

Arm

Intervention/Treatment

Experimental: Twalet Deba Group

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

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martine Poitevien	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami
Cigna Foundation

Investigators

Principal Investigator: Erin Kobetz-Kerman, PhD, MPH, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erin Kobetz-Kerman, PhD, MPH, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05907187

Other Study ID Numbers:

20170445
NCI-2023-00177

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erin Kobetz-Kerman, PhD, MPH, Professor, University of Miami

Twalet Deba

Additional relevant MeSH terms:

Papillomavirus Infections

Uterine Cervical Neoplasms

Papilloma

Study Results

No Results Posted as of Jun 18, 2023