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NCT ID: NCT03800394 Recruiting - Tuberculosis Clinical Trials

Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents

Start date: January 28, 2019
Phase:
Study type: Observational

Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.

NCT ID: NCT03800381 Recruiting - Tuberculosis Clinical Trials

Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet

Start date: January 28, 2019
Phase:
Study type: Observational

Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) > 8 mg/L and pyrazinamide Cmax > 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.

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: NCT03549754 Recruiting - Hypertension Clinical Trials

iCaReMe Global Registry

iCaReMe
Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

NCT ID: NCT03414060 Recruiting - Obstetric; Injury Clinical Trials

Feasibility of the Menstrual Cup for VVF

FMCVVF
Start date: August 8, 2016
Phase: N/A
Study type: Interventional

This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a health facility in Ghana. The repeated measures design utilizes a 2-hr pad test to compare urinary leakage with and without the insertable cup, a questionnaire on acceptability and perceived effect is administered and a clinical exam is completed. Subsequently, semi-structured interviews will be carried out with up to 24 additional women seeking treatment at a health facility in Ghana. Interviews will cover women's experiences of living with fistula, including strategies for coping with urinary incontinence and resulting stigma, as well as user acceptability to the intervention.

NCT ID: NCT03237585 Recruiting - Domestic Violence Clinical Trials

Impact Assessment of the Rural Response System to Reduce Violence Against Women in Ghana

GhanaCHiPS
Start date: October 1, 2015
Phase: N/A
Study type: Interventional

AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS) in reducing violence against women (VAW) in Ghana. METHODS: Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm- Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies. Control arm - No intervention. Qualitative component Setting: Rural and urban communities in the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the other two (Agona and Upper Denkyira) are inland districts. ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services). Interventions: Carried out in two Districts - Agona district and Komenda district. Workings of the intervention arm will be facilitated by the Gender Studies and Human Rights Documentation Centre in Ghana. Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm (approximately 82 households per cluster) will be recruited at baseline and again at post-intervention survey. Sampling format will be a community survey with independent samples design (i.e. in each community, the people surveyed at baseline may not necessarily be the same people who are surveyed at post intervention. Clusters refer to the selected localities and their participating communities in each district. Evaluation design: Pre-test all study participants with a standardized instrument then introduce the independent variable (intervention) to the experimental group while withholding it from the control group. After 24 months of intervention, post-test both groups with the same instrument and under the same conditions as the pretest (baseline). Compare the amount of change in dependent variable for both experimental and control groups. Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence of IPV will be compared between arms in the study.

NCT ID: NCT03070795 Recruiting - Clinical trials for Cesarean Section Complications

Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

Start date: February 23, 2017
Phase: N/A
Study type: Interventional

study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.

NCT ID: NCT02251704 Recruiting - Malaria Clinical Trials

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Start date: October 22, 2014
Phase: Phase 4
Study type: Interventional

This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

NCT ID: NCT02199951 Recruiting - Malaria Clinical Trials

Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

Start date: September 2013
Phase: Phase 4
Study type: Observational

WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the African market and will be used by the public health care system. The collection of safety data and risk evaluation through observational data are critical in order to assess risk/benefit profile of each ACT through its life cycle and providing information on the best use. Additionally there is need to assess the impact of the introduction of a new ACT in the evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries. This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo), Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as first-line treatment of uncomplicated malaria an objective to evaluate the safety of Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg except pregnant women will be enrolled and Eurartesim® administered as a single daily dose regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to assess recovery and any adverse events.

NCT ID: NCT02088528 Recruiting - Glaucoma Clinical Trials

The Ghana Primary Tube Versus Trabeculectomy Study

GPTVT
Start date: March 2014
Phase: N/A
Study type: Interventional

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution. The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.