China Adherence for Life (AFL)

This study has been completed.
Sponsor:
Collaborators:
Beijing Ditan Hospital
Second People's Hospital, Dali
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00661258
First received: April 11, 2008
Last updated: May 8, 2008
Last verified: April 2008
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014