[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Stellenbosch\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100463634","cough-audio-classification-as-a-tb-triage-test-100463634",false,"NCT05317247","Cough Audio Classification as a TB Triage Test","Automated Smartphone-based Cough Audio Classification for Rapid Tuberculosis Triage Testing (Cough Audio triaGE for TB; CAGE-TB)","CAGE-TB","Inclusion Criteria:\n\n* participant must be at least 12 years old\n* participant must have a prolonged cough (for at least two weeks)\n* participant must provide informed consent\n* participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling\n\nExclusion Criteria:\n\n* individuals who refuse informed consent\n* individuals who have received treatment for TB in the 60 days prior to enrolment\n* individuals who are unable to provide a sputum specimen for microbiological testing\n* individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings","ALL","12 Years",{"count":20,"type":21},1751,"ESTIMATED","OBSERVATIONAL","TB is the single biggest infectious cause of death (1.5 million died in 2018), killing more HIV-positive people than any other disease, and is arguably the most important poverty-related disease in the world. TB's estimated incidence in Africa has been declining over recent years but progress is slow and plateauing. To avert stagnation, truly innovative and ambitious technologies are needed, especially those that improve case finding and time-to-diagnosis as, in mathematical models based on the TB care cascade framework, interventions that accomplish this will have the most impact on disrupting population-level transmission, including when deployed at facilities where patients are readily accessible. Critically, these interventions (triage tests) must promote access to confirmatory testing (e.g., Xpert MTB\u002FRIF Ultra) by enabling patients to be referred rapidly and efficiently during the same visit. The investigators will optimise and evaluate a technology that, aside from the investigators early case-controlled study to show feasibility, is hitherto not meaningfully investigated for TB. This gap is alarming given, on one hand, the enormity of the TB epidemic and the need for a triage test and, on the other hand, promising proofs-of-concept that demonstrate high diagnostic accuracy of cough audio classifier for respiratory diseases such as pneumonia, asthma. pertussis, croup, and COPD. In some cases, these classification systems are CE-marked, awaiting FDA-approval, and subject to late-stage clinical trials. This demonstrates the promise of the underlying technological principle. CAGE-TB's innovation is further enhanced by: applying advanced machine learning methods that the team have specifically developed for TB patient cough audio analysis, use of mixed methods research - drawing from health economics, implementation science, and medical anthropology - to inform product design and assess barriers and facilitators to implementation, and uniquely for a TB diagnostic test, its potential deployment as a pure mHealth (smartphone-based) innovation that mitigates many barriers that typically jeopardise TPP criteria fulfilment.",[25],"Tuberculosis",[27,28,29],"Triage","Cough audio classification","Smartphone application","RECRUITING","2026-04-29",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":34},"2022-04-19",{"date":38,"type":21},"2027-12-30",{"name":40,"class":41},"University of Stellenbosch","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100416278","pre--and-post-treatment-lung-microbiota-metabolome-and-immune-signatures-at-the-site-of-disease-in-patients-with-active-pulmonary-tuberculosis-100416278","NCT04700579","Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis","TB-LUNG","Inclusion Criteria:\n\n* 18-60 years old.\n* Agree to undergo CXR and\u002For CT scan.\n* Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).\n* No evidence of prior TB treatment and\u002For CXR\u002FCT does not have obvious evidence of prior TB.\n* Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.\n* If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.\n* Able and willing to return for follow-up visits, with no plans to move in the near future.\n* Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.\n\nExclusion Criteria:\n\n* Less than 18 years or older than 60 years of age.\n* Has already initiated TB treatment.\n* Rifampicin resistant.\n* Has a previous history of TB.\n* Bilateral TB disease defined as both lungs with extensive TB disease\n* Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)\n* Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome\n* Has a contraindication for bronchoscopy (e.g., FEV1 \\\u003C70%), as determined by bronchoscopists according to best practice guidelines\n* Has a daily alcohol intake of more than 6 beers or 4 mixed drinks\n* Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period\n* Recent hospitalization for any reason",true,"18 Years","60 Years",{"count":54,"type":21},150,"18 Months","The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world. The investigators will study the site-of-disease microbiome (in the lung bronchoalveolar space) in TB cases to investigate how, before TB treatment, metabolic compounds made by microbes affect host biomarkers important for TB control. The investigators will ask this question again at the end-of-treatment and one year later. Specifically, the investigators will sample the lung at the active TB hotspot identified by imaging and compare this to a non-involved lung segment usually in the opposite lung. The investigators will compare the lung microbiome to other sites in the body (i.e. oral cavity, nasopharynx, supraglottis, and gut). A small amount of blood (\\~15 ml) will be collected to assess peripheral immunological correlates of the host microbiome. Protected specimen brushings of the lung will be used to explore transcriptomic signatures and how these relate to the lung microbiome. The investigators will also apply these questions to the same number of controls (healthy patients and patients with an alternative diagnoses). This will lay the foundation for clinical trials to evaluate if specific bacteria have diagnostic (e.g., PCR) or therapeutic potential (e.g., antibiotics, prebiotics, probiotics, vaccines) where targeting the microbiome could improve clinical outcomes.",[58,59],"TB - Tuberculosis","HIV\u002FAIDS",[61,62,63],"Microbiome","Short Chain Fatty Acids","Immunological Biomarkers",{"date":33,"type":34},{"date":66,"type":34},"2021-03-04",{"date":68,"type":21},"2027-12-31",{"name":40,"class":41},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":50,"sex":78,"minAge":51,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100544594","harnessing-male-peer-networks-to-enhance-engagement-with-hiv-prevention-100544594","NCT06370923","Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention","Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention: A Large-scale Cluster Randomized Trial to Increase HIV Self-testing and PrEP Uptake Among Men in Eastern Zimbabwe","IMPERATIVE","Inclusion Criteria:\n\n* Resident in study site","MALE",{"count":80,"type":21},3591,"INTERVENTIONAL",[83],"NA","Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA.\n\nThe objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe.\n\nThe study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \\>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high.",[86],"HIV Infections",[88,89,90],"HIV self test","HIV Pre Exposure Prophylaxis","Peer Networks","2025-05-02",{"date":93,"type":34},"2025-05-04",{"date":95,"type":34},"2024-10-21",{"date":97,"type":21},"2028-05-31",{"name":40,"class":41},1,""]