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NCT ID: NCT05047315 Not yet recruiting - Tuberculosis Clinical Trials

Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV

Start date: October 1, 2021
Study type: Observational

Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and people living with HIV (PLHIV).

NCT ID: NCT05022407 Recruiting - Covid19 Clinical Trials

Impact of COVID-19 Epidemic on Clinical Outcomes and Service Delivery Among People Living With HIV and Health Care Workers in Mozambique

Start date: July 15, 2021
Study type: Observational

While COVID-19 (coronavirus disease 2019) is an important emergent issue for all in the country, there is a significant number of people in the population who are especially vulnerable to the potential impact that the novel coronavirus epidemic may have on their health. The overall purpose of the study is to investigate: (1) the dynamics of COVID-19 infection among people living with HIV and health care workers providing HIV services; (2) the provision of HIV and HIV/TB care and treatment services at health facilities, within the scope of COVID-19 or in the context of COVID-19 and; (3) the perceptions of COVID-19 and access to care among people living with HIV and health care workers providing HIV services.

NCT ID: NCT04998240 Not yet recruiting - Covid19 Clinical Trials

Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines in Mozambique

Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults in Mozambique.

NCT ID: NCT04930367 Not yet recruiting - HIV Clinical Trials

CombinADO: Evaluation of an Intervention Aimed at Improving HIV Outcomes Among Adolescents and Young Adults Living With HIV in Mozambique

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

This is a cluster-randomized trial designed to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, antiretroviral therapy (ART) adherence and retention in HIV care among adolescents living with HIV (ALHIV) ages 10 to 24 years attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities. The goal of this study is to learn whether an enhanced, tailored intervention helps AYAHIV do better with their HIV care (take their medications, stay in care) than the usual care that they receive.

NCT ID: NCT04825327 Recruiting - Tuberculosis Clinical Trials

Predicting the Future: Incipient Tuberculosis

Start date: April 21, 2021
Study type: Observational [Patient Registry]

The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xpert Host Response (HR) cartridge result develop active TB within 12 months. They will also investigate if there is a correlation between progressing to active TB within 12 months and having high levels of the iron homeostasis markers (Hepcidin, Ferritin and Transferrin). Identified index cases who agree to participate will refer their household or close contacts to also join the study. These contacts will be tested for TB and only contacts who are negative will be enrolled and followed-up at 6 months and 12 months. Blood samples will be collected at baseline and 6 months for testing. During the study period, TB testing will be done on contacts who meet symptoms criteria. At 12 months, all contacts will undergo a chest x-ray to assist in the diagnosis of TB. PreFIT will target people aged 12 to 60 years of age and both HIV negative and positive. 1515 trial participants will be recruited at Stellenbosch University in South Africa, 1515 at Fundaçao Manhiça in Mozambique and 1010 at Makerere University in Uganda, respectively.

NCT ID: NCT04781257 Recruiting - Tuberculosis Clinical Trials

Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries

Start date: March 2021
Study type: Observational

The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among those who are infected, most will stay healthy but some will develop TB themselves. These people would benefit from preventive treatment, which would also stop TB from being spread to other persons. The problem currently is that it is impossible to determine with certainty who would require preventive treatment, and who will remain healthy. Out of 100 persons exposed to an infectious TB patient, only 2 will go on to have TB according to a study in Vietnam, but there are no good tests available to identify those with a risk for TB disease. Treating 100 persons to prevent 2 cases of TB is not effective, so preventive treatment is not used in adults and adolescents in Tanzania, Mozambique and Zimbabwe, where this study will be conducted, but also in many other settings. The ERASE - TB project will evaluate a number of newly developed diagnostic tests, to see which of those will be able to predict TB in persons at risk, and therefore steer preventive treatment well. For this, the investigators will invite 2,100 household contacts (HHC) of infectious TB patients, who are at least 10 years old, into the study. Everyone will be examined initially, and again in regular intervals, for 1.5 to 2 years; and whenever the participants will present with symptoms that could indicate that they develop TB. At every visit, the investigators will perform an X-ray and take some blood and urine samples to perform new candidate tests. At the first/baseline visit, all household contacts without TB will undergo a spirometry to evaluate their pulmonary function. If someone is unwell, the investigators will also examine sputum for the presence of TB bacilli. In the end, the investigators will then be able to say who of the persons in the study developed TB, and who remained healthy. From all samples taken at different timepoints, the investigators will then determine which test found TB early, and clearly distinguished between persons developing TB, and persons who would remain healthy .

NCT ID: NCT04724161 Recruiting - Malaria Clinical Trials

Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Mozambique

Start date: December 9, 2020
Study type: Observational

This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor prevalence of malaria and the coverage of malaria control interventions. The use of a questionnaire, to include standard malaria rapid diagnostic testing, will be piloted with consenting women attending their first ANC visit at 21 individual health facilities across three of the New Net Project pilot study districts in western Mozambique: seven facilities each from Changara, Chemba, and Guro Districts. The results of the ANC questionnaires will be analyzed to see how well they correlate to similar malaria prevalence and intervention coverage estimates obtained during the contemporary community-based cross-sectional surveys administered during New Net Project pilot evaluation activities. As part of the New Nets Project, Mozambique is deploying next-generation ITNs through mass campaigns in pre-determined provinces. The present study aims to leverage planned New Nets Project cross-sectional surveys and strengthened routine case surveillance data in three of the study districts (Changara, Guro, and Chemba) to assess (1) whether the malaria infection prevalence data collected during ANC surveillance correlates with the cross-sectional survey estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data. All pregnant women attending first ANC visit at seven health facilities in each study district will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facility will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants.

NCT ID: NCT04716387 Recruiting - Malaria Clinical Trials

Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Mozambique

Start date: August 18, 2020
Study type: Observational

The use of insecticide-treated bed nets (ITNs) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance to commonly used insecticides in important mosquito vector populations. Newly developed, next-generation ITNs that use two insecticides, or an insecticide synergist and an insecticide, are effective at killing resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs in two regions of Mozambique. Over three years, data on the entomological and epidemiological impact of the different ITN types will be collected. Data collection will occur in six districts: two districts receiving the dual-active ingredient ITN Interceptor® G2 (BASF: alphacypermethrin + chlorfenapyr); one district that will receive the dual-active ingredient ITN Royal Guard® (Disease Control Technologies: alphacypermethrin + pyriproxyfen); one district receiving an ITN containing an insecticide plus an insecticide synergist , Olyset®Plus (Sumitomo Chemical: permethrin + piperonyl butoxide); and two districts receiving the standard pyrethroid-only ITNs DuraNet® (Shobikaa Impex Private Limited: alphacypermethrin). Data will be collected on malaria vector bionomics, disease epidemiology, and ITN use in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.

NCT ID: NCT04641858 Recruiting - Covid19 Clinical Trials

BCG to Reduce Absenteeism Among Health Care Workers During the COVID-19 Pandemic

Start date: December 3, 2020
Phase: Phase 4
Study type: Interventional

The COVID-19 pandemic challenges available hospital capacity. Strategies to protect health care workers (HCW) are desperately needed. Bacille Calmette- Guérin (BCG) has protective non-specific effects against other infections; a plausible immunological mechanism has been identified in terms of "trained innate immunity". The primary objective of the study is to evaluate whether BCG can reduce unplanned absenteeism due to illness among HCW during the COVID-19 pandemic. Secondary objectives are to reduce the number of HCW that are infected with COVID-19, reduce hospital admissions for HCW and to improve the capacity for clinical research. Design: Single-blind, parallel-group placebo-controlled multi-centre block randomized trial including a total of 1050 HCW. The study sites will be the Manhiça hospital in Mozambique, Central Hospital Dr. Agostinho Neto and Central Hospital Dr. Baptista de Sousa in Cape Verde and Hospital Nacional Simão Mendes and other hospitals in the capital Bissau in Guinea-Bissau. Population: HCW (nurses/physicians/others) ≥18 years. Intervention: Block randomization 1:1 to intradermal standard dose (0.1 ml) of BCG vaccine or placebo (saline). Endpoints: Primary: Days of unplanned absenteeism due to illness. Secondary: Days of absenteeism because of documented COVID-19; cumulative incidence of infectious disease hospitalizations. Follow-up: mobile phone interviews every second week, regarding symptoms, absenteeism and causes, COVID-19 testing (if done) and their results. Perspectives: If BCG can reduce HCW absenteeism it has global implications. The intervention can quickly be scaled up all over the world.

NCT ID: NCT04466293 Recruiting - Tuberculosis Clinical Trials

Choice Architecture Based TB Preventive Therapy Prescribing

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what investigators know works and what is actually delivered at the clinic-level to patients, is known as the "science-to-service gap." In the realm of tuberculosis (TB) prevention, this gap is reflected in <20% of TB preventive therapy (TPT)-eligible persons living with HIV (PLWH) being offered or initiated on isoniazid preventive therapy (IPT) in many settings. Recent innovation in TPT have brought new pharmacological options allowing for shorter courses, intermittent dosing, or both. A 12-dose once-weekly rifapentine and isoniazid (3HP) regimen has been demonstrated to be effective and well tolerated. This regimen has several potential advantages over IPT; however, if patients are never assessed for 3HP eligibility and 3HP is not prescribed, TPT packets will remain on pharmacy shelves and the potential health benefits will not reach those who need it. The overarching goal of this study is to identify a generalizable approach to overcome current barriers to delivery of TPT in order to achieve high levels of TPT delivery during routine care in public clinics. Investigators are proposing a choice architecture that makes prescribing TPT the "default" or standard option and that for TPT not to be prescribed will require a choice by a clinician to "opt-out" of TPT for a specific patient. Methods: Investigators will use a cluster randomized design with the larger IMPAACT4TB (I4TB) program to deliver 3HP to countries in Africa, Asia, and Latin America. A subset of countries and clinics within these I4TB countries will be included with each clinic the unit of randomization. Clinics within study countries will be randomized to one of two strategies: (1) standard implementation within the UNITAID project (clinic training on TPT along with posters and other standard medication material) and (2) choice architecture default TPT. Clinical process data will be used to assess the effectiveness of each strategy to determine the proportion of PLWH (1) screened for TB preventive therapy, (2) eligible for TPT, and (3) prescribed TPT. Significance: Identifying a pragmatic approach will lead the way for improving TPT prescribing across the study sites. It will furthermore contribute to implementation science at large in describing implementation strategies that may be applied to clinic-level implementation of other innovations.