NCT04998318 is a NA clinical trial of Pocket Colposcope in Cervical Cancer, sponsored by Duke University.

Who is sponsoring NCT04998318?

NCT04998318 is sponsored by Duke University.

What drugs are being tested in NCT04998318?

Interventions in NCT04998318: Pocket Colposcope, Standard of Care Colposcopy.

What condition does NCT04998318 study?

NCT04998318 studies Cervical Cancer, HPV Infection, HIV Infections.

Is NCT04998318 still recruiting?

NCT04998318 is currently completed. Last updated 24 June 2025.

Are results published for NCT04998318?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-24 · How we verify

NCT04998318

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

1:1 Comparison of the Pocket Colposcope in Kenya

Completed NA Results posted Last updated 24 June 2025

What this trial tests

NA trial testing Pocket Colposcope in Cervical Cancer in 434 participants. Completed in 16 June 2024.

Timeline

28 November 2022

Primary endpoint
16 May 2024

16 June 2024

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	434
Start date	28 November 2022
Primary completion	16 May 2024
Estimated completion	16 June 2024
Sites	1 location across Kenya

Drugs / interventions tested

Pocket Colposcope
Standard of Care Colposcopy

Conditions studied

Cervical Cancer — all drugs for Cervical Cancer →
HPV Infection — all drugs for HPV Infection →
HIV Infections — all drugs for HIV Infections →

Sponsor

Duke University

Who can join

Adults 25 to 65, female only, with Cervical Cancer or HPV Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Exams With Lesions Identified Primary · Baseline

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

Group	Value	95% CI
Pocket Colposcope	14.3	9.7 – 20.0
Standard of Care (VIA)	17.3	12.4 – 23.1
Mis-weighted Randomization to Pocket Colposcope	0	0 – 0
Mis-weighted Randomization to Standard of Care (VIA)	21.1	2.3 – 39.8

Sensitivity Primary · Baseline

Sensitivity of Pocket vs VIA

Group	Value	95% CI
Pocket Colposcope	26.3
Standard of Care (VIA)	25.0

Specificity Primary · Baseline

Specificity of Pocket vs VIA

Group	Value	95% CI
Pocket Colposcope	88.9
Standard of Care (VIA)	84.0

Negative Predictive Value (NPV) Primary · Baseline

Negative predictive value (NPV) of Pocket vs VIA

Group	Value	95% CI
Pocket Colposcope	82.9
Standard of Care (VIA)	87.1

Positive Predictive Value (PPV) Primary · Baseline

Positive predictive value (PPV) of Pocket vs VIA

Group	Value	95% CI
Pocket Colposcope	37.5
Standard of Care (VIA)	20.6

Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire Secondary · baseline

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

Pre-exam

Group	Value	95% CI
Pocket Colposcope	21.6
Standard of Care (VIA)	21.8

Post-exam

Group	Value	95% CI
Pocket Colposcope	0.5
Standard of Care (VIA)	0.5

Percent of Providers Who Reported Experiencing no Challenges During the Exam Secondary · baseline

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

Group	Value	95% CI
Pocket Colposcope	96.3
Standard of Care (VIA)	97.0

Percent of Participants Who Reported Experiencing Pain During Their Exam Secondary · Baseline

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

None

Group	Value	95% CI
Pocket Colposcope	21.6
Standard of Care (VIA)	21.8

A little

Group	Value	95% CI
Pocket Colposcope	73.2
Standard of Care (VIA)	74.1

Somewhat

Group	Value	95% CI
Pocket Colposcope	5.3
Standard of Care (VIA)	3.0

Very much

Group	Value	95% CI
Pocket Colposcope	0
Standard of Care (VIA)	1.0

Percent of Participants Who Expressed Confidence in Their Provider's Assessment Secondary · Baseline

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

None

Group	Value	95% CI
Pocket Colposcope	0.0
Standard of Care (VIA)	0.0

A little

Group	Value	95% CI
Pocket Colposcope	3.2
Standard of Care (VIA)	2.5

Somewhat

Group	Value	95% CI
Pocket Colposcope	28.4
Standard of Care (VIA)	28.4

Very much

Group	Value	95% CI
Pocket Colposcope	68.4
Standard of Care (VIA)	69.0

Percent of Participants Who Would Recommend the Exam to a Friend Secondary · Baseline

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

Not likely at all

Group	Value	95% CI
Pocket Colposcope	0.0
Standard of Care (VIA)	0.5

Not likely

Group	Value	95% CI
Pocket Colposcope	1.1
Standard of Care (VIA)	0.0

Likely

Group	Value	95% CI
Pocket Colposcope	22.6
Standard of Care (VIA)	18.8

Very likely

Group	Value	95% CI
Pocket Colposcope	76.3
Standard of Care (VIA)	80.7

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Randomized Clinical Trial Comparing Visual Inspection with Acetic Acid (VIA) to Pocket Colposcopy for the Triage of HPV+ women living with HIV in Kisumu, Kenya
Dotson ME, Steinberg E, Santos MO, Ambaka J, et al · · 2024 · DOI 10.1101/2024.11.05.24316753

Verify or expand the search:

Other trials of Pocket Colposcope

Trials testing the same drug.

NCT06458062 — Pocket Colposcopy Using CARE Algorithm · NA · recruiting

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04998318 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 24 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04998318.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing