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NCT ID: NCT05403684 Recruiting - Clinical trials for Postnatal Growth Restriction

Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia

Start date: May 23, 2022
Phase: N/A
Study type: Interventional

The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).

NCT ID: NCT05361148 Recruiting - Diabetes Clinical Trials

Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas

SAMPA
Start date: October 12, 2021
Phase:
Study type: Observational

Whilst there is an increasing prevalence of overweight and obesity worldwide, malnutrition remains common. In addition, malnutrition, overweight, and infections often interact. The consequences of malnutrition after birth are little studied. Severe acute malnutrition in childhood remains common in Africa and Asia and many adult patients with tuberculosis or HIV, diseases which are common in Africa and Asia, may become malnourished. We are interested in diabetes, which in Africa and Asia affects people at younger age and lower weight than in Europe. There is evidence that severe postnatal malnutrition increases the risk of later diabetes but the evidence is piecemeal and there is little information as to the mechanisms involved. It is thus difficult to determine what treatments or preventative strategies are appropriate. We wish to focus on the pancreas which is a key organ in digestion and metabolic processes, especially in relation to diabetes. We will investigate pancreas size, microscopic structure, hormone and digestive enzyme production, and the body's response to these hormones among groups of people in Tanzania, Zambia, India and the Philippines. These groups have participated in the research team's previous studies of malnutrition and were malnourished before birth, as children, or as adults. They now live in places with a wide range of access to foods high in fat and sugar which could affect their risk of diabetes. We will compare their pancreas function to that of never-malnourished controls at each site. We will use advanced statistical methods to understand the links between early malnutrition and later diabetes, taking into account the factors often associated with diabetes such as age, current overweight and infection. Even if we find no important link between early malnutrition and later diabetes, the research will lead to improved understanding of the long-term consequences of malnutrition and the presentation and underlying metabolism of diabetes in Africa and Asia. Thus, the project will lead to improved health care for both malnourished and diabetic people.

NCT ID: NCT05220163 Recruiting - HIV Infections Clinical Trials

Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is now the commonest cause of death in many African countries. Globally, ~35% (almost 1 in 3) of TB cases are 'missed' (remain undiagnosed or undetected). In sub-Saharan Africa, 40-50% of the TB case burden remains undiagnosed within the community. These 'missed' TB cases (at primary care level) serve as a reservoir, which severely undermines TB control. With rapid advances in the development of TB screening tests, the investigators aim to determine the pragmatic utility of computer-assisted x-ray diagnosis (CAD). Recent data suggest that CAD performs on par with experienced radiologists to identify potential TB cases, hereby reducing the frequency at which Xpert tests are requested and helps to focus limited resources on the relevant cases. In addition, the investigators aim to test nascent screening technologies for TB diagnosis such as evaluating urine-based TB screening biosignatures. The COVID-19 pandemic has ravaged African peri-urban communities where TB is also common. With the pressing need to improve screening and diagnosis of COVID-19, the investigators plan to explore the potential for urine- and blood-based COVID-19 screening assays. Symptoms of COVID-19 and TB overlap, and limited affordability, as well as the stigma associated with both diseases, severely limits testing. Data are now urgently needed about the feasibility of co-screening and testing for TB and COVID-19. The utility of such an approach, if any, has not been studied in African communities.

NCT ID: NCT05168813 Recruiting - HIV Infections Clinical Trials

Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

CoVPN3008
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

NCT ID: NCT05154331 Recruiting - Maternal Health Clinical Trials

Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)

ARCH
Start date: March 29, 2022
Phase:
Study type: Observational

The purpose of this study is to establish a longitudinal health, demographics, and pregnancy surveillance study in Lusaka, Zambia to precisely characterize the pregnancy rate, pregnancy outcomes, health and disease burden of women of reproductive age and their children under 2 years prior to, during, and following pregnancy and to investigate the structural, socio-demographic, and clinical covariates that contribute to adverse outcomes in each reproductive epoch.

NCT ID: NCT05139940 Recruiting - Tuberculosis Clinical Trials

Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Start date: November 22, 2021
Phase:
Study type: Observational

Tuberculosis (TB) is a global epidemic and for many years has remained a major cause of death throughout the developing world. Zambia is among the top 30 TB/HIV high burden countries. Chest X-ray (CXR) is recommended as a triaging test for TB, and a diagnostic aid when available. However, many high-burden settings lack access to experienced radiologists capable of interpreting these images, resulting in mixed sensitivity, poor specificity, and large inter-observer variation. In recognition of this challenge, the World Health Organization has recommended the use of automated systems that utilize artificial intelligence (AI) to read CXRs for screening and triaging for TB. In this study, we primarily evaluate the performance of our AI algorithm for TB, and secondarily for Abnormal/Normal.

NCT ID: NCT05119959 Enrolling by invitation - Child Development Clinical Trials

Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

ZICS-BOOST
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted. There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months. In this RCT the investigators will test the following hypotheses: Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs. Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure. This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).

NCT ID: NCT05118373 Completed - Evaluation Study Clinical Trials

Generic Behavioural Change Campaign for COVID-19 Prevention

Start date: August 18, 2021
Phase: N/A
Study type: Interventional

Since the start of the COVID-19 pandemic in Zambia, multiple information, education and communication (IEC) materials and strategies have been disseminated by national risk communication and community engagement (RCCE) committees to create awareness on the facts of the novel coronavirus, prevention measures and care-seeking options. To complement these efforts in Zambia, CIDRZ in collaboration with the London School of Hygiene and Tropical Medicine (LSHTM) are implementing an internationally produced communication campaign that promotes the uptake of four key behaviours to reduce the transmission of COVID-19, namely, hand washing with soap, mask wearing, social distancing and surface cleaning. The campaign presents these behaviours as a 'password' that should be enacted to get lives back to normal and was created by the Hygiene Behaviour Change Coalition (HBCC). The idea of a password has been used to symbolize access into a world where protective habits are practiced in order to get back a world that is corona free. The password in this case is Hands-Face-Space-Surface. This campaign is a mass media campaign that will be delivered through TV, radio and billboards. This study aims to evaluate the process and effect of the HBCC campaign on the uptake of COVID-19 preventative behaviours among people living in Lusaka and Copperbelt Provinces of Zambia.

NCT ID: NCT05005130 Recruiting - HIV Clinical Trials

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

TASKPEN
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".

NCT ID: NCT04972903 Not yet recruiting - Tuberculosis Clinical Trials

Impact of Malnutrition on Pharmacokinetic or Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in TB-HIV Co-infected Children

TB-Speed TB-PK
Start date: August 2021
Phase:
Study type: Observational

TB-Speed TB-PK is a cross-sectional PK study of anti-TB treatment nested in the TB-Speed HIV and TB-Speed SAM studies aiming at assessing the impact of malnutrition on PK of rifampicin, isoniazid, pyrazinamide, and ethambutol in TB-HIV co-infected children in Uganda and Zambia.