Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
NCT07225530 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2026-02-25
Summary
This study aims to conduct a randomized controlled trial to evaluate the effectiveness of same-day HPV-based screen and treat among women living with HIV (WLH) in La Romana, Dominican Republic. With cervical cancer being a leading cause of cancer-related deaths in women living with HIV, and cervical cancer deaths being preventable through screening and early detection, this project seeks to identify factors associated with the successful implementation of the Screen, Triage, and Treat approach to inform future implementation and scale-up.
Conditions
- HIV Infections
- HPV Infection
- Cervical Cancer
Interventions
- OTHER
-
Screen, Triage, and Treat
A screening test is used to determine who is eligible for treatment, eliminating steps related to histological confirmation. Those who meet the HPV criteria will be immediately evaluated for suitability for on-site ablative treatment on the same day. Women not suitable for treatment will be referred for colposcopy and further management at the appropriate facility.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Clínica de Familia La Romana, Dominican Republic
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Rebecca Schnall, PhD, MPH · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-23
- Primary Completion
- 2029-05-01
- Completion
- 2029-11-01
Countries
- Dominican Republic
Study Locations
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