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BACKGROUND AND OBJECTIVES: Currently, HTLV screening is not performed in South Africa (SA). This report describes an economic assessment (budget impact and cost-effectiveness) of implementing different HTLV screening strategies. METHODS: A modified version of the Alliance of Blood Operators risk-based decision-making framework was used to assess the risk and consequences of HTLV in the blood supply in SA. We developed a deterministic model of the cost and consequences of four screening strategies: none, universal, all donors once and first time donors only assuming a transfusion-transmission (TT) efficiency of 10% and a manifestation of clinical disease of 6%. RESULTS: Unscreened blood results in 3·55 symptomatic TT-HTLV cases and a total healthcare cost of Rand (R)3 446 950 (US Dollars (USD)229 800) annually. Universal screening would cost R24 000 000 (USD1 600 000) per annum and prevent 3·54 (99·8%) symptomatic TT-HTLV cases in the first year and 0·55 (98·4%) symptomatic TT-HTLV cases in the second year at a cost per TT-HTLV prevented of R6 780 000 (USD450 000) in year one and R43 254 000 (USD2 890 000) in year two. Screening all donors once would cost R16,200,000 (USD1 080 000) or R4 600 000 (USD306 000) per symptomatic TT-HTLV infection prevented in year one. Total costs decrease to R5 100 000 (USD340 000) in year 2 but the cost per TT-HTLV prevented increases to R10 700 000 (USD713 333). CONCLUSION: This analysis contributed to the decision not to implement HTLV screening as the healthcare budget and particularly the budget for blood transfusion in SA is insufficient to provide appropriate treatment. Arguably, available resources can be more efficiently utilized in other healthcare programs.

Background and objectivesDonated blood is not currently screened for human T-cell lymphotropic virus (HTLV) in South Africa. Several small studies have detected HTLV-1 in South Africa, but prevalence by geographic region or population group is unavailable.Materials and methodsWe performed a large seroprevalence study of South African blood donors during 3 months in 2013. All geographic regions except the Western Cape were included, and Black and Coloured (local term for mixed race) donors were oversampled. Identity-unlinked plasma samples were screened with the Abbott Prism HTLV-1/2 assay, and repeatedly reactive samples were tested by the Inno-LIA HTLV-1/2 Score confirmatory assay. Odds ratios were calculated with multivariable logistic regression.ResultsOf 46 752 donors tested, 133 (0·28%) were initially reactive, 111 (0·24%) repeatedly reactive and 57 (0·12%) confirmed positive for HTLV-1; none were HTLV-2 positive. Prevalence was 0·062% weighted to annual blood donations but highly concentrated in the Black population group (OR = 20·24 CI: 2·77-147·88); higher in females than males (OR = 1·81 CI: 1·06-3·08); and in donors aged >50 years compared to ages 16-19 (OR = 6·4 CI: 2·95-13·86). After controlling for age, sex and population group, there was no difference in prevalence between new and repeat blood donors or among geographic regions within South Africa.ConclusionsWe conclude that HTLV-1 infection is widespread among the Black population of South Africa and its epidemiology is similar to other endemic areas. Because South Africa is increasing its recruitment of Black blood donors, the implications for blood screening require further consideration.

BackgroundObstetric hemorrhage (OH) and access to peripartum blood transfusion remains a global health challenge. The rates of peripartum transfusion in South Africa exceed those in high-income countries despite comparable rates of OH. We sought to evaluate factors associated with peripartum transfusion.Study design and methodsA case-control study was conducted at four large South African hospitals. Transfused peripartum women (cases) and nontransfused controls were stratum matched 1:2 by hospital and delivery date. Data on obstetric, transfusion, and human immunodeficiency virus (HIV) history were abstracted from medical records. Blood was obtained for laboratory evaluation. We calculated unadjusted and adjusted odds ratios (ORs) for transfusion using logistic regression.ResultsA total of 1200 transfused cases and 2434 controls were evaluated. Antepartum hemorrhage (OR, 197.95; 95% confidence interval [CI], 104.27-375.78), hemorrhage with vaginal delivery (OR, 136.46; 95% CI, 75.87-245.18), prenatal anemia (OR, 22.76; 95% CI, 12.34-41.93 for prenatal hemoglobin level

Among 397,640 first-time blood donors screened in South Africa during 2012-2015, HIV prevalence was 1.13%, hepatitis B virus prevalence 0.66%, and hepatitis C virus prevalence 0.03%. Findings of note were a high HIV prevalence in Mpumalanga Province and the near absence of hepatitis C virus nationwide.

BackgroundGlobally, as in South Africa, obstetric hemorrhage (OH) remains a leading cause of maternal mortality and morbidity. Although blood transfusion is critical to OH management, the incidence and predictors of transfusion as well as their relation to human immunodeficiency virus (HIV) infection are poorly described.Study design and methodsA cross-sectional study was conducted of all peripartum patients at four major hospitals in South Africa (April to July 2012). Comprehensive clinical data were collected on patients who sustained OH and/or were transfused. Logistic regression was used to model risk factors for OH and transfusion.ResultsA total of 15,725 peripartum women were evaluated, of whom 3969 (25.2%) were HIV positive. Overall, 387 (2.5%) women sustained OH and 438 (2.8%) received transfusions, including 213 (1.4%) women with both OH and transfusion. There was no significant difference in OH incidence between HIV-positive (2.8%) and HIV-negative (2.3%) patients (adjusted odds ratio [OR], 0.95; 95% confidence interval [CI], 0.72-1.25). In contrast, the incidence of blood transfusion was significantly higher in HIV-positive (3.7%) than in HIV-negative (2.4%) patients (adjusted OR, 1.52; 95% CI, 1.14-2.03). Other risk factors for transfusion included OH, low prenatal hemoglobin, the treating hospital, lack of prenatal care, and gestational age of not more than 34 weeks.ConclusionIn the South African obstetric setting, the incidence of peripartum blood transfusion is significantly higher than in the United States and other high-income countries while OH incidence is similar. While OH and prenatal anemia are major predictors of transfusion, HIV infection is a common and independent contributing factor.

IntroductionStable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.MethodsHIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months.ResultsFrom July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758) of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [IQR (28-40) and (26-39) respectively]. Most couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0) and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1-2.0)]. During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8); 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10) copies/mL (IQR 3.31-4.53) and median CD4 count was 496 cells/µL (IQR 375-662); the majority (64%) had WHO stage 1 HIV-1 disease.ConclusionsCouples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245).

Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Methods Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. Results A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Conclusion Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Trial registration Clinicaltrials.gov NCT00866619

Background: Globally, data on antenatal blood transfusion practices are scarce. We sought to characterize the epidemiology of antenatal transfusion in South Africa.Study Design and Methods: A cross-sectional study was conducted of women who were transfused during pregnancy (>48 hr before anticipated delivery) at two hospitals in Durban and Soweto in 2014 to 2015. Medical record data on demographics, obstetric history, anemia, HIV status, and indications for blood transfusion were abstracted.Results: The records on a total of 560 transfused pregnant women were evaluated; mean age was 28 years, 98% were of black African ethnicity, and 28% were HIV positive. At time of transfusion, one-half were in the first trimester. Hemorrhage was noted in 76% of women, most of which was associated with abortion (67%) or ectopic pregnancy (27%). Most women were transfused with red blood cells (RBCs; median, 2 units); 14% of women were transfused with plasma and 2% with platelets. Median pre- and posttransfusion hemoglobin levels were 6.9 g/dL and 9.2 g/dL, respectively; the latter differed by hospital (8.7 g/dL vs. 9.5 g/dL; p < 0.01). Hemorrhage was associated with missing HIV status, lower gestational age, and transfusion of 3 or more RBC units (all p < 0.01). In contrast, diagnoses of anemia (Soweto only) were associated with HIV infection, later gestational age, and lower (<3 units) RBC dose (all p < 0.01).Conclusion: Abortion and ectopic pregnancy with associated hemorrhage were the leading indications for antenatal transfusion and were concentrated in early gestation. By contrast, anemia was associated with HIV infection and transfusion in the third trimester. [ABSTRACT FROM AUTHOR]

Background: Several studies in developed countries have demonstrated high levels of iron deficiency (ID) among blood donors. There is a paucity of data for developing countries where blood shortages remain a major concern.Study Design and Methods: A total of 4412 donors were enrolled in the study. Specimens were collected for full blood count, iron, transferrin saturation, and ferritin assessment. Donor demographics were recorded. ID was indicated by a ferritin level of less than 20 ng/mL for men and less than 12 ng/mL for women. Anemia was defined as hemoglobin levels less than 12.5 g/dL. Regression models for predictors of ID were developed.Results: A total of 17.5% of all donors had ID, with 16.3% prevalence in women and 18.6% in men. Low hemoglobin had the highest association with ID (adjusted odds ratio [AOR], 11.078; 95% confidence interval [CI], 7.915-15.505); male donors had twice the odds of ID compared to female donors (AOR, 2.501; 95% CI, 1.964-3.185), while increasing age was associated with lower odds (AOD, 0.965; 95% CI, 0.956-0.975). Among male donors, an interdonation interval of less than 3 months (AOR, 2.679; 95% CI, 1.929-3.720) was associated with ID. Compared to other females combined, colored female donors (AOR, 2.335; 95% CI, 1.310-4.160) had higher odds and black female donors (AOR, 0.559; 95% CI, 0.369-0.845) lower odds of ID.Conclusion: ID is common among South African donors; low hemoglobin, gender, ethnicity, and past donation history is independently associated with ID. Recommendations aimed at protecting donor health may increase blood shortages in South Africa. [ABSTRACT FROM AUTHOR]

A response from the authors of the article "Health Policy Implications of Blood Transfusion-Related Human T-cell Lymphotropic Virus Type 1 Infection and Disease" in the current issue is presented.

Despite numerous publications on the appropriate use of blood and blood products, few specifically consider the role of transfusion in the management of HIV. This review is a synthesis of conditions encountered in the management of HIV-infected patients where the transfusion of blood or blood products may be indicated. A consistent message emerging from the review is that the principles of transfusion medicine do not differ between HIV-negative and -positive patients. The aim of the review is to provide clinicians with a practical and succinct overview of the haematological abnormalities and clinical circumstances most commonly encountered in the HIV setting, while focusing on the rational and appropriate use of blood and blood products for HIV patients. Important ethical considerations in dealing with both the collection and transfusion blood and blood products in the HIV era have also been addressed. [ABSTRACT FROM AUTHOR]

Background: A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres., Methods: Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners., Results: A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials., Conclusion: Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials., Trial Registration: Clinicaltrials.gov NCT00866619.