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

NCT04092257 | Completed Results DMC

• 3 other identifiers: LCCC 1905R21CA236770AID-OAA-A-11-00012
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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

HPV Infection; Cervical Cancer; HIV Infections

Keywords

Visual inspection with acetic acid (VIA)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• HPV Screen-triage-treat Algorithm for Cervical Cancer Screening

  Up to 24 weeks

Study Arms (1)

VIA and thermocoagulation

EXPERIMENTAL

Participants will undergo same day VIA and thermocoagulation

Procedure: VIA and thermocoagulation

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.

VIA and thermocoagulation

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

University of North Carolina (UNC) Project-Malawi

Lilongwe, Malawi

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; HIV Infections

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

The small sample size of women with cervical precancer and the experienced research team may limit the generalizability of findings, especially in national screening programs where providers have multiple tasks.

Results Point of Contact

• Title: Melahat Garipagaoglu
• Organization: UNC Lineberger Comprehensive Cancer Center

Melahat_Canter@med.unc.edu

919-962-0000

Study Officials

• Lameck Chinula, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: June 24, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2025
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)