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Completed

NCT Number: NCT03910218

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

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).

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Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NCM4HIV

Behavioral

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

Behavioral

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

Primary outcomes

  1. Number of Participants Who Use Preventive Prophylaxis (PrEP)

    Time frame: baseline

  2. Number of Participants Who Use Preventive Prophylaxis (PrEP)

    Time frame: At completion of the 3-month intervention (Month 3)

    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.

  3. Number of Participants Who Use Preventive Prophylaxis (PrEP)

    Time frame: 3 months after intervention (Month 6)

    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.

  4. Number of Participants Who Use Preventive Prophylaxis (PrEP)

    Time frame: 6 months after intervention (Month 9)

    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.

  5. Number of Participants Who Use Preventive Prophylaxis (PrEP)

    Time frame: 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.

  6. Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)

    Time frame: baseline

  7. Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)

    Time frame: At completion of the 3-month intervention (Month 3)

    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.

  8. Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)

    Time frame: 3 months after intervention (Month 6)

    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.

  9. Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)

    Time frame: 6 months after intervention (Month 9)

    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.

  10. Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)

    Time frame: 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.

  11. Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey

    Time frame: baseline

    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.

  12. Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey

    Time frame: At completion of the 3-month intervention (Month 3)

    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.

  13. Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey

    Time frame: 3 months after intervention (Month 6)

    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.

  14. Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey

    Time frame: 6 months after intervention (Month 9)

    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.

  15. Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey

    Time frame: 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.

  16. Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

    Time frame: Baseline

    Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.

  17. Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

    Time frame: At completion of the 3-month intervention (Month 3)

    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.

  18. Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

    Time frame: 3 months after intervention (Month 6)

    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.

  19. Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

    Time frame: 6 months after intervention (Month 9)

    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.

  20. Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

    Time frame: 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.

Secondary outcomes

  1. Mental Health as Measured by the Brief Symptom Index-18

    Time frame: baseline

    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.

  2. Mental Health as Measured by the Brief Symptom Index-18

    Time frame: At completion of the 3-month intervention (Month 3)

    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. Mental Health as Measured by the Brief Symptom Index-18

    Time frame: 3 months after intervention (Month 6)

    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.

  4. Mental Health as Measured by the Brief Symptom Index-18

    Time frame: 6 months after intervention (Month 9)

    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.

  5. Mental Health as Measured by the Brief Symptom Index-18

    Time frame: 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.

  6. Housing Status

    Time frame: baseline

    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  7. Housing Status

    Time frame: At completion of the 3-month intervention (Month 3)

    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  8. Housing Status

    Time frame: 3 months after intervention (Month 6)

    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  9. Housing Status

    Time frame: 6 months after intervention (Month 9)

    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  10. Housing Status

    Time frame: 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.

  11. Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II

    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)

    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.

  12. Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: baseline

    The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression

  13. Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: At completion of the 3-month intervention (Month 3)

    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.

  14. Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months after intervention (Month 6)

    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.

  15. Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: 6 months after intervention (Month 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.

  16. Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  17. Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2019
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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