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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Female Reproductive System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Interview

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.

• Study Type: Interventional
• Enrollment (Actual): 619
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic, 10302
    • Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening (biospecimen collection, cytology, interview); 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; Collection of blood; urine; cervical, anal, vaginal samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Biopsy when indicated; Biological Sample Collected; Other: Interview; Attend interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of cervical precancerous lesions (CIN3) 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
Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+	Estimate the diagnostic accuracy parameters (TPR, FPR, positive predictive value or PPV, negative predictive value or NPV) and their approximate 95% confidence intervals for the p16/Ki-67 dual staining triage strategy for WLWH who tested positive for restricted hrHPV genotyping at Month 0. Will also assess and compare the accuracy parameters (TPR/FPR) of the dual staining method as it applies to hrHPV16 positive WLWH versus those who are positive for other types of hrHPV in two-sample (unpaired) comparisons of proportions (two-sample proportion tests).	At baseline
Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach	Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them.	At baseline
Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling	Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them.	At baseline
CIN2+ Incidence	Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points.	At 12 and 24 months
Detection of repeat CIN2+	Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.	At 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of cervical precancerous lesions (CIN3) 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
Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+	Estimate the diagnostic accuracy parameters (TPR, FPR, positive predictive value or PPV, negative predictive value or NPV) and their approximate 95% confidence intervals for the p16/Ki-67 dual staining triage strategy for WLWH who tested positive for restricted hrHPV genotyping at Month 0. Will also assess and compare the accuracy parameters (TPR/FPR) of the dual staining method as it applies to hrHPV16 positive WLWH versus those who are positive for other types of hrHPV in two-sample (unpaired) comparisons of proportions (two-sample proportion tests).	At baseline
Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach	Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them.	At baseline
Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling	Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them.	At baseline
CIN2+ Incidence	Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points.	At 12 and 24 months
Detection of repeat CIN2+	Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.	At 12 and 24 months
Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy	Post hoc evaluation not impacting treatment decision comparing colposcopy to image score by Cohen's kappa using a scale of normal, precancer+ and greyzone/low grade using a coordinated scale	At baseline
Assess overall burden of HPV disease	Prevalence of non-cervical visible lesions, histological confirmation of non-cervix lesions (at the vulva, vagina, and peri-anal region), and hrHPV testing status at the vagina and anal canal	At baseline

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet); Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
• Investigators: Principal Investigator: Margaret M. Madeleine, PhD, MPH, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): October 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Specimen Handling
• Other Study ID Numbers: RG1122164 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); 10893 (Fred Hutch/University of Washington Cancer Consortium); U54CA242977 (U.S. NIH Grant/Contract); NCI-2021-14229 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); ULACNET-302 (Other Identifier: DCP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of original data, data and specimens may be shared upon request with other investigators at academic or nonprofit institutions in a limited data set, as defined under HIPAA. The final dataset and specimens will be stripped of identifiers prior to release for sharing.
• IPD Sharing Time Frame: One month after publication of the final report in manuscript form to a peer-reviewed journal.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No