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

Study Overview
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Brief Summary
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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).

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

Conditions
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Behavior, Risk

Intervention / Treatment
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* Behavioral: NCM4HIV
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCM4HIV<br>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<br>* 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<br>|
| Placebo Comparator: Usual care<br>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<br>* 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<br>|

What is the study measuring?
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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) |  | immediately after intervention (at end of 3-month intervention) | 
| Number of participants who use preventive prophylaxis (PrEP) |  | 3 months after intervention | 
| Number of participants who use preventive prophylaxis (PrEP) |  | 6 months after intervention | 
| Number of participants who use preventive prophylaxis (PrEP) |  | 9 months after intervention | 
| Number of participants who use non-occupational post-exposure prophylaxis (nPEP) |  | baseline | 
| Number of participants who use non-occupational post-exposure prophylaxis (nPEP) |  | immediately after intervention (at end of 3-month intervention) | 
| Number of participants who use non-occupational post-exposure prophylaxis (nPEP) |  | 3 months after intervention | 
| Number of participants who use non-occupational post-exposure prophylaxis (nPEP) |  | 6 months after intervention | 
| Number of participants who use non-occupational post-exposure prophylaxis (nPEP) |  | 9 months after intervention | 
| Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey |  | baseline | 
| Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey |  | 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 |  | 3 months after intervention | 
| Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey |  | 6 months after intervention | 
| Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey |  | 9 months after intervention | 
| Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests |  | Baseline | 
| Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests |  | immediately after intervention (at end of 3-month intervention) | 
| Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests |  | 3 months after intervention | 
| Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests |  | 6 months after intervention | 
| Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests |  | 9 months after intervention | 

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. | immediately after intervention (at end of 3-month intervention) | 
| 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 | 
| 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 | 
| 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 | 
| 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. | immediately after intervention (at end of 3-month intervention) | 
| 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 | 
| 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 | 
| 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 | 
| Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II |  | baseline | 
| Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II |  | 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 |  | 3 months after intervention | 
| Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II |  | 6 months after intervention | 
| Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II |  | 9 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, homeless