Stepped Care for Youth Living With HIV
Condition: HIV; Mental Health; Illicit Substance Use; Sexually Transmitted Infections (STI)
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional

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.
    

Detailed description: 
      Viral suppression requires linkage and retention in care, as well as ARV adherence. These are
      key steps on the HIV Treatment Continuum. Youth Living with HIV (YLH) are far less likely to
      link or be retained in care, compared to adults. Only 36%-62% of YLH who know their
      serostatus are linked to medical care within 12 months of diagnosis. Young people are also
      more likely to drop out from care than adults 25+ years old. Among one sample was YLH
      (atypically 72% female), initial ARV adherence of 69%; but by one year, ARV adherence was
      negligible, because only 30% were retained in care. In one ATN study, of YLH, ARV adherence
      appeared to be about 50%. Originally an undetectable viral load was expected to require 95%
      ARV adherence. However rates as low as 70% may lead to viral suppression.

      In this study, our primary outcome measure will be having a suppressed viral load (i.e., VL<
      200) at each four month assessment for 12 months. Viral suppression typically requires
      adherence to ARV for 24 weeks until an undetectable viral load is achieved. There are many
      interpersonal and logistical barriers to retaining YLH in care and on ARV consistently. ARV
      adherence is related to the patient-provider relationship and to perceived side effects, the
      prescribed regimen, ease of getting ARV refills and a number of personal factors. Medication
      regimens are becoming much easier, as one pill a day is now one of the most highly used
      regimens. Unfortunately, the problem behaviors that lead to acquisition of HIV by YLH are
      factors which are consistently related to low adherence. Low adherence for both YLH and
      adults living with HIV is associated with younger age, depression, substance abuse and
      homelessness. Each of these challenges characterizes the lives of the YLH. The interventions
      proposed focus a great deal on problem-solving, automated messages, and monitoring of these
      comorbid conditions, so that ARV adherence is not derailed.

      This study has a comprehensive retention plan to retain YLH. This plan will be particularly
      relevant to YLH nationally, who face challenges of homelessness, mental health problems,
      school-job issues, contact with criminal justice system and risks within their sexual
      partnerships, in addition to their seropositive HIV status. YLH are likely to deal with
      coming out as gay, bisexual or transgender, have substantial family conflict, to have abused
      drugs, may barter sex in order to survive and have a history of mental health problems or
      disorders. Studies of ARV adherence and retention in care have consistently found depression
      and the types of life challenges young people are experiencing to be directly related to
      engagement, retention and adherence to care over time. If the investigators fail to address
      these comorbid issues with YLH, they expect YLH to fail at achieving viral suppression.

      Our Stepped Care approach aims to address these issues with increasingly intensive
      interventions, based on individual YLH's needs. While addressing comorbid issues may be more
      costly, it may have substantial saving in the YLH's lowered probability of transmitting HIV.

      Stepped Care has been used as an intervention strategy with other chronic diseases and mental
      health disorders; the investigators believe this will be the first evaluation of stepped care
      with YLH. The Stepped Care model is a cost-effective and patient-centered approach for
      achieving better treatment outcomes for chronic illnesses. Under the Stepped Care model,
      simpler interventions are tried first with more intensive interventions reserved for those
      who do not benefit from the simple first-line treatments. Stepped Care might be an efficient
      method of delivering successfully more intensive interventions based on the YLH's behavior.
      If at any assessment (past a 12 month period when ARV initiated), a YLH in the Stepped Care
      condition demonstrates an unsuppressed viral load, the next level of intervention is
      triggered. The strategy typically makes best use of available resources for allocating
      resources to patients. Rather than everyone getting the same intervention, the dose and type
      of intervention is linked to outcomes.

      An Automated Messaging and Monitoring (AMMI) is being proposed as the Enhanced Standard Care
      and the Level 1 of the Stepped Care Intervention. Both daily text messages, which aim to
      motivate, inform and encourage usage of care, and weekly probes regarding YLH's risk
      behaviors have been repeatedly linked to outcomes for a variety of conditions and
      populations. The investigators will tailor and adapt pre-existing libraries of
      theoretically-based messages that have been found successful in other RCTs with populations
      similar to this study - adults with HIV, transgender women, methamphetamine-using men who
      have sex with men (MSM) - for the YLH in this study. This is included with the Enhanced
      Standard Care condition as implementing an AMMI intervention is low-cost and easily scalable.

      Level 2 of the Stepped Care Intervention will be electronically-based peer support, plus AMMI
      tailored to the YLH. Positive relationships are the second major dimension related to
      retention in care and adherence to ARV medications. Reviews of peer support among persons
      living with HIV, aimed at reducing stress, demonstrate peer support to be a critical
      intervention component. Peer support will be delivered through online, private social media
      groups. YLH will be incentivized to participate in online, private social media groups (i.e.,
      posting and responding to topics) for period(s) of 4 months.

      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 Treatment
      Continuum, and other relevant topics. Coaches and Project Coordinators will be available to
      provide factual information (as needed), and remove inappropriate content.

      Coaching - Level 3 - is the most intensive strategy for securing viral suppression and ARV
      adherence among YLH. Coaching has been used specifically to support families: to increase
      healthy eating and exercise, to enhance patient self-management and improve outcomes, to
      reduce community violence and domestic violence, to provide family therapy when some family
      members refuse, and to improve parenting skills around health and behavioral challenges. Now
      referred to as health coaching, these strategies differ from traditional health education by
      emphasizing goal-setting, problem-solving, and skill building. Coaching addresses multiple
      risk factors concurrently and aims to problem-solve emerging challenges.

      This study will provide guidelines on how to implement Evidence-Based Practices, rather than
      replicating with fidelity an evidence-based intervention manual.
    

Intervention name(s): Level 1; Level 2; Level 3
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV Treatment Continuum; HIV Disease Progression; Mental Health; Substance Use; ARV Adherence; Retention in Care; STI