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HPV-Based Screen-and-Treat Demonstration Project in Lilongwe

NCT04092257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2025-08-06

Study results available
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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.

Conditions

Interventions

PROCEDURE

VIA and thermocoagulation

Participants will self-collect a vaginal brush for hr-HPV testing. HPV-positive women and every 10th consecutive HPV-negative woman will complete same-day VIA with colposcopically-directed cervical biopsy and ECC (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy. If no lesion is seen on colposcopy, the woman will have a cervical pap smear and ECC collected, and no thermocoagulation will be performed. Finally, women who are suspicious for cancer at VIA will undergo colposcopically-directed cervical biopsies.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • United States Agency for International Development (USAID)

    collaborator FED

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lameck Chinula, MD · University of North Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2024-02-28
Completion
2025-02-28

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092257 on ClinicalTrials.gov