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Trial record 1 of 1 for:    NCT00273780
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Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

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.
 
ClinicalTrials.gov Identifier: NCT00273780
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : August 27, 2012
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE January 5, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date August 27, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
Pill count [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
Pill count
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
  • CD4 count [ Time Frame: 18 months ]
  • HIV-1 viral load [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
  • CD4 count
  • HIV-1 viral load
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
Official Title  ICMJE HAART Adherence Interventions in Africa: An RCT
Brief Summary This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.
Detailed Description

The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART (highly active antiretroviral therapy) for the first time. Patients who are eligible to be initiated on HAART at the UW/Coptic Hope Center for Infectious Diseases will be referred for enrollment. Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent.

Study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. Participants will be followed in the study for 1 ½ years after enrollment and randomization. Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. During follow-up visits, blood will be drawn and stored for CD4 counts and HIV-1 viral analyses.

Within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Behavioral: Adherence counseling
    Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.
  • Device: Alarm device
    This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
    Other Name: ALRT Med Reminder PC200
Study Arms  ICMJE
  • Active Comparator: Adherence counseling
    Intervention: Behavioral: Adherence counseling
  • Active Comparator: Alarm device
    Intervention: Device: Alarm device
  • Active Comparator: Counseling and alarm
    Participants in this arm will receive both education counseling and a pocket alarm device.
    Interventions:
    • Behavioral: Adherence counseling
    • Device: Alarm device
  • No Intervention: Control
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
Actual Enrollment  ICMJE
 (submitted: January 5, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
  • Must be above 18 years of age
  • Must be HAART treatment-naïve
  • Must agree to home visits, and plan to live in Kenya for at least two years.

Exclusion Criteria:

  • Individuals who are mentally incompetent or are pregnant are excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00273780
Other Study ID Numbers  ICMJE 29936-G
1K23AI065222-01 ( U.S. NIH Grant/Contract )
5K23AI065222-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Michael H Chung, MD, MPH University of Washington
PRS Account University of Washington
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP