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

Primary Purpose

HIV Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence report
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infection focused on measuring HIV, antiretroviral therapy, medication adherence, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • uses a pill box

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Received report

Routine care

Arm Description

Patients receive usual, routine, care.

Outcomes

Primary Outcome Measures

Antiretroviral medication adherence as assessed by electronic pill cap monitoring.

Secondary Outcome Measures

Self-reported medication adherence

Full Information

First Posted
March 26, 2009
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00870792
Brief Title
Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Acronym
MAP
Official Title
Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, HIV Infections
Keywords
HIV, antiretroviral therapy, medication adherence, Treatment Experienced

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Received report
Arm Type
Active Comparator
Arm Title
Routine care
Arm Type
Placebo Comparator
Arm Description
Patients receive usual, routine, care.
Intervention Type
Behavioral
Intervention Name(s)
Adherence report
Intervention Description
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.
Primary Outcome Measure Information:
Title
Antiretroviral medication adherence as assessed by electronic pill cap monitoring.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-reported medication adherence
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: on ART willing to use MEMS cap speaks and reads English detectable viral loads Exclusion Criteria: uses a pill box
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira B. Wilson, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17577653
Citation
Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
Results Reference
background
PubMed Identifier
18503620
Citation
Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.
Results Reference
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Learn more about this trial

Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals

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