NCT07225530

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Dominican Republic (DR) has experienced a high burden of human immunodeficiency virus (HIV) over the last two decades. Unlike the United States, women are represented in almost equal numbers to men in the population living with HIV. Cervical cancer is the most common cancer among Women Living with HIV (WLH) and WLH are more likely to be infected with HPV and have persistent human papillomavirus (HPV) infection leading to precancer. Additionally, Latin America and the Caribbean are second only to sub-Saharan Africa in their cervical cancer burden. The DR has both a higher incidence of cervical cancer and a higher mortality rate from cervical cancer than the rest of the Caribbean. In fact, cervical cancer is the leading cause of cancer death for women 15-44 years of age in the DR. Cervical cancer persists in the DR largely because of the failure of routine screening. Coverage for cervical cancer screening is less than 50%, and fewer than 25% of the screen-positives complete the full round of follow-up care. Screening programs are critical so that every woman with precursor lesions is treated, and avoidable deaths are prevented. For a cervical cancer prevention and control program to have impact, retention in a full cycle of screening and treatment is fundamental. The purpose of this randomized clinical trial (RCT) is to evaluate, through use of a clinical decision support system (CDSS), the effectiveness of primary screening for HPV using either the iSTAR approach with same day results return and same-day treatment for those eligible compared to standard of care (SOC). The iSTAR approach circumvents the multistep screening process by conducting the screening test (HPV), the triage step (HPV VL), and if suitable for ablative therapy, the treatment procedure (thermocoagulation) in a single visit. Those who are HPV positive and meet the HPV VL triage criteria but are not suitable for ablative therapy (large lesions, upper limit not seen, etc.) are referred to colposcopy services. This study will allow us to evaluate potential strategies for ensuring widespread implementation of Screen, Triage, and Treat in future work.

Conditions

• HIV Infections
• HPV Infection
• Cervical Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-23
• Primary completion: 2029-05-01
• Completion: 2029-11-01
• First posted: 2025-11-06
• Last updated: 2026-02-25

Locations

1 site across 1 country: Dominican Republic