Behavior, Risk
Conditions
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
Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Baseline | Sexually 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 Survey | baseline | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental Health as Measured by the Brief Symptom Index-18 | baseline | The Brief Symptom Inventory 18 (BSI-18) consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress. |
| Housing Status | baseline | Participants 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 II | At completion of the 3-month intervention (Month 3), 3 months after intervention (Month 6), 6 months after intervention (Month 9), 9 months after intervention (Month 12) | An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | baseline | The 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
| Arm | Count |
|---|---|
| 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 |
| Total | 450 |
Baseline characteristics
| Characteristic | NCM4HIV | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 21 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 Participants | 25 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 255 Participants | 121 Participants | 376 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 185 Participants | 94 Participants | 279 Participants |
| Race (NIH/OMB) More than one race | 37 Participants | 19 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants | 22 Participants | 58 Participants |
| Race (NIH/OMB) White | 39 Participants | 12 Participants | 51 Participants |
| Region of Enrollment United States | 303 participants | 147 participants | 450 participants |
| Sex/Gender, Customized Decline to Answer | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Female | 138 Participants | 57 Participants | 195 Participants |
| Sex/Gender, Customized Genderqueer, neither exclusively male nor female | 3 Participants | 2 Participants | 5 Participants |
| Sex/Gender, Customized Male | 149 Participants | 77 Participants | 226 Participants |
| Sex/Gender, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Transgender Female | 8 Participants | 3 Participants | 11 Participants |
| Sex/Gender, Customized Transgender Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 318 | 2 / 156 |
| other Total, other adverse events | 0 / 318 | 0 / 156 |
| serious Total, serious adverse events | 5 / 318 | 1 / 156 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 63 Participants |
| Usual Care | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 24 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 43 Participants |
| Usual Care | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 19 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 32 Participants |
| Usual Care | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 13 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 44 Participants |
| Usual Care | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 24 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 38 Participants |
| Usual Care | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | 18 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 74 Participants |
| Usual Care | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 34 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 81 Participants |
| Usual Care | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 36 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 86 Participants |
| Usual Care | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 34 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 64 Participants |
| Usual Care | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 41 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 84 Participants |
| Usual Care | Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | 23 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 6 Participants |
| Usual Care | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 5 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 7 Participants |
| Usual Care | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 4 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 6 Participants |
| Usual Care | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 4 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 10 Participants |
| Usual Care | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 3 Participants |
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 6 Participants |
| Usual Care | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | 14 Participants |
Number of Participants Who Use Preventive Prophylaxis (PrEP)
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 20 Participants |
| Usual Care | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 18 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 55 Participants |
| Usual Care | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 21 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 37 Participants |
| Usual Care | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 17 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 45 Participants |
| Usual Care | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 17 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 42 Participants |
| Usual Care | Number of Participants Who Use Preventive Prophylaxis (PrEP) | 12 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Housing Status | My own place | 13 Participants |
| NCM4HIV | Housing Status | Family/Foster Family home | 16 Participants |
| NCM4HIV | Housing Status | Friend's home | 41 Participants |
| NCM4HIV | Housing Status | Home of boyfriend/girlfriend/sexual partner | 4 Participants |
| NCM4HIV | Housing Status | Shelter | 181 Participants |
| NCM4HIV | Housing Status | Hotel or motel | 2 Participants |
| NCM4HIV | Housing Status | Transitional living program | 10 Participants |
| NCM4HIV | Housing Status | street, park, or outside | 17 Participants |
| NCM4HIV | Housing Status | abandoned building or squat | 9 Participants |
| NCM4HIV | Housing Status | car, bus, light rail, or metro | 2 Participants |
| NCM4HIV | Housing Status | Other | 7 Participants |
| NCM4HIV | Housing Status | Unknown/Not Reported | 1 Participants |
| Usual Care | Housing Status | Other | 5 Participants |
| Usual Care | Housing Status | My own place | 7 Participants |
| Usual Care | Housing Status | Transitional living program | 5 Participants |
| Usual Care | Housing Status | Family/Foster Family home | 2 Participants |
| Usual Care | Housing Status | car, bus, light rail, or metro | 1 Participants |
| Usual Care | Housing Status | Friend's home | 14 Participants |
| Usual Care | Housing Status | street, park, or outside | 10 Participants |
| Usual Care | Housing Status | Home of boyfriend/girlfriend/sexual partner | 1 Participants |
| Usual Care | Housing Status | Unknown/Not Reported | 0 Participants |
| Usual Care | Housing Status | Shelter | 95 Participants |
| Usual Care | Housing Status | abandoned building or squat | 4 Participants |
| Usual Care | Housing Status | Hotel or motel | 3 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Housing Status | Home of boyfriend/girlfriend/sexual partner | 5 Participants |
| NCM4HIV | Housing Status | Transitional living program | 9 Participants |
| NCM4HIV | Housing Status | Friend's Home | 24 Participants |
| NCM4HIV | Housing Status | Street, park or outside | 8 Participants |
| NCM4HIV | Housing Status | Shelter | 103 Participants |
| NCM4HIV | Housing Status | Abandoned building or squat | 3 Participants |
| NCM4HIV | Housing Status | Family/Foster Family Home | 25 Participants |
| NCM4HIV | Housing Status | car, bus, light rail, or metro | 1 Participants |
| NCM4HIV | Housing Status | Hotel or Motel | 8 Participants |
| NCM4HIV | Housing Status | Other | 2 Participants |
| NCM4HIV | Housing Status | My own place | 33 Participants |
| Usual Care | Housing Status | Other | 3 Participants |
| Usual Care | Housing Status | My own place | 16 Participants |
| Usual Care | Housing Status | Family/Foster Family Home | 8 Participants |
| Usual Care | Housing Status | Friend's Home | 14 Participants |
| Usual Care | Housing Status | Home of boyfriend/girlfriend/sexual partner | 6 Participants |
| Usual Care | Housing Status | Shelter | 46 Participants |
| Usual Care | Housing Status | Hotel or Motel | 5 Participants |
| Usual Care | Housing Status | Transitional living program | 5 Participants |
| Usual Care | Housing Status | Street, park or outside | 4 Participants |
| Usual Care | Housing Status | Abandoned building or squat | 0 Participants |
| Usual Care | Housing Status | car, bus, light rail, or metro | 1 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Housing Status | My own place | 49 Participants |
| NCM4HIV | Housing Status | Transitional living program | 3 Participants |
| NCM4HIV | Housing Status | Home of boyfriend/girlfriend/sexual partner | 8 Participants |
| NCM4HIV | Housing Status | street, park, or outside | 6 Participants |
| NCM4HIV | Housing Status | Family/Foster Family home | 21 Participants |
| NCM4HIV | Housing Status | abandoned building or squat | 3 Participants |
| NCM4HIV | Housing Status | Shelter | 60 Participants |
| NCM4HIV | Housing Status | car, bus, light rail, or metro | 0 Participants |
| NCM4HIV | Housing Status | Friend's home | 21 Participants |
| NCM4HIV | Housing Status | Other | 7 Participants |
| NCM4HIV | Housing Status | Hotel or motel | 8 Participants |
| Usual Care | Housing Status | Other | 4 Participants |
| Usual Care | Housing Status | Family/Foster Family home | 12 Participants |
| Usual Care | Housing Status | My own place | 15 Participants |
| Usual Care | Housing Status | Friend's home | 14 Participants |
| Usual Care | Housing Status | Home of boyfriend/girlfriend/sexual partner | 6 Participants |
| Usual Care | Housing Status | Shelter | 17 Participants |
| Usual Care | Housing Status | Hotel or motel | 4 Participants |
| Usual Care | Housing Status | Transitional living program | 4 Participants |
| Usual Care | Housing Status | street, park, or outside | 6 Participants |
| Usual Care | Housing Status | abandoned building or squat | 0 Participants |
| Usual Care | Housing Status | car, bus, light rail, or metro | 3 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Housing Status | Home of boyfriend/girlfriend/sexual partner | 8 Participants |
| NCM4HIV | Housing Status | Transitional living program | 3 Participants |
| NCM4HIV | Housing Status | Friend's home | 23 Participants |
| NCM4HIV | Housing Status | street, park, or outside | 5 Participants |
| NCM4HIV | Housing Status | Shelter | 33 Participants |
| NCM4HIV | Housing Status | abandoned building or squat | 3 Participants |
| NCM4HIV | Housing Status | Family/Foster Family home | 17 Participants |
| NCM4HIV | Housing Status | car, bus, light rail, or metro | 2 Participants |
| NCM4HIV | Housing Status | Hotel or motel | 10 Participants |
| NCM4HIV | Housing Status | Other | 6 Participants |
| NCM4HIV | Housing Status | My own place | 64 Participants |
| Usual Care | Housing Status | Other | 2 Participants |
| Usual Care | Housing Status | My own place | 18 Participants |
| Usual Care | Housing Status | Family/Foster Family home | 13 Participants |
| Usual Care | Housing Status | Friend's home | 8 Participants |
| Usual Care | Housing Status | Home of boyfriend/girlfriend/sexual partner | 3 Participants |
| Usual Care | Housing Status | Shelter | 19 Participants |
| Usual Care | Housing Status | Hotel or motel | 5 Participants |
| Usual Care | Housing Status | Transitional living program | 2 Participants |
| Usual Care | Housing Status | street, park, or outside | 5 Participants |
| Usual Care | Housing Status | abandoned building or squat | 1 Participants |
| Usual Care | Housing Status | car, bus, light rail, or metro | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Housing Status | Shelter | 21 Participants |
| NCM4HIV | Housing Status | Hotel or motel | 7 Participants |
| NCM4HIV | Housing Status | Family/Foster Family home | 27 Participants |
| NCM4HIV | Housing Status | Transitional living program | 5 Participants |
| NCM4HIV | Housing Status | Friend's home | 19 Participants |
| NCM4HIV | Housing Status | abandoned building or squat | 2 Participants |
| NCM4HIV | Housing Status | My own place | 69 Participants |
| NCM4HIV | Housing Status | car, bus, light rail, or metro | 5 Participants |
| NCM4HIV | Housing Status | Home of boyfriend/girlfriend/sexual partner | 12 Participants |
| NCM4HIV | Housing Status | Other | 8 Participants |
| NCM4HIV | Housing Status | street, park, or outside | 9 Participants |
| Usual Care | Housing Status | Other | 5 Participants |
| Usual Care | Housing Status | street, park, or outside | 7 Participants |
| Usual Care | Housing Status | Home of boyfriend/girlfriend/sexual partner | 2 Participants |
| Usual Care | Housing Status | Family/Foster Family home | 14 Participants |
| Usual Care | Housing Status | My own place | 23 Participants |
| Usual Care | Housing Status | Friend's home | 13 Participants |
| Usual Care | Housing Status | Shelter | 12 Participants |
| Usual Care | Housing Status | Hotel or motel | 2 Participants |
| Usual Care | Housing Status | Transitional living program | 1 Participants |
| Usual Care | Housing Status | abandoned building or squat | 1 Participants |
| Usual Care | Housing Status | car, bus, light rail, or metro | 2 Participants |
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.
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.
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.
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.
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.
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCM4HIV | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 6.9 score on a scale | Standard Deviation 6.82 |
| Usual Care | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 8.1 score on a scale | Standard Deviation 7.52 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCM4HIV | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 8.8 score on a scale | Standard Deviation 6.99 |
| Usual Care | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 8.5 score on a scale | Standard Deviation 7.25 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCM4HIV | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 7.7 score on a scale | Standard Deviation 6.81 |
| Usual Care | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 8.9 score on a scale | Standard Deviation 7.92 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCM4HIV | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 7.3 score on a scale | Standard Deviation 7.09 |
| Usual Care | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 8 score on a scale | Standard Deviation 7.21 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCM4HIV | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 7.7 score on a scale | Standard Deviation 7.09 |
| Usual Care | Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | 6.6 score on a scale | Standard Deviation 6.73 |
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NCM4HIV | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | At completion of the 3-month intervention (Month 3) | 162 Participants |
| NCM4HIV | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 3 months after intervention (Month 6) | 140 Participants |
| NCM4HIV | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 6 months after intervention (Month 9) | 138 Participants |
| NCM4HIV | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 9 months after intervention (Month 12) | 146 Participants |
| Usual Care | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 9 months after intervention (Month 12) | 60 Participants |
| Usual Care | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | At completion of the 3-month intervention (Month 3) | 70 Participants |
| Usual Care | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 6 months after intervention (Month 9) | 74 Participants |
| Usual Care | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 3 months after intervention (Month 6) | 79 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCM4HIV | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 170 Participants |
| Usual Care | Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | 79 Participants |