HIV/AIDS Clinical Trial
Official title:
Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
In this study, the investigators propose to develop a real-time adherence intervention based
on SMS (i.e., text messages), wireless adherence monitoring (with the Wisepill device), and
engagement of social support that is tailored to rural sub-Saharan Africa. The investigators
will build on research by others who have shown SMS reminders improve adherence and viral
suppression in Kenya, albeit with relatively small effect sizes and suboptimal virologic
failure rates even in the intervention arm. Moreover, little is known about which patients
benefit from SMS, why they benefit, and what can be done to further improve adherence and
treatment success rates. Understanding the mechanisms of effect will make it possible to
design and test evidence-based interventions with the highest likelihood for efficacy.
In a cohort of HIV-infected individuals starting ART and being monitored with Wisepill, the
investigators will test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders
linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications
of 48+hour gaps in adherence to members of social support networks. The investigators will
conduct qualitative interviews to learn the experiences of participants and members of their
social support networks with the different types of SMS. This staged approach will allow us
to fully understand and compare the additive effects and acceptability of SMS-based
interventions. The investigators will also determine behavioral effect mechanisms, as well
as compare the impact of each type of SMS with a control population receiving only Wisepill
monitoring on adherence and HIV RNA.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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