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N/A N=120 Randomized Health Services Research

China Adherence Through Technology Study

Medication Adherence

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Difference in Proportion of Subjects Who Achieve >/= 95% Adherence — 55; 29 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
adherence feedback (Behavioral); standard of care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boston University
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference in Proportion of Subjects Who Achieve >/= 95% Adherence
55; 29
SECONDARY
Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period
52; 29 <0.05 sig

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01722552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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