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

NCT01413529 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-01-20

No results posted yet for this study

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.

Conditions

  • HIV
  • Drug Use Disorders

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Seth Himelhoch, MD, MPH · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413529 on ClinicalTrials.gov