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NCT01413529 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT01413529: Completed Phase 2 study, sponsored by University of Maryland, Baltimore.

NCT01413529 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01413529, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

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.

Primary Outcome

telephone based unannounced pill counts

Interventions

  • BEHAVIORAL HEART to HAART
  • BEHAVIORAL adherence counseling with the addition of smartphone control

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2011-09
Est. Completion 2015-04
Phase Phase 2
University of Maryland, Baltimore

560 total trials

What the finished NCT01413529 record still lists

NCT01413529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which HEART to HAART is the first listed.

NCT01413529 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01413529 about?

NCT01413529 is a clinical study titled "HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users". 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 potenti...

What is the current status of trial NCT01413529?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2011-09. Estimated completion is 2015-04.

What interventions are being tested in trial NCT01413529?

The interventions under investigation include: HEART to HAART (BEHAVIORAL), adherence counseling with the addition of smartphone control (BEHAVIORAL).

Who is sponsoring clinical trial NCT01413529?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01413529's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01413529, the US trial registry maintained by the National Library of Medicine. NCT01413529 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.