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CompletedNCT03910218Updated Jun 26, 2025Results posted

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

An interventional study of NCM4HIV and Usual Care in Behavior, Risk, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Behavior, Risk

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Keywords

  • HIV prevention
  • homeless
03

In context

Risk-Taking

136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.

This study's enrollment of 474 is above the median of 255 across 117 interventional studies indexed under Risk-Taking.

Browse Risk-Taking studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Browse The University of Texas Health Science Center, Houston studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • youth with very low literacy
  • severe acute mental symptoms
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
474 participants (actual)

Study arms

  • Experimental
    NCM4HIV

    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

  • Placebo comparator
    Usual care

    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

Interventions

  • BehavioralNCM4HIV

    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

  • BehavioralUsual 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

06

What researchers measure

Primary outcomes

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

    Time frame: baseline

  2. 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)

  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)

  4. 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)

  5. 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: 9 months after intervention (Month 12)

  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)

    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)

  8. 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)

  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: 6 months after intervention (Month 9)

  10. 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)

  11. 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

  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.\\ 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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)

  18. 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)

  19. 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)

  20. 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)

Secondary outcomes

  1. 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

  2. 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)

  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)

  4. 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)

  5. 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)

  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: baseline

  7. 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)

  8. 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)

  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: 6 months after intervention (Month 9)

  10. 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)

  11. 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)

  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

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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

07

Results

Posted Jun 26, 2025

Participant flow

Participant flow — Overall Study
MilestoneNCM4HIVUsual Care
Started318156
Received intervention303147
Completed303147
Not completed159

Outcome measures

PrimaryNumber of Participants Who Use Preventive Prophylaxis (PrEP)
Time frame:
baseline
Reported as:
Count of participants · Participants
Number of Participants Who Use Preventive Prophylaxis (PrEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Preventive Prophylaxis (PrEP)2018
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Preventive Prophylaxis (PrEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Preventive Prophylaxis (PrEP)5521
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Preventive Prophylaxis (PrEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Preventive Prophylaxis (PrEP)3717
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Preventive Prophylaxis (PrEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Preventive Prophylaxis (PrEP)4517
PrimaryNumber 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:
9 months after intervention (Month 12)
Reported as:
Count of participants · Participants
Number of Participants Who Use Preventive Prophylaxis (PrEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Preventive Prophylaxis (PrEP)4212
PrimaryNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
Time frame:
baseline
Reported as:
Count of participants · Participants
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)614
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)74
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)64
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)103
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)65
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey8634
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey8136
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey6441
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey8423
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey
ParticipantsNCM4HIVUsual Care
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey7434
PrimaryNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)6324
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)4319
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)3213
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)4424
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)
ParticipantsNCM4HIVUsual Care
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)3818
SecondaryMental 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

No measurements were reported for this outcome.

SecondaryMental 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)

No measurements were reported for this outcome.

SecondaryMental 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)

No measurements were reported for this outcome.

SecondaryMental 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)

No measurements were reported for this outcome.

SecondaryMental 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)

No measurements were reported for this outcome.

SecondaryHousing Status

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

Time frame:
baseline
Reported as:
Count of participants · Participants
Housing Status
ParticipantsNCM4HIVUsual Care
My own place137
Family/Foster Family home162
Friend's home4114
Home of boyfriend/girlfriend/sexual partner41
Shelter18195
Hotel or motel23
Transitional living program105
street, park, or outside1710
abandoned building or squat94
car, bus, light rail, or metro21
Other75
Unknown/Not Reported10
SecondaryHousing 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)
Reported as:
Count of participants · Participants
Housing Status
ParticipantsNCM4HIVUsual Care
My own place3316
Family/Foster Family Home258
Friend's Home2414
Home of boyfriend/girlfriend/sexual partner56
Shelter10346
Hotel or Motel85
Transitional living program95
Street, park or outside84
Abandoned building or squat30
car, bus, light rail, or metro11
Other23
SecondaryHousing 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)
Reported as:
Count of participants · Participants
Housing Status
ParticipantsNCM4HIVUsual Care
My own place4915
Family/Foster Family home2112
Friend's home2114
Home of boyfriend/girlfriend/sexual partner86
Shelter6017
Hotel or motel84
Transitional living program34
street, park, or outside66
abandoned building or squat30
car, bus, light rail, or metro03
Other74
SecondaryHousing 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)
Reported as:
Count of participants · Participants
Housing Status
ParticipantsNCM4HIVUsual Care
My own place6418
Family/Foster Family home1713
Friend's home238
Home of boyfriend/girlfriend/sexual partner83
Shelter3319
Hotel or motel105
Transitional living program32
street, park, or outside55
abandoned building or squat31
car, bus, light rail, or metro20
Other62
SecondaryHousing 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)
Reported as:
Count of participants · Participants
Housing Status
ParticipantsNCM4HIVUsual Care
My own place6923
Family/Foster Family home2714
Friend's home1913
Home of boyfriend/girlfriend/sexual partner122
Shelter2112
Hotel or motel72
Transitional living program51
street, park, or outside97
abandoned building or squat21
car, bus, light rail, or metro52
Other85
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II
ParticipantsNCM4HIVUsual Care
At completion of the 3-month intervention (Month 3)16270
3 months after intervention (Month 6)14079
6 months after intervention (Month 9)13874
9 months after intervention (Month 12)14660
SecondaryMental 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
Reported as:
Mean · score on a scale
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)
score on a scaleNCM4HIVUsual Care
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)8.8 ± 6.998.5 ± 7.25
SecondaryMental 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)
Reported as:
Mean · score on a scale
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)
score on a scaleNCM4HIVUsual Care
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.7 ± 6.818.9 ± 7.92
SecondaryMental 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)
Reported as:
Mean · score on a scale
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)
score on a scaleNCM4HIVUsual Care
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)6.9 ± 6.828.1 ± 7.52
SecondaryMental 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)
Reported as:
Mean · score on a scale
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)
score on a scaleNCM4HIVUsual Care
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.3 ± 7.098 ± 7.21
SecondaryMental 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)
Reported as:
Mean · score on a scale
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)
score on a scaleNCM4HIVUsual Care
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.7 ± 7.096.6 ± 6.73
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II
ParticipantsNCM4HIVUsual Care
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II17079

Adverse events

Collected over up to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NCM4HIV1/318 (0.3%)5/318 (1.6%)0/318 (0%)
Usual Care2/156 (1.3%)1/156 (0.6%)0/156 (0%)
Most frequent serious events
Most frequent serious events
EventNCM4HIVUsual Care
Suicidal ideationPsychiatric disorders1/3181/156
HospitalizationPsychiatric disorders2/3180/156
HospitalizationGeneral disorders1/3180/156
Reported child abuseGeneral disorders1/3180/156

Baseline characteristics

Includes all participants who received intervention.

Age, Continuous
Age, Continuous(years)NCM4HIVUsual CareTotal
Mean21 ± 2.121.1 ± 2.121.1 ± 2.1
Sex/Gender, Customized
Sex/Gender, Customized(Participants)NCM4HIVUsual CareTotal
Female13857195
Male14977226
Transgender Male257
Transgender Female8311
Genderqueer, neither exclusively male nor female325
Other224
Decline to Answer112
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NCM4HIVUsual CareTotal
Hispanic or Latino472572
Not Hispanic or Latino255121376
Unknown or Not Reported112
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NCM4HIVUsual CareTotal
American Indian or Alaska Native505
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American18594279
White391251
More than one race371956
Unknown or Not Reported362258
Region of Enrollment
Region of Enrollment(participants)NCM4HIVUsual CareTotal
United States303147450
08

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Maria DS, Nyamathi A, Lightfoot M, Paul M, Quadri Y, Padhye N, Businelle M, Fernandez-Sanchez H, Jones JT. Results of a Randomized Wait-List Controlled Trial of CAYA: A Nurse Case Management HIV Prevention Intervention for Youth Experiencing Homelessness. AIDS Behav. 2025 Feb;29(2):613-625. doi: 10.1007/s10461-024-04544-3. Epub 2024 Nov 12. PubMed 39531116 ↗
  • Santa Maria DM, Padhye N, Ostrosky-Zeichner L, Grimes CZ, Nyamathi A, Lightfoot M, Quadri Y, Paul ME, Jones JT. COVID-19 Vaccination Uptake, Infection Rates, and Seropositivity Among Youth Experiencing Homelessness in the United States. Nurs Res. 2024 Sep-Oct 01;73(5):373-380. doi: 10.1097/NNR.0000000000000747. Epub 2024 May 10. PubMed 38809559 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Apr 2024, 52 months.

Results were first posted in Jun 2025, 1 year 2 months after primary completion.

Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 52 months is above that.

Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2019
First posted
Apr 10, 2019
StartActual
Nov 11, 2019
Primary completionActual
Apr 3, 2024
CompletionActual
Apr 3, 2024
Results first posted
Jun 26, 2025
Last update
Jun 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03910218
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Diane Santa Maria (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Apr 10, 2019
Start date
Nov 11, 2019
Primary completion
Apr 3, 2024
Completion
Apr 3, 2024
Results posted
Jun 26, 2025
Last update
Jun 26, 2025

Study contacts

Diane Santa Maria, DrPH
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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