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316 active trials for HIV

Self-management of HIV Among Adolescents

There are over 73,000 adolescents living with HIV (ALHIV) in Uganda constituting 4% of the worldwide population of ALHIV. HIV remains a leading cause of death among adolescents despite widespread availability of antiretroviral medication. Generally, ALHIV have poor outcomes with higher rates of loss to follow up compared with other age groups. Mortality rates and loss to follow up are highest during the transition period. Transition success may be maximized for ALHIV who are better prepared to negotiate care in adult HIV clinic settings. This study proposes to develop a self-management intervention for ALHIV transitioning to adult HIV care and test the impacts of the intervention on HIV outcomes. Conducting the proposed studies in this application will complement my prior training in psychiatry while filling key gaps in three areas: (a) behavioral science theories and their application to behavioral interventions, (b) adaptation and design of behavioral interventions, and (c) testing of behavioral interventions through randomized trials. To fill these gaps, the investigators will conduct qualitative research to elaborate a conceptual framework of the barriers faced by ALHIV transitioning to adult HIV care in Uganda (Aim 1), develop a self-management intervention that will enable ALHIV to successfully transition to adult HIV care (Aim 2), and assess feasibility, acceptability, and preliminary effects of the self-management intervention on HIV outcomes for ALHIV transitioning to adult HIV care (Aim 3). This study will be the first to develop a self-management intervention targeting the critical transition period from pediatric to adult HIV care in sub-Saharan Africa and the first to use a randomized design to test the effect of a self-management intervention on health outcomes among ALHIV in Uganda who are transitioning to adult HIV care. These findings will have significant public health impact by optimizing health outcomes for a key population in the global HIV epidemic. The proposed research will serve as the basis for a competitive R01 grant proposal, submitted in year 4, to conduct a fully-powered, randomized controlled trial to evaluate the effectiveness of a behavioral intervention to improve retention in care and viral suppression among ALHIV in Uganda who are navigating the critical period of transition to adult HIV care.

Start: October 2021
Nonalcoholic Fatty Liver Disease in HIV Database

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH) , as NAFLD in PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of biopsy-proven NAFLD in PLWH (HIV-associated NAFLD).

Richmond, VirginiaStart: October 2021
VRC 611: Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS)Administered Via Subcutaneous and Intravenous Injection in Healthy Adults

Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researches want to test an antibody, CAP256V2LS. Objective: To test CAP256V2LS to see if it is safe and how the body responds to it. Eligibility: Healthy people ages 18-60. Design: Participants will be screened with a medical history, physical exam, and blood tests. Some will have a pregnancy test. Participants will be assigned to one of two groups. Based on their group, they will get 1 dose of CAP256V2LS in 1 of 2 ways: Some participants will get CAP256V2LS as an infusion. A thin tube will be placed in an arm vein. CAP256V2LS will be given into the vein using a pump. Some participants will get CAP256V2LS injected under the skin. A small needle will inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They will get 1 to 4 injections. On the day they get CAP256V2LS, participants will give blood samples at different time points. This visit will last about 8 hours. Participants will be asked to check their temperature every day for 7 days after receiving CAP256V2LS. They will use a tool to measure any redness, swelling, or bruising they may have at the injection site. Participants will have visits at least 2-3 times during the first week after they get CAP256V2LS. Then they will have about 9 more visits over the next 6 months. Visits will include blood tests....

Bethesda, MarylandStart: September 2021
Effects of COVID-19 on Endothelium in HIV-Positive Patients in Sub-Saharan Africa

Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in the world, especially in terms of health system capacity and economic burden. People from sub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus (HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIV infection and anti-retroviral treatment (ART) in altered cardiovascular risk is questionable and there is still need to further carry out research in this field. However, thus far it is unclear, what impact the COVID-19 co-infection in people living with HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims to investigate whether and how HIV-infection in COVID-19 patients modulates the time course of the disease, alters cardiovascular risk, and changes vascular endothelial function and coagulation parameters/ thrombosis risk. Methods: In this long-term study, cardiovascular research on PLHIV with or without ART with COVID-19 and HIV-negative with COVID-19 will be carried out via clinical and biochemical measurements for cardiovascular risk factors and biomarkers of cardiovascular disease (CVD). Vascular and endothelial function will be measured by brachial artery flow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, and retinal blood vessel analyses, along with vascular endothelial biomarkers and cogualation markers. The correlation between HIV-infection in COVID-19 PLHIV with or without ART and its role in enhancement of cardiovascular risk and endothelial dysfunction will be assessed. Potential changes in these endpoints by COVID-19 will be followed for 4 weeks across the three groups (PLHIVwith or without ART and HIV negatives). Impact of project: The ENDOCOVID project aims to evaluate in the long-term the cardiovascular risk and vascular endothelial function in PLHIV thus revealing an important transitional cardiovascular phenotype in COVID-19.

MthathaStart: February 2021
PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia

Background: Tuberculosis (TB) is a health threat for people living with human immunodeficiency virus (HIV). People living with HIV are more likely than others to develop active TB. Also, TB makes HIV progress faster. TB is a leading cause of death among people in the West African country of Liberia. Researchers want to find an effective testing method for latent tuberculosis infection (LTBI) to help people living with HIV in Liberia. Objective: To compare the interferon-gamma release assay (IGRA) and tuberculin skin test (TST) as LTBI screening tests in people living with HIV in Liberia. Eligibility: People ages 18 and older who take part in NIH study #19-I-N014 and are scheduled to have or have had IGRA at a Month 12 HONOR study visit. Design: Participants will be screened with a medical history and physical exam. Their medical records and HONOR study records will be reviewed. Participants will have TST. Purified protein derivative will be placed in the skin of their forearm. They will be observed for adverse reactions for 15 minutes. Between 48 and 72 hours after placement, they will have a second study visit to have the TST read. If they miss this time frame, they can return up to 7 days after placement. If they have a positive test result, they will have a chest x-ray. They will have a third study visit to review the results of the chest x-ray. They will be referred for clinical care if needed. They will take a pregnancy test if needed. Participation will last from 2 days to 6 weeks.

MonroviaStart: September 2021
Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

Background: People with chronic illness often are at risk for developing neurobehavioral problems due to effects of the disease or associated treatments. These problems may include cognitive impairments involving problem-solving, remembering things, paying attention, and understanding and using language, or emotional functioning or quality of life. The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group has collected data from neurobehavioral evaluations of infants, children, adolescents and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to collect data from patients enrolled in current protocols. The data from these evaluations, along with demographic and medical information are stored in an NIH computer database. Investigating the neurobehavioral functioning of patients with chronic illness is important for identifying and monitoring the effects of the disease and treatments over time, determining possible at-risk subgroups, evaluating response to therapy, and recommending educational and rehabilitative interventions. Objectives: -To learn about how certain illnesses or treatments may affect a person s cognitive abilities, emotional functioning and quality of life. Eligibility: Patients currently enrolled in NIH studies who are having neuropsychological testing or completing quality-of-life questionnaires as part of that study. Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past or future NIH protocol. Design: This study does not involve any extra tests or questionnaires; it uses information collected from evaluations that subjects have already completed or will complete as part of other NIH studies. Information about participating patients that may help elucidate how cognitive abilities, emotional functioning, and quality of life are affected in people with chronic illness may be collected and stored.

Bethesda, MarylandStart: March 2007