Stepped Care for Youth Living With HIV
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03109431 |
Recruitment Status :
Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV Mental Health Illicit Substance Use Sexually Transmitted Infections (STI) | Behavioral: Level 1 Behavioral: Level 2 Behavioral: Level 3 | Not Applicable |

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 : | May 31, 2021 |
Estimated Study Completion Date : | May 31, 2022 |
Arm | Intervention/treatment |
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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.
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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. |
- 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.
- Retention in Care [ Time Frame: 12 month to 24 months ]At least two medical appointments annually, verified using medical charts
- ARV Adherence [ Time Frame: 12 month to 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.
- Reductions in Substance Use [ Time Frame: 12 month to 24 months ]Rapid diagnostic tests (RDT) for alcohol, marijuana, methamphetamines, cocaine/crack, and opiates at each four-month assessment point
- Sexual Partnerships [ Time Frame: 12 month to 24 months ]Self-reported number of sexual partners, number of concurrent sexual partners, and condom use assessed at each four-month assessment point
- Mental Health [ Time Frame: 12 month to 24 months ]Self-reported symptoms of depression and anxiety

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90024 | |
United States, Louisiana | |
Tulane University Health Sciences Center | |
New Orleans, Louisiana, United States, 70112 |
Principal Investigator: | Mary Jane Rotheram-Borus, PhD | University of California, Los Angeles |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mary Jane Rotheram-Borus, Principal Investigator, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT03109431 |
Other Study ID Numbers: |
U19HD089886 - Study 2 U19HD089886 ( U.S. NIH Grant/Contract ) |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
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 |
HIV Treatment Continuum HIV Disease Progression Mental Health Substance Use |
ARV Adherence Retention in Care STI |
Sexually Transmitted Diseases Infection Virus Diseases |