Positive Steps to Enhance Problem Solving Skills

NCT03092531 | Completed DMC

• 1 other identifier: 1R01NR017098-01A1
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 4

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.

Conditions

Adherence

Keywords

HIV; ART Adherence; Adolescents

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Reduced HIV Symptoms

  Baseline, 4 month, 8 month, 12 month

• Engagement in HIV Care

  Baseline, 4 month, 8 month, 12 month

• Medication changes to ART

  Baseline, 4 month, 8 month, 12 month

Study Arms (2)

Positive STEPS

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Positive STEPS BEHAVIORAL

Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.

Positive STEPS

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Brown University: collaborator

Study Sites (4)

UCLA Center for LGBTQ+ Advocacy, Research & Health

Los Angeles, California, 90095, United States

Location

Lurie Childrens Hospital

Chicago, Illinois, 60611, United States

Location

Fenway Health Institute

Boston, Massachusetts, 02215, United States

Location

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

• 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.

  PMID: 34995162 DERIVED

• 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.

  PMID: 30001703 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Block randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 28, 2017
• Study Start: February 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (4)