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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00870792
First received: March 26, 2009
Last updated: April 6, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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$
Study First Received: March 26, 2009
Last Updated: April 6, 2009
Health Authority: United States: Federal Government

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
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 23, 2013