N/A
N=434
1:1 Comparison of the Pocket Colposcope in Kenya
Cervical Cancer · HPV Infection · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04998318 ↗Enrolled (actual)
434
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Percent of Exams With Lesions Identified — 14.3; 17.3; 0; 21.1 percent of exams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pocket Colposcope (Device); Standard of Care Colposcopy (Procedure)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Exams With Lesions Identified |
14.3; 17.3; 0; 21.1 | — |
| PRIMARY Sensitivity |
26.3; 25.0 | — |
| PRIMARY Specificity |
88.9; 84.0 | — |
| PRIMARY Negative Predictive Value (NPV) |
82.9; 87.1 | — |
| PRIMARY Positive Predictive Value (PPV) |
37.5; 20.6 | — |
| SECONDARY Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire |
21.6; 21.8; 0.5; 0.5 | — |
| SECONDARY Percent of Providers Who Reported Experiencing no Challenges During the Exam |
96.3; 97.0 | — |
| SECONDARY Percent of Participants Who Reported Experiencing Pain During Their Exam |
21.6; 21.8; 73.2; 74.1; 5.3; 3.0 | — |
| SECONDARY Percent of Participants Who Expressed Confidence in Their Provider's Assessment |
0.0; 0.0; 3.2; 2.5; 28.4; 28.4 | — |
| SECONDARY Percent of Participants Who Would Recommend the Exam to a Friend |
0.0; 0.5; 1.1; 0.0; 22.6; 18.8 | — |
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. 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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04998318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.