Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
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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 |
- 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.
- 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 |
| Estimated Study Completion Date: | August 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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 |
young children receiving HIV antiretroviral therapy in a rural African setting
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| Uganda | |
| Mbarara University Teaching Hospital | |
| Mbarara, Uganda | |
| 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: | March 12, 2012 |
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013