We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01413529
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug Use Disorders Behavioral: HEART to HAART Behavioral: adherence counseling with the addition of smartphone control Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users
Actual Study Start Date : September 2011
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.
Active Comparator: Adherence counseling
Adherence counseling with the addition of a smart phone control
Behavioral: adherence counseling with the addition of smartphone control
Participants will receive adherence counseling with the addition of smartphone control.


Outcome Measures

Primary Outcome Measures :
  1. adherence to antiretroviral medication [ Time Frame: 6 months ]
    telephone based unannounced pill counts


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413529


Locations
United States, Maryland
Jacques Initiative
Baltimore, Maryland, United States, 21210
Sponsors and Collaborators
University of Maryland
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Seth Himelhoch, MD, MPH University of Maryland
More Information

Responsible Party: Seth Himelhoch, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01413529     History of Changes
Other Study ID Numbers: HP-00049374
1R34DA032411 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Seth Himelhoch, University of Maryland:
HIV infected persons with co-occurring drug use

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders