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Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

NCT01140633 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2013-09-02

No results posted yet for this study

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.

Conditions

  • HIV-infection/Aids

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Mbarara University of Science and Technology

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jessica E Haberer, MD, MS · Massachusetts General Hospital

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-01-31
Completion
2012-08-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140633 on ClinicalTrials.gov