Active clinical trials for "HIV Infections"

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

Indonesia is not yet on course to end HIV and AIDS by 2030. Epidemic transmission of HIV infection among key affected populations (KAPs), specifically FSWs, crucially has contributed to not achieving the target. Although the number of HIV tests performed annually has grown steadily in recent years, reaching 3,077,653 in calendar year 2018, pregnant women is accounted for a fairly large proportion of an increased number of persons being tested (MoH, 2018). Regarding the FSWs, it has been a significant challenge to increase HIV testing uptake among this population. The challenge has been affected by Indonesia's national policy to close brothels. As consequence, many FSWs have become hidden and hard to reach. The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground, especially many FSWs utilize the new popularity of digital platforms to sell sexual services. It needs more effective case finding strategies to be implemented to reach them accordingly. If it is considered from the FSWs side, there are some barriers to access HIV test services according to several reports. They consist of lack of money, time, stigma, discrimination, low-risk perception, fear, lack of accessibility, reluctance of health service providers to offer HIV testing and limited human resources. Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing (UNAIDS, 2016). For this study, OraQuick is used as an alternative strategy for HIV testing among FSWs. The primary objectives of this study are to assess whether proportion of FSW, who know their HIV status, increases or not; whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not; and whether "assisted" or "unassisted" community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not. Furthermore, CBS study aims to assess whether "assisted" and "unassisted" community HIV screening results to an increasing number of HIV positive case finding or not; and whether community HIV screening increases proportion of initiation of antiretroviral therapy (ART) or not. The secondary objectives of this study, meanwhile, are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs, who has participated, towards the delivery of community-based self-screening. Regarding the inclusion criteria of this study, participant must be women 18 years old or older at enrollment; has a transactional sex (vaginal, oral and/or anal) at least once in the past month; does not uptake HIV test in the last 6 months; and acknowledges her HIV status 'negative' or 'unknown'. There are several exclusion criteria, which are FSW does not able to fulfill one of inclusion criteria that has been explained above; FSW does not has desire to participate due to several reasons; and she is currently participating in another HIV prevention study. Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing; who receive assisted and unassisted self-testing. Moreover, it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing; proportion of FSWs who receive HIV test out of those who got offered for the test (including self-testing) in the intervention group with proportion of FSWs who receive HIV test in the control group; the proportion of FSWs taking confirmatory test (including self-testing) out of those receive the test in intervention groups and control group. It compares, furthermore, the proportion of HIV positive in the assisted, unassisted (intervention) and HIV positive in the control group. This study also compares ART initiation in the assisted, unassisted (intervention) and the control group. Additionally, it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted, unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group. It calculates, lastly, the cascade of HIV testing and treatment.

Background: Several major studies have demonstrated the success of Truvada as pre-exposure prophylaxis (PrEP) in preventing HIV infection.The CDC guidelines recommend PrEP for people who are at elevated risk of HIV including men who have sex with men (MSM) and people who use injection drugs. People who are incarcerated bear a disproportionate of disease burden, including HIV. Furthermore, men who have been involved with the criminal justice system are more likely to engage in risky behaviors following their release, including condomless sex with partners of unknown serostatus, and injection drug use. The incarceration setting provides a place to engage men who may be at risk of HIV after they are released. Following release, community clinics, including the STD clinic at The Miriam Hospital (TMH) Immunology Center, that perform routine testing for HIV and other sexually transmitted diseases (STDs) may be ideal settings to engage vulnerable populations in care, including PrEP. Despite the demonstrated clinical efficacy of PrEP in reducing HIV transmissions, few clinical programs have piloted the use of PrEP in real-world settings, particularly criminal justice settings. Furthermore, studies demonstrate numerous challenges to PrEP uptake and adherence, including a lack of access or discontinuing care. Engaging at risk men in PrEP care before they leave prison and potentially lost to care during the transition may increase uptake, adherence, and retention. Objective: This study protocol will evaluate a clinical program that aims to prevent new HIV infections among recently-incarcerated men using a once daily dosing of tenofovir/emtricitabine (Truvada) as pre-exposure prophylaxis (PrEP). This protocol presents an overview of the clinical program, which uses standard-of-care clinical practices and Centers for Disease Control and Prevention (CDC) guidelines for prescribing and monitoring PrEP. Male inmates at the Rhode Island Department of Corrections (RIDOC) will be screened for HIV risk and, if eligible and interested, will be prescribed and given a one-month supply of PrEP shortly before their release, and receive follow up care at The Miriam Hospital (TMH) Immunology Center following their release.

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

"Enhancing a universal testing and treatment strategy in jail to promote viral load suppression among justice-involved people living with HIV" is an observational research study led by Dr. Matthew Akiyama, MSc of Albert Einstein College of Medicine and Montefiore Medical Center and Dr. Anne Spaulding, MPH of Emory University's Rollins School of Public Health. Due to the high rates of undiagnosed Human Immunodeficiency Virus (HIV) in the correctional setting and the short length of stay in jails, this study aims to evaluate whether care coordination within the D.C. Central Detention Facility (DC DOC) and upon release, including testing procedures and antiretroviral therapy (ART) initiation, can improve the connection of adults (age 18 and over) living with HIV to care in the community. The researchers will retrospectively look at the aggregate-level de-identified data of roughly 3,000 individuals admitted to the DC DOC over a 6-month period to determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting. Over the course of these 6 months, the correctional facility will transition from using POC only to POC + antigen/antibody (Ag/Ab), to solely using Ag/Ab, each for a 2-month duration. Individuals from this time period who are identified by corrections staff as HIV-positive either through testing upon admission, their electronic medical record (EMR) or self-report, and have a known release date will be considered eligible for the follow-up study to assess if care coordination is effective in linking others with HIV leaving the DC DOC to care. This follow-up will enroll 100 of these individuals who have consented to participate following their release from the DC DOC, and will consist of a chart review of their DC DOC EMRs and those from their community healthcare provider for up to two years after their release.

The primary objective of this study is to examine acceptability, patterns of use, rates of adherence, safety , and measured levels of drug when high risk men who have sex with men (MSM) are provided open-label tenofovir/emtricitabine (TDF/FTC) for PrEP in South Korea. Secondary objectives are 1) to evaluate HIV incidence among study participants, 2) to evaluate risk behavior and risk compensation among study participants, and 3) to identify barriers and facilitators of PrEP among study participants. The design of this study is a prospective, open-label cohort study assessing PrEP implementation in tertiary hospital infectious diseases clinics in South Korea for 1 year. Baseline data will be collected 1 months before initiation of PrEP, and the date of initiation of PrEP. All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects, adherence, and HIV acquisition risk behaviors. Drug concentration will be measured every 6 months. It is anticipated that approximately 100 Korean MSM will be enrolled in this study.

The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra

The prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index [BMI] >25 kg/m2) and obese (BMI >30 kg/m2) HIV-infected individuals has been rising over time and is reaching parity with the general population. Adipose tissue has broad effects on immune function relevant to HIV infection, including the basal inflammatory state and peripheral lymphocyte populations, but there are few data on the effects of high adiposity on HIV immunology. This issue is directly relevant to promoting the long-term health of ART-treated individuals, many of which can now survive for decades on treatment, as emerging evidence suggests that increased immune activation is a major risk factor for the development of cardiovascular and metabolic diseases in this population. HIV-infected individuals on ART have an approximately 2-fold higher risk of myocardial infarction and a 4-fold higher risk of type 2 diabetes mellitus, and the proportion of deaths among HIV-infected individuals due to non-AIDS conditions now exceeds those due to AIDS. Despite the increasing proportion of overweight and obese HIV-infected persons, few prior studies have investigated the interaction between adipose tissue, immune activation, and risk factors for cardiovascular and metabolic disease in treated HIV. The overall goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. To this end, we will use an observational, cross-sectional cohort design to compare in vivo markers of immune activation, ex vivo cytokine expression, and metabolic and cardiovascular disease markers in HIV-infected individuals with a range of body composition profiles and between overweight/obese HIV-infected and uninfected individuals.

HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.

The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. This is a two-stage cluster sampled cross-sectional survey of 6,417 randomly selected households in Swaziland. Approximately 20,292 eligible persons will be approached (4,664 participants 0-14 years; 12,563 participants 15-49 years; 3,065 participants 50 years and older). Of the sample approached, 15,403 are expected to agree to a blood draw for home-based HIV rapid testing including 3,361 participants 0-14 years; 9,680 participants 15-49 years; and 2,362 participants 50 years and older. SHIMS 2, 2016 will characterize HIV incidence, prevalence, viral load suppression, cluster of differentiation 4 (CD4) T-cell distribution, and risk behaviors in a household-based, nationally-representative sample of the Swazi population and will describe uptake of key HIV prevention, care, and treatment services.