Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
(iSTAR)
2 other identifiers
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Feb 2026
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2025
CompletedFirst Posted
Study publicly available on registry
November 6, 2025
CompletedStudy Start
First participant enrolled
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
February 25, 2026
February 1, 2026
3.2 years
November 4, 2025
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Screen-positives Completing Full Screening Cascade
The investigators will calculate the percent of screen-positives who complete all follow-up steps in the screening cascade. For the iSTAR approach, this will include the percentage among those suitable for ablative therapy who undergo ablative therapy within 1 week of screening combined with the percentage of those not suitable for ablative therapy who complete all colposcopy referral steps which lead either to a treatment procedure or to a negative confirmatory diagnosis within 2 months. In the standard of care arm, this will include the percentage of all screen-positives who complete the colposcopy steps within 2 months.
2 Months
Percentage of Women in the HPV+VL Triage Negative Group
The investigators will calculate the percentage of women with HPV+ by HPV VL triage negative who have abnormal pap results. Given the high specificity of cytology, this will quantify the extent of missed disease with the HPV VL triage approach.
Day 1
Study Arms (2)
Standard of Care
NO INTERVENTIONParticipants randomized to the standard of care group will receive standard examinations and management of screen positives (ablative therapy or colposcopy referral at a follow-up visit).
Screen, Triage, and Treat
EXPERIMENTALParticipants randomized to the screen, triage, and treat group will be examined using the screen and treat approach (same day results and ablative therapy or colposcopy referral, if applicable).
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age;
- female sex assigned at birth (any gender identity);
- HIV-positive;
- women who have had cervical cancer precursor lesions which were removed more than 6 months ago; and
- understand Spanish
You may not qualify if:
- women who are pregnant, less than 6 weeks postpartum, or in whom pregnancy cannot be excluded;
- history of a Loop Electrosurgical Excision Procedure (LEEP) procedure in the last 6 months;
- history of a hysterectomy;
- previous diagnosis of gynecological cancer;
- history of cancer of the anogenital tract; or
- unable or unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Cancer Institute (NCI)collaborator
- Clínica de Familia La Romana, Dominican Republiccollaborator
Study Sites (1)
Clínica de Familia La Romana
La Romana, Dominican Republic
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD, MPH
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be randomly assigned to one of two trial arms through REDCap using randomly permuted block design where the block size itself is randomly selected, treatment assignment is pre-determined before the trial begins, and assignments remain static throughout the course of the trial to reduce opportunities for selection bias.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Disease Prevention and Health Promotion
Study Record Dates
First Submitted
November 4, 2025
First Posted
November 6, 2025
Study Start
February 23, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share