Clinical trials

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

This study aims to implement two interventions to determine the most effective one that can improve Ghanaian women's decision to get their breasts examined by a healthcare professional. The two interventions are (1) a system where community health nurses will be leveraged to educate women on breast cancer screening; (2) a system where women will be sent text messages about breast cancer screening. Both interventions will be carried out over five months. A survey will be conducted before the intervention is introduced. Then, after the sixth month, another survey will be implemented to determine whether there have been changes. Only women who are 25 years or older will be included in the study.

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.

The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.

This cluster-randomized crossover trial evaluates the impact of two different packaging formats for small-quantity lipid-based nutrient supplements (SQ-LNS) on adherence and acceptability among caregivers of young children in Northern Ghana. SQ-LNS are a proven intervention for reducing child malnutrition, but optimizing packaging formats may improve adherence and scalability. Sixteen health facilities participating in growth monitoring services will each receive both formats: a 1-day sachet (20g daily) and a 7-day bulk container (140g weekly), with the order of delivery randomized. Each packaging format will be distributed for one month before cross-over. The primary outcomes are adherence (measured through caregiver self-report and sachet counts) and acceptability (assessed via caregiver interviews). Secondary outcomes include caregiver preference, ease of use, and qualitative insights into feeding practices, beliefs, and packaging usability. This implementation research study uses a convergent mixed-methods design, integrating quantitative adherence and acceptability data with in-depth interviews and structured observations to inform real-world program implementation. Findings will guide policy and program decisions for integrating SQ-LNS into child health platforms in Ghana and other low-resource settings.

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.

The investigators propose to develop and/or adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana. These "implementation support strategies (ISS)" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice. The ultimate goal is to facilitate health system adoption and sustainment.

Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk. Aspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established. This is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.

Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Stroke survivors in Africa are at an inordinately high (and worsening) risk of adverse outcomes including recurrent stroke and cardiac events over the medium- to longterm. Given the paucity of resources in the region, testing of therapies, which are potentially highly clinically efficacious and cost-effective, while developing local stroke research capacity and contributing to the global secondary stroke prevention evidence base, is urgently needed. Cilostazol, a phosphodiesterase 3 inhibitor, has shown promising efficacy and safety mainly among an Asian population by cutting risk of major adverse cardiovascular events including stroke, in half, when added to aspirin or clopidogrel (8% vs. 4%, HR 0.52, 95% CI 0.35-0.77), with no increased risk in bleeding or serious adverse events. Cilostazol's potentially strong efficacy, presumed pleiotropic effects, and relatively low cost, make it a highly appealing agent for use in stroke-prone, low-resource settings. Therefore, the overall objective of the CiLostAzol for pReventIon of recurrent sTroke in Africa (CLARITY-AFRICA) study is to deploy a hybrid study design to demonstrate the efficacy and safety of cilostazol twice daily in reducing MACE over 24 months vs. placebo among 1100 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, CLARITY-AFRICA also seeks to develop an implementation strategy for routine integration and policy adoption of cilostazol for post-stroke cardiovascular risk reduction in an under-resourced system. Given its compelling efficacy among a predominantly Asian population, the National Institute of Neurological Disorders and Stroke (NINDS) is poised to fund a US-based clinical trial to assess the longer-term efficacy and safety of cilostazol in a study titled CiLostAzol for pReventIon of recurrent sTroke (CLARITY). The investigators are also aware that European and Australian funding agencies are considering stroke trials of cilostazol. A concurrently executed CLARITYAfrica trial would allow recruitment of a historically underrepresented and high-risk group (Africans), test a therapy that if efficacious could be affordable for broader regional implementation, permit transcontinental mentorship/collaborations, and leverage NINDS impending investment. CLARITY-AFRICA will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of cilostazol in Ghana to inform policy. Regardless of its outcome, findings from CLARITYAFRICA will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of cilostazol into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization. This application will focus on the first 2 aims of CLARITY-AFRICA to conduct the trial and assess secondary outcomes.

The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.

Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions. Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change. The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.

This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.

Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries. A way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life. One of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries. However, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies. This RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.

This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) Influenza: Baloxavir marboxil, Oseltamivir, Corticosteroids (dexamethasone) Community-acquired pneumonia: Corticosteroids (dexamethasone)

This study seeks to address the urgent need for theoretically and empirically informed interventions that would address the increasing numbers of unaccompanied minors migrating from rural to urban centers in developing countries for better economic opportunities. This process often results in hazardous child labor defined as work that is mentally, physically, socially or morally dangerous and harmful; interfering with schooling and health and mental health functioning, and leading to several other disproportionate risks. Unaccompanied migrant child laborers' vulnerability is further intensified by the lack of parental protection and community belonging in the host urban center. The International Labor Organization (ILO) estimates that 9.6% of children (ages 5 to 17) across the globe are child laborers and draws attention to migrant child laborers as an underreported and highly vulnerable group, a significant portion of which are female with no education. Poverty has been identified as the main driver of child labor, with family context also being a critical contributing factor. Sub-Saharan Africa (SSA) has the highest rates of child labor (24%), with Ghana -the focus of this study- registering one of the highest child labor prevalence at 22%, including unaccompanied child migrant laborers. In Ghana, unaccompanied adolescent girls migrate from the Northern region to urban centers in the south to work in the informal economy. Load carrying is the most common type of labor for this population and exposes migrant girls to multiple developmental and health risks. Building on the recently concluded R21 study (with 97 adolescent girls aged 11 to 14 years and their caregivers) that showed high feasibility and acceptability, and promising preliminary impact of the ANZANSI (resilience in Dagbani -local language) combination intervention in the same region, we propose to test its effectiveness in a larger two-arm cluster randomized clinical trial among 960 adolescent girls (age 11 to 14 years) at risk of school dropout nested within 32 public junior high schools in the Northern region of Ghana and their caregivers. The schools will be randomly assigned to one of two study conditions: 1) ANZANSI (FEE+MFG) and 2) bolstered usual care. The intervention will be delivered for 12 months, with assessments conducted at baseline and at 12-, 24-, and 36-month follow-ups post-intervention initiation. The study specific aims are: Aim 1: Examine the short- and medium-term impacts of ANZANSI intervention on the incidence of unaccompanied migration for child labor (primary outcome), and academic progress and psychosocial outcomes (secondary); Aim 2: Examine the impact of the ANZANSI intervention on potential mechanisms of change at the individual, family, and community levels; Aim 3: Evaluate the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine participants, facilitators, and school leadership's experiences with the intervention.

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are: Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique? Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant. Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will: Receive surfactant replacement therapy by the less invasive surfactant administration technique. Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

The goal of this observational study is to determine the feasibility and effectiveness of initiating a multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital. The main question it aims to answer is: In a before-and-after study design, we will test the hypothesis that multidisciplinary care for pregnant women with SCD in a non-academic hospital will result in a 50% relative risk reduction in mortality compared to the mortality rate in pregnant women with SCD in the same hospital before the multidisciplinary care. Participants will be managed using the academic hospital's multidisciplinary sickle cell disease obstetrics protocol adapted for the non-academic hospital

The ICU-related Out-of-Pocket Expenses (ICOPE) study is a multinational, prospective observational study conducted in African and Asian countries to quantify ICU-related out-of-pocket expenditures and catastrophic health expenditure among patients and families. The study will include all patients admitted to participating ICUs during a predefined 14-day recruitment window, provided they have an ICU stay longer than 24 hours and informed consent is obtained. A minimum sample size of 354 patients is planned, including both ventilated and non-ventilated patients. Participants will be followed until ICU discharge, with additional follow-up at 30 days and 6 months after admission, resulting in a total study duration of 18 months. The primary objective is to quantify ICU-related out-of-pocket costs and assess the proportion of patients experiencing catastrophic health expenditure, comparing ventilated and non-ventilated groups, while secondary objectives include identifying risk factors for catastrophic expenditure and documenting coping strategies used by families to manage ICU costs.

This study is an anonymous online survey on clinical knowledge of sepsis among healthcare professionals in seven countries in sub-Saharan Africa. The survey is to be repeated every 12-24 months.

Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study: 1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment. 2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment. 3. To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration. This registration focuses on the shadow-mode cohort study. Participants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.

Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria. A pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines. To better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures. The study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.