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HIV Infections clinical trials

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NCT ID: NCT06005298 Recruiting - HIV Infections Clinical Trials

Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention

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

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.

NCT ID: NCT06003192 Not yet recruiting - HIV Infections Clinical Trials

Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention

S2P
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question[s] it aims to answer are: 1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process? 2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will 1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history 2. Have the opportunity to opt-out of clinician-ordered HIV testing 3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment.

NCT ID: NCT06002126 Recruiting - HIV Infections Clinical Trials

Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

Cervical cancer is a relatively common cancer among women living with human immunodeficiency virus (HIV). This study will test women for human papillomavirus (HPV) infection of the cervix. The main purpose of this study is to determine the best way to test for damaged areas of the cervix. Damaged areas of the cervix should be treated and removed to prevent cancer of the cervix. Women in this study will be seen once, twice or three times in a year. Women will provide several samples related to screening for cervical cancer including a swab of the cervix, a self-collected swab of the vagina and urine. Women will have a detailed examination of the cervix called colposcopy and have a few biopsies, or small pinches of the cervix, to look for areas at risk for turning into cancer. If HPV of the cervix is found but treatment of the cervix is not indicated, women will return in 6 months and in 12 months to repeat these tests. Most women will only need 1 visit. Women found to have damaged areas of the cervix at risk for turning into cancer will be referred for treatment. This protocol will compare different tests to understand the best test to identify women at risk for cervical cancer.

NCT ID: NCT05996471 Active, not recruiting - HIV Infections Clinical Trials

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

EMBRACE
Start date: August 17, 2023
Phase: Phase 2
Study type: Interventional

The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV.

NCT ID: NCT05996094 Recruiting - HIV Infections Clinical Trials

Antiretroviral Adherence and Drug-level Monitoring

Start date: October 16, 2020
Phase:
Study type: Observational

This observational study aims to investigate medication adherence and drug-level monitoring of antiretroviral agents in a cohort of people living with HIV in Indonesia. The study is conducted in outpatients receiving tenofovir-based regimens in a university medical centre.

NCT ID: NCT05996081 Not yet recruiting - HIV Infections Clinical Trials

Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The goal of this usability study and a cluster randomised controlled trial is to investigate the effectiveness of an adherence toolkit as a decision support tool to improve adherence to antiretroviral therapy. The main questions it aims to answer are: 1) is the adherence toolkit useable and acceptable among HIV care providers in Indonesian clinical practice? and 2) is the adherence toolkit superior than the usual care in improving adherence to antiretroviral therapy among people living with HIV in Indonesia? HIV clinics in Surabaya, Indonesia, will be recruited to participate in the study. HIV care providers will be included in the usability study, whereas people living with HIV will be enrolled in the cluster randomised controlled trial. People living with HIV will be randomly assigned in a 1:1 ratio to the control group receiving usual HIV care and the intervention group receiving an intervention using the adherence toolkit in addition to usual HIV care.

NCT ID: NCT05996016 Recruiting - HIV Infections Clinical Trials

Gut and Vaginal Microbiota Profile Study for HIV Women

Start date: November 9, 2022
Phase:
Study type: Observational [Patient Registry]

Women Living with HIV Infection (WLHIV)are intended to acquire HPV infection which usually contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection,thereafter results in severe cervical lesion.

NCT ID: NCT05993767 Not yet recruiting - HIV Infection Clinical Trials

UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

UNIVERSAL1
Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.

NCT ID: NCT05991622 Recruiting - Clinical trials for Human Immunodeficiency Virus

Combined Injectable Treatment for HIV and OUD

CHOICE
Start date: April 1, 2022
Phase: Early Phase 1
Study type: Interventional

This is a one-year study that seeks to evaluate perspectives of combined injectable treatment for HIV and OUD. Specifically, with the development of new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine (XR-B) there is a need to better understand factors that influence the delivery and uptake of this type of treatment. Therefore, this study will conduct qualitative (1:1) interviews with 32-45 key stakeholders to assess interest, knowledge, attitudes, barriers, and facilitators to integrated injectable treatment. Our team will utilize qualitative findings to inform clinical strategies to promote uptake and maintenance of long-acting injectable medications for HIV and OUD.

NCT ID: NCT05983679 Not yet recruiting - HIV Infections Clinical Trials

Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population

PREMINF
Start date: December 4, 2024
Phase:
Study type: Observational [Patient Registry]

Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population