Clinical trial NCT05413798: Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Official title: Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
CIN2
CIN3
Keywords: cervical cancer
HPV
urine test
HIV
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.

Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.

Detailed description: Invasive cervical cancer is a significant health burden in low and middle income countries.

HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk \~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.

Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.

The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.

This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.

Eligibility criteria: Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Confirmed HIV-1 infection
2. Age 25 years and older.
3. Be willing and able to provide written informed consent.

Exclusion Criteria:

1. Pregnant or intend to become pregnant within 90 days of enrollment
2. Have been screened for cervical cancer within the preceding year (365 days)
3. Have an active sexually transmitted infection (STI; women may participate once treated)
4. Have a surgically absent cervix
5. Have a history of cervical cancer
6. have been vaccinated against HPV.

Primary outcomes:
measure: Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
timeFrame: 4 weeks (Entry visit)
Secondary outcomes:
measure: Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
timeFrame: 4 weeks
measure: The proportion of participants positive for hrHPV
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Westdene
country: South Africa
facility: Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
state: Johannesburg
Study officials:
affiliation: Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
name: Carla Chibwesha, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: