There are about 140 clinical studies being (or have been) conducted in Mozambique. 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.
This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 4 sites of the two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first line treatment for malaria in mozambique, for the treatment of uncomplicated malaria in children aged<5 years.
Polio is an acute transmissible disease caused by any of the three polio virus serotypes (types 1, 2 or 3). In Mozambique, polio vaccination is part of the immunization schedule of the expanded vaccination program. The oral vaccine (OPV) is administered at months 0,2,3, and 4 and a single dose of the inactivated poliovirus vaccine (IPV) is given intramuscularly at month 4. In 2016 shortage of IPV supply caused stock-outs and put strain on IPV use for routine immunizations as well as for poliovirus outbreak response. Therefore, assessment of new vaccine regimens using smaller doses of IPV are needed. Administration of fractionated IPV (fIPV), i.e., 1/5 (0.1mL) of the standard dose, intradermally has shown to be safe and to provide an immune response similar to the standard dose of IPV that is currently given intramuscularly. However, intradermal administration of fIPV is technically difficult and many countries are hesitant to adopt fIPV in their routine immunization schedules. Therefore, the investigators need data confirming that the use of the fIPV vaccine intramuscularly is safe and the immune response is not inferior to the use of fIPV intradermally. Study Objective: to compare the immunogenicity of fIPV administered intramuscularly or intradermally in infants at 2 and 4 months of age. Study Hypotheses: the seroconversion rate after administration of one or two doses of fIPV intramuscularly is not inferior to the fIPV intradermally. The priming effect after fIPV administered intramuscularly is not inferior to the fIPV intradermally. Study Methods: This will be a phase II non-inferiority clinical trial. 360 children will be enrolled in two study groups, with prior consent of the parents / guardians. In group I, 180 children will receive 0.1 ml of IPV intramuscularly and in group II 180 children will receive the same dose intradermally. There will not be a group control. The children will be selected at birth at pre-defined health units in Maputo city. The fractional IPV vaccine will be given to children at 2 and 4 months of age during routine vaccinations. In total there will be four study visits, of which the first two are vaccination visits. All visits will be performed at the health units. 1 ml of blood will be collected at each study visit to assess the immune response before and after vaccination. Data will be collected by trained and qualified personnel and in accordance with Good Clinical Practice standards. Adverse events following administration of the vaccine will be monitored and all serious adverse events will be reported to ethics and regulatory committees, and to World Health Organization (WHO). Evaluation of the immune response: Seroconversion rates and priming effect will be evaluated. Serum will be tested for the presence of neutralizing antibodies against poliovirus using standard neutralization assays and immunogenicity will be assessed by titration of anti-polio 2 immunoglobulin G.
The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy. The specific objective is to detect trends over time in the proportion of symptomatic children with a positive rapid diagnostic test (RDT) residing in the areas where C-IPTp is implemented who carry parasites with dhfr/dhps mutations compared to those in control areas with no community SP distribution.
The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being. A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities"). This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics. Follow-up data collection will begin in March 2019. It has several components: 1. Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program. 2. Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test. In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community. 3. Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.
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 World Health Organization (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. The sub-study on Covid-19 will assess the prevalence and impact of the Covid-19 in young children hospitalized with severe pneumonia. The sub-study findings are expected to guide policy makers and clinicians on potential specific screening and management measures for these vulnerable groups of children. They are also key to analysing TB-Speed Pneumonia results on mortality in a context of the Covid-19 outbreak and to take into consideration SARS-CoV-2 infection status in the main study analysis.
This study evaluates changes in knowledge, attitudes, practices and coverage of key reproductive, maternal, newborn, and child health (RMNCH) areas, including malaria, family planning (FP), nutrition, water, sanitation and hygiene (WASH), and gender equity among the population in Nampula and Sofala provinces targeted by the Maternal and Child Survival Program (MCSP) in Mozambique.
This study will serve as a platform to evaluate new diagnostics in children suspected to have TB, establish diagnostic performance (sensitivity and specificity) and calculate positive and negative predictive values in a real-life cohort. Finally, this study will comprise the results of several tests in its database. This will allow simulation of diagnostic algorithms, that may be composed of screening (i.e. rule-out) tests together with confirmatory tests to maximize sensitivity and specificity.
Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.
This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.
This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).