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NCT05340322 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05340322
Other study ID # Pro00106490
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date October 15, 2023

Study information
Verified date June 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 497
Est. completion date October 15, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 49 Years
Eligibility Inclusion Criteria: - HPV+ pap smear - Women must between the ages of 30-49yo Exclusion Criteria: - HPV (-) pap smear - people without a cervix

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Colposcopy using pocket colpscope and thermocoagulator
If HPV+, visualization with pocket colposcope and treatment with thermocoagulator

Locations
Country Name City State
Peru Universidad Peruana Cayetano Heredia Lima

Sponsors (3)
Lead Sponsor Collaborator
Duke University United States Agency for International Development (USAID), Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 2 years
Secondary 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. 6 months after initial visit
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