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HIV clinical trials

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NCT ID: NCT02793804 Completed - HIV Clinical Trials

HIV Self-Testing Africa Zambia

STAR Zambia
Start date: June 2016
Phase: N/A
Study type: Interventional

This study consists of a Cluster Randomised Trial (CRT) of community and facility-based HIVST distribution by the Society for Family Health (SFH) in multiple rural and peri-urban settings. The study will take place in 6 matched pairs of health facilities and their catchment areas have been selected for study inclusion in collaboration with the district medical office (DMO). One clinic catchment area from each pair will be randomly allocated to the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In the HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be conducted as currently.

NCT ID: NCT02789800 Completed - Stroke Clinical Trials

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

PACEinMM-QC
Start date: April 22, 2016
Phase: N/A
Study type: Interventional

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

NCT ID: NCT02788175 Completed - HIV Clinical Trials

Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption

Start date: May 28, 2016
Phase: Phase 1
Study type: Interventional

Background: In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again. They can also become resistant to cART and have lasting side effects. Researchers want to test if the drug vedolizumab is effective at controlling HIV infection without the need for cART. Objective: To test if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken. Eligibility: People ages 18-65 who have HIV and are being treated with cART Design: Participants will be screened with: Physical exam Medical history Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity. Blood and urine tests Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It will include repeats of the screening tests and: Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white blood cells from the blood. The rest of the blood is returned to the participant. Neurologic exam: The nerves and reflexes are tested. First vedolizumab infusion through an arm vein Participants will have visits every 4 weeks for 30 weeks. These will include: Vedolizumab infusions Repeats of baseline tests Participants will have more visits for blood draws. Participants will keep taking cART until after the week 22 infusion. After discontinuing cART at study week 22, participants will be seen every two weeks to monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in between infusion visits and will only take about 1 hour to complete. cART will be restarted if a participant's HIV levels go up to high, or if their CD4 cell counts decreases by too much. For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will include blood tests and a physical exam. ...

NCT ID: NCT02787499 Completed - HIV Clinical Trials

Resistance Testing to Improve Management of Virologic Failure in Sub-Saharan Africa

REVAMP
Start date: December 8, 2016
Phase: N/A
Study type: Interventional

The study design is an open-label, randomized controlled trial. The study will be conducted at study sites in Uganda and South Africa. The study population will include HIV-infected patients on first-line antiretroviral therapy with a recent viral load >1,000 copies/milliliter (or dried blood spot viral load >1,000 copies/milliliter). Eligible participants will be randomized to the WHO-based standard of care for management of virologic failure or immediate resistance testing to guide ART regimen decisions. The primary outcome of interest will be viral suppression (<200 copies/mL) at 9 months after study enrollment, and will be assessed using an intention to treat analysis, where missing or absent results will be considered failures. Secondary outcomes of interest will be viral suppression below the limit of assay detection, viral suppression on continuation of first-line (non-nucleoside reverse transcriptase inhibitor [NNRTI]-based) therapy, drug resistance at study conclusion, and mortality, among others. The overarching goal of this study is to determine whether addition of routine resistance testing, to guide management of virologic failure and sustain the successful completion of the HIV continuum of care, improves clinical outcomes and reduces costs for patients with virologic failure on first-line therapy in sub-Saharan Africa.

NCT ID: NCT02786758 Completed - HIV Clinical Trials

Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals

co-EC
Start date: April 2016
Phase:
Study type: Observational

This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection, thereby reducing new primary infections and re-infection.

NCT ID: NCT02786615 Completed - HIV Clinical Trials

Increasing MSM in the Continuum of Care in Kazakhstan

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

This study addresses the disproportionate representation of men who have sex with men (MSM) in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic in Kazakhstan, a country that has seen some of the largest growth in new HIV infections since the turn of the century. Using a stepped wedge trial across 3 cities in Kazakhstan, the proposed study will test a strategic and innovative social network-based intervention for MSM who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV continuum of care.

NCT ID: NCT02785835 Completed - HIV Clinical Trials

Hepatocellular Carcinoma in HIV-infected Patients

GEHEP-002
Start date: May 2014
Phase:
Study type: Observational

Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.

NCT ID: NCT02785666 Completed - HIV Clinical Trials

Swiss HCVree Trial

HCVree
Start date: June 2016
Phase: Phase 3
Study type: Interventional

The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a nested project of the Swiss HIV Cohort Study entitled "The Swiss HCVree Trial".

NCT ID: NCT02785302 Completed - HIV Clinical Trials

Transitioning HIV+ Adolescents to Adult Care: Exploring Adolescent and Adult Medicine Clinics Role in the Process

Start date: August 2015
Phase: N/A
Study type: Observational

This is a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. To achieve this goal, the transition process is characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff.

NCT ID: NCT02782130 Completed - HIV Clinical Trials

Epic Allies HIV ART Adherence Intervention

Start date: June 2015
Phase: N/A
Study type: Interventional

This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability, impact, and long-term sustainability of the Epic Allies intervention application (app), a theory-based mobile app that utilizes game mechanics and social networking features to improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral suppression among HIV-positive young men who have sex with men (YMSM) and trans women who have sex with men. Subjects will be randomized to either the intervention branch of the Epic Allies app or the control branch of the app.