Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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See above.

Conditions

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HIV-infection/Aids

Keywords

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HIV/AIDS pediatric wireless adherence monitoring HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jessica Haberer, MD

Assistant in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica E Haberer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Mbarara University Teaching Hospital

Mbarara, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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K23MH087228

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-P-001062

Identifier Type: -

Identifier Source: org_study_id