Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00273780
First received: January 5, 2006
Last updated: August 23, 2012
Last verified: August 2012

January 5, 2006
August 23, 2012
May 2006
September 2008   (final data collection date for primary outcome measure)
Pill count [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Pill count
Complete list of historical versions of study NCT00273780 on ClinicalTrials.gov Archive Site
  • CD4 count [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • HIV-1 viral load [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.
    Interventions:
    • Behavioral: Adherence counseling
    • Device: Alarm device
  • No Intervention: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00273780
29936-G, 1K23AI065222-01, 5K23AI065222-02
Yes
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