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

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT04092257
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • VIA and thermocoagulation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jun 24, 2020
Status verified
Jul 2025
Primary completion
Feb 28, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
1,250 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VIA and thermocoagulation
    Participants will undergo same day VIA and thermocoagulation

Primary Outcome Measure

Same-day Visual Inspection With Acetic Acid (VIA) Rate [ Time Frame: Baseline ]

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