Strategies to AchieVe Viral Suppression for Youth With HIV

NCT06886971 | Recruiting DMC

• 2 other identifiers: IRB00421059R01MH134724
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants who reach viral suppression

  Viral suppression (VL\<20 copies/mL)

  12 months

Secondary Outcomes (4)

• Health related quality of life (HRQOL) as assessed by the Short Form 12 (SF-12)

  12 months

• Self-Efficacy as assessed by the Self-efficacy scale

  12 months

• Barriers to treatment adherence

  12 months

• HIV stigma scale

  12 months

Study Arms (2)

Virally suppressed at entry (VL<50 copies/mL)

OTHER

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: 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

Not virally suppressed at entry (VL >= 50 copies/mL)

OTHER

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.

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

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 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 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.

Also known as: CHOICE counseling, HIV-ASSIST

Not virally suppressed at entry (VL >= 50 copies/mL); Virally suppressed at entry (VL<50 copies/mL)

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Allison Agwu, MD, SCM

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Agwu, MD, SCM

CONTACT

410-614-3917; ageorg10@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: November 10, 2024
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)