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HIV clinical trials

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NCT ID: NCT06395129 Not yet recruiting - Hiv Clinical Trials

Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries

Start date: September 2024
Phase:
Study type: Observational

Implementation and evaluation of a distribution program for low dead-space syringes/needles (LDSS/N) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS/N distribution programs which will enhance acceptability and sustain high levels of LDSS/N uptake. People who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS/N. Throughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program. Primary outcomes assessed through this study include 1) community values and preferences for LDSS/N, 2) barriers and facilitators to accessing LDSS/N, 3) feasibility and effectiveness of the distribution program on increasing LDSS/N uptake, 4) model the potential public health impact and cost effectiveness of LDSS/N distribution in this setting.

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: NCT06389565 Not yet recruiting - Depression Clinical Trials

Pilot Randomized Clinical Trial of Change My Story

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.

NCT ID: NCT06375122 Not yet recruiting - HIV Clinical Trials

Natural History Study of Kaposi Sarcoma

Start date: May 8, 2024
Phase:
Study type: Observational

Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. Objective: To learn more about the natural history of KS. Eligibility: People aged 18 years and older with KS. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: Eye exam. Ultrasound exam of the heart (electrocardiogram). Collection of saliva and urine samples. Biopsies of the skin or lymph nodes. Swabs of the anus and cervix. Photographs of skin lesions. Removal of fluid samples from the space around the lungs, intestine, or heart. The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. Participants will follow their standard treatment for KS during the study.

NCT ID: NCT06370481 Not yet recruiting - Hiv Clinical Trials

HIV, Equity, and Addiction Training (HEAT) Program

HEAT
Start date: June 2024
Phase: N/A
Study type: Interventional

This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama.

NCT ID: NCT06366386 Not yet recruiting - Hypertension Clinical Trials

Integrating Hypertension Management in DSD for HIV

HTN-DSD
Start date: May 1, 2024
Phase:
Study type: Observational

The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are: 1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care? 2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care? 3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda? 4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda? 5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda? 6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda.

NCT ID: NCT06350682 Not yet recruiting - Hiv Clinical Trials

Resilient HIV Implementation Science With SGM Youths Using Evidence

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

The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.

NCT ID: NCT06340698 Recruiting - HIV Clinical Trials

An RCT to Improve HRQoL of HIV+ Mothers and Children

Start date: February 20, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China. The main questions it aims to answer are: 1. Whether baseline resilience and treatment adherence are associated with the HRQoL; 2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping; 3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping; 4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups; 5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups. Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.

NCT ID: NCT06335121 Not yet recruiting - HIV Clinical Trials

Implementation of PrEP Care Among Women in Family Planning Clinics

Start date: September 2024
Phase: N/A
Study type: Interventional

This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.

NCT ID: NCT06332339 Recruiting - HIV Clinical Trials

Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.

Start date: April 10, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question[s] it aims to answer are: - Are these vaccine regimens safe and well tolerated? - Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.