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

Not Applicable

Completed

• Conditions: Behavior, Risk

• Registration Number: NCT03910218
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2019-11-11
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Results First Submitted: 2025-04-02
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Results First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

Not provided

Exclusion Criteria

• youth with very low literacy
• severe acute mental symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Use Preventive Prophylaxis (PrEP)	9 months after intervention (Month 12)	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.
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	9 months after intervention (Month 12)	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.
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	9 months after intervention (Month 12)	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.
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	9 months after intervention (Month 12)	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.

Secondary Outcome Measures

Name	Time	Method
Mental Health as Measured by the Brief Symptom Index-18	9 months after intervention (Month 12)	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.
Housing Status	9 months after intervention (Month 12)	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II	baseline	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.
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	9 months after intervention (Month 12)	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States