HIV-infection/Aids
Conditions
Keywords
HIV/AIDS, pediatric, wireless adherence monitoring, HIV Infections
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.
Interventions
None listed
Sponsors
National Institute of Mental Health (NIMH)
Mbarara University of Science and Technology
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Uganda
Outcome results
None listed