Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
- Conditions
- Malignant Female Reproductive System Neoplasm
- Interventions
- Procedure: Biospecimen CollectionOther: Interview
- Registration Number
- NCT05556772
- Lead 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 619
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Screening (biospecimen collection, cytology, interview) Biospecimen Collection 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. Screening (biospecimen collection, cytology, interview) 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.
- Primary Outcome Measures
Name Time Method Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"
🇩🇴Santo Domingo, Dominican Republic