RecruitingNot ApplicableNCT07225530

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


Sponsor

Columbia University

Enrollment

600 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study, called iSTAR, is implementing a cervical cancer screening and treatment program for women living with HIV in La Romana, Dominican Republic. It is testing a same-day "screen and treat" approach where precancerous cervical cells can be identified and treated in one visit, which is especially important in settings where follow-up care is difficult to access. **You may be eligible if...** - You are a woman assigned female sex at birth (any gender identity), 25 years of age or older - You are HIV-positive - You have had precancerous cervical lesions removed more than 6 months ago - You speak Spanish **You may NOT be eligible if...** - You are currently pregnant, less than 6 weeks postpartum, or pregnancy cannot be ruled out - You had a LEEP procedure (cervical loop excision) within the past 6 months - You have had a hysterectomy (surgical removal of the uterus) - You have a previous diagnosis of gynecological cancer or cancer of the anogenital area - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERScreen, 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.


Locations(1)

Clínica de Familia La Romana

La Romana, Dominican Republic

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NCT07225530


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