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NCT ID: NCT04466293 Completed - Tuberculosis Clinical Trials

Choice Architecture Based TB Preventive Therapy Prescribing

CAT
Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what investigators know works and what is actually delivered at the clinic-level to patients, is known as the "science-to-service gap." In the realm of tuberculosis (TB) prevention, this gap is reflected in <20% of TB preventive therapy (TPT)-eligible persons living with HIV (PLWH) being offered or initiated on isoniazid preventive therapy (IPT) in many settings. Recent innovation in TPT have brought new pharmacological options allowing for shorter courses, intermittent dosing, or both. A 12-dose once-weekly rifapentine and isoniazid (3HP) regimen has been demonstrated to be effective and well tolerated. This regimen has several potential advantages over IPT; however, if patients are never assessed for 3HP eligibility and 3HP is not prescribed, TPT packets will remain on pharmacy shelves and the potential health benefits will not reach those who need it. The overarching goal of this study is to identify a generalizable approach to overcome current barriers to delivery of TPT in order to achieve high levels of TPT delivery during routine care in public clinics. Investigators are proposing a choice architecture that makes prescribing TPT the "default" or standard option and that for TPT not to be prescribed will require a choice by a clinician to "opt-out" of TPT for a specific patient. Methods: Investigators will use a cluster randomized design with the larger IMPAACT4TB (I4TB) program to deliver 3HP to countries in Africa, Asia, and Latin America. A subset of countries and clinics within these I4TB countries will be included with each clinic the unit of randomization. Clinics within study countries will be randomized to one of two strategies: (1) standard implementation within the UNITAID project (clinic training on TPT along with posters and other standard medication material) and (2) choice architecture default TPT. Clinical process data will be used to assess the effectiveness of each strategy to determine the proportion of PLWH (1) screened for TB preventive therapy, (2) eligible for TPT, and (3) prescribed TPT. Significance: Identifying a pragmatic approach will lead the way for improving TPT prescribing across the study sites. It will furthermore contribute to implementation science at large in describing implementation strategies that may be applied to clinic-level implementation of other innovations.

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: NCT04403880 Completed - COVID-19 Clinical Trials

Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

Start date: May 13, 2020
Phase:
Study type: Observational

The purpose of this study is to learn more about 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 will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.

NCT ID: NCT04371835 Completed - Clinical trials for Coronavirus Infection

COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings

Start date: August 12, 2020
Phase:
Study type: Observational

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

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: NCT04206241 Completed - HIV Infections Clinical Trials

Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

Start date: January 1, 2018
Phase:
Study type: Observational

This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

NCT ID: NCT04140266 Completed - HIV Infections Clinical Trials

Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.

NCT ID: NCT04058405 Completed - Severe Preeclampsia Clinical Trials

Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

Start date: November 12, 2018
Phase:
Study type: Observational

This proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in Zimbabwe.

NCT ID: NCT04050449 Completed - HIV-1-infection Clinical Trials

Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of TLD

Start date: October 28, 2019
Phase:
Study type: Observational

Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people: - People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1). - People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2). - People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study. - People starting TLD who have not taken anti-HIV medication before (Group 4). Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.

NCT ID: NCT04048629 Completed - HIV Infections Clinical Trials

Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe

Start date: August 5, 2019
Phase: N/A
Study type: Interventional

The Ministry of Health and Child Care (MOHCC) in collaboration with Clinton Health Access Initiative (CHAI) will conduct an observational cohort study to determine the impact and cost-effectiveness of POC VL testing for pregnant women. It is hypothesized that POC VL testing will enable an increased proportion of pregnant women to be virally suppressed at delivery, which will avert vertical transmission.