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NCT ID: NCT06314386 Not yet recruiting - Tuberculosis Clinical Trials

Systems Analysis and Improvement Approach to Prevent TB

SAIA-TB
Start date: January 6, 2025
Phase: N/A
Study type: Interventional

This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to: - Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts - Determine the drivers of SAIA-TB implementation success or failure across clinics The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period.

NCT ID: NCT06281119 Not yet recruiting - Clinical trials for Human Papillomavirus Infection

Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years

Start date: June 2024
Phase: Phase 3
Study type: Interventional

Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.

NCT ID: NCT06277141 Active, not recruiting - Clinical trials for Breast Cancer Female

The Vitality Mammography Messaging Study

VMS
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages.

NCT ID: NCT06275867 Recruiting - Clinical trials for Health Knowledge, Attitudes, Practice

Improved Access to Quality Care and Healthcare Use

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5

NCT ID: NCT06269107 Recruiting - Type 2 Diabetes Clinical Trials

A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)

COMBINE 4
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

NCT ID: NCT06268873 Not yet recruiting - Clinical trials for Chronic Kidney Disease and Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

NCT ID: NCT06267872 Not yet recruiting - HIV Clinical Trials

A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

Start date: May 31, 2024
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.

NCT ID: NCT06253715 Not yet recruiting - Tuberculosis Clinical Trials

Shortened Regimen for Drug-susceptible TB in Children

SMILE-TB
Start date: September 30, 2024
Phase: Phase 3
Study type: Interventional

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

NCT ID: NCT06248190 Recruiting - Stroke Clinical Trials

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

ENHANCE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are: 1. To test and estimate the effect of the intervention in people with MLTCs attending PHCs on: i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention. The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

NCT ID: NCT06221969 Recruiting - Type 2 Diabetes Clinical Trials

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.