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

NCT ID: NCT07225530

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-11-01

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 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

Keywords

People living with HIV (PLWH); Cervical cancer screening; Spanish speakers; HPV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Screen, Triage, and Treat

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Clínica de Familia La Romana, Dominican Republic

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Professor of Disease Prevention and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Clínica de Familia La Romana

La Romana, , Dominican Republic

Countries

Dominican Republic

Central Contacts

Rebecca Schnall, PhD, MPH

Role: CONTACT

Phone: 212-342-6886

Email: rb897@columbia.edu

Facility Contacts

Pamela Baez Caraballo, MD, MSc

Role: primary

Other Identifiers

U01CA275110

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAV3441

Identifier Type: -

Identifier Source: org_study_id