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CompletedNCT05907187REMEDUpdated Jun 18, 2023

Research in Ethno-Medicine and Education (REMED)

An interventional study of Cervical Cancer Prevention Education in Cervical Cancer, Human Papilloma Virus and HPV, sponsored by University of Miami. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by University of Miami · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Nov 2017, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

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

Keywords

  • Twalet Deba
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In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 100 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralCervical 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 days

  2. 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.

    Time frame: Up to 30 days

  3. 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.

    Time frame: Up to 30 days

  4. 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.

    Time frame: Up to 30 days

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Study locations

1 site
  • Martine Poitevien
    Miami, Florida 33136, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05907187
Lead sponsor
University of Miami
Collaborators
Cigna Foundation
Responsible party
Erin Kobetz-Kerman, PhD, MPH (Professor, University of Miami) — Principal investigator
First posted
Jun 18, 2023
Start date
Nov 7, 2017
Primary completion
Nov 21, 2018
Completion
Jun 9, 2020
Last update
Jun 18, 2023

Study contacts

Erin Kobetz-Kerman, PhD, MPH
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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