There are about 292 clinical studies being (or have been) conducted in Zambia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.
This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.
This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).
Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. Infection with HBV can be self-limiting depending on age and immunity status of the infected person. Acute infection with HBV is cleared within six months of initial infection while chronic infection can last longer than six months. HBV can be transmitted perinatally, sexually, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood. Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCWs). In this population, HBV infection can occur through occupational exposure. In fact, the hepatitis B virus is more contagious than human immunodeficiency virus (HIV) during a needle stick injury (30% versus 0.5%). It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission. Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.
This trial evaluates the impact of providing comprehensive, community-based and peer-led sexual and reproductive health services to adolescents and young people aged 15 to 24 on their knowledge of their HIV status. The trial includes 20 clusters in two communities, half the clusters receive the intervention. After 18-months of implementation, a cross-sectional survey will be conducted to evaluate the impact of the intervention on the primary outcome: knowledge of HIV status.
Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). In this study the investigators will develop and pilot a new approach to inpatient HIV care that follows international guidelines for management of advanced HIV disease.
The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to <8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.
Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.
The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented with 6 geographic regions randomized into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. HIV testing will be assessed among the SHIELD only HIV negative or unknown (HIV-/u) cohort and retention in care along with viral load suppression will be primarily assessed in the IWC clinics and SHIELD HIV positive (HIV+) cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback following the trial. Cost-effectiveness of the interventions and budgetary impacts will be assessed through using a cost assessment tool.