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Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals (MAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00870792
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE March 26, 2009
First Posted Date  ICMJE March 27, 2009
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE November 2002
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
Antiretroviral medication adherence as assessed by electronic pill cap monitoring. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00870792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
Self-reported medication adherence [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Official Title  ICMJE Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Brief Summary We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV Infection
  • HIV Infections
Intervention  ICMJE Behavioral: Adherence report
During the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression.
Study Arms  ICMJE
  • Active Comparator: Received report
    Intervention: Behavioral: Adherence report
  • Placebo Comparator: Routine care
    Patients receive usual, routine, care.
    Intervention: Behavioral: Adherence report
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2009)
156
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • on ART
  • willing to use MEMS cap
  • speaks and reads English
  • detectable viral loads

Exclusion Criteria:

  • uses a pill box
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00870792
Other Study ID Numbers  ICMJE ibwadhrct88$
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ira B. Wilson, MD, MSc, Tufte Medical Center
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ira B. Wilson, MD Tufts Medical Center
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP