NCT04092257Completed
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1250 (actual)
- First submitted
- 13 Sept 2019
- Start date
- 24 Jun 2020
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT04092257
What you commit to
- Study type: Interventional
- Participants enrolled: 1250
- From 24 Jun 2020 to the primary completion date, 28 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
- Prior HPV vaccination.
Other illness
- Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
- Participants with known allergy to acetic acid.
- Participants with a history of total hysterectomy.
- Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.
Other
- Participants who are pregnant or plan on becoming pregnant during the study period.
- Participants who are less than 12 weeks postpartum.
Who the study is looking for
- Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
- Ability and willingness of participant to provide written informed consent.
Age in the registry: 25 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina (UNC) Project-Malawi Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.