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NCT ID: NCT04944966 Completed - Malaria Clinical Trials

Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria

MALHERBAL
Start date: June 2, 2021
Phase: Phase 2
Study type: Interventional

Antimalarial Herbal medicine known as Maytenus senegalensis will be evaluated for its safety, tolerability and efficacy among Tanzanian male adults aged 18 to 45 years. The first primary objective is to assess the safety and tolerability of malaria herbal remedy of Maytenus senegalensis among healthy male adults aged 18 to 45 years in Tanzania. And the second objective is to evaluate the safety, tolerability as well as efficacy of malaria herbal remedy Maytenus senegalensis (MALHERBAL) for the treatment of Tanzanian adults aged 18 to 45 years with uncomplicated malaria compared to Artemether-lumefantrine.

NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04920292 Completed - Filariasis Clinical Trials

PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets

HELP-OFZ
Start date: April 21, 2022
Phase: Phase 1
Study type: Interventional

The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.

NCT ID: NCT04910750 Completed - Pneumonia Clinical Trials

Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care

TIMCI
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

By introducing pulse oximetry, with or without clinical decision support algorithms, to primary care facilities in India, Kenya, Senegal and Tanzania, the Tools for Integrated Management of Childhood Illness (TIMCI) project aims to contribute to reducing morbidity and mortality for sick children under-five while supporting the rational and efficient use of diagnostics and medicines by healthcare providers. The multi-country, multi-method evaluation aims to generate evidence on the health and quality of care impact, operational priorities, cost and cost-effectiveness of introducing these tools to facilitate national and international decision-making on scale-up.

NCT ID: NCT04863898 Completed - Clinical trials for Drug Use Stigma in HIV Treatment Clinics

Addressing Drug Use Stigma in Human Immunodeficiency Virus (HIV) Care and Treatment Clinics in Tanzania

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to adapt and pilot an effective health facility HIV stigma-reduction intervention to address drug use stigma in HIV Care and Treatment clinics (CTCs) in Tanzania, a barrier to linkage and retention in HIV care for People Living with HIV (PLWH) who use drugs. In Tanzania, there are an estimated 300,000 People Who use Drugs (PWUD), primarily heroin. Although most heroin is inhaled or ingested, an estimated 10% (30,000) of PWUD inject. HIV prevalence among PWUD who do not inject (18-25%) and those who do inject (35%) is 4-7 times higher than in the general population (5%). PWUD face high levels of stigma, including when they try to seek HIV treatment at HIV CTCs, presenting a barrier to linkage and retention in HIV treatment for this highly HIV vulnerable group. Reducing drug use stigma in HIV CTCs is critical to improving access to and retention in HIV treatment services for PWUD. In response to this need, the investigators will: 1) Adapt a health facility HIV stigma-reduction participatory training intervention to address drug use stigma in HIV CTCs (Aim 1). 2) Pilot test the adapted drug use stigma-reduction intervention for acceptability, appropriateness, and feasibility (Aim 2). The investigators will achieve Aim 1 through a systematic, multi-stage adaptation process that will include a formative phase of in-depth interviews with PLWH who use drugs and CTC staff to inform initial adaptation of the Health Policy Plus (HP+) intervention. Stakeholders, including PLWH who use drugs and CTC staff, will provide feedback on the initial materials through a participatory workshop, leading to a training manual that will be reviewed by topic experts and then finalized. Experienced Tanzanian HIV stigma-reduction trainers will deliver the intervention to CTC staff. The pilot test will include 150 staff (the study participants) based in seven CTCs in Dar-es-Salaam. A mixed methods evaluation will comprise pre-post surveys, observation of trainings, and post-training focus group discussions with staff (study participants) who complete the intervention and trainers. Changes in CTC staff (study participants) mean scores on stigma scales from pre- to post-intervention will be assessed, along with measures of intervention acceptability, appropriateness, and feasibility (measured at end line only). Post-intervention focus group discussions will explore themes around the experience of participating in the drug use stigma-reduction training.

NCT ID: NCT04788862 Completed - Malaria Clinical Trials

A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior exposure to P. falciparum.

NCT ID: NCT04788303 Completed - Anemia Clinical Trials

Meals, Education, and Gardens for In-School Adolescents (MEGA) Project

MEGA
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

This purpose of this study is to assess effects of a comprehensive, school-based nutrition intervention package on anemia status, anthropometric indicators, school performance/attendance, and development indicators among adolescents, and the knowledge, attitudes, and practices of nutrition, agriculture, and WASH among parents, in Tanzania.

NCT ID: NCT04781257 Active, not recruiting - Tuberculosis Clinical Trials

Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries

ERASE-TB
Start date: March 1, 2021
Phase:
Study type: Observational

The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among those who are infected, most will stay healthy but some will develop TB themselves. These people would benefit from preventive treatment, which would also stop TB from being spread to other persons. The problem currently is that it is impossible to determine with certainty who would require preventive treatment, and who will remain healthy. Out of 100 persons exposed to an infectious TB patient, only 2 will go on to have TB according to a study in Vietnam, but there are no good tests available to identify those with a risk for TB disease. Treating 100 persons to prevent 2 cases of TB is not effective, so preventive treatment is not used in adults and adolescents in Tanzania, Mozambique and Zimbabwe, where this study will be conducted, but also in many other settings. The ERASE - TB project will evaluate a number of newly developed diagnostic tests, to see which of those will be able to predict TB in persons at risk, and therefore steer preventive treatment well. For this, the investigators will invite 2,100 household contacts (HHC) of infectious TB patients, who are at least 10 years old, into the study. Everyone will be examined initially, and again in regular intervals, for 1.5 to 2 years; and whenever the participants will present with symptoms that could indicate that they develop TB. At every visit, the investigators will perform an X-ray and take some blood and urine samples to perform new candidate tests. At the first/baseline visit, all household contacts without TB will undergo a spirometry to evaluate their pulmonary function. If someone is unwell, the investigators will also examine sputum for the presence of TB bacilli. In the end, the investigators will then be able to say who of the persons in the study developed TB, and who remained healthy. From all samples taken at different timepoints, the investigators will then determine which test found TB early, and clearly distinguished between persons developing TB, and persons who would remain healthy .

NCT ID: NCT04752592 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

SeroSelectTB
Start date: September 21, 2021
Phase: N/A
Study type: Interventional

The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements. Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be collected. A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high TB-burden countries.

NCT ID: NCT04700423 Completed - Hookworm Infections Clinical Trials

Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration

Start date: March 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura. The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment. This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).