Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Study Overview
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Brief Summary
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Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).

Detailed Description
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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.

Official Title
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Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Conditions
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HIV/AIDS, Adherence

Intervention / Treatment
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* Device: Fixed SMS, real-time monitoring
* Device: Triggered SMS, real-time monitoring


Participation Criteria
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Eligibility Criteria
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Wisepill Participants: Inclusion Criteria: HIV-infected Initiating ART within the next two weeks Age 18 years and older Owns a cell phone for personal use and has reliable cellular phone reception at home on a network supported by the technology used in this study Lives in the Mbarara District (i.e, within 20 km of the ISS Clinic) Has at least one person who could be named as a social supporter(see criteria below). Exclusion Criteria: Unable to use SMS Unwilling to receive SMS reminders Severe mental condition limiting the ability to provide consent Cellular phone reception is not reliable Social supporters (i.e., recipients of the SMS notifications for Wisepill participants in the intervention arms): Inclusion criteria: Knows Wisepill participant has HIV Age 18 years or older Reports having provided social support to the intervention participant at least once Own a cell phone for personal use and have reliable cellular phone reception at home on a network supported by the technology used in this study Lives in the Mbarara District Exclusion criteria: Unable to use SMS Unwilling to receive SMS notifications regarding interruptions in the intervention participant's adherence Severe mental condition limiting the ability to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed SMS, real-time monitoring<br>SMS will be sent daily for one month, then weekly for two months. Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study. | Device: Fixed SMS, real-time monitoring<br>* SMS reminders will be sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.<br>* Other names: Wisepill;|
| Experimental: Triggered SMS, real-time monitoring<br>Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study. | Device: Triggered SMS, real-time monitoring<br>* SMS reminders will be sent as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.<br>* Other names: Wisepill;|
| No Intervention: control<br>Real-time adherence monitoring only (no SMS) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Therapy (ART) Adherence Levels | ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%. | real time (for 9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV RNA Suppression | HIV RNA suppression (<100 copies/ml) in each study arm | After month 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, adherence, real time monitoring, SMS, mHealth, social support