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China Adherence Through Technology Study (CATS)

This study has been completed.
Sponsor:
Collaborators:
FHI 360
Guangxi Center for Disease Control and Prevention
Dimagi Inc.
Massachusetts General Hospital
Information provided by (Responsible Party):
Lora Sabin, Boston University
ClinicalTrials.gov Identifier:
NCT01722552
First received: November 3, 2012
Last updated: March 11, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Medication Adherence Behavioral: adherence feedback Behavioral: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: China Adherence Through Technology Study

Further study details as provided by Lora Sabin, Boston University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period [ Time Frame: 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.


Enrollment: 120
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722552

Locations
United States, Massachusetts
Boston University Center for Global Health and Development
Boston, Massachusetts, United States, 02118
China, Guangxi
Guangxi CDC ART Clinic
Nanning, Guangxi, China
Sponsors and Collaborators
Boston University
FHI 360
Guangxi Center for Disease Control and Prevention
Dimagi Inc.
Massachusetts General Hospital
Investigators
Principal Investigator: Lora Sabin, PhD Boston University Center for Global Health and Development
  More Information

Responsible Party: Lora Sabin, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT01722552     History of Changes
Other Study ID Numbers: 1R34DA032423-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: November 3, 2012
Results First Received: March 11, 2017
Last Updated: March 11, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: We have no IPD sharing plan.

Keywords provided by Lora Sabin, Boston University:
HIV
AIDS
antiretroviral therapy
adherence
China

ClinicalTrials.gov processed this record on June 26, 2017