Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

August 30, 2013 updated by: Jessica Haberer, MD, Massachusetts General Hospital

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 Overview

Status

Completed

Conditions

Detailed Description

See above.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbarara, Uganda
        • Mbarara University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

young children receiving HIV antiretroviral therapy in a rural African setting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Monthly adherence levels will be determined over the six-month study period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessments will be made a the one-month time point.
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
Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

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

Investigators

  • Principal Investigator: Jessica E Haberer, MD, MS, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (ESTIMATE)

June 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-001062
  • K23MH087228 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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