China Adherence Through Technology Study (CATS)
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.
|Medication Adherence||Behavioral: adherence feedback Behavioral: standard of care|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||China Adherence Through Technology Study|
- Difference in Proportion of Subjects Who Achieve >/= 95% Adherence [ Time Frame: 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.
- Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period [ Time Frame: 6 months ]
|Study Start Date:||November 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Behavioral: adherence feedback|
Active Comparator: standard of care
Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
|Behavioral: standard of care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722552
|United States, Massachusetts|
|Boston University Center for Global Health and Development|
|Boston, Massachusetts, United States, 02118|
|Guangxi CDC ART Clinic|
|Nanning, Guangxi, China|
|Principal Investigator:||Lora Sabin, PhD||Boston University Center for Global Health and Development|