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NCT ID: NCT04431414 Completed - COVID-19 Clinical Trials

A Study of Immune Responses to the Virus That Causes COVID-19

CoVPN 5001
Start date: July 20, 2020
Phase:
Study type: Observational

The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

NCT ID: NCT04296292 Completed - HIV Clinical Trials

The Lived Experience of Participants in an African Randomised Trial

LEOPARD
Start date: February 5, 2020
Phase:
Study type: Observational

There has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. The investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of HIV-associated cryptococcal meningitis.

NCT ID: NCT04156919 Completed - Dietary Habits Clinical Trials

The Impact of a Health Video Game on User-Game Engagement and Dietary Choices

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

Pediatric obesity is one of the most serious public health challenges of the 21st century. It is a serious problem that is expected to create lifelong health challenges and potentially overwhelm the ability of healthcare providers to manage the consequences. While many factors contribute to pediatric obesity, dietary choices are the leading cause. A key concern is how to inculcate healthy dietary habits early among young children. Over the past 20 years, there has been significant scientific interest in examining the potential learning consequences of playing video games given children's interests in such games. This study investigates the impact of a health video game on children's nutritional knowledge and dietary choices.

NCT ID: NCT04119154 Completed - Lymphoma Clinical Trials

Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Chedza
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.

NCT ID: NCT03819114 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin (RIF)-containing tuberculosis (TB) therapy. The safety of double-dose (3.0 mg) LNG versus standard-dose (1.5 mg) was also compared.

NCT ID: NCT03760458 Completed - HIV Infections Clinical Trials

The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

Start date: September 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.

NCT ID: NCT03707977 Completed - HIV Infection Clinical Trials

Dual bNAb Treatment in Children

Start date: June 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.

NCT ID: NCT03698981 Completed - HIV Clinical Trials

Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will use empirically tested stigma interventions that have shown efficacy for serious mental illness and to adapt these to HIV. Additionally, a novel component of this intervention is the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective stigma reduction agent for other conditions but has not yet been widely used with HIV. The investigators propose to leverage this middle-income context to conduct a Randomized Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The investigators examine the stigma intervention for outcomes among mothers (including adherence to Antiretroviral therapy [ART] and antenatal treatment), and conduct exploratory birth outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building activities to transfer stigma intervention knowledge will occur throughout the project to enable investigators in Botswana to independently develop stigma interventions, thus serving as a model for other African countries. Finally, this pilot intervention will provide valuable data for future intervention trials to reduce stigma and improve ART adherence.

NCT ID: NCT03571555 Completed - Hiv Clinical Trials

Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana

Start date: March 1, 2019
Phase:
Study type: Observational

Adolescents/young adults with perinatally acquired HIV (PAH) face a number of antiretroviral (ART) adherence and well-being challenges. Two psychosocial interventions that have been developed to address a range of needs of this population (and their caregivers) are residential interventions (camps) and support groups (clubs). There has been little quantitative evaluation of the effects of attending camps for young people and clubs (for children or caregivers), globally. This study aims to investigate whether a package of psychosocial support (camps and clubs) offered to young people living with HIV and their caregivers in Botswana by the Sentebale organisation, is associated with improvements in psychological, behavioural and clinical outcomes from first attendance to one year follow-up. In addition, the study will explore how the psychosocial programme is experienced by young people and their caregivers, and what the perceived impact is. The project as a whole will take place over three years. There will be an initial six month preparatory phase that will include the adaptation of self-report measures for the study context. Subsequently, two studies will be undertaken. The main study will involve a single group within-participants prospective cohort design with two time points (baseline and one year follow-up) with young people and caregivers. The sub-study will involve a qualitative cross sectional design involving semi-structured interviews with young people and caregivers. Young people will be eligible to participate if they are aged 10 to 19 years at the time of study enrolment, are living with HIV and aware of HIV-positive status, have recently started attending the Sentebale programme, and are able to give informed assent/consent. We will aim to retain 175 young people (of 253 recruited) . We will also aim to retain 178 caregivers (of 263 recruited). The sample size for the sub-study will consist of ten young people and ten caregivers.

NCT ID: NCT03345875 Completed - Cervical Cancer Clinical Trials

Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Botswana

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

Aims of the Study: To assess feasibility and acceptability of introducing HPV testing of self-collected vaginal specimens (self-collection for HPV) of women age 30-49 years, followed by visual assessment of the cervix for treatment (VAT) and treatment of women testing HPV positive at a district hospital, surrounding clinics and communities in Botswana. Background and Rationale: High HIV prevalence correlates with high rates of precancerous and cancerous changes on the cervix, and Botswana has the third highest HIV prevalence rate (22.2%) in the world. In Botswana, cervical cancer is the leading cause of cancer and cancer-related deaths among women. While the Government of Botswana has made cervical cancer a public health priority, and has provided cytology-based screening (Pap smears) for the past 20 years and in recent years began also offering VIA coupled with immediate cryotherapy for eligible precancerous lesions in a screen-and-treat (S&T) approach, the program still encounters multiple challenges. These include delays in reporting/receiving cytology results, referral bottlenecks for specialist care, and ultimately far fewer women being screened and treated than set targets. In response, in 2012 Botswana's Ministry of Health and Wellness (MoHW) developed a National Cervical Cancer Prevention Programme (NCCPP) Comprehensive Prevention and Control Strategy that includes implementing a demonstration project to gauge acceptability and obtain lessons that will be used in planning the roll-out of this screening method. As a result, the MoHW is exploring human papillomavirus (HPV) testing as a primary screening method with the future service delivery in mind through HPV testing, specifically using self-collected samples, as a primary screening method. HPV testing is more sensitive and reliable for the detection of cervical precancer and cancer than Pap testing and VIA. This increased sensitivity translates into two important benefits: 1) earlier detection of significant precancerous lesions that if treated results in a ~50% reduction in the incidence of cervical cancer within 4-5 years compared to Pap testing and 50% reduction in related deaths within 8 years compared to Pap testing and VIA and 2) lower cancer risk for many years for those with a negative result, which permits screening at an extended interval of 5-10 years. The Xpert HPV test, which will be used in this study, has high sensitivity (100%) and relatively high specificity (81.5%) for CIN. HPV tests run on the GeneXpert® machine allow multiple tests (four in the model to be used in this study) to be run in an hour.