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Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine

Primary Purpose

Cervical Cancer, HPV Infection, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Colposcopy using pocket colpscope and thermocoagulator
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer screening, Pap smear, colposcopy

Eligibility Criteria

30 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HPV+ pap smear
  • Women must between the ages of 30-49yo

Exclusion Criteria:

  • HPV (-) pap smear
  • people without a cervix

Sites / Locations

  • Universidad Peruana Cayetano HerediaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPV+ Pap smear

Arm Description

Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.

Outcomes

Primary Outcome Measures

Number of HPV+ women examined
Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope

Secondary Outcome Measures

Proportion of HPV positive women who completed the 6 month follow-up after evaluation and treatment.
Proportion of participants of HPV+ women who completed the 6 month follow-up visit after evaluation and treatment.

Full Information

First Posted
April 11, 2022
Last Updated
June 29, 2023
Sponsor
Duke University
Collaborators
United States Agency for International Development (USAID), Universidad Peruana Cayetano Heredia
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1. Study Identification

Unique Protocol Identification Number
NCT05340322
Brief Title
Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine
Official Title
Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Agency for International Development (USAID), Universidad Peruana Cayetano Heredia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.
Detailed Description
The goal is to demonstrate that the combination of self-sampling, the Pocket colposcope and the thermocoagulator will yield a high proportion of HPV positive women who complete treatment and follow-up care. The bulk of this trial will occur over a two-year period in Peru. Duke will provide the Pocket colposcope and the Calla application to run the device only. Dr. Garcia will recruit and train community women for the distribution of self-collection HPV test kits, identify and partner with 10 to 12 health centers in the Andean region of Peru, conduct baseline data collection in each health center, procure necessary equipment and technology, and conduct training for HPV testing, Pocket colposcopy, and thermocoagulation. Within 18 months trained community women will distribute 10,000 HPV tests to women within the region. The investigators anticipate that 10% of the women screened will be HPV positive and they will be recruited for our trial. As part of the study the participants will be followed to determine if the participants attend a health center, receive Pocket colposcopy, and if needed whether the participants are treated with the thermocoagulator device. All women will be appointed to return to the health center for a follow-up evaluation six months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, HPV Infection, HIV Infections
Keywords
cervical cancer screening, Pap smear, colposcopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPV+ Pap smear
Arm Type
Experimental
Arm Description
Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.
Intervention Type
Device
Intervention Name(s)
Colposcopy using pocket colpscope and thermocoagulator
Intervention Description
If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Primary Outcome Measure Information:
Title
Number of HPV+ women examined
Description
Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Proportion of HPV positive women who completed the 6 month follow-up after evaluation and treatment.
Description
Proportion of participants of HPV+ women who completed the 6 month follow-up visit after evaluation and treatment.
Time Frame
6 months after initial visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HPV+ pap smear Women must between the ages of 30-49yo Exclusion Criteria: HPV (-) pap smear people without a cervix
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patty Garcia, MD
Phone
+51991886872
Email
patricia.garcia@upch.pe
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Gallagher, BA
Email
jennifer.gallagher@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimmi Ramanujam, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Garcia, MD
Email
patricia.garcia@upch.pe

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine

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