Clinical trial NCT03910218: Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth
Official title: Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Risk
Keywords: HIV prevention
homeless
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-04-10
Enrollment: 450
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who use preventive prophylaxis (PrEP)
timeFrame: baseline
measure: Number of participants who use preventive prophylaxis (PrEP)
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Number of participants who use preventive prophylaxis (PrEP)
timeFrame: 3 months after intervention
measure: Number of participants who use preventive prophylaxis (PrEP)
timeFrame: 6 months after intervention
measure: Number of participants who use preventive prophylaxis (PrEP)
timeFrame: 9 months after intervention
measure: Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
timeFrame: baseline
measure: Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
timeFrame: 3 months after intervention
measure: Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
timeFrame: 6 months after intervention
measure: Number of participants who use non-occupational post-exposure prophylaxis (nPEP)
timeFrame: 9 months after intervention
measure: Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
timeFrame: baseline
measure: Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
timeFrame: 3 months after intervention
measure: Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
timeFrame: 6 months after intervention
measure: Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey
timeFrame: 9 months after intervention
measure: Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
timeFrame: Baseline
measure: Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
timeFrame: 3 months after intervention
measure: Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
timeFrame: 6 months after intervention
measure: Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests
timeFrame: 9 months after intervention
Secondary outcomes:
measure: Mental health as measured by the Brief Symptom Index-18
timeFrame: baseline
measure: Mental health as measured by the Brief Symptom Index-18
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Mental health as measured by the Brief Symptom Index-18
timeFrame: 3 months after intervention
measure: Mental health as measured by the Brief Symptom Index-18
timeFrame: 6 months after intervention
measure: Mental health as measured by the Brief Symptom Index-18
timeFrame: 9 months after intervention
measure: Housing status
timeFrame: baseline
measure: Housing status
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Housing status
timeFrame: 3 months after intervention
measure: Housing status
timeFrame: 6 months after intervention
measure: Housing status
timeFrame: 9 months after intervention
measure: Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
timeFrame: baseline
measure: Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
timeFrame: immediately after intervention (at end of 3-month intervention)
measure: Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
timeFrame: 3 months after intervention
measure: Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
timeFrame: 6 months after intervention
measure: Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II
timeFrame: 9 months after intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Diane Santa Maria, DrPH
role: PRINCIPAL_INVESTIGATOR
References: