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HIV clinical trials

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NCT ID: NCT04039217 Completed - HIV Clinical Trials

Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM

Start date: September 30, 2019
Phase: Phase 4
Study type: Interventional

The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how long it persists in different body compartments, including mucosal tissues, as it may be considered for PrEP or PEP regimens in the future.

NCT ID: NCT04036851 Completed - Hiv Clinical Trials

Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women

Start date: August 30, 2019
Phase: N/A
Study type: Interventional

Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.

NCT ID: NCT04012931 Completed - HIV Clinical Trials

A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.

NCT ID: NCT04000724 Completed - HIV Clinical Trials

TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission

Start date: October 18, 2019
Phase: N/A
Study type: Interventional

TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake. Participants are randomized into one of three conditions for a 6-month intervention: Group 1: culturally relevant theory-based text messages (Text+Step); or, Group 2: culturally relevant mobile-enhanced website (WebApp+Step); or, Group 3: informational website control condition with no theoretically based text messages or WebApp.

NCT ID: NCT03999411 Completed - HIV Clinical Trials

Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients

Start date: September 9, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

NCT ID: NCT03996018 Active, not recruiting - HIV Infections Clinical Trials

T-cell Responses to Concurrent HIV and Herpesvirus Infections

Start date: June 19, 2019
Phase:
Study type: Observational

This is a research study in which we are trying to discover new information about how HIV and herpes viruses interact with the immune system. The goal of the study is to learn more about how T-cells in your immune system respond to and fight off long-term (chronic) viruses, in order to improve medical care in the future.

NCT ID: NCT03995953 Completed - HIV Clinical Trials

Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented with 6 geographic regions randomized into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. HIV testing will be assessed among the SHIELD only HIV negative or unknown (HIV-/u) cohort and retention in care along with viral load suppression will be primarily assessed in the IWC clinics and SHIELD HIV positive (HIV+) cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback following the trial. Cost-effectiveness of the interventions and budgetary impacts will be assessed through using a cost assessment tool.

NCT ID: NCT03988387 Completed - HIV Clinical Trials

IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

Start date: October 31, 2019
Phase: N/A
Study type: Interventional

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

NCT ID: NCT03986697 Not yet recruiting - Clinical trials for Coronary Artery Disease

How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: A Serial CT Study

HART CT
Start date: November 4, 2019
Phase: Phase 4
Study type: Interventional

Combined antiretroviral therapy (cART) is thought to promote coronary artery disease via a number of mechanisms: abnormal lipid profiles, endothelial dysfunction, hypertension, insulin resistance and renal impairment are the main pathological mechanisms driving atherosclerosis as a consequence of cART. An association between protease inhibitors and increased cardiovascular disease risk has been shown in many large cohort trials. CT Coronary Angiography (CTCA) is now widely used to assess for the presence of atherosclerosis, typically in patients presenting with chest pain. This imaging technique allows visualisation of the coronary arteries and quantification of any atherosclerotic disease that may be present. This technique is being increasingly used as a surrogate for cardiovascular disease risk. HART CT is an open label, prospective, randomised-control pilot study to investigate the feasibility of performing a future appropriately powered multi-centred randomised control trial using CT based outcome data as a surrogate for cardiovascular disease risk. Participants will be randomised to either continue their usual cART or switch to Biktarvy (a fixed dose combination of bictegravir, emtricitabine and tenofovir alafenamide). A baseline CT scan will be performed. If there is any evidence of atherosclerosis a further CT scan will be performed at the end of the study (approximately 48 weeks). This will allow quantification of any change in coronary artery plaque burden or characteristic. Participants will be also followed up for any changes in metabolic health.

NCT ID: NCT03959826 Recruiting - HIV Clinical Trials

Promoting Employment in Persons Living With HIV/AIDS

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

Many persons living with HIV/AIDS (PLWHA) are unemployed, with estimates indicating rates as high as 60%. This study will examine the efficacy of reinforcing job-acquisition activities for improving employment outcomes in PLWHA who desire to return to the workforce in part- or full-time capacity. In total, this study will randomly assign 144 unemployed PLWHA to one of two interventions. All participants will receive usual unemployment services with an emphasis on specific issues related to HIV/AIDS, plus encouragement for completing activities geared toward employment readiness and acquisition. The enhanced intervention will involve that same treatment plus chances to win prizes for engaging in job-related activities each week. Participants will receive study treatments for 16 weeks and complete follow-up evaluations throughout 18 months. The hypothesis is that participants reinforced for completing job-related activities will transition to employment at higher and faster rates and work more often than those who are not reinforced for job-related activities.