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NCT ID: NCT04625452 Active, not recruiting - Hypertension Clinical Trials

Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants

BBCC+5A's+GS
Start date: August 13, 2020
Phase: N/A
Study type: Interventional

The purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients

NCT ID: NCT04542473 Active, not recruiting - SEPSIS Clinical Trials

Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

PB-SAM
Start date: July 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Children with severe malnutrition who are sick and admitted to hospitals have high mortality, usually because of infection. Malnourished children have more potentially harmful bacteria in their upper intestines than well-nourished children and this may contribute to inflammation in the gut and whole body. These bacteria may cross from the intestines to the bloodstream causing life-threatening infections. A related abnormality among malnourished children is reduction in the digestive enzymes made by the pancreas and the liver. Apart from helping with digestion of food, these enzymes are important in helping the body control bacteria in the upper intestines. It is therefore possible that treatment with digestive enzymes could help reduce the burden of harmful bacteria and thus lower inflammation and the risk of serious infection. One study conducted in Malawi has shown that children with severe malnutrition who were supplemented with pancreatic enzymes had a lower risk of dying. However, this was a small study and although promising, requires validation. No studies of supplementation with bile acids have been done among severely malnourished children. However, bile acids are commonly used to manage patients with liver function abnormalities, something that malnourished children suffer from as well. The investigators want to find out if supplementing these pancreatic enzymes and bile acids among ill children with severe acute malnutrition is safe and reduces the risk of death, deterioration or readmission to hospital.

NCT ID: NCT04468399 Active, not recruiting - HIV Clinical Trials

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi

SPRINT-Malawi
Start date: May 21, 2020
Phase:
Study type: Observational

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Malawi Ministry of Health has provided detailed guidance on how to implement this recommendation. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Malawi. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.

NCT ID: NCT04311502 Active, not recruiting - HIV Clinical Trials

Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Start date: June 16, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with CFZ loading dose versus 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).

NCT ID: NCT04193189 Active, not recruiting - HIV Infection Clinical Trials

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

BEe-HIVe
Start date: December 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.

NCT ID: NCT04190303 Active, not recruiting - Meningitis Clinical Trials

BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally

Start date: February 17, 2021
Phase:
Study type: Observational

Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings. Aim: This study sets out to improve the diagnosis and early management of people with suspected acute (<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach. Outcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test. Participants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi. Study procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention.

NCT ID: NCT04092257 Active, not recruiting - HIV Infections Clinical Trials

HPV-Based Screen-and-Treat Demonstration Project in Lilongwe

Start date: June 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.

NCT ID: NCT03965923 Active, not recruiting - HIV Infections Clinical Trials

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Start date: January 9, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

NCT ID: NCT03915366 Active, not recruiting - Tuberculosis Clinical Trials

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

EMPIRICAL
Start date: March 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

NCT ID: NCT03878147 Active, not recruiting - HIV Infections Clinical Trials

Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package

Start date: March 30, 2020
Phase: N/A
Study type: Interventional

The investigators will use Brain Power Games or Village Builder, two different MSU-developed computer-based learning games for children on Tablets, as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate brain/behavior functional integrity in HIV-affected children. This dual use of BPG is a key innovative feature. Each of the 5 core BPG games lasts 10 minutes and trains fine motor, monitoring/attention, visual/auditory working memory, spatial navigational learning. Village Builder (VB) uses similar graphics as BPG, but is a pro-social "world-building" game where children gather and protect resources to build a village. thus VB emphasizes planning/reasoning (executive function or EF) neurocognitive abilities, while BPG emphasizes attention, memory, and learning tasks. In As an African child plays with BPG or VB on a touch-screen tablet, we will use games as a dynamic window into the child's developing brain and EF-based frontal lobe development Aim 1. Evaluate concurrent and predictive validity of BPG static (baseline) and dynamic (during 12 training sessions) cognitive assessments Aim 2. Compare the validity of BPG static and dynamic assessments Aim 3. Test the sensitivity of dynamic assessment to learning loss over time by evaluating how much BPG and/or VB performance gains diminish during a 6-month absence of training The investigator's central hypothesis is that the BPG and VB performance gains (dynamic assessment) will explain the additional variation in the gold-standard measures at time points after static (baseline) assessment, and more effectively capture the effects of HIV/ARV exposure and treatment across HIV affected cohorts (HIV, HEU, HUU) of children in Uganda and Malawi.