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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT06205511 Recruiting - Clinical trials for Human Immunodeficiency Virus

The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV

SWISH
Start date: April 1, 2023
Phase:
Study type: Observational

The study will evaluate 300 people living with HIV that attend the Vivent Clinic for HIV care. We will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, HPV vaccination status, other HPV disease, and lab values such as CD4 count and HIV viral load. We will compare results between participants who are HPV positive and negative. We will also evaluate the relationship between HPV oral infections and lesions and the variables above to better understand possible predictors of HPV infections and lesions.

NCT ID: NCT06176859 Recruiting - HIV Clinical Trials

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

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

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

NCT ID: NCT06139224 Recruiting - Clinical trials for Alcohol Use Disorder

Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 20 HIV+ ART+ (10 AUD- and 10 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept observational study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will have two study visits, where stool collection and blood draw will be collected, as well as questionnaires. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. We will recruit the following groups of participants: HIV+ ART+ AUD-; HIV+ ART+ AUD+; HIV- AUD- ; HIV- AUD+. Blood, urine, stool, and intestinal biopsies will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois. Second, lleal/colonic organoids from HIV- and HIV ART+ individuals will be generated to examine their resilience to alcohol-induced intestinal barrier disruption.

NCT ID: NCT06035445 Recruiting - HIV Clinical Trials

Support for Adolescents Living With HIV in South Africa

InTSHA VIP
Start date: February 2, 2024
Phase: N/A
Study type: Interventional

This is a cluster randomized controlled trial determining the effectiveness of in-person or mHealth-based adolescent-friendly transition interventions compared to standard care on retention in care and viral suppression among adolescents living with HIV who have low transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in KwaZulu-Natal, South Africa.

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: NCT05933226 Recruiting - Clinical trials for Human Immunodeficiency Virus

Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a stepped care behavioral intervention for HIV medication adherence and substance use ("Khanya") integrated into an HIV primary care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors with lived substance use experience (i.e., peers), using a task sharing, stepped care model in local primary care clinics. The Khanya stepped care package will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months.

NCT ID: NCT05850728 Recruiting - Clinical trials for Human Immunodeficiency Virus

First in Human Study of TLC-ART 101 (ACTU 2001)

Start date: April 1, 2023
Phase: Phase 1
Study type: Interventional

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.

NCT ID: NCT05841797 Recruiting - Clinical trials for Human Immunodeficiency Virus

Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya

Tatua
Start date: March 25, 2024
Phase: N/A
Study type: Interventional

This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial. The overall goal of this protocol is to determine whether risk stratification of PWLWH in conjunction with a tailored psychosocial support intervention can optimize health outcomes for the vulnerable women and infants. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties.

NCT ID: NCT05786547 Recruiting - Smoking Cessation Clinical Trials

V+PSF-M for Tobacco Cessation in HIV Care in India

Start date: January 2, 2024
Phase: Phase 3
Study type: Interventional

The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV). The study interventions used in this research study are: - Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program) - Varenicline (or Chantix, apovarenicline, Champix or Nocrav)

NCT ID: NCT05642858 Recruiting - Clinical trials for Cardiovascular Diseases

Text Education About Cardiovascular Health and HIV (TEACH-HIV)

Start date: March 12, 2023
Phase: N/A
Study type: Interventional

The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).