Strategies to AchieVe Viral Suppression for Youth With HIV (The SAVVY Study)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 30
Healthy Volunteers: f
View:

• prescribed ART,

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

Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Allison Agwu, MD, SCM
ageorg10@jhmi.edu
410-614-3917
Time Frame
Start Date: 2024-11-10
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 288
Treatments
Other: Virally suppressed at entry (VL<50 copies/mL)
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.
Other: Not virally suppressed at entry (VL >= 50 copies/mL)
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov