Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Not Applicable

Completed

Conditions: HIV/AIDS
Adherence

Interventions: Device: Fixed SMS, real-time monitoring
Device: Triggered SMS, real-time monitoring

Registration Number: NCT01957865

Lead Sponsor: Massachusetts General Hospital

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed SMS, real-time monitoring	Fixed SMS, real-time monitoring	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.
Triggered SMS, real-time monitoring	Triggered SMS, real-time monitoring	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.

Primary Outcome Measures

Name	Time	Method
Antiretroviral Therapy (ART) Adherence Levels	real time (for 9 months)	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%.

Secondary Outcome Measures