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NCT ID: NCT03866213 Not yet recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings

Start date: March 14, 2019
Phase: N/A
Study type: Interventional

A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.

NCT ID: NCT03855995 Not yet recruiting - Malaria Clinical Trials

A Study to Evaluate the Safety, Effectiveness and Impact of the GlaxoSmithKline Biologicals' Malaria Vaccine- RTS, S/AS01E in Young Children in Sub-Saharan Africa

EPI-MAL-003
Start date: March 21, 2019
Phase:
Study type: Observational

The RTS, S/AS01E vaccine has been developed for routine immunization of children living in malaria-endemic countries of sub-Saharan Africa. This study is intended as a post-implementation safety study (after vaccine implementation), with the primary objective to evaluate the safety of vaccine after its administration. In addition to the primary objective, the study will also evaluate the impact and effectiveness of the vaccine.

NCT ID: NCT03840031 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Bio Fortified Iron OFSP Malawi

SASHA-II
Start date: February 11, 2019
Phase: N/A
Study type: Interventional

To combat Iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, we need to assess the iron bioavailability of the new biofortified breed. In our study this is the iron from a new bio fortified Orange Fleshed Sweet Potato breed. In this study we compare the fractional and total iron absorption of a normal Orange Flesh Sweet Potato variety and a high-iron bio fortified variety in Malawian women of reproductive age with marginal iron status.

NCT ID: NCT03806465 Enrolling by invitation - Mortality Clinical Trials

Malaria Vaccine Evaluation Programme

MVPE
Start date: February 25, 2019
Phase:
Study type: Observational

This is an evaluation of feasibility, safety and impact of the RTS,S/AS01 vaccine introduction, implemented in a pilot programme by Ministries of Health using an expanded schedule of their routine EPI contacts in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. The Ministries of Health in Ghana, Kenya and Malawi plan to introduce the malaria vaccine, sub nationally. This provides an opportunity in each country to evaluate the following : 1. To evaluate the programmatic feasibility to deliver a 4 dose schedule; 2. To collect information on a larger scale on the safety of the malaria vaccine with focus on cerebral malaria and meningitis; 3. To evaluate the impact of the malaria vaccine on all cause mortality.

NCT ID: NCT03801317 Recruiting - Stunting Clinical Trials

Clinical Effectiveness Trial of PTM1001 to Reduce Stunting and Ameliorate Environmental Enteric Dysfunction in Malawian Infants

Start date: December 3, 2018
Phase: N/A
Study type: Interventional

The trial will consist of adding a supplement called PTM1001(4.3 egg powder + 5.7 g bovine colostrum) along with a multiple micronutrient powder to the diet of children 10-13 months of age. This should improve linear growth and gut health. Children will be receive either the supplement or control for 12 weeks. At enrollment at at week 12 stool and urine will be collected. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.

NCT ID: NCT03734172 Recruiting - Tuberculosis Clinical Trials

Rapid and Accurate Diagnosis of Paediatric (RaPaed) TB - An AIDA (Assessment of Innovative Diagnostics and Algorithms for Early and Sensitive Detection of Acute TB) Platform Study

RaPaed-AIDA-TB
Start date: January 21, 2019
Phase:
Study type: Observational

This study will serve as a platform to evaluate new diagnostics in children suspected to have TB, to establish diagnostic performance (sensitivity and specificity) and calculation of positive and negative predictive values in a real-life cohort. Finally, this study will comprise results of several tests in its database. This will allow simulation of diagnostic algorithms, that may be composed of screening (i.e. rule-out) tests together with confirmatory tests to maximize sensitivity and specificity.

NCT ID: NCT03724214 Recruiting - Gastroschisis Clinical Trials

Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.

NCT ID: NCT03705611 Recruiting - HIV Infections Clinical Trials

Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients

ANC/FRS
Start date: September 12, 2018
Phase: N/A
Study type: Interventional

A three arm cluster randomized trial randomizing government primary health clinics to a) standard of care (SOC) with clinic invitation only; b) standard of care (SOC) and one self-test kit to give to sexual partner (s); c) standard of care (SOC) and self-test kit and monetary incentive given to partner conditional on clinic attendance and completion of pre-set procedures to determine secondary accuracy. Trial to be conducted in four districts (Blantyre, Zomba, Machinga and Chikwawa) in Malawi in collaboration with the Ministry of Health. Two primary outcomes: 1. proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus (HIV) within 28 days of enrolling the woman 2. Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client. Data analysed as intention to treat with all eligible antenatal care (ANC) attendees and index clients at each health facility as the denominator, with unpaired t-test used to compare each intervention arm to the standard of care (SOC).

NCT ID: NCT03671239 Not yet recruiting - HIV Prevention Clinical Trials

Rectal Microbicide Acceptability, Tolerability and Adherence

Start date: March 2019
Phase: N/A
Study type: Interventional

MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product application.

NCT ID: NCT03654898 Recruiting - HIV/AIDS Clinical Trials

VITAL Start: Brief Facility-based Video Intervention

VITAL
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.