Stepped Care for Youth Living With HIV (NCT03109431) | Clinical Trial Compass
CompletedNot Applicable
Stepped Care for Youth Living With HIV
United States170 participantsStarted 2017-05-06
Plain-language 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.
Who can participate
Age range
12 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.