N/A
N=1,250
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
HPV Infection · Cervical Cancer · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04092257 ↗Enrolled (actual)
1,250
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Same-day Visual Inspection With Acetic Acid (VIA) Rate — 469; 459 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VIA and thermocoagulation (Procedure)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Same-day Visual Inspection With Acetic Acid (VIA) Rate |
469; 459 | — |
| PRIMARY Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage |
110; 109 | — |
| PRIMARY High Risk (hr)-Human Papillomavirus (HPV) Positive Rate |
295; 181 | — |
| SECONDARY HPV Screen-triage-treat Algorithm for Cervical Cancer Screening |
49; 10; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
- Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
- Prior HPV vaccination.
- Participants with known allergy to acetic acid.
- Participants with a history of total hysterectomy.
- Participants who are pregnant or plan on becoming pregnant during the study period.
- Participants who are less than 12 weeks postpartum.
- 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.
Data sourced from ClinicalTrials.gov (NCT04092257). 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.