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

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 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 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	Active Comparator: Received report Intervention: Behavioral: Adherence report; Placebo Comparator: Routine care Patients receive usual, routine, care. Intervention: Behavioral: Adherence report
Publications *	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. Epub 2007 Jun 19.; 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.
* 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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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