Trial Outcomes & Findings for China Antiretroviral Treatment Adherence for Life (NCT NCT00661258)

Results Overview

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 (\[number of doses taken ±1 hour of dose time\] / \[total number of prescribed doses\]).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Month 12 (last month of 6-month intervention period) and 6-month post-intervention period

Results posted on

2017-05-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	34	34
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1	0
Overall Study caught by police and in detox center	2	1

Baseline Characteristics

China Antiretroviral Treatment Adherence for Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=34 Participants 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 n=34 Participants 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 n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 8.3 • n=5 Participants	35.1 years STANDARD_DEVIATION 8.0 • n=7 Participants	35.6 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment China	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12 (last month of 6-month intervention period) and 6-month post-intervention period

Population: Of 68 subjects randomized at 6 months, 64 completed the full 12 months of data collection, 31 in Intervention Arm and 33 in Comparison Arm.

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 (\[number of doses taken ±1 hour of dose time\] / \[total number of prescribed doses\]).

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants 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 n=33 Participants 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
Mean Adherence, as Measured by Electronic Drug Monitors (EDM) Mean adherence in Month 12	96.5 percentage of doses taken on time Standard Deviation 4.8	84.5 percentage of doses taken on time Standard Deviation 21.0
Mean Adherence, as Measured by Electronic Drug Monitors (EDM) Mean adherence in intervention period (Months 7-12	96.4 percentage of doses taken on time Standard Deviation 3.4	84.1 percentage of doses taken on time Standard Deviation 21.4

SECONDARY outcome

Timeframe: Month 6, Month 12

Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants 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 n=33 Participants 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
Change in CD4 Count	90.0 cells/µL Standard Deviation 171.6	-8.8 cells/µL Standard Deviation 152.6

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lora Sabin

Boston University Center for Global Health and Development

Phone: 617-414-1272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place