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285 active trials for HIV

Smoking Cessation for People Living With HIV/AIDS

In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke). Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.

Start: August 2013

Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer

Background: - There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful. Objective: - To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve communication about advanced care planning. Eligibility: - Adults 18 to 39 years old being treated for cancer. Design: Participants will answer questions about their age, gender, employment, religion, health, and marital status. They will also complete several brief questionnaires: General Anxiety Short Form Peace, Equanimity and Acceptance in the Cancer Experience Functional Assessment of Social Support Quality of Communication Prior Communication about Advanced Care Planning Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations. The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.

Start: April 2014

Clinical Outcomes of People Who Acquired HIV in Early Life

Background: - Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Researchers are interested in studying how HIV infection and the medicines used to treat it affect people who were infected early in life. They want to find out if there are any problems with how HIV-infected children grow and develop as adults, especially if they have developed heart problems. As part of this study, people with HIV will be compared with healthy volunteers. Objectives: - To study the effect of HIV infection and treatment on people who acquired HIV infection in early life. Eligibility: Individuals at least 18 years of age who acquired HIV infection in early life. Healthy volunteers at least 18 years of age without HIV will serve as controls Design: Participants will be screened with a physical exam and medical history. They will have regular study visits about once a year for up to 10 years to collect health information. Blood and urine samples will be collected to look at kidney and liver function. X-ray scans will be used to look at bone density and the amount of fat and muscle in the body. Treatment will not be provided as part of this study.

Start: August 2012

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.

Start: March 2007

Early Infant HIV Treatment in Botswana

The overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing future periods off ART.

Start: February 2015

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....

Start: June 2021

mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)

This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.

Start: November 2018

PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)

Background: There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there. Researchers want to collect health data from Liberians with HIV over several years. This may help HIV prevention and treatment programs in Liberia. Objective: To learn more about how HIV affects people in Liberia. Eligibility: People with HIV in Liberia Design: Participants will be screened with a blood sample. Participants will visit the study clinic about 10 times over 3 years. They will need to return to the clinic after some visits to get test results. The visits will be closer together during the first part of the study and less frequent later. At each study visit, participants will: Have a brief physical exam Answer questions about how they are feeling and what medicines they are taking Have blood taken from an arm vein by a needle Give urine samples Participants ages 12 years or older may be asked questions about HIV risk behaviors. These include sex practices and drug use. Participants ages 18 years or older may be asked how their HIV infection makes them feel emotionally. Participants may be asked to join a research substudy. This will be about tuberculosis (TB) testing in people with HIV. For this substudy, participants will have a TB skin test. A small amount of liquid will be injected under the skin on the arm. Participants will return to the clinic a few days later. The test area will be checked. They will get their test results.

Start: August 2019

Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)

The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.

Start: June 2018

To Reach Unrestricted Services for Transgender Women

Florida has the fifth largest transgender population in the United States. Transgender women, particularly those of color, in the southern part of Florida are a marginalized population who are impacted by co-morbidities of substance abuse and HIV in their communities. The overall objective of the study is to use a vetted adapted brief intervention to stem the development of substance abuse in at-risk transgender women, and thereby increase primary and secondary prevention methods such as routine HIV screening, uptake of pre-exposure prophylaxis (PrEP) and use of non-occupational post-exposure prophylaxis (nPEP).

Start: September 2019

A Study to Evaluate Virologic Response in Participants Newly Diagnosed With HIV-1

The purpose of this study is to determine the proportion of newly diagnosed participants with Human Immunodeficiency Virus (HIV)-1 (naive participants) with virologic response at Week 48-defined as HIV-1 Ribonucleic acid (RNA) less than (<) 50 copies/milliliter (mL) (Food And Drug Administration snapshot) - after the implementation of the Test & Treat model of care and in a historical cohort.

Start: December 2019

Promoting Reductions in Intersectional StigMa (PRISM) - GHANA

HIV prevalence among men with have sex with men (MSM) in Ghana is at least eight times higher than that of the general population (2%). MSM in Ghana face high levels of stigma due to HIV status (actual or perceived), same-sex behavior, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. In our preliminary work in Ghana (N=137), one-third of MSM had never been tested for HIV. This study is a randomized controlled trial to evaluate the feasibility, acceptability and estimate effect size of a multi-component, multi-level (organizational, interpersonal, and intrapersonal-level) intersectional stigma-reduction intervention to increase HIV testing frequency among MSM in Ghana where HIV, same-sex behavior and gender non-conformity are highly stigmatized. To date, stigma-reduction interventions in Ghana have focused on uni-level targets (e.g., health care facilities (HCFs)) and addressed one type of stigma (e.g., HIV), without engaging the intersectional character of the multiple stigmas that MSM encounter. Our specific aims are: to evaluate the feasibility and acceptability of a novel multi-component, multi-level intervention to address intersectional stigma. to estimate effect size of the intervention for scale up to a definitive efficacy trial. Our primary endpoint are: For MSM: HIV testing, intervention feasibility and acceptability For HCFs: intervention feasibility, acceptability and appropriateness Our secondary endpoints are: MSM: Intersectional stigma reduction HCF: Intersectional stigma reduction This study will combine three theory-based interventions that were previously implemented separately in Ghana for reducing stigma at HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Convergence Framework will be used for combining interventions. The ADAPT-ITT framework guides our approach to enhancing the interventions' content on intersectional stigma. To achieve these aims a systematic adaptation that will be used to refine the individually developed HCF, peer- and individual-level interventions to produce a comprehensive multi-level intersectional stigma reduction intervention.

Start: October 2020

HIV-related Insomnia and Inflammation

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.

Start: July 2021

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).

Start: September 2015

Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with very early HIV infection (estimated date of infection within the last 90 days). The primary aim of the study is to evaluate whether initiation of dolutegravir plus emtricitabine/tenofovir during acute/early HIV infection leads to protection of CD4+ T cells and other immune cells in the peripheral blood and lymphoid tissue from infection.

Start: December 2015

Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection

This study aims to evaluate the role of extracellular vesicles in HIV-infection, by determining the expression profile and content of EVs before and after treatment initiation in HIV-infected patients, through extensive blood and tissue sampling (leukapheresis, stool sampling and colon biopsies). A one-time sampling (blood, stool, colon biopsies) will also be performed in HIV-seronegative healthy volunteers to confirm that results found in HIV-infected patients are related to the disease.

Start: January 2021

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

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. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN 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 these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

Start: July 2021

Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.

Start: September 2021

A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV

More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

Start: March 2018

A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines

The object of the study is to assess the safety profile of candidate vaccines ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers. In addition, the study will assess the immune responses generated of the candidate vaccines ChAdOx1.tHIVconsv1, MV.tHIVconsv3 and MVA.tHIVconsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers. 3 healthy, HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1.tHIVconsv1. A further 10 healthy, HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1.tHIVconsv1, followed by one vaccination each of MVA.tHIVconsv3 and MVA.tHIVconsv4 4 weeks later.

Start: June 2021