Medication Adherence
Conditions
Keywords
HIV, AIDS, antiretroviral therapy, adherence, China
Brief summary
The CATS project is designed to increase understanding of interventions that are feasible and effective in helping injection drug users (IDU) or other patients at high risk of poor medication adherence who are HIV-positive to maintain a high ART adherence. The study will involve: assessing the feasibility and acceptability of using real-time feedback, a wireless technology-updated adaptation of an approach the investigators found to be feasible and effective in China, to promote ART adherence among Chinese patients, including IDU; generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and HIV viral load; and identifying the factors that explain how real-time feedback influences intervention success or failure. The specific aims of the study are: SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless technology-updated adaptation of an approach we found to be feasible and effective in China, to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT of the real-time feedback intervention among Chinese patients in order to assess its feasibility and acceptability in this population. SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count, and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of effect sizes on these important endpoints. SA3: Describe the factors that explain how real-time feedback influences intervention success or failure. The investigators will use a quantitative-qualitative mixed-methods research approach to explore how the intervention influences the experience of adherence support in this patient population.
Detailed description
The investigators will implement CATS over 2.5 years by implementing a randomized controlled trial to assess real-time feedback, an intervention that utilizes wireless technology via an electronic pill container device ('Wisepill'), and investigating the mechanisms by which the intervention operates using quantitative and qualitative research methods. 120 patients will be enrolled in a HIV clinic in Nanning, capital of Guangxi province, a border province with high rates of HIV and IDU. Enrolled patients will be randomized to intervention vs. comparison group for the 6-month intervention. The study will follow all patients for an additional 3 months to determine sustainability of intervention impact. In addition to adherence and clinical data, quantitative and qualitative data will be collected using survey instruments, focus groups, and in-depth interviews. Analysis of these data will enable achievement of the specific aims and contribute to the scientific evidence base on effective approaches to promoting ART adherence among IDU and other patients.
Interventions
BEHAVIORALadherence feedback
BEHAVIORALstandard of care
Sponsors
FHI 360
Guangxi Center for Disease Control and Prevention
Dimagi Inc.
Massachusetts General Hospital
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are 18 years of age and above, currently on ART or about to begin ART at the Guangxi CDC clinic, deemed at risk for poor adherence either by patients or medical staff, own a cell phone, and provide written consent.
Exclusion criteria
* Persons who do not speak Mandarin Chinese or who have mental health issues such that they cannot provide written informed consent will not be allowed to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Proportion of Subjects Who Achieve >/= 95% Adherence | Measured at 6 months after start of intervention | Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period | 6 months | Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers. |
Countries
China, United States
Participant flow
Recruitment details
We recruited subjects from December 2012-April 2013. They were recruited at the Guangxi Provincial ART clinic in Nanning, China. Patients were eligible if they were receiving or initiating antiretroviral therapy (ART), aged 18 years or above, deemed at risk for poor adherence by clinic staff or patients themselves, and owned a mobile phone.
Pre-assignment details
After enrollment, each subject was given a Wisepill electronic adherence monitoring container for use with his/her ART medications. Subjects selected one or more ART medications to be monitored within the device. All subjects underwent baseline adherence monitoring using Wisepill for 3 months before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Adherence Feedback Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was \<95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Adherence Feedback |
|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 56 |
| serious Total, serious adverse events | 0 / 63 | 0 / 56 |
Outcome results
Primary
Difference in Proportion of Subjects Who Achieve >/= 95% Adherence
Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
Time frame: Measured at 6 months after start of intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adherence Feedback | Difference in Proportion of Subjects Who Achieve >/= 95% Adherence | 55 Participants |
| Control | Difference in Proportion of Subjects Who Achieve >/= 95% Adherence | 29 Participants |
Secondary
Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period
Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adherence Feedback | Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period | 52 Participants |
| Control | Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period | 29 Participants |
Comparison: The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.p-value: <0.0595% CI: [1.21, 2.1]Chi-squared