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Summary: HbSC disease is a common form of sickle cell disease with significant morbidity and early mortality. Whether hydroxyurea is beneficial for HbSC disease is unknown. Prospective Identification of Variables as Outcomes for Treatment (PIVOT, Trial ID PACTR202108893981080) is a double‐blind, randomised, placebo‐controlled phase II trial of hydroxyurea for people with HbSC, age 5–50 years, in Ghana. After screening, participants were randomised to placebo (standard of care) or hydroxyurea. The primary outcome is the cumulative incidence of haematological toxicities during 12 months of blinded treatment; secondary outcomes include multiple laboratory and clinical assessments. Between April 2022 and June 2023, 112 children and 102 adults were randomised, including 44% females and average age 21.6 ± 14.5 years. Participants had substantial morbidity including previous hospitalisations (93%), vaso‐occlusive events (86%), malaria (79%), often received transfusions (20%), with baseline haemoglobin 11.0 ± 1.2 g/dL and foetal haemoglobin 1.8% ± 1.5%. The spleen was palpable in six children and one adult, and ultrasonographic volumes were collected. Proliferative sickle retinopathy was common (30% children, 75% adults), but proteinuria was less common (3% children, 8% adults). Whole blood viscosity, ektacytometry, point‐of‐sickling, transcranial Doppler, near‐infrared spectrometry (NIRS), 6‐minute walk, and quality of life were also measured. Now fully enrolled, PIVOT will document the safety and potential benefits of hydroxyurea on clinical and laboratory outcomes in HbSC disease. [ABSTRACT FROM AUTHOR]

Introduction Materials and Methods Results Conclusion In sub‐Saharan Africa (SSA), an adequate supply of safe blood for transfusion is a major developmental challenge. In Ghana, deferral from blood donation for anemia accounts for nearly half of the ineligible blood donors. We conducted a longitudinal two‐arm parallel‐group non‐inferiority trial to test if iron supplementation among blood donors with iron deficiency (ID) or anemia could increase their hemoglobin levels to near those without ID or anemia.A structured questionnaire was used to collect participants' sociodemographic and medical information after written informed consent was obtained. Blood samples were analyzed for full blood count (FBC), serum ferritin, malaria rapid test, and a peripheral blood smear. The primary outcome was hemoglobin level after 4 months comparing anemic donors who received iron supplementation to the standard of care participants, nonanemic donors who did not receive iron supplementation. All donors received nutritional counseling.Adherence to low‐dose iron supplementation three times a week was poor. Hemoglobin levels in the iron supplementation arm were not close enough to those in the control group after 4 months of iron supplementation to declare non‐inferiority. However, non‐inferiority was met when the 4 month hemoglobin comparison was restricted to female donors.After 4 months of iron supplementation, hemoglobin levels in the iron supplementation group did not sufficiently match those in the control group to declare non‐inferiority. Data from this pilot trial informed and shaped the design of a larger randomized control type 1 pragmatic effectiveness implementation hybrid trial which is currently ongoing. [ABSTRACT FROM AUTHOR]

Background: Worldwide, about 20-25 million people are affected by sickle cell disease (SCD), with 60% of patients living in sub-Saharan Africa. Despite recent therapeutic advancements resulting in improved life expectancy among SCD patients, the prevalence of high-risk human papillomavirus (hr-HPV) and cervical lesions have not been studied in women with SCD. We determined the prevalence of hr-HPV and cervical lesions among women with SCD and recommended strategies for reducing cervical cancer incidence in this cohort. Methods: Through the mPharma 10,000 Women Initiative, women with SCD attending routine visits at the Ghana Institute of Clinical Genetics SCD clinic were screened by trained nurses. Screening was performed via concurrent MA-6000 hr-HPV DNA testing and enhanced visual assessment (EVA) mobile colposcopy from mobileODT. Results: Among 168 participants screened (mean age, 43.0 years), the overall prevalence rates of hr-HPV infection and cervical lesions were 28.6% (95% CI, 21.7-35.4) and 3.6% (95% CI, 0.8-6.4), respectively. The hr-HPV prevalence rates stratified by haemoglobin genotype were 29.4% (95% CI, 19.7-39.1) and 28.6% (95% CI, 18.5-38.7) for genotypes SS and SC, respectively. None of the five women with the SF genotype tested hr-HPV positive, and the only patient with Sbthal genotype tested hr-HPV positive. Two women were EVA 'positive' but hr-HPV negative, whereas four were EVA positive and hr-HPV positive. Exploratory analysis revealed no significant associations between hr-HPV positivity and age, education level, marital status or parity. Conclusion: In the absence of a comprehensive national cervical screening programme aimed at including women with SCD as a special population, cervical cancer may increase in frequency among SCD patients. Thus, there is a need to build capacity and expand the scope of screening services for women with SCD. [ABSTRACT FROM AUTHOR]

Background: The supply of blood in many low‐ and middle‐income nations in Sub‐Saharan Africa (SSA) does not meet the patient care needs. Lack and delay of blood transfusion cause harm to patients and slow the rate of progress in other parts of the health system. Recognizing the power of implementation science, the BLOODSAFE Program was initiated which supports three SSA research study teams and one data coordinating center (DCC) with the goal to improve access to safe blood transfusion in SSA. Study Design and Methods: The study team in Ghana is focusing on studying and decreasing iron deficiency in blood donors and evaluating social engagement of blood donors through different approaches. The study team in Kenya is building a "vein to vein" workflow model to elucidate and devise strategies to overcome barriers to blood donation and improve infrastructural components of blood product production and use. The Malawi team is studying the infectious disease ramifications of blood donation as well as blood donor retention strategies aimed at blood donors who commence their donation career in secondary schools. Results and Discussion: Together the project teams and the DCC work as a consortium to support each other through a shared study protocol that will study donor motivations, outcomes, and adverse events across all three countries. The BLOODSAFE Program has the potential to lead to generalizable improvement approaches for increasing access to safe blood in SSA as well as mentoring and building the research capacity and careers of many investigators. [ABSTRACT FROM AUTHOR]

We report a case of a young Ghanaian male who developed Bleomycin Induced Pneumonitis (BIP) after being treated for Hodgkin's Lymphoma. Pulmonary toxicity is the most feared complication of bleomycin therapy despite its effectiveness in achieving cure in patients with Hodgkin's lymphoma and germ cell tumors. BIP has a significant mortality rate if detected late and a high index of suspicion is required in all patients on bleomycin-based therapies with sudden onset of respiratory symptoms. [ABSTRACT FROM AUTHOR]

Background: Africans have an increased risk for multiple myeloma (MM) compared to other races. Reports from Africa are few and involve small cohorts, but suggest significant epidemiological and clinical differences from Caucasian patients. Objective: This report describes the clinic-pathological features of MM patients in Ghana at diagnosis, and the factors affecting their survival. Methods: A retrospective review of 169 MM cases diagnosed in a Ghanaian tertiary hospital from 2002-2016. Results: Median age was 58 years, with 29% ≤50 years. One-third presented >12 months after onset of symptoms, which included bone pain (96%), anaemia (67%), weight loss (55%) and fractures (44%). Myeloma-related tissue impairment included hypercalcaemia (36%), renal impairment (33%), severe anaemia (52%) and osteolytic lesions (76%); 51.3% of patients were diagnosed in ISS Stage III. Median survival was 33 months; 1-year and 5-year overall survival were 51.6% and 15.5%, respectively. Neither the age at diagnosis nor the duration of symptoms prior to diagnosis correlated with prognosis. Median survival improved with early ISS stage, haemoglobin >8g/dL, plasmacytosis <20%, and normal creatinine and calcium levels. Conclusion: Early onset and late stage presentation are common at diagnosis of MM patients in Ghana, but do not affect survival. Studies into genetic associations are recommended. [ABSTRACT FROM AUTHOR]

Background: Hemoglobin SC (HbSC) is a common sickle hemoglobinopathy that causes acute complications, chronic organ damage, and early death with no established disease-modifying treatment. In this trial, we examined the safety and efficacy of hydroxyurea treatment in patients with HbSC., Methods: Prospective Identification of Variables as Outcomes for Treatment (PIVOT) was a double-blind, randomized, placebo-controlled, non-inferiority phase 2 trial in which we assigned children and adults with HbSC in Ghana to 12 months of hydroxyurea or placebo. The primary end point was hematologic dose-limiting toxicities (DLTs), including cytopenias or elevated hemoglobin levels during 12 months of blinded treatment. Clinical end points included vaso-occlusive pain events, acute chest syndrome, hospitalizations, transfusions, and malaria. Quality-of-life measures, organ function assessments, and rheological measurements were also collected., Results: Of the 243 enrolled patients (118 female), 212 eligible participants initiated blinded treatment at 20.0±5.0 mg/kg/day. DLTs occurred in more participants on hydroxyurea (33%) than the placebo (11%), with a difference of 22 percentage points (95% confidence interval [CI],11 to 34 percentage points), which exceeded the predefined 15 percentage point noninferiority margin. Elevated levels of hemoglobin occurred in 12 participants on hydroxyurea and 10 on the placebo. Hydroxyurea treatment was associated with 57.0 versus 149.6 vaso-occlusive pain events per 100 person-years (incidence rate ratio [IRR] 0.38; 95% CI, 0.28 to 0.52), and 12.9 versus 30.6 hospitalizations per 100 person-years (IRR 0.42; 95% CI, 0.22 to 0.81). A composite of acute sickle-related events occurred in 37 participants on hydroxyurea versus 69 participants on placebo (IRR 0.39; (95% CI, 0.26 to 0.59), a difference observed in both children and adults., Conclusions: The PIVOT trial did not meet its primary end point. Hydroxyurea at 20 mg/kg in patients with HbSC was associated with more hematologic DLTs than placebo, but most were mild and transient. Hydroxyurea was associated with less vaso-occlusive pain and fewer sickle-related events in both children and adults; a new trial will need to be done to establish the efficacy of this approach. (Funded by Theravia; Pan-African Clinical Trials Registry number, PACTR 202108893981080).