STEPS: Positive Steps to Enhance Problem Solving Skills

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03092531
• Collaborator: Brown University (Other)
• Enrollment: 192
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 70.9
• Patients Per Site: 64
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adherence	Behavioral: Positive STEPS	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Block randomization
• Primary Purpose: Supportive Care
• Official Title: Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reduced HIV Viral Load [Baseline, 4 month, 8 month, 12 month]

   Blood specimen collection tested for HIV Viral Load

2. ART Medication Level in Hair Sample [Baseline, 4 month, 8 month, 12 month]

   Collection of hair sample to measure level of ART

3. Daily ART adherence [4 month, 8 month, 12 month]

   Monitoring of Wisepill device for electronic adherence data

4. Daily ART Adherence [Baseline, 4 month, 8 month, 12 month]

   Self report via research assessment

Secondary Outcome Measures

1. Reduced HIV Symptoms [Baseline, 4 month, 8 month, 12 month]

   Medical record review for increase or decrease in symptoms associated with HIV

2. Engagement in HIV Care [Baseline, 4 month, 8 month, 12 month]

   Number of kept versus number of scheduled visits verified by medical record

3. Medication changes to ART [Baseline, 4 month, 8 month, 12 month]

   Verified by medical record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurie Childrens Hospital	Chicago	Illinois	United States	60611
2	Fenway Health Institute	Boston	Massachusetts	United States	02215
3	Brown University School of Public Health	Providence	Rhode Island	United States	02912

Sponsors and Collaborators

• University of California, Los Angeles
• 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

Study Documents (Full-Text)

• Informed Consent Form - Mar 7, 2019

More Information

Publications

None provided.

• Responsible Party: Matthew Mimiaga, ScD, MPH, MA, Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03092531
• Other Study ID Numbers: 1 R01 MH111632-01
• First Posted: Mar 28, 2017
• Last Update Posted: May 17, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matthew Mimiaga, ScD, MPH, MA, Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine, University of California, Los Angeles: HIV; ART Adherence; Adolescents

Study Results

No Results Posted as of May 17, 2022