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NCT Number: NCT05556772

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Santo Domingo, 10302, Dominican Republic

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

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

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy when indicated, Biological Sample Collected

interview

Other

Attend interview

Primary outcomes

  1. 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).

Other outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 27, 2022
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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