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HIV Infections clinical trials

View clinical trials related to HIV Infections.

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NCT ID: NCT03512418 Completed - HIV Infections Clinical Trials

Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

PrEPSteps
Start date: June 20, 2019
Phase: Phase 3
Study type: Interventional

This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).

NCT ID: NCT03508908 Completed - HIV Infections Clinical Trials

Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission

TMP
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

This study will assess the impact of an HIV-1 RNA testing intervention targeting adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and meet specific risk criteria for acute HIV infection. All newly diagnosed HIV-infected patients in the intervention arm will be linked to care and offered both immediate treatment and assisted partner notification. Partners will also be tested using the HIV testing intervention, and pre-exposure prophylaxis will be offered to uninfected individuals with HIV-infected partners. The cost-effectiveness of this intervention will be evaluated.

NCT ID: NCT03508310 Completed - HIV Infections Clinical Trials

A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV

TCOM
Start date: June 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this project is to beta-test a brief waiting room video intervention that promotes early initiation of antiretroviral treatment among treatment-naïve HIV-positive patients, adherence to antiretroviral treatment and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their health providers. The video is currently being created, and will be ready for beta-testing by June 1, 2016. Results of the beta-testing will be used to refine and improve the video before dissemination to HIV/AIDS treatment facilities nationally. This video project is being funded by the Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention (DHAP).

NCT ID: NCT03505866 Completed - Depression Clinical Trials

Community Home-based Care Intervention and Its Health Outcome in HIV-positive People

HIV
Start date: March 1, 2015
Phase: N/A
Study type: Interventional

An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at the home of HIV-positive people. The intervention started in March, 2018 and completed in August 2018. The major measurements of the interventions were ART adherence, status of depression, anxiety, and stress levels.

NCT ID: NCT03502005 Completed - Clinical trials for Human Immunodeficiency Virus

Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).

NCT ID: NCT03500302 Completed - Clinical trials for Coronary Artery Disease

Effect of Evolocumab on Coronary Endothelial Function

EVOLVE
Start date: May 4, 2018
Phase: Phase 2
Study type: Interventional

The investigators propose a pilot study using (1) MRI to assess coronary artery endothelial function, (2) brachial ultrasound to assess systemic endothelial function, (3) serum markers of inflammation and of endothelial cell function and (4) echocardiographic measures of left ventricular diastolic and systolic properties, before and following initiation of PCSK9 antibody in HIV positive subjects.

NCT ID: NCT03499795 Completed - Anal Neoplasm Clinical Trials

VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2

Start date: May 15, 2018
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

NCT ID: NCT03494777 Completed - HIV/AIDS Clinical Trials

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

NCT ID: NCT03490058 Completed - HIV/AIDS Clinical Trials

The Prevention Options for Women Evaluation Research (POWER) Cohort

Start date: June 14, 2017
Phase:
Study type: Observational

The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.

NCT ID: NCT03489421 Completed - Clinical trials for Mitochondrial Diseases

Mitochondria in HIV and Aging (MITO+)

(MITO+)
Start date: December 15, 2018
Phase:
Study type: Observational

Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Furthermore, the investigators hypothesize that the older antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide (TAF).