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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: HPV Infection; HIV Infections; Cervical Cancer

Treatments: Procedure: VIA and thermocoagulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04092257

AID-OAA-A-11-00012 (Other Grant/Funding Number)

R21CA236770 (U.S. NIH Grant/Contract)

LCCC 1905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,250 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,250 participants in 1 patient group

VIA and thermocoagulation

Experimental group

Description:

Participants will undergo same day VIA and thermocoagulation

Treatment:

Procedure: VIA and thermocoagulation