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Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT00273780
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
400
Enrollment
1
Location
4
Arms
28.1
Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adherence counseling
  • Device: Alarm device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Official Title:
HAART Adherence Interventions in Africa: An RCT
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Adherence counseling

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.
Active Comparator: Alarm device

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 Names:
  • ALRT Med Reminder PC200

    		•
    Active Comparator: Counseling and alarm

    Participants in this arm will receive both education counseling and a pocket alarm device.

    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 Names:
  • ALRT Med Reminder PC200

    		•
    No Intervention: Control

    Outcome Measures

    Primary Outcome Measures

    1. Pill count [18 months]

    Secondary Outcome Measures

    1. CD4 count [18 months]

    2. HIV-1 viral load [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hope Center for Infectious Diseases Nairobi Kenya

    Sponsors and Collaborators

    • University of Washington
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Michael H Chung, MD, MPH, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Washington
    ClinicalTrials.gov Identifier:
    NCT00273780
    Other Study ID Numbers:
    • 29936-G
    • 1K23AI065222-01
    • 5K23AI065222-02
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Aug 27, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by University of Washington
    Patient compliance
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Aug 27, 2012