Addis Ababa

Researchers are evaluating different methods of providing balanced energy and protein (BEP) supplements to pregnant women in Addis Ababa, Ethiopia. The study aims to find out which individual-based targeting strategies are most effective in preventing negative pregnancy outcomes, compare their cost-effectiveness against universal BEP supplementation, and assess how feasible and acceptable these different approaches are for use during pregnancy. The study involves three groups receiving BEP supplements along with standard prenatal care: one group receives supplements based on low baseline nutritional status (low BMI or small arm circumference), another group receives supplements based on both low baseline nutritional status and monthly monitoring of gestational weight gain with additional supplements if needed, and the third group receives universal supplementation throughout pregnancy. Pregnant women are enrolled before 24 weeks gestation and followed through delivery. Participants will be monitored from pregnancy through six weeks after birth. Researchers will assess outcomes such as small-for-gestational-age births within 72 hours of delivery, maternal and child health measures, as well as adherence and acceptability of the supplement strategies. The study helps to understand how different BEP delivery methods affect pregnancy outcomes and their practical use in this setting.

Researchers are evaluating the use of curcumin as an additional treatment for women with advanced cervical cancer who are receiving standard palliative radiotherapy. This trial aims to find out if adding curcumin is feasible, safe, and if it improves the response to treatment. The study also investigates how much curcumin is absorbed in the body and how long it stays after administration. Participants will take curcumin capsules containing a special formulation designed for better absorption, at a dose of 250 mg four times daily for 4 to 6 weeks alongside their prescribed palliative radiotherapy, which delivers a biologically effective dose of 45-55 Gy over three to five weeks. The radiotherapy follows local treatment guidelines at Tikur Anbessa Hospital Radiotherapy Center. This trial is an open-label pilot study focusing on women with FIGO Stage IIIB-IVA cervical cancer. During the study, participants will provide blood and urine samples for laboratory testing and curcumin level measurement. They will also undergo CT scans to assess tumor response and complete questionnaires to evaluate any changes in their quality of life. Researchers will monitor treatment adherence and measure outcomes such as treatment fidelity and objective response rate over 13 to 17 weeks. Safety and follow-up will be closely observed throughout the study period.

Researchers are evaluating different models of decentralized hepatitis B (HBV) treatment care in Ethiopia, focusing on improving access to antiviral therapy in rural and low-income settings. Chronic hepatitis B affects 5-10% of the Ethiopian population, and without treatment, 15-40% may die from complications. Antiviral therapy can prevent disease progression and death, but availability is limited due to complex guidelines, poor lab capacity, and funding issues. This study aims to compare three models of decentralized care: a standard model, a simplified inclusive model, and a test-and-treat model to see which is most effective and feasible in Ethiopia. The study involves providing free treatment with Tenofovir Disoproxil Fumarate (300 mg once daily) to patients who meet treatment criteria under each care model. These models will be implemented at primary hospitals and health clinics across Ethiopia. The study builds on previous pilot programs in tertiary and secondary hospitals, moving care closer to rural populations. Researchers will compare clinical, laboratory, and programmatic outcomes across the three decentralized models and assess cost-effectiveness compared to hospital-based care. Participants will be adults aged 18 or older with hepatitis B infection confirmed by HBsAg positivity. Researchers will monitor outcomes including death or liver decompensation over three years, along with laboratory and program success indicators. The study includes assessments of clinical progress, lab tests, and program data to evaluate each care model's effectiveness. Results are expected to inform international hepatitis B guidelines and support efforts to eliminate viral hepatitis as a public health threat by 2030.

Researchers are investigating how tuberculosis (TB) infection affects the structure and function of the placenta during pregnancy and whether TB contributes to pregnancy-related complications. This observational study focuses on pregnant women in Addis Abeba, Ethiopia, to explore links between TB infection, placental pathology, and pregnancy outcomes, including infant health at birth and six weeks later. The study examines immune responses and markers of mycobacterial activity to understand these effects in depth. Participants will be enrolled at labor wards in two public hospitals, where blood samples will be collected before delivery to test for TB infection using an interferon-gamma release assay. Placental tissue will be collected immediately after delivery for detailed pathological and molecular analyses, including RNA and protein expression studies and electron microscopy. Women with TB infection will undergo additional procedures such as chest X-rays and sputum testing. The study compares placental findings between women with and without TB infection, including examination of immune cell types and mycobacterial presence. During the study, researchers will gather clinical data, medical history, and physical measurements using electronic questionnaires. Follow-up occurs six weeks after birth to communicate TB test results and collect further information. Outcomes measured include placental pathological lesions, gene and protein expression linked to pregnancy disorders, and infant health. Safety and routine test results, including HIV and malaria status, will also be recorded. The total participation involves delivery and a follow-up visit six weeks later.

Researchers are conducting a three-year study in Ethiopia to develop and test interventions aimed at improving three key maternal health outcomes: institutional delivery, antenatal care (ANC), and iron-folic acid (IFA) supplementation among pregnant women. The study uses a Human-Centered Design (HCD) approach to create prototype solutions that encourage pregnant women to use and stick with these health services. The interventions are developed through rapid and extended design processes and evaluated in two phases. In Phase 1, a design sprint workshop will produce prototype solutions focusing on ANC and institutional delivery. These solutions may include social and behavior change campaigns delivered via print, mass media, social media, and community educational events. These high-fidelity prototypes will be implemented for four months, followed by baseline and midline assessments. Phase 2 will refine these prototypes with extended HCD to address challenges not solved in Phase 1. The refined prototypes will again be implemented for four months in selected geographic areas (Woredas) in Ethiopia, with a post-intervention evaluation. Participants will be pregnant women between 15 and 49 years old, recruited at different times during the study for baseline, midline, and end-line assessments. The study will measure changes in institutional delivery rates and the number of antenatal care visits using surveys at baseline and after four months. Qualitative interviews will also explore psychosocial outcomes and how well the interventions are implemented. This comprehensive approach aims to understand and improve maternal health behaviors over the full three years of the project.

Researchers are evaluating the effect on newborn birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. This program effectiveness study uses a cluster randomized trial design to compare the impact of MMS versus IFA on birthweight. The study addresses recommendations from the World Health Organization to assess MMS in real-world settings and aims to inform the Ethiopian Ministry of Health about the benefits and feasibility of MMS implementation in multiple districts. The trial involves 42 districts randomized to either continue IFA supplementation or switch to MMS, which contains 15 essential vitamins and minerals including iron. The program started in March 2022, with birthweight data collected continuously from January 2023 to December 2024 using digital scales in health facilities. Facility surveys assessing process, costs, acceptability, and adherence will be conducted at baseline, midline, and endline, with additional interviews planned to explore implementation challenges. Participants include women aged 15 to 49 who deliver liveborn infants in enrolled health facilities. Data collection focuses on birthweight measured as part of routine maternity care. Secondary measures include the cost and cost-effectiveness of MMS, adherence rates, acceptability to women and providers, and implementation fidelity. The total study duration is 42 months, with final analysis expected in April 2025.

Researchers are studying how miltefosine, a drug used to treat cutaneous leishmaniasis caused by Leishmania aethiopica, works in patients, especially children. The study aims to better understand how the parasite is cleared from the body and how the drug is processed in the blood and skin during treatment. This information is important to improve dosing and treatment length for patients worldwide, with a focus on Ethiopian and pediatric patients. Participants will receive miltefosine prescribed by their treating physician for at least 4 weeks. If the response to treatment is not sufficient, the physician may extend treatment up to 8 weeks. The study will measure how miltefosine concentrations change over time in the blood, and track parasite levels during this treatment period. Throughout the study, participants will undergo multiple blood tests on specified days (Day 0, 3, 7, 14, 21, 28, 42 or 56, 90, and 180) to check miltefosine levels and monitor parasite clearance. The study will also explore factors like resistance, nutritional status, and co-infections that might affect treatment response. Participants will be followed closely during treatment and afterward to assess drug levels and treatment outcomes.

Researchers are investigating the immune response specific to different strains of SARS-CoV-2 in healthcare workers and the general population at Jimma Medical Center and St. Paul Hospital in Addis Ababa. This study focuses on how natural infection and COVID-19 vaccination affect the presence of SARS-CoV-2 Spike IgG antibodies and clinical protection against COVID-19. Participants will be grouped based on their previous infection and vaccination status and followed over time to understand antibody prevalence, incidence, and dynamics, as well as COVID-19 breakthrough infections. Participants will be followed every three months for up to two years. At each visit, blood samples will be taken to measure immune responses including SARS-CoV-2 spike IgG and neutralizing antibodies, along with T-cell responses. Clinical assessments for COVID-19 infections will be performed using history, PCR testing, and antibody seroconversion. A subset of samples will undergo advanced analyses such as virus neutralization assays, antibody epitope mapping, and T-cell immunity tests. The study also aims to evaluate the cost-effectiveness of simplified COVID-19 vaccination strategies in populations with existing natural immunity. During the study, participants will provide blood samples and health information regularly. Researchers will monitor immune responses, COVID-19 disease occurrence, and antibody levels over time. Results will help understand immune protection correlates and inform vaccination approaches in Ethiopia. The total participation duration can be up to 24 months with follow-ups every three months to assess long-term immunity and breakthrough infections.

Plasmodium vivax malaria is challenging to eliminate because it can form dormant liver stages called hypnozoites, which can reactivate weeks to months after the initial infection and cause repeated malaria episodes. These relapses contribute significantly to ongoing parasite spread and illness. Since direct detection of hypnozoites is not currently possible, researchers developed a test that measures antibodies from recent blood-stage infections to identify individuals infected within the last nine months, roughly the lifespan of hypnozoites. This trial evaluates a new approach called Plasmodium vivax Serological Testing and Treatment (PvSeroTAT). The study randomly assigns 48 clusters in Ethiopia and Madagascar to either receive the PvSeroTAT intervention or serve as controls. In the intervention clusters, participants will be tested twice (at month 0 and month 6) for antibodies against P. vivax. Those who test positive will have their G6PD enzyme activity measured to ensure safety before receiving targeted treatment with primaquine and either chloroquine or artesunate-amodiaquine, depending on the country. Control clusters also have two rounds of antibody testing, but positive results do not lead to treatment. Participants will be monitored for side effects and medication adherence during the first 7 days after treatment. Malaria incidence will be tracked through local health posts for 18 months after the first intervention. Additionally, blood samples will be collected at months 12 and 18 to measure P. vivax and P. falciparum prevalence using PCR assays. The main outcome is the proportion of individuals with detectable P. vivax infections six months after the second treatment or blood draw, helping to assess the feasibility and impact of the PvSeroTAT strategy.

Researchers are studying the development of a sustainable cardiac surgery service in Ethiopia to reduce the burden of rheumatic heart disease (RHD) in a low-income country. The study aims to compare the short- and long-term outcomes of cardiac surgery patients with those who could not have surgery due to limited service availability. It also evaluates the quality of anticoagulant therapy in patients after cardiac surgery compared to controls in Norway, focusing on complications such as valve dysfunction, bleeding, and thrombosis. The main intervention is cardiac surgery performed at Black Lion Hospital in Ethiopia. Approximately 50 patients with RHD will be operated on by the study team. The study includes follow-up periods of 30 and 180 days to assess outcomes such as mortality and complications including heart failure, arrhythmias, thrombosis, bleeding, stroke, and infections. The anticoagulant therapy quality is continuously monitored for a longer period. Participants will undergo regular assessments including clinical evaluations and echocardiographic classification. Researchers will monitor anticoagulation levels by measuring time in therapeutic INR range along with any related complications. Outcomes will be compared to matched control patients undergoing valve replacement surgery in Norway. The total follow-up duration for the short-term outcome is 180 days, with ongoing monitoring for anticoagulation therapy quality.