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

A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cervical Cancer; HPV Infection
• Intervention / Treatment: Procedure: VIA and thermocoagulation

Detailed Description

This is a single arm, prospective study of 1,250 women (625 HIV-positive and 625 HIV-negative) enrolled from outpatient clinics that provide sexual and reproductive health (SRH) services and/or HIV care services in Lilongwe, Malawi. The primary objectives of this study are to assess completion of a novel ICC screen-and-treat strategy among HIV-positive women in Lilongwe, Malawi, using self-collected vaginal brush for hr-HPV testing, followed by same-day NIA and thermocoagulation for HPV-positive/NIA-positive/ablation-eligible (by colposcopy) women, and to determine the 24-week efficacy of thermocoagulation among HIV-positive women with CIN2/3. The secondary objective will be to evaluate the performance of the ICC screen-and-treat strategy by estimating overtreatment for women who are HPV-positive/NIA-positive/ablation-eligible, and undertreatment among HPV-positive/NIA-negative women.

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • University of North Carolina (UNC) Project-Malawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
2. Ability and willingness of participant to provide written informed consent.

Exclusion Criteria:

1. Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
2. Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
3. Prior HPV vaccination.
4. Participants with known allergy to acetic acid.
5. Participants with a history of total hysterectomy.
6. Participants who are pregnant or plan on becoming pregnant during the study period.
7. Participants who are less than 12 weeks postpartum.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Same-day Visual Inspection With Acetic Acid (VIA) Rate	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.	Baseline
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage	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.	Baseline
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	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.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Lameck Chinula, MD, University of North Carolina

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Visual inspection with acetic acid (VIA)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Infections; Communicable Diseases; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: LCCC 1905; R21CA236770 (U.S. NIH Grant/Contract); AID-OAA-A-11-00012 (Other Grant/Funding Number: USAID/NAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No