Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2018-02-01
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Positive STEPS
Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.
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.
No interventions assigned to this group
Interventions
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Positive STEPS
Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
29 Years
ALL
Yes
Sponsors
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Brown University
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Matthew Mimiaga, ScD, MPH, MA
Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine
Principal Investigators
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Matthew J Mimiaga, ScD, MPH
Role: PRINCIPAL_INVESTIGATOR
UCLA, School of Public Health, Department of Epidemiology, Fielding School of Public Health
Robert Garofalo, MD
Role: PRINCIPAL_INVESTIGATOR
Lurie Children's Hospital
Locations
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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
Brown University School of Public Health
Providence, Rhode Island, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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