An observational study in HIV-infection/Aids, sponsored by Massachusetts General Hospital. Completed at 1 site in Uganda. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2013-09-02.
Sponsored by Massachusetts General Hospital · Observational
Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.
This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.
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2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 46 is below the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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young children receiving HIV antiretroviral therapy in a rural African setting
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Exclusion Criteria:
Distribution of adherence
Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda.
Time frame: Monthly adherence levels will be determined over the six-month study period.
Feasibility and acceptability of wireless adherence measures
Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures
Time frame: Assessments will be made a the one-month time point.
Model of adherence behavior
Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting
Time frame: Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.
The record gives a start of Apr 2010, a primary completion of Jan 2011 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Massachusetts General Hospital →