Stepped Care for Youth Living With HIV

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 24 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 24 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.

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