Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

This study has been completed.
Sponsor:
Collaborator:
Mbarara University of Science and Technology
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01957865
First received: September 25, 2013
Last updated: September 22, 2016
Last verified: September 2016

September 25, 2013
September 22, 2016
September 2013
June 2015   (final data collection date for primary outcome measure)
Antiretroviral Therapy (ART) Adherence Levels [ Time Frame: real time (for 9 months) ] [ Designated as safety issue: No ]
Difference in ART adherence among the 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%.
Antiretroviral Therapy (ART) Adherence Levels [ Time Frame: real time (for 9 months) ] [ Designated as safety issue: No ]
Difference in adherence among the study arms
Complete list of historical versions of study NCT01957865 on ClinicalTrials.gov Archive Site
HIV RNA Suppression [ Time Frame: After month 9 ] [ Designated as safety issue: No ]
HIV RNA suppression (<100 copies/ml) was compared by study arms with Fisher's exact test.
HIV RNA Suppression [ Time Frame: After months 3 and 9 ] [ Designated as safety issue: No ]
Difference in percent of participants with HIV RNA suppression among the study arms
Not Provided
Mechanism by which SMS impact adherence [ Time Frame: Month 3 and between Months 4-9 ] [ Designated as safety issue: No ]
Qualitative interviews will be conducted to understand the mechanisms by which SMS impact adherence (e.g., overcoming cognitive barriers, providing social support). All participants will have one interview at Month 3. The second interview will occur after the first 48+ hour gap in adherence between Months 4-9 (or at Month 9 if there is no 48+ hour gap in adherence).
 
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV/AIDS
  • Adherence
  • 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
  • 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
  • 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.
    Intervention: Device: Fixed SMS, real-time monitoring
  • 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.
    Intervention: Device: Triggered SMS, real-time monitoring
  • No Intervention: control
    Real-time adherence monitoring only (no SMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01957865
R34MH100940-01
Yes
Yes
De-identified data will be available at the end of the study upon request.
Jessica Haberer, MD, Massachusetts General Hospital
Massachusetts General Hospital
Mbarara University of Science and Technology
Principal Investigator: Jessica Haberer, MD, MS Massachusetts General Hospital
Principal Investigator: Angella Musiimenta, PhD Mbarara University of Science and Technology
Massachusetts General Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP