Establishing a Multicenter Longitudinal Clinical Cohort Study in Ethiopia Advanced Clinical Monitoring of Antiretroviral Treatment Project

Abstract

Background: The purpose of this paper is to describe theestablishment of the Advanced Clinical Monitoring of ART Projectin Ethiopia for monitoring and evaluation of the longitudinaleffectiveness of the ART program and to show the opportunities itpresents. This cohort was established in response to the 2005 callby WHO for establishing additional mechanisms for strongermonitoring of ART and the need for creating the platform togenerate evidence to guide the care given for the ever increasingnumber of patients on ART in Ethiopia.Method: A participatory and multi-stage process which startedfrom a consensus building workshop and steered by a motherprotocol as well as guiding documents which dictated the degree ofengagement and expectations was followed. The primary andsecondary aims of the study were agreed upon. A multi-sitelongitudinal observational clinical cohort was established by aconsortium of stakeholders including seven Ethiopian medicalschools and their affiliated referral hospitals, John HopkinsUniversity, Ethiopian Public Health Institute, Ministry of Scienceand Technology, US Centers for Disease Prevention and Control -CDC-Ethiopia, and the Federal Ministry of Health. Adult andadolescent cohorts covering the age range of 14+ years) andpediatric cohorts covering those below age 14 years were the twomain cohorts. During the initial recruitment of these cohortsinformation was extracted from existing documents for a total of2,100 adult participants. In parallel, a prospective cohort of 1,400adult and adolescent patients were enrolled for ART initiation andfollow-up. Using similar recruitment procedures, a total of 120children were enrolled in each of retrospective and prospectivecohorts. Replacement of participants were made in subsequentyears based on lost follow up and death rates to maintain adequacyof the sample to be followed-up.Achievements: Between January 2005 and August 2013 a total of4,339 patients were followed for a median of 41.6 months and dataon demographic characteristics, baseline and ongoing clinicalfeatures, hospitalization history, medication andlaboratory information were collected. 39,762aliquots and 25,515 specimens of plasma and dry-blood-spots respectively were obtained and storedlongitudinally from October 2009 to August 2013.The project created a research platform forresearchers, policy and decision makers.Moreover, it encouraged local and internationalinvestigators to identify and answer clinically andprogrammatically relevant research questionsusing the available data and specimens. Calls forconcept notes paired with multiple trainings tostimulate investigators to conduct analyses furtherboosted the potential for doing research.Conclusions: A comprehensive and resourcefulmechanism for scientific inquiry was establishedto support the national HIV/ART program. Withmeaningful involvement and defined roles,establishment of a study, which involved multipleinstitutions and investigators, was possible. SinceACM is the largest multi-site clinical cohort ofpatients on antiretroviral treatment in Ethiopia---which can be used for research and for improvingclinical management---considering options tosustain the project is crucial.