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Nurse Case Management for Risky Behaviors
N/A
Waitlist Available
Led By Diane Santa Maria, DrPH
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months after intervention
Awards & highlights
Study Summary
This trial will compare the effects of the NCM4HIV intervention to usual care on HIV prevention among YEH.
Who is the study for?
This trial is for English-speaking homeless youth who engage in high-risk sexual behaviors or intravenous drug use and plan to stay in the metro area during the study. It's not suitable for those with very low literacy or severe acute mental health symptoms.Check my eligibility
What is being tested?
The study is testing a Nurse Case Management HIV prevention program (NCM4HIV) against usual care methods to see if it's more effective at preventing HIV among homeless youth.See study design
What are the potential side effects?
Since this trial involves case management rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience emotional or psychological impacts from discussing sensitive topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sexually Transmitted Diseases
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
+1 moreSecondary outcome measures
Housing status
Mental health as measured by the Brief Symptom Index-18
Substance Abuse Detection
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NCM4HIVExperimental Treatment1 Intervention
Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring,Pre exposure prophylaxis (PrEP) eligibility screening,PrEP/non occupational post exposure prophylaxis(nPEP)services (labs, medication), healthcare planning/coordination, Motivational Interviewing (MI) counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
Group II: Usual carePlacebo Group1 Intervention
Participants will receive the usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling,substance use treatment referrals,PrEP/nPEP referrals
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
909 Previous Clinical Trials
323,291 Total Patients Enrolled
1 Trials studying Risky Behaviors
100 Patients Enrolled for Risky Behaviors
National Institute of Nursing Research (NINR)NIH
583 Previous Clinical Trials
10,376,670 Total Patients Enrolled
1 Trials studying Risky Behaviors
814 Patients Enrolled for Risky Behaviors
Diane Santa Maria, DrPHPrincipal Investigator - The University of Texas Health Science Center, Houston
Medical School - Isfahan University of Medical Sciences Faculty of Medicine, Doctor of Medicine
Cornell University, Wyckoff Heights Medical Center, Residency in Family Medicine
2 Previous Clinical Trials
1,283 Total Patients Enrolled
1 Trials studying Risky Behaviors
100 Patients Enrolled for Risky Behaviors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You engage in risky sexual activity or use intravenous drugs.You do not have a stable place to live.I struggle a lot with reading and writing.You are experiencing severe mental health symptoms right now.
Research Study Groups:
This trial has the following groups:- Group 1: NCM4HIV
- Group 2: Usual care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment restricted to individuals aged 75 years or below for this experiment?
"This trial's inclusion criteria necessitates that all participants are between 16 and 25 years old. Simultaneously, there are 6 studies dedicated to minors under 18 and 4 trials specifically for individuals over 65."
Answered by AI
Are patients currently being accepted for this research study?
"Absolutely. The information posted on clinicaltrials.gov confirms that enrollment for this trial is taking place now; the study was initially released in October of 2019 and was most recently updated November 7th 2022. 450 patients are being sought from 1 medical centre."
Answered by AI
Is my participation in this medical research possible?
"The target population of this trial consists of 450 adolescents and young adults, aged 16-25 years old who exhibit high risk behavior such as substance abuse or unprotected sex. In addition, homeless youth are also encouraged to join the study."
Answered by AI
What is the aggregate number of individuals participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this trial, which was initially launched on October 21st 2019, is currently recruiting participants. A total of 450 individuals need to be enrolled at just 1 location."
Answered by AI
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