HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users
Condition: HIV; Drug Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      HIV infected drug users have greater difficulty adhering to highly active antiretroviral
      therapy compared to non-drug users. As sustained adherence to highly active antiretroviral
      therapy is critical to reducing HIV related morbidity, mortality, and reducing the spread of
      HIV, innovative and potentially sustainable treatment strategies that can optimize the
      durability of adherence enhancing interventions among drug users is urgently needed. The goal
      of this study is to further develop and pilot test a smartphone based intervention called
      HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to enhance
      adherence to HAART among HIV infected drug users.
    

Detailed description: 
      Significance: HIV infected drug users have greater difficulty adhering to HAART compared to
      non-drug users. As sustained adherence is critical to reducing HIV related morbidity and
      mortality, innovative and potentially sustainable treatment strategies that can optimize the
      durability of adherence enhancing interventions among drug users are urgently needed.
      Increasingly, interventions using communication technologies (e.g.,smartphones) to assess and
      enhance treatments are being used for a variety of somatic, mental health and substance abuse
      conditions.

      Innovation/Approach: Consistent with the National Institute on Drug Abuse's mission to
      develop novel technological based interventions to promote adherence to HAART the goal of
      this study is to use the stage model of behavioral therapy research to adapt, further
      develop, complete preliminary usability and pilot testing of a smart phone based intervention
      called HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to
      enhance, promote, and improve long-term adherence to HAART among HIV infected drug users in
      the non-methadone maintenance setting. Informed by Wagner's Chronic Care Model, the HEART to
      HAART intervention is designed to enhance ongoing adherence counseling by providing (1) real
      time information about medication adherence (using Wisepill device); (2) periodic assessment
      of medication side effects, depressive symptoms and drug use frequency (as these are linked
      to poor adherence among drug users) using ecological momentary assessment and (3) tailored
      education, recommendation and encouragement based on assessments. The participant (using
      their phone) and their adherence team (using a clinician interface) can jointly track real
      time changes in adherence increasing the potential for shared decision-making.

      This proposal has three aims consistent with stage 1A and 1B of the stage of behavioral
      therapy research. Aims 1 and 2 seek to adapt and further develop (Stage 1A) HEART to HAART.
      Aims 1 and 2 will use an iterative user-centered design that allows end users of a system to
      influence how a design takes shape to increase the ease with which a system can be learned
      and used. Aim 3 will test the preliminary efficacy (Stage 1B) of the finalized form of HEART
      to HAART. In aim 3, a total of 50 HIV infected, drug users receiving adherence counseling at
      an urban, outpatient HIV clinic will be randomly assigned to receive either HEART to HAART
      versus usual care with the addition of a smart phone control. The intervention will last 24
      weeks and the primary outcome will be change in adherence as measured by unannounced
      telephone based random pill counts. Changes in biological outcomes including HIV viral load
      and CD4 count will also be evaluated.

      Implication: If shown to be acceptable and efficacious HEART to HAART may introduce a
      fundamentally new method of HAART medication self-management and provide a tailored,
      potentially sustainable and less cost intensive intervention that can increase adherence
      among HIV infected drug users over the long term.
    

Intervention name(s): HEART to HAART; adherence counseling with the addition of smartphone control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The HEART to HAART intervention is designed to enhance ongoing adherence counseling by providing (1) real time information about medication adherence (using Wisepill device); (2) periodic assessment of medication side effects, depressive symptoms and drug use frequency (as these are linked to poor adherence among drug users) using ecological momentary assessment and (3) tailored education, recommendation and encouragement based on assessments. The participant (using their phone) and their adherence team (using a clinician interface) can jointly track real time changes in adherence increasing the potential for shared decision-making.; Participants will receive adherence counseling with the addition of smartphone control.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: HIV infected persons with co-occurring drug use