China Adherence Through Technology Study

Medication Adherence Clinical Trial

— CATS  

Official title:

China Adherence Through Technology Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722552
• Other study ID #: 1R34DA032423-01A1
• Status: Completed
• Phase: N/A
• First received: November 3, 2012
• Last updated: May 21, 2014
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• adherence feedback

Locations

Country	Name	City	State
China	Guangxi CDC ART Clinic	Nanning	Guangxi
United States	Boston University Center for Global Health and Development	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Boston University	Dimagi Inc., FHI 360, Guangxi Center for Disease Control and Prevention, Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured at 6 months after start of intervention	No
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.	6 months	No