Research Activities 2021  

Study 1: Global Surveillance of HIV Diversity and Evaluation of Test Performance Using Viral Panels Derived from Recently Infected Blood Donors 

Start/End Dates: January 2020-December 2023

SubPI Name: CLAUDE TAYOU TAGNY

In partnership with the Vitalant Research Institute and Duke University, the US

Project Description:

In the past three decades, Sub-Saharan Africa had the highest number of HIV/AIDS cases. In 2019, 59% of new HIV infections were registered in Sub-Saharan Africa¹. In 2018, the risk of HIV in candidate blood donors was up to 3.4% french speaking African countries². A Francophone Africa Research Network, that encompassed more than 21 countries, was created in 2007 to identify the best strategies that could improve blood safety in the region. Several sub-types of HIV including recombinant forms are found in Francophone Africa^3,4. The negative impact of unusual subtype and recombinant HIV infections on blood safety and availability is a real threat to the whole transfusion safety system in African countries as mutations are often associated with a high increase of undetected infected units^5,6. Despite this, little data are available on the incidence of unusual and recombinant subtypes in blood donations as most countries and blood services focus on the common forms. It is important to assess and monitor the emergent risk of mutations and to define appropriate screening approaches. In 2019, the Vitalant research institute and EQAPOL initiated a study in collaboration with the Francophone Network for Transfusion Medicine Research (FNTMR) to determine the incidence of the genotypes and to monitor the HIV screening performance. The pilot phase included Cameroon, Burkina Faso and the Central Africa Republic.  The results of the study are being analyzed.

Objectives: Building upon the success of this pilot phase work, the current application proposes to extend the monitoring of  HIV infection in a greater number of countries with the following Aims: 

• Aim  1) Perform annual cross-sectional studies of HIV 1&2 genotypes  

• Aim  2) Determine the incidence of the genotypes

• Aim  3) Form a biorepository of HIV 1&2 genotypes

• Aim 4) Monitor the HIV screening performance of the current strategies used in Francophone countries

Methods: The proposed Epidemiological surveillance project objective will be to collect and analyze a total of 400 HIV EIA repeatedly reactive blood donor samples (200 samples annually) from 6 Central and West African francophone blood services ( 4 new centres) during a two-year time line. A total volume of 110ml of blood will be collected at the time of enrollment from blood units declared repeatedly HIV positive. Plasma specimens will be collected into two 50ml conic tubes and one 10ml dry aliquot saved at -30°C in an appropriate freezer in the study repository of each site. They will be sent to Cameroon for confirmation by the Biorad Geenius HIV 1&2 testing. Samples will be tested for confirmation on the 10ml plasma in Cameroon. The two 50ml plasma in conical tubes declared positive after confirmation will be then sent to VRI  for future testing, including genotyping and assessment of reagent performance. We will provide the following outcome variables:

• Proportion of recent HIV infection

• Types and Proportion of HIV genotypes

• Type of HIV screening reagents that are reported efficient on the identified genotypes

• Phylogenetic analysis of HIV variants

  The IRB approval will be obtained from the SBFA ethics committee and the Cameroon National Ethics committee.

  Expected results: This will have a high impact in several areas of transfusion medicine and infectious disease. First, this would both provide information to the blood services on the diversity of viruses currently circulating in donor populations and will be useful for an external quality assessment scheme of HIV screening. Second, the biorepository will increase transfusion safety by providing samples for molecular epidemiology, viral discovery and increase viruses represented in the EQAPOL Viral Diversity Panel, in collaboration with investigators at VRI. Finally, the effort will build capacity for biological research at West African blood centers, and serve as a pilot project for larger surveillance in that region of Africa. 

  Study 1:Evaluation of an African specific Donor Health Questionnaire for HIV screening in Cameroonian blood services

  Start/End Dates: July 2020-June 2021

  SubPI Name: CLAUDE TAYOU TAGNY

  In partnership with the University of California, San Francisco, the US.

  Project Description:

  Background: The World Health Organization has listed the provision of safe blood transfusion as one of its essential medical therapies. In high-income countries, blood supplies are generally adequate and the risk of transfusion-transmitted infections (TTI) is extremely low. However in sub-Saharan Africa, there exist numerous gaps in the provision of safe and adequate blood supplies. Our review of the literature and preliminary studies conducted as part of the Francophone Africa transfusion research network have revealed numerous gaps, including the high residual risk of HIV infection in blood units to be transfused due to inadequate blood donor recruitment, particularly of volunteer donors; high rates of donor deferral based upon donor history questionnaires that may not be appropriate for the local environment; high prevalence of blood-borne viral infections in combination with viral testing algorithms that are neither sensitive nor specific.

  Objectives: The overarching aim of this project is to improve the risk factor deferral process by implementing a new donor history questionnaire that will identify HIV infected individuals and prevent blood-borne HIV transmission in Cameroon generated through basic scientific inquiry. We propose to validate an African Specific donor heath Questionnaire and its scoring system developed in a previous pilot study in Cameroon.

  Specific Aims include:

• Determine the sensitivity and specificity of the new ASDHQ by comparing i) HIV status of accepted versus deferred donors and ii) the rate of risk deferrals compared to historical data; and

• Determine operational acceptability of the new ASDHQ by monitoring HIV prevalence in accepted donors, also compared to historical data, as well as comprehension and time required for the questionnaire.

Methods: This will be done using a simple cross-sectional design comparing HIV status in accepted versus deferred donors. All consenting volunteer or replacement blood donors aged between 18 and 65, in good general health, with adequate hemoglobin levels will be enrolled in the study.  The ASDHQ will be administered to all donor candidates in the 2 sites independently of the existing questionnaire: YaoundéUniversity Teaching Blood service and Yaounde Central Hospital Blood Service. Assuming an average of 13% of deferral in the three sites, we estimate that 1,950 (15,000X13%) will be deferred and invited to participate in the study.  Autologous blood donors will be excluded.  It is a comprehensive questionnaire of 16 questions that can be administered within 15 minutes.  Blood samples will be collected on ASDHQ deferred donors (ASDHQ score <80) and tested for HIV the same way as the samples collected on accepted donors according to good screening standards in the laboratories of the blood services. Sample with Indeterminate HIV results will be confirmed at the Yaounde university Blood service with the Bio-Rad Geenius™ HIV 1/2 Supplemental Assay.  We will compare the current HIV prevalences in deferred donors and accepted donors in each site with those obtained with the new questionnaire.

Expected results: We expect, by the end of the project period, to have developed a real-world intervention that can be utilized in the Cameroonian blood services and will also have relevance for other sub-Saharan African countries. 

Promoting the health renewal of Africa through increased access to Safe Blood