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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
474
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
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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants Who Use Preventive Prophylaxis (PrEP)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 9 months after intervention (Month 12)
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months after intervention (Month 12)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Housing Status
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline