Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth

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: Completed
• Conditions: Behavior, Risk
• Intervention / Treatment: Behavioral: NCM4HIV; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 474
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	Behavioral: NCM4HIV; 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	Behavioral: Usual Care; 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	Measure Description	Time Frame
Number of Participants Who Use Preventive Prophylaxis (PrEP)		baseline
Number of Participants Who Use Preventive Prophylaxis (PrEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3)
Number of Participants Who Use Preventive Prophylaxis (PrEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	3 months after intervention (Month 6)
Number of Participants Who Use Preventive Prophylaxis (PrEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	6 months after intervention (Month 9)
Number of Participants Who Use Preventive Prophylaxis (PrEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	9 months after intervention (Month 12)
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)		baseline
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3)
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	3 months after intervention (Month 6)
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	6 months after intervention (Month 9)
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	9 months after intervention (Month 12)
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.	baseline
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.\ Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3)
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	3 months after intervention (Month 6)
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	6 months after intervention (Month 9)
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	9 months after intervention (Month 12)
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.	Baseline
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3)
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	3 months after intervention (Month 6)
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	6 months after intervention (Month 9)
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	9 months after intervention (Month 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health as Measured by the Brief Symptom Index-18	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	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.	At completion of the 3-month intervention (Month 3)
Mental Health as Measured by the Brief Symptom Index-18	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 (Month 6)
Mental Health as Measured by the Brief Symptom Index-18	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 (Month 9)
Mental Health as Measured by the Brief Symptom Index-18	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 (Month 12)
Housing Status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	baseline
Housing Status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	At completion of the 3-month intervention (Month 3)
Housing Status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	3 months after intervention (Month 6)
Housing Status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	6 months after intervention (Month 9)
Housing Status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	9 months after intervention (Month 12)
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II	An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3), 3 months after intervention (Month 6), 6 months after intervention (Month 9), 9 months after intervention (Month 12)
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression	baseline
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	At completion of the 3-month intervention (Month 3)
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	3 months after intervention (Month 6)
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	6 months after intervention (Month 9)
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.	9 months after intervention (Month 12)
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II	An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported.	baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Diane Santa Maria, DrPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): April 3, 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): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; homeless
• 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
• product manufactured in and exported from the U.S.: No