Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic

NCT05556772 | Active Not Recruiting DMC

• 5 other identifiers: RG1122164NCI-2021-14229ULACNET-302U54CA24297710893
• Study Type: interventional
• Target: 619
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping

  Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR).

  At baseline

Other Outcomes (8)

• Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy

  At baseline

• Assess overall burden of HPV disease

  At baseline

• Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping

  At baseline

Study Arms (1)

Screening (biospecimen collection, cytology, interview)

EXPERIMENTAL

Participants participate in an interview and clinical exam, lasting approximately 2 hours. Participants undergo vaginal self-sampling, cervical provider-sampling, and collection of blood and urine samples. Participants also undergo a pelvic exam. After first interview and clinical exam at enrollment, participants have two subsequent study visits over a 2 year period.

Procedure: Biospecimen Collection; Other: Interview

Interventions

Biospecimen Collection PROCEDURE

Collection of blood; urine; cervical, anal, vaginal samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy when indicated, Biological Sample Collected

Screening (biospecimen collection, cytology, interview)

Interview OTHER

Attend interview

Screening (biospecimen collection, cytology, interview)

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet): collaborator
• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP): collaborator

Study Sites (1)

Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"

Santo Domingo, 10302, Dominican Republic

Location

MeSH Terms

Interventions

Specimen Handling; Interviews as Topic

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Margaret M. Madeleine, PhD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 27, 2022
• Study Start: November 14, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One month after publication of the final report in manuscript form to a peer-reviewed journal.
• Access Criteria: Investigators requesting access to data and specimens must sign a data-sharing agreement that provides for: (1) a commitment to using the data or specimens only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) not sharing the data or specimens with third parties. We reserve the right to limit data provided to outside investigators. We will not share data if we believe there is a possibility of deductive disclosure of subjects with unusual characteristics.

Locations

DO (1)