Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
NCT ID: NCT00273780
Last Updated: 2012-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2006-05-31
2008-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
NONE
Study Groups
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Adherence counseling
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.
Alarm 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.
Counseling and alarm
Participants in this arm will receive both education counseling and a pocket alarm device.
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.
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.
Control
No interventions assigned to this group
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Michael H Chung, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Hope Center for Infectious Diseases
Nairobi, , Kenya
Countries
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References
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Marson KG, Tapia K, Kohler P, McGrath CJ, John-Stewart GC, Richardson BA, Njoroge JW, Kiarie JN, Sakr SR, Chung MH. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic. PLoS One. 2013 Oct 24;8(10):e78900. doi: 10.1371/journal.pone.0078900. eCollection 2013.
Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.
Other Identifiers
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