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HIV Infections clinical trials

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NCT ID: NCT04408729 Completed - HIV/AIDS Clinical Trials

PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

Start date: August 10, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04406727 Not yet recruiting - HIV-1 Infection Clinical Trials

UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

NCT ID: NCT04405700 Recruiting - Pregnancy Related Clinical Trials

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

MANGO
Start date: September 29, 2020
Phase:
Study type: Observational

The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

NCT ID: NCT04401917 Recruiting - HIV Infections Clinical Trials

Evaluation of Neuroinflammation FNOS PET/CT in HIV (+) and (-) Subjects With OUD and Healthy Controls

Start date: December 7, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of [18F]NOS. Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.

NCT ID: NCT04399551 Completed - HIV Infections Clinical Trials

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Start date: September 28, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.

NCT ID: NCT04396678 Completed - HIV/AIDS Clinical Trials

Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

PEARL
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

NCT ID: NCT04393935 Recruiting - Clinical trials for Human Immunodeficiency Virus

Pharmacy-based Pre-exposure Prophylaxis

Start date: May 19, 2022
Phase: N/A
Study type: Interventional

The proposed research will develop a culturally appropriate pharmacy PrEP delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.

NCT ID: NCT04385719 Completed - HIV/AIDS Clinical Trials

Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy

RemTLAR
Start date: May 5, 2021
Phase: Phase 2
Study type: Interventional

Ebola and HIV are found predominately in the same regions of the world and countries in sub-Saharan Africa are most affected by both diseases. For Ebola, no approved therapies exist. However, new investigational drugs are being evaluated to understand if they are effective against the Ebola virus. Remdesivir is an anti-Ebola investigational drug for the treatment of Ebola. Little is known about how the blood levels of remdesivir relate to how effective it is in patients with HIV taking antiretroviral therapy. This study will explore how commonly utilized ART (tenofovir/lamivudine and atazanavir/ritonavir) affect the drug levels of remdesivir.

NCT ID: NCT04383769 Active, not recruiting - HIV Infections Clinical Trials

Differentiated Service Delivery for Antiretroviral Therapy

Start date: December 15, 2019
Phase:
Study type: Observational

This study is a prospective observational cohort. The target study population is PLHIV who receive ART at hospitals and community-based organizations (CBOs) in Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. Participants will receive ART service in the same standard as in the hospital setting. Secondary data will be collected from the medical records already existed in the hospital and CBO systems.

NCT ID: NCT04383223 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus

iTransition Development

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Youth living with HIV are at high risk of falling out of care when they transition from pediatric to adult care. The investigators are proposing to develop a mobile app to help both clinical providers and patients navigate this process.