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NCT ID: NCT05168813 Recruiting - HIV Infections Clinical Trials

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

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 Not yet recruiting - Maternal Health Clinical Trials

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

Start date: January 31, 2022
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 Not yet recruiting - Tuberculosis Clinical Trials

Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Start date: November 22, 2021
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 Not yet recruiting - Child Development Clinical Trials

Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

Start date: January 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 Not yet recruiting - HIV Clinical Trials

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

Start date: August 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
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.

NCT ID: NCT04891250 Not yet recruiting - SARS-CoV-2 Clinical Trials

The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19

Start date: October 2021
Phase: Phase 4
Study type: Interventional

The study aims to test whether Ivermectin would decrease mortality and reduces chances of getting infected with corona virus, improve management of clinical symptoms and reduce length of stay in ICU and transition probabilities to ICU (ventilator).

NCT ID: NCT04888377 Recruiting - Clinical trials for Neurodevelopmental Abnormality

ASPIRIN: Neurodevelopmental Follow-up Trial

Start date: September 1, 2021
Study type: Observational

A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo. This will allow the researchers to compare results of the two groups of children and determine if children exposed antenatally to low dose aspirin will have scores on the Bayley Scales of Infant Development-III (BSID-III) examination at 36 months of life (+/-3months) that are not inferior to the child's peers who were not exposed (i.e., by no more than a margin of 4 points).

NCT ID: NCT04844255 Completed - Blood Pressure Clinical Trials

Acute Salt Sensitivity of Blood Pressure

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim in the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.