SAVVY Intervention for HIV
(SAVVY Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAllison Agwu, MD, SCM

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adolescents and young adults living with HIV who face challenges in achieving viral suppression. It's designed to help those struggling with the standard oral ART treatment by offering personalized options, including long-acting injectable ART.

Inclusion Criteria

Willing to sign informed consent (including communication with one's primary HIV provider)

I am on antiretroviral therapy.

Exclusion Criteria

Pregnancy

Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair participation

Severe illness/hospitalization at the time of enrollment

+3 more

Participant Groups

The SAVVY study tests a new approach called CHOICE counseling combined with an evidence-based tool, HIV-ASSIST, to optimize personal ART choice. It also aims to facilitate access to long-acting injectable ART and understand barriers in its uptake.

2Treatment groups

Experimental Treatment

Group I: Virally suppressed at entry (VL<50 copies/mL)Experimental Treatment1 Intervention

Participants are on ART and are currently virally suppressed. Participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. The SAVVY long-acting access team (SLAT) will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.

Group II: Not virally suppressed at entry (VL >= 50 copies/mL)Experimental Treatment1 Intervention

Participants are on ART and are currently not virally suppressed. The participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. As the participant will not be able to switch to LAI-ART given the viremic state, the participant will have q2 week monitoring (for 3 months) of the viral load and if the participant becomes suppressed will then be offered CHOICE counseling again and can select at that point if the participant wants to stay on oral or transition to LAI-ART. The SAVVY long-acting access team will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. If the participant has not become suppressed by 3 months the participant would continue to be monitored by standard of care practices. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.