View clinical trials related to HIV.
Filter by:Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. Objective: To learn more about the natural history of KS. Eligibility: People aged 18 years and older with KS. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: Eye exam. Ultrasound exam of the heart (electrocardiogram). Collection of saliva and urine samples. Biopsies of the skin or lymph nodes. Swabs of the anus and cervix. Photographs of skin lesions. Removal of fluid samples from the space around the lungs, intestine, or heart. The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. Participants will follow their standard treatment for KS during the study.
The contemporary drug crisis and the COVID-19 pandemic have exposed the complex syndemics of addiction and infectious diseases: rising rates of substance use disorder (SUD) have outpaced our ability to respond with a limited healthcare workforce and public health capacity. SUD is increasing in those living with and at risk for HIV, and infectious consequences of SUD, like hepatitis C, have continued, unmitigated, in rural parts of the U.S. where many states lack Medicaid expansion, syringe service programs, and public health infrastructure to respond to the drug crisis and comorbid infections. Systemic racism and regressive policies in the Deep South criminalize people who use drugs, creating additional barriers to care, HIV prevention, and addiction treatment. As a result, people who use drugs rarely receive comprehensive addiction and HIV treatment. Yet telemedicine has the potential to overcome these barriers and bypass the constraints of a brick-and-mortar clinic to link vulnerable people, including those with HIV, to care. Although telemedicine has become mainstream in recent years, few studies have evaluated telemedicine for SUD in the Deep South from the perspective of patients and providers.
The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are: 1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care? 2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care? 3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda? 4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda? 5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda? 6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda.
The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.
The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China. The main questions it aims to answer are: 1. Whether baseline resilience and treatment adherence are associated with the HRQoL; 2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping; 3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping; 4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups; 5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups. Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.
This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.
The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question[s] it aims to answer are: - Are these vaccine regimens safe and well tolerated? - Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.
The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits.
This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2).
Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community.