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OpenTrials
Completed

NCT Number: NCT01140633

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.

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Key information

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 1 to 10 years
  • HIV-infected, meeting Ugandan criteria for antiretroviral therapy
  • living within 30 km of Mbarara, Uganda

Exclusion criteria

  • lack of mobile-phone reception

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mbarara University of Science and Technology
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 9, 2010
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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