Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat...
HIV InfectionsImplementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.
Buddhism Beliefs and HIV Stigma in Thailand
HIV InfectionsStigma2 moreThailand remains one of the countries with the largest population of people living with HIV (PLWH). It is estimated that 30 Thai provinces account for 75% of the HIV infections in that country, with ChiangMai as the most prevalent province in northern Thailand. Also, HIV/AIDS remains among the top 10 most common causes of death in Thailand. This high mortality rate may be partially explained by the notable HIV treatment cascade in Thailand: Among all the Thai PLWH, only 74% were retained in care, while 68% received ART, and roughly 50% reached viral suppression. An important reason for this is that HIV-related stigma still poses significant barriers for Thai PLWH to access healthcare and carry out health-protective behaviors, including adherence to medication schedules, to manage their HIV. In Thailand, substance use, including use of tobacco, alcohol, and other emerging recreational drugs, is a pressing health concern. In the HIV+ population in Thailand, it was found that 15% use tobacco, 70% use alcohol, and 2% use recreational drugs. In addition, among Thai HIV+ alcohol drinkers, about 13%-22% were heavy drinkers and 40% had sex under the influence of alcohol. Although the literature evaluating prevalence of substance use among Thai HIV+ individuals is emerging, the knowledge remains very limited regarding their risk and protective factors for substance use. Self-management interventions, typically include training modules for symptom management skills and coping strategies. In Buddhist-Thai culture, the goal of self-management may become assisting PLWH to find the peace and harmony within themselves by gradually "letting go" of those strong desires for certain materials or status that contribute to the uncertainty in lives. Therefore, this project aims to further the investigator's knowledge about self-management behaviors in HIV+ substance users in the context of Buddhist-Thai culture. The investigator aims to: 1. Explore how PLWH experience and interpret substance use, mental health, and self-management and identify key social-cultural factors that influence these factors. 2. Test the associations among mental health, substance use, self-management, health outcomes and selected key social-cultural factors among PLWH using a partial correlation network model. The results will be used for development of a culturally tailored, evidence-based self-management intervention to promote better health outcomes among Thai PLWH.
Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir...
HIV InfectionsThis is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections...
Human Immunodeficiency Virus Type 1 (HIV-1)This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable...
Human Immunodeficiency Virus Type 1 (HIV-1) InfectionThe goal of this clinical study is to learn more about the impact of cobicistat (COBI) (P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and strong cytochrome P450 enzyme [CYP]3A inhibitor), voriconazole (VOR) (strong CYP3A inhibitor), and rifabutin (RFB) (moderate CYP3A inducer) on the study drug, vesatolimod (VES), in people with HIV-1 on antiretroviral therapy (ART).
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants...
Human Immunodeficiency Virus Type 1The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir...
InfectionHuman Immunodeficiency Virus1 moreThe Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)...
HIV InfectionThis study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
Combinatorial Therapy to Induce an HIV Remission
HIV/AIDSCombination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).
Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program...
HivThe Ryan White HIV/AIDS Program (RWHAP) for low-income people with HIV (PWH) is a key resource for reducing HIV health disparities and scaling up evidence-based interventions. As RWHAP serves >50% of US PWH, RWHAP outcomes are vital to achieving "getting-to-zero"/ Ending the HIV Epidemic (EHE) Plan targets. As a grantee for RWHAP Part A (RWPA) funding distributed to the counties/cities severely affected by HIV, New York City (NYC) conducts regular HIV care continuum monitoring citywide and in its RWPA programs, which offer support services to reduce social and behavioral barriers to care/treatment. Local data consistently show lower viral suppression (VS) among RWPA clients in HIV care than among non-RWPA PWH in HIV care. Relative to NYC HIV cases overall, NYC RWPA clients (~14,000 per year) over-represent Black and Latinx PWH and high-poverty neighborhoods. To address local outcome disparities and to fill gaps left by data-to-care strategies and research focused on medical care (re-)linkage, the investigators propose to implement and rigorously evaluate the effectiveness of a novel 'data-to-suppression' (D2S) intervention among RWPA behavioral health and housing program clients who are in HIV care but unsuppressed. Surveillance-based reports on unsuppressed clients plus D2S capacity-building assistance will guide RWPA providers in targeting and delivering evidence-informed strategies to improve VS.