[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre for Infectious Disease Research in Zambia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,80,108,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100637308","how-gut-health-affects-immune-responses-to-the-oral-rotavirus-vaccine-in-adults-in-zambia-100637308",false,"NCT07626606","How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia","Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy","Rota-Omics","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 50 years.\n* Able and willing to provide written informed consent.\n* Reside within Lusaka district and available for scheduled follow-up.\n* Willing to undergo two endoscopy procedures with serial sample collection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).\n* Known severe immunodeficiency (HIV with CD4 \\\u003C 200 cells\u002Fmm³, current cancer chemotherapy, systemic corticosteroids equivalent to \\>20 mg\u002Fday prednisolone for \\>2 weeks).\n* Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).\n* Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.\n* Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.\n* Any condition judged by the investigator to compromise participant safety or data integrity.\n* Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.\n\nPregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.",true,"ALL","18 Years","50 Years",{"count":22,"type":23},43,"ESTIMATED","OBSERVATIONAL","The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.\n\nA major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.\n\nThe RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term \"omics\" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.\n\nThe study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.\n\nOne important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.\n\nThe study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.\n\nIn addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.\n\nOverall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.",[27,28,29,30],"Feasibility Study","Vaccine Immune Response","Rota Virus Gastroenteritis","Transcriptomics",[30,32,33,34,35,36],"Feasibility","Microbiome","Immunity","Rotavirus","Vaccine","RECRUITING","2026-06-02",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":41},"2026-03-30",{"date":45,"type":23},"2026-12-31",{"name":47,"class":48},"Centre for Infectious Disease Research in Zambia","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100601209","phase-1-phase-1b-ascending-dose-study-of-panchol-in-healthy-volunteers-100601209","NCT07107516","Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers","Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults","PanChol","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated) and any other authorizations required by local law and be able to comply with all study requirements.\n2. Healthy adults aged from 18 to 55 years old.\n3. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.\n4. Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period.\n5. Female participants must be non-pregnant and non-lactating and either\n\n   1. surgically sterile (history of bilateral ligation, bilateral salpingectomy, bilateral oophorectomy, total hysterectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)\n   2. be of child-bearing potential and practicing an acceptable method of contraception or abstaining from all activities that could result in pregnancy for at least 28 days before vaccination until 3 months after receiving the investigational product.\n\nAcceptable methods of contraception include barrier methods (such as condom, diaphragm, or cervical cap used in conjunction with spermicide), intrauterine device, hormonal contraception (that may be taken or administered by oral, intravaginal, transdermal, subdermal or IM route), vasectomized partner (the vasectomized partner should be the sole partner for that participant)\n\nExclusion Criteria:\n\n1. Confirmed or suspected immunosuppressive condition, as a result of a disease (e.g., primary immune deficiency, malignancy, HIV infection) or have taken any systemic immunosuppressive therapy within 6 months of enrollment.\n2. Pregnant or lactating women.\n3. History of gastrointestinal (GI) disorder, such as previous major GI surgery, malabsorption, or any chronic GI disorders that would interfere, according to the investigator, with the IP.\n4. Acute GI or febrile illness within 7 days of enrollment.\n5. Have any acute or chronic medical condition that, in the opinion of the investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.\n6. History of cholera vaccination.\n7. History of cholera infection.\n8. Abnormal stool pattern, defined as \\\u003C 3 or \\>21 stools per week.\n9. Allergy or intolerance to PanChol or placebo component (sodium bicarbonate, lactose, ascorbic acid)\n10. Use of any systemic antibiotics within 1 month of PanChol administration.\n11. Receipt of a live vaccine in the previous 4 weeks or planned in the 4 weeks following enrollment.\n12. Receipt of a killed or subunit (non-live) vaccine in the previous 2 weeks or planned in the 2 weeks following enrollment.\n13. Individuals who do not speak English\n14. Childcare workers with direct contact with children ≤ 2 years of age\n15. Individuals whose occupation involves handling of food\n16. Healthcare workers who have direct contact with patients who are immunodeficient, HIV-positive, or have an unstable medical condition\n17. Use laxatives regularly\n18. Have diarrhea within 48 hours before enrollment\n19. Have a history of hypersensitivity to any of the tetracyclines\n20. Have a history of hypersensitivity to streptomycin or any aminoglycoside due to the known cross-sensitivity of patients to drugs in this class.\n21. Individuals who have a household member who are immunodeficient, HIV-positive, or have an unstable medical condition.","55 Years",{"count":60,"type":23},32,"INTERVENTIONAL",[63],"PHASE1","Cholera is a serious diarrheal disease that can be fatal within hours of onset. The current available cholera vaccines to prevent the disease are not very effective. Panchol is a new oral cholera vaccine that may be an improvement over the currently available vaccines in use. The goal of this study is to learn safety of this new oral cholera vaccine and the body's immune response to the vaccine.\n\nThe researchers will compare the PanChol vaccine to placebo to see the side effects experienced in participants.\n\nThe participants will be adults aged between 18 and 55 years and they will be required to:\n\n1. Be admitted to hospital until they stop passing the cholera vaccine in their stool. During admission, all side effects will be recorded by the researchers.\n2. After discharge, the participants will visit the research site every month for 3 months with an optional visit at the 4th month for the researchers to assess the participants' general health.",[66],"Cholera Vaccination Reaction",[68,69,70],"cholera","vaccine","safety","NOT_YET_RECRUITING","2025-08-19",{"date":74,"type":41},"2025-08-24",{"date":76,"type":23},"2025-10-01",{"date":78,"type":23},"2026-01-31",{"name":47,"class":48},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":61,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100594564","person-centered-approaches-to-viremia-connection-rapport-and-engagement-study-100594564","NCT07021092","PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY","P-CoRE","Inclusion Criteria:\n\n1. Patients that are lost to follow up (\\[LTFU\\] from HIV care i.e. confirmed \\>30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.)\n2. Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)\n3. Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status)\n4. Patients that have a last documented VL that is elevated, \\> 1000 copies\u002Fml at time of sampling in current clinic population (CCP) (regardless of care status)\n5. Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.\n\nExclusion Criteria:\n\n1. Patients that are unable to provide consent or unwilling to participate in the study\n2. Participant who is NOT living with HIV\u002FAIDS;\n3. Participant is too sick i.e., failing to talk, general discomfort and emergency cases);",{"count":88,"type":23},3000,[90],"NA","The study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. The study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.The study will be implemented over a period of 36 months in 24 facilities in Lusaka and Central province, Zambia.",[93,94],"HIV Viremia","HIV -1 Infection",[96,97,98],"Uncontrolled Viremia","Person Centred Care","Unmonitored Viral Load","2025-06-12",{"date":101,"type":41},"2025-06-13",{"date":103,"type":41},"2025-04-01",{"date":105,"type":23},"2027-06-30",{"name":47,"class":48},2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":107},"100595255","surveillance-assessment-and-detection-of-influenza-associated-respiratory-infections-in-hiv-positive-and-negative-individuals-in-lusaka-zambia-100595255","NCT07030075","SURVEILLANCE, ASSESSMENT AND DETECTION OF INFLUENZA ASSOCIATED RESPIRATORY INFECTIONS IN HIV POSITIVE AND NEGATIVE INDIVIDUALS IN LUSAKA, ZAMBIA","Inclusion Criteria:\n\n* i. age ≥18 years old ii. presenting with flu-like symptoms or acute respiratory infection with ≥2 to 7 days history of cough and \u002For sore throat and fever, +\u002F- sneezing, +\u002F- congestion, +\u002F- myalgia, +\u002F- fatigue, +\u002F- wheezing, shortness of breath)\\[55-57\\] iii. willing to share their HIV status or be tested iv. willing to share their COVID-19 vaccination status v. able and willing to give informed consent vi. willing to provide a nasal\u002F nasopharyngeal sample for testing as part of standard of care vii. willing to provide exhaled breath aerosol samples i.e. wear a mask and provide a breath sample viii. willing to fill a symptoms diary card for symptom tracking for 7 days ix. agree to be followed-up and attend study visits up to two weeks after study entry\n\nExclusion Criteria:\n\n* i. individuals who are unwilling to provide any reference standard samples such as the nasopharyngeal swabs ii. those with symptoms for \\>7 days, or iii. those unwilling or unable to provide informed consent",{"count":115,"type":23},594,"Background and rationale:The World Health Organisation (WHO), estimates influenza global deaths at 290,000 to 650,000 annually. Although influenza is mostly associated with upper respiratory tract infections (URTIs), its role in lower respiratory tract infections (LRTIs) and the associated poor clinical outcomes have been overlooked in sub-Saharan Africa. A study conducted in eight SSA countries estimated that 8.2% of cases and 2.8% of deaths from LRTIs were due to primary infection with influenza. Pneumonia and influenza-associated illness are responsible for 8.5% of respiratory deaths in Zambia. However, in routine practice, testing to distinguish between bacterial and viral etiology of RTIs is seldom done outside sentinel surveillance due to the high cost and lack of available testing options. This consequently underestimates viral RTIs in the population. It is particularly important to diagnose flu early on in vulnerable populations so that they receive timely and appropriate medical care. Although Zambia is a high HIV burden country with a prevalence of 11%, there is presently no study that has described the burden of influenza in the HIV positive population. This research study will address gaps in current scientific knowledge, providing key insights about the prevalence, circulating types, seasonality and associated clinical outcomes of influenza, RSV and SARS-CoV-2 infection in Zambia in the post COVID-19 era.\n\nObjectives Primary To determine the prevalence of influenza (A and\u002For B) infections in a high HIV burden setting in Lusaka, Zambia over one or more influenza seasons.\n\nSecondary\n\n1. To determine the prevalence of influenza co-infection with RSV and\u002For SARS-CoV-2\n2. To determine the clinical outcomes of influenza (A and\u002For B) infection among Zambian adults, with and without co-infection with RSV and COVID-19, by HIV and COVID-19 vaccination status.\n3. To evaluate the accuracy and yield of aerosol-based sampling for diagnosis of respiratory viruses (influenza, SARS-CoV-2, and RSV) compared to nasal\u002F nasopharyngeal swabs, for rapid diagnosis of infection among symptomatic individuals in Zambia.\n4. To evaluate the acceptability of exhaled breath aerosol (XBA) sampling for diagnosis and screening of respiratory infections of pandemic potential.\n\nStudy design and participants:\n\nPrimary objective and secondary objective 1:\n\nCross sectional surveillance study of individuals presenting with flu-like symptoms at two first level hospitals in Lusaka, Zambia. Recruitment of 594 participants will be done over the study period and participants will include both males and females presenting with 2-7 days of flu-like symptoms, able to provide informed consent, aged ≥18 years, with a known HIV status or willing to be tested, with a known COVID 19 vaccination status and available for symptom follow-up.\n\nSecondary objective 2:\n\nProspective follow up of participants enrolled in aim 1 for 14 days will be done to document clinical symptom progression and outcomes. Appropriate care will be provided to all participants within routine care services.\n\nSecondary objective 3 \\& 4:\n\nMixed methods approach. All patients enrolled under aim 1 will be requested to provide in addition to the routine nasopharyngeal sample, an aerosol-based sample for diagnostic accuracy and yield evaluation. We will also conduct an investigator-administered questionnaire to ascertain end-user experience and preferences for either sampling method.\n\nLocation Zambia (Kanyama and Chawama sub-districts) Duration April 2025 to November 2026 (Participant enrolment duration)",[118,119,120],"Influenza","RSV","COVID - 19",{"date":122,"type":41},"2025-06-19",{"date":124,"type":41},"2025-05-20",{"date":126,"type":23},"2027-01",{"name":47,"class":48},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":18,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":61,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100585498","piloting-a-biomarker-augmented-alcohol-screening-brief-intervention-and-referral-to-treatment-sbirt-program-among-hiv-affected-adolescents-and-young-adults-in-zambia-100585498","NCT06903143","Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia","Inclusion Criteria:\n\n* 16-24 years of age\n* Residing in Lusaka, Zambia\n* Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).\n\nExclusion Criteria:\n\n• Unable or unwilling to provide informed assent\u002Fconsent","16 Years","24 Years",{"count":137,"type":23},60,[90],"This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:\n\nSpecific aims:\n\n1. Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low\u002Fmoderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).\n2. Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.",[141],"Alcohol",{"date":101,"type":41},{"date":144,"type":23},"2025-08-01",{"date":146,"type":23},"2026-04-30",{"name":47,"class":48},""]