Stepped Care for Youth Living With HIV

NCT03109431 | Completed DMC

• 2 other identifiers: U19HD089886 - Study 2U19HD089886
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

Optimizing the HIV Treatment Continuum with a Stepped Care Model for Youth Living with HIV (YLH) aims to achieve viral suppression among YLH. A cohort of 220 YLH will be identified in Los Angeles, CA and New Orleans, LA and recruited into a randomized controlled trial (RCT) with reassessments every 4 months over a 12 month follow-up period. The goal is to optimize the HIV Treatment Continuum over 12 months. YLH will be randomized into one of two study conditions: 1) Enhanced Standard Care Condition (n=110); or 2) Stepped Care (n=110). The Enhanced Standard Care condition will consist of an Automated Messaging and Monitoring Intervention (AMMI) with daily motivational, instructional and referral text messaging, and a brief weekly monitoring survey. The Stepped Care Condition will consist of three levels. Level 1 is the Enhanced Standard Care Condition. Level 2 is the Enhanced Standard Care Condition plus peer support using social media. Level 3 is the Enhanced Standard Care Condition and peer support plus coaching, which will be delivered primarily through electronic means (e.g., social media, text messaging, email, phone). All participants in the Stepped Care Condition begin at Level 1 but if they fail to have a suppressed viral load at any four-month assessment point, their intervention level will increase by one step until reaching Level 3.

Conditions

HIV; Mental Health; Illicit Substance Use; Sexually Transmitted Infections (STI)

Keywords

HIV Treatment Continuum; HIV Disease Progression; Mental Health; Substance Use; ARV Adherence; Retention in Care; STI

Outcome Measures

Primary Outcomes (1)

• Viral Suppression reflected as VL<200

  Viral loads to be monitored at each 4-month assessment point using a blood draw and Quest Diagnostics HIV-1 quantitative real time-PCR in a research laboratory to measure HIV-1 RNA levels.

  12 month to 24 months

Secondary Outcomes (5)

• Retention in Care

  12 month to 24 months

• ARV Adherence

  12 month to 24 months

• Reductions in Substance Use

  12 month to 24 months

• Sexual Partnerships

  12 month to 24 months

• Mental Health

  12 month to 24 months

Study Arms (2)

Enhanced Standard Care

EXPERIMENTAL

Youth randomized to the Enhanced Standard Care arm will receive an Automated Messaging and Monitoring Intervention (AMMI), which involves receiving 1-5 texts per day to motivate, inform and refer to HIV care and health services. Message banks will focus on the HIV Treatment Continuum, with libraries dedicated to healthcare, wellness, sexual health, drug use and ARV adherence for YLH. Youth will also receive a weekly monitoring survey that covers six domains related to the HIV Treatment Continuum, including: ARV adherence, condomless sex, potential symptoms of STI, excessive use of alcohol and/or drugs, feelings of sadness or depression, and housing or food insecurity.

Behavioral: Level 1

Stepped Care

EXPERIMENTAL

Youth randomized to the Stepped Care arm will receive up to three levels of intervention, depending on whether or not they have achieved viral suppression at each four-month assessment point. All youth will begin at Level 1 which is the same as the Enhanced Standard Care arm. If they fail to achieve viral suppression at a reassessment in four months, they will be moved to Level 2, which includes both Level 1 and enrollment in private, online peer support groups. If they fail to achieve viral suppression at another four-month assessment point, they will be moved to Level 3, which includes both Levels 1-2 and Coaching. Coaches will provide support using a strengths-based coaching approach.

Behavioral: Level 1; Behavioral: Level 2; Behavioral: Level 3

Interventions

Level 1 BEHAVIORAL

Youth will receive 1-5 text messages per day for at least 12 months. Banks of about 750 messages (70-120 messages per domain) focus on the HIV Treatment Continuum, with messages focused on dedicated to healthcare, wellness, sexual health, drug use and medication reminders. Youth will be able to choose the time and frequency that they receive daily texts. Preferences for the timing and type of messages can be updated at 4-month assessment points. Youth will complete weekly monitoring surveys by text message. The survey will cover six domains related to the HIV Treatment Continuum. If YLH do not respond to the text, reminder messages will be sent to the youth. After three days of non-response a follow-up call by an interviewer will be made to the YLH.

Enhanced Standard Care; Stepped Care

Level 2 BEHAVIORAL

Youth will be enrolled in online, private discussion groups. Peer Support will be offered by fellow participants and/or Youth Advisory Board members that have been trained in basic information on HIV, STI, drug use, mental health, homelessness, and stigma; using social media to create wall posts and use chat functions; and, how to initiate conversations on sensitive topics. By posting and responding to messages, Peer Supporters will encourage and broadly guide conversation related to the HIV Prevention Continuum, and other relevant topics. Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content.

Stepped Care

Level 3 BEHAVIORAL

Youth will have be assigned to a Coach trained in a strengths--based Coaching intervention, as well as common foundational theory, principles and skills used in adolescent HIV Evidence-Based Interventions (EBI). Youth preferences will drive the intervention delivery - whether in-person, electronically via the phone, email, text message, social media private messaging.

Stepped Care

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV-positive serostatus
• Established HIV infection (not acutely infected)
• Able to provide informed consent

You may not qualify if:

• Youth under 12 years of age or above 24 years of age
• HIV-negative (high-risk HIV-negative youth will be invited to participate in another study)
• Acutely infected with HIV (RNA test will determine whether HIV infection is acute or established; acutely infected youth will be invited to participate in another study, once they are stable)
• Unable to understand the study procedures due to intoxication or cognitive difficulties (any youth who appear to be under the influence of alcohol or drugs will be unable to enroll in the study but invited to return at a later date)
• Unable to provide voluntary written informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Tulane University Health Sciences Center: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

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Related Links

• AIDS Action Committee. (2015). Adolescents, young adults \& the HIV/AIDS continuum.

MeSH Terms

Conditions

Psychological Well-Being; Sexually Transmitted Diseases; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mary Jane Rotheram-Borus, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: May 6, 2017
• Primary Completion: May 31, 2022
• Study Completion: November 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)