International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)
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Purpose
Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.
| Condition |
|---|
|
HIV/AIDS |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda |
- Adherence to antiretroviral therapy [ Time Frame: real time (up to 3 years) ] [ Designated as safety issue: No ]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.
- Correlates of adherence to antiretroviral therapy [ Time Frame: every four months ] [ Designated as safety issue: No ]Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status.
- Biological consequences of adherence (or incomplete adherence) [ Time Frame: every four months and during adherence interruptions ] [ Designated as safety issue: No ]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.
- Adherence to antiretroviral therapy by self report [ Time Frame: every four months ] [ Designated as safety issue: No ]Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.
Biospecimen Retention: Samples With DNA
plasma, buffy coat, saliva
| Estimated Enrollment: | 775 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| UARTO |
Detailed Description:
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 775 participants.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Inclusion Criteria:
- HIV positive patients over 18 years
- ART naive and initiating therapy at the Mbarara Immune Suppression Syndrome (ISS) Clinic
- Live within 60 kilometers of the clinic
- Women who have received a single dose of nevirapine for prevention of mother to child transmission, but have not received other ART, will be included
Exclusion Criteria:
- Patients who do initiate therapy during the course of the study recruitment
- Patients who decline or are unable to give consent
Contacts and Locations| Contact: Mwebasa Bwana, MBChB | 011256485420786 | mwebesa_bwana@yahoo.com |
| Contact: Annet Kembabazi, BA, MA | 011256782027158 | akembabazi5@yahoo.com |
| Uganda | |
| Mbarara ISS Clinic, Mulago HIV Clinic | Recruiting |
| Mbarara, Uganda | |
| Principal Investigator: Mwebesa Bwana, Mmed, ChB | |
| Principal Investigator: | David Bangsberg, MD | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | David Bangsberg, MD, Director, MGH Center for Global Health, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01596322 History of Changes |
| Other Study ID Numbers: | UARTO, R01 MH054907 |
| Study First Received: | April 22, 2010 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Institutional Review Board Uganda: National Council for Science and Technology |
Keywords provided by Massachusetts General Hospital:
|
HIV/AIDS in resource limited setting HIV treatment outcomes in resource limited setting Adherence to HIV treatment in resource limited setting ART resistance in resource limited setting |
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 16, 2013