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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCM4HIV | Experimental | 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 |
|
| Usual care | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCM4HIV | Behavioral | Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Use Preventive Prophylaxis (PrEP) | baseline | |
| Number of Participants Who Use Preventive Prophylaxis (PrEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3) |
| Number of Participants Who Use Preventive Prophylaxis (PrEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 3 months after intervention (Month 6) |
| Number of Participants Who Use Preventive Prophylaxis (PrEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 6 months after intervention (Month 9) |
| Number of Participants Who Use Preventive Prophylaxis (PrEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Santa Maria, DrPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531116 | Derived | 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. | |
| 38809559 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Includes all participants who received intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Use Preventive Prophylaxis (PrEP) | Posted | Count of Participants | Participants | baseline |
|
up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Santa Maria, DrPH | The University of Texas Health Science Center at Houston | 713-500-2187 | diane.m.santamaria@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Apr 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2021 | Apr 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Usual Care | Behavioral | Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals |
|
| 9 months after intervention (Month 12) |
| Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | baseline |
| Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3) |
| Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 3 months after intervention (Month 6) |
| Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 6 months after intervention (Month 9) |
| Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 9 months after intervention (Month 12) |
| Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. | baseline |
| Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.\ Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3) |
| Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 3 months after intervention (Month 6) |
| Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 6 months after intervention (Month 9) |
| Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey | An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 9 months after intervention (Month 12) |
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. | Baseline |
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3) |
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 3 months after intervention (Month 6) |
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 6 months after intervention (Month 9) |
| Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 9 months after intervention (Month 12) |
| 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. |
| At completion of the 3-month intervention (Month 3) |
| Mental Health as Measured by the Brief Symptom Index-18 | The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress. | 3 months after intervention (Month 6) |
| Mental Health as Measured by the Brief Symptom Index-18 | The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress. | 6 months after intervention (Month 9) |
| Mental Health as Measured by the Brief Symptom Index-18 | The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress. | 9 months after intervention (Month 12) |
| Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | baseline |
| Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | At completion of the 3-month intervention (Month 3) |
| Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 3 months after intervention (Month 6) |
| Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 6 months after intervention (Month 9) |
| Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 9 months after intervention (Month 12) |
| Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3), 3 months after intervention (Month 6), 6 months after intervention (Month 9), 9 months after intervention (Month 12) |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression | baseline |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | At completion of the 3-month intervention (Month 3) |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 3 months after intervention (Month 6) |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 6 months after intervention (Month 9) |
| Mental Health as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets. | 9 months after intervention (Month 12) |
| Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II | An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported. | baseline |
| 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Count of Participants | Participants | At completion of the 3-month intervention (Month 3) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months after intervention (Month 6) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months after intervention (Month 9) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 9 months after intervention (Month 12) |
|
|
|
| Primary | Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP) | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | At completion of the 3-month intervention (Month 3) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months after intervention (Month 6) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months after intervention (Month 9) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 9 months after intervention (Month 12) |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | At completion of the 3-month intervention (Month 3) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months after intervention (Month 6) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months after intervention (Month 9) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 9 months after intervention (Month 12) |
|
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| Primary | Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI) | Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Posted | Count of Participants | Participants | At completion of the 3-month intervention (Month 3) |
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| 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. | Posted | Count of Participants | Participants | 3 months after intervention (Month 6) |
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| 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. | Posted | Count of Participants | Participants | 6 months after intervention (Month 9) |
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| 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. | Posted | Count of Participants | Participants | 9 months after intervention (Month 12) |
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| 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. | 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. | Posted | baseline |
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| 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. | 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. | Posted | At completion of the 3-month intervention (Month 3) |
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| 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. | 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. | Posted | 3 months after intervention (Month 6) |
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| 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. | 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. | Posted | 6 months after intervention (Month 9) |
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| 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. | 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. | Posted | 9 months after intervention (Month 12) |
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| Secondary | Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | Posted | Count of Participants | Participants | baseline |
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| Secondary | Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 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 | Posted | Count of Participants | Participants | At completion of the 3-month intervention (Month 3) |
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| Secondary | Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 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 | Posted | Count of Participants | Participants | 3 months after intervention (Month 6) |
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| Secondary | Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 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 | Posted | Count of Participants | Participants | 6 months after intervention (Month 9) |
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| Secondary | Housing Status | Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc. | 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 | Posted | Count of Participants | Participants | 9 months after intervention (Month 12) |
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| 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. | Posted | Count of Participants | Participants | 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) |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | At completion of the 3-month intervention (Month 3) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months after intervention (Month 6) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months after intervention (Month 9) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 9 months after intervention (Month 12) |
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| 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. | Posted | Count of Participants | Participants | baseline |
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| 1 |
| 318 |
| 5 |
| 318 |
| 0 |
| 318 |
| EG001 | 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 | 2 | 156 | 1 | 156 | 0 | 156 |
| Hospitalization | General disorders | Non-systematic Assessment |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Reported child abuse | General disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| Friend's home |
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| Home of boyfriend/girlfriend/sexual partner |
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| Shelter |
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| Hotel or motel |
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| Transitional living program |
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| street, park, or outside |
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| abandoned building or squat |
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| car, bus, light rail, or metro |
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| Other |
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| Unknown/Not Reported |
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| Friend's Home |
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| Home of boyfriend/girlfriend/sexual partner |
|
| Shelter |
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| Hotel or Motel |
|
| Transitional living program |
|
| Street, park or outside |
|
| Abandoned building or squat |
|
| car, bus, light rail, or metro |
|
| Other |
|
| Friend's home |
|
| Home of boyfriend/girlfriend/sexual partner |
|
| Shelter |
|
| Hotel or motel |
|
| Transitional living program |
|
| street, park, or outside |
|
| abandoned building or squat |
|
| car, bus, light rail, or metro |
|
| Other |
|
| Friend's home |
|
| Home of boyfriend/girlfriend/sexual partner |
|
| Shelter |
|
| Hotel or motel |
|
| Transitional living program |
|
| street, park, or outside |
|
| abandoned building or squat |
|
| car, bus, light rail, or metro |
|
| Other |
|
| Friend's home |
|
| Home of boyfriend/girlfriend/sexual partner |
|
| Shelter |
|
| Hotel or motel |
|
| Transitional living program |
|
| street, park, or outside |
|
| abandoned building or squat |
|
| car, bus, light rail, or metro |
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| Other |
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| 6 months after intervention (Month 9) |
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| 9 months after intervention (Month 12) |
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