Clinical trial NCT04092257: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HPV Infection
Cervical Cancer
HIV Infections
Keywords: Visual inspection with acetic acid (VIA)
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: United States Agency for International Development (USAID)
First posted: 2019-09-17
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: High risk (hr)-human papillomavirus (HPV) rate
timeFrame: 2 years
measure: same-day visual inspection with acetic acid (VIA) rate
timeFrame: 2 years
measure: Thermocoagulation performed the same-day rate colposcopy who receive thermocoagulation same-day
timeFrame: 2 years
Secondary outcomes:
measure: Screened invasive cervival carcinoma treatment strategy
timeFrame: 2 years
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: University of North Carolina (UNC) Project-Malawi
Study officials:
affiliation: University of North Carolina
name: Lameck Chinula, MD
role: PRINCIPAL_INVESTIGATOR
References: