Clinical trial · Interventional
Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (biospecimen collection, cytology, interview)
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Interview
Primary outcomes (1)
- measure
- Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
- timeFrame
- At baseline
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available