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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

619 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Malignant Female Reproductive System Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

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

Interview

Intervention Type OTHER

Attend interview

Interventions

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Biospecimen Collection

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

Intervention Type PROCEDURE

Interview

Attend interview

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Biopsy when indicated Biological Sample Collected

Eligibility Criteria

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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

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret M. Madeleine, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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

Santo Domingo, , Dominican Republic

Site Status

Countries

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Dominican Republic

Provided Documents

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Document Type: Informed Consent Form

View Document