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Sponsors and Collaborators: |
University of Washington National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00273780 |
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 | Intervention |
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HIV Infections |
Behavioral: Education counseling Device: Alarm device |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | HAART Adherence Interventions in Africa: An RCT |
Enrollment: | 400 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Behavioral: Education 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.
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2: Active Comparator |
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.
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3: Active Comparator
Participants in this arm will receive both education counseling and a pocket alarm device.
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Behavioral: Education 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.
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4: No Intervention |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Washington ( Michael H. Chung ) |
Study ID Numbers: | 06-1342-G, 1K23AI065222-01, 5K23AI065222-02 |
Study First Received: | January 5, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00273780 |
Health Authority: | United States: Institutional Review Board |
Patient compliance |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |