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

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

Study Contact Backup

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.

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

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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