To hear about similar clinical trials, please enter your email below
Trial Title:
Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
NCT ID:
NCT05556772
Condition:
Malignant Female Reproductive System Neoplasm
Conditions: Official terms:
Genital Neoplasms, Female
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Collection of blood; urine; cervical, anal, vaginal samples
Arm group label:
Screening (biospecimen collection, cytology, interview)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Other name:
Biopsy when indicated
Other name:
Biological Sample Collected
Intervention type:
Other
Intervention name:
Interview
Description:
Attend interview
Arm group label:
Screening (biospecimen collection, cytology, interview)
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.
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
25 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"
Address:
City:
Santo Domingo
Zip:
10302
Country:
Dominican Republic
Start date:
November 14, 2022
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
Agency class:
Other
Collaborator:
Agency:
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
Agency class:
Other
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556772
