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. These fantastic personal and public health benefits require a high level of adherence to the prescribed treatment regimen. High rates of virologic suppression can be achieved with an adherence rate of 90%, but adherence of 95% or more appears to produce the best combination of a higher probability of virologic suppression and a lower probability of the development of resistance to the medications. 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, and there is a substantial need for novel and effective ART adherence interventions.

Injection drug use and crack cocaine use are major factors in the transmission of HIV and have been associated with non-adherence to ART. Several types of interventions have been effective in promoting short-term ART adherence in these populations. Counseling strategies and reminders (e.g., beepers, calendars, etc.) have each had modest effects. Still more successful approaches have included directly administered antiretroviral therapy (DAART, in which patients are observed by care providers as they take their medication), medication assisted therapy (e.g., methadone maintenance), and contingency management (monetary incentives for maintaining adherence to HIV medications). However, a core problem with all ART adherence interventions is that their effects do not appear to last after the interventions are discontinued. In a recent review of ART adherence interventions for drug users, researchers expressed concern over the "virtual lack of interventions with sustained post-intervention adherence and virologic benefits." The common finding of post-intervention dissipation of effects suggests that ART adherence interventions may need to be implemented as long-term or even permanent adjuncts to ART for drug users.

The investigators seek to develop an intensive intervention that incorporates the most effective techniques for promoting ART adherence in drug users, and deliver them in a manner that allows for their large-scale implementation as long-term or even permanent adjuncts to ART. The investigators propose a three year development project for an ART adherence intervention that bundles 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. Toward that end, the intervention to be developed under this project will (1) facilitate consultation with care providers (2) provide reminders when a dose is overdue, (3) provide remote electronic observation of medication-taking, and (4) provide incentives for ART adherence. The proposed intervention (SteadyRx) is highly innovative: no previous ART adherence intervention has involved direct observation of medication administration and contingency management, despite their respective effectiveness in isolation. Importantly, no mobile/remote intervention currently under development is as intensive as SteadyRx.

The developmental process for this application will begin with modification of existing technology, which will be followed by conducting focus groups with the intended target population as well as with physicians, primary care staff, and health administrators, respectively, in order to enhance the adoptability of the intervention by including application functions and interface design that is sensitive to the needs of all stakeholders. Small scale testing with members of the target population will be used to further refine the application and produce a beta version for use in a pilot randomized controlled trial.

In the pilot study, 50 HIV+ adults with a history of problem drug use will be randomly assigned to receive either usual care services at a primary care facility or these services plus the SteadyRx intervention. The project has the following Specific Aims: