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NCT ID: NCT05764746 Not yet recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial

3ACT
Start date: April 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Artemisinin resistance has emerged in parts of Southeast Asia, and there are reports in Africa of reduced susceptibility of Plasmodium falciparum parasites against artemisinin-based combination therapy (ACT). No new drugs are available in the pipeline to replace ACTs in case they fail. This study aims to assess whether a sequential administration of triple ACTs with different partner-drugs can improve the efficacy of ACT for treatment of uncomplicated malaria. Methods: A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO). Eligible children aged 6 - 120 months and with microscopy confirmed uncomplicated P. falciparum malaria will be enrolled, administered with trial medicines and followed-up at 0 (just prior to first drug intake) and 8 hours on day 0, 12 hourly on days 1, 2, 3, 4, 5, followed by once daily on days 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28, 35, 42 and 56 for clinical and laboratory evaluations. Clinical evaluation will involve assessment of signs and symptoms related to the disease and or trial medicine during follow-up. Laboratory evaluation will include microscopic determination of presence of malaria parasites and species, hemoglobin level, molecular analysis for markers of drug resistance and to differentiate recrudescence from new infection. The primary outcome will be Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological cure rate on days 28 and 42. Expected outcomes: The findings will give an insight on whether 3 ACTs are more efficacious than the use of first-line regimen alone, and are tolerable for treatment of uncomplicated falciparum malaria.

NCT ID: NCT02938975 Not yet recruiting - Malaria Clinical Trials

Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents for Malaria Prevention

URCT
Start date: November 2017
Phase: Phase 3
Study type: Interventional

Purpose While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. It is not known if there is an added benefit from combining the two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region. The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU) and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo lotion. Both participants and investigators will be blinded to treatment allocation. The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by Polymerase Chain Reaction every month by active case detection.

NCT ID: NCT02168985 Not yet recruiting - Child Maltreatment Clinical Trials

Impact Evaluation Study of The Faithful House Programme on Violence Reduction in Families

TFHEVAL
Start date: July 2014
Phase: N/A
Study type: Interventional

The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to increase household resilience by strengthening families. TFH draws on improved communication and conflict resolution skill building and the individual's faith-values as a catalyst for transformation in attitudes regarding gender roles in care giving and the use of violence in the home. The study hypothesis is that couples who complete the Faithful House Programme will demonstrate increased communication skills with their spouses and children, which reduces the negative impact of family stress triggers and ultimately leads to a reduction of intimate partner violence witnessed by children as well as physical and emotional violence against children by parents. The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or conflicted couples and a child in each household, focus group discussions (FGD) of men, women and children and key informant interviews of local experts in family violence and social protection service network providers.

NCT ID: NCT01541631 Not yet recruiting - Anemia Clinical Trials

A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

Start date: May 2012
Phase: N/A
Study type: Interventional

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

NCT ID: NCT01192646 Not yet recruiting - Pregnancy Clinical Trials

Home Based Life Saving Skills Training in a Rural Area in Tanzania

HBLSS
Start date: August 2011
Phase: N/A
Study type: Interventional

Background The maternal mortality ratio in Tanzania has been persistently high for ten years with no signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and 2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric haemorrhage, obstructed labour, pregnancy induced hypertension, sepsis and abortion complications. Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of births that occur outside the health facilities 31% are attended by relatives, 19% by traditional births attendants (TBA) while 3% have no assistance at all. Though, the proportional of mothers delivering in health facilities (47%) and receiving skilled attendance at birth (46%) is low but more than 94 percent of women attend antenatal care (ANC) in health facilities at least once. This indicates that there are factors that impede these women delivering in the health facilities. Low awareness of obstetric danger signs may be one of the contributing factors for delay to decide to seek care when a complication occur thus contributing the first phase of delay. Studies in Tanzania show that most women are not aware of danger signs of obstetric complications during pregnancy, delivery and after delivery. A study conducted in Mtwara rural to assess the use and determinants of skilled attendants at delivery showed that proportional of women delivered with skilled care increases with increasing knowledge of pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger signs An increasing body of evidence supports the importance of community participation in maternal and infant health programs for establishing ownership, identifying problems effectively, achieving equity and helping to institutionalize health programs. To mount an effective maternal health effort aimed at reducing maternal and infant mortality, multiple levels of program and policies need to be in place and functioning. In addition, linkages, from the communities, local dispensaries and health centres to first referral hospitals that are adequately equipped, need to be developed and sustained A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women and their primary family caregivers and home birth attendants on critical knowledge and skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn complications and promote the adoption of health care and health-seeking behaviours at the individual and community levels. The aim of this strategy is to prevent maternal and neonatal morbidity and mortality through creating awareness on women's birth preparedness and access to emergency obstetric care services RESEARCH QUESTIONS 1. Can HBLSS increase women empowerment and male involvement in the decisions relating to access of emergency obstetric and newborn cares? 2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal danger signs, birth preparedness and emergency readiness in a rural community? Objectives Broad Objectives: 1. To investigate social-cultural, community and traditional practices that impact on women's birth preparedness and access and utilization of emergency obstetric care services in rural district. 2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery awareness of obstetric and neonatal danger signs, birth preparedness Specific Objectives 1. To explore customs, taboos and practices including herbal remedies during pregnancy and labour that influence birth preparedness and utilization of emergency obstetric care services. 2. To assess perception, attitude and health seeking behaviour when a complication occur. 3. To determine the effect of HBLSS educational programme on hospital delivery, birth preparedness, emergency readiness and utilization of emergency obstetric care services among women in Rufiji district. 4. To assess the impact of HBLSS educational programme on male awareness and involvement in assisting women on birth preparedness and access to emergency obstetric care services. 5. To determine the cost-effectiveness of HBLSS educational programme Methodology A Cluster Randomized Trial 28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other 14 clusters will not receive HBLSS training.