Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
2 other identifiers
observational
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 2, 2013
August 1, 2013
9 months
June 7, 2010
August 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Monthly adherence levels will be determined over the six-month study period.
Secondary Outcomes (2)
Feasibility and acceptability of wireless adherence measures
Assessments will be made a the one-month time point.
Model of adherence behavior
Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.
Eligibility Criteria
young children receiving HIV antiretroviral therapy in a rural African setting
You may qualify if:
- age 1 to 10 years
- HIV-infected, meeting Ugandan criteria for antiretroviral therapy
- living within 30 km of Mbarara, Uganda
You may not qualify if:
- lack of mobile-phone reception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mbarara University Teaching Hospital
Mbarara, Uganda
Biospecimen
Plasma samples with HIV viral DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica E Haberer, MD, MS
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant in Medicine
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
April 1, 2010
Primary Completion
January 1, 2011
Study Completion
August 1, 2012
Last Updated
September 2, 2013
Record last verified: 2013-08