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NCT ID: NCT06157281 Enrolling by invitation - Hiv Clinical Trials

Positive Deviance to Improve Retention in HIV Care HIV Care in South Africa

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot trial is to test the effectiveness of a newly developed multicomponent clinic-level intervention for improving retention in HIV care among people living with HIV in South Africa. The intervention was developed based on intensive study of clinics with high retention rates. The main questions this study aims to answer are: 1. Does the intervention improve retention in HIV care for people living with HIV (PLWH)? 2. Does the intervention improve viral load suppression for PLWH on antiretroviral therapy? The intervention, called "Connect," consists of several strategies within three domains, as follows: Domain 1: Engage, Encourage, Support Staff Strategy 1a: Monthly staff huddle with staff recognition activities and compassion-focused rounds Strategy 1b: Compassion training Domain 2: Create a welcome physical environment Strategy 2a: Aesthetic improvements toward a warm, welcoming environment Domain 3: Expedite and augment workflow practices Strategy 3a: Pre-pull patient folders; hold folders for immediate tracking; map patients to identify locations Strategy 3b: Integrate welcome-back services for those who miss follow-up appointments HIV staff at three clinics with below-average retention rates who consent to participate will take part in intervention activities. Results will be compared to those of all other lower-retention clinics within the same health system.

NCT ID: NCT06037564 Enrolling by invitation - HIV Clinical Trials

B-free Multistage Trial

B-free
Start date: November 13, 2023
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of a booster-free regimen including DOR/DTG/3TC among HIV-suppressed PLWH with previous virological failure. The key secondary objectives are i) to determine whether switching to DOR / DTG / 3TC leads to lower burden of DDI compared to continuing a booster-containing regimen, and ii) to assess changes in patient perception on treatment acceptability and satisfaction, as well as health-related quality of life after a switch to booster-free ART. Qualitative sub-study: Qualitative objectives will be met using semi-structured interviews. Thirty people (15 from the intervention arm, 15 from the control arm) will be interviewed twice, at week 0 and week 48. Additional 15 individuals from the observational cohort will be interviewed once. Interviews will take place following study visits and performed using semi-structured guides. The guide for the interviews at week 48 will be based on results from analyses of the interviews conducted at week 0.

NCT ID: NCT05852860 Enrolling by invitation - HIV Clinical Trials

A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

NCT ID: NCT05704764 Enrolling by invitation - HIV Clinical Trials

Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances

IRIS
Start date: February 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test an intervention to reduce stigma among people living with HIV who use opioids and cocaine. The main question it aims to answer is: - Does reducing internalized stigma about HIV and/or drug use lead to improved HIV care outcomes? After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances, 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention. The intervention itself will consist of less than ten group-based meetings to discuss and work through the stigmas people commonly associate with HIV and/or drug use.

NCT ID: NCT05694637 Enrolling by invitation - Hiv Clinical Trials

Botswana Smoking and Abstinence Reinforcement Trial

BSMART
Start date: July 25, 2023
Phase: Phase 4
Study type: Interventional

Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.

NCT ID: NCT05584397 Enrolling by invitation - HIV Clinical Trials

Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART

Start date: September 1, 2022
Phase:
Study type: Observational

The goal of the project is to determine the difference in immune activation and HIV reservoir size between People living with HIV (PWH) on tenofovir-containing antiretroviral therapy (ART) versus PWH on nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART. Tenofovir (TFV), a phosphonated nucleoside reverse transcriptase inhibitor (NRTI), is being used for oral pre-exposure prophylaxis (PrEP). The investigators will test this hypothesis: tenofovir, and perhaps NRTIs in general, stimulate a type I/III interferon also in PWH who take these drugs. Because chronic interferon stimulation may promote the survival and proliferation of cells with integrated provirus, the investigators also hypothesize that these drugs antagonize decay of the HIV latent reservoir in PWH on ART. Consequently, the researchers hypothesize that PWH who have switched from NRTI-containing ART to NRTI-sparing ART exhibit lower type I/III interferon pathway activation and lower latent HIV reservoir size. The investigators also hypothesize that independently of treatment, the extent of type I/III interferon activation correlates with latent HIV reservoir size. Thus, the proposed study seeks to answer these two questions. Can the gastrointestinal epithelium be impacted by ART, and contribute to chronic immune activation and expansion of the HIV-1 reservoir? If so, what therapeutic approaches can the investigators implement to reduce the HIV-1 proviral load? The data will reveal pathways that can be targeted therapeutically to treat chronic immune activation in PWH. The findings of this study will immediately translate to optimize the standard of care in PWH.

NCT ID: NCT05540964 Enrolling by invitation - HIV Clinical Trials

An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy

Start date: July 19, 2022
Phase:
Study type: Observational

To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.

NCT ID: NCT05529342 Enrolling by invitation - HIV Clinical Trials

Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T

Start date: August 29, 2022
Phase:
Study type: Observational

Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.

NCT ID: NCT05463692 Enrolling by invitation - Hiv Clinical Trials

CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama

CAMELLIA
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.

NCT ID: NCT05376371 Enrolling by invitation - HIV Clinical Trials

Criminal Justice Coordinated Transitional Care

CJC-TraC
Start date: November 29, 2022
Phase: N/A
Study type: Interventional

This project aims to enroll 220 incarcerated individuals living with HIV, Hepatitis C (HCV), or history of substance misuse preparing for release into a pilot implementation study to test the feasibility and acceptability of an adapted Coordinated Transitional Care intervention in a Criminal Justice setting (CJC-TraC). Participants can expect to be on study for up to 6 months.