Clinical Research Directory

Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

This research will test the effects of a novel program (ENHANCE-TTS) with tools, training, and clinic facilitation support that capitalizes on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. This effectiveness-implementation study will evaluate the effects of the ENHANCE-TTS program on implementation outcomes and patient-level smoking cessation outcomes in people living with HIV and concurrently identify key barriers and facilitators to implementing this program in practice.

Implementing Depression and Adherence Treatment

The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression. The main questions it aims to answer are: What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)? Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance. Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.

A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa

The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.

Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users

The DC Cohort Longitudinal HIV Status Neutral Study

The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for patients diagnosed with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) or at higher risk for acquiring HIV and receiving care in Washington, DC.

The Collaborative Care PrTNER Study

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

ALHIV Smartphone Game Study

This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).

The Quality of Life and Viral Control Effect of AIDS Patients After Long-acting Injection of Cabotegravir and Rilpivirine

"AIDS" was once regarded as the Black Death of the 20th century. However, with the advent of cocktail therapy, the survival rate of infected people has been greatly improved and the average life expectancy has been increased. Today, AIDS is considered a chronic disease, just like hypertension and diabetes. As long as you have regular checkups and take medication on time every day, you can complete the treatment, just like a normal person. However, there is still a risk of missing medication when taking it every day, and long-term missed medications can easily lead to drug resistance and increase the risk of treatment failure. After the HIV-infected person has stabilized the viral load, their mobility, self-care and daily activities are no different from those of normal people. However, they experience side effects such as fatigue, lack of energy, difficulty sleeping, depression, changes in appearance, tension and anxiety, dizziness, headache, vomiting, etc., which affect their quality of life. The long-acting AIDS injection is a long-acting dosage form for intramuscular injection. It has been included in the national health insurance reimbursement standards. Treatment with long-acting injections can reduce the risk of infected people forgetting to take medicine, and there is no need to worry about the exposure of the disease when storing the medicine. Through this study, we hope to collect the results of long-acting injections for stable HIV treatment cases (health status, daily activities, injection site, satisfaction), and confirm that long-acting injections can significantly improve the quality of daily life of HIV-infected people.

Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2025. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV

The purpose of this study is to examine the extent of mpox viral spread and immunologic markers in people with advanced HIV. Study findings will enhance knowledge of mpox pathogenesis in severely immunocompromised people, which can inform treatment and prevention of severe illness and deaths associated with mpox in people with advanced HIV.

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.

Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the real world

Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia

Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.

The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH

Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution. Evaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.

Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients