HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users

This study is not yet open for participant recruitment.
Verified August 2011 by University of Maryland
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01413529
First received: August 8, 2011
Last updated: August 9, 2011
Last verified: August 2011

August 8, 2011
August 9, 2011
September 2011
September 2014   (final data collection date for primary outcome measure)
adherence to antiretroviral medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
telephone based unannounced pill counts
Same as current
Complete list of historical versions of study NCT01413529 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users
HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • HIV
  • Drug Use Disorders
  • Behavioral: HEART to HAART
    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.
  • Behavioral: adherence counseling with the addition of smartphone control
    Participants will receive adherence counseling with the addition of smartphone control.
  • Experimental: HEART to HAART
    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.
    Intervention: Behavioral: HEART to HAART
  • Active Comparator: Adherence counseling
    Adherence counseling with the addition of a smart phone control
    Intervention: Behavioral: adherence counseling with the addition of smartphone control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of HIV
  • English speaking
  • History of drug use in the last 6 months
  • Able to carry a cell phone
  • Able to read English
  • Starting or switching to a new anti-retroviral medications
  • Receiving care in a clinic participating in the study

Exclusion Criteria:

  • Clinical problems that would not allow someone to use a cell phone or fulfill study procedures.
Both
18 Years to 65 Years
No
Contact: Seth Himelhoch, MD, MPH 410-706-2490 shimelho@psych.umaryland.edu
United States
 
NCT01413529
HP-00049374, 1R34DA032411-01
No
Seth Himelhoch, MD, MPH, University of Maryland
University of Maryland
National Institute on Drug Abuse (NIDA)
Principal Investigator: Seth Himelhoch, MD, MPH University of Maryland
University of Maryland
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP