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China Adherence Through Technology Study (CATS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01722552
First Posted: November 7, 2012
Last Update Posted: April 21, 2017
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.
Collaborators:
FHI 360
Guangxi Center for Disease Control and Prevention
Dimagi Inc.
Massachusetts General Hospital
Information provided by (Responsible Party):
Lora Sabin, Boston University
Results First Submitted: March 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Medication Adherence
Interventions: Behavioral: adherence feedback
Behavioral: standard of care

  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
We recruited subjects from December 2012-April 2013. They were recruited at the Guangxi Provincial ART clinic in Nanning, China. Patients were eligible if they were receiving or initiating antiretroviral therapy (ART), aged 18 years or above, deemed at risk for poor adherence by clinic staff or patients themselves, and owned a mobile phone.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, each subject was given a Wisepill electronic adherence monitoring container for use with his/her ART medications. Subjects selected one or more ART medications to be monitored within the device. All subjects underwent baseline adherence monitoring using Wisepill for 3 months before randomization.

Reporting Groups
  Description
Adherence Feedback

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback


Participant Flow:   Overall Study
    Adherence Feedback
STARTED   120 [1] 
COMPLETED   116 [2] 
NOT COMPLETED   4 
[1] Number of subjects enrolled
[2] Number of subjects who completed the intervention



  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.
Intervention arm baseline information

Reporting Groups
  Description
Adherence Feedback

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback


Baseline Measures
   Adherence Feedback 
Overall Participants Analyzed 
[Units: Participants]
 63 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.9  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  33.3% 
Male      42  66.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      63 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      0   0.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Difference in Proportion of Subjects Who Achieve >/= 95% Adherence   [ Time Frame: Measured at 6 months after start of intervention ]

2.  Secondary:   Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period   [ Time Frame: 6 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Lora Sabin
Organization: Boston University School of Public Health
phone: 617-414-1272 ext 617
e-mail: lsabin@bu.edu



Responsible Party: Lora Sabin, Boston University
ClinicalTrials.gov Identifier: NCT01722552     History of Changes
Other Study ID Numbers: 1R34DA032423-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2012
First Posted: November 7, 2012
Results First Submitted: March 11, 2017
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017