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NCT ID: NCT06340698 Recruiting - HIV Clinical Trials

An RCT to Improve HRQoL of HIV+ Mothers and Children

Start date: February 20, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06332339 Recruiting - HIV Clinical Trials

Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 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.

Start date: April 10, 2024
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

NCT ID: NCT06282328 Recruiting - HIV Infections Clinical Trials

HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting

HIV-HOTE
Start date: February 14, 2024
Phase:
Study type: Observational

This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors. This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason. The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization. Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside. In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day.

NCT ID: NCT06269081 Recruiting - HIV Clinical Trials

Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.

NCT ID: NCT06202898 Recruiting - Hiv Clinical Trials

Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.

NCT ID: NCT06186128 Recruiting - HIV Clinical Trials

Universal Basic Income and Structural Racism in the US South: HIV Care

017744S
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

Universal Basic Income (UBI) is a promising strategy aimed at recalibrating economic systems that are grounded in structural racism. Black men have long been the target of oppressive and interconnected systems of finance and healthcare access, leading to a disproportionate burden of exposure to infectious disease with little healthcare support. Yet to our knowledge, no published UBI studies have ever been implemented exclusively with Black men living with HIV in the US. Motivated and inspired by the innovative health and social science being conducted in extremely resource-limited environments in other parts of the world, we recognize an urgent need to better understand the effect of cash transfers on HIV care among Black men in the US South. The proposed study will be based in Arkansas, which, like other Southern states, has a long history of institutional racism and extremely high rates of racial health disparities, poverty, and chronic disease. We will use a mixed methods research design to conduct an in-depth exploration of a UBI intervention to reduce the racial wage gap and promote the use of culturally relevant protective factors. The provision of a UBI is intended to increase receipt and retention of HIV care services and treatment for Black men through the influx of capital and subsequent increases in culturally-based protective factors such as personal agency and social connections. We hypothesize that providing UBI of $500 per month for 6 months will result in increased HIV care utilization among low-income Black men living with HIV. Secondarily, we hypothesize that the effect of UBI will also increase adherence to HIV medication, such that more UBI recipients will achieve and maintain viral suppression compared to individuals in the control condition.

NCT ID: NCT06176859 Recruiting - HIV Clinical Trials

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

NCT ID: NCT06171919 Recruiting - HIV Clinical Trials

Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions

Start date: October 12, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.

NCT ID: NCT06162897 Recruiting - HIV Clinical Trials

Case Management Dyad

CM2
Start date: September 9, 2022
Phase: N/A
Study type: Interventional

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.