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NCT ID: NCT05006625 Completed - Depression Clinical Trials

Implementation of a Collaborative Care Model to Manage Depression Among Adolescents and Young Adults in HIV Services in Thailand

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

This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are seeking HIV treatment and prevention services at a hospital in Bangkok, Thailand. Analyses will be guided by the consolidated framework for implementation research (CFIR), which will include the identification of facilitators and barriers to implementation of this CCM. In the last 3 years, 10-20% of AYA patients at King Chulalongkorn Memorial Hospital (KCMH) who seek HIV treatment or prevention services suffer from mental health disorders. As a result, CCM integration for depression screening and treatment was implemented at the 'CU Buddy Clinic' KCMH with the ultimate goal of increasing access to and engagement in mental healthcare with a goal to improve the overall quality of life for Thai AYA. This project will inform a future implementation science study that will focus on how the optimization of integrated mental healthcare into routine AYA HIV treatment and prevention services can impact health outcomes for patients, including ART adherence and long-term viral suppression (AYA living with HIV) and HIV acquisition risk behaviors and PrEP adherence (AYA at risk for HIV).

NCT ID: NCT05006391 Completed - Hiv Clinical Trials

Tele-Coaching Community-Based Exercise (CBE) Study

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

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

NCT ID: NCT05005130 Completed - HIV Clinical Trials

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

TASKPEN
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".

NCT ID: NCT05001373 Active, not recruiting - Hiv Clinical Trials

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

Start date: November 12, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

NCT ID: NCT04999137 Recruiting - HIV Clinical Trials

Evaluation of Safety and Dosing of a Vitamin C Bundle for Sepsis Treatment in Africa

REVISTA-DOSE
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

Open-label phase 2a Randomized Controlled Trial (RCT) assessing the pharmacokinetics of two different doses of intravenous vitamin C given alongside vitamin B1 in adult medical patients with sepsis and hypotension.

NCT ID: NCT04993820 Not yet recruiting - HIV Clinical Trials

The Effects of a Mobile-Application Based Physical Activity Intervention in PLWH

Start date: August 2021
Phase: N/A
Study type: Interventional

A series of adverse physical and mental health effects are often reported among people living with HIV (PLWH) as a consequence of the infection and ART use. Physical activity (PA) has been linked to improved physical an mental health in PLWH. However, Most interventions in the HIV literature evaluating the effects of PA on physical and mental health have included face-to-face supervised exercise in highly controlled environments which is not representative of how the majority of this population engages in PA. Mobile application (app) and text-message based PA interventions are a safe and innovative approach for the delivery of PA programs aimed at improving physical and mental health without the need of direct supervision. Nonetheless, the use of these types of interventions have not been well evaluated in PLWH. Therefore the purpose of this study is to evaluate the effects of a 12-week mobile app and text-based PA intervention on physical and mental health in PLWH. Participants in the PA group will be given a PA program delivered through a mobile health app which will be accessed through smartphones. As part of the program, weekly text messages will be sent to encourage PA participation. The goal of the intervention is to increase moderate to vigorous PA (MVPA) by at least 150 weekly/mins. The PA program will also include muscle strengthening exercises. Investigators expect improvements in mental health outcomes (i.e., depressive symptoms and HRQoL) and cardiometabolic outcomes (i.e., cardio-autonomic function, body fat percentage, physical activity, and functional exercise capacity) in the PA group when compared to the CON group at the end of 12-weeks.

NCT ID: NCT04991402 Recruiting - Obesity Clinical Trials

Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir

ORCHID
Start date: September 21, 2021
Phase:
Study type: Observational

A total of 1900 pregnant women in the 1st trimester and their children will be enrolled and followed for two years (ORCHID study main cohort). As part of this, mother-infant pairs will be required to attend up to 10 study visits separate from routine clinic visits, these visits include 3 antenatal visits (less than or equal to 18, 24-28 and 32-36 weeks) and 16 postnatal visits (<2 and 6 weeks, 3, 6, 12, 18, and 24 months). Participants will also be asked to engage in long-term follow-up, with visits occurring every 6 months through Month 60 (at 30, 36, 42, 48, 54, and 60 months). Measurements in mothers will include demographics and health status, HIV disease and ART use, intercurrent medical history including concomitant medication use, HIV viral load testing, ART adherence, HIV antibody testing in women without HIV; body composition, caloric intake, dysglycemia and insulin resistance (IR), lipid profiles, anthropometry, resting energy expenditure, hepatic steatosis, specimen collection (whole blood, plasma, serum, urine, placenta and breastmilk), systemic and adipose inflammation, as well as metabolites, lipid subspecies and eicosanoids. Measurements in infants will include uterine gestational age and fetal growth, as well as metabolites, lipid subspecies and eicosanoids, body composition, dysglycemia and IR, lipid profiles, anthropometry, feeding, specimen collection (cord blood, whole blood, plasma and serum) and intercurrent medical history including concomitant medication use. Additional data on maternal health in pregnancy and birth outcomes will be abstracted from medical records.

NCT ID: NCT04983030 Recruiting - HIV Clinical Trials

Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults

Start date: April 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).

NCT ID: NCT04982614 Active, not recruiting - Hiv Clinical Trials

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

This is a multi-site, open-label non-inferiority study of the 9vHPV vaccine among a population of children, adolescents and young women living with HIV in Eswatini. This protocol seeks to assess immunogenicity of a two-dose 9vHPV vaccine regimen among girls and boys (9-14 years) and young women (15-26 years) living with HIV on antiretroviral therapy versus a three-dose 9vHPV vaccine regimen among HIV uninfected young women (15-26 years) in Eswatini. The secondary objectives include examining the safety profiles of the two-dose 9vHPV regimen in those living with HIV and the three-dose 9vHPV regimen in HIV-uninfected young women, as well as measuring the completion of the vaccination series among those living with HIV and those who are not infected with HIV.

NCT ID: NCT04958889 Completed - HIV Clinical Trials

COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

Start date: June 11, 2021
Phase:
Study type: Observational

This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.