China Adherence for Life - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Electronic drug monitoring feedback intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Adherence for Life Pilot Study: Phases II and III

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:

adherence to antiretroviral treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CD4 count [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	June 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intervention The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.	Behavioral: Electronic drug monitoring feedback intervention 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 data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
No Intervention: Control The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.	Behavioral: Electronic drug monitoring feedback intervention 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 data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.

Arms

Assigned Interventions

Experimental: Intervention

The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.

Behavioral: Electronic drug monitoring feedback intervention

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 data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.

No Intervention: Control

The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.

Behavioral: Electronic drug monitoring feedback intervention

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 data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are 18 years of age and above, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661258

Locations

China, Yunnan
Dali Second People's Hospital
Dali, Yunnan, China

Sponsors and Collaborators

Boston University

Beijing Ditan Hospital

Second People's Hospital, Dali

Investigators

Principal Investigator:

Lora L Sabin, PhD

Center for International Health and Development, Boston University

More Information

No publications provided

Responsible Party:	Lora Sabin, Center for International Health and Development, Boston University
ClinicalTrials.gov Identifier:	NCT00661258 History of Changes
Other Study ID Numbers:	H-25495, GHS-A-00-03-00030-00
Study First Received:	April 11, 2008
Last Updated:	May 8, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston University:

HIV antiretroviral treatment adherence intervention China
adherence to antiretroviral treatment
treatment experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013

China Adherence for Life (AFL)