Recruiting

LAI-ARTStrategies to AchieVe Viral Suppression for Youth With HIV

Sponsor:

Johns Hopkins University

Code:

NCT06886971

Conditions

Human Immunodeficiency Virus (HIV) Infection

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Study ID

NCT06886971

Start date

Nov 10, 2024

Status verified date

Feb, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

Number of participants who reach viral suppression [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Allison Agwu, MD, SCM

410-614-3917 ageorg10@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Allison Agwu, MD ScM

410-614-3917 ageorg10@jhmi.edu

Steven Huettner

4105504151 shuettn1@jhmi.edi

Principal Investigator:

Allison Agwu, MD ScM

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

adolescents
long-acting antiretroviral treatment
youth
young adu;ts
viral suppression
effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-04.