Positive Steps to Enhance Problem Solving Skills (STEPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Adherence
• Intervention / Treatment: Behavioral: Positive STEPS

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for LGBTQ+ Advocacy, Research & Health
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Childrens Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Health Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Positive STEPS; Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.
No Intervention: Standard of Care; 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?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Brown University
• Investigators: Principal Investigator: Matthew J Mimiaga, ScD, MPH, UCLA, School of Public Health, Department of Epidemiology, Fielding School of Public Health; Principal Investigator: Robert Garofalo, MD, Lurie Children's Hospital

Publications and helpful links

General Publications

• Klasko-Foster LB, Biello KB, Lodge W 2nd, Olson J, Mimiaga MJ. Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct HIV-Focused Interventions. Telemed J E Health. 2022 Jul;28(7):1070-1073. doi: 10.1089/tmj.2021.0190. Epub 2022 Jan 6.
• Mimiaga MJ, Kuhns LM, Biello KB, Olson J, Hoehnle S, Santostefano CM, Hughto JMW, Safi H, Salhaney P, Chen D, Garofalo R. Positive STEPS - a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol. BMC Public Health. 2018 Jul 13;18(1):867. doi: 10.1186/s12889-018-5815-9.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; HIV; ART Adherence
• Other Study ID Numbers: 1R01NR017098-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Present at least annually on data collected after the second year when sufficient baseline data is collected. Randomized controlled efficacy trial, we anticipate that most of the papers and data-based projects and presentations will happen in year 5, once baseline data and follow-up assessments have occurred. Sharing findings will involve several papers, including a baseline paper, intervention-specific paper, primary paper describing the study outcomes, secondary outcomes papers and potentially a book that describes the intervention, submitting to lead workshops on the intervention approach at relevant national and international meetings and conferences. Raw data for additional analysis will be available by contacting the Principal Investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No