Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,002

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

March 31, 2027

Conditions
Cervix CancerHPV InfectionCervical High Grade Squamous Intraepithelial LesionHIV Infections
Interventions
DIAGNOSTIC_TEST

Xpert HPV

The Cepheid Xpert HPV Assay (Xpert HPV) is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of hrHPV DNA. The assay is formatted in a single-use, Xpert HPV test cartridge and is run on the Cepheid Xpert® System, a multi-analyte, random access, molecular-diagnostic platform ranging in capacity from 1 to 80 test processing modules. Importantly, a single hrHPV DNA test can be completed in one hour, permitting same-day screening and diagnosis (e.g. colposcopy) or treatment (e.g. cryotherapy), reducing the potential for loss to follow-up in lower-resource settings. It uses liquid-based cytologic media and yields five separate results or channels: HPV 16, HPV 18/45, HPV 31/33/35/52/58, HPV 51/59, HPV 39/68/56/66 all with a corresponding cycle threshold.

DIAGNOSTIC_TEST

QIAsure Methylation Test

The Qiagen QIAsure assay is a multiplex real-time PCR test that amplifies the methylated promoter regions of the tumor suppressor genes, FAM19A4 and has-mir124-2, as well as a methylation-unspecific fragment of the ACTB reference gene. Hypermethylation of the host genes FAM19A4 and has-mir124-2 has been shown to detect high-grade cervical lesions and cancer.

Trial Locations (2)

62209

National Institute of Public Health, Mexico, Cuernavaca

05403-911

University of São Paulo, São Paulo

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

collaborator

University of Sao Paulo

OTHER

collaborator

Mexican National Institute of Public Health

OTHER_GOV

collaborator

University of California, San Diego

OTHER

collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

lead

Weill Medical College of Cornell University

OTHER

NCT06002126 - Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries | Biotech Hunter | Biotech Hunter