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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, HPV Infection, HIV Infections

Intervention / Treatment
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* Device: Colposcopy using pocket colpscope and thermocoagulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HPV+ pap smear Women must between the ages of 30-49yo Exclusion Criteria: HPV (-) pap smear people without a cervix

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer screening, Pap smear, colposcopy