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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03910218
Enrollment
474
Registered
2019-04-10
Start date
2019-11-11
Completion date
2024-04-03
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Risk

Keywords

HIV prevention, homeless

Brief summary

The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH).

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)BaselineSexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Number of Participants Who Use Preventive Prophylaxis (PrEP)baseline
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)baseline
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior SurveybaselineAn 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.

Secondary

MeasureTime frameDescription
Mental Health as Measured by the Brief Symptom Index-18baselineThe 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.
Housing StatusbaselineParticipants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen IIAt 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.
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)baselineThe Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression

Countries

United States

Participant flow

Participants by arm

ArmCount
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 NCM4HIV: Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
303
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 Usual Care: Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals
147
Total450

Baseline characteristics

CharacteristicNCM4HIVUsual CareTotal
Age, Continuous21 years
STANDARD_DEVIATION 2.1
21.1 years
STANDARD_DEVIATION 2.1
21.1 years
STANDARD_DEVIATION 2.1
Ethnicity (NIH/OMB)
Hispanic or Latino
47 Participants25 Participants72 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
255 Participants121 Participants376 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants0 Participants5 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
185 Participants94 Participants279 Participants
Race (NIH/OMB)
More than one race
37 Participants19 Participants56 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
36 Participants22 Participants58 Participants
Race (NIH/OMB)
White
39 Participants12 Participants51 Participants
Region of Enrollment
United States
303 participants147 participants450 participants
Sex/Gender, Customized
Decline to Answer
1 Participants1 Participants2 Participants
Sex/Gender, Customized
Female
138 Participants57 Participants195 Participants
Sex/Gender, Customized
Genderqueer, neither exclusively male nor female
3 Participants2 Participants5 Participants
Sex/Gender, Customized
Male
149 Participants77 Participants226 Participants
Sex/Gender, Customized
Other
2 Participants2 Participants4 Participants
Sex/Gender, Customized
Transgender Female
8 Participants3 Participants11 Participants
Sex/Gender, Customized
Transgender Male
2 Participants5 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 3182 / 156
other
Total, other adverse events
0 / 3180 / 156
serious
Total, serious adverse events
5 / 3181 / 156

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)63 Participants
Usual CareNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)24 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)43 Participants
Usual CareNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)19 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)32 Participants
Usual CareNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)13 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)44 Participants
Usual CareNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)24 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)38 Participants
Usual CareNumber of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)18 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey74 Participants
Usual CareNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey34 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey81 Participants
Usual CareNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey36 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey86 Participants
Usual CareNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey34 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey64 Participants
Usual CareNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey41 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey84 Participants
Usual CareNumber of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey23 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)6 Participants
Usual CareNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)5 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)7 Participants
Usual CareNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)4 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)6 Participants
Usual CareNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)4 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)10 Participants
Usual CareNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)3 Participants
Primary

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

Time frame: baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)6 Participants
Usual CareNumber of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)14 Participants
Primary

Number of Participants Who Use Preventive Prophylaxis (PrEP)

Time frame: baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Preventive Prophylaxis (PrEP)20 Participants
Usual CareNumber of Participants Who Use Preventive Prophylaxis (PrEP)18 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Preventive Prophylaxis (PrEP)55 Participants
Usual CareNumber of Participants Who Use Preventive Prophylaxis (PrEP)21 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Preventive Prophylaxis (PrEP)37 Participants
Usual CareNumber of Participants Who Use Preventive Prophylaxis (PrEP)17 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Preventive Prophylaxis (PrEP)45 Participants
Usual CareNumber of Participants Who Use Preventive Prophylaxis (PrEP)17 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants Who Use Preventive Prophylaxis (PrEP)42 Participants
Usual CareNumber of Participants Who Use Preventive Prophylaxis (PrEP)12 Participants
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NCM4HIVHousing StatusMy own place13 Participants
NCM4HIVHousing StatusFamily/Foster Family home16 Participants
NCM4HIVHousing StatusFriend's home41 Participants
NCM4HIVHousing StatusHome of boyfriend/girlfriend/sexual partner4 Participants
NCM4HIVHousing StatusShelter181 Participants
NCM4HIVHousing StatusHotel or motel2 Participants
NCM4HIVHousing StatusTransitional living program10 Participants
NCM4HIVHousing Statusstreet, park, or outside17 Participants
NCM4HIVHousing Statusabandoned building or squat9 Participants
NCM4HIVHousing Statuscar, bus, light rail, or metro2 Participants
NCM4HIVHousing StatusOther7 Participants
NCM4HIVHousing StatusUnknown/Not Reported1 Participants
Usual CareHousing StatusOther5 Participants
Usual CareHousing StatusMy own place7 Participants
Usual CareHousing StatusTransitional living program5 Participants
Usual CareHousing StatusFamily/Foster Family home2 Participants
Usual CareHousing Statuscar, bus, light rail, or metro1 Participants
Usual CareHousing StatusFriend's home14 Participants
Usual CareHousing Statusstreet, park, or outside10 Participants
Usual CareHousing StatusHome of boyfriend/girlfriend/sexual partner1 Participants
Usual CareHousing StatusUnknown/Not Reported0 Participants
Usual CareHousing StatusShelter95 Participants
Usual CareHousing Statusabandoned building or squat4 Participants
Usual CareHousing StatusHotel or motel3 Participants
Secondary

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)

Population: Data were not collected for 82 participants in the NCM4HIV arm and 39 participants in the Usual Care arm due to loss to follow-up

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NCM4HIVHousing StatusHome of boyfriend/girlfriend/sexual partner5 Participants
NCM4HIVHousing StatusTransitional living program9 Participants
NCM4HIVHousing StatusFriend's Home24 Participants
NCM4HIVHousing StatusStreet, park or outside8 Participants
NCM4HIVHousing StatusShelter103 Participants
NCM4HIVHousing StatusAbandoned building or squat3 Participants
NCM4HIVHousing StatusFamily/Foster Family Home25 Participants
NCM4HIVHousing Statuscar, bus, light rail, or metro1 Participants
NCM4HIVHousing StatusHotel or Motel8 Participants
NCM4HIVHousing StatusOther2 Participants
NCM4HIVHousing StatusMy own place33 Participants
Usual CareHousing StatusOther3 Participants
Usual CareHousing StatusMy own place16 Participants
Usual CareHousing StatusFamily/Foster Family Home8 Participants
Usual CareHousing StatusFriend's Home14 Participants
Usual CareHousing StatusHome of boyfriend/girlfriend/sexual partner6 Participants
Usual CareHousing StatusShelter46 Participants
Usual CareHousing StatusHotel or Motel5 Participants
Usual CareHousing StatusTransitional living program5 Participants
Usual CareHousing StatusStreet, park or outside4 Participants
Usual CareHousing StatusAbandoned building or squat0 Participants
Usual CareHousing Statuscar, bus, light rail, or metro1 Participants
Secondary

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)

Population: Data were not collected for 117 participants in the NCM4HIV arm and 62 participants in the Usual Care arm due to loss to follow-up

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NCM4HIVHousing StatusMy own place49 Participants
NCM4HIVHousing StatusTransitional living program3 Participants
NCM4HIVHousing StatusHome of boyfriend/girlfriend/sexual partner8 Participants
NCM4HIVHousing Statusstreet, park, or outside6 Participants
NCM4HIVHousing StatusFamily/Foster Family home21 Participants
NCM4HIVHousing Statusabandoned building or squat3 Participants
NCM4HIVHousing StatusShelter60 Participants
NCM4HIVHousing Statuscar, bus, light rail, or metro0 Participants
NCM4HIVHousing StatusFriend's home21 Participants
NCM4HIVHousing StatusOther7 Participants
NCM4HIVHousing StatusHotel or motel8 Participants
Usual CareHousing StatusOther4 Participants
Usual CareHousing StatusFamily/Foster Family home12 Participants
Usual CareHousing StatusMy own place15 Participants
Usual CareHousing StatusFriend's home14 Participants
Usual CareHousing StatusHome of boyfriend/girlfriend/sexual partner6 Participants
Usual CareHousing StatusShelter17 Participants
Usual CareHousing StatusHotel or motel4 Participants
Usual CareHousing StatusTransitional living program4 Participants
Usual CareHousing Statusstreet, park, or outside6 Participants
Usual CareHousing Statusabandoned building or squat0 Participants
Usual CareHousing Statuscar, bus, light rail, or metro3 Participants
Secondary

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)

Population: Data were not collected for 129 participants in the NCM4HIV arm and 71 participants in the Usual Care arm due to loss to follow-up

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NCM4HIVHousing StatusHome of boyfriend/girlfriend/sexual partner8 Participants
NCM4HIVHousing StatusTransitional living program3 Participants
NCM4HIVHousing StatusFriend's home23 Participants
NCM4HIVHousing Statusstreet, park, or outside5 Participants
NCM4HIVHousing StatusShelter33 Participants
NCM4HIVHousing Statusabandoned building or squat3 Participants
NCM4HIVHousing StatusFamily/Foster Family home17 Participants
NCM4HIVHousing Statuscar, bus, light rail, or metro2 Participants
NCM4HIVHousing StatusHotel or motel10 Participants
NCM4HIVHousing StatusOther6 Participants
NCM4HIVHousing StatusMy own place64 Participants
Usual CareHousing StatusOther2 Participants
Usual CareHousing StatusMy own place18 Participants
Usual CareHousing StatusFamily/Foster Family home13 Participants
Usual CareHousing StatusFriend's home8 Participants
Usual CareHousing StatusHome of boyfriend/girlfriend/sexual partner3 Participants
Usual CareHousing StatusShelter19 Participants
Usual CareHousing StatusHotel or motel5 Participants
Usual CareHousing StatusTransitional living program2 Participants
Usual CareHousing Statusstreet, park, or outside5 Participants
Usual CareHousing Statusabandoned building or squat1 Participants
Usual CareHousing Statuscar, bus, light rail, or metro0 Participants
Secondary

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)

Population: Data were not collected for 119 participants in the NCM4HIV arm and 65 participants in the Usual Care arm due to loss to follow-up

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NCM4HIVHousing StatusShelter21 Participants
NCM4HIVHousing StatusHotel or motel7 Participants
NCM4HIVHousing StatusFamily/Foster Family home27 Participants
NCM4HIVHousing StatusTransitional living program5 Participants
NCM4HIVHousing StatusFriend's home19 Participants
NCM4HIVHousing Statusabandoned building or squat2 Participants
NCM4HIVHousing StatusMy own place69 Participants
NCM4HIVHousing Statuscar, bus, light rail, or metro5 Participants
NCM4HIVHousing StatusHome of boyfriend/girlfriend/sexual partner12 Participants
NCM4HIVHousing StatusOther8 Participants
NCM4HIVHousing Statusstreet, park, or outside9 Participants
Usual CareHousing StatusOther5 Participants
Usual CareHousing Statusstreet, park, or outside7 Participants
Usual CareHousing StatusHome of boyfriend/girlfriend/sexual partner2 Participants
Usual CareHousing StatusFamily/Foster Family home14 Participants
Usual CareHousing StatusMy own place23 Participants
Usual CareHousing StatusFriend's home13 Participants
Usual CareHousing StatusShelter12 Participants
Usual CareHousing StatusHotel or motel2 Participants
Usual CareHousing StatusTransitional living program1 Participants
Usual CareHousing Statusabandoned building or squat1 Participants
Usual CareHousing Statuscar, bus, light rail, or metro2 Participants
Secondary

Mental Health as Measured by the Brief Symptom Index-18

The Brief Symptom Inventory 18 (BSI-18) consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

Time frame: baseline

Population: Data were not collected for this outcome measure because the Brief Symptom Index-18 survey was not administered to participants. Instead, the Patient Health Questionnaire (PHQ-9) was used to assess mental health. As a result, no participants received the Brief Symptom Index-18 survey, and no data were collected for this outcome measure. Therefore, zero participants were analyzed for this outcome. Data from the PHQ-9 are reported under a different outcome measure.

Secondary

Mental Health as Measured by the Brief Symptom Index-18

The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

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

Population: Data were not collected for this outcome measure because the Brief Symptom Index-18 survey was not administered to participants. Instead, the Patient Health Questionnaire (PHQ-9) was used to assess mental health. As a result, no participants received the Brief Symptom Index-18 survey, and no data were collected for this outcome measure. Therefore, zero participants were analyzed for this outcome. Data from the PHQ-9 are reported under a different outcome measure.

Secondary

Mental Health as Measured by the Brief Symptom Index-18

The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

Time frame: 3 months after intervention (Month 6)

Population: Data were not collected for this outcome measure because the Brief Symptom Index-18 survey was not administered to participants. Instead, the Patient Health Questionnaire (PHQ-9) was used to assess mental health. As a result, no participants received the Brief Symptom Index-18 survey, and no data were collected for this outcome measure. Therefore, zero participants were analyzed for this outcome. Data from the PHQ-9 are reported under a different outcome measure.

Secondary

Mental Health as Measured by the Brief Symptom Index-18

The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

Time frame: 6 months after intervention (Month 9)

Population: Data were not collected for this outcome measure because the Brief Symptom Index-18 survey was not administered to participants. Instead, the Patient Health Questionnaire (PHQ-9) was used to assess mental health. As a result, no participants received the Brief Symptom Index-18 survey, and no data were collected for this outcome measure. Therefore, zero participants were analyzed for this outcome. Data from the PHQ-9 are reported under a different outcome measure.

Secondary

Mental Health as Measured by the Brief Symptom Index-18

The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

Time frame: 9 months after intervention (Month 12)

Population: Data were not collected for this outcome measure because the Brief Symptom Index-18 survey was not administered to participants. Instead, the Patient Health Questionnaire (PHQ-9) was used to assess mental health. As a result, no participants received the Brief Symptom Index-18 survey, and no data were collected for this outcome measure. Therefore, zero participants were analyzed for this outcome. Data from the PHQ-9 are reported under a different outcome measure.

Secondary

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)

ArmMeasureValue (MEAN)Dispersion
NCM4HIVMental Health as Measured by the Patient Health Questionnaire (PHQ-9)6.9 score on a scaleStandard Deviation 6.82
Usual CareMental Health as Measured by the Patient Health Questionnaire (PHQ-9)8.1 score on a scaleStandard Deviation 7.52
Secondary

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

ArmMeasureValue (MEAN)Dispersion
NCM4HIVMental Health as Measured by the Patient Health Questionnaire (PHQ-9)8.8 score on a scaleStandard Deviation 6.99
Usual CareMental Health as Measured by the Patient Health Questionnaire (PHQ-9)8.5 score on a scaleStandard Deviation 7.25
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
NCM4HIVMental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.7 score on a scaleStandard Deviation 6.81
Usual CareMental Health as Measured by the Patient Health Questionnaire (PHQ-9)8.9 score on a scaleStandard Deviation 7.92
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
NCM4HIVMental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.3 score on a scaleStandard Deviation 7.09
Usual CareMental Health as Measured by the Patient Health Questionnaire (PHQ-9)8 score on a scaleStandard Deviation 7.21
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
NCM4HIVMental Health as Measured by the Patient Health Questionnaire (PHQ-9)7.7 score on a scaleStandard Deviation 7.09
Usual CareMental Health as Measured by the Patient Health Questionnaire (PHQ-9)6.6 score on a scaleStandard Deviation 6.73
Secondary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen IIAt completion of the 3-month intervention (Month 3)162 Participants
NCM4HIVNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II3 months after intervention (Month 6)140 Participants
NCM4HIVNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II6 months after intervention (Month 9)138 Participants
NCM4HIVNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II9 months after intervention (Month 12)146 Participants
Usual CareNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II9 months after intervention (Month 12)60 Participants
Usual CareNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen IIAt completion of the 3-month intervention (Month 3)70 Participants
Usual CareNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II6 months after intervention (Month 9)74 Participants
Usual CareNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II3 months after intervention (Month 6)79 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NCM4HIVNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II170 Participants
Usual CareNumber of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II79 Participants

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026