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Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

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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

Study Description
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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
HIV Infections Behavioral: Adherence counseling Device: Alarm device Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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 Name: 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 Name: ALRT Med Reminder PC200
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Pill count [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. CD4 count [ Time Frame: 18 months ]
  2. HIV-1 viral load [ Time Frame: 18 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273780


Locations
Kenya
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00273780     History of Changes
Other Study ID Numbers: 29936-G
1K23AI065222-01 ( U.S. NIH Grant/Contract )
5K23AI065222-02 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by University of Washington:
Patient compliance

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases