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NCT ID: NCT03920761 Not yet recruiting - Neonatal Physiology Clinical Trials

Evaluation of Technologies for Neonates in Africa

ETNA
Start date: May 2019
Phase:
Study type: Observational

This is a diagnostic accuracy evaluation and clinical feasibility study of investigational devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are admitted for routine observation and care will be enrolled.

NCT ID: NCT03894358 Not yet recruiting - Gut Microbiota Clinical Trials

Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants

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

The aim of this study is to measure the effect of a prebiotic (high dose/low dose) mixture at different doses within a wheat-based instant cereal, on fractional iron absorption (FIA), gut microbiota and inflammation after three weeks. FIA will be compared with and without three weeks of pre-feeding with two different doses of the prebiotic mixture.

NCT ID: NCT03876483 Not yet recruiting - Clinical trials for Transition From Pediatric to Adult HIV Care

Planning the mPACT Trial - mHealth Strategies for the Pediatric to Adult HIV Care Transition

mPACT
Start date: August 2019
Phase: N/A
Study type: Interventional

In contrast all other age groups, adolescents (age 10-19 years) have experienced constant, rather than declining, HIV-related mortality in the last decade. This is due in part to poor retention in care and adherence to antiretroviral therapy (ART) in this age group. As youth living with HIV enter adulthood, they transition from pediatric to adult HIV care. The transition to adult care presents heightened challenges to retention, due to disruption of established relationships with pediatric healthcare providers and a shift to an adult care model that requires greater autonomy and offers less specialized support. Resources to support youth through the transition are lacking. Mobile technology for health promotion (mHealth) using social media is a promising approach to maintain engagement in care through the transition. mHealth reminders, education, and support from healthcare workers have been successful in improving ART adherence in the adult HIV care setting and there have been limited, though promising, results in youth care. This study will support the development of a novel mHealth strategy for the Pediatric to Adult HIV Care Transition (mPACT). The conceptual framework for this intervention is based on providing support to youth who are transitioning to adult care through a combination of virtual group peer support and 1-to-1 communication with a healthcare worker trained in youth HIV care. The aims of this study are to (1) identify the specific barriers to successful youth transition to adult HIV care, develop the mPACT intervention messaging strategy, and create a prototype of the mHealth platform; (2) Pilot the mPACT intervention to determine its effect on the intermediate outcomes of transition preparedness, ART knowledge, stigma, depression, social and caregiver support. Using an iterative mixed methods approach we will develop and pilot the mPACT intervention to improve transition to adult HIV care. Aim 1 focuses on identifying barriers, assessing user requirements, developing and refining communication content and strategies, and adapting existing technology platforms through in-depth individual interviews and focus group discussions and with youth living with HIV, healthcare works, caregivers, and policy makers. Aim 2 will pilot the intervention tool using a cluster randomized trial to evaluate the impact of the intervention on intermediate factors relevant to transition to adult HIV care.

NCT ID: NCT03866837 Not yet recruiting - Iron-deficiency Clinical Trials

Prebiotic GOS and Lactoferrin With Iron Supplements

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

The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with a high infection burden. The hypothesis underlying this project is that co-administration of prebiotic galacto-oligosaccharides (GOS) and bovine lactoferrin (bLF) during iron supplementation will promote development of a beneficial, protective gut microbiota that will prevent iron-induced increases of opportunistic enteropathogens. The investigators will conduct a randomized clinical trial in 6 month-old Kenyan infants in conjunction with mechanistic microbiota studies using a novel long-term continuous polyfermenter platform inoculated with immobilized fecal microbiota from Kenyan infants. The period from 6 months to 1 year of age is vital both for iron nutrition and for the establishment of a healthy gut microbiome that promotes immune system development, local immune homeostasis and limits pathogen colonization. Oral iron supplements are associated with a significant 15% increase in the rate of diarrhea in children in malaria-endemic areas. The most recent studies have shown that prebiotic galacto-oligosaccharides (GOS) can provide partial amelioration of the adverse effects of iron supplementation by enhancing the growth of barrier populations of bifidobacteria and lactobacilli. The investigators hypothesize that the combination of GOS with bovine lactoferrin, adding iron sequestration as well as antimicrobial and immunomodulatory activities, will provide almost complete protection against the adverse effects of added iron on the intestinal microbiota. This research has two specific aims: 1. to conduct a randomized, controlled double-blind 9-month clinical trial in 6-month old Kenyan infants comparing the effects on gut microbiome composition among groups receiving in-home fortification for 6 months with micronutrient powders with 5 mg iron (as sodium iron EDTA [2.5 mg] and ferrous fumarate [2.5 mg]) and (i) galacto-oligosaccharides (GOS; 7.5 mg), (ii) bovine lactoferrin (bLF, 1.0 g), (iii) GOS (7.5 mg) and bLF (1.0 g), and (iv) no GOS or bLF. Each infant will then be followed for an additional 3 months to determine the longer-term effects of the treatments. 2. to examine microbiota composition, metabolic activity, and inflammatory potential in vitro with treatments paralleling those in Specific Aim 1, using immobilized fecal microbiota from Kenyan infants to inoculate a long-term continuous polyfermenter intestinal model, and cellular studies.

NCT ID: NCT03862261 Not yet recruiting - Tuberculosis Clinical Trials

Integrating Pediatric TB Services Into Child Healthcare Services in Africa

INPUT
Start date: March 15, 2019
Phase: N/A
Study type: Interventional

Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.

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: NCT03848728 Not yet recruiting - HIV Clinical Trials

Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

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

The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.

NCT ID: NCT03824067 Enrolling by invitation - HIV/AIDS Clinical Trials

Impact of Point-of-Care EID for HIV-Exposed Infants

POC-EID
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

NCT ID: NCT03820323 Recruiting - Clinical trials for Chronic HIV Infection

Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy

Opt4Kids
Start date: March 7, 2019
Phase: N/A
Study type: Interventional

Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a UNAIDS fast-track and PEPFAR priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of first-line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. This pilot study will evaluate two critical components related to viral suppression in children via: 1) Point-of-care (POC) VL testing (Aim 1) and 2) targeted DRM testing (Aim 2) among children on first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with access to POC VL testing and time to suppression shorter compared to children with standard VL testing and 2) DRM testing will shorten time to viral suppression and that the investigators will observe high levels of 1st line antiretroviral DRMs among children on ART without viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.

NCT ID: NCT03810014 Recruiting - Malaria Clinical Trials

A Randomized Experiment of Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 1

TESTsmART
Start date: March 28, 2019
Phase: N/A
Study type: Interventional

The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of participants seeking care for their febrile illness in the private retail sector. Conditional ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a malaria rapid diagnostic test administered at the retail outlet; only participants with a positive test will have access to an additional discount on a quality-assured ACT. The main objective of Aim 1 of this study is to identify a combination of conditional ACT and RDT subsidies that maximizes the proportion of participants that choose to have a malaria diagnostic test before taking a drug. The investigators will test two levels of conditional ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and 50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with patient age. These subsidy levels were chosen to keep the estimated program cost of the combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between 20-40% of participants having a positive RDT). These estimates represent an upper bound since testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between 1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals without malaria. Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria illness will be randomized to one of the four groups in equal proportions. A total of 840 participants will be enrolled (210 per arm). Their choices concerning uptake of testing and drug purchase will be recorded. The main outcome will be the proportion of participants that choose to take a test. Secondary outcomes include the proportion of participants who adhered to the results of the RDT among those who were tested (used ACT when positive and did not use an ACT when negative or without a test). The results of this study will be used to inform the subsidy levels in the intervention for Aim 2 of this trial.