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

Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cervical Cancer; HPV Infection
• Intervention / Treatment: Device: Colposcopy using pocket colpscope and thermocoagulator

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.

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • Universidad Peruana Cayetano Heredia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV+ Pap smear; Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.	Device: Colposcopy using pocket colpscope and thermocoagulator; If HPV+, visualization with pocket colposcope and treatment with thermocoagulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HPV Positive Women Examined	Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope	up to approximately 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment	6 months after initial visit

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Agency for International Development (USAID); Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Nimmi Ramanujam, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: colposcopy; Pap smear; cervical cancer screening
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: Pro00106490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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