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NCT ID: NCT06325657 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants

MORISOT
Start date: March 12, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother. The study will look at the safety, tolerability, and immune activity in mothers and their infants. This study is seeking pregnant women who are: - Less than or equal to 49 years old and have HIV (Human immunodeficiency virus - - Receiving standard medical care during the pregnancy - Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection). - Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days. - agree to be present for all study visits, procedures, and blood draws. Participants will either receive: - RSVpreF vaccine - A placebo. A placebo does not have any medicine it but looks just like the study vaccine. Pregnant participants will be involved in the study from: - consent during their current pregnancy, and - for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.

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: 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.

NCT ID: NCT06221488 Recruiting - Tuberculosis Clinical Trials

Testing Health Workers At Risk to Advance Our Understanding of TB Infection

THWART-TB
Start date: January 15, 2024
Phase:
Study type: Observational

It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening. THWART-TB is a prospective longitudinal cohort study of health workers (HWs) in Cape Town, South Africa, where our preliminary data reveals HWs have a high annual TB infection risk (34%). This cohort, who will undergo frequent serial evaluation (every 3 months) with a combination of novel assays never previously evaluated together, presents a unique opportunity to evaluate immune responses at the time of initial infection and to characterize the dynamic profile of these immune responses over time in a high-risk population. The knowledge generated will improve our understanding of TB infection and help to identify which people exposed to TB may remain at risk, enabling us to better target preventive strategies.

NCT ID: NCT06214910 Recruiting - Tuberculosis Clinical Trials

ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa

ThiPhiSA
Start date: February 20, 2024
Phase: Phase 4
Study type: Interventional

This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB preventive therapy. We hypothesize that persons receiving multi-month dispensing of TPT in the community will have a higher rate of TPT completion at 3 months than persons receiving TPT via standard of care with monthly clinic-based refills.

NCT ID: NCT06181162 Recruiting - Physical Activity Clinical Trials

YoPA - A Youth-centred Participatory Action

YoPA
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Background A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations. Methods In diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner. Discussion YoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.

NCT ID: NCT06176859 Recruiting - HIV Clinical Trials

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

NCT ID: NCT06163274 Recruiting - Safety Clinical Trials

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

MATRIX-003
Start date: February 28, 2024
Phase: Early Phase 1
Study type: Interventional

This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.