NCT01413529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_2 hiv

Timeline
Completed

Started Sep 2011

Typical duration for phase_2 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

3.6 years

First QC Date

August 8, 2011

Last Update Submit

January 4, 2022

Conditions

HIVDrug Use Disorders

Keywords

HIV infected persons with co-occurring drug use

Outcome Measures

Primary Outcomes (1)

  • adherence to antiretroviral medication

    telephone based unannounced pill counts

    6 months

Study Arms (2)

HEART to HAART

EXPERIMENTAL

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

Adherence counseling

ACTIVE COMPARATOR

Adherence counseling with the addition of a smart phone control

Behavioral: adherence counseling with the addition of smartphone control

Interventions

HEART to HAARTBEHAVIORAL

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.

HEART to HAART
adherence counseling with the addition of smartphone controlBEHAVIORAL

Participants will receive adherence counseling with the addition of smartphone control.

Adherence counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical problems that would not allow someone to use a cell phone or fulfill study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacques Initiative

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Seth Himelhoch, MD, MPH

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 10, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

US(1)