search
Back to results

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

Primary Purpose

Malignant Female Reproductive System Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
Biospecimen Collection
Interview
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Malignant Female Reproductive System Neoplasm

Eligibility Criteria

25 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ages 25 - 49 years old will be eligible to participate in the study
  • Women and transgender men 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (biospecimen collection, cytology, interview)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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.
CIN2+ Incidence
Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points.
Detection of repeat CIN2+
Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.

Full Information

First Posted
August 29, 2022
Last Updated
September 29, 2023
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)
search

1. Study Identification

Unique Protocol Identification Number
NCT05556772
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (biospecimen collection, cytology, interview)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy when indicated, Biological Sample Collected
Intervention Description
Collection of blood; urine; cervical, anal, vaginal samples
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Attend interview
Primary Outcome Measure Information:
Title
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
Description
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).
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping
Description
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).
Time Frame
At baseline
Title
Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+
Description
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).
Time Frame
At baseline
Title
Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach
Description
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.
Time Frame
At baseline
Title
Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling
Description
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.
Time Frame
At baseline
Title
CIN2+ Incidence
Description
Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points.
Time Frame
At 12 and 24 months
Title
Detection of repeat CIN2+
Description
Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.
Time Frame
At 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy
Description
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
Time Frame
At baseline
Title
Assess overall burden of HPV disease
Description
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
Time Frame
At baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ages 25 - 49 years old will be eligible to participate in the study Women and transgender men 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angélica Mondragón
Phone
206-667-5963
Email
amondrag@fredhutch.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Shrader
Phone
206-667-5963
Email
kshrader@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M. Madeleine, PhD, MPH
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"
City
Santo Domingo
ZIP/Postal Code
10302
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeycy Donastorg, MD, MPH
Phone
809-684-6265
Email
ydonastorg@hvtudr.org
First Name & Middle Initial & Last Name & Degree
Yeycy Donastorg, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs