Clinical Research Directory

Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment

Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment. Testing may be offered where they are, but starting medication usually requires going to a clinic somewhere else, and many people are not able to make that second trip. This study tests a program called CONNECT. In CONNECT, a community health worker and a nurse offer HIV services directly at homeless shelters. People can take an HIV self-test on-site. If the test is negative and the person is at risk for HIV, the nurse can start them the same day on a prevention medicine called PrEP. If the test is positive, the nurse can help them start HIV treatment quickly and connect to ongoing care. The study will compare this on-site program to the usual approach of referring people elsewhere, to see whether it helps more people start HIV prevention or treatment on time.

SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV

The purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis \[PrEP\]). The study will assess whether women assigned to SEPA+PrEP-Women demonstrate higher PrEP uptake than controls and will generate initial effect size estimates to inform a future definitive trial.

Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix

Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1. Treat Infection of Multiple Gene Mutation HIV Virus Strains. 2. Activate Human Antigen Presentation Reaction to HIV Specific Antigen. 3. The human antigen presenting cells (APCs) can take up and process HIV target antigen protein into small peptide fragments, and then HIV virus can be killed by APCs directly.

Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically

Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.

Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study

In this study, investigators plan to test whether statins can preserve and/or improve diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy. Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial steatosis prior to initiation of statin or placebo therapy and then two years after initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk, systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes.

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

People living with human immunodeficiency virus (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.

Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease, is an increasingly recognized comorbidity in people living with human immunodeficiency virus (HIV). Chronic low-grade inflammation, altered lipid metabolism, and certain antiretroviral therapy (ART) regimens may heighten the vulnerability of people living with HIV (PLWH) to liver fat accumulation, progressive liver fibrosis, and cardiometabolic complications. The primary purpose of this observational case-control study is to determine the prevalence, clinical characteristics, and laboratory findings of MASLD and hepatic fibrosis among PLWH compared with matched HIV-negative individuals. The study also aims to evaluate dietary quality, lifestyle habits, and cardiovascular risk profiles in both groups, and to determine whether adherence to a healthy lifestyle protects against significant liver disease. Adult participants (aged 18 years and older) attending the Department of Tropical Medicine and Gastroenterology at Assiut University Hospitals will be enrolled into two groups: people living with HIV and HIV-negative individuals matched by age, sex, and degree of liver steatosis. All participants will complete the following non-invasive evaluations: * Hepatic Assessment: Abdominal ultrasound and transient elastography (FibroScan) to detect fatty liver and quantify liver stiffness, alongside non-invasive scoring systems (FIB-4 score and NAFLD Fibrosis Score). * Laboratory Investigations: Fasting blood tests including liver function tests, lipid profiles, glycemic status (HbA1c), kidney function, complete blood count, and immune markers (CD4+ T-cell count and CD4/CD8 ratio). * Physical and Body Measurements: Measurement of body mass index (BMI), waist circumference, and mid-arm muscle circumference (MAMC). * Dietary and Lifestyle Questionnaires: Validated assessment tools including the Food Frequency Questionnaire (FFQ), Short Healthy Eating Index (sHEI), and Healthy Lifestyle Questionnaire to quantify nutritional quality, physical activity, and daily lifestyle habits. * Cardiometabolic Risk Calculation: Calculation of predicted cardiovascular risk using the American Heart Association PREVENT risk score. Findings from this study are intended to clarify the role of dietary quality and lifestyle factors in liver and metabolic health among people living with HIV, potentially informing proactive screening and management strategies.

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM). This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial. Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Precision Microbiota Interventions for Senoreduction Trial

People with HIV who drink alcohol are at increased risk for accelerated aging biology, including increased immune senescence. This randomized, double-blind, crossover clinical trial evaluates two generally recognized as safe (GRAS) microbiota-targeted interventions on immune senescence biomarkers.

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

HIV Engagement and Adolescent Depression Support (HEADS-UP)

This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.

A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2). The study is designed to include the following phases: Randomized Intervention Phase (Step 1), Analytical Treatment Interruption (ATI) Phase (Step 2), and Follow-up Phase (Step 3).

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.

Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Atlanta

This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.

The TAIL-PrEP Study

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Developing a Chatbot to Promote HIV Testing

In this study, the feasibility of a Chatbot in promoting HIV testing in men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will receive automated personalized messages containing HIV testing-related information, motivation and skills.

Clinical Decision Support for PrEP

Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.

Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected

The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth

Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706

The clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.

A Long-term Follow-up of the HIV-NAT Cohort

With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.