Positive Steps to Enhance Problem Solving Skills

Study Overview
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Brief Summary
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This randomized control trial is to test the efficacy of a stepped-care adaptive Antiretroviral Therapy (ART) adherence intervention (Positive STEPS) for HIV infected adolescents and young adults, ages 16 to 29. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.

Detailed Description
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HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to: Positive STEPS - a stepped care, adherence intervention with integrated technology (2-way daily text messaging aimed at improving ART adherence). If text messaging is not sufficient to overcome the barriers to ART adherence;these individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy. Standard of Care comparison group including a brief adherence educational session. This will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.The participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness.

Official Title
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Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth

Conditions
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Adherence

Intervention / Treatment
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* Behavioral: Positive STEPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 16 and 29 years of age HIV-infected (perinatally, transfusion, or behaviorally-acquired) Currently taking or prescribed antiretroviral therapy and: 1) Began taking ART < 3 months ago, OR 2) Has been taking ART for >3 AND has missed one or more doses in the past week or more than 3 doses in the past month. Daily access to a cell phone Has lived in the greater Providence, Boston, or Chicago area greater than three months Self-reports < 90% ART medication adherence in the past month (i.e., missed one or more doses in the past week or more than 3 doses in the past month) at screening Able to speak and understand English Not currently enrolled in another ART-adherence intervention study Willing and able to complete all study visits in person or remotely via video conferencing platform Exclusion Criteria: Unable to give informed consent due to severe mental or physical illness, cognitive limitation, or substance intoxication at baseline visit HIV-uninfected Not currently on antiretroviral therapy Does not own a cell phone Has lived in the greater Providence, Boston, or Chicago area for less than three months or is planning to move outside the area within the next year Self-reports > 90% ART medication adherence in the past month AND has been taking ART for more than 3 months Unable to speak and understand English Currently enrolled in another ART-adherence intervention study Not willing to and able to complete all study visits in person or remotely via video conferencing platform

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive STEPS<br>Step 1) all participants randomized to the experimental condition will receive low-intensity, daily two-way SMS texts of personalized reminders to take medications as prescribed (social-cognitive cues). If a participants demonstrates >90% adherence they will remain on step one. Participants who continue to have difficulty adhering to their HIV medications at one month after baseline or anytime up to the end of month three (weeks five through twelve) will progress to Step 2) Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes. | Behavioral: Positive STEPS<br>* Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.<br>|
| No Intervention: Standard of Care<br>The standard health services offered at each site (e.g., mental health services, case management) and a brief adherence educational session. This will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.The participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced HIV Viral Load | Blood specimen collection tested for HIV Viral Load | Baseline, 4 month, 8 month, 12 month | 
| ART Medication Level in Hair Sample | Collection of hair sample to measure level of ART | Baseline, 4 month, 8 month, 12 month | 
| Daily ART adherence | Monitoring of Wisepill device for electronic adherence data | 4 month, 8 month, 12 month | 
| Daily ART Adherence | Self report via research assessment | Baseline, 4 month, 8 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced HIV Symptoms | Medical record review for increase or decrease in symptoms associated with HIV | Baseline, 4 month, 8 month, 12 month | 
| Engagement in HIV Care | Number of kept versus number of scheduled visits verified by medical record | Baseline, 4 month, 8 month, 12 month | 
| Medication changes to ART | Verified by medical record | Baseline, 4 month, 8 month, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, ART Adherence, Adolescents