Treatment Trials

33 Clinical Trials for Various Conditions

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COMPLETED
PrEP iT! Mobile App Intervention
Description

The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP iT! Primary aims include: Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and refine iterations through input from a community advisory board (CAB). Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for young MSM.

COMPLETED
Use of Antiretroviral (ARV) Drug Levels in Dried Blood Spots (DBS) to Assess and Manage ART Adherence in South Africa
Description

This is a prospective, pilot study of HIV-positive individuals who have been on tenofovir-containing antiretroviral therapy for at least 4 months. The overall goal of this research is to determine the feasibility of giving patients and their providers monthly feedback about Tenofovir-Diphosphate (TFV-DP) drug levels and to examine patient and provider behaviors in response to receiving this information. This study will build upon the Aim 1 observational study and the subsequent patient and providerFeedback Development Workgroups (FDWs).

RECRUITING
Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
Description

This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.

COMPLETED
Kentucky Access to Recovery Evaluation
Description

Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.

COMPLETED
RAE (Realize, Analyze, Engage)
Description

The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder

COMPLETED
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV
Description

This study will determine whether a managed problem solving intervention can help patients with HIV better follow their anti-HIV drug regimen and can control HIV better than the standard of care.

Conditions
ACTIVE_NOT_RECRUITING
Culturally Aware AET Non-Initiation Intervention
Description

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

COMPLETED
Improving Substance Abuse Treatment Aftercare Adherence and Outcome
Description

Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.

RECRUITING
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Description

Can the investigators create an effective way to improve adherence to immunosuppressant medication and reduce rejection, graft loss, and death in adolescents and young adults who have undergone kidney or liver transplantation? The investigators' mobile technology intervention uses real-time electronic pillbox-assessed dose timing and text message prompts to address antirejection medication nonadherence when nonadherence is detected.

COMPLETED
Interactive Study to Increase Glaucoma Adherence to Treatment
Description

Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.

Conditions
COMPLETED
Using Artificial Intelligence to Measure and Optimize Adherence in Patients on Anticoagulation Therapy.
Description

AiCure uses artificial intelligence and visual recognition technology to confirm medication ingestion. The software is available as an app and downloaded onto a smart phone. The single-site, parallel-arm, randomized controlled trial will test the feasibility and impact of using the platform in a stroke population. End points: usability, consistent use of the device, and optimization of treatment.

Conditions
RECRUITING
CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
Description

This project aims to address healthcare disparities among Navaho people diagnosed with hypertension or prehypertension through three main objectives. Firstly, it identifies and shares insights on healthcare access disparities affecting Navaho individuals experiencing nonadherence to hypertension treatment. Secondly, the proposal develops a telehealth solution based on factors identified as knowledge gaps caused by healthcare access disparities in hypertension management; we will use the factors to design a series of engaging minigames that can be incorporated into the larger CardioCare Quest. These minigames will be co-designed with end users and clinicians. Finally, the proposal conducts comprehensive qualitative and quantitative assessments of user experiences, perceptions, and challenges with CardioCare Quest.

UNKNOWN
A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device
Description

This goal of this study is to assess the suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) device for patients on injectable medications in the home-setting, for the management of respiratory disorders. The HealthBeacon ICMS is composed of the Smart Sharps Bin, Companion App and Care Team support. The Smart Sharps Bin a digitally connected sharps container and is pre-programmed with a patient's injection schedule. It creates a time-stamped record of each used injection deposited into it to calculate a patients' adherence to treatment. Following disposal, the next date of injection and rotating injection site is updated without requiring any extra work on behalf of the patient. The system also proactively supports enhanced compliance through a series of smart dose reminders and intervention calls, to help patients stay on track. Clinical teams can then review patient adherence data remotely via an online platform. The main aims of this study include the following: * To demonstrate the suitability of the HealthBeacon ICMS as an RTM device for respiratory patients through successful billing and reimbursement for physicians * To provide data to support the reimbursement of the HealthBeacon ICMS by Private Payors in the future Participants prescribed injectable medication for the treatment of a diagnosed respiratory condition will be enrolled by the Principal Investigator (PI) and referred to HealthBeacon. Participants will then be provided with access to the HealthBeacon ICMS to remotely track and support their adherence to treatment in the home-setting. Participants will use the system for 6 months and their adherence data during this time will be collected, which the PI and clinical team involved will be able to remotely access and review. At various stages of the study, the applicable RTM codes will be billed for, for each participant. These stages include when providing each participant with access to the HealthBeacon system, including the Smart Sharps Bin, when providing each participant with education on how to use the device, and when the clinical team monitors each individual patients' adherence data collected by the HealthBeacon system on a monthly basis.

UNKNOWN
Improving Medication Self-Administration and Health After Brain Injury
Description

The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.

UNKNOWN
Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?
Description

This study is being conducted by Bassett Healthcare Network in coordination with Bassett Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider consent to this study. This study will try to establish if nursing interventions can help improve patients' adherence to taking their oral chemotherapies as prescribed by their doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer diagnoses. Adherence to the prescribed treatment plan is very important to gain the best response to these types of treatments. The study will examine if nursing intervention via weekly phone calls may help improve adherence to oral chemotherapy treatment plans.

COMPLETED
Determinants of Compliance With Glaucoma Therapy
Description

The purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.

COMPLETED
Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention
Description

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

COMPLETED
Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
Description

This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatment adherence problems.

COMPLETED
Therapy Optimization in Multiple Sclerosis (MS)
Description

The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.

COMPLETED
Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder
Description

In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.

COMPLETED
Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients
Description

This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.

COMPLETED
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients
Description

Goal: To define the causes and issues associated with nonadherence in our population Hypothesis: There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients Methods: 1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence. 2. A brief review of demographics and pertinent laboratory information at the same encounter

COMPLETED
A Mindfulness Based Approach to HIV Treatment Side Effects
Description

We are exploring the effect that an 8 week stress reduction program based in mindfulness practices will have on the experience of medication side effects reported by HIV-infected men and women taking antiretroviral therapy.

Conditions
COMPLETED
Directly Observed Therapy for HIV Infected Adolescents
Description

Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in the past.

Conditions
COMPLETED
Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis
Description

The purpose of this study is to evaluate the coorelation between patient factors, health care provider factors, drug factors and compliance in patients with relapsing forms of multiple sclerosis (RMS) treated with Disease Modifying Agents (DMA). We hypothesize that a number of factors influence compliance with DMA's.

COMPLETED
Improving Chronic Pain Treatment in Primary Care
Description

The primary objective of this study is to determine to what extent a collaborative intervention improves chronic pain-related outcomes in a VA primary care setting. We will also determine to what extent the intervention affects 1) treatment of co-occurring depression, 2) adherence of providers to guidelines for treating chronic pain, and 3) patient and provider satisfaction and attitudes related to chronic pain treatment.

COMPLETED
Promoting Adherence to Anti-HIV Drug Regimens
Description

One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.

Conditions
TERMINATED
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
Description

The purpose of this study is to evaluate the effectiveness of a computer-assisted, self-administered adherence program for patients on complicated anti-HIV drug regimens.

COMPLETED
A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
Description

The purpose of this study is to look at different ways to help patients follow their anti-HIV medication schedules. It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications.

Conditions
COMPLETED
Youth Opioid Recovery Support: Improving Care Systems
Description

Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment. Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse. MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families. The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment. This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.