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NCT ID: NCT03519425 Active, not recruiting - Hiv Clinical Trials

A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi

PROSPECT
Start date: November 15, 2018
Phase: N/A
Study type: Interventional

A pragmatic open, three-arm individually-randomised controlled trial and economic evaluation will be conducted in one primary health care centre in Blantyre, Malawi, where HIV and TB are major contributors to early mortality. Participants will be adults with symptoms of tuberculosis (cough of any duration) attending the primary clinic with an acute care episode. We will exclude adults who have taken treatment for TB within the previous 6-months, who are taking isoniazid preventive therapy, who are not resident of Blantyre, or who plan to move out of Blantyre in the following 6-months. Participants will be randomly allocated into one of three groups: Group 1: Standard of care: Participants will be seen by facility health workers and receive clinician-directed screening for HIV and TB according to Malawi national guidelines. Group 2: Optimised HIV testing and treatment linkage: Participants will be offered testing for HIV using rapid oral fluid kits by research assistants. Those with confirmed HIV infection will be linked to the HIV care clinic where facility healthworkers will screen for TB using standard sputum-based diagnostics. Group 3: Optimised TB diagnosis, HIV screening and treatment linkage: Participants will receive a high-throughput and high-sensitivity TB screening intervention, in addition to the HIV testing intervention. This will comprise of an initial digital chest x-ray classified by the CAD4TB image-recognition software as either "high probability of TB", or "low probability of TB". Participants whose x-rays are suggestive of TB will receive confirmatory sputum testing with Xpert MTB/Rif Ultra cartridges, whilst participants whose x-rays have a low probability of TB will be referred to facility healthworkers for routine care. All participants will be seen at the health facility at day 56, where they will be tested for HIV (if not on ART) and screened for TB. The Primary Trial Outcome will compare between groups the time to tuberculosis treatment initiation by day 56. The trial is sufficiently powered to permit 3 pairwise comparisons between groups (i.e. Group 1 vs. 2; Group 2 vs. 3; and Group 1 vs. 3). This three-arm pragmatic trial design allows us to efficiently answer two separate, important public health questions: firstly, by comparing Group 2 to Group 1, we should be able to determine whether HIV care should be prioritised for adults with TB symptoms. Additionally, by comparing Group 3 to Group 2, we will provide strong evidence for the effectiveness of an optimised and integrated HIV and TB diagnostic and treatment linkage approach.

NCT ID: NCT03410680 Active, not recruiting - HIV Clinical Trials

A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico

FUERTES
Start date: December 5, 2017
Phase: N/A
Study type: Interventional

In general, several studies show that adherence to antiretroviral therapy (ART) among men who have sex with men (MSM) is low. Yet, high adherence to ART is essential-not only to improve the quality of life and survival rates among MSM living with HIV, but also to reduce HIV transmission among their partners. Our project aims to address this unmet need through a community-based habit-formation intervention, which incorporates elements of gamification. This intervention will provide MSM living with HIV who have been recently diagnosed and linked to care several tools to develop the habit of taking their medication and overcome disruptive adherence events (DAE) that would otherwise lead to treatment abandonment or lower adherence. Between 2015 and 2017, the investigators conducted a study funded by CONACYT -the Mexican Council for Research-in two Mexican cities to involve MSM living with HIV in the design of an intervention to improve ART adherence. Results from this study show that at the beginning of ART, MSM living with HIV can benefit greatly from a habit-formation community-based intervention that includes support mechanisms to tackle the multiple barriers they face. Using these findings, the investigators created FUERTES, an intervention with two main components: 1) the provision of a simple tool that MSM can access to learn how to develop an habit of taking their ART drugs, and 2) the support of a trained peer with background in psychology to help teach them how to overcome the myriad of barriers they may face in achieving medication adherence. This is a multicentre, parallel, randomized, controlled trial. The project's aim is to pilot-test the intervention and document its implementation. Specifically, the investigators will assess the effect of the intervention on ART adherence among MSM living with HIV at four and ten months. Secondary outcomes include viral load and CD4 cell counts. They will also assess the scalability of the intervention by measuring the costs of the intervention. The duration of the project is two years starting December 2017. The researchers hypothesize that the FUERTES intervention will improve ART adherence among MSM living with HIV starting ART by at least 15%, measured by the medication possession ratio.

NCT ID: NCT03041012 Active, not recruiting - Hiv Clinical Trials

Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART

eCLEAR
Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent HIV-1 reservoir in treatment naïve HIV-1 patients initiating antiretroviral therapy (ART)

NCT ID: NCT03011957 Active, not recruiting - HIV Clinical Trials

Biomarkers for Muscle Function and Aging in Chronic HIV Infection

MATCH
Start date: February 2015
Phase: N/A
Study type: Observational

MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy (ART) and demographically matched uninfected adults to evaluate muscle and aging.

NCT ID: NCT02990858 Active, not recruiting - Hiv Clinical Trials

An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

Start date: November 3, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.

NCT ID: NCT02957799 Active, not recruiting - Depression Clinical Trials

Improving South African Government Workers' Capacities to Deliver HIV Interventions

Start date: June 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.

NCT ID: NCT02907697 Active, not recruiting - HIV Clinical Trials

Adherence Intervention for HIV-infected Drug Users

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Many people living with HIV use illicit drugs, which leads to worsened health outcomes and increased transmission of HIV due to poor adherence to medication regimens. This research will develop an intervention targeting medication adherence that is tailored to the unique needs of HIV-infected drug users. This research will promote adherence and improve treatment outcomes among HIV-infected drug users thereby minimizing the development of drug resistant strains of HIV and reducing transmission.

NCT ID: NCT02906007 Active, not recruiting - HIV Clinical Trials

Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV

Start date: September 21, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed rifampin-resistant tuberculosis (RR-TB). The study is designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks.

NCT ID: NCT02897596 Active, not recruiting - HIV Clinical Trials

Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

EARLY-HEP-C
Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

NCT ID: NCT02889094 Active, not recruiting - HIV Clinical Trials

French HIV-HBV Cohort

COVViB
Start date: October 2016
Phase:
Study type: Observational

The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.