China Adherence Through Technology Study (CATS)

• ClinicalTrials.gov Identifier: NCT01722552
• Recruitment Status: Completed
• First Posted: November 7, 2012
• Results First Posted: April 21, 2017
• Last Update Posted: April 21, 2017
• Sponsor: Boston University
• Collaborators: FHI 360; Guangxi Center for Disease Control and Prevention; Dimagi Inc.; Massachusetts General Hospital
• Information provided by (Responsible Party): Lora Sabin, Boston University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Medication Adherence	Behavioral: adherence feedback; Behavioral: standard of care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: China Adherence Through Technology Study
• Study Start Date: November 2012
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 1R34DA032423-01A1 ( U.S. NIH Grant/Contract )
• First Posted: November 7, 2012
• Results First Posted: April 21, 2017
• Last Update Posted: April 21, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• 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