Lusaka

Researchers are studying pediatric cryptosporidiosis to better understand how this infection presents and progresses in children aged 6 to 59 months. The focus is on characterizing the clinical features and course of diarrhea caused by Cryptosporidium, a parasite common in certain regions. This observational study aims to gather detailed information on symptoms and outcomes in affected children. Participants are children with diarrhea due to Cryptosporidium infection confirmed by specific stool tests. The study observes children with varying durations of diarrheafrom acute to chronicand different nutritional statuses. The study follows children for up to 21 days, monitoring diarrhea severity, dehydration, and parasite presence without administering any treatment. During participation, children will be assessed at multiple time points including baseline, days 3, 7, 14, and up to day 21. Researchers will collect stool samples and evaluate dehydration severity, diarrhea resolution time, and parasite shedding. Additional factors like age, nutritional status, and breastfeeding history will be analyzed to understand their association with illness duration and severity. Participants will be followed closely to capture the natural course of infection and symptoms.

Researchers are evaluating the effectiveness of a phone-based tobacco cessation program specifically designed for people living with HIV PLWH in Uganda and Zambia. This study compares this intervention to the standard care, which includes brief advice to quit smoking and nicotine replacement therapy using nicotine patches. The research aims to understand how well this approach works, how feasible it is to deliver, and how affordable it might be in healthcare settings with varying tobacco use, policies, and resources. Participants are assigned to one of four groups standard care with advice to quit, standard care plus nicotine patches, standard care plus supportive text messaging, or a combination of all three. The study uses a previously tested SMS platform to provide tailored support messages. This design allows researchers to see which combination helps maintain tobacco abstinence over six months after starting the program. During the study, participants will be monitored for tobacco use abstinence at several points, including 4 weeks, 8 weeks, 3 months, and especially at 6 months after enrollment, which is the main outcome. The study also tracks feasibility and acceptability of the interventions within HIV treatment centers. Participants will undergo assessments to support these measurements, with ongoing engagement through text messaging and nicotine therapy where applicable, providing insight into the best ways to support quitting tobacco among PLWH in these regions.

Researchers are investigating whether longer admission to the Kangaroo Mother Care KMC ward after discharge from the neonatal intensive care unit NICU reduces postpartum depression in mothers of low birthweight preterm infants in low-resource settings. This randomized controlled trial compares extended KMC admission of more than 2 days to standard care of less than 2 days. The study also explores the impact on infant neurodevelopment, paternal depression, barriers to KMC practice, and cost effectiveness. Participants in the trial are randomly assigned to either stay on the KMC ward for more than 2 days or less than 2 days following NICU discharge. Mothers and infants practice kangaroo care, breastfeeding, and infant care during their stay. The study involves follow-up visits at 2 weeks, 6-8 weeks, and at 6, 12, and 18 months, to assess maternal depression, paternal depression, infant development, and barriers to KMC both in the hospital and after discharge. Mothers and fathers will be screened for depression at multiple time points while infants undergo neurodevelopmental assessments up to 18 months of age. Researchers will track hours spent practicing KMC, breastfeeding duration, infant growth measurements, morbidity, mortality, and healthcare costs. Data collection includes questionnaires on social support and interviews to identify KMC barriers. The study aims to provide a comprehensive view of maternal, paternal, and infant outcomes related to KMC duration in a low-resource setting.

Researchers are studying advanced HIV disease AHD among adults in Zambia who are starting or restarting antiretroviral therapy ART. The study aims to understand the characteristics, care, and outcomes of clients diagnosed with AHD during their first six months on ART, a period when risks of disengagement from care and death are highest. This observational study collects data to help the Zambia Ministry of Health and partners improve treatment guidelines and interventions for AHD patients. The study involves several groups a prospective cohort of adults newly screened for AHD, a hybrid cohort of adults screened in the previous year, an inpatient cohort of adults hospitalized for AHD management, and a provider cohort of health workers involved in AHD care. Participants will be enrolled based on ART initiation status and AHD screening, with data collected from medical records, surveys, interviews, and focus groups. Data collection includes retrospective and prospective periods, covering up to 12 months before and after enrollment. Participants will undergo clinical record reviews and complete surveys and interviews about their care experiences and socioeconomic status. Healthcare providers at study sites will also provide input through surveys and interviews. Researchers will measure outcomes such as retention in care and viral suppression at 6 and 12 months, inpatient characteristics, guideline adherence, and costs. The study will monitor participants during their first six months on ART, with some follow-up extending to 12 months, to better understand and support AHD clients in Zambia.

Researchers are conducting a prospective longitudinal study in Lusaka, Zambia, to better understand the pregnancy rates and outcomes among women of reproductive age. The study aims to explore the health and well-being of women before, during, and after pregnancy, as well as the factors that may affect adverse outcomes during these reproductive periods. This information is intended to improve care for mothers and their children in the future. Women aged 15 to 49 years who live in the study area will be enrolled and followed for up to three years. Participants will be visited every three months, during which their medical records will be reviewed, a brief physical exam and urine pregnancy test will be conducted, and they will answer survey questions. Women will also collect vaginal swabs themselves for future testing. Infants born to participating women during the study will also be included. During the study, researchers will collect data on pregnancy rates, term live births, and infant mortality, measured over the entire enrollment period up to 36 months. The study involves regular health assessments and surveys to monitor participants well-being. Safety and data interpretation will be closely monitored, considering any social or medical factors that could affect participation. Total participation may last up to three years, with quarterly visits to support continuous observation and data collection.

Tuberculosis TB remains a major global health issue with over 3 million people undiagnosed each year and 1 million deaths. The ADAPT study aims to reduce this burden by evaluating new point-of-care TB diagnostic tests that are faster, simpler, and less costly. The study focuses on adolescents and adults with suspected TB symptoms or risk factors, assessing these novel tests in real-world outpatient settings in high TB burden countries. The study also evaluates the usability and acceptability of these tests by health workers. Participants will be involved in testing novel TB triage and diagnostic tools, including semi-automated or automated molecular assays based on tongue swabs. These tests will be compared against standard reference methods like sputum Xpert MTBRIF Ultra and mycobacterial culture. The study plans to enroll about 450 participants per year at each of three sites to assess various diagnostic tests and 50 health workers to evaluate test usability. During the study, participants will undergo diagnostic testing and screening based on TB symptoms or risk factors. Health workers will be observed and surveyed regarding the ease of use and acceptance of the new tests. Researchers will track the proportion of positive and negative test results among participants with and without TB over two years. The study involves follow-up visits and consent, ensuring adherence and data collection, with the goal of improving rapid TB diagnosis and management worldwide.

Researchers are evaluating the effects of antibiotic treatment on asymptomatic bacteriuria AB during pregnancy in low- and middle-income countries. This phase 3 randomized controlled trial aims to reduce the incidence of small vulnerable newborns SVN and stillbirths SB, contributing to global health goals to prevent early childhood deaths. The study involves pregnant individuals and newborns across seven international sites collaborating with the NICHD Global Network for Womens and Childrens Health Research. Participants with AB are randomly assigned to one of two groups one group receives a 7-day course of oral nitrofurantoin monohydratemacrocrystals at 100 mg twice daily 14 doses total, while the other group receives a matching placebo on the same schedule. The study compares the impact of this antibiotic treatment versus placebo during pregnancy. During the study, participants will complete screening, randomization, treatment, and follow-up visits, with monitoring continuing until 42 days after birth. Researchers will assess the number of small vulnerable newborns or stillbirths as the main outcome. Participants must remain in the study area for the full postpartum follow-up period, during which health and safety are monitored carefully.

Adolescents and young adults living with HIV in Zambia face higher risks of developing cancers such as Kaposi sarcoma, non-Hodgkins lymphoma, and cervical cancer compared to their uninfected peers. This research aims to evaluate peer-to-peer education and support strategies designed to increase early cancer diagnosis and improve treatment completion among this vulnerable group. The ARROW program is being tested against a one-time education campaign to determine its effectiveness in reducing premature cancer mortality in this population. The study compares two approaches the ARROW strategies, which include peer counselors supporting patients, peer-led education sessions for providers, and a collaborative forum involving health administrators and policy makers and a one-time education campaign providing informational brochures alongside usual care. These interventions are implemented within HIV treatment facilities and cancer centers to boost early cancer screening and ensure adherence to recommended treatments. Participants will be followed for up to three years, with key assessments including completion of cancer screenings and treatments within 12 months of enrollment or diagnosis. Researchers will monitor the proportion of patients who complete screenings, initiate and complete cancer treatment, and survive at 12 months. Implementation outcomes like acceptability and cost-effectiveness of the ARROW program will also be studied to support future scaling of these strategies in Zambia and potentially other regions.

This research aims to determine if continuing caffeine citrate treatment after hospital discharge can prevent apneic events causing sick visits in moderately preterm infants. It also evaluates whether caffeine use improves developmental outcomes at 12 months of age. The study compares caffeine citrate to a placebo to assess its effects on apnea and infant development. Participants receive either caffeine citrate at 20mgkgday or a placebo of sterile water orally once daily for up to 28 days following hospital discharge. The doses are prepared based on the infants weight prior to discharge and are not adjusted afterward. Parents or guardians administer the medication daily and keep a diary of symptoms and apneic events. Weekly phone calls monitor the infants condition until day 28, with an additional follow-up call at 2 months. Participants return to the clinic for physical examinations at 28 days and 2 months after discharge. At 12 months, infants undergo a neurodevelopmental assessment using the Ages and Stages Questionnaire. Data collected includes the number of apneic events, healthcare visits related to apnea, all-cause sick visits, neonatal mortality, and developmental outcomes. Study data is securely stored and managed to protect participant confidentiality throughout the trial.

This trial evaluates oral caffeine treatment compared to placebo in newborns diagnosed with moderate to severe hypoxic ischemic encephalopathy HIE, a brain injury caused by lack of oxygen around birth. The study aims to reduce death or serious neurodevelopmental problems by 18 to 22 months of age. HIE is usually treated with cooling therapy, but this study explores caffeine as a potentially beneficial and low-cost alternative. Newborns at least 36 weeks gestation and weighing 1800 grams or more, diagnosed within six hours after birth, are randomly assigned to receive either caffeine or placebo. The caffeine group receives one 20 mgkg dose followed by two 10 mgkg doses at 24-hour intervals by mouth or feeding tube. The placebo group receives identical doses without caffeine. Sub-studies include blood sampling for caffeine levels, brain imaging with MRI, and cord blood collection for molecular analysis. Participants undergo assessments during hospitalization and follow-up visits up to 18 to 22 months old. Researchers measure survival and neurodevelopmental outcomes using physical exams, developmental tests, neurological scales, growth measures, and kidney function tests. Safety is monitored closely, and serious adverse events are recorded. The total study duration extends until final outcome assessments at nearly two years of age.