Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

HIV-infection/Aids Clinical Trial

Official title:

Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140633
• Other study ID #: 2009-P-001062
• Secondary ID: K23MH087228
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: August 30, 2013
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: National Council for Science and Technology
• Study type: Observational

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection/Aids

Locations

Country	Name	City	State
Uganda	Mbarara University Teaching Hospital	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of adherence	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.	No
Secondary	Feasibility and acceptability of wireless adherence measures	Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures	Assessments will be made a the one-month time point.	No
Secondary	Model of adherence behavior	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.	No