Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01140633|
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : September 2, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||August 2012|
- Distribution of adherence [ Time Frame: Monthly adherence levels will be determined over the six-month study period. ]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. ]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. ]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
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): NCT01140633
|Mbarara University Teaching Hospital|
|Principal Investigator:||Jessica E Haberer, MD, MS||Massachusetts General Hospital|