Viewing Study NCT01413529



Ignite Creation Date: 2024-05-05 @ 11:46 PM
Last Modification Date: 2024-10-26 @ 10:39 AM
Study NCT ID: NCT01413529
Status: COMPLETED
Last Update Posted: 2022-01-20
First Post: 2011-08-08

Brief Title: HEART to HAART Smartphone Intervention to Improve HAART Adherence for Drug Users
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: HEART to HAART Smartphone Intervention to Improve HAART Adherence for Drug Users
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 egsmartphones to assess and enhance treatments are being used for a variety of somatic mental health and substance abuse conditions

InnovationApproach Consistent with the National Institute on Drug Abuses 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 Wagners 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R34DA032411 NIH None httpsreporternihgovquickSearch1R34DA032411