Strategies to AchieVe Viral Suppression for Youth With HIV

Summary

Although there have been advances in antiretroviral treatment (ART) for HIV, adolescents and young adults living with HIV (AHIV) continue to have disparate HIV outcomes particularly viral suppression (VS), when compared to other populations likely related to multi-layered challenges (social determinants, cognitive development), system, and biomedical challenges including the reliance on oral ART as the only choice for HIV treatment. Given that approximately 1/3 of AHIV despite being in care fail to attain or sustain VS with resultant individual and public health risk, there is a need to develop real-world implementable interventions that can improve the participants virologic outcomes. The Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study aims to 1) optimize personal ART choice by using the HIV-ASSIST clinical program to inform CHOICE counseling regarding an AHIV's preferred approach, including the possibility of long-acting injectable ART (LAI-ART); 2) facilitate access to the participants preferred choice through deploying a focused team to navigate barriers to attaining LAI-ART; and 3) decipher and address the patient, provider, and systemic barriers to the uptake and routinization of LAI-ART among AHIV by applying an implementation science framework and assessing cost-effectiveness providing critical data to support comprehensive approaches to optimizing ART and VS for AHIV, a key population identified in the Ending the HIV Epidemic in the United States Initiative.

Conditions

• Human Immunodeficiency Virus (HIV) Infection

Interventions

OTHER

The SAVVY intervention includes CHOICE counseling and shared decision-making regarding ART preference (informed by the evidence-based HIV-ASSIST) and facilitating LA-ART access

The SAVVY intervention includes CHOICE counseling and shared decision-making regarding ART preference (informed by the evidence-based HIV-ASSIST) and facilitating LA-ART access to that choice through the deployment of the SLAT team. HIV-ASSIST is an interactive tool that offers clinicians comprehensive, individualized validated patient-specific ARV decision support along with evidence-based supporting educational material. The free online, interactive tool is designed to augment interpretation of current HIV clinical practice guidelines (CPG).It will be included in the CHOICE counseling providing participants with patient-centered approach, specifically addresses the patient's expressed needs, problems, issues and concerns with a goal of providing accurate and unbiased information on available choices. After CHOICE counseling, if the participant chooses LAI-ART, the participant is referred to the SAVVY LAI-ART access team (SLAT) to facilitate access.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Allison Agwu, MD, SCM · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-10

Primary Completion

2027-11-15

Completion

2028-07-31

Countries

• United States

Study Locations