Lusaka

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 evaluating whether extended admission to the Kangaroo Mother Care (KMC) ward can help prevent postpartum depression (PPD) in mothers of low birthweight preterm infants in low-resource settings. This randomized controlled trial compares longer KMC ward stays to the standard care of shorter stays to examine effects on maternal depression, infant neurodevelopment, paternal depression, barriers to KMC practice, and cost effectiveness. The study includes mothers, infants, fathers, and family members to understand these outcomes comprehensively. The study involves two groups: one group of mother-infant pairs admitted to the KMC ward for more than 2 days after discharge from the neonatal intensive care unit (NICU), and the other group admitted for less than 2 days. Both groups receive support for kangaroo mother care, breastfeeding, and preterm infant care during their respective ward stays before going home. The trial enrolls mothers with infants weighing between 1000-2000 grams who have been stable in the NICU for more than 48 hours. Participants will be assessed at discharge and during follow-up visits at 2 weeks, 6-8 weeks, and at 6, 12, and 18 months. Mothers and fathers will be screened for depression, and infants will undergo neurodevelopmental screenings. Researchers will also collect information on social support, breastfeeding duration, KMC barriers, infant growth, mortality, morbidity, and healthcare costs throughout the study. The trial aims to provide detailed insights into the benefits and challenges of extended KMC in this population over an 18-month period.

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 MTB/RIF 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 Women's and Children's Health Research. Participants with AB are randomly assigned to one of two groups: one group receives a 7-day course of oral nitrofurantoin monohydrate/macrocrystals 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-Hodgkin's 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.

Researchers are studying how adapting and implementing practice guidelines for acute abdomen at the primary care level in Zambia can affect patient care. The study uses a mixed method approach, combining qualitative and quantitative data from healthcare workers to modify guidelines originally developed for high-income countries to fit a low- and middle-income context. The main goal is to see if these adapted guidelines can reduce hospital stay length and improve outcomes for patients with acute abdomen. The study compares two sites: an intervention site where the adapted acute abdomen guidelines will be put into practice, and a control site where no new guidelines will be introduced. This allows researchers to evaluate the effect of guideline implementation on patient management. The intervention site will follow specific adjusted guidelines tailored for acute abdomen care at the primary level. Participants in the study include all patients aged 18 and older presenting with acute abdomen, except those with trauma-related cases or immediate postoperative patients from other facilities. Data collection will focus on length of hospital stay as the primary outcome measured over 7 days. The study is designed to improve management capacity at primary care and may help reduce morbidity and mortality associated with acute abdomen in this setting. The study is sponsored by the University of Bergen and runs from September 2025 through December 2028.

Researchers are evaluating the effects of a multi-level intervention called TASKPEN, adapted from the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN), on clinical and implementation outcomes in people living with HIV (PLHIV) who also have cardio-metabolic conditions in Lusaka, Zambia. This hybrid effectiveness-implementation stepped wedge trial aims to assess control of both HIV and cardio-metabolic diseases, intervention reach, and quality of life improvements among the participants. The TASKPEN intervention includes five evidence-based components: integrated HIV and non-communicable disease care in a single service point, adapted WHO PEN protocols and training materials, access to cardio-metabolic screening and laboratory monitoring, an electronic medical record module focused on non-communicable diseases, and a strengthened supply chain for related medications. The trial involves 12 health facilities transitioning sequentially from standard care to the TASKPEN intervention in randomized clusters over several months. Participants will complete bio-behavioral surveys at baseline and at multiple follow-up points, totaling about 5,100 participants across all sites. A nested cohort of approximately 320 participants with cardio-metabolic conditions will be followed longitudinally for detailed clinical outcomes. Researchers will monitor HIV viral suppression, blood pressure, glucose levels, cardiovascular risk scores, medication adherence, and quality of life over up to 24 months, alongside implementation outcomes and factors influencing the intervention's success.

This research aims to evaluate differentiated service delivery (DSD) models for HIV treatment in high-prevalence countries, focusing on Zambia. It addresses key questions about how widely these models are offered, who is eligible, patient participation, health outcomes like viral suppression, resource use compared to traditional care, and sustainability without external support. The study is observational and analyzes existing medical record data to provide insights for future decision-making. The study collects routine medical records from electronic systems and paper charts without interacting directly with patients or providers. It compares patients enrolled in various DSD models to those receiving standard HIV care. There is no intervention administered; instead, existing data sets from the Ministry of Health and partners are analyzed to assess coverage, uptake, benefits, and costs of these service models. Participants include patients aged 15 years or older accessing HIV care within the data collection period, from any HIV transmission risk group. Researchers will review patient-months enrolled in DSD models over 6, 12, and 24 months. Since this is a data analysis study, no additional tests or visits are required. The analysis will inform on clinic efficiency, treatment outcomes, and long-term sustainability of differentiated HIV care delivery in Zambia.