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NCT ID: NCT03455127 Completed - Child Development Clinical Trials

Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

FSI-ECD
Start date: March 10, 2017
Phase: N/A
Study type: Interventional

Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.

NCT ID: NCT03334747 Completed - Malaria Clinical Trials

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.

NCT ID: NCT03311399 Completed - Clinical trials for Surgical Site Infection

Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

The present study aims to examine whether or not the use of mobile Health (mHealth) by community health workers (CHWs) can improve the identification of surgical site infection (SSI) and a timely return to care among patients who undergo cesarean-section surgery at a rural hospital in Rwanda.

NCT ID: NCT03303963 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

DIAMA
Start date: May 4, 2017
Phase:
Study type: Observational

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

NCT ID: NCT03184948 Completed - Jaundice, Neonatal Clinical Trials

Understanding Neonatal Jaundice in Rwanda

Start date: May 29, 2017
Phase: N/A
Study type: Interventional

This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.

NCT ID: NCT03154177 Completed - Preterm Birth Clinical Trials

Group Antenatal/Postnatal Care in Rwanda

PTBi Rwanda
Start date: May 15, 2017
Phase: N/A
Study type: Interventional

The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge, and Rubavu). 36 health centers in these districts are included in this cluster randomized control trial (RCT) of group ANC and PNC care to measure this alternative model's effects on gestational age at birth, survival of preterm and low birth weight infants at 42 days of life, and ANC and PNC coverage. To improve antenatal assessment of gestational age, nurses will be trained in obstetric ultrasound at 18 health centers. These facilities will also incorporate pregnancy testing with urine dipstick to be performed by community health workers in charge of maternal health to facilitate early entry into ANC. This trial will test the hypothesis that women who participate in this alternative model of group ANC will experience increased gestational age at birth, as compared to women who receive standard focused ANC. This study is a collaboration with the University of Rwanda, the Rwandan Ministry of Health (MOH), the Rwanda Biomedical Center, and UCSF. The group care model used in this study is Rwanda-specific model developed by a Rwandan technical working group. The model includes an individual clinical visit for the first antenatal visit, followed by three group visits spaced about 8 weeks apart throughout pregnancy and a postnatal group visit at approximately 6 weeks after birth. Women will be grouped into stable groups of approximately 8-12 women with similar due dates. A community health worker (CHW) and a health center nurse will work together as co-facilitators to lead each of the groups. Each group visit includes clinical assessment, education, and treatments as appropriate for the women who attend. The model is founded on facilitative leadership of the groups, in which the co-facilitators allow women's experiences and interests to drive the content and women are encouraged to help one another cope with obstacles to optimal health. Facilitators will be supported by master trainers who will visit health centers to observe group sessions and offer supportive feedback. Data collected in this trial will include measures of the satisfaction of both women and providers with the group care, content of care differences between standard and group care, and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth weight infant survival.

NCT ID: NCT03067519 Completed - Clinical trials for Elective Surgical Procedures

Fast Track Surgery for Abdominal Surgery in Rwanda

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

Fast Track Surgery (FTS) was started in colorectal surgery, but was later applied to other surgical fields. Core elements include epidural or regional anaesthesia, perioperative fluid management, minimally invasive surgical techniques, pain control, and early mobilization and feeding. Beneficial effects of FTS include reduced costs, early hospital discharge, and increased availability of hospital beds.The main aim of this study was to explore the efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS. it is study comparing the management of surgical patients using traditional management and fast track surgery. the study was done on patients undergoing elective abdominal surgery only

NCT ID: NCT03045809 Completed - Clinical trials for Urinary Tract Infections

Women's Improvement of Sexual Health (WISH) Demonstration Project

WISH
Start date: July 5, 2016
Phase:
Study type: Observational

The current standard of care for urogenital infections in Rwanda is syndromic management. Many urogenital infections are asymptomatic and therefore completely missed, and the management of vaginal discharge syndrome is known to be suboptimal. The primary objective of this study is to evaluate whether it is feasible to improve urogenital infection care in high risk women in Kigali, Rwanda, using point of care (POC) diagnostic testing for HIV, Trichomonas vaginalis (TV), and bacterial vaginosis (BV) in all women; POC testing for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and syphilis in pregnant women and women assessed to be at high risk for these infections using a risk scoring questionnaire; and management of vaginal candidiasis, urinary tract infection (UTI), genital ulcers/inguinal bubos, and lower abdominal pain in women reporting relevant symptoms. The secondary objectives of this study are 1) to evaluate the performance and 2) to obtain the opinions of Rwandan stakeholders.

NCT ID: NCT03031431 Completed - Clinical trials for Hypothermia Neonatal

Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

Start date: July 2016
Phase: N/A
Study type: Interventional

Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer. After laboratory based prototype testing for safety and efficacy, the investigators aim to study the supervised use of the warmer under routine implementation conditions in a resource-limited setting.

NCT ID: NCT02964091 Completed - Chronic Hepatitis C Clinical Trials

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

SHARED
Start date: October 2016
Phase: Phase 4
Study type: Interventional

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.