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 the establishment of the Advanced Clinical Monitoring of ART Project in Ethiopia for monitoring and evaluation of the longitudinal effectiveness of the ART program and to show the opportunities it presents. This cohort was established in response to the 2005 call by WHO for establishing additional mechanisms for stronger monitoring of ART and the need for creating the platform to generate evidence to guide the care given for the ever increasing number of patients on ART in Ethiopia.

Method: A participatory and multi-stage process which started from a consensus building workshop and steered by a mother protocol as well as guiding documents which dictated the degree of engagement and expectations was followed. The primary and secondary aims of the study were agreed upon. A multi-site longitudinal observational clinical cohort was established by a consortium of stakeholders including seven Ethiopian medical schools and their affiliated referral hospitals, John Hopkins University, Ethiopian Public Health Institute, Ministry of Science and Technology, US Centers for Disease Prevention and Control - CDC-Ethiopia, and the Federal Ministry of Health. Adult and adolescent cohorts covering the age range of 14+ years) and pediatric cohorts covering those below age 14 years were the two main cohorts. During the initial recruitment of these cohorts information was extracted from existing documents for a total of 2,100 adult participants. In parallel, a prospective cohort of 1,400 adult and adolescent patients were enrolled for ART initiation and follow-up. Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective and prospective cohorts. Replacement of participants were made in subsequent years based on lost follow up and death rates to maintain adequacy of the sample to be followed-up.

Achievements: Between January 2005 and August 2013 a total of 4,339 patients were followed for a median of 41.6 months and data on demographic characteristics, baseline and ongoing clinical features, hospitalization history, medication and laboratory information were collected. 39,762 aliquots and 25,515 specimens of plasma and dryblood-spots respectively were obtained and stored longitudinally from October 2009 to August 2013. The project created a research platform for researchers, policy and decision makers. Moreover, it encouraged local and international investigators to identify and answer clinically and programmatically relevant research questions using the available data and specimens. Calls for concept notes paired with multiple trainings to stimulate investigators to conduct analyses further boosted the potential for doing research.

Conclusions: A comprehensive and resourceful mechanism for scientific inquiry was established to support the national HIV/ART program. With meaningful involvement and defined roles, establishment of a study, which involved multiple institutions and investigators, was possible. Since ACM is the largest multi-site clinical cohort of patients on antiretroviral treatment in Ethiopia-which can be used for research and for improving clinical management-considering options to sustain the project is crucial.

Keywords: ART Monitoring and Evaluation; Antiretroviral therapy; Establishing Longitudinal Cohort Study; Ethiopia; HIV clinical cohort.

Figure 1

Advanced clinical monitoring (ACM) project organization, January 1, 2005 to August 31, 2013, Ethiopia ACM.

Fig 2

Specimen and Data Flow of the advanced clinical monitoring (ACM) project, January 1, 2005 to August 31, 2013, Ethiopia. Specimens from the 2 sites in Addis Ababa were being sent same day as collected and those from out of Addis were being sent within 2 weeks after partial processing. Note: communication was bidirectional with the intent of ensuring quality of data and specimens.

Figure 3

Data and specimen flow to central data and specimen warehouse at Ethiopian Public Health Institute (EPHI), January 1, 2005 to August 31, 2013, Ethiopia. All de-identified data was gathered in the central database, a SQL server based system developed specifically for this purpose.

Figure 4

Advanced clinical monitoring (ACM) multisite database and repository cohort enrollment by year, January 1, 2005 to August 31, 2013, Ethiopia.