5,066 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
HIV-1-infection
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
HIV Infections
The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).
Hiv, Opioid Use
The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are: 1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic? 2. What things make it easier or harder to ask about PrEP in a family planning clinic setting? 3. What things make it easier or harder to begin PrEP in a family planning clinic setting? Patient participants: 1. Will receive standardized counseling about PrEP. 2. Will have the opportunity to begin PrEP as part of their routine, ongoing care. 3. Will be asked to complete a survey about their experiences. Physician participants: 1. Will receive standardized education about PrEP. 2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP. 3. Will be asked to complete pre-and post-study surveys about their experiences. 4. May be asked to complete a post-study in-depth interview about their experiences.
HIV, PrEP
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
HIV-1-infection
This is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time this combination of study products is being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health. Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
HIV-1-infection
The goal of this observational study is to learn about the pilot test of the employment program among young Black sexual minority men. The main question it aims to answer is: What is the feasibility and acceptability of the employment program? Young Black sexual minority male participants will attend the two day employment program and will complete four study surveys over the course of 13 months. Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.
HIV
Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
The goal of this HIV and Aging Pilot Program Proposal is to foster interdisciplinary collaborations in HIV and geroscience by providing emerging researchers with experience and mentorship in translational research. The focus is on collecting data on the efficacy and feasibility of short-term high-intensity interval training among older people with HIV (PWH) and co-occurring hypertension. Non-AIDS defining comorbidities are increasingly prevalent among aging PWH. The use of antiretroviral therapies (ART) has extended life expectancy, presenting unique risks for aging-related multimorbidities. Hypertension, affecting over 50% of HIV-infected adults in the U.S., is a significant chronic disorder among PWH. Regular exercise improves function and prevents decline in adults with comorbidities. Functional outcomes are good predictors of cardiovascular health in older PWH with hypertension. Exercise improves cardiovascular, metabolic, and functional measures in young PWH, but older PWH often do not meet physical activity guidelines due to barriers like motivation, time, and pain. The impact of high-intensity exercise on physical function in older PWH is unknown, despite evidence of benefits from low-moderate intensity exercise. Assessing the feasibility and acceptability of high-intensity exercise in older PWH with hypertension will provide valuable information for future studies. The specific aims of the proposed study are to assess the integrity of the study protocol, including safety, adherence, and retention, to develop standard operating procedures for future trials, while determining participant perceived benefits and barriers. Additionally, the study aims to assess the variance of secondary outcomes and the effects of the intervention on the 6-minute walk test, lower extremity function as assessed by the Short Physical Performance Battery, skeletal muscle strength and endurance as assessed by isokinetic muscle testing, chronic pain evaluated by the Brief Pain Inventory and Pain assessments, markers of vascular health such as arterial stiffness, and circulating indices of inflammation including inflammatory profile, skeletal muscle degradation, and metabolism.
HIV, Hypertension, Exercise
Although there have been advances in antiretroviral treatment (ART) for HIV, adolescents and young adults living with HIV (AHIV) continue to have disparate HIV outcomes particularly viral suppression (VS), when compared to other populations likely related to multi-layered challenges (social determinants, cognitive development), system, and biomedical challenges including the reliance on oral ART as the only choice for HIV treatment. Given that approximately 1/3 of AHIV despite being in care fail to attain or sustain VS with resultant individual and public health risk, there is a need to develop real-world implementable interventions that can improve the participants virologic outcomes. The Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study aims to 1) optimize personal ART choice by using the HIV-ASSIST clinical program to inform CHOICE counseling regarding an AHIV's preferred approach, including the possibility of long-acting injectable ART (LAI-ART); 2) facilitate access to the participants preferred choice through deploying a focused team to navigate barriers to attaining LAI-ART; and 3) decipher and address the patient, provider, and systemic barriers to the uptake and routinization of LAI-ART among AHIV by applying an implementation science framework and assessing cost-effectiveness providing critical data to support comprehensive approaches to optimizing ART and VS for AHIV, a key population identified in the Ending the HIV Epidemic in the United States Initiative.
Human Immunodeficiency Virus (HIV) Infection
HIV testing and service uptake are infrequent among people who use drugs (PWUD) in the United States. In partnership with a community-based syringe service program (SSP), this project will develop the SSP-based "Prevention Ambassadors" (PA) intervention to promote HIV testing and service uptake among PWUD via the secondary distribution (i.e., peer delivery) of HIV self-testing (HIVST) kits with local HIV service information and referrals to HIV service navigation in the social networks of SSP clients (i.e., PWUD). The PA intervention will then be piloted to assess its preliminary effects, acceptability, and feasibility among PWUD in the Ending the HIV Epidemic priority jurisdiction of Riverside County, California.
HIV
The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. The condition of excess lipid within and around muscle, termed myosteatosis, predisposes Veterans to physical function decline, frailty, disability, and cardiometabolic diseases such as diabetes and cardiovascular disease. In the investigators current Merit supported cohort, the investigators found that 36% of Veterans with treated HIV and obesity have "myosteatotic type obesity". Based on the investigators findings, the investigators have designed a multipronged integrated intervention that combines: 1) dietary replacement of saturated with unsaturated fats; 2) administration of L-carnitine and omega-3 fatty acid supplementation; and 3) targeted resistance exercise training.
HIV, Obesity
The goal of this pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. The program aims to address housing instability among people with HIV (PWH) using a Housing First model. The main questions it seeks to answer are: 1. How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence? 2. What are the program's effects on economic, psychological, and secondary health outcomes? 3. How feasible, acceptable, and scalable is the program for broader implementation? Participants will be assigned to immediate program access or a waitlist using a random lottery system, creating treatment and control groups, respectively. Surveys and health data will be collected at baseline and over 36 months to assess changes in outcomes such as viral suppression, housing security, mental health, and financial well-being. Qualitative interviews with participants and stakeholders will complement quantitative findings to explore mechanisms of change and guide program optimization.
HIV, HIV Antiretroviral Therapy (ART) Adherence, Housing Instability
This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.
Systemic Inflammation, Immune Dysregulation, Injection Drug Use, HIV
Pending...
Human Immunodeficiency Virus
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
HIV
This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.
HIV
This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).
HIV
The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The evaluation will apply use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations of interventions. The impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in analysis.
HIV Testing, PrEP Uptake
This is a basic human experimental study utilizing 4 groups of individuals with and without HIV and complex morbidities of cannabis use disorder and major depression who will participate in 2 sessions of the Yale Pain Stress Task (YPST) and follow-up phase to assess drug use and mood symptoms.
HIV, Depression, Cannabis Use Disorder, Stress, Pain
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.
HIV-1-infection
This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.
HIV Prevention
MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
HIV/AIDS
Eye Movement Desensitization and Reprocessing therapy is a time-limited trauma-response therapy that treats symptoms of stress that result disturbing life experiences. Eye Movement Desensitization and Reprocessing therapy has been used to treat trauma-related symptoms for people living with HIV. People living with HIV tend to experience higher psychiatric morbidity rates of depression, anxiety, and post-traumatic stress symptoms than the general population. However, even with case studies of Eye Movement Desensitization and Reprocessing therapy on people living with HIV, there is no definitive protocol for the clinician as they navigate the therapy. This study aims to assess the feasibility and acceptability of delivering an Eye Movement Desensitization and Reprocessing therapy protocol tailored for people living with HIV and trauma. 20 people living with HIV will be recruited to participate in an eight-week Eye Movement Desensitization and Reprocessing therapy. The therapy will be focused on assessing the viability of an Eye Movement Desensitization and Reprocessing protocol that is specified for people living with HIV.
HIV Infected Individuals
The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).
HIV Infections
The purpose of this study is to investigate safety and tolerability following single ascending subcutaneous (SC) and intramuscular (IM) doses of VH4011499 in participants without HIV. The study will also describe the pharmacokinetics following single ascending SC and IM doses of VH4011499 in participants without HIV.
HIV Infections
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
HIV Prevention, PrEP, Women, Intimate Partner Violence (IPV)
Adolescent girls and young women (AGYW) between the ages of 15-24 years continue to bear the brunt of Human Immunodeficiency Virus (HIV) infections in South Africa despite progress recorded in prevention and treatment programmes. The ongoing susceptibility of young women to HIV infection and the sub-optimal uptake of prevention options such as Pre-Exposure Prophylaxis (PrEP) that are highly effective creates a need for an HIV vaccine to benefit populations at substantial risk of HIV infection. However, lessons from previous vaccine studies and the recent COVID-19 vaccine have highlighted significant barriers to vaccine uptake, such as widespread misinformation and vaccine hesitancy. These challenges threaten the successful implementation of a future HIV vaccine. Building on these insights, this study will utilise psychological inoculation theory to develop and evaluate HIV vaccine messages among adolescent girls and young women. Primary objective: To compare changes in intentions to receive HIV vaccine following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost. Secondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioral economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a three-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about the HIV vaccine in South Africa. Participants will be randomly assigned to a control group or one of two intervention arms: (1) inoculation message arm, or (2) enhance inoculation message with insights from behavioural economics.
Misinformation, HIV Vaccine
The present study investigates the feasibility of working memory training in people aging with HIV (PAWHIV). In a cross-over design this stage 1 feasibility trial, will evaluate acceptability, and estimate possible effect sizes related to working memory training by examining potential differential effects in PAWHIV and those aging without HIV. This project highlights the importance of tailored cognitive assessments and interventions, engaging with underrepresented communities to enhance inclusivity in cognitive health research.
Cognitive Change