An observational study in HIV/AIDS, sponsored by Massachusetts General Hospital. Completed at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Massachusetts General Hospital · Observational
Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.
The investigators will study use a novel method of real-time wireless adherence monitoring in one of the best established multi-disciplinary HIV antiretroviral treatment cohorts in rural Africa. The investigators will advance our theoretical understanding of HIV antiretroviral adherence behavior, HIV pathogenesis, and to address the monitoring and prevention of HIV antiretroviral treatment failure. Based on a successful pilot study in rural Uganda and favorable cost-effective estimates, the investigators will deploy the Wisepill real-time wireless adherence monitoring system to objectively monitor adherence in real time. The investigators will determine to what extent social capital mitigates economic barriers to long-term adherence and determine if the pervasive impact of stigma on adherence operates through social capital (Aim 1). The investigators will determine the relationship between missed doses, low-level viremia (between 1 and 50 copies RNA/mL), inflammation, bacterial translocation, suboptimal CD4 response, and mortality (Aim 2). Finally, The investigators will examine the relationship between complex adherence patterns and viral failure to both inform selective viral load monitoring and to lay the foundation for the first-of-kind intervention to prevent viral failure after missed doses, but before viral rebound (Aim 3). The investigators will secure behavioral and biologic data over nine years of potential treatment by recruiting 500 additional people to our existing cohort in Mbarara, Uganda for a total of 750 participants.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 750 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIV positive adults 18 years and older, who are ART naive and initiating ART at either Mbarara HIV clinic or Mulago HIV clinic in Uganda
Exclusion Criteria:
Adherence to antiretroviral therapy
Adherence is assessed through a medication event monitoring system which records every time the device is opened (e.g. for pill taking). Before June 2012, this data was stored on the device and downloaded monthly. After June 2012, this data is transmitted through cellular networks to a central server in real time.
Time frame: real time (up to 7 years)
Correlates of adherence to antiretroviral therapy
Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status.
Time frame: every four months
Biological consequences of adherence (or incomplete adherence)
Specimens are collected for immunologic and genetic testing at baseline and every four months, as well as during interruptions in adherence as detected by the real time adherence monitoring system.
Time frame: every four months and during adherence interruptions
Adherence to antiretroviral therapy by self report
Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.
Time frame: every four months
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Massachusetts General Hospital