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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04092257
• Other study ID #: LCCC 1905
• Secondary ID: R21CA236770AID-O
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1250
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• HIV Infections
• HPV Infection
• Infections
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Malawi	University of North Carolina (UNC) Project-Malawi	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI), United States Agency for International Development (USAID)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Primary	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.	2 years