Trial results for an HPV-based screen-and-treat demonstration project in Lilongwe, focusing on cervical cancer screening in HIV-positive women, were posted on ClinicalTrials.gov on 2025-08-06. The study enrolled 1250 participants.
Background
HIV infection is associated with an increased risk of human papillomavirus (HPV) infection and subsequent cervical cancer. Women living with HIV are particularly vulnerable to persistent HPV infections and more rapid progression to cervical precancer and cancer. In resource-limited settings, where access to advanced screening and treatment facilities may be limited, effective and accessible screen-and-treat algorithms are crucial for preventing invasive cervical cancer. This demonstration project aimed to assess the completion and performance of a novel algorithm designed to improve cervical cancer prevention among HIV-positive women.
Trial design
This completed study, designated as Phase NA, enrolled 1250 participants, with the screen-and-treat algorithm specifically assessed among 625 HIV-positive women. The trial investigated conditions including HPV Infection, Cervical Cancer, and HIV Infections. The algorithm involved rapid testing of self-collected vaginal brush for primary high-risk (hr)-HPV, same-day visual inspection with acetic acid (VIA) for women who were hr-HPV positive, and thermocoagulation for VIA positive/ablation-eligible women as determined by cervical colposcopy.
Key results
The trial reported several key measurements related to HPV infection rates and the completion of the screen-and-treat algorithm components:
- For the Same-day Visual Inspection With Acetic Acid (VIA) Rate among HPV-positive participants, 469 participants and 459 participants were reported.
- Regarding the Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage, 110 participants and 109 participants received the treatment.
- The High Risk (hr)-Human Papillomavirus (HPV) Positive Rate was observed in 295 participants who were HIV positive, and 181 participants who were HIV negative.
- For the HPV Screen-triage-treat Algorithm for Cervical Cancer Screening, specific outcomes included:
- 49 participants who were HIV Positive, HPV Positive, VIA Positive, and had no high grade cervical intraepithelial neoplasia.
- 10 participants who were HIV Positive, HPV Positive, VIA Positive, and had biopsy-proven cervical precancer in the endocervix.
- 0 participants who were HIV Positive, HPV Negative, and VIA Positive.
What this means
The posted results provide data on the performance and completion rates of an HPV-based screen-and-treat algorithm for cervical cancer prevention, particularly among HIV-positive women. The observed rates for same-day VIA and thermocoagulation suggest the feasibility of implementing such an algorithm in a real-world setting. The data also highlights the prevalence of high-risk HPV infection, with a higher number of HIV-positive participants testing positive compared to HIV-negative participants. These findings contribute to understanding effective strategies for cervical cancer screening and treatment in vulnerable populations, especially where co-infection with HIV increases risk.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04092257, titled "HPV-Based Screen-and-Treat Demonstration Project in Lilongwe", were posted on 2025-08-06 on clinicaltrials.gov.