Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

N/ACompletedNCT01957865

Massachusetts General Hospital63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

HIV/AIDS Adherence

Interventions

Fixed SMS, real-time monitoringDEVICE

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.

Triggered SMS, real-time monitoringDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mbarara Immune Suppression Syndrome(ISS) Clinic

Mbarara, Mbarara District, Uganda

Outcomes

Primary Outcomes

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%.

Time frame: real time (for 9 months)

Secondary Outcomes

HIV RNA Suppression

HIV RNA suppression (\<100 copies/ml) in each study arm

Time frame: After month 9

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.