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HIV Infections clinical trials

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NCT ID: NCT04583267 Recruiting - HIV Infections Clinical Trials

HIV Pre-exposure Prophylaxis Implementation Study in South Korea

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04579146 Recruiting - HIV Infections Clinical Trials

Coronary Artery Disease (CAD) in Patients HIV-infected

CoroVIH
Start date: September 7, 2020
Phase:
Study type: Observational

HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

NCT ID: NCT04578145 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Community Based Screening for HIV Self Testing in FSW in 23 Priority Districts in Indonesia

CBS-FSW
Start date: April 17, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04577313 Recruiting - HIV Infections Clinical Trials

HIV Treatment Adherence Dose Determination Trial

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The proposed research will conduct the first dose-determination trial to find the optimal number of behavioral counseling sessions (dose) needed to achieve and sustain optimal HIV treatment adherence. The results of this study will determine how much intervention is needed for whom and at what cost to guide health policy and implementation of behavioral interventions designed to improve durable viral suppression.

NCT ID: NCT04568967 Recruiting - Tuberculosis Clinical Trials

TB-CAPT EXULTANT - HIV

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.

NCT ID: NCT04560621 Recruiting - HIV/AIDS Clinical Trials

Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.

NCT ID: NCT04560569 Recruiting - HIV/AIDS Clinical Trials

Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.

NCT ID: NCT04532970 Recruiting - HIV Infections Clinical Trials

BAPS in Botswana: The Thotloetso Trial

BOTS
Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The main purpose of this research study is to compare traditional behavioral smoking cessation therapy with a different type of behavioral therapy-known as behavioral activation problem solving (BAPS)-for smoking cessation. Standard smoking cessation counseling (SC) focuses on self-monitoring, identifying smoking triggers and how to manage them, relaxation and social support for non-smoking, and relapse prevention. BAPS focuses on recognizing he feelings you are having that lead to smoking and how to overcome those feelings and focus on activities that discourage you from smoking and avoid activities that encourage you to smoke. Both counseling types include gathering information about your personal smoking patterns, your likes, dislikes, and other personal characteristics about your lifestyle. Half of participants who enroll in the study will receive standard smoking cessation counseling (SC) and half will receive BAPS counseling. We will compare the rates of quitting smoking across the two groups at the end of treatment (study week 10), and 12 weeks after the end of treatment (study week 26)

NCT ID: NCT04523519 Recruiting - HIV Infections Clinical Trials

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

PRIME
Start date: April 30, 2021
Phase: Phase 4
Study type: Interventional

In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks. The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use. We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP.

NCT ID: NCT04518228 Recruiting - HIV Infections Clinical Trials

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Start date: September 1, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.