NCT04092257

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

Completed NA Results posted Last updated 6 August 2025

What this trial tests

NA trial testing VIA and thermocoagulation in HPV Infection in 1,250 participants. Completed in 28 February 2025.

Timeline

24 June 2020

Primary endpoint
28 February 2024

28 February 2025

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,250
Start date	24 June 2020
Primary completion	28 February 2024
Estimated completion	28 February 2025
Sites	1 location across Malawi

Drugs / interventions tested

• VIA and thermocoagulation

Conditions studied

• HPV Infection — all drugs for HPV Infection →
• Cervical Cancer — all drugs for Cervical Cancer →
• HIV Infections — all drugs for HIV Infections →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

Adults 25 to 50, female only, with HPV Infection or Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Same-day Visual Inspection With Acetic Acid (VIA) Rate Primary · Baseline

The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.

Visual Inspection with Acetic Acid (VIA) performed

Group	Value	95% CI
HPV Positive	469

Visual Inspection with Acetic Acid (VIA) performed on the same day

Group	Value	95% CI
HPV Positive	459

Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage Primary · Baseline

Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.

HPV-positive participants eligible for thermocoagulation based on colposcopy triage

Group	Value	95% CI
HPV Positive	110

Thermocoagulation completed among HPV-positive participants on same day of self-collection

Group	Value	95% CI
HPV Positive	109

High Risk (hr)-Human Papillomavirus (HPV) Positive Rate Primary · Baseline

The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.

Group	Value	95% CI
HIV Positive	295
HIV Negative	181

HPV Screen-triage-treat Algorithm for Cervical Cancer Screening Secondary · Up to 24 weeks

To evaluate the performance of the proposed ICC screen-and-treat strategy for cervical carcinoma screening among women who are HIV- positive, the rates of overtreatment and undertreatment rates were estimated. Overtreatment for women who are HPV-positive VIA- positive/ablation-eligible and would have received thermocoagulation but had no cervical precancer (i.e., high-grade cervical intraepithelial neoplasia), and undertreatment among HPV-positive with high-grade cervical intraepithelial neoplasia but were VIA-positive and eligible for thermocoagulation, and those who were VIA-negative.

Group	Value	95% CI
HIV Positive, HPV Positive, VIA Positive, and Had no High Grade Cervical Intraepithelial Neoplasia	49
HIV Positive,HPV Positive, VIA Positive, and Had Biopsy-proven Cervical Precancer in the Endocervix	10
HIV Positive, HPV Negative, VIA Positive	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 4 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HIV Positive -VIA and Thermocoagulation

Serious: 0/22 (0%)

Deaths: 1/22

HIV Negative -VIA and Thermocoagulation

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (10 terms — click to expand)

Reaction	System	HIV Positive -VIA and Ther…	HIV Negative -VIA and Ther…
vaginal discharge	Reproductive system and breast disorders	—	—
Pelvic pain	Reproductive system and breast disorders	—	—
vaginal bleeding	Reproductive system and breast disorders	—	—
Vaginal hemorrhage	Reproductive system and breast disorders	—	—
Amenorrhea	Reproductive system and breast disorders	—	—
Menorrhagia	Reproductive system and breast disorders	—	—
Dysuria	Renal and urinary disorders	—	—
Vaginal Inflammation	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT04092257 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers.
   Lin LL, Lakomy DS, Chiao EY, Strother RM, et al · · 2020 · cited 19× · PMID 32697667 · DOI 10.1200/go.20.00153
2. A novel cervical cancer screen-triage-treat demonstration project with HPV self-testing and thermal ablation for women in Malawi: Protocol for a single-arm prospective trial.
   Chinula L, McGue S, Smith JS, Saidi F, et al · · 2022 · cited 10× · PMID 35243124 · DOI 10.1016/j.conctc.2022.100903