Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Completed

• Conditions: HIV-infection/Aids

• Registration Number: NCT01140633
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

See above.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-01
• Study Completion: 2012-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-30
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of adherence	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

Name	Time	Method
Feasibility and acceptability of wireless adherence measures	Assessments will be made a the one-month time point.	Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures
Model of adherence behavior	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

Trial Locations

Locations (1)

Mbarara University Teaching Hospital; 🇺🇬 Mbarara, Uganda