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HIV clinical trials

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NCT ID: NCT02764684 Completed - HIV Clinical Trials

The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients

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

Objective: In this study the investigators aim at investigating: 1. probiotics ability to modulate the microbiome and microbial translocation, 2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and 3. if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract. Design: The study is a prospective clinical intervention trial of 40 HIV-infected patients. Method: The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.

NCT ID: NCT02763995 Completed - HIV Clinical Trials

Pharmacotherapy Follow-up in Older HIV-infected Patients

Start date: April 2013
Phase: N/A
Study type: Interventional

Cardiovascular diseases (CVD) are the main cause of death in Spain. In HIV patients, the uncontrolled viral replication, antiretroviral therapy (ART) and coinfections contribute to develop metabolic diseases and increase the prevalence of risk factors for CVD. These patients are aging which results in a higher probability of comorbidities, increased number of medications, possibility of having a negative outcome associated with medication (NOM) and increased cardiovascular risk (CVR). Various studies have established that pharmaceutical care (PC) results in better control of cardiovascular risk factors. The purpose of this study is to evaluate the impact of pharmaceutical care achieved through pharmacotherapy follow-up on cardiovascular risk and health related quality of life (HRQoL) of HIV patients older than 50.

NCT ID: NCT02758093 Completed - HIV Clinical Trials

Speed of Processing Training in Adults With HIV

SOP
Start date: September 28, 2016
Phase: N/A
Study type: Interventional

As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Although interventions are needed to protect/improve cognitive functioning, one intervention already exists to improve speed of processing. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N = 2,802 community-dwelling older adults) has the ability to enable "older people to maintain their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE Study, this intervention uniquely improves driving, instrumental activities of daily living (IADL), health-related quality of life, self-rated health, internal locus of control, and protects one from depression; these represent areas of needed intervention for adults with HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing declines are associated with poorer driving simulator performance and more self-reported at-fault automobile crashes; such speed of processing declines on driving alone represent a significant public health concern. These studies also demonstrated that Speed of Processing Training improved this cognitive ability and translated into improved performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized computer-contact control (sham) condition. AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this cognitive ability at post-test, year 1, and year 2 after baseline. AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday functioning at post-test, year 1, and year 2 after baseline. Exploratory AIM: Determine whether improvement in speed in speed of processing and/or everyday functioning over time mediate improvement quality of life (e.g., depression, health related quality of life).

NCT ID: NCT02753842 Completed - HIV Clinical Trials

Condom Performance in a Longitudinal Enhanced Assessment of User Experiences

C-PLEASURE
Start date: May 2016
Phase: N/A
Study type: Interventional

This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based on combinations of length (approximately 10 mm increments) and circumference (approximately 2 mm increments), with user-determined size based on a paper template measurement instrument. Participants will be randomly assigned to the sequence in which the crossover intervention conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for each condition. Participants will attend at least four, and up to seven, biweekly study visits.

NCT ID: NCT02752061 Completed - HIV Clinical Trials

Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care

Start date: May 13, 2016
Phase: N/A
Study type: Interventional

Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival. The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.

NCT ID: NCT02744586 Completed - HIV Clinical Trials

Zambia One Love Aim 3 Trial

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

The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing (CVCT), among concordant HIV-negative couples living in Zambia.

NCT ID: NCT02744404 Completed - HIV Clinical Trials

Point of Care Early Infant Diagnosis Patient Impact Study

Start date: September 2015
Phase:
Study type: Observational

In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.

NCT ID: NCT02743026 Completed - HIV Clinical Trials

HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

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

Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV and sexually transmitted infections (STI) prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre non-randomised cohort pilot study using a pre-test/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in eighteen communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the intervention, and a 12-month follow up.

NCT ID: NCT02742597 Completed - Stroke Clinical Trials

Patient-Centred Innovations for Persons With Multimorbidity - Ontario

PACEinMM-ON
Start date: January 12, 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 4 other provinces: British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). 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: NCT02740179 Completed - HIV Clinical Trials

Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)

Start date: January 2017
Phase: N/A
Study type: Interventional

HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population.