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Completed

NCT Number: NCT03092531

Positive Steps to Enhance Problem Solving Skills

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.

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Key information

Conditions

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for LGBTQ+ Advocacy, Research & Health, Los Angeles, California, United States

Loading trial locations.

About this study

HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to:

  • "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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Brown University

Registry information

Official study title

Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth

Acronym: STEPS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2017
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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