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

Malignant Female Reproductive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05556772
• Other study ID #: RG1122164
• Secondary ID: NCI-2021-14229RG
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 619
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Collection of blood; urine; cervical, anal, vaginal samples

Other:
• Interview
Attend interview

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"	Santo Domingo

Sponsors (4)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP), National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Detection of repeat CIN2+	Calculate the proportion positive a second time for CIN2+ at Month 12 or 24.	At 12 and 24 months