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NCT ID: NCT05084716 Active, not recruiting - HIV Clinical Trials

Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

Start date: September 24, 2021
Phase: N/A
Study type: Interventional

This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for providing PrEP in fisherfolk communities in Lake Victoria, Uganda.

NCT ID: NCT05040308 Active, not recruiting - HIV-1-infection Clinical Trials

Uganda PrEP and Harm Reduction Evaluation

Start date: February 11, 2022
Phase: N/A
Study type: Interventional

This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to address key outcomes. Additionally, research components will be implemented to support greater understanding of PrEP use and experiences of participants engaged with the PrEP programs.

NCT ID: NCT04994509 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV Infection

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

PURPOSE 1
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.

NCT ID: NCT04978272 Active, not recruiting - Malaria Clinical Trials

Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)

MIC-DroP
Start date: February 8, 2022
Phase: Phase 3
Study type: Interventional

The MIC-DroP trial will test the hypothesis that preventing early life blood-stage malaria antigenic exposure with intermittent preventive therapy (IPT) enhances protective immunity to malaria. This study will take advantage of a unique opportunity to study infants born to mothers followed in a NIH-funded randomized controlled trial of novel intermittent preventive therapy in pregnancy (IPTp) regimens (NCT04336189). MIC-DroP will leverage the parent IPTp study to enroll 924 children who will be randomized at 8 weeks of age to receive no intermittent preventive therapy in childhood (IPTc), monthly DP from 8 weeks to 1 year of age, or monthly DP from 8 weeks to 2 years of age, and then follow children to 4 years of age. The primary outcome of this study will be to compare the incidence of malaria from 2 to 4 years of age among children randomized to receive no IPTc, monthly DP for the first year of life, or monthly DP for the first two years of life. Investigators will also leverage this trial to evaluate immune development during early childhood.

NCT ID: NCT04946071 Active, not recruiting - Clinical trials for Knowledge, Attitudes, Practice

Reducing HIV-related Stigma in School Children in Northern Uganda

Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Over 2.6 million children aged 0-15 years are living with HIV globally, with the majority living in low and middle income countries in sub-Saharan Africa. Addressing stigma associated with HIV is key given the significant harm that may be experienced in the form of negative health and social outcomes, reduced access to HIV prevention services, and increased vulnerability to infection. This stepped-wedge, cluster randomized trial with assess the impact of an arts-based HIV stigma intervention on knowledge and attitudes towards children who are HIV+ and - affected; enacted, internalized, anticipated, courtesy, and perceived stigma (primary outcomes); HIV testing frequency among sexually active participants; linkage to care, antiretroviral therapy (ART) initiation and adherence among HIV+ participants; and viral suppression among HIV+ participants (secondary outcomes) of children aged 10+ years in Omoro District, Uganda, post-intervention and 5-months post-intervention.

NCT ID: NCT04904549 Active, not recruiting - COVID-19 Clinical Trials

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

VAT00008
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

NCT ID: NCT04860284 Active, not recruiting - Covid19 Clinical Trials

Hydroxychloroquine for Treatment of Non-Severe COVID-19

HONEST
Start date: September 18, 2020
Phase: Phase 2
Study type: Interventional

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19 .Both Hydroxychloroquine(HCQ) and Chloroquine(CQ) have demonstrated activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have been investigated in small clinical trials with contradicting reports on their benefits or harm in treatment of COVID-19 .Several authors agree that the use of HCQ for treatment of COVID-19 needs to be assessed in large randomized controlled trials

NCT ID: NCT04825327 Active, not recruiting - Tuberculosis Clinical Trials

Predicting the Future: Incipient Tuberculosis

PreFIT
Start date: April 21, 2021
Phase:
Study type: Observational [Patient Registry]

The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xpert Host Response (HR) cartridge result develop active TB within 12 months. They will also investigate if there is a correlation between progressing to active TB within 12 months and having high levels of the iron homeostasis markers (Hepcidin, Ferritin and Transferrin). Identified index cases who agree to participate will refer their household or close contacts to also join the study. These contacts will be tested for TB and only contacts who are negative will be enrolled and followed-up at 6 months and 12 months. Blood samples will be collected at baseline and 6 months for testing. During the study period, TB testing will be done on contacts who meet symptoms criteria. At 12 months, all contacts will undergo a chest x-ray to assist in the diagnosis of TB. PreFIT will target people aged 12 to 60 years of age and both HIV negative and positive. 1515 trial participants will be recruited at Stellenbosch University in South Africa, 1515 at Fundaçao Manhiça in Mozambique and 1010 at Makerere University in Uganda, respectively.

NCT ID: NCT04810650 Active, not recruiting - Hypertension Clinical Trials

A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

SAPPHIRE
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.

NCT ID: NCT04750707 Active, not recruiting - Clinical trials for Sickle Cell Anemia in Children

Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )

BRAINSAFEII
Start date: March 9, 2021
Phase: Phase 3
Study type: Interventional

Worldwide, an estimated 200,000 babies are born with Sickle Cell Anemia (SCA) annually. Affected children suffer chronic ill health with some having frequent hospitalization. The patients are also at a high risk of brain injury arising from small and large cerebral blood vessel damage in SCA, also called sickle cell vasculopathy (SCV). SCV is associated with the high risk of stroke. Such injury may manifest with neurological and cognitive impairment. An abnormal blood flow to the brain, as measured by a Doppler Ultrasound scan is a known risk factor for stroke. The hypothesis is that hydroxyurea therapy will prevent, stabilize or improve SCV and its effects. The study is an open label, single arm clinical trial to test the impact of hydroxyurea treatment in 270 children with SCA starting at ages 3-9 years. Following baseline assessments, all participants will begin hydroxyurea therapy starting at about 20mg/kg/day. Changes in the frequency and severity of each test (neurological and cognitive tests and cerebral blood flow velocity) will be compared with their baseline tests (prior to hydroxyurea) by repeating these tests at 18 and 36 months. In a randomly selected subset of 90 participants, an evaluation of the impact of hydroxyurea on structural brain vascular injury using magnetic resonance brain imaging (MRI) and magnetic vessel imaging ,also called angiography (MRA) at baseline and at 36 months. Lastly, an assessment of changes to biomarkers of anemia, inflammation and malnutrition from before and during hydroxyurea therapy and determine their relationship to the outcomes. The proposed intervention with hydroxyurea is the first Africa-based trial to broadly prevent or ameliorate manifestations of SCV.