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Search / Trial NCT06458062

Pocket Colposcopy Using CARE Algorithm

Launched by DUKE UNIVERSITY · Jun 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hpv Testing Colposcopy Cervical Cancer Screening

ClinConnect Summary

This clinical trial is studying a new tool called the Pocket colposcope, which is used to examine the cervix in women who have tested positive for HPV, a virus that can lead to cervical cancer. The trial will involve about 1,054 women aged 25 to 65 who are receiving treatment at clinics in Kisumu County. These women will undergo a procedure called colposcopy, where the Pocket colposcope will be used to take a closer look at their cervix after they give their consent to participate.

To be eligible for this trial, women must be between 25 and 65 years old and have had a positive HPV test in the last six months. However, pregnant women, those with a negative HPV test, individuals who cannot give consent, those with a history of cervical cancer, or women showing signs of cervical issues will not be able to participate. If you join this study, you'll help researchers learn more about how this device can assist in monitoring and treating HPV-related conditions, which is important for improving women's health in the future.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age \> 25 years old and \< 65 years old
  • 2. Sex: Female
  • 3. Positive HPV test within past 6 months
  • Exclusion Criteria:
  • 1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
  • 2. Women with a negative HPV test
  • 3. Patients incapable of giving informed consent
  • 4. Women with a history of cervical cancer
  • 5. Pelvic exam concerning for cervical cancer or cervical infection

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Nairobi, , Kenya

Patients applied

0 patients applied

Trial Officials

Megan Huchko, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported