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

January 5, 2006
January 9, 2006
August 27, 2012
May 2006
September 2008   (Final data collection date for primary outcome measure)
Pill count [ Time Frame: 18 months ]
Pill count
Complete list of historical versions of study NCT00273780 on Archive Site
  • CD4 count [ Time Frame: 18 months ]
  • HIV-1 viral load [ Time Frame: 18 months ]
  • CD4 count
  • HIV-1 viral load
Not Provided
Not Provided
Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
HAART Adherence Interventions in Africa: An RCT
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
HIV Infections
  • 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
  • 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.
    • Behavioral: Adherence counseling
    • Device: Alarm device
  • No Intervention: Control

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2008
September 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
1K23AI065222-01 ( U.S. NIH Grant/Contract )
5K23AI065222-02 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Washington
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Michael H Chung, MD, MPH University of Washington
University of Washington
August 2012

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