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

December 11, 2025 updated by: Fred Hutchinson Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
619

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
Time Frame: At baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping
Time Frame: At baseline
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+
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At 12 and 24 months
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+
Time Frame: At 12 and 24 months
Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.
At 12 and 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping
Time Frame: At baseline
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+
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At 12 and 24 months
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+
Time Frame: At 12 and 24 months
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
Time Frame: At baseline
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
Time Frame: At baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margaret M. Madeleine, PhD, MPH, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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