Improving Antiretroviral Medication Adherence Among HIV-infected Youth
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,
      when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy.
      However, adherence among HIV-infected young people is suboptimal, and few interventions are
      available to help adolescents adhere to treatment.

      The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted
      form of the Life-Steps behavioral intervention) to improve medication adherence among
      HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to
      recruit, feasibility of intervention delivery with study counselors and all study procedures,
      and initial clinically significant improvement in medication adherence via MEMS caps. This
      research will lay the groundwork for a federal grant application for a multi-site randomized
      controlled intervention trial.
    

Detailed description: 
      Aims:

        1. To conduct a randomized controlled pilot test of a behavioral adherence intervention to
           improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all
           study procedures and participant acceptability will be assessed.

        2. To explore whether the intervention leads to improved medication adherence among youth
           who receive the intervention, compared to a control group of youth who do not.

      40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS
      intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized
      into one of two arms (half and half). Randomization for all participants will occur after the
      beginning of the week 2 study visit. The duration of the study is 3 months

      Randomization:

      The investigators will conduct block randomization based on two categories of electronic
      adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence
      in order to be eligible for the study, although they may vary in the extent of non-adherence.
      Because insufficient information is known about the range of non-adherence in the population
      to determine the most valid non-adherence cut-off points, the investigators may need to
      reconsider adherence categories over the course of the pilot study. The investigators will
      regularly examine the data to determine whether finer adherence categories are needed, and
      the investigators will adjust the categories if such a determination is made.

      Intervention arm:

        -  Participants will receive one on one Positive STEPS counseling sessions (~1 hour
           sessions per week for 5 weeks).

        -  Participants will receive motivational reminders to take medications sent via text
           message to their cell phones

        -  Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap
           monitoring device to measure antiretroviral medication adherence.

      Comparison condition arm:

      • Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap
      monitoring device to measure antiretroviral medication adherence.
    

Intervention name(s): Positive STEPS
Intervention type(s): Behavioral
Intervention description(s): This intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV; antiretroviral medication; adherence; adolescent