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

Behavior, Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03910218
• Other study ID #: HSC-SN-18-0993
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Risk

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who use preventive prophylaxis (PrEP)		baseline
Primary	Number of participants who use preventive prophylaxis (PrEP)		immediately after intervention (at end of 3-month intervention)
Primary	Number of participants who use preventive prophylaxis (PrEP)		3 months after intervention
Primary	Number of participants who use preventive prophylaxis (PrEP)		6 months after intervention
Primary	Number of participants who use preventive prophylaxis (PrEP)		9 months after intervention
Primary	Number of participants who use non-occupational post-exposure prophylaxis (nPEP)		baseline
Primary	Number of participants who use non-occupational post-exposure prophylaxis (nPEP)		immediately after intervention (at end of 3-month intervention)
Primary	Number of participants who use non-occupational post-exposure prophylaxis (nPEP)		3 months after intervention
Primary	Number of participants who use non-occupational post-exposure prophylaxis (nPEP)		6 months after intervention
Primary	Number of participants who use non-occupational post-exposure prophylaxis (nPEP)		9 months after intervention
Primary	Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey		baseline
Primary	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)
Primary	Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey		3 months after intervention
Primary	Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey		6 months after intervention
Primary	Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey		9 months after intervention
Primary	Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests		Baseline
Primary	Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests		immediately after intervention (at end of 3-month intervention)
Primary	Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests		3 months after intervention
Primary	Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests		6 months after intervention
Primary	Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests		9 months after intervention
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Housing status	Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.	baseline
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II		baseline
Secondary	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)
Secondary	Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II		3 months after intervention
Secondary	Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II		6 months after intervention
Secondary	Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II		9 months after intervention