Early Capture of HIV Cohort (ECHO)
Description of the study
Title: HIV-1 Prevalence, Incidence, Cohort Retention, and Host Genetics and Viral Diversity in Cohorts in East Africa and Thailand”
This is a multi-center, non-randomized clinical observational study conducted in three East African countries (Tanzania, Kenya, Uganda) and Thailand. The research collaboration outlined in this study measures the epidemiology of HIV in a volunteer cohort drawn from high-risk populations in these countries. The study focus more on acute infection acquisition rather than high risk cohort development alone.
Sponsors
The study is funded by Division of AIDS (DAIDS) of the US National Institutes of Health (NIH) through USHMRP
Objectives
Primary Objectives:
i. The primary objective of the study is to estimate HIV-1 incidence and retention in a volunteer cohort established to test vaccine strategies.
ii. Define the risk behaviour, prevalence and incidence of HIV infection and retention of a high risk cohort of adults in Thailand, Uganda, Kenya and Tanzania
iii. Obtain approximately 150 acute HIV infections (AHI) with at least 30% captured within Fiebig stages I and II to support the full characterization of host responses and viral dynamics
Secondary/Exploratory Objectives:
i. Assess and optimize HIV diagnostic strategies in HIV primary infection across multiple subtypes and risk groups
ii. Define the genetic diversity and evolution of HIV-1 in the prevalent and incident HIV cases with particular emphasis on characterization of acute, primary HIV infection
iii. Characterize immune activation, innate and adaptive cellular immunity in the early acute HIV-1 infection
iv. Characterize B cell responses in peripheral and mucosal compartments arising in early acute HIV-1 infection
v. Characterize genetic polymorphisms in genes controlling host restriction, innate and adaptive Immunity, and their influence on HIV acquisition and early control of HIV infections
vi. Characterize clinical events including endemic infection as risk factors for HIV acquisition
This study aims to develop a cohort of 2,000 individuals at high-risk of HIV infection in Uganda (subtype D, A, A/D), Tanzania (subtype C, A, A/C), Kenya (subtype A), and Thailand (subtype CRF_01 AE, B). Volunteers are screened in each country from populations with very high prevalence (20-70%) to yield incidence rates of >3%.
This study also defines the prevalence of HIV-1 in this volunteer cohort, determine the distribution of HIV-1 genotypes and different host genetic backgrounds, assess the range of CD4 and viral load in HIV-1 infected volunteers, characterize behavioral and other risk factors associated with HIV-1 infection, and augment HIV-1 prevention and education programs, human resources, and laboratory infrastructure to support future vaccine trials.
Future plans
With the ongoing/upcoming protocol amendment, a number of interventional trials in acute HIV infected individuals will be implemented along with RV 217 study procedures.
RV 217 team
PI: Dr Lucas Maganga
Study Coordinator: Erica Sanga
Study Doctors: Wiston William, Joseph Hidda and Sylivia Urio
Study QA/AC: Lucas Lazaro
Study Secretary: Dogo Ngalison
Study Nurses: Vumilia Kaduma, Irene Joseph, Amina Abu
Laboratory team: Exhaud Ngomuo, Donata Wililo andLast Mwaipopo
