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China Antiretroviral Treatment Adherence for Life (AFL)

This study has been completed.
Sponsor:
Collaborators:
Beijing Ditan Hospital
Second People's Hospital, Dali
Information provided by (Responsible Party):
Lora Sabin, Boston University
ClinicalTrials.gov Identifier:
NCT00661258
First received: April 11, 2008
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: April 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Behavioral: Electronic drug monitoring feedback data

  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
A total of 80 patients were recruited at the Dali 2nd People's Hospital, in Dali, Yunnan Province, from June to November 2006 in the 6-month pre-intervention period. A total of 68 patients completed this passive phase and were randomized to intervention vs. control arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
Control The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.

Participant Flow:   Overall Study
    Intervention   Control
STARTED   34   34 
COMPLETED   31   33 
NOT COMPLETED   3   1 
Death                1                0 
caught by police and in detox center                2                1 



  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.
No text entered.

Reporting Groups
  Description
Intervention The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
Control The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   34   68 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      34 100.0%      68 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.1  (8.3)   35.1  (8.0)   35.6  (8.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  26.5%      9  26.5%      18  26.5% 
Male      25  73.5%      25  73.5%      50  73.5% 
Region of Enrollment 
[Units: Participants]
     
China   34   34   68 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Adherence, as Measured by Electronic Drug Monitors (EDM)   [ Time Frame: Month 12 (last month of 6-month intervention period) and 6-month post-intervention period ]

2.  Secondary:   Change in CD4 Count   [ Time Frame: Month 6, Month 12 ]


  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
No text entered.


  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: Dr. Lora Sabin
Organization: Boston University Center for Global Health and Development
phone: 617-414-1272
e-mail: lsabin@bu.edu



Responsible Party: Lora Sabin, Boston University
ClinicalTrials.gov Identifier: NCT00661258     History of Changes
Other Study ID Numbers: H-25495
GHS-A-00-03-00030-00 ( Other Grant/Funding Number: GHS-A-00-03-00030-00 )
Study First Received: April 11, 2008
Results First Received: April 19, 2013
Last Updated: May 11, 2017