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NCT05556772 | Active, not recruiting | Malignant Female Reproductive System Neoplasm

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

Fred Hutchinson Cancer Center

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.

Condition or disease

Malignant Female Reproductive System Neoplasm

Intervention/treatment

Biospecimen Collection

Interview

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 619 participants
Masking : None (Open Label)
Primary Purpose : Screening
Official Title : Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2026
Arm Intervention/treatment

Experimental: 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.

Procedure: Biospecimen Collection

Other: Interview
Ages Eligible for Study: 25 Years to 49 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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
Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Dominican Republic,

Dominican Dermatological Institute and Skin Surgery (IDCP) "Dr. Huberto Bogaert Diaz"

Santo Domingo, Dominican Republic, 10302