Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

This study has been completed.
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01140633
First received: June 7, 2010
Last updated: August 30, 2013
Last verified: August 2013

June 7, 2010
August 30, 2013
April 2010
January 2011   (final data collection date for primary outcome measure)
Distribution of adherence [ Time Frame: Monthly adherence levels will be determined over the six-month study period. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01140633 on ClinicalTrials.gov Archive Site
  • Feasibility and acceptability of wireless adherence measures [ Time Frame: Assessments will be made a the one-month time point. ] [ Designated as safety issue: No ]
    Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures
  • 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. ] [ Designated as safety issue: No ]
    Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting
Same as current
Not Provided
Not Provided
 
Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
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.

See above.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma samples with HIV viral DNA.

Non-Probability Sample

young children receiving HIV antiretroviral therapy in a rural African setting

HIV-infection/Aids
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
August 2012
January 2011   (final data collection date for primary outcome measure)

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
Both
1 Year to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01140633
2009-P-001062, K23MH087228
No
Jessica Haberer, MD, Massachusetts General Hospital
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
Massachusetts General Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP