Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Boston University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mean Adherence, as Measured by Electronic Drug Monitors (EDM)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to antiretroviral treatment among the study population.
Detailed Description
This study is a continuation of "Adherence for Life (AFL): Phase I: Exploratory Research" (H-25203), which focused on collecting and analyzing qualitative data on adherence to antiretroviral treatment (ART) among HIV-positive patients in Dali, Yunnan Province, China. Like Phase I, the AFL Pilot Study (Phases II and III) will be a collaborative effort between US researchers based in Boston, MA and Chinese researchers based in Beijing and Dali. The current study, Phases II and III, will focus on collecting and analyzing qualitative and quantitative data related to adherence to ART over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to ART among the study population. The questionnaires used in these phases of the study will draw on the results of Phase I as well as standardized instruments adapted to the Chinese context. The specific aims of the study are as follows: (1) To determine the best surrogate measure of ART adherence among the study population; (2) To determine ART adherence rates in this population; (3) To analyze the relationship between adherence factors and measured adherence rates; and (4) To generate preliminary effectiveness data on an intervention that makes use of electronic drug monitors (EDM) to improve ART adherence.
Investigators
Lora Sabin
Associate Professor
Boston University
Eligibility Criteria
Inclusion Criteria
- •Patients who are 18 years of age or older, currently on antiretroviral treatment or about to begin it, live in the study catchment area, and are willing to provide informed consent.
Exclusion Criteria
- •Persons below the age of 18 years, persons who are not currently on or about to start antiretroviral treatment, persons who live outside the study catchment area, or person not willing to provide informed consent.
Outcomes
Primary Outcomes
Mean Adherence, as Measured by Electronic Drug Monitors (EDM)
Time Frame: Month 12 (last month of 6-month intervention period) and 6-month post-intervention period
We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA \<400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time (\[number of doses taken ±1 hour of dose time\] / \[total number of prescribed doses\]).
Secondary Outcomes
- Change in CD4 Count(Month 6, Month 12)