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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870792
First Posted: March 27, 2009
Last Update Posted: January 11, 2017
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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
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.

Condition Intervention
HIV Infection HIV Infections Behavioral: Adherence report

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Antiretroviral medication adherence as assessed by electronic pill cap monitoring. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Self-reported medication adherence [ Time Frame: 6 months ]

Enrollment: 156
Study Start Date: November 2002
Study Completion Date: February 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Received report 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.
Placebo Comparator: Routine care
Patients receive usual, routine, care.
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • uses a pill box
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870792


Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ira B. Wilson, MD Tufts Medical Center
  More Information

Publications:
Responsible Party: Ira B. Wilson, MD, MSc, Tufte Medical Center
ClinicalTrials.gov Identifier: NCT00870792     History of Changes
Other Study ID Numbers: ibwadhrct88$
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: January 11, 2017
Last Verified: March 2009

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV
antiretroviral therapy
medication adherence
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
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