Clinical trial NCT00661258: China Antiretroviral Treatment Adherence for Life
Official title: Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV antiretroviral treatment adherence intervention China
adherence to antiretroviral treatment
treatment experienced
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Second People's Hospital, Dali
First posted: 2008-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Adherence, as Measured by Electronic Drug Monitors (EDM)
timeFrame: Month 12 (last month of 6-month intervention period) and 6-month post-intervention period
Secondary outcomes:
measure: Change in CD4 Count
timeFrame: Month 6, Month 12
Other outcomes:
Locations:
city: Dali
country: China
facility: Dali Second People's Hospital
state: Yunnan
Study officials:
affiliation: Center for International Health and Development, Boston University
name: Lora L Sabin, PhD
role: PRINCIPAL_INVESTIGATOR
References: