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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
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: HIV/AIDS
Adherence
Interventions: Device: Fixed SMS, real-time monitoring
Device: Triggered SMS, real-time monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fixed SMS, Real-time Monitoring SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Triggered SMS, Real-time Monitoring SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Control Real-time adherence monitoring only (no SMS)

Participant Flow:   Overall Study
    Fixed SMS, Real-time Monitoring   Triggered SMS, Real-time Monitoring   Control
STARTED   21   20   22 
COMPLETED   21   18   19 
NOT COMPLETED   0   2   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Fixed SMS, Real-time Monitoring SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Triggered SMS, Real-time Monitoring SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Control Real-time adherence monitoring only (no SMS)
Total Total of all reporting groups

Baseline Measures
   Fixed SMS, Real-time Monitoring   Triggered SMS, Real-time Monitoring   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   20   21   62 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 33 
 (28 to 40) 
 33 
 (26 to 35) 
 27 
 (24 to 32) 
 30 
 (25 to 35) 
Gender 
[Units: Participants]
       
Female   15   7   18   40 
Male   6   13   3   22 
Region of Enrollment 
[Units: Participants]
       
Uganda   21   20   21   62 
Median CD4 count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 309 
 (241 to 385) 
 291 
 (213 to 350) 
 382 
 (249 to 457) 
 309 
 (231 to 397) 


  Outcome Measures
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1.  Primary:   Antiretroviral Therapy (ART) Adherence Levels   [ Time Frame: real time (for 9 months) ]

2.  Secondary:   HIV RNA Suppression   [ Time Frame: After month 9 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jessica Haberer
Organization: Massachusetts General Hospital
phone: 617 724 0351
e-mail: jhaberer@partners.org



Responsible Party: Jessica Haberer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01957865     History of Changes
Other Study ID Numbers: R34MH100940-01 ( US NIH Grant/Contract Award Number )
Study First Received: September 25, 2013
Results First Received: April 5, 2016
Last Updated: September 22, 2016
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology