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NCT ID: NCT05686356 Not yet recruiting - Tuberculosis Clinical Trials

A Pan-TB Regimen Targeting Host and Microbe

panTB-HM
Start date: January 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

NCT ID: NCT05644067 Not yet recruiting - Malaria Clinical Trials

Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country

SUM-101
Start date: February 2023
Phase: Phase 1
Study type: Interventional

Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria vaccine approved for use in the pediatric population, which provides a moderate and short-lived protection. Therefore, there is a need to develop a malaria vaccine that will be essential to further strengthen malaria control measures in future. A Phase Ia trial with the same IMP (SumayaVac-1 vaccine developed using a full-length recombinant MSP-1 administered along with the adjuvant GLA-SE) in Caucasians in Heidelberg, Germany, proved to be well tolerated and safe. However, a Phase Ib clinical trial on healthy participants residing in a malaria endemic country would be essential to evaluate the safety and reactogenicity in the target population. The project aims to investigate the safety, reactogenicity, immunogenicity of the candidate malaria vaccine, SumayaVac-1 (SUM-101) in 40 healthy participants (men and women) of African origin in Bagamoyo, Tanzania. It will also employ the Controlled Human Malaria Infection model to evaluate the ability of this vaccine candidate to induce immune responses that prevent malaria parasites from getting into the red blood cells thereby preventing development of malaria.

NCT ID: NCT05616767 Not yet recruiting - HPV Clinical Trials

Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

The long-term objective of the parent study is "to reduce the effects of OPCa through secondary prevention (i.e., early detection, diagnosis and treatment referral)." Consistent with this, this supplement will test HPV-related interventions tailored for Sexual Minority Men (SMM). Acceptability, feasibility and preliminary effectiveness of a smart-phone delivered Oropharyngeal Cancer (OPCA) self-assessment tool will be assessed. Given that homosexuality is stigmatized and criminalized in Tanzania, and that cell phone use is the key way SMM communicate in Tanzania, a self-assessment screening cell phone intervention holds particular promise for SMM in Tanzania but warrants separate evaluation.

NCT ID: NCT05614089 Not yet recruiting - Type 1 Diabetes Clinical Trials

Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

HumAn-1
Start date: January 2023
Phase: Phase 4
Study type: Interventional

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

NCT ID: NCT05598970 Recruiting - Parenting Clinical Trials

Family and Childhood Development: The Next Generation ('Kizazi Kijacho')

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Digital solutions can significantly improve the delivery of Early Childhood Development (ECD) services in Low- and Middle-Income Countries (LMICs). Traditional home-visits and community group-based parenting approaches require intense levels of training, mentoring and supervision of Community Health Workers (CHWs) that is difficult to sustain when transitioning to scale. Context relevant digital tools can support CHWs in delivering high-quality, respectful, and standardised multi-sectoral household ECD services by tailoring services to pregnant women and engaging male caregivers. This could have significant impacts on child development, including stimulation, speech and language development, nutrition, and cognition. Moreover, cash delivered through digital modes of payment is faster, safer, easier to administer, is scalable and has potential to empower women, influence parental investment and affect household decision making. The study will conduct a clustered multi-arm Randomised Controlled Trial (cRCT) targeting pregnant mothers across all 7 districts (and all 8 district councils) in the Dodoma region in Tanzania. Following the study sample for 15 months from 5-7 months pregnancy. The study will test and compare the causal effects of (i) a digitally supported Parenting Intervention delivered by CHWs, which aims to improve caregivers' access to quality ECD services; (ii) a mobile unconditional cash transfer which aims to relax financial resource constraints; and (iii) a digitally supported Parenting Intervention when combined with a mobile unconditional cash transfer. Findings from the study are expected to have important policy implications for the design of scalable ECD interventions targeting pregnant mothers in Tanzania and other LMIC settings.

NCT ID: NCT05586230 Not yet recruiting - Tuberculosis Clinical Trials

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Start date: February 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).

NCT ID: NCT05567016 Not yet recruiting - Malaria Clinical Trials

Child Health and Infection With Low Density (CHILD) Malaria

CHILD Malaria
Start date: April 2023
Phase: Phase 3
Study type: Interventional

This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania

NCT ID: NCT05542511 Recruiting - Tuberculosis Clinical Trials

Host Blood RNA Signatures for Diagnosis of TB (RADIANT)

RADIANT
Start date: June 20, 2022
Phase:
Study type: Observational

Tuberculosis (TB) is the biggest infectious cause of death worldwide, and the biggest cause of death in Sub-Saharan Africa among HIV-positive patients. There is need for a non-sputum-based rapid triage test that identifies individuals with presumptive TB requiring confirmatory diagnostic investigation. Such a test could reduce the burden on health systems, expedite referral and confirmatory testing, and treatment thereby reducing transmission. A non-sputum triage test is needed as many symptomatic patients including those with HIV, can often not produce high quality sputum (which most current diagnostics rely on). Several blood transcriptional diagnostic signatures produced due to immune responses to M. tuberculosis infection have previously been described, however there is lack of real-world performance data especially in high TB/HIV-endemic African settings where rates of HIV (that could compromise sensitivity) and previous TB (that could compromise specificity) are high. Furthermore, by building on prior research that used untargeted sequencing approaches to identify candidate signatures, the investigators are now at a stage to perform the targeted signature measurement at a large scale and cost-efficient manner as part of prospective diagnostic accuracy analyses in real-world settings. Using the framework provided by an EDCTP-funded parent study (SeroSelectTB; PI Holm-Hansen), which is a pan-African evaluation of a point-of-care serological test for active TB, RADIANT has a unique opportunity to pursue several important research questions. RADIANT aims are to 1) evaluate the sensitivity and specificity of selected concise peripheral host transcriptional signatures for active TB among symptomatic persons (in South Africa=1260 and Tanzania=840); 2) design a cost-optimised diagnostic algorithm based on transcriptional signatures, SeroSelectTB results, and confirmatory bacteriological testing, and 3) characterise bacteriologically-negative patients classified as non-TB to determine if those with elevated host transcriptional signatures (n=100 expected) have other respiratory pathogens (detected in nasopharyngeal swabs using a commercial multiplex panel) and/or develop active TB within six months (incident active TB).

NCT ID: NCT05538767 Recruiting - Hookworm Infections Clinical Trials

Efficacy and Safety of Emodepside in Adults Infected With Hookworm

Start date: September 16, 2022
Phase: Phase 2
Study type: Interventional

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 18-60, inclusive, infected with hookworm.

NCT ID: NCT05525533 Not yet recruiting - Hiv Clinical Trials

Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers

Start date: March 2023
Phase: N/A
Study type: Interventional

The goal of the study is to operationalize and test the preliminary impact of providing regular customer feedback from adolescent girls and young women (AGYW) to drug shopkeepers on the distribution of contraceptives and HIV self-testing to AGYW over 18 months.