Positive Steps to Enhance Problem Solving Skills

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    192
  • sponsor
    Brown University
Updated on 25 January 2021

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.

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.

Details
Condition Adherence
Treatment Positive STEPS
Clinical Study IdentifierNCT03092531
SponsorBrown University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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