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

March 13, 2024 updated by: UNC Lineberger Comprehensive Cancer Center

A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for HIV-infected 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

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single arm, prospective study of 625 HIV-positive women attending ART clinics 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 VIA and thermocoagulation for HPV-positive/VIA-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/VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.

Study Type

Interventional

Enrollment (Actual)

1250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible.
  3. 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 sexual 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Number (and %) of women with HPV-positive results who receive VIA same-day
Time Frame: 2 years
We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and
2 years
Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day
Time Frame: 2 years
We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are VIA positive/ablation-eligible (by colposcopy) who have thermocoagulation performed the same-day.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2020

Primary Completion (Actual)

February 28, 2024

Study Completion (Estimated)

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)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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