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

Fred Hutchinson Cancer Center (FHCC)

Status: Active, not recruiting

Conditions: Malignant Female Reproductive System Neoplasm

Treatments: Procedure: Biospecimen Collection; Other: Interview

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05556772

U54CA242977 (U.S. NIH Grant/Contract)

10893 (Registry Identifier)

NCI-2021-14229 (Registry Identifier)

ULACNET-302 (Other Identifier)

RG1122164 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 619 patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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619 participants in 1 patient group

Screening (biospecimen collection, cytology, interview)

Experimental group

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.

Treatment:

Other: Interview

Procedure: Biospecimen Collection