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HIV Infections clinical trials

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NCT ID: NCT06267508 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

LIFE2Scale
Start date: March 2024
Phase:
Study type: Observational

This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.

NCT ID: NCT06266416 Not yet recruiting - HIV Infections Clinical Trials

IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

IMAGE
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.

NCT ID: NCT06258876 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Human Immunodeficiency Virus Pre-exposure Prophylaxis Program in General Practice

PrEPInTheCity
Start date: February 15, 2024
Phase:
Study type: Observational

The Human Immunodeficiency Virus (HIV) epidemic persists in France, with approximately 6000 new cases per year. Various prevention tools against HIV exist, including condoms, regular testing, Post-Exposure Prophylaxis (PEP), HIV treatment for seropositive partners, single-use disposable injection equipment for drug use and pre-exposure prophylaxis (PrEP). Continuous or on-demand PrEP with tenofovir disoproxil fumarate/emtricitabine has proven effective in reducing the risk of HIV infection. France was the first European country to authorize PrEP, leading to an unprecedented impact on seropositivity discovery rates in 2018, with a 7% decrease in new infections compared to 2017. However, the effectiveness of PrEP can be hindered by challenges in retaining users within the healthcare system. According to the EPIPHARE report, which has been monitoring Truvada® or generic PrEP use since 2017, a substantial proportion of new users do not receive PrEP renewal in the first 6 months after initiation. Such early interruptions, increasing in frequency, affected around a quarter of individuals who initiated PrEP in the second half of 2021. A recent study reported that these early interruptions have a significant detrimental impact on PrEP effectiveness in real life, especially among those under 30 years old and in socio-economic precarious situations. The main barriers to PrEP adherence are multifactorial, including social precarity, limited PrEP access, and a low perception of HIV risk. To address this, in France, general practitioners have been authorized to issue initial PrEP prescriptions since June 1, 2021. The future challenge is to increase PrEP use and optimize retention to combat the HIV epidemic, relying significantly on general medicine. The goal of our study is to broaden PrEP access by optimizing its initial prescription in general medicine and to assess user retention in PrEP care through the established partnership between general practitioners and patients. The research will be conducted in collaboration between Saint Louis Hospital in the 10th arrondissement of Paris and general practitioners willing to participate in the study, located in the 3rd, 10th, 11th, 13th, and 19th arrondissements. Participating general practitioners may be in private practice, employed in health centers, or working in health houses. As part of the study, general practitioners will receive training from the infectious diseases department of Saint-Louis and Lariboisière hospitals. This training will be both theoretical and practical, with the opportunity to attend initiation and follow-up PrEP consultations in the department. A dedicated phone line in the infectious diseases department of Saint Louis Hospital will be available for participating general practitioners seeking specialized advice. They will be encouraged to register as PrEP prescribers in their appointment scheduling software. Patients will be informed of the study objectives and its process by the general practitioner, and their oral non-opposition will be collected. Each inclusion consultation will last approximately 20-40 minutes, allowing the general practitioner to prescribe PrEP, conduct the usual care consultation, and collect clinical, demographic, socio-economic, lifestyle, medical history, and patient vaccination data on a dedicated data collection form. The follow-up duration will be two years, with consultation frequency matching that of regular PrEP follow-ups, and data collection will occur at M6, M12, M18, and M24 using a dedicated data collection form. Data collected during inclusion and follow-up consultations will be anonymized and integrated into the electronic Clinical Report Form. During each PrEP consultation (initiation and follow-up), general practitioners will provide patients with a PrEP prescription if the pre-PrEP biology report allows it (according to HAS (Haute Autorité de Santé) recommendations). For patients who have not been attending consultations, a telephone survey will be offered to inquire about PrEP continuation and collect information on follow-up or reasons for stopping PrEP.

NCT ID: NCT06258122 Not yet recruiting - HIV Infections Clinical Trials

Evolution of the Clinical, Immuno-virological and Aging Trajectory of Patients Living With HIV

TEMPO2
Start date: March 15, 2024
Phase:
Study type: Observational

Main objective is: - To characterize the evolution of the immuno-virological profile of circulating blood cells and immune aging in patients who had participated to TEMPO-1 in 2007-2008 - To evaluate the role of immune aging and inflammatory profile in the occurrence of comorbidities in HIV-infected individuals over a 15-year period The alterations that affect the innate and adaptive immune cell compartments in HIV-infected patients are reminiscent of the process of immune aging, characteristic of old age. These alterations, the presumed cause of which is the chronic systemic immune activation established in patients, contribute to the depletion of lymphoid resources which probably leads to the decline of immune competence with the progression of HIV disease. The comparison between HIV-1-infected patients and uninfected older adults goes beyond the mere appearance of immunosenescence and extends to the deterioration of a number of physiological functions linked to inflammation and to systemic aging. By inducing persistent and lasting immune activation, HIV-1 infection is now considered a model of accelerated immunosenescence and systemic aging. During this process, the immune system quickly becomes exhausted, because the source of its exhaustion (i.e. HIV) cannot be eliminated. To determine which factors may contribute to immunosenescence in HIV-1 infection, we propose an extensive immune and virological evaluation in patients who participated in a cross-sectional assessment of immune functions and TEMPO-1 viral reservoirs after 15 years of evolution in order to determine their immune and viral trajectories, to compare these trajectories with the major clinical events and the comorbidities occurring in them.

NCT ID: NCT06253533 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus

ICVAX as a HIV Therapeutic DNA Vaccine

Start date: February 14, 2023
Phase: Phase 1
Study type: Interventional

The clinical trial is a dose-escalation, randomized, double-blind, placebo-controlled phase I study at a single center to evaluate the safety, tolerability and immunogenicity of HIV Therapeutic DNA Vaccine, ICVAX, in clinically stable HIV patients under ART treatment.

NCT ID: NCT06250504 Recruiting - HIV Infections Clinical Trials

Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

LAPIS
Start date: February 27, 2024
Phase: Phase 3
Study type: Interventional

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa. Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.

NCT ID: NCT06248190 Recruiting - Stroke Clinical Trials

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

ENHANCE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are: 1. To test and estimate the effect of the intervention in people with MLTCs attending PHCs on: i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention. The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

NCT ID: NCT06244966 Not yet recruiting - HIV Infections Clinical Trials

GUM Remote Testing v4.0

Start date: May 2024
Phase: N/A
Study type: Interventional

Capillary blood sample results are compared to venous blood results

NCT ID: NCT06233331 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV

Start date: August 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are: - The maximum tolerated dose of ACU-D1 - Safety and tolerability of topical ACU-D1 - Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions - Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals Participants will be asked - To apply ACU-D1 on the lesions twice daily for 4 weeks - 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.

NCT ID: NCT06230367 Recruiting - HIV Infections Clinical Trials

Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys

SHAG
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.