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:

1. Develop the SteadyRx Smartphone intervention

1. Conduct focus groups with the target population, physicians, primary care staff,
and health administrators, respectively, prior to creating the application and
instructional materials

2. Create alpha versions of the smartphone application and related instructional
materials

3. Create a beta version of the application to use in the pilot randomized controlled
trial.

2. Implement SteadyRx in a pilot randomized controlled trial

1. Evaluate SteadyRx's acceptability to stakeholders, user experience, and user
engagement.

2. Collect preliminary data on the effectiveness of SteadyRx in improving ART
adherence, reducing viral load, and promoting high CD4 counts

3. Collect preliminary assessment of associations between ongoing drug use and health
literacy and the effectiveness of SteadyRx.

Overall, the combination of consultation, reminders, direct observation, and incentives for
adherence, when delivered as a long-term adjunct to ART via Smartphone application could
prove to be a maximally effective and practical means of realizing the fantastic potential of
modern ART for improving the lives of individuals with HIV/AIDS and for reducing the rate of
HIV transmission by high-risk patients.

STUDY PROCEDURES Application Development Alpha Version. As the first step in the development
of the application, the investigators will create an alpha version of the application that
includes the PillWatch feature. Note that the PillWatch feature will require only minor
modification from the existing Mōtiv8 technology used by Dallery (Co-I). Other aspects of the
planned application will require more substantial development and thus will not be fully
developed until after the focus group sessions described below.

Focus Groups. As the second step in the development of the application, the investigators
will conduct three focus group sessions. All focus groups will be designed and moderated by
Baltimore Research, a full service marketing research company with over 50 years of
experience (See Facilities and Other Resources for further details). Baltimore Research will
also handle all data collection and analysis for the focus group sessions and provide the
study team with a final report for each session. Each focus group will include a relatively
homogeneous set of stakeholders: Physicians/primary care staff, health administrators (e.g.,
see Priority Partners letter of support), and patients, respectively. All focus groups will
include approximately eight participants, as this has been identified as an ideal number of
participants in a focus group session. In order to ensure that approximately eight
participants will be included, the investigators will attempt to recruit at least 10
participants, because all participants must show up at the same time for a specific scheduled
session, and this usually results in some people who agree to participate but do not show up
at the scheduled time. These groups will be held as one-time sessions designed to generate
ideas that will enhance the application's usability and adoptability from the perspective of
the professionals who are most likely to be involved in the institutional decision making
processes relevant to the dissemination of the proposed intervention. The investigators
anticipate that recruitment of health professionals will be straightforward given our
extensive connections to professionals throughout the local health care systems in Baltimore,
and consultation by Baltimore Research will ensure that these recruitment processes are free
of bias. The third focus group session (patients) will be the beginning of an iterative
process in which the investigators first solicit ideas about the functionality and interface
of the application. Participants for this focus group will be recruited using methods
identical to those described below for the pilot randomized controlled trial.

Create the Beta Version. Following the initial four focus group sessions, the beta version of
the application will be created with the critical features described above. The end product
of this part of the development process will be the beta version that will be used in the
pilot study described below.

PILOT STUDY The investigators expect that all participants will be patients at the
Comprehensive Care Practice (CCP). CCP is located in the Mason F. Lord Building at the Johns
Hopkins Bayview Medical Center in Baltimore, MD. CCP provides primary medical care to ~450
HIV+ adults and will serve as the recruitment site.

Participants will be recruited from their regularly scheduled HIV care appointments at the
CCP at which current viral load and CD4 counts are evaluated. Any HIV+ patient with a
substance use disorder will be told by their CCP doctor about our research study and given a
recruitment flyer that explains the benefits of participation. If they express interest, the
doctor will immediately contact the CCP Medical Case Manager who is in charge of study
recruitment and assessment (hereafter, outreach coordinator). The outreach coordinator will
briefly explain the intake interview process and basic purpose of the study. If the patient
agrees to move forward they will begin with a formal consent process. During this process,
the outreach coordinator will read the consent form aloud in its entirety while the
participant follows along. After signing the consent form, the patient will proceed
immediately to the intake interview unless their schedule precludes it, in which case they
will provide contact information and schedule the intake interview for a time on the next day
or as soon as possible. Participants who have signed consent but who have not returned to CCP
will be given reminder calls related to their scheduled intake interview. They will also
receive follow up calls if they fail to show up for their scheduled appointment time.

For any given pilot study participant, study participation will last for six months, and will
include an intake visit plus six visits at 30 day intervals thereafter. For focus group
participants, study participation will consist of a single focus group session.

Inclusion Criteria:

- Applicants will be eligible to participate in the study if they:

1. are 18 to 100 years old;

2. are HIV positive;

3. have a primary care physician who is providing their HIV-related care including
prescribed ART;

4. have a substance use disorder

5. can operate a smartphone

6. speak English fluently

Exclusion Criteria:

- Applicants will be excluded if they:

1. report current suicidal or homicidal ideation;

2. report active hallucinations;

3. are participating in another HIV related study.