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Stepped Care for Youth Living With HIV

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ClinicalTrials.gov Identifier: NCT03109431
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wake Forest University Health Sciences
Tulane University Health Sciences Center
Columbia University
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles

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 24 month follow-up period. The goal is to optimize the HIV Treatment Continuum over 24 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.

Condition or disease Intervention/treatment Phase
HIV Mental Health Illicit Substance Use Sexually Transmitted Infections (STI) Behavioral: Level 1 Behavioral: Level 2 Behavioral: Level 3 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing the HIV Treatment Continuum With a Stepped Care Model for Youth Living With HIV
Actual Study Start Date : May 6, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Enhanced Standard Care

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

Youth will receive 1-5 text messages per day for 24 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.


Experimental: Stepped Care
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

Youth will receive 1-5 text messages per day for 24 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.


Behavioral: Level 2

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.


Behavioral: Level 3
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.




Primary Outcome Measures :
  1. Viral Suppression reflected as VL<200 [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Retention in Care [ Time Frame: 24 months ]
    At least two medical appointments annually, verified using medical charts

  2. ARV Adherence [ Time Frame: 24 months ]
    Adherence is assumed through decreasing viral loads. Viral loads are assessed using Quest Diagnostics HIV-1 quantitative real time-PCR to measure HIV-1 RNA levels.

  3. Reductions in Substance Use [ Time Frame: 24 months ]
    Rapid diagnostic tests (RDT) for alcohol, marijuana, methamphetamines, cocaine/crack, and opiates at each four-month assessment point

  4. Sexual Partnerships [ Time Frame: 24 months ]
    Self-reported number of sexual partners, number of concurrent sexual partners, and condom use assessed at each four-month assessment point

  5. Mental Health [ Time Frame: 24 months ]
    Self-reported symptoms of depression and anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109431


Contacts
Contact: Mary Jane Rotheram-Borus, PhD (310) 794-8278 mrotheram@mednet.ucla.edu
Contact: Julia Tubert, BA (310) 794-8278 Jtubert@mednet.ucla.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Sung-Jae Lee, PhD    310-794-0357    sjlee@mednet.ucla.edu   
Contact: Maryann Koussa, MPH    (310) 794-1260    mkoussa@mednet.ucla.edu   
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Leslie Kozina, RN    504-988-5348    lkozina@tulane.edu   
Sponsors and Collaborators
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wake Forest University Health Sciences
Tulane University Health Sciences Center
Columbia University
Investigators
Principal Investigator: Mary Jane Rotheram-Borus, PhD University of California, Los Angeles

Additional Information:
Publications:
Van Zandvoort M, Irwin JD, Morrow D. The impact of co-active life coaching on female university students with obesity. International Journal of Evidence Based Coaching and Mentoring. 2009;7(1):104-18.
Kliewer W, Murrelle L, Prom E, Ramirez M, Obando P, Sandi L, Karenkeris MD. Violence exposure and drug use in central american youth: Family cohesion and parental monitoring as protective factors. Journal of Research on Adolescence. 2006;16(3):455-77.
Morawska A, Stallman HM, Sanders MR, Ralph A. Self-directed behavioral family intervention: Do therapists matter? Child & Family Behavior Therapy. 2005;27(4):51-72.
Butterworth S, Linden A, McClay W. Health Coaching as an Intervention in Health Management Programs. Disease Management and Health Outcomes. 2007;15(5):299-307.

Responsible Party: Mary Jane Rotheram-Borus, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03109431     History of Changes
Other Study ID Numbers: U19HD089886 - Study 2
U19HD089886 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Jane Rotheram-Borus, University of California, Los Angeles:
HIV Treatment Continuum
HIV Disease Progression
Mental Health
Substance Use
ARV Adherence
Retention in Care
STI

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female