Same-day HPV screen-and-treat for women with HIV in La Romana
Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
This project will test whether offering same-day HPV screening and immediate treatment improves detection and treatment completion for Spanish-speaking women living with HIV in La Romana, Dominican Republic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (La Romana) |
| Trial ID | NCT07225530 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares an iSTAR same-day HPV-based screen-and-treat approach supported by a clinical decision support system (CDSS) against standard care among women living with HIV at Clínica de Familia La Romana. Eligible participants are Spanish-speaking people assigned female at birth, age 25 or older, living with HIV and not pregnant or recently treated for cervical precancer. Participants who screen positive for high-risk HPV will receive same-day triage and treatment per protocol, and key outcomes include treatment completion, retention in care, and implementation factors affecting scale-up. The study will identify facilitators and barriers to implementing single-visit screen-and-treat in a high-burden, low-resource setting.
Who should consider this trial
Good fit: Spanish-speaking people assigned female at birth who are 25 or older, living with HIV, able to provide informed consent, not pregnant or recently postpartum, and without recent LEEP, hysterectomy, or prior gynecologic cancer are ideal candidates.
Not a fit: People who are pregnant, less than six weeks postpartum, recently had a LEEP, have a hysterectomy or prior gynecologic cancer, or cannot provide informed consent are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase same-day treatment rates and reduce preventable cervical cancer cases and deaths among women living with HIV in the Dominican Republic.
How similar studies have performed: Single-visit HPV screen-and-treat programs have shown promising results in other low-resource settings, but evidence specifically for women living with HIV and CDSS-supported implementation remains limited.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
La Romana
- Clínica de Familia La Romana — La Romana, Dominican Republic (Recruiting)
Study contacts
- Principal investigator: Rebecca Schnall, PhD, MPH — Columbia University
- Study coordinator: Rebecca Schnall, PhD, MPH
- Email: rb897@columbia.edu
- Phone: 212-342-6886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.