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OpenTrials
Completed

NCT Number: NCT05340322

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

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.

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Key information

Conditions

Cervical Cancer Blood-Borne Infections Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections HPV Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

30 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Peruana Cayetano Heredia

Lima, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Colposcopy using pocket colpscope and thermocoagulator

Device

If HPV+, visualization with pocket colposcope and treatment with thermocoagulator

Primary outcomes

  1. Number of HPV Positive Women Examined

    Time frame: up to approximately 1 year

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

Secondary outcomes

  1. Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment

    Time frame: 6 months after initial visit

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • United States Agency for International Development (USAID)
  • Universidad Peruana Cayetano Heredia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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