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Cervical Exams for the Prevention of Cervical Cancer for Women Living with HIV in Latin American and the Caribbean
Trial Status: active
This clinical trial tests whether cervical exams (colposcopies) work to prevent cervical cancer in women living with human immunodeficiency virus (HIV) in Latin America and the Caribbean. Cervical cancer is a relatively common cancer among women living with HIV. This study may help doctors to determine the best way to test for damaged areas of the cervix. Damaged areas of the cervix should be treated and removed to prevent cancer of the cervix.
Inclusion Criteria
HIV-1 infection, as documented by 1) any Food and Drug Administration (FDA) approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test), 2) a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, 3) documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber’s name or antiretrovirals (ARVs) dispensed from an HIV clinical treatment program with two participant identifiers affixed to the bottles or packages
Cisgender women or transgender men
Aged 25 to 65
Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant
Exclusion Criteria
History of cervical, vulvar, vaginal, perianal, anal or oral cancer
Have undergone cervical cancer screening in the last 6 months
Have undergone cervical HSIL treatment in the past year
Have a history of hysterectomy with removal of the cervix
Have never had sexual intercourse (oral or genital or anal)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of acquired immune deficiency syndrome [AIDS] and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study due to the lack of safety data of performing colposcopy during pregnancy
Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators
Additional locations may be listed on ClinicalTrials.gov for NCT06002126.
I. Compare unmodified versus (i) channel selection and (ii) cycle threshold optimized Cepheid Xpert human papillomavirus (HPV) Assay for detection of high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia [CIN]2+ on cervical histology) in women living with human immunodeficiency virus (HIV).
SECONDARY OBJECTIVES:
I. Assess whether triage testing with the S5 methylation classifier improves the test false positivity rate for HSIL detection in women living with HIV compared to the modified Cepheid Xpert HPV Assay alone.
II. Describe differences in sensitivity and specificity of modified Cepheid Xpert HPV Assay in self-collected vaginal specimens as compared to provider collected cervical specimens for the detection of HSIL (CIN 2+ on cervical histology) in women living with HIV.
EXPLORATORY OBJECTIVES:
I. Describe differences in sensitivity and specificity for AmpFire HPV genotyping assay compared to optimized Cepheid Xpert HPV in self- and provider-collected specimens for detection of HSIL (CIN2+ on cervical histology) in women living with HIV.
II. Characterize HPV type distribution in biopsy specimens of CIN2+ (by sun protection factor [SPF]-10 polymerase chain reaction [PCR]) among women living with HIV.
III. Create a specimen repository for use in future research, including archived residual biopsy from HSIL and cervical cancer, cervical and vaginal specimens for additional biomarker testing (e.g., HPV messenger ribonucleic acid [mRNA]); urine specimens for assessment as a primary cervical cancer screening specimen; oral gargle and anal swab for future HPV testing and methylation; and digital colposcopy imaging for future studies.
OUTLINE:
Patients undergo a colposcopy at baseline. Patients who are positive for high risk HPV (hrHPV) undergo another colonoscopy at 6 months and at 12 months. Patients also undergo collection of urine, vaginal, oral, blood, and anal specimens and complete questionnaires over 30 minutes at baseline, 6 months, and 12 months.
