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

Inclusion Criteria11

  • 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
  • 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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07225530


Related Trials