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Clinical Trials/NCT05907187
NCT05907187CompletedNot Applicable

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

University of Miami2 sites in 1 country100 target enrollmentStarted: November 7, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Methods of using plant products for intravaginal twalet deba.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erin Kobetz-Kerman, PhD, MPH

Professor

University of Miami

Study Sites (2)

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