Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01957865|
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : November 10, 2016
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Adherence||Device: Fixed SMS, real-time monitoring Device: Triggered SMS, real-time monitoring||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: 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.
Device: Fixed SMS, real-time monitoring
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.
Other Name: Wisepill
Experimental: 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.
Device: Triggered SMS, real-time monitoring
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.
Other Name: Wisepill
No Intervention: control
Real-time adherence monitoring only (no SMS)
- Antiretroviral Therapy (ART) Adherence Levels [ Time Frame: 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%.
- HIV RNA Suppression [ Time Frame: After month 9 ]HIV RNA suppression (<100 copies/ml) in each study arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957865
|Mbarara Immune Suppression Syndrome(ISS) Clinic|
|Mbarara, Mbarara District, Uganda|
|Principal Investigator:||Jessica Haberer, MD, MS||Massachusetts General Hospital|
|Principal Investigator:||Angella Musiimenta, PhD||Mbarara University of Science and Technology|