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South Africa has one of the largest HIV epidemics in the world. HIV prevalence is 18.8% among those 15-49 years of age, and estimated HIV incidence in sexually active persons [...]

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 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. [ABSTRACT FROM AUTHOR]

Background and objectives: Donated 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 Methods: We 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. Results: Of 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. Conclusions: We 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. [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]

Background: Obstetric 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 Methods: A 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.Results: A 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 < 7 g/dL), and failed access to prenatal care (OR, 6.71; 95% CI, 4.32-10.42) were the major risk factors for transfusion. Platelet (PLT) count (ORs, 4.10, 2.66, and 1.77 for ≤50 × 109 , 51 × 109 -100 × 109 , and 101 × 109 -150 × 109 cells/L, respectively), HIV infection (OR, 1.29; 95% CI, 1.02-1.62), and admitting hospital (twofold variation) were also associated with transfusion. Mode of delivery, race, age category, gravidity, parity, gestational age, and birthweight were not independently associated with transfusion.Conclusion: Major risk factors of peripartum transfusion in South Africa, namely, prenatal anemia and access to prenatal care, may be amenable to intervention. HIV infection and moderately low PLT count are novel risk factors that merit further investigation. [ABSTRACT FROM AUTHOR]

Human leukocyte antigen- (HLA-) A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 allele and haplotype frequencies were studied in a subset of 237 volunteer bone marrow donors registered at the South African Bone Marrow Registry (SABMR). Hapl-o-Mat software was used to compute allele and haplotype frequencies from individuals typed at various resolutions, with some alleles in multiple allele code (MAC) format. Four hundred and thirty-eight HLA-A, 235 HLA-B, 234 HLA-DRB1, 41 HLA-DQB1, and 29 HLA-C alleles are reported. The most frequent alleles were A∗02:02g (0.096), B∗07:02g (0.082), C∗07:02g (0.180), DQB1∗06:02 (0.157), and DRB1∗15:01 (0.072). The most common haplotype was A∗03:01g~B∗07:02g~C∗07:02g~DQB1∗06:02~DRB1∗15:01 (0.067), which has also been reported in other populations. Deviations from Hardy-Weinberg equilibrium were observed in A, B, and DRB1 loci, with C~DQB1 being the only locus pair in linkage disequilibrium. This study describes allele and haplotype frequencies from a subset of donors registered at SABMR, the only active bone marrow donor registry in Africa. Although the sample size was small, our results form a key resource for future population studies, disease association studies, and donor recruitment strategies. [ABSTRACT FROM AUTHOR]

Infectious risk associated with blood transfusion remains a major public health challenge in Africa, where prevalence rates of the major transfusion-transmissible infections (ie, hepatitis B, hepatitis C, human immunodeficiency virus, and syphilis) are among the highest in the world. Resource-limited blood services often operate with minimal predonation screening safeguards, prompting exclusive reliance on laboratory testing to mitigate infectious risk. Transfusion screening with rapid diagnostic tests (RDTs) has been adopted in areas that lack the capacity to support the routine use of more sophisticated technologies. However, uncertainty surrounding the performance of some RDTs in the field has spurred debate regarding their application to blood donation screening. Our review of the literature identified 17 studies that evaluated RDTs for the infectious screening of blood donors in Africa. The review highlights the variable performance of available RDTs and the importance of their use in a quality-assured manner. Deficiencies in performance observed with some RDTs underscore the need to validate test kits prior to use under field conditions with locally acquired samples. Suboptimal sensitivities of some available tests, specifically hepatitis B virus rapid assays, question their suitability in single-test algorithms, particularly in high-prevalence regions. Although RDTs have limitations, many of which can be addressed through improved training and quality systems, they are frequently the only viable option for infectious screening in resource-poor African countries. Therefore, additional studies and specific guidelines regarding the use of RDTs in the context of blood safety are needed. [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]

Objective: To evaluate critically whether treatment models existed in the literature to treat a soldier with multiple psychiatric and other comorbidities and propose a mental health model consisting of an integrated multidisciplinary treatment team for use in military outpatient settings.Method: A case example was described to demonstrate the complexity of presentation including depression, anxiety, insomnia, post-traumatic stress disorder, chronic pain, substance abuse, relationship problems, and suicide attempts. Literature search was conducted for the period 2004-2009. Articles that referred to collaborative/integrated care were examined in detail.Results: Seven articles described collaborative care. Of these, five described collaboration with only primary care and 2 with other specialties including pain, substance abuse, and vocational rehabilitation services. Most articles gave a broader description of the collaborative model. Some postulated a theoretical framework. One described collaborative care in detail but was coordinated by only one professional. None described integration of providers involved in the patient's care. The process of implementation was not sufficiently described.Conclusion: Because of limitations in the published literature, a mental health model consisting of a multidisciplinary integrated treatment team is proposed to treat the soldiers in the military outpatient setting. [ABSTRACT FROM AUTHOR]

Objective: To evaluate critically whether treatment models existed in the literature to treat a soldier with multiple psychiatric and other comorbidities and propose a mental health model consisting of an integrated multidisciplinary treatment team for use in military outpatient settings. Method: A case example was described to demonstrate the complexity of presentation including depression, anxiety, insomnia, post-traumatic stress disorder, chronic pain, substance abuse, relationship problems, and suicide attempts. Literature search was conducted for the period 2004-2009. Articles that referred to collaborative/integrated care were examined in detail. Results: Seven articles described collaborative care. Of these, five described collaboration with only primary care and 2 with other specialties including pain. substance abuse, and vocational rehabilitation services. Most articles gave a broader description of the collaborative model. Some postulated a theoretical framework. One described collaborative care in detail but was coordinated by only one professional. None described integration of providers involved in the patient's care. The process of implementation was not sufficiently described. Conclusion: Because of limitations in the published literature, a mental health model consisting of a muhidisciplinary integrated treatment team is proposed to treat the soldiers in the military outpatient setting. [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.

Introduction: Stable 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., Methods: HIV-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., Results: From 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., Conclusions: Couples 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).