HIV Infections Clinical Trial
Official title:
HBV Prevention for Homeless at Risk for HBV/HCV/HIV
In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case management strategies, found successful with homeless adults as well as contingency management strategies, found successful with gay and bisexual homeless adults by the community partners, the investigators will evaluate the effectiveness of a program that combines both strategies. As stimulant use threatens to increase homeless persons' risk of exposure to hepatitis A and B viruses, particularly among young users who may not yet be HBV-infected, this research is targeted to engage this group in treatment, until they are suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.
Homeless adults are at high risk for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and
HIV infection due to high rates of injection drug use and unprotected sexual activity. Our
NIDA-funded RO1 award has enabled us to implement a successful intervention designed to
evaluate the effectiveness of a HBV vaccination intervention with homeless adults. Our
findings revealed that a greater percent of homeless adults randomized to the Nurse Case
Managed Plus Incentive and Tracking group completed the HAV/HBV vaccine series compared to a
Standard program without tracking. Homeless persons least likely to complete the vaccine
series were young (< 40), and were men having sex with men (MSM); a significant number of
these young adults also reported methamphetamine (MA) and cocaine/crack use. Stimulants
(SAs), including MA and cocaine/crack are commonly used by homeless MSM, who contend with
disorganized lives, unemployment, and little access to health and social services; thus, HBV
vaccination is particularly challenging in this population. HAV/HBV vaccination and
effective behavioral treatment are two of the most important strategies for reducing HBV
infection among this at-risk group of SA users.
Based upon advice from our community partners who have successfully treated SA-using gay and
bisexual men (GBM), we will incorporate contingency management into our vaccination
completion program, which had lower completion rates among young adults and MSMs. Thus, in
this competitive renewal, we propose a randomized, experimental, two-group design to
evaluate the effectiveness of a Nurse Case Managed Program, which includes specialized
education and Contingency Management and Tracking (NCCMT), with a Standard Program,
including brief education, Contingency Management and Tracking (SCMT) with 500 homeless,
young (18-39), SA-using GBM, on completion of the Twinrix HAV/HBV vaccine and, secondarily,
on reduction of risk for hepatitis and HIV. This study is innovative in that it will allow
us to look at the effect of an enhanced case management and contingency management program
versus a standard contingency management program. The proposed study combines optimal
strategies to approach, engage and intervene with a hidden and high-risk population to
assess the feasibility and efficacy of interventions that may prove beneficial in preventing
HBV and HAV infections. We will also assess the relative cost of these programs in terms of
completion of the HAV/HBV vaccination series. As use of SAs threatens to intensify homeless
persons' risk of exposure to HAV and HBV, particularly among young users who may not yet be
HBV-infected, research targeted to engage this group in treatment, until they are suitably
protected from HBV, is critical.
;
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 |