There are about 3545 clinical studies being (or have been) conducted in South Africa. 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.
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.
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.
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.
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.
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.
The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n<10) or have not yet attended a follow-up visit (n<10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n<8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n<60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n<10).
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.
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.
The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).