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

Not Applicable

Active, not recruiting

• Conditions: Cervical Cancer; HIV Infections; HPV Infection
• Interventions: Procedure: VIA and thermocoagulation

• Registration Number: NCT04092257
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2020-06-24
• Primary Completion: 2024-02-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VIA and thermocoagulation	VIA and thermocoagulation	Participants will undergo same day VIA and thermocoagulation

Primary Outcome Measures

Name	Time	Method
High risk (hr)-human papillomavirus (HPV) rate	2 years	The proportion of women tested for High risk (hr)-human papillomavirus (HPV) using a self-collected vaginal brush.
same-day visual inspection with acetic acid (VIA) rate	2 years	The proportion of women who are HPV positive who have VIA performed same-day.
Thermocoagulation performed the same-day rate colposcopy who receive thermocoagulation same-day	2 years	The proportion of women who are VIA positive/ablation-eligible (by colposcopy) who have thermocoagulation performed the same day.

Secondary Outcome Measures

Name	Time	Method
Screened invasive cervival carcinoma treatment strategy	2 years	Estimation of over-treatment and undertreatment rates of screened women with invasive cervical carcinoma. To evaluate the performance of the proposed ICC screen-and-treat strategy among women, including HIV-positive women, by estimating overtreatment for women who are HPV-positive/VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.

Trial Locations

Locations (1)

University of North Carolina (UNC) Project-Malawi; 🇲🇼 Lilongwe, Malawi