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Completed

NCT Number: NCT04998318

1:1 Comparison of the Pocket Colposcope in Kenya

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. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

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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

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Nairobi, Kenya

About this study

Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 25 years old and < 65 years old
  • Sex: Female
  • Positive HPV test within past 6 months
  • HIV+ women

Exclusion criteria

  • Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
  • Women with a negative HPV test
  • Patients incapable of giving informed consent
  • Women with a history of cervical cancer
  • Pelvic exam concerning for cervical cancer or cervical infection

Treatment and study plan

Pocket Colposcope

Device

Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects.

Standard of Care Colposcopy

Procedure

VIA and VILI as previously described,

Primary outcomes

  1. Percent of Exams With Lesions Identified

    Time frame: Baseline

    The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.

  2. Sensitivity

    Time frame: Baseline

    Sensitivity of Pocket vs VIA

  3. Specificity

    Time frame: Baseline

    Specificity of Pocket vs VIA

  4. Negative Predictive Value (NPV)

    Time frame: Baseline

    Negative predictive value (NPV) of Pocket vs VIA

  5. Positive Predictive Value (PPV)

    Time frame: Baseline

    Positive predictive value (PPV) of Pocket vs VIA

Secondary outcomes

  1. Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire

    Time frame: baseline

    Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.

  2. Percent of Providers Who Reported Experiencing no Challenges During the Exam

    Time frame: baseline

    Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.

  3. Percent of Participants Who Reported Experiencing Pain During Their Exam

    Time frame: Baseline

    Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"

  4. Percent of Participants Who Expressed Confidence in Their Provider's Assessment

    Time frame: Baseline

    Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?"

  5. Percent of Participants Who Would Recommend the Exam to a Friend

    Time frame: Baseline

    Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?"

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Kenya Medical Research Institute

Registry information

Official study title

Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2021
Registry last updated
Jun 24, 2025

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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