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HIVNCT03109431

Stepped Care for Youth Living With HIV

A study testing Level 1, Level 2 and Level 3 in people with HIV and Mental Health, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 24 yearsHealthy volunteers can take part
Conditions the study is for
HIV, Mental Health, Illicit Substance Use
What is being tested?
Level 1, Level 2 and Level 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesUnited States
Study dates
6 May 2017to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of California, Los Angeles

    Los Angeles, California, 90024

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Level 1, Level 2, Level 3
Keywords
HIV Treatment Continuum, HIV Disease Progression, Mental Health, Substance Use, ARV Adherence, Retention in Care, STI
Medical subject headings
Psychological Well-Being, Sexually Transmitted Diseases, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Level 1Behavioural

    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 2Behavioural

    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 3Behavioural

    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.

Study groups in NCT03109431
Study groupRoleWhat they receive
Enhanced Standard CareExperimentalYouth 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.
Receives: Behavioral: Level 1
Stepped CareExperimentalYouth 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.
Receives: Behavioral: Level 1; Behavioral: Level 2; Behavioral: Level 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 month to 24 months

Secondary outcomes (5)
  1. Retention in Care

    At least two medical appointments annually, verified using medical charts

    Measured: 12 month to 24 months

  2. 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.

    Measured: 12 month to 24 months

  3. Reductions in Substance Use

    Rapid diagnostic tests (RDT) for alcohol, marijuana, methamphetamines, cocaine/crack, and opiates at each four-month assessment point

    Measured: 12 month to 24 months

  4. Sexual Partnerships

    Self-reported number of sexual partners, number of concurrent sexual partners, and condom use assessed at each four-month assessment point

    Measured: 12 month to 24 months

  5. Mental Health

    Self-reported symptoms of depression and anxiety

    Measured: 12 month to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start6 May 2017
  3. Primary completion31 May 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03109431
Sponsor's protocol ID
U19HD089886 - Study 2
Other IDs
U19HD089886
Status last verified
Dec 2022
First submitted
6 Apr 2017
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zanoni BC, Mayer KH. The adolescent and young adult HIV cascade of care in the United States: exaggerated health disparities. AIDS Patient Care STDS. 2014 Mar;28(3):128-35. doi: 10.1089/apc.2013.0345.

    PubMed 24601734
  • Hall HI, Holtgrave DR, Maulsby C. HIV transmission rates from persons living with HIV who are aware and unaware of their infection. AIDS. 2012 Apr 24;26(7):893-6. doi: 10.1097/QAD.0b013e328351f73f.

    PubMed 22313960
  • Gardner JM, Powell CA, Baker-Henningham H, Walker SP, Cole TJ, Grantham-McGregor SM. Zinc supplementation and psychosocial stimulation: effects on the development of undernourished Jamaican children. Am J Clin Nutr. 2005 Aug;82(2):399-405. doi: 10.1093/ajcn.82.2.399.

    PubMed 16087985
  • Belzer ME, Fuchs DN, Luftman GS, Tucker DJ. Antiretroviral adherence issues among HIV-positive adolescents and young adults. J Adolesc Health. 1999 Nov;25(5):316-9. doi: 10.1016/s1054-139x(99)00052-x.

    PubMed 10551660
  • Ferrand R, Ford N, Kranzer K. Maximising the benefits of home-based HIV testing. Lancet HIV. 2015 Jan;2(1):e4-5. doi: 10.1016/S2352-3018(14)00039-3. Epub 2014 Dec 23. No abstract available.

    PubMed 26424234
  • Garofalo R, Kuhns LM, Hotton A, Johnson A, Muldoon A, Rice D. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2016 May;20(5):1049-59. doi: 10.1007/s10461-015-1192-x.

    PubMed 26362167
  • Murphy DA, Belzer M, Durako SJ, Sarr M, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Longitudinal antiretroviral adherence among adolescents infected with human immunodeficiency virus. Arch Pediatr Adolesc Med. 2005 Aug;159(8):764-70. doi: 10.1001/archpedi.159.8.764.

    PubMed 16061785
  • Fernandez MI, Huszti HC, Wilson PA, Kahana S, Nichols S, Gonin R, Xu J, Kapogiannis BG. Profiles of Risk Among HIV-Infected Youth in Clinic Settings. AIDS Behav. 2015 May;19(5):918-30. doi: 10.1007/s10461-014-0876-y.

    PubMed 25117556
  • Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.

    PubMed 10877736
  • Bangsberg DR. Less than 95% adherence to nonnucleoside reverse-transcriptase inhibitor therapy can lead to viral suppression. Clin Infect Dis. 2006 Oct 1;43(7):939-41. doi: 10.1086/507526. Epub 2006 Aug 23.

    PubMed 16941380
  • Murphy DA, Wilson CM, Durako SJ, Muenz LR, Belzer M; Adolescent Medicine HIV/AIDS Research Network. Antiretroviral medication adherence among the REACH HIV-infected adolescent cohort in the USA. AIDS Care. 2001 Feb;13(1):27-40. doi: 10.1080/09540120020018161.

    PubMed 11177463
  • Beach MC, Keruly J, Moore RD. Is the quality of the patient-provider relationship associated with better adherence and health outcomes for patients with HIV? J Gen Intern Med. 2006 Jun;21(6):661-5. doi: 10.1111/j.1525-1497.2006.00399.x.

    PubMed 16808754
  • Schneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. J Gen Intern Med. 2004 Nov;19(11):1096-103. doi: 10.1111/j.1525-1497.2004.30418.x.

    PubMed 15566438
  • Palepu A, Milloy MJ, Kerr T, Zhang R, Wood E. Homelessness and adherence to antiretroviral therapy among a cohort of HIV-infected injection drug users. J Urban Health. 2011 Jun;88(3):545-55. doi: 10.1007/s11524-011-9562-9.

    PubMed 21409604
  • Hudelson C, Cluver L. Factors associated with adherence to antiretroviral therapy among adolescents living with HIV/AIDS in low- and middle-income countries: a systematic review. AIDS Care. 2015;27(7):805-16. doi: 10.1080/09540121.2015.1011073. Epub 2015 Feb 23.

    PubMed 25702789

Questions about this trial

What is this clinical trial studying?

A study testing Level 1, Level 2 and Level 3 in people with HIV and Mental Health, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral Suppression reflected as VL<200 (time frame: 12 month to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109431, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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