NCT01413529|CompletedPhase 2
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Sponsor study identifier
Secondary identifiers
NIH
interventional
35
1 country
1
Study Start
September 2011
Actual (reported)Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2011
Actual (reported)August 10, 2011
Actual (reported)September 2011
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)adherence to antiretroviral medication
telephone based unannounced pill counts
6 months
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.
Adherence counseling with the addition of a smart phone control
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.
Jacques Initiative
Baltimore, Maryland, 21210, United States
Seth Himelhoch, MD, MPH
University of Maryland
35 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2011
First Posted
August 10, 2011
Study Start
September 2011
Actual (reported)Development of an Empowerment Intervention for Young Women Living With HIV
Participants will receive adherence counseling with the addition of smartphone control.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
January 20, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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