Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01413529 |
| Other study ID # |
HP-00049374 |
| Secondary ID |
1R34DA032411 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 2011 |
| Est. completion date |
April 2015 |
Study information
| Verified date |
January 2022 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
