China Antiretroviral Treatment Adherence for Life

HIV Infections Clinical Trial

— AFL  

Official title:

Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661258
• Other study ID #: H-25495
• Secondary ID: GHS-A-00-03-0003
• Status: Completed
• Phase: N/A
• First received: April 11, 2008
• Last updated: May 11, 2017
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: May 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Electronic drug monitoring feedback data
All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.

Locations

Country	Name	City	State
China	Dali Second People's Hospital	Dali	Yunnan

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Beijing Ditan Hospital, Second People's Hospital, Dali

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Adherence, as Measured by Electronic Drug Monitors (EDM)	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]).	Month 12 (last month of 6-month intervention period) and 6-month post-intervention period
Secondary	Change in CD4 Count	Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)	Month 6, Month 12