The Wise App Trial for Improving Health Outcomes in PLWH
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2018 |
| Start Date: | January 31, 2018 |
| End Date: | August 31, 2021 |
| Contact: | Rebecca Schnall, PhD, RN |
| Email: | rb897@cumc.columbia.edu |
| Phone: | 212-342-6886 |
The Wise App Trial for Improving Health Outcomes in People Living With HIV
The overall goal of this study is to design a user-centered design app linked to a smart pill
box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled
trial. The proposed trial is scientifically significant in representing a principled and
systematic effort to test the efficacy of a smartphone intervention linked to a smart pill
box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong
theoretical framework building on earlier user-centered design work and integrating a
real-time monitoring device, this work has the potential to improve ART adherence in PLWH and
have a sustainable public health impact.
box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled
trial. The proposed trial is scientifically significant in representing a principled and
systematic effort to test the efficacy of a smartphone intervention linked to a smart pill
box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong
theoretical framework building on earlier user-centered design work and integrating a
real-time monitoring device, this work has the potential to improve ART adherence in PLWH and
have a sustainable public health impact.
Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral
suppression through adherence to antiretroviral (ART) therapy is a critical determinant of
successful transmission prevention and long-term outcomes in HIV-infected patients. However
only about 25% of persons living with HIV (PLWH) in the US are virally suppressed,
demonstrating the need for effective interventions that enhance ART adherence. mHealth is a
tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH
have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the
need for improving medication adherence in PLWH, and the great promise of mHealth, the
investigators propose to build and test a user-centered smartphone app linked to a smart pill
box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized
since it typically overestimated adherence especially in unmasked trials. Current adherence
assessments, such as patient recall, pill counts and pharmacy refill data, typically detect
missed doses long after they occur. This study will use real-time, wireless monitoring
strategies via the Wisepill dispenser, for measuring ART adherence.
suppression through adherence to antiretroviral (ART) therapy is a critical determinant of
successful transmission prevention and long-term outcomes in HIV-infected patients. However
only about 25% of persons living with HIV (PLWH) in the US are virally suppressed,
demonstrating the need for effective interventions that enhance ART adherence. mHealth is a
tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH
have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the
need for improving medication adherence in PLWH, and the great promise of mHealth, the
investigators propose to build and test a user-centered smartphone app linked to a smart pill
box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized
since it typically overestimated adherence especially in unmasked trials. Current adherence
assessments, such as patient recall, pill counts and pharmacy refill data, typically detect
missed doses long after they occur. This study will use real-time, wireless monitoring
strategies via the Wisepill dispenser, for measuring ART adherence.
Inclusion Criteria:
- Have a diagnosis of HIV
- Be able to communicate and read in English
- Live in the US
- Have a smartphone
- Be taking ART medications
- Must be Medicaid eligible
Exclusion Criteria:
- Participation in any other mobile app study for PLWH, including text messaging studies
- Diagnosis of a clinical problem that would preclude someone from using a smartphone
We found this trial at
1
site
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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