View clinical trials related to HIV/AIDS.
Filter by:Background: This is a pilot randomized clinical trial (RCT) to demonstrate the feasibility and acceptability of a structural and behavioral intervention to reduce mortality following hospital discharge for people with HIV (PWH) in South Africa. Investigators' prior study showed that among 121 PWH discharged, 54% were readmitted and 26% had died by six months following discharge. In the prior study, investigators identified that missing clinic visits after discharge was associated with death. Here investigators are seeking to overcome key barriers in piloting a home-based post-hospital care intervention. Investigators' approach is informed by a conceptual model of key barriers to the care transition along with a behavioral explanatory model, the Behavioral Model for Vulnerable Populations. The overarching goal of this study is to tailor and pilot the intervention that shifts initial post-discharge care from the out-patient clinic to the home and provides patient-centered counseling (Home Link intervention). For the intervention to prove effective it will need to substantially reduce post-discharge mortality. Specifically, in the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed. Aims: The aims of the study are to pilot a randomized clinical trial of home delivery of health services during the post-hospital period for PWH. Methods: This project is a pilot randomized clinical trial (RCT) to refine and test the feasibility, acceptability, and preliminary effectiveness of the HomeLink intervention. At the conclusion of the R34 grant period investigators will have a protocol and procedural manual ready for a full RCT powered for effectiveness. Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, tuberculosis (TB), and sexually transmitted infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses."
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.
This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.
This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.
The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).
This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.
The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of community-based HIV and NCD care with group microfinance will improve retention in care and rates of viral suppression (VS) among people living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and easier access to care. The specific aims are as follows: 1. To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) standard care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving standard care and not involved in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is that A > B > C in terms of viral suppression and retention in care. 2. To identify specific mechanisms through which microfinance and integrated community-based care impact VS. Using a mixed methods approach, the study will characterize the mechanisms of effect on patient outcomes. Investigators will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). Investigators will also use qualitative methods and multi-stakeholder panels to contextualize implementation of the intervention. 3. To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. The working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved. The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.