Stepped Care for Youth Living With HIV

HIV Clinical Trial

Official title:

Optimizing the HIV Treatment Continuum With a Stepped Care Model for Youth Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109431
• Other study ID #: U19HD089886 - Study 2
• Secondary ID: U19HD089886
• Status: Completed
• Phase: N/A
• Start date: May 6, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Illicit Substance Use
• Mental Health
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (STI)
• Substance-Related Disorders

Intervention

Behavioral:
• Level 1
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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	Tulane University Health Sciences Center	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Tulane University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Retention in Care	At least two medical appointments annually, verified using medical charts	12 month to 24 months
Secondary	ARV Adherence	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.	12 month to 24 months
Secondary	Reductions in Substance Use	Rapid diagnostic tests (RDT) for alcohol, marijuana, methamphetamines, cocaine/crack, and opiates at each four-month assessment point	12 month to 24 months
Secondary	Sexual Partnerships	Self-reported number of sexual partners, number of concurrent sexual partners, and condom use assessed at each four-month assessment point	12 month to 24 months
Secondary	Mental Health	Self-reported symptoms of depression and anxiety	12 month to 24 months

External Links

•   AIDS Action Committee. (2015). Adolescents, young adults & the HIV/AIDS continuum.
•   CDC. (2011). HIV among youth in Atlanta.