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HIV Infections clinical trials

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NCT ID: NCT06393387 Not yet recruiting - HIV Infections Clinical Trials

Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States

Start date: June 1, 2024
Phase:
Study type: Observational

This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States

NCT ID: NCT06388109 Not yet recruiting - HIV Infections Clinical Trials

Positive Peers Intervention Clinical Trial

PoPIT
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV. Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma? Participants will: - download the mobile app onto their personal smartphone - Use the mobile app as they find useful - complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months.

NCT ID: NCT06375304 Not yet recruiting - HIV Infections Clinical Trials

The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study

Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).

NCT ID: NCT06374758 Recruiting - HIV Infections Clinical Trials

Accelerated ART Initiation for PWHIV Who Are Out of Care

ACCELERATE
Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.

NCT ID: NCT06370923 Not yet recruiting - HIV Infections Clinical Trials

Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention

IMPERATIVE
Start date: July 2024
Phase: N/A
Study type: Interventional

Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA. The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe. The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving >80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high.

NCT ID: NCT06370780 Recruiting - HIV Infections Clinical Trials

Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically

EPI-LoVE
Start date: February 9, 2024
Phase: N/A
Study type: Interventional

Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.

NCT ID: NCT06368986 Not yet recruiting - HIV Infections Clinical Trials

A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants

Start date: April 16, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.

NCT ID: NCT06368453 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus I Infection

A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing. The study aims to: To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results). To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.

NCT ID: NCT06353295 Recruiting - HIV/AIDS Clinical Trials

Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study

P4P
Start date: April 24, 2024
Phase: N/A
Study type: Interventional

The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention.

NCT ID: NCT06347146 Not yet recruiting - HIV/AIDS Clinical Trials

Bridges2Scale: Testing Implementation Strategies

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS [AYaAIDS] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome). Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect.