Clinical trial Recruiting at 1 site Interventional Ages 25 and up Women only

Using a portable colposcope for cervical cancer screening

Official title: Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening

Run by Duke University · NCT06458062 · Data updated 2026-11-12

This study is testing a portable device to help screen women for cervical cancer and HPV in Kenya, aiming to improve diagnosis and treatment options.

Quick facts

Study typeInterventional
Ages25 Years and up
SexWomen only
Enrollment1079 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Nairobi)
StatusRecruiting
StartedFebruary 15, 2024
Main results expectedApril 30, 2027
Study endsApril 30, 2027
Registry record updatedJanuary 12, 2026
Trial IDNCT06458062 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 25 to 65 who have tested positive for HPV within the last six months.

Probably not a fit

Patients who are pregnant, have a negative HPV test, or a history of cervical cancer will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves the use of a portable colposcope to screen women for cervical cancer and HPV infection in outpatient clinics in Kisumu County, Kenya. Women aged 25 to 65 who test positive for HPV will undergo colposcopy, where biopsies will be taken from any suspicious lesions or randomly if none are visible. Eligible participants will receive immediate treatment if appropriate, while those with concerning lesions will be referred for further procedures. The study aims to develop a CARE algorithm to assist in diagnosis based on the collected images.

Why it matters

Potential benefit: If successful, this approach could enhance cervical cancer screening and treatment accessibility for women in low-resource settings.

How similar studies have gone: Other studies using portable colposcopy have shown promise, indicating potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH)
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 within the past 9 months
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
6. History of hysterectomy

Where it's running

  • Kenya Medical Research Institute
    Nairobi, Kenya
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • At-home HPV self-collection kits for cervical cancer screening

    We are testing different ways to give at-home HPV self-collection kits to under-screened people aged 25–65 to see if more of them complete cervical cancer screening and follow-up.

    Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07453459

  • CHW4CervixHealth: HPV self-collection kits with community health workers

    This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

    Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07336134

  • Same-day HPV screen-and-treat for women with HIV in La Romana

    This project will test whether offering same-day HPV screening and immediate treatment improves detection and treatment completion for Spanish-speaking women living with HIV in La Romana, Dominican Republic.

    Recruiting Columbia University · La Romana · NCT07225530

  • Non-invasive plasma treatment for HPV infections

    This study is testing a new non-invasive plasma treatment to see if it can help people clear HPV infections without causing any cervical issues.

    Recruiting University Hospital Tuebingen · Tübingen · NCT06291311

  • Investigating HPV and skin cancer risks in organ transplant recipients

    This study is trying to see if organ transplant recipients have a higher risk of HPV infections and skin cancer compared to people with normal immune systems.

    Recruiting at 3 sites Bispebjerg Hospital · Copenhagen NV, Capital Region and 2 other locations · NCT05284877

  • HPV vaccination and screening for cervical cancer in young women in Sweden

    This study is testing whether giving the HPV vaccine and screening for cervical cancer at the same time can help young women in Sweden reduce HPV infections more quickly.

    Recruiting Phase 4 Region Stockholm · Stockholm · NCT04910802

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.