Clinical trial NCT01596322: International HIV Antiretroviral Adherence, Resistance and Survival
Official title: Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Department of Health and Human Services
name: Mbarara University of Science and Technology
name: University of British Columbia
name: Dana-Farber Cancer Institute
First posted: 2012-05-11
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.

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 750 participants.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to antiretroviral therapy
timeFrame: real time (up to 7 years)
Secondary outcomes:
measure: Correlates of adherence to antiretroviral therapy
timeFrame: every four months
measure: Biological consequences of adherence (or incomplete adherence)
timeFrame: every four months and during adherence interruptions
measure: Adherence to antiretroviral therapy by self report
timeFrame: every four months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara ISS Clinic, Mulago HIV Clinic
Study officials:
affiliation: Massachusetts General Hospital
name: Jessica Haberer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Friedland GH, Williams A. Attaining higher goals in HIV treatment: the central importance of adherence. AIDS. 1999 Sep;13 Suppl 1:S61-72.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: UNAIDS. Report on the global HIV/AIDS epidemic. Geneva: UNAIDS, 2002
citation: 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.