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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Department of Health and Human Services | FED |
| Mbarara University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UARTO |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | real time (up to 7 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlates of adherence to antiretroviral therapy | Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status. | every four months |
| Biological consequences of adherence (or incomplete adherence) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Haberer, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara ISS Clinic, Mulago HIV Clinic | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9735090 | Result | Altice FL, Friedland GH. The era of adherence to HIV therapy. Ann Intern Med. 1998 Sep 15;129(6):503-5. doi: 10.7326/0003-4819-129-6-199809150-00015. No abstract available. | |
| 10546786 | Result | Friedland GH, Williams A. Attaining higher goals in HIV treatment: the central importance of adherence. AIDS. 1999 Sep;13 Suppl 1:S61-72. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| University of British Columbia |
| OTHER |
| Dana-Farber Cancer Institute | OTHER |
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plasma, buffy coat, saliva
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. |
| 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. | every four months |
| 11647150 | Result | Sontag D, Richardson L. Doctors withhold H.I.V. pill regimen from some. N Y Times Web. 1997 Mar 2:1, 35. No abstract available. |
| 11242178 | Result | Tchetgen E, Kaplan EH, Friedland GH. Public health consequences of screening patients for adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2001 Feb 1;26(2):118-29. doi: 10.1097/00042560-200102010-00003. |
| 9643862 | Result | Wainberg MA, Friedland G. Public health implications of antiretroviral therapy and HIV drug resistance. JAMA. 1998 Jun 24;279(24):1977-83. doi: 10.1001/jama.279.24.1977. |
| 11502341 | Result | Harries AD, Nyangulu DS, Hargreaves NJ, Kaluwa O, Salaniponi FM. Preventing antiretroviral anarchy in sub-Saharan Africa. Lancet. 2001 Aug 4;358(9279):410-4. doi: 10.1016/s0140-6736(01)05551-9. |
| 11873017 | Result | Popp D, Fisher JD. First, do no harm: a call for emphasizing adherence and HIV prevention interventions in active antiretroviral therapy programs in the developing world. AIDS. 2002 Mar 8;16(4):676-8. doi: 10.1097/00002030-200203080-00025. No abstract available. |
| Result | UNAIDS. Report on the global HIV/AIDS epidemic. Geneva: UNAIDS, 2002 |
| 29946683 | Derived | Chang JL, Tsai AC, Musinguzi N, Haberer JE, Boum Y, Muzoora C, Bwana M, Martin JN, Hunt PW, Bangsberg DR, Siedner MJ. Depression and Suicidal Ideation Among HIV-Infected Adults Receiving Efavirenz Versus Nevirapine in Uganda: A Prospective Cohort Study. Ann Intern Med. 2018 Aug 7;169(3):146-155. doi: 10.7326/M17-2252. Epub 2018 Jun 26. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |