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

Not Applicable

Not yet recruiting

• Conditions: HIV Infections; HPV Infection; Cervical Cancer

• Registration Number: NCT07225530
• Lead Sponsor: Columbia University

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.

Detailed Description

The Dominican Republic (DR) has experienced a high burden of humman immunnodeficiency 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.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-04
• Study First Submitted QC: 2025-11-04
• Last Update Submitted: 2025-11-04
• Study First Posted: 2025-11-06
• Last Update Posted: 2025-11-06
• Study Start: 2025-12-01
• Primary Completion: 2029-05-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 25 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

Exclusion Criteria

• ages outside of the specified inclusion criteria;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Screen-positives Completing Full Screening Cascade	2 Months	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.
Percentage of Women in the HPV+VL Triage Negative Group	Day 1	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.

Trial Locations

Locations (1)

Clínica de Familia La Romana; 🇩🇴 La Romana, Dominican Republic