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NCT02317614 · ClinicalTrials.gov registry record · NA

SteadyRx: Smartphone ART Adherence Intervention for Drug Users

A NA study, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
51
Enrollment target

NCT02317614: Completed NA study, sponsored by Johns Hopkins University.

NCT02317614 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02317614, a NA study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
51 participants
Enrollment target

Study Summary

Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals infected with HIV, and can reduce the chance of HIV transmission, but a high degree of adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients in North America report ART adherence \>90%. Thus, ART adherence interventions are a critical part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major factors in the transmission of HIV, and are associated with non-adherence to ART. Several types of interventions, most notably directly administered antiretroviral therapy (direct observation of antiretroviral administration and patient supports) and contingency management (the provision of incentives contingent upon objective evidence of adherence) have been effective in promoting ART adherence in drug users. However, a core problem with all ART adherence interventions is that their effects do not last after the interventions are discontinued. The common finding of post-intervention dissipation of effects suggests that ART adherence interventions may need to be long-term or even permanent adjuncts to ART for drug users. The investigators intend to develop an intensive intervention that incorporates the most effective techniques for promoting ART adherence in drug users, and delivers them in a manner that allows for their large-scale implementation as long-term or even permanent adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions into a smartphone application that is easy for patients to use, simple to manage, and maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention that is highly effective and scalable. Toward that end, the SteadyRX intervention to be developed under this project will be largely automated and will (1) facilitate consultation with care providers (2) provide reminders when a dose is overdue, (3) provide electronic remote observatio

Primary Outcome

The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.

Interventions

  • BEHAVIORAL SteadyRx

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2016-05-02
Est. Completion 2018-04-30
Phase NA
Johns Hopkins University

1,448 total trials

What the finished NCT02317614 record still lists

NCT02317614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which SteadyRx is the first listed.

NCT02317614 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02317614 about?

NCT02317614 is a clinical study titled "SteadyRx: Smartphone ART Adherence Intervention for Drug Users". Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals infected with HIV, and can reduce the chance of HIV transmission, but a high degree of adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients in North America report ART ad...

What is the current status of trial NCT02317614?

This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2016-05-02. Estimated completion is 2018-04-30.

What interventions are being tested in trial NCT02317614?

The interventions under investigation include: SteadyRx (BEHAVIORAL).

Who is sponsoring clinical trial NCT02317614?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02317614's enrollment target sits among peer trials

51 1279th of 2000 higher than 722 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02317614, the US trial registry maintained by the National Library of Medicine. NCT02317614 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.