Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

Sponsor
Columbia University
Study ID
NCT07225530
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Screen, Triage, and Treat — OTHER
    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.

Study Details

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.

Key Dates

First listed
Nov 6, 2025
Start date
Feb 23, 2026
Status verified
Feb 2026
Primary completion
May 1, 2029
Completion
Nov 1, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • No Intervention: Standard of Care
    Participants 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).
  • Experimental: Screen, Triage, and Treat
    Participants 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).

Primary Outcome Measure

Percentage of Screen-positives Completing Full Screening Cascade [ Time Frame: 2 Months ]

Central Contacts

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