Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Mass General Brigham

Status: Completed

Conditions: Adherence; HIV/AIDS

Treatments: Device: Fixed SMS, real-time monitoring; Device: Triggered SMS, real-time monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01957865

R34MH100940-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Fixed SMS, real-time monitoring

Experimental group

Description:

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.

Treatment:

Device: Fixed SMS, real-time monitoring

Triggered SMS, real-time monitoring

Experimental group

Description:

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.

Treatment:

Device: Triggered SMS, real-time monitoring

control

No Intervention group

Description:

Real-time adherence monitoring only (no SMS)