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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

Detailed Description:
See above.

Study Design

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
Study Start Date : April 2010
Primary Completion Date : January 2011
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Plasma samples with HIV viral DNA.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
young children receiving HIV antiretroviral therapy in a rural African setting

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
Contacts and Locations

Information from the National Library of Medicine

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
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Mbarara University of Science and Technology
Principal Investigator: Jessica E Haberer, MD, MS Massachusetts General Hospital
More Information

Responsible Party: Jessica Haberer, MD, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01140633     History of Changes
Other Study ID Numbers: 2009-P-001062
K23MH087228 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by Jessica Haberer, MD, Massachusetts General Hospital:
wireless adherence monitoring
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases