Positive Steps to Enhance Problem Solving Skills

Not Applicable

Completed

Brief Summary: 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: HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to:

1. "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.

2. 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Positive STEPS	Positive STEPS	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (4): Brown University School of Public Health
🇺🇸
Providence, Rhode Island, United States
UCLA Center for LGBTQ+ Advocacy, Research & Health
🇺🇸
Los Angeles, California, United States
Lurie Childrens Hospital
🇺🇸
Chicago, Illinois, United States
Fenway Health Institute
🇺🇸
Boston, Massachusetts, United States