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Trial record 1 of 1 for:    HIV | Positive STEPS | Providence, Rhode Island, U.S.
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Positive Steps to Enhance Problem Solving Skills (STEPS)

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ClinicalTrials.gov Identifier: NCT03092531
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Mimiaga, Brown University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Reduced HIV Viral Load [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Blood specimen collection tested for HIV Viral Load

  2. ART Medication Level in Hair Sample [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Collection of hair sample to measure level of ART

  3. Daily ART adherence [ Time Frame: 4 month, 8 month, 12 month ]
    Monitoring of Wisepill device for electronic adherence data

  4. Daily ART Adherence [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Self report via research assessment


Secondary Outcome Measures :
  1. Reduced HIV Symptoms [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Medical record review for increase or decrease in symptoms associated with HIV

  2. Engagement in HIV Care [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Number of kept versus number of scheduled visits verified by medical record

  3. Medication changes to ART [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    Verified by medical record



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092531


Contacts
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Contact: Matthew J Mimiaga, ScD, MPH 401 863-6559 matthew_mimiaga@brown.edu
Contact: Robert Garofalo, MD 800-543-7362 rgarofalo@Luriechildrens.org

Locations
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United States, Illinois
Lurie Childrens Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Garofalo, MD    800-543-7362    rgarofalo@luriechildrens.org   
United States, Massachusetts
Fenway Health Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ken Mayer, MD    617-927-6087    kmayer@fenwayhealth.org   
Contact: Jennifer Olson    (401) 863 -3292    jennifer_olson1@brown.edu   
Principal Investigator: Ken Mayer, MD         
United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Matthew J Mimiaga, ScD, MPH    401-863-6559    matthew_mimiaga@brown.edu   
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Matthew J Mimiaga, ScD, MPH Brown University, School of Public Health, Center for Health Equity Research
Principal Investigator: Robert Garofalo, MD Lurie Children's Hospital
  Study Documents (Full-Text)

Documents provided by Matthew Mimiaga, Brown University:
Informed Consent Form  [PDF] March 7, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Mimiaga, Professor, Departments of Behavioral & Social Health Sciences and Epidemiology, School of Public Health Professor, Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University
ClinicalTrials.gov Identifier: NCT03092531    
Other Study ID Numbers: 1 R01 MH111632-01
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Mimiaga, Brown University:
HIV
ART Adherence
Adolescents