Clinical trial NCT05556772: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
Official title: Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
name: Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
First posted: 2022-09-27
Enrollment: 619
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.

Detailed description: OUTLINE:

Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.

Eligibility criteria: Inclusion Criteria:

* Women ages 25 - 49 years old will be eligible to participate in the study
* Women living with HIV who have an intact cervix
* Intent to reside in the Santo Domingo area
* Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
* Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria

Exclusion Criteria:

* Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
* Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
* Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
* Women who have no history of vaginal sexual exposure will not be eligible for the study

Primary outcomes:
measure: Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
measure: Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy
timeFrame: At baseline
measure: Assess overall burden of HPV disease
timeFrame: At baseline
measure: Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping
timeFrame: At baseline
measure: Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+
timeFrame: At baseline
measure: Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach
timeFrame: At baseline
measure: Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling
timeFrame: At baseline
measure: CIN2+ Incidence
timeFrame: At 12 and 24 months
measure: Detection of repeat CIN2+
timeFrame: At 12 and 24 months
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Margaret M. Madeleine, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: