- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910218
Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth
November 10, 2023 updated by: Diane Santa Maria, The University of Texas Health Science Center, Houston
The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diane Santa Maria, DrPH
- Phone Number: (713)500-2187
- Email: diane.m.santamaria@uth.tmc.edu
Study Contact Backup
- Name: Jennifer Torres, MPH
- Phone Number: 713-500-9928
- Email: jennifer.d.torres@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- youth engaged in high-risk sexual activity or intravenous drug use
- speak English
- homeless
- not planning to move out of the metro area during the study
Exclusion Criteria:
- youth with very low literacy
- severe acute mental symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NCM4HIV
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
|
Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, 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
|
Placebo Comparator: Usual care
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
|
Participant will receive 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who use preventive prophylaxis (PrEP)
Time Frame: baseline
|
baseline
|
Number of participants who use preventive prophylaxis (PrEP)
Time Frame: immediately after intervention (at end of 3-month intervention)
|
immediately after intervention (at end of 3-month intervention)
|
Number of participants who use preventive prophylaxis (PrEP)
Time Frame: 3 months after intervention
|
3 months after intervention
|
Number of participants who use preventive prophylaxis (PrEP)
Time Frame: 6 months after intervention
|
6 months after intervention
|
Number of participants who use preventive prophylaxis (PrEP)
Time Frame: 9 months after intervention
|
9 months after intervention
|
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
Time Frame: baseline
|
baseline
|
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
Time Frame: immediately after intervention (at end of 3-month intervention)
|
immediately after intervention (at end of 3-month intervention)
|
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
Time Frame: 3 months after intervention
|
3 months after intervention
|
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
Time Frame: 6 months after intervention
|
6 months after intervention
|
Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
Time Frame: 9 months after intervention
|
9 months after intervention
|
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Time Frame: baseline
|
baseline
|
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Time Frame: immediately after intervention (at end of 3-month intervention)
|
immediately after intervention (at end of 3-month intervention)
|
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Time Frame: 3 months after intervention
|
3 months after intervention
|
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Time Frame: 6 months after intervention
|
6 months after intervention
|
Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
Time Frame: 9 months after intervention
|
9 months after intervention
|
Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
Time Frame: Baseline
|
Baseline
|
Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
Time Frame: immediately after intervention (at end of 3-month intervention)
|
immediately after intervention (at end of 3-month intervention)
|
Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
Time Frame: 3 months after intervention
|
3 months after intervention
|
Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
Time Frame: 6 months after intervention
|
6 months after intervention
|
Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
Time Frame: 9 months after intervention
|
9 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health as measured by the Brief Symptom Index-18
Time Frame: baseline
|
The Brief Symptom Inventory 18 (BSI-18) consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days).
Total score ranges from 0 to 72, with higher scores indicating greater distress.
|
baseline
|
Mental health as measured by the Brief Symptom Index-18
Time Frame: immediately after intervention (at end of 3-month intervention)
|
The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days).
Total score ranges from 0 to 72, with higher scores indicating greater distress.
|
immediately after intervention (at end of 3-month intervention)
|
Mental health as measured by the Brief Symptom Index-18
Time Frame: 3 months after intervention
|
The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days).
Total score ranges from 0 to 72, with higher scores indicating greater distress.
|
3 months after intervention
|
Mental health as measured by the Brief Symptom Index-18
Time Frame: 6 months after intervention
|
The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days).
Total score ranges from 0 to 72, with higher scores indicating greater distress.
|
6 months after intervention
|
Mental health as measured by the Brief Symptom Index-18
Time Frame: 9 months after intervention
|
The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days).
Total score ranges from 0 to 72, with higher scores indicating greater distress.
|
9 months after intervention
|
Housing status
Time Frame: baseline
|
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
|
baseline
|
Housing status
Time Frame: immediately after intervention (at end of 3-month intervention)
|
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
|
immediately after intervention (at end of 3-month intervention)
|
Housing status
Time Frame: 3 months after intervention
|
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
|
3 months after intervention
|
Housing status
Time Frame: 6 months after intervention
|
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
|
6 months after intervention
|
Housing status
Time Frame: 9 months after intervention
|
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
|
9 months after intervention
|
Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
Time Frame: baseline
|
baseline
|
|
Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
Time Frame: immediately after intervention (at end of 3-month intervention)
|
immediately after intervention (at end of 3-month intervention)
|
|
Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
Time Frame: 3 months after intervention
|
3 months after intervention
|
|
Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
Time Frame: 6 months after intervention
|
6 months after intervention
|
|
Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
Time Frame: 9 months after intervention
|
9 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Diane Santa Maria, DrPH, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2019
Primary Completion (Estimated)
February 28, 2024
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
April 8, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 10, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SN-18-0993
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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