Trial Outcomes & Findings for Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth (NCT NCT03910218)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

474 participants

Primary outcome timeframe

baseline

Results posted on

2025-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	318	156
Overall Study Received Intervention	303	147
Overall Study COMPLETED	303	147
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NCM4HIV n=303 Participants 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	Usual Care n=147 Participants 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	Total n=450 Participants Total of all reporting groups
Age, Continuous	21 years STANDARD_DEVIATION 2.1 • n=5 Participants	21.1 years STANDARD_DEVIATION 2.1 • n=7 Participants	21.1 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex/Gender, Customized Female	138 Participants n=5 Participants	57 Participants n=7 Participants	195 Participants n=5 Participants
Sex/Gender, Customized Male	149 Participants n=5 Participants	77 Participants n=7 Participants	226 Participants n=5 Participants
Sex/Gender, Customized Transgender Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Transgender Female	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Sex/Gender, Customized Genderqueer, neither exclusively male nor female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex/Gender, Customized Decline to Answer	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants	25 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	255 Participants n=5 Participants	121 Participants n=7 Participants	376 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	185 Participants n=5 Participants	94 Participants n=7 Participants	279 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	12 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	37 Participants n=5 Participants	19 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	303 participants n=5 Participants	147 participants n=7 Participants	450 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Preventive Prophylaxis (PrEP)	18 Participants	20 Participants

PRIMARY outcome

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

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Preventive Prophylaxis (PrEP)	21 Participants	55 Participants

PRIMARY outcome

Timeframe: 3 months after intervention (Month 6)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Preventive Prophylaxis (PrEP)	17 Participants	37 Participants

PRIMARY outcome

Timeframe: 6 months after intervention (Month 9)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Preventive Prophylaxis (PrEP)	17 Participants	45 Participants

PRIMARY outcome

Timeframe: 9 months after intervention (Month 12)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Preventive Prophylaxis (PrEP)	12 Participants	42 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	14 Participants	6 Participants

PRIMARY outcome

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

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	4 Participants	7 Participants

PRIMARY outcome

Timeframe: 3 months after intervention (Month 6)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 6 months after intervention (Month 9)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	3 Participants	10 Participants

PRIMARY outcome

Timeframe: 9 months after intervention (Month 12)

Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Non-occupational Post-exposure Prophylaxis (nPEP)	5 Participants	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	34 Participants	86 Participants

PRIMARY outcome

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

An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.\\ Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	36 Participants	81 Participants

PRIMARY outcome

Timeframe: 3 months after intervention (Month 6)

An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	41 Participants	64 Participants

PRIMARY outcome

Timeframe: 6 months after intervention (Month 9)

An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	23 Participants	84 Participants

PRIMARY outcome

Timeframe: 9 months after intervention (Month 12)

An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Use Condoms at Last Sex as Measured by the Youth Risk Behavior Survey	34 Participants	74 Participants

PRIMARY outcome

Timeframe: Baseline

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	24 Participants	63 Participants

PRIMARY outcome

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

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	19 Participants	43 Participants

PRIMARY outcome

Timeframe: 3 months after intervention (Month 6)

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	13 Participants	32 Participants

PRIMARY outcome

Timeframe: 6 months after intervention (Month 9)

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	24 Participants	44 Participants

PRIMARY outcome

Timeframe: 9 months after intervention (Month 12)

Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants Who Tested Positive for HIV or Sexually Transmitted Infection (STI)	18 Participants	38 Participants

SECONDARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Housing Status My own place	7 Participants	13 Participants
Housing Status Family/Foster Family home	2 Participants	16 Participants
Housing Status Friend's home	14 Participants	41 Participants
Housing Status Shelter	95 Participants	181 Participants
Housing Status Hotel or motel	3 Participants	2 Participants
Housing Status Transitional living program	5 Participants	10 Participants
Housing Status street, park, or outside	10 Participants	17 Participants
Housing Status abandoned building or squat	4 Participants	9 Participants
Housing Status car, bus, light rail, or metro	1 Participants	2 Participants
Housing Status Other	5 Participants	7 Participants
Housing Status Home of boyfriend/girlfriend/sexual partner	1 Participants	4 Participants
Housing Status Unknown/Not Reported	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Usual Care n=108 Participants 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	NCM4HIV n=221 Participants 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
Housing Status My own place	16 Participants	33 Participants
Housing Status Family/Foster Family Home	8 Participants	25 Participants
Housing Status Friend's Home	14 Participants	24 Participants
Housing Status Home of boyfriend/girlfriend/sexual partner	6 Participants	5 Participants
Housing Status Shelter	46 Participants	103 Participants
Housing Status Hotel or Motel	5 Participants	8 Participants
Housing Status Transitional living program	5 Participants	9 Participants
Housing Status Street, park or outside	4 Participants	8 Participants
Housing Status Abandoned building or squat	0 Participants	3 Participants
Housing Status car, bus, light rail, or metro	1 Participants	1 Participants
Housing Status Other	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Usual Care n=85 Participants 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	NCM4HIV n=186 Participants 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
Housing Status car, bus, light rail, or metro	3 Participants	0 Participants
Housing Status Other	4 Participants	7 Participants
Housing Status My own place	15 Participants	49 Participants
Housing Status Family/Foster Family home	12 Participants	21 Participants
Housing Status Friend's home	14 Participants	21 Participants
Housing Status Home of boyfriend/girlfriend/sexual partner	6 Participants	8 Participants
Housing Status Shelter	17 Participants	60 Participants
Housing Status Hotel or motel	4 Participants	8 Participants
Housing Status Transitional living program	4 Participants	3 Participants
Housing Status street, park, or outside	6 Participants	6 Participants
Housing Status abandoned building or squat	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Usual Care n=76 Participants 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	NCM4HIV n=174 Participants 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
Housing Status My own place	18 Participants	64 Participants
Housing Status Hotel or motel	5 Participants	10 Participants
Housing Status Transitional living program	2 Participants	3 Participants
Housing Status street, park, or outside	5 Participants	5 Participants
Housing Status abandoned building or squat	1 Participants	3 Participants
Housing Status car, bus, light rail, or metro	0 Participants	2 Participants
Housing Status Other	2 Participants	6 Participants
Housing Status Family/Foster Family home	13 Participants	17 Participants
Housing Status Friend's home	8 Participants	23 Participants
Housing Status Home of boyfriend/girlfriend/sexual partner	3 Participants	8 Participants
Housing Status Shelter	19 Participants	33 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Usual Care n=82 Participants 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	NCM4HIV n=184 Participants 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
Housing Status My own place	23 Participants	69 Participants
Housing Status Family/Foster Family home	14 Participants	27 Participants
Housing Status Home of boyfriend/girlfriend/sexual partner	2 Participants	12 Participants
Housing Status Shelter	12 Participants	21 Participants
Housing Status Friend's home	13 Participants	19 Participants
Housing Status Hotel or motel	2 Participants	7 Participants
Housing Status Transitional living program	1 Participants	5 Participants
Housing Status street, park, or outside	7 Participants	9 Participants
Housing Status abandoned building or squat	1 Participants	2 Participants
Housing Status car, bus, light rail, or metro	2 Participants	5 Participants
Housing Status Other	5 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
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	162 Participants
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	140 Participants
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	138 Participants
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	146 Participants

SECONDARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	8.5 score on a scale Standard Deviation 7.25	8.8 score on a scale Standard Deviation 6.99

SECONDARY outcome

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

The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	8.9 score on a scale Standard Deviation 7.92	7.7 score on a scale Standard Deviation 6.81

SECONDARY outcome

Timeframe: 3 months after intervention (Month 6)

The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	8.1 score on a scale Standard Deviation 7.52	6.9 score on a scale Standard Deviation 6.82

SECONDARY outcome

Timeframe: 6 months after intervention (Month 9)

The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	8 score on a scale Standard Deviation 7.21	7.3 score on a scale Standard Deviation 7.09

SECONDARY outcome

Timeframe: 9 months after intervention (Month 12)

The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression. Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Mental Health as Measured by the Patient Health Questionnaire (PHQ-9)	6.6 score on a scale Standard Deviation 6.73	7.7 score on a scale Standard Deviation 7.09

SECONDARY outcome

Timeframe: baseline

An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported.

Outcome measures

Outcome measures
Measure	Usual Care n=147 Participants 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	NCM4HIV n=303 Participants 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
Number of Participants With Substance Use as Measured by Item 11 in the Texas Christian University (TCU) Drug Screen II	79 Participants	170 Participants

Adverse Events

NCM4HIV

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	NCM4HIV n=318 participants at risk 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	Usual Care n=156 participants at risk 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
Psychiatric disorders Suicidal ideation	0.31% 1/318 • Number of events 2 • up to 1 year	0.64% 1/156 • Number of events 1 • up to 1 year
General disorders Hospitalization	0.31% 1/318 • Number of events 1 • up to 1 year	0.00% 0/156 • up to 1 year
Psychiatric disorders Hospitalization	0.63% 2/318 • Number of events 2 • up to 1 year	0.00% 0/156 • up to 1 year
General disorders Reported child abuse	0.31% 1/318 • Number of events 1 • up to 1 year	0.00% 0/156 • up to 1 year

Other adverse events

Adverse event data not reported

Additional Information

Diane Santa Maria, DrPH

The University of Texas Health Science Center at Houston

Phone: 713-500-2187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place