Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
HIV-infection/Aids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Plasma samples with HIV viral DNA.


Enrollment: 46
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

See above.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

young children receiving HIV antiretroviral therapy in a rural African setting

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140633

Locations
Uganda
Mbarara University Teaching Hospital
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Mbarara University of Science and Technology
Investigators
Principal Investigator: Jessica E Haberer, MD, MS Massachusetts General Hospital
  More Information

No publications provided

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
Study First Received: June 7, 2010
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology

Keywords provided by Massachusetts General Hospital:
HIV/AIDS
pediatric
wireless adherence monitoring
HIV Infections

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

ClinicalTrials.gov processed this record on November 24, 2014