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N/A N=51 Randomized Treatment

SteadyRx: Smartphone ART Adherence Intervention for Drug Users

HIV · Medication Adherence

Enrolled (actual)
51
Serious AEs
4.0%
Results posted
Nov 2018
Primary outcome: Primary: Medication Adherence as Assessed by the Medication Event Monitoring System (MEMS) Cap — 52.2; 27.2 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SteadyRx (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Medication Adherence as Assessed by the Medication Event Monitoring System (MEMS) Cap
52.2; 27.2
PRIMARY
Percentage of Participants Achieving an Undetectable Viral Load in Six Months
88.1; 100
SECONDARY
Monthly Percent Adherence to Antiretroviral Medications.
87.97; 73.88
SECONDARY
Viral Load
248.17; 23.38

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 observation of medication-taking, and (4) reward ART adherence. In addition to developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+ adults with a history of problem drug use. In this study, participants will be randomly assigned to receive usual care, or usual care plus the SteadyRX intervention.

Eligibility Criteria

Inclusion Criteria

  • Applicants will be eligible to participate in the study if they:
  • are 18 to 100 years old;
  • are HIV positive;
  • have a primary care physician who is providing their HIV-related care including prescribed ART;
  • have a substance use disorder
  • can operate a smartphone
  • speak English fluently

Exclusion Criteria

  • Applicants will be excluded if they:
  • report current suicidal or homicidal ideation;
  • report active hallucinations;
  • are participating in another HIV related study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02317614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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