Clinical and implementation outcomes of a point of care sexually transmitted infection testing strategy to improve HIV prevention service delivery in adolescents

The National Institute of Mental Health (NIMH), under the Mental Health Research Grants program (CFDA 93.242), awarded a $223,550 Project Grant to Icahn School of Medicine at Mount Sinai effective June 9, 2025, with completion targeted for June 8, 2027. The research initiative focuses on clinical and implementation outcomes of a point-of-care sexually transmitted infection (STI) testing strategy designed to improve HIV prevention service delivery in adolescents. The project addresses significant gaps in CDC-recommended HIV prevention services, with current data indicating that only 55% of youth seeking STI care receive HIV testing and 8% receive counseling on HIV pre-exposure prophylaxis (PrEP). The research will leverage point-of-care testing (POCT) technology for gonorrhea and chlamydia detection, which delivers results within 30 minutes compared to the standard 2-3 day laboratory-based testing timeline.

The grant supports a pragmatic pilot feasibility trial to test the hypothesis that GC/CT POCT will improve HIV testing, PrEP counseling, and PrEP delivery while serving as a feasible, acceptable, and appropriate implementation strategy in adolescents seeking STI testing in pediatric settings. This research represents the first clinical and implementation outcome evaluation of GC/CT POCT devices (FDA-approved in 2021) in routine pediatric care settings. By accelerating STI test results and heightening HIV risk perception among patients and clinicians, the initiative aims to create same-day access to HIV prevention services for adolescents already present in clinical settings, thereby closing critical evidence-to-implementation gaps in HIV prevention service delivery.

Abstract

While centers for disease control and prevention clinical practice guidelines recommend delivering HIV prevention services to all adolescents seeking sexually transmitted infection (STI) testing and treatment, only 55% of youth seeking STI care receive HIV testing and 8% are counseled on HIV pre-exposure prophylaxis (prep). These gaps in service delivery have persisted over the last decade, despite both STI rates being at an all-time historic high in adolescents and HIV disproportionally affecting adolescents and young adults. Innovative implementation strategies-discrete tools and practices to close evidence to implementation gaps- are needed to enhance HIV testing and prep delivery in adolescents. One such strategy is point of care testing (poct) for gonorrhea and chlamydia (GC/CT), which delivers test results within 30 minutes, rather than the standard 2-3 days for laboratory-based testing. The first GC/CT poct device was approved by the food and drug administration in 2021, but, as yet there are no clinical or implementation outcome data for GC/CT poct in routine pediatric settings. This new testing modality can increase opportunities for delivery of HIV testing and prep services by heightening HIV risk perception for patients and clinicians and allowing adolescents same- day access to HIV prevention services when they are already in clinic. The proposed research will test our overarching hypothesis-that GC/CT poct will improve HIV testing, prep counseling, and prep delivery and be a feasible, acceptable, and appropriate implementation strategy in adolescents seeking STI testing in pediatric settings-through a pragmatic pilot feasibility trial. Leveraging funding for the poct equipment and supplies provided through a penn centers for aids research equipment grant, in aim 1, we will use a phased implementation design to assess population and patient-level associations between test modality (poct versus laboratory-based) through analysis of electronic health record data from patients seeking STI testing (n~12000) at three diverse adolescent health clinics. We will use causal inference methods, including interrupted time series analysis and inverse probability regression adjustment, to strengthen the rigor of our statistical models. In aim 2, we will conduct an embedded mixed methods study using surveys and semi-structured interviews grounded in the health beliefs model and consolidated framework for implementation research to assess determinants and outcomes of feasibility, acceptability, and appropriateness of poct as an HIV prevention implementation strategy in clinicians and clinic staff (n~40) and adolescent patients (n~175). We will integrate these data into an implementation research logic model that will guide design of a type II effectiveness-implementation trial. This R21 will provide critical funding to support this clinical and implementation outcomes research, which will yield foundational data to inform a large-scale trial testing the clinical effectiveness of GC/CT poct, paired with various implementation strategies identified in this R21 research, as a strategy to improve HIV testing and prep delivery outcomes in pediatric settings.