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

Tracking Information

First Received Date ^ICMJE

March 26, 2009

Last Updated Date

April 6, 2009

Start Date ^ICMJE

November 2002

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antiretroviral medication adherence as assessed by electronic pill cap monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

156

Completion Date

February 2005

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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