There are about 36 clinical studies being (or have been) conducted in Congo. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.
The aim of the study is to evaluate the impact of a large-scale urban water supply improvement intervention on cholera and other diarrhoeal diseases. The study uses a step wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention on cholera centre admission rates and confirmed cholera cases. A nested cohort study will examine changes in water-related practices following the intervention.
In the developed world critical illness is routinely treated in an intensive care unit (ICU) by highly specialized physicians, nurses and support staff. This model of intensive care is spreading rapidly to low and middle income countries and as it spreads, challenges and limitations to this model arise. In resource-poor settings, inadequate human resources, training, and equipment all present barriers to safe and effective use of life-saving procedures. The advances in medical informatics and human factors engineering have provided tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that can be applied in a complex and busy hospital setting. Real-time data feeds and standardized patient care tasks in a simulated acute care environment have been proven to have a significant advantage of a novel interface (compared to a conventional) in reducing provider cognitive load and errors. Currently researchers within the investigator's research group have developed and are pilot testing a simple electronic decision support tool: CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been successfully tested and validated in simulated settings and is being implemented as pilot study in 18 countries. Worldwide infant and early childhood mortality continues to be very high partly due to the inability to recognize and respond aggressively to critical illnesses. Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a powerful tool to improve on the medical care of children in developing countries. Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and evaluate the impact of the tool on the processes and patient outcomes.
1. Introduction Cervical cancer (CC) is a major public health problem in Low-income countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the estimated number of cases is 3839 per year. (WHO, 2010). Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary cause for the development of CC. Thus, CC is a disease that is easily preventable primarily by vaccination against HPV and secondarily through screening and treatment of precancerous lesions of the cervix. In LICs, the high incidence of CC is due to both high rates of infection with HPV, a failure to initiate and sustain effective screening programs based on cytology and the non-availability of vaccination against HPV. These situations highlight the need to implement simple and inexpensive screening and treatment methods suitable for LICs. These methods include screening by visual inspection of the cervix after application of acetic acid (VIA) and treatment with a topical antiviral drug (AV2). 2. Aims This study aims to: - Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of the uterine cervix; - Identify HPV genotypes found in Kinshasa; - Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment; 3. Methods After basic training of local health workers on VIA, on collection of cervical samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based cytology (LBC) and on application of AV2, a screening and treatment program will be offered to women aged 25 and older who will give their informed consent. All women with lesions on VIA will be randomized into one of two groups to receive either treatment by AV2 or placebo. All women with lesions on VIA will be monitored and reviewed after two months and after six months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and reinfection rates).
Treatment of hookworm infected groups with albendazole has been shown to result in an increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases in hemoglobin levels due to treatment have been associated with significant gains in adult labor productivity. In this study, the investigators hypothesize that regular treatment of women smallholder farmers in a high prevalence area with the anti-hookworm drug albendazole and iron supplementation will improve hookworm associated anemia. Further, regular treatment of albendazole and iron supplementation will improve their work capacity when compared to a control group
The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.
The objective is to test the effectiveness of a village-led microfinance program, Pigs for Peace, on health, household economic stability, and reintegration of trauma survivors to family and community. The five-year experimental trial will use mixed-methods to address the following aims: 1. Determine the effectiveness of a village-led microfinance program on participants health and reintegration in intervention households compared to participants in delayed control households. Health and reintegration will be measured at baseline and six, twelve, and 18-months post-baseline using self-report in both intervention and delayed control groups. We hypothesize that at six, twelve and 18 months post-baseline participants in intervention households will have improved health and increased reintegration to families in comparison to participants in control households. 2. Determine the effectiveness of a village-led microfinance program on household economic stability in intervention households compared to delayed control villages. Household economic stability will be measured at baseline and six, twelve and 18 months post- baseline using self-report in both intervention and control households. We hypothesize that at six, twelve and 18-months post-baseline the intervention households will have improved household economic stability in comparison to control households. 3. Examine the role of a village-led microfinance program on village-level health, economics, stigma and reintegration of survivors and their families in intervention and delayed control villages. Village members (n=5 in each village, n=50 total) will complete a baseline and 18 month post-baseline qualitative interview to examine the role of microfinance on village-level health, economics, stigma and reintegration in both intervention and control households.
The investigators will test the effectiveness of a youth-led animal husbandry microfinance program, Rabbits for Resilience, combined with the adult microfinance, Pigs for Peace (PFP), program on youth, family and community resilience outcomes. The following aims will be completed over the five-year longitudinal, mixed-method, cluster randomized community trial: Specific Aim 1: Determine the relative effectiveness of a youth-led microfinance combined with the adult microfinance on youth and family resilience outcomes (reduced mental health distress, increased economic stability, improved family functioning) compared to a youth-led microfinance only and adult microfinance only approaches. - We hypothesize that at six, twelve and 18-months post-baseline youth and adults in households in the youth-led and adult microfinance approach will report improved individual and family resilience outcomes compared to households in the youth-led microfinance only and adult microfinance only approaches. Specific Aim 2: Determine the relative effectiveness of a youth-led microfinance combined with PFP microfinance on community resilience (e.g. social capital and participation in community groups by youth and adults) compared to youth-led microfinance only and adult microfinance only approaches. - We hypothesize that at 18-months post baseline in households in the youth-led and adult microfinance will report improved community resilience compared to households in the youth-led microfinance only and adult microfinance only approaches Specific Aim 3: Determine if changes in youth resilience (caregiving ability, empathy and outlook for the future) mediate the relationship between youth engagement in microfinance and outcomes, as measured by reduced mental health distress, improved family functioning and improved social capital. Specific Aim 4: Examine youth perspectives on resilience in the context of multiple adversities (war, poverty, loss of family, displacement, victimization). Youth participants (N=50, ages 10-15 years) will be invited (with parent/caregiver consent) to complete at baseline and 18 month post-baseline qualitative interview/group discussion to examine individual, family and community resilience and what that they perceive as key to buffering the negative health and social consequences of prolonged conflict and other adversities.
In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. The primary hypothesis to be assessed in this study is that antenatal ultrasound screenings performed by medical officers and non-physician health care staff will significantly reduce a composite outcome consisting of maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource settings. Underpinning this hypothesis are two assumptions. The first assumption is that antenatal detection of complicated pregnancies will lead to appropriate referral at the right time for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. The second assumption is that ultrasound's introduction will increase antenatal attendance leading to greater rates of institutional delivery. To assess these underlying assumptions beyond the composite end point, this study will investigate the health system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent) and an assessment of medical officers and non-physician health care provider ultrasound competence and training quality.
Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can significantly reduce malaria-related morbidity and mortality in the mother and baby. However, therapeutic choices are limited by concerns about possible toxicity to the fetus and because of these concerns pregnant women are normally excluded from clinical trials. This, combined with the lack of adverse events reporting system, results in a scarcity of data on drug safety and efficacy in pregnancy. Moreover, changes in the maternal physiology in pregnancy often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a highly efficacious artemisinin-based combination therapy approved by the World Health Organisation for use in the 2nd and 3rd trimesters, although it is still infrequently used in pregnancy and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN are altered in pregnancy, resulting in reduced plasma concentrations and while the standard adult dose is still effective in high transmission settings, where pregnant women have higher levels of immunity, efficacy is reduced significantly in low transmission settings where women have lower levels of immunity. Inadequate antimalarial treatment dosing in pregnancy risks treatment failure or breakthrough infection and exposure of malaria parasites to sub-therapeutic drug concentrations thus selecting for drug resistance.