There are about 472 clinical studies being (or have been) conducted in Tanzania. 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.
Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth. The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.
A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
Emerging evidence from high-income countries suggests that diabetes mellitus is become a major health problem among HIV-infected patients. However, due to differences in social, environmental, and genetic factors data from high-income countries can not be extrapolated directly to low-income countries. This study investigates HIV, ART, inflammation, and body composition changes as risk factors for diabetes mellitus among HIV-infected patients in Tanzania.
This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. We will identify HIV sero-discordant couples through the HIV self-testing component, and through identifying discordant couples at the local HIV clinic. HIV sero-discordant couples (N=64 couples) will be administered a baseline, 6- ,12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data.
This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 107 newly enrolled patients per community. Specifically, the aims are to determine: 1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing. 2. If integrating DM/HTN care with HIV care enhances engagement in HIV care. 3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care. 4. The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.
Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with low immunity. Common clinical practice is to start CPT in any patient with CD4 counts below 200/µL, and, conversely, to stop CPT when immunity has been restored by antiretroviral treatment to CD4 counts above 200/µL or when viral suppression has been documented for 3 months. However, the latest WHO guidelines widely expands the indication for CPT by advocating for settings with high prevalence of malaria and bacterial infections, that all patients with HIV start CPT regardless of CD4 counts and clinical stage. Furthermore, WHO recommends these patients to continue CPT indefinitely regardless of evidence of immune restoration (The recommendation is for settings with high prevalence of malaria and bacterial infections, not for high-income countries). There is limited scientific evidence to recommend prolonged CPT, as studies have shown it is associated with modestly reduced morbidity due to pneumonia, meningitis and malaria, but no corresponding reduction in mortality. The impact of such a large increase in antibiotic use on the emergence of antimicrobial resistance has not been thoroughly considered. Our previous studies in Tanzania showed that multidrug-resistant bacteria frequently cause bloodstream infections with resultant very high case-fatality rates. As genes encoding for multiple antibiotic resistance traits are transferred by plasmids together with resistance towards cotrimoxazole, prolonged CPT will likely favor the selection of carriage of multidrug-resistant gut bacteria. The proposed randomized clinical trial is designed to assess whether prolonged CPT in HIV-positive patients results in increased fecal carriage of multi-drug resistant gut microbes or increased nasal carriage of methicillin-resistant Staphylococcus aureus (MRSA). Secondary endpoints are morbidity (clinical events, hospitalizations) and mortality. Stool specimens, nasal swabs and clinical data will be collected from persons attending voluntary counseling and testing facilities and HIV-clinics in Dar es Salaam, Tanzania. The study results may have important impact on public health in terms of assisting development of rational recommendations for CPT use, and may help prevent emerging antibiotic resistance.
Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of zinc is based on a number of studies that showed that zinc reduces the duration and severity of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14 days. This dose is associated with an increased risk of vomiting. No dosing studies are available to determine the optimal dose of zinc, which while maintaining the benefits also has a low risk of vomiting. The investigators will conduct a double-blind randomized controlled trial of three doses of zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the other in South Asia. The study population will be 4500 children with diarrhoea of less than 72 hours duration who are aged 6-59 months. They will be recruited from outpatient health facilities. All enrolled children will receive ORS and continued feeding as recommended by the World Health Organization. Those allocated to the standard zinc dose will receive an oral dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is later. In addition, study children will be assessed again at thirty (30), forty-five (45), and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number of stools and proportion of children with vomiting.
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.
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 purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.