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NCT ID: NCT03836833 Not yet recruiting - HIV Clinical Trials

Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

LOLIPOP
Start date: February 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children. The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.

NCT ID: NCT03835234 Recruiting - PONV Clinical Trials

Incidence and Factors Associated With PONV in Regional Anaesthesia

Start date: September 10, 2018
Phase:
Study type: Observational

Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Patients above the age of 18 who have consented and are undergoing surgery under regional anaesthesia will be enrolled into the study over 6months. They will then be observed for up to 24 hours post operatively to determine the incidence of PONV and factors associated with it.

NCT ID: NCT03832530 Recruiting - HIV Prevention Clinical Trials

Periconception PrEP for HIV-exposed Ugandan Women

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.

NCT ID: NCT03832023 Not yet recruiting - Tuberculosis Clinical Trials

Community-based Tuberculosis Tracing and Preventive Therapy

CONTACT
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of these gaps are considered to be the health system infrastructure, limited worker resources and parents' reluctance to bring their children to the facility for screening. There would be great advantages of using a symptom-based screening at community level where only the symptomatic contacts are referred to hospital for further evaluation and asymptomatic contacts are started on PT in the community. Household or community-based screening is likely to improve the uptake and acceptability of child contact screening and management as well as adherence to PT and to reduce cost and workload at facility level. This study proposes to compare the cascade of care between two models for TB screening and management of household TB child contacts in two high TB burden and limited resource countries, Cameroon and Uganda. In the facility-based model, children will be screened at facility (Cameroon) or household level (Uganda) and preventive therapy initiation, refills of PT therapy and follow-up will be done at facility level. In the intervention group (community-based model), child contacts will be screened in the household by a community health worker (CHW). Those with symptoms suggestive of TB will be referred to the facility for TB investigations. Asymptomatic child contacts from high risk groups (under-5 years or HIV infected 5-14) will be initiated on PT (3 months isoniazid-rifampicin) in the household. Refills of PT therapy will also be done in the communities by the CHW. In both models, symptomatic children requiring further investigations for TB diagnosis will be referred to a health facility.

NCT ID: NCT03831906 Not yet recruiting - Tuberculosis Clinical Trials

TB-Speed Pneumonia

Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children. Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current WHO standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia. In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples. TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia.

NCT ID: NCT03825952 Recruiting - HIV/AIDS Clinical Trials

Optimizing mHealth for Adherence Monitoring and Intervention

OAsIS
Start date: March 28, 2018
Phase: N/A
Study type: Interventional

High and sustained adherence is critical for achieving the individual and public health benefits of HIV antiretroviral therapy (ART). Electronic adherence monitors provide a detailed understanding of adherence and enable real-time interventions. Research has shown the benefit of these monitors and low-cost models have recently become available; however, their use to date has largely been confined to the research context. This study is an implementation science-driven assessment of strategies to improve uptake of electronic adherence monitoring and associated interventions for routine, clinical delivery of ART in Uganda. The study consists of two aims. In Aim 1, we will conduct multi-level formative interviews to design a preliminary implementation strategy. In Aim 2, we will use an iterative approach to optimize the implementation strategy. All work will be guided by the Consolidated Framework for Research Implementation.

NCT ID: NCT03822039 Recruiting - Clinical trials for Surgical Site Infection

WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital

Start date: July 16, 2018
Phase:
Study type: Observational

This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .

NCT ID: NCT03800888 Recruiting - Tuberculosis Clinical Trials

Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda

MAT K43
Start date: January 10, 2019
Phase: N/A
Study type: Interventional

With an estimated 60,000 people diagnosed with TB (Tuberculosis) annually, Uganda holds the 16th position of the 22 countries with highest cases of TB in the world. The Uganda national target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat 85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6% TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda. Causes of non-adherence to TB medication include lack of patient follow-up, patients' lack of transport to go to the clinics to pick up drugs, patients' forgetfulness. There is evidence that real time adherence monitoring linked with SMS reminders and social support notifications can address barriers to sustained ART (antiretroviral therapy) adherence. Such novel interventions addressing TB medication adherence challenges in low resource settings to date are limited. The prevailing SMS-based studies for TB medication adherence report mixed results, do not strategically link interventions with missed doses, and have largely been implemented in developed countries. To date, little is known about the use of real-time adherence monitoring technologies for TB medication adherence in resource-limited settings. The goal of this research is to investigate the use of real time adherence monitoring technology linked with SMS reminders and notifications for TB medication adherence in rural southwestern Uganda. The investigator will develop and quantitatively test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. The investigator will randomize participants (1:1:1) to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.

NCT ID: NCT03800849 Recruiting - Clinical trials for Mechanically Ventilated Patients

Mechanical Ventilation Practices in Uganda's Intensive Care Units

Start date: August 14, 2018
Phase:
Study type: Observational

A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.

NCT ID: NCT03773146 Completed - Clinical trials for Surveys and Questionnaires

Use of Airtime Structure to Improve Interactive Voice Response Surveys in Bangladesh and Uganda

Start date: March 26, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effect of three different airtime incentive structures on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to a control group, in Bangladesh and Uganda.