There are about 3576 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.
ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence. Currently, adherence is assessed by asking patients directly and then confirming with a viral load test, which is expensive and is often only done when the viral load is already raised. Therefore there is a need to find a method to detect problems with adherence early before the viral load rises. A urine-based test was recently developed, called UTRA (urine tenofovir rapid assay). This test can give clinic staff immediate results about a person's adherence to the antiretroviral medication Tenofovir (TDF). The study will compare the results of this urine test to drug levels found in blood, self-reported adherence and pharmacy collection records to see if this test can be used as part of routine care in ART clinics. If the test is effective it would allow clinic staff to identify people with adherence difficulties early and give them the necessary support before their viral load rises.
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use. Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.
TB is the single biggest infectious cause of death (1.5 million died in 2018), killing more HIV-positive people than any other disease, and is arguably the most important poverty-related disease in the world. TB's estimated incidence in Africa has been declining over recent years but progress is slow and plateauing. To avert stagnation, truly innovative and ambitious technologies are needed, especially those that improve case finding and time-to-diagnosis as, in mathematical models based on the TB care cascade framework, interventions that accomplish this will have the most impact on disrupting population-level transmission, including when deployed at facilities where patients are readily accessible. Critically, these interventions (triage tests) must promote access to confirmatory testing (e.g., Xpert MTB/RIF Ultra) by enabling patients to be referred rapidly and efficiently during the same visit. The investigators will optimise and evaluate a technology that, aside from the investigators early case-controlled study to show feasibility, is hitherto not meaningfully investigated for TB. This gap is alarming given, on one hand, the enormity of the TB epidemic and the need for a triage test and, on the other hand, promising proofs-of-concept that demonstrate high diagnostic accuracy of cough audio classifier for respiratory diseases such as pneumonia, asthma. pertussis, croup, and COPD. In some cases, these classification systems are CE-marked, awaiting FDA-approval, and subject to late-stage clinical trials. This demonstrates the promise of the underlying technological principle. CAGE-TB's innovation is further enhanced by: applying advanced machine learning methods that the team have specifically developed for TB patient cough audio analysis, use of mixed methods research - drawing from health economics, implementation science, and medical anthropology - to inform product design and assess barriers and facilitators to implementation, and uniquely for a TB diagnostic test, its potential deployment as a pure mHealth (smartphone-based) innovation that mitigates many barriers that typically jeopardise TPP criteria fulfilment.
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+). Through a cluster randomized trial with a modified factorial design, 24 Cape Town communities consisting of catchment areas for clinics that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), will receive either a stigma awareness and education workshop or no workshop with repeated measures. Within clinic catchment areas, 480 couples (young women and their primary male sex partners both aged 18 to 30) will be recruited. These couples will receive HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on their intervention arm. The overarching aim of these interventions is to prevent new cases of HIV. It is hypothesized that communities that are assigned to the stigma awareness and education workshop will demonstrate higher levels of social acceptance and fewer cases of enacted/experienced stigma at the community level. Additionally, it is expected couples assigned to the Couples Health CoOp Plus (CHC+) intervention will have greater antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence, lower alcohol and other drug (AOD) use, less sexual risk, less gender-based violence (GBV), and more positive gender norms and communication. Specifically, the study aims to: Aim 1: Modify the Couples Health CoOp (CHC) intervention to include antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) in a formative phase and with review from the Community Collaborative Board (CCB) and Peer Advisory Board (PAB). Aim 2: Evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and other people seeking HIV services (testing/ART/PrEP) and other health services at 4- and 8-month follow-up. Aim 3: Test the efficacy of the Couples Health CoOp Plus (CHC+) to increase both partners' antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence (primary outcome) and reduce alcohol and other drug (AOD) use, sexual risk and gender-based violence (GBV), and enhance positive gender norms and communication relative to HIV testing services (HTS) (secondary outcomes). Aim 4: Examine through mixed methods the interaction of a stigma awareness and education workshop and the Couples Health CoOp Plus (CHC+) on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention, and adherence among young women and their primary partners.
This study is looking at how Mim8 works compared to other medicines in children with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeds. Mim8 will be injected with a thin needle into the skin. The study will last for about 54-98 weeks, from screening to follow-up visit, In case the participant experiences bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor.
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
Incurable oesophageal cancer remains a global problem and in South Africa the vast majority of patients with oesophageal cancer have advanced disease at first presentation and are not curable. Likely the most distressing symptom of advanced cancer in the oesophagus is dysphagia, which is the inability to swallow solids and later also liquids. This is successfully addressed in most cases by the placement of a stent in the oesophagus which opens the area of obstruction. When placed in the lower oesophagus, one of the major drawbacks of these stents is that they disrupt the anti-reflux mechanism of the oesophago-gastric junction, which can result in severe acid reflux, severely impacting the quality of life of the patient. To address this problem, a range of approved anti-reflux stents have been developed and tested in numerous trials. To date, the evidence is conflicting and there is insufficient current evidence to support the routine use of these stents. However, the trials are not all similar in how the acid reflux was measured or what type of stent was used. Furthermore, the use of anti-reflux medication, such as proton pump inhibitors, which may help reduce reflux, are not standardised across the trials and make further conclusions about these stents difficult to interpret. No data from Sub-Saharan Africa on the use of anti-reflux stents in these patients is available. South Africa faces a large burden of incurable oesophageal cancer and improving the quality of life of these patients is of paramount importance. This randomised controlled trial aims to investigate whether anti-reflux stents do indeed reduce acid reflux in patients with incurable oesophageal cancer compared to conventional oesophageal stents that do not have such an anti-reflux mechanism. Reflux will be measured using patient questionnaires about reflux, and other quality of life parameters, and will also be objectively measured using oesophageal scintigraphy, which has not been used in previous similar trials.
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.
Primary Objective: - To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age. - To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age. Secondary Objectives: - To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age. - To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age. - To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age. - To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age. - To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age. - To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention. - To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU. - To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.