JMIR Publications

ABSTRACT

Background:

Despite significant advancements in HIV care, all components of the care continuum from diagnosis to antiretroviral treatment (ART) uptake and sustained virologic suppression (VS) are worse for adolescents and young adults with HIV (AHIV) (ages 12-30). ART adherence remains elusive for ≈60% of AHIV, impeding the goal of the Ending the HIV Epidemic in the United States Initiative (EHE). Even when AHIV are suppressed, medication fatigue and other factors threaten sustained virologic control. Long-acting injectable ART (LAI-ART) has the potential to improve the care continuum for AHIV.

Objective:

The Strategies to Achieve Viral Suppression for Youth with HIV Study (SAVVY) aims to evaluate the impact and implementation of an informed choice-counseling intervention on ART options, including its impact on intervention acceptability, participants’ ART selection and later facilitated access, and the clinical outcome of VS rates among AHIV. We also aim to assess determinants influencing LAI-ART implementation outcomes, guided by the Consolidated Framework for Implementation Research.

Methods:

SAVVY is a preference-guided, observational, type-1 effectiveness implementation study, investigating the efficacy of precision engagement approaches to patient counselling on options for ART that are approved for patients with viral load (VL) <50 copies/mL. Patients eligible for enrollment are AHIV (ages 12-30) engaged in clinical care and prescribed ART (N=288). All participants undergo CHOICE counseling (CC), where they are presented with and decide on their preferred ART options (oral ART [oART] or LAI-ART) using a computer-assisted precision engagement tool (HIV-ASSIST). The SAVVY LAI-ART Access Team facilitates [EW1.1][EO1.2]access and logistics for those who qualify for and choose LAI-ART. At entry, enrollees are divided into two cohorts: those with HIV RNA PCR VL ≥50 copies/mL (Cohort 1a) and those with VL <50 copies/mL (Cohort 1b). Cohort 1a participants are informed of VL requirements to qualify for LAI-ART, receive supportive messages and biweekly VL measurements [EW2.1][EW2.2]for three months, and are re-offered CC upon achieving VL<50 copies/mL. Enrollees with persistent VL ≥50 copies/mL at 3 months continue standard oART with the option of referral for LAI-ART once VL is <50 copies/mL. Cohort 1b participants undergo CC and can proceed to LAI-ART or maintain oART. The primary outcome is VS (VL<20 copies/mL), comparing the oART and LAI-ART groups. SAVVY is JHU IRB-approved and registered on clinicaltrials.gov (NCT06886971). The first participant was enrolled in November 2024 with full accrual anticipated in 36 months.

Results:

n/a

Conclusions:

SAVVY represents a pragmatic, feasible implementation strategy towards informed, personalized ART decision-making among AHIV, which could expand access to beneficial novel technologies. It aims to use the proven approach of youth-centered care, where treatment choices are self-driven by youth, to improve LAI-ART uptake and persistence[EW3.1], increase VS, and improve overall outcomes for AHIV.