China Antiretroviral Treatment Adherence for Life (AFL)
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|ClinicalTrials.gov Identifier: NCT00661258|
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Electronic drug monitoring feedback data||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
The intervention group patients were given their electronic drug monitoring feedback 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.
Behavioral: Electronic drug monitoring feedback data
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 feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
No Intervention: Comparison
The comparison group patients were not given the data from the electronic data monitoring feedback data. 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.
- 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 ]We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA <400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time ([number of doses taken ±1 hour of dose time] / [total number of prescribed doses]).
- Change in CD4 Count [ Time Frame: Month 6, Month 12 ]Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661258
|Dali Second People's Hospital|
|Dali, Yunnan, China|
|Principal Investigator:||Lora L Sabin, PhD||Center for International Health and Development, Boston University|