Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda|
- Distribution of adherence [ Time Frame: Monthly adherence levels will be determined over the six-month study period. ] [ Designated as safety issue: No ]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.
- Feasibility and acceptability of wireless adherence measures [ Time Frame: Assessments will be made a the one-month time point. ] [ Designated as safety issue: No ]Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures
- Model of adherence behavior [ Time Frame: Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period. ] [ Designated as safety issue: No ]Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting
Biospecimen Retention: Samples With DNA
Plasma samples with HIV viral DNA.
|Study Start Date:||April 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140633
|Mbarara University Teaching Hospital|
|Principal Investigator:||Jessica E Haberer, MD, MS||Massachusetts General Hospital|