HIV Infections Clinical Trial
Official title:
Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
Although screening, brief intervention, and referral to treatment (SBIRT) approaches are
effective in reducing alcohol misuse and its associated risk-taking behaviors and negative
consequences, there is little research demonstrating the effectiveness of SBIRT for illicit
and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently
seek medical care in emergency departments (EDs), particularly for reasons related to their
misuse. As a result, the ED is well suited as a site to conduct an analysis of the
effectiveness of SBIRT for this population.
The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a
randomized, controlled, trial that will include adult ED patients at a large, academic,
trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who
have a subcritical illness or injury and whose screening indicates illicit and/or
prescription drug misuse. BIDMED participants will be randomized to receive screening only
(SO) or brief intervention (BI) with appropriate referral to treatment. Participants will
complete a battery of blinded baseline assessments using standardized instruments as well as
adapted instruments specific to the aims of this study. All participants will undergo
blinded follow-up assessments at three, six, and twelve months post-randomization. The
primary hypotheses addressed in the BIDMED study are that, compared to participants in the
SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug
misuse within the prior 30 days at three months post-randomization, (2) behaviors associated
with drug misuse at six months post-randomization; and (3) negative physical health,
psychosocial health, and socioeconomic consequences at twelve months post-randomization. As
a secondary aim, the impact of BI compared to SO will be assessed on participants
contacting, enrolling in, and completing a drug treatment program. In addition, the impact
of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be
measured. A mechanisms of change model that addresses the expected mediators and moderators
of change to explain the effects of SBIRT in this setting will also be developed and tested.
Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a
random sample of ED patients.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |