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Adherence, Medication clinical trials

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NCT ID: NCT05592613 Recruiting - HIV Infection Clinical Trials

Next Generation Ingestible Sensors for Medication Adherence Measurement

NextGen
Start date: February 20, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.

NCT ID: NCT05546931 Recruiting - Quality of Life Clinical Trials

Mobile Health Program for Rural Hypertension

Start date: September 4, 2023
Phase: N/A
Study type: Interventional

Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).

NCT ID: NCT05515497 Recruiting - Clinical trials for Adherence, Medication

BMT4me: Post-HSCT Medication Adherence mHealth App

Bmt4me 2
Start date: November 29, 2022
Phase: N/A
Study type: Interventional

This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase post-HSCT, and 3) the potential efficacy of an mHealth app on adherence to immunosuppressants in post-HSCT children discharged during the acute phase.

NCT ID: NCT05495698 Recruiting - Copd Clinical Trials

Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

TRICOLON
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.

NCT ID: NCT05474313 Recruiting - HIV Prevention Clinical Trials

A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW

PrEP-3D RCT
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.

NCT ID: NCT05389358 Recruiting - Depression Clinical Trials

Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care

Start date: April 26, 2022
Phase: N/A
Study type: Interventional

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).

NCT ID: NCT05378399 Recruiting - HIV Infections Clinical Trials

SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder

SmartSteps
Start date: December 20, 2022
Phase: Phase 3
Study type: Interventional

This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and study eligibility will be confirmed. Eligible participants will attend three additional visits over the course of the study - the Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4). Participants will take one PrEP digital pill per day, for 60 days total, while using the digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days, participants will receive brief surveys prompting them to report the reasons for their missed dose, as well as their engagement in substance use and sexual activity. Timeline followback will be conducted at the Month 1 and Month 2 Visits to understand the context of any nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be conducted at the Month 2 Visit.

NCT ID: NCT05374109 Recruiting - HIV-1-infection Clinical Trials

SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

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

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

NCT ID: NCT05332158 Recruiting - Clinical trials for Adherence, Medication

Medicines Gaps Study

MeGa
Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The adherence project aims to understand adherence rates and barriers to Direct oral anticoagulants (DOACs) and statins and improve awareness of healthcare professionals on adherence across Leeds. During the first component of the project, the investigation of rates of non-adherence was classed as service evaluation. The second component of this project, which this IRAS application refers to, will look into patient perspectives and barriers to adherence. Currently, such information is not routinely collected and only requested as part of shorter or longer consultations depending on a pre-defined clinical agenda and with little attention to adherence. Two specific questionnaires have been designed and integrated within the primary care medical records systems. Following invitation for target patients on DOACs and/or statins to respond anonymously, responses to the questionnaire(s) will be stored in their medical records. Data will then be extracted from the two systems [SystmOne and Egton Medical Information Systems (EMIS)] using unique system identifiers, that will be pseudonymised at the time of extraction. All patient pseudonymised information (including medical records system identifiers and responses to the questionnaire) will be extracted by the LTHT Researcher-Pharmacist following access provided by each participating General Practitioner (GP) Practice, based on searches built centrally by the Data Quality Team of the Leeds Clinical Commissioning Group (CCG). Apart from the dissemination of findings based on the questionnaire, a training package for health professionals will be designed and delivered. The aim of the training is to combine and disseminate all findings of the project, raise awareness on real-world non-adherence prevalence and the common barriers to adherence, demonstrate the usefulness of routine adherence estimation and suggest tools to address non-adherence in daily practice. The objectives of this training will also consider the training needs of healthcare professionals locally, as per the healthcare professionals survey that has been designed and circulated.

NCT ID: NCT05301855 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut Main Hospital

Start date: March 2022
Phase:
Study type: Observational

Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries [1].DM leads to serious problems in heart, blood vessels, kidney and nerves.The World Health Organization (WHO) had anticipated that DM is going tobecome the seventh most significant primary cause of death worldwide by theyear 2030 [2]