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HIV/AIDS clinical trials

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NCT ID: NCT02586584 Recruiting - HIV/AIDS Clinical Trials

The I-Score Study: Developing a New Patient-Reported Tool for the Routine HIV Care of Patients on Antiretroviral Therapy

Start date: April 2016
Phase:
Study type: Observational

The purpose of this Canada-France study is to develop and validate a multidimensional patient-reported measure of perceived barriers to antiretroviral therapy adherence for HIV-positive patients undergoing treatment that will be theoretically founded, easy to use and helpful to clinicians in their medical decision-making, in a clinical or research setting.

NCT ID: NCT02578654 Completed - HIV/AIDS Clinical Trials

Interventions to Improve HIV Care Engagement After Hospital Discharge

Start date: November 2012
Phase: N/A
Study type: Interventional

A quasi-experitmental study of the efficacy interventions, including additional HIV care team daily inpatient round and three telephone calls to remind the upcoming clinic appointment, in improving HIV care engagement within 30 days after hospital discharge among HIV-infected patients.

NCT ID: NCT02535455 Completed - HIV/AIDS Clinical Trials

Acceptance and Compassion to Enhance Self-care Pilot

ACES Pilot
Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP) among HIV+ substance users, who experience profound health disparities that amplify onward transmission risk. This project will systematically develop, refine and conduct an open pilot to assess the feasibility and acceptability of a two-phase emotion regulation intervention that targets emotional barriers to HIV-related self-care among individuals who endorse active substance use. Emotional barriers such as shame and internalized stigma have been identified as barriers to optimal HIV care among individuals struggling with HIV and substance use. To effectively implement TasP, strategies for addressing these barriers are needed. Utilizing transdiagnostic approaches (e.g., positive affect-focused emotional regulation, mindfulness and self-compassion) investigators will develop, refine and pilot a two-phase emotional regulation intervention that requires only 5 face-to-face hours and can ultimately be implemented by a case-management-level staff person or trained peer educator. The first phase of the intervention will be a multicomponent in-person intervention targeting emotional, cognitive and behavioral barriers to HIV self-care behaviors among HIV+ substance users. The second phase of the intervention will extend the intervention benefits by sending personalized positive self-reappraisal text messages in response to text message queries about participants' mood. This phase will use an innovative personalized bi-directional platform, which will leverage an existing text message delivery system. This project will be instrumental in developing a relatively low-resource intervention strategy to address unmet emotional barriers to optimal HIV-care among individuals who are actively using substances. This work will provide the necessary pilot data for a subsequent grant submission to assess the preliminary efficacy of the intervention. The resulting intervention has the potential to address emotional barriers to self-care along the HIV care cascade: including retention in care, antiretroviral treatment adherence and persistence, and ultimately viral suppression.

NCT ID: NCT02532673 Completed - HIV/AIDS Clinical Trials

Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.

NCT ID: NCT02530827 Completed - HIV/AIDS Clinical Trials

Energy Expenditure of People Living With HIV/AIDS

Start date: March 2013
Phase: N/A
Study type: Observational

Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome. The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

NCT ID: NCT02514707 Recruiting - HIV/AIDS Clinical Trials

Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment

ART Long Term
Start date: January 2015
Phase: N/A
Study type: Observational

Study Title: Outcomes of HIV infected individuals after ten years on antiretroviral treatment Short Title/Study ID: ALT cohort Protocol Version and Date: Version 1.0 June 2013 Clinical Phase: NA Methodology: Prospective observational study Study Duration: 01 January 2014- 30th June 2025 Study Centre(s): Single centre (Infectious Diseases Institute, Kampala, Uganda) Number of Subjects: Enrollment of 1,000 study participants. All patients discharged from the IDI Research cohort (10 years of follow up on ART) will be offered to participate in the study. Additional patients with similar characteristics will be enrolled from he clinic Diagnosis and Main Inclusion Criteria: HIV patients above 18 years and in their 10th year of ART Main Exclusion Criteria: ART started outside IDI Study Product, Dose, Route, Regimen: ART will be provided according to standard of care at IDI and according to the WHO and Ugandan guidelines Duration of follow up: 10 years Reference therapy, Dose, Route, Regimen: Not applicable Recruitment Schedule: 1 January 2014- 30 June 2015 Statistical Methodology: Time to event analysis (end of treatment, failure, death, switch, occurrence of drug toxicities) including Kaplan-Meier curves and Cox regression will be performed. Endpoints will be correlated with characteristics at ART start and at study enrollment. Possible confounding variables, if available, will be considered. GCP Statement: This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, and ICH-GCP as well as all national legal and regulatory requirements.

NCT ID: NCT02499978 Withdrawn - HIV/AIDS Clinical Trials

Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity

TMC114HIV2030
Start date: May 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.

NCT ID: NCT02497989 Completed - HIV/AIDS Clinical Trials

Evaluating Demand Creation Strategies for Voluntary Medical Male Circumcision (VMMC) in Kenya

TASCO
Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of two interventions - Inter-Personal Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39 years for Voluntary Medical Male Circumcision (VMMC) services.

NCT ID: NCT02492061 Active, not recruiting - HIV/AIDS Clinical Trials

Demand Creation for Couples' HIV Counseling and Testing

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

This study aims at assessing the effect of a demand-creation intervention on couples' HIV counseling and testing (couples' HCT) uptake among married couples who have never tested together as a couple. The study is being implemented in 12 clusters; six intervention and six comparison clusters. A total of 1,538 couples will be enrolled into the study; 769 couples per arm. Couples in the intervention communities are invited to participate in small group, couple-focused or men-only, interactive sessions lasting 3-4 hours in which the advantages and fears associated with couples' HCT are discussed with invited couples to motivate them to consider testing together as a couple. The meetings are reinforced with testimonies from previously tested couples. At the end of the sessions, couples or men receive invitation coupons which they present to a designated health facility to receive couples' HCT services (couples are free to receive individual HCT or not to honor the invitation, if they are not interested in taking the HCT offer). In the comparison communities, standard of care health education activities including general adult community sessions are held but couples do not receive any invitations to test as a couple. Nevertheless, couples in the comparison communities have unlimited access to HIV counseling and testing services that are offered by the Rakai Health Sciences Program within the study communities. The investigators hypothesize that couples in the intervention arm will be more likely to test together than those in the comparison arm. The study objectives include: a) exploring the motivations for and barriers to couples' HCT uptake; b) assessing the effect of a demand-creation intervention on couples' HCT uptake among married couples with no prior couples' HCT experience, and c) exploring the effect of couples' HCT vs. individual HCT on linkage to and retention in HIV care.

NCT ID: NCT02474303 Completed - HIV/AIDS Clinical Trials

Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal

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

Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to rethink HIV prevention and treatment strategies, especially for key populations such as Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the potential to have a profound population-level impact on the course of the HIV/AIDS pandemic. Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to translate these trial results into population-level effects is the next critical step. PrEP "demonstration" projects, in collaboration with local stakeholders and at sites of routine care for high-risk populations provide an opportunity to move promising research results into actual public health benefits. With these key features in mind, the investigators propose an HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The objective of the proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program for FSW in Dakar, Senegal while demonstrating the feasibility of providing daily oral PrEP with Truvada (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics (Pikine, Mbao, Rufisque and Diamniadio Health Centers). Critical milestones for this demonstration project with be feasibility, uptake, acceptability, use of TDF/FTC PrEP and programmatic retention of FSWs in Dakar MoH clinics. The investigators have assembled an expert team from RARS,The University of Washington, and Westat that have had greater than 2 decades of collaboration on HIV related projects in FSWs in Senegal. The investigators expect the results of this project will show that Senegal provides a unique opportunity to assess acceptability, feasibility, uptake and effectiveness of oral HIV PrEP at reducing HIV transmission in a high-risk FSW population.