Acquired Immune Deficiency Syndrome (HIV/AIDS)

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants' HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals' knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Researchers are studying HIV-1 infected adults who are currently on a stable triple drug regimen to see how switching to a dual therapy affects the virus and immune system. This trial compares dual therapy with dolutegravir and lamivudine (DTG/3TC, Dovato) against a triple regimen with bictegravir, tenofovir alafenamide, and emtricitabine (BIC/TAF/FTC, Biktarvy). The main goal is to check if the dual therapy is not worse than the triple therapy in terms of the amount of intact HIV virus in blood cells after 48 weeks, while monitoring immune activation and inflammation markers. Participants will be randomly assigned to either continue their triple therapy or to switch to dual therapy. The study includes a 48-week primary period and extends up to 240 weeks to assess longer-term effects. Researchers will measure viral sequences, immune system markers, metabolic health indicators like weight and insulin resistance, and body composition using scans such as DXA and FibroScan. Patient experiences will also be evaluated through questionnaires. During the study, participants will attend regular visits for blood sample collection and assessments of viral load, immune function, metabolic health, and liver condition. These include measuring markers like interleukin-6, C-reactive protein, T cell activation and exhaustion indicators, and others. The study aims to ensure safety and monitor any health complications over nearly five years. Participants must agree to ongoing blood sample storage for research and complete scheduled assessments throughout the study.

Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants' electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the intervention's preliminary effectiveness.

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 (HIV-1). This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is as effective or better than a standard daily pre-exposure prophylaxis (PrEP) in preventing HIV-1 infection. The study also assesses the safety and tolerability of MK-8527. Participants are randomly assigned to one of two groups: one group takes 11 mg of MK-8527 once monthly plus a placebo daily pill matching FTC/TDF, and the other group takes 200 mg FTC/245 mg TDF daily plus a placebo monthly pill matching MK-8527. This treatment phase lasts up to approximately two years. Afterward, all participants receive open-label FTC/TDF daily for an additional 28 days. During the study, participants are closely monitored for HIV-1 infection, adverse events, and any discontinuation due to side effects over the two-year treatment period. The primary outcomes include the number of participants who acquire HIV-1 infection, experience any adverse events, or stop the study intervention because of adverse events. Follow-up and safety assessments continue through the entire treatment period to evaluate the medicine's performance and participant well-being.

Researchers are evaluating whether combining HIV-specific broadly neutralizing antibodies (bNAbs) with antiretroviral therapy (ART) in adults newly diagnosed with acute HIV infection (AHI) is safe and can delay viral rebound compared to ART alone. This phase II, randomized, double-blind, placebo-controlled study aims to assess the impact of this combination on viral load, immune response, and viral reservoirs. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Participants are randomly assigned to receive either a combination of two bNAbs, VRC07-523LS and PGT121.414.LS, given as intravenous infusions once at study entry alongside daily oral ART, or a placebo infusion with daily ART. The study involves several steps, including treatment initiation, analytic treatment interruption, and monitoring phases. The bNAbs are administered intravenously at specific doses over 15 to 60 minutes at enrollment. ART consists of a daily oral tablet containing bictegravir, emtricitabine, and tenofovir alafenamide. During the study, participants attend scheduled visits for safety assessments, blood tests measuring viral load and immune cells, and monitoring for side effects or adverse events. Researchers track the time to viral rebound after stopping ART, changes in immune cell counts, and drug levels in the blood. Participants who meet criteria for restarting ART will do so and continue to be monitored. The total participation includes treatment and follow-up periods, with close observation to evaluate safety and treatment effects up to 24 weeks after ART interruption.

Researchers are conducting an observational study to understand prognostic and predictive factors affecting patients with anal squamous cell carcinoma (CCA), both with and without HIV infection. The study seeks to describe patient profiles worldwide, including factors such as CD4 counts, duration of HIV infection, viral load, AIDS diagnosis, geographic treatment regions, clinical staging, medication interactions, comorbidities, use and duration of highly active antiretroviral therapy (HAART), and radiotherapy types. It aims to compare clinical outcomes between patients living with HIV and those without. Participants include patients diagnosed with anal squamous cell carcinoma, with or without HIV infection. The study groups are divided based on HIV status. Data collected will reflect real-world treatment modalities, including conventional 3D radiotherapy versus Intensity Modulated Radiotherapy (IMRT), and responses to specific chemotherapy regimens. There are no interventional treatments assigned by the study, as this is an observational record. Participants will be followed to assess key outcomes such as median disease-free survival over three years, complete clinical response at six months, and overall survival from treatment start to death from any cause within three years. Researchers will gather data on treatment details, clinical staging, medication use, and other health factors. The study aims to provide comprehensive insights into how HIV status and related factors influence anal cancer treatment outcomes and survival over time.

Researchers are conducting a long-term observational study to understand the outcomes of people living with HIV who have participated in previous HIV-NAT trials. This study aims to provide insights into the long-term safety and durability of different antiretroviral treatments, the effectiveness of HIV viral load and CD4 cell counts in predicting disease progression and mortality, and the impact of adherence to treatment. It also seeks to explore various complications and quality of life over an extended period. The study follows participants who were previously or are currently involved in HIV-NAT trials, collecting and evaluating ongoing clinical outcomes. It assesses long-term consequences related to different antiretroviral drug classes, including risks of metabolic issues like lipodystrophy, resistance patterns, and effects on various body systems such as cardiovascular, renal, and hepatic functions. The study also monitors opportunistic infections or malignancies among co-infected patients and evaluates immune recovery and quality of life. Participants provide written consent and their health is monitored over a period that can extend up to 30 years. The study involves regular evaluations of clinical outcomes, adherence to medication, and quality of life assessments. Researchers analyze data to better understand long-term effects and disease progression in HIV, helping to inform future treatment approaches and patient care strategies.

Researchers are evaluating the mobile game Viral Combat to see if it helps improve adherence to PrEP among diverse participants aged 15 to 34 years receiving PrEP care in clinical settings in New England and Mississippi. The study includes formative interviews with healthcare workers, clinic administrators, and patients to adapt the game for different populations and clinics. A randomized controlled trial will then compare Viral Combat to a non-PrEP related game to assess effects on biological and behavioral measures. Participants will be randomly assigned to one of two groups. One group will receive the Multilevel Gaming Adherence Intervention, which includes the Viral Combat mobile game and adherence-based text messages for 24 weeks. The other group will receive treatment as usual plus a non-HIV related mobile game. After the trial, additional interviews will evaluate factors that could affect future use of the game in clinical settings. Participants will complete assessments including biological tests measuring tenofovir blood levels at 24 and 48 weeks, self-reported medication adherence, and medical appointment adherence. The study will also collect data on knowledge, motivation, self-efficacy, and game metrics. The total participation includes a 24-week intervention period with follow-up assessments, along with interviews before and after the trial to inform game adaptation and implementation.

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.