Clinical trial NCT01957865: Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Official title: Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Adherence
Keywords: HIV/AIDS
adherence
real time monitoring
SMS
mHealth
social support
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2013-10-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Antiretroviral Therapy (ART) Adherence Levels
timeFrame: real time (for 9 months)
Secondary outcomes:
measure: HIV RNA Suppression
timeFrame: After month 9
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Immune Suppression Syndrome(ISS) Clinic
state: Mbarara District
Study officials:
affiliation: Massachusetts General Hospital
name: Jessica Haberer, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mbarara University of Science and Technology
name: Angella Musiimenta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Musiimenta A, Atukunda EC, Tumuhimbise W, Haberer JE. Resilience after withdrawing a technology-based medication adherence support intervention from people living with HIV in rural Uganda. AIDS Care. 2018 Aug;30(sup5):S89-S96. doi: 10.1080/09540121.2018.1510107. Epub 2019 Jan 9.
citation: Musiimenta A, Atukunda EC, Tumuhimbise W, Pisarski EE, Tam M, Wyatt MA, Ware NC, Haberer JE. Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 17;6(5):e122. doi: 10.2196/mhealth.9031.
citation: Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, Bangsberg DR. Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016 May 15;30(8):1295-300. doi: 10.1097/QAD.0000000000001021.