China Adherence for Life (AFL)

This study has been completed.
Sponsor:
Collaborators:
Beijing Ditan Hospital
Second People's Hospital, Dali
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00661258
First received: April 11, 2008
Last updated: May 8, 2008
Last verified: April 2008

April 11, 2008
May 8, 2008
June 2006
November 2007   (final data collection date for primary outcome measure)
adherence to antiretroviral treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661258 on ClinicalTrials.gov Archive Site
CD4 count [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
China Adherence for Life
Adherence for Life Pilot Study: Phases II and III

This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to antiretroviral treatment among the study population.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Behavioral: Electronic drug monitoring feedback intervention
All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
  • Experimental: 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.
    Intervention: Behavioral: Electronic drug monitoring feedback intervention
  • No Intervention: 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.
    Intervention: Behavioral: Electronic drug monitoring feedback intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are 18 years of age and above, currently on antiretroviral treatment or about to begin it, live in the study catchment area, and are willing to provide informed consent.

Exclusion Criteria:

  • Persons below the age of 18 years, persons who are not currently on or about to start antiretroviral treatment, persons who live outside the study catchment area, or person not willing to provide informed consent.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00661258
H-25495, GHS-A-00-03-00030-00
No
Lora Sabin, Center for International Health and Development, Boston University
Boston University
  • Beijing Ditan Hospital
  • Second People's Hospital, Dali
Principal Investigator: Lora L Sabin, PhD Center for International Health and Development, Boston University
Boston University
April 2008

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