HIV Infections
Conditions
Keywords
HIV antiretroviral treatment adherence intervention China, adherence to antiretroviral treatment, treatment experienced
Brief summary
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.
Detailed description
This study is a continuation of Adherence for Life (AFL): Phase I: Exploratory Research (H-25203), which focused on collecting and analyzing qualitative data on adherence to antiretroviral treatment (ART) among HIV-positive patients in Dali, Yunnan Province, China. Like Phase I, the AFL Pilot Study (Phases II and III) will be a collaborative effort between US researchers based in Boston, MA and Chinese researchers based in Beijing and Dali. The current study, Phases II and III, will focus on collecting and analyzing qualitative and quantitative data related to adherence to ART over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to ART among the study population. The questionnaires used in these phases of the study will draw on the results of Phase I as well as standardized instruments adapted to the Chinese context. The specific aims of the study are as follows: (1) To determine the best surrogate measure of ART adherence among the study population; (2) To determine ART adherence rates in this population; (3) To analyze the relationship between adherence factors and measured adherence rates; and (4) To generate preliminary effectiveness data on an intervention that makes use of electronic drug monitors (EDM) to improve ART adherence.
Interventions
BEHAVIORALElectronic 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.
Sponsors
Beijing Ditan Hospital
Second People's Hospital, Dali
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are 18 years of age or older, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adherence, as Measured by Electronic Drug Monitors (EDM) | 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 (\[number of doses taken ±1 hour of dose time\] / \[total number of prescribed doses\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4 Count | Month 6, Month 12 | Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention) |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | caught by police and in detox center | 2 | 1 |
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 34 Participants | 68 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 8 | 36.1 years STANDARD_DEVIATION 8.3 | 35.6 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment China | 34 participants | 34 participants | 68 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Mean Adherence, as Measured by Electronic Drug Monitors (EDM)
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 (\[number of doses taken ±1 hour of dose time\] / \[total number of prescribed doses\]).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 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 |
| Intervention | 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 |
| Control | Mean Adherence, as Measured by Electronic Drug Monitors (EDM) | Mean adherence in Month 12 | 84.5 percentage of doses taken on time | Standard Deviation 21 |
| Control | Mean Adherence, as Measured by Electronic Drug Monitors (EDM) | Mean adherence in intervention period (Months 7-12 | 84.1 percentage of doses taken on time | Standard Deviation 21.4 |
Secondary
Change in CD4 Count
Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)
Time frame: Month 6, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in CD4 Count | 90.0 cells/µL | Standard Deviation 171.6 |
| Control | Change in CD4 Count | -8.8 cells/µL | Standard Deviation 152.6 |