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NCT ID: NCT04824131 Recruiting - HIV Infections Clinical Trials

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084

Start date: November 4, 2020
Phase: Phase 2
Study type: Interventional

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

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: NCT04733157 Recruiting - Clinical trials for Postpartum Hemorrhage

The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section

Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

NCT ID: NCT04480749 Recruiting - Syphilis Clinical Trials

Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)

Start date: October 14, 2020
Phase: Phase 4
Study type: Interventional

Syphilis infection is a major global health problem, leading to substantial morbidity among key populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM) are disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been increasing amongst MSM in many countries in the last decade. A growing evidence base supporting HIV self-testing shows that self-testing kits based on the same proposed clinical pathways are feasible and reliable. The proposed study will leverage this body of evidence and apply it to syphilis self-testing. This is a pilot study conducted in Zimbabwe. It aims to collect initial data on the feasability of implementing syphilis self-testing to establish if a large scale-RCT of this approach would be appropriate and, if so, to inform the design of this trial. The investigators will recruit 100 MSM in Harare to join the pilot program. Participants will be recruited through two methods: in-person at MSM community-based organizations that currently operate HIV self-testing programs and online through banner advertisements that advertise HIV self-testing. Study Arms: Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) Arm 2: One arm will receive standard free facility-based syphilis testing (Control Arm). Intervention: In the intervention arm the investigators will provide a treponemal rapid syphilis test kit to all participants in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection. Among participants in the control group, they will receive a list of local clinics that can provide free syphilis testing. Data Collection: For individuals in the intervention am the investigators will aim to obtain confirmation of test uptake. This will be done using either photographic confirmation sent via encrypted message on a smartphone, SMS message of a unique code or sending a unique five-digit code along with their test result to the study coordinator. The investigators will conduct cross-sectional surveys at baseline and six months later to assess sexual risk behaviours, HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey data tool the investigators will conduct in-depth interviews with a small number of participants to gain additional data about their experience of syphilis self-testing. The investigators will obtain information on linkage to care from routine clinic administrative records and by providing study participants with a unique code to be provided when attending at the facility. Analysis: The investigators will used mixed-methods to evaluate our pilot intervention including The investigators will examine the proportion of individuals who undertake a syphilis test in the interventional and control arms; among those who receive a test, the proportion of individuals who receive appropriate post-testing services. The investigators will also collect qualitative data on attitudes to syphilis self-testing and quantitative data on syphilis prevalence to inform a subsequent clinical trial.

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.

NCT ID: NCT04431414 Recruiting - COVID-19 Clinical Trials

A Study of Immune Responses to the Virus That Causes COVID-19

CoVPN 5001
Start date: July 20, 2020
Study type: Observational

The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

NCT ID: NCT04403880 Active, not recruiting - COVID-19 Clinical Trials

Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

Start date: May 13, 2020
Study type: Observational

The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.

NCT ID: NCT04371835 Recruiting - Clinical trials for Coronavirus Infection

COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings

Start date: August 12, 2020
Study type: Observational

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

NCT ID: NCT04303104 Recruiting - Tuberculosis Clinical Trials

Xpert Active Case-finding Trial 3 (XACT-3)

Start date: March 26, 2021
Phase: N/A
Study type: Interventional

TB remains the foremost infectious disease killer globally. A startling statistic is that two out of every five TB cases globally (40%) remain undiagnosed and untreated. These 'missed' or undiagnosed cases are disproportionately concentrated in large peri-urban 'slums' and informal settlements of large cities in Africa and Asia (they are frequently minimally symptomatic but remain infectious). The lack of a sensitive low cost same-day test represented a major challenge to active community-based case finding (ACF) compared to the current model where patients 'self-seek' care (passive case finding). More recently, sensitive TB DNA-detection tests called Gene Xpert (Xpert) have become available. This is a nucleic acid amplification test-based technology which can rule-in a diagnosis of TB in two thirds of smear negative pulmonary TB cases. GeneXpert® has now been rolled out in many African countries and is the frontline TB test in primary care clinics in South Africa. The investigators recently showed that GeneXpert® significantly reduced the time to treatment initiation in the setting of passive case finding (elaborated in next section). The investigators further showed that GeneXpert® can be performed by a minimally trained healthcare worker. However, historically technical and logistical demands meant that the GeneXpert® MTB-RIF assay was not ideally suited to use at point of care and in South Africa it is still centrally located. Small portable battery-operated versions of these tests are now available (EDGE, GeneXpert two-module mobile platform). The investigators conducted a large study in South Africa and Zimbabwe (published in 2016) that showed that using the old non-portable version of Xpert on a mini-truck equipped with a generator was feasible and highly effective for ACF. A subsequent study funded by the American government (XACT II), showed that using the portable version of Xpert on the back of a small low-cost scalable panel van (in effect a mobile mini-clinic) was feasible and had a very high pick-up rate of TB in peri-urban communities (~10% of those undergoing targeted screening). In this study, the investigators will test the hypothesis that community-based active case finding (ACF) using Gene Xpert Edge (in a low cost scalable mini-mobile clinic) performed at point-of-care (POC) is feasible and more effective (lower proportion of TB cases failing to initiate treatment especially if they are 'super-spreaders' i.e. highly infectious) than Xpert performed in a centralised laboratory.

NCT ID: NCT04296292 Recruiting - HIV Clinical Trials

The Lived Experience of Participants in an African Randomised Trial

Start date: February 5, 2020
Study type: Observational

There has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. The investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of HIV-associated cryptococcal meningitis.