Clinical trial NCT06886971: Strategies to AchieVe Viral Suppression for Youth With HIV
Official title: Strategies to AchieVe Viral Suppression for Youth With HIV (The SAVVY Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV) Infection
Keywords: adolescents
long-acting antiretroviral treatment
youth
young adu;ts
viral suppression
effectiveness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-20
Enrollment: 288
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The SAVVY intervention includes CHOICE counseling and shared decision-making regarding ART preference (informed by the evidence-based HIV-ASSIST) and facilitating long-acting injectable ART (LAI-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 antiretroviral (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). SAVVY will use HIV-ASSIST and CHOICE counseling (an evidence-based strategy addressing patient knowledge about effectiveness, advantages, and identified needs) to facilitate selection of participants preferred treatment strategy and then evaluate outcomes (HIV (viral suppression) and quality of life indicators)). SAVVY will also evaluate uptake of long-acting injectable over the study period.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Adolescents and young adults (AHIV) ages 12-30 years have disproportionately poorer outcomes across the HIV care continuum, including lower rates of adherence to oral ART (oART) and viral suppression (VS) than older adults, correlating with individual risk of poor health and disease progression and public health risk of secondary transmission. AHIV are a priority population in the Ending the HIV Epidemic in the United States Initiative (EHE). Unique multi-layered factors (e.g., cognitive development, psychosocial determinants, system barriers) underlie AHIV's nonadherence and VS; therefore, AHIV-specific interventions are needed to address those factors and ultimately improve VS. Toward this aim, the investigators has shown that AHIV are more likely to be retained in care and achieve and maintain VS if cared for at clinics with youth-friendly structures and services, more likely to achieve VS with single tablet regimens (STR) vs. multi-tablet oral ART (oART) regimens, and have high interest in ART strategies not taken orally, specifically long-acting injectable ART (LAI-ART). These findings underscore the importance of engaging AHIV in decision-making and providing access to alternative biomedical strategies that obviate daily adherence, like LAI-ART, should the participant choose. Though uptake and roll-out has been slow, LAI-ART (cabotegravir/rilpivirine) administered q4-8 weeks has been approved for HIV treatment in those \>12 years-old who have achieved VS-excluding up to 50% of all AHIV due to the decreased likelihood of VS. The investigators have reported provider biases and disparities in ART initiation by patient age and have concern that AHIV may have decreased access to LAI-ART, resulting in a tiered system that precludes LAI-ART access from those who may want and benefit from it most. AHIV need biomedical and care delivery innovations to address the challenges meeting EHE goals by optimizing feasibility of delivering novel biomedical tools for AHIV through minimizing medication and healthcare system barriers. The central hypothesis of the Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study is that informed choice, counseling on ART options, and facilitating access, will increase rates of achieving and sustaining VS among AHIV. The study proposes to present and solicit informed choice of ART among both AHIV with and without VS, including facilitating LAI-ART (if VS can be achieved). For AHIV who prefer LAI-ART, the SAVVY intervention will support AHIV in successfully meeting or maintaining criteria (VL\<50 copies/mL) for LAI-ART consideration, and deploy a focused team that facilitates access to LAI-ART. Study outcomes include VS and health-related quality of life (HRQOL) for AHIV undergoing the SAVVY intervention, identification of implementation barriers utilizing an established implementation science framework, and assessment of the cost-effectiveness of SAVVY using an economic-epidemiologic model. The investigators interdisciplinary team has expertise to implement the SAVVY study and the investigators anticipate that the results of The SAVVY study will inform the real-world implementation and optimization of LAI-ART AHIV toward reducing disparities in outcomes and ending the epidemic for the key population of AHIV.

Eligibility criteria: Inclusion Criteria:

* prescribed ART,
* willing to sign informed consent (including communication with one's primary HIV provider)

Exclusion Criteria:

* Relevant drug resistance mutations (per medical record) that compromises activity of Cabotegravir (CBG) + rilpivirine (RPV)
* disallowed medications,
* 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,
* plan to move away in the next 12 months.

Primary outcomes:
measure: Number of participants who reach viral suppression
timeFrame: 12 months
Secondary outcomes:
measure: Health related quality of life (HRQOL) as assessed by the Short Form 12 (SF-12)
timeFrame: 12 months
measure: Self-Efficacy as assessed by the Self-efficacy scale
timeFrame: 12 months
measure: Barriers to treatment adherence
timeFrame: 12 months
measure: HIV stigma scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Allison Agwu, MD, SCM
role: PRINCIPAL_INVESTIGATOR
References: