Transfusion medicine and Blood safety: Policy, Diagnostics and Standards development
Investigator: Mike Busch, MD, PhD
Location(s): South Africa; Brazil
The Recipient Epidemiology and Donor Evaluation Study REDS-III, is developing evidence to inform policy in blood systems in Brazil and South Africa. The international projects will focuses on donor and donation databases. The addition of databases will provide a critical resource for future studies along many lines of investigation, including health policy research. In addition for each site, specific protocols have been developed. The overview below provides summary information on the proposed aims for each major protocol.
Brazil – a continuation of two studies from REDS-II and development of major new initiatives that are highly relevant to the Brazil context. The Brazil collaborating organizations include Fundacao ProSangue/Hemocentro Sao Paulo, Sao Paulo, Hemominas, Belo Horizonte, Hemope, Recife, and Hemorio, Rio de Janeiro. The new initiatives and study objectives are: 1. Transfusion-Transmitted Dengue. Further analysis of the highly important and successfully completed prevalence and transmission study were achieved by the Brazil team.
a. Establish background DENV seroprevalence rates in blood donors and recipients according to their transfusion history.
b. Launch a DENV transmission and disease penetrance study in one epidemic/outbreak region
c. Retain linked donation and recipient samples from aim b (above) as a repository for investigation of potential new transfusion transmissible arboviruses.
2. Sickle Cell Disease transfusion and predictors of health outcomes study
a. Develop a centralized, comprehensive electronic database of clinical, laboratory and transfusion information and a biospecimen repository for SCD patients seen at the four REDS III sites in Brazil.
b. Characterize the immune modulation in transfused and non-transfused SCD patients.
c. Identify particular single nucleotide polymorphisms (SNPs) that contribute to the risk of red blood cell alloimmunization in SCD by performing a genome-wide association study (GWAS)
d. Risk factors for HIV infection in SCD patients in Brazil
3. Notification and HIV counseling, and linkage of HIV positive donors to health care.
a. Conduct an analysis of blood donor notification in Brazil to determine whether there are differences the success in notifying donors according to infection and blood center.
b. Conduct follow-up audio computer assisted self-interviews (ACASI) of HIV positive donors to assess whether these donors subsequently attend HIV referral centers for counseling, treatment and follow-up after notification.
c. Use HIV positive blood donors (from the previous aim) as key informants by inquiring through ACASI about ways we can improve the disclosure of HIV risks in donors during the eligibility assessment interview. The continuation activities from REDS-II include:
4. Donor/Donation Core Database. Collection of the donor and donation databases.
5. Chagas Recall Study. Assess evolution of Chagas’ disease among seropositive donors and Chagasic cardiac patients, and correlate progression with genomic/proteomic and parasitemia biomarkers.
6. HIV Molecular and Risk Factor Surveillance Study. Determine risk factors associated with longstanding or recently acquired HIV infection, including HIV subtype and drug resistance profile among HIV positive donors.
South Africa – Our primary collaborator is the South African National Blood Service (SANBS). In addition we will partner with Western Province Blood Transfusion Service (WPBTS) on specific projects and also with clinicians at major hospitals in Durban, Johannesburg, and Cape Town.
1. Incident HIV/HBV infection in South African blood donors: behavioral risk factors, HIV genotypes and biological characterization of early infection.
a. Identify the demographic and behavioral risk factors associated with incident HIV and incident HBV infections and to compare these factors with those in donors with prevalent infection.
b. Determine HIV subtype and drug resistance profiles among HIV positive donors with recently acquired infection. Determine HBV genotype among HBV positive donors with recently acquired infection.
c. Prospectively characterize the virology, immunology and natural history of incident HIV infection in a cohort of recently infected blood donors and smaller cohort of elite controllers in South Africa.
USA – The UCSF/BCP clinical hub is involved in many activities in the REDS-III domestic study. The fast track studies and core activities I am leading include a study of determinants of survival and assessment of immune system activation parameters in persons with advanced HIV also infected GBVC, and a qualitative interview and survey study of two groups in the Blood Donation Rules Opinion Study (Blood DROPS); men who have sex with men (MSM) and male blood donors to estimate compliance and non-compliance with the current US policy with respect to blood donation by MSM.