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

Primary Purpose

HPV Infection, Cervical Cancer, HIV Infections

Status

Active

Phase

Not Applicable

Locations

Malawi

Study Type

Interventional

Intervention

VIA and thermocoagulation

About this trial

This is an interventional treatment trial for HPV Infection focused on measuring Visual inspection with acetic acid (VIA)

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible.
Ability and willingness of participant to provide written informed consent.

Exclusion Criteria:

Current or prior history of cervical, vaginal or vulvar cancer or dysplasia
Current symptomatic sexual 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.

Sites / Locations

University of North Carolina (UNC) Project-Malawi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VIA and thermocoagulation

Arm Description

Participants will undergo same day VIA and thermocoagulation

Outcomes

Primary Outcome Measures

Number (and %) of women with HPV-positive results who receive VIA same-day

We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and

Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04092257

First Posted

September 13, 2019

Last Updated

November 28, 2022

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI), United States Agency for International Development (USAID)

1. Study Identification

Unique Protocol Identification Number

NCT04092257

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 24, 2020 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI), United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Infection, Cervical Cancer, HIV Infections

Keywords

Visual inspection with acetic acid (VIA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIA and thermocoagulation

Arm Type

Experimental

Arm Description

Participants will undergo same day VIA and thermocoagulation

Intervention Type

Procedure

Intervention Name(s)

VIA and thermocoagulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number (and %) of women with HPV-positive results who receive VIA same-day

Description

We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and

Time Frame

2 years

Title

Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day

Description

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.

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening). Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible. Ability and willingness of participant to provide written informed consent. Exclusion Criteria: Current or prior history of cervical, vaginal or vulvar cancer or dysplasia Current symptomatic sexual 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lameck Chinula, MD

Organizational Affiliation

University of North Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina (UNC) Project-Malawi

City

Lilongwe

Country

Malawi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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