HIV Infections Clinical Trials

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are: 1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process? 2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will 1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history 2. Have the opportunity to opt-out of clinician-ordered HIV testing 3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment. Read Less

This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions (in this study - HIV) and with age. Read Less

This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial/ethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) /Oropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC/OPSCC prevention. Read Less

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Read Less

The purpose of this study is to determine whether Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation (MY-RIDE) decreases substance use , to determine whether MY-RIDE increases human immunodeficiency virus (HIV) prevention strategies and to evaluate MY-RIDE effects on willingness to take Pre-Exposure Prophylaxis (PrEP), stress, substance use urge, and use of mental health and substance use services when compared to attention control youth Read Less

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. Read Less

Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention and HIV prevention study among people who use drugs (PWUD). Specifically, SCOPE will provide access to drug-checking services for PWUD to better understand the contents of the drug supply, in combination with PrEP for those who are HIV-, to both reduce overdose and HIV among PWUD in Baltimore City. Read Less

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. Read Less

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. Read Less

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID). Read Less

The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV, at Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA), or Courage Medicine, a nonprofit health services clinic located in Philadelphia (PA, USA). Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group. To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are: * Does participation in TIARAS reduce HIV risk among WWID? * If observed, how long do beneficial effects last? * How and why do WWID experience benefits from TIARAS? Read Less

This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH). Read Less