Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth
Phase: NA
Conditions: Behavior, Risk
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
UT Houston Protocol NCM4HIV 
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Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care 
Intervention among Homeless Youth 
 
NCT03910218 
 
Version Date: 03/09/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
UT Houston Protocol NCM4HIV 
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Protocol Title: 
Come As You Are - Assessing the Efficacy of a Nurse Case 
Management HIV Prevention and Care Intervention among 
Homeless Youth 
 
Principal Investigator: 
Diane Santa Maria 
 
Co-Investigators: 
Adey Nyamathi, Marguerita Lightfoot, Mary Paul, Yasmeen 
Quadri, Nikhil Padhye 
 
Consultants 
 
Study Coordinator: 
Cathy E. Crouch, Michael Businelle, Charlene Flash 
Jennifer Torres 
Population: 
Community Advisory Group = 10; Youth Advisory Group = 10; 
RCT = 450 youth experiencing homelessness or unstable housing 
who are emancipated minors 16-17 years old or young adults 18- 
25 years old. 
 
Number of Sites: 
Single site 
 
Study Duration: 
5 years 
 
Subject Duration: 
12 months per participant 
 
 
General Information 
Randomized Controlled Trial of NCM4HIV 
We will conduct a wait-list control RCT to determine the efficacy of the NCM4HIV intervention 
compared to usual care among YEH aged 16-25 years (Figure 2). We will determine whether 
NCM4HIV increases uptake of HIV prevention strategies (e.g., PrEP and nPEP uptake, HIV 
testing, STI screening and treatment, and condom use) when compared with usual care among 
YEH (N=450) at immediate post-intervention, 3, 6, and 9 months. The second aim is to 
determine whether the intervention improves mental health, substance use, and housing status. 
As an exploratory aim, we will determine whether health seeking, coping, HIV risk perception, 
PrEP/nPEP barriers and facilitators, and condom self-efficacy mediate the effect of the 
intervention on uptake of PrEP/nPEP, condom use, and HIV/STI testing. YEH will be recruited 
from shelters, drop-in centers, clinics and street outreach (see LOSs). In YR-1 we will finalize 
the protocol, obtain IRB approval, train study staff, and begin enrolling youth. In YRS 1-4, we 
will enroll a total sample size of 450 youth. In YR-4, we will complete the 9-month follow-ups. In 
YR-5, we will complete intervention delivery for the wait-list control group, analyze the data, 
prepare manuscripts, and disseminate the findings. 

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Background Information 
Millions of Youth Experience Homelessness and Suffer from High Morbidity and 
Mortality. On any given night in the United States, 1.7 to 2.5 million youth under age 25 are 
homeless.17-19 YEH are more likely than housed youth to experience premature death, suicide, 
drug overdose, HIV, pregnancy, substance use, and mental illness.20-25 While the need for 
prevention interventions tailored to the special considerations of this high-risk, complex 
population is undeniable, they continue to be understudied and underserved.26 However, YEH 
are interested in health promotion programs, can be recruited and retained in interventions and 
research studies,27,28 and demonstrate improved outcomes when programs are tailored and 
relevant.29 
Youth experiencing homelessness (YEH) are at high risk for HIV but many do not access 
the prevention services they need. YEH are 6-12 times more likely to become infected with 
HIV than housed youth,1 with HIV prevalence as high as 16%.2 A number of risk behaviors drive 
infection rates in YEH. YEH have earlier sexual debuts; are more likely to have multiple 
partners; trade sex for food, shelter, money, or substances,2,30,31 use substances before sex; are 
less likely to use condoms or contraception; and sexual minority YEH (men who have sex with 
men) are at particular high risk for HIV.23,32 YEH who trade sex are also at high risk for HIV as 
they are rarely able to negotiate condom use and often lack knowledge about biomedical 
advances in HIV prevention like PrEP.33 Additionally, while 27% of YEH are raped while 
homeless, only 29% of victims seek medical care when nPEP can be provided.6 Our recent 7- 
city (Houston, Denver, St. Louis, Phoenix, Los Angeles, San Jose, New York City) study of 1427 
YEH (58% male, 81% youth of color, 31% LGBTQ) showed that 71% had little to no knowledge 
of PrEP. Despite these high risks, only 53% had undergone HIV testing in the preceding 3 
months. Furthermore, a recent systematic review of interventions to prevent HIV in homeless 
youth found only 3 eligible studies, highlighting the paucity of research with YEH, and concluded 
that more research is needed. The review also indicated the need for novel interventions and 
more robust evaluations. Therefore, while programs exist that address HIV prevention among 
YEH, HIV rates are still high, most interventions don’t address the full continuum of behavioral 
and biomedical HIV prevention, and additional research to develop interventions for YEH is 
critically needed. 
Co-occurrence of mental health problems and substance use also drive risk in YEH. HIV 
risk is further entangled with multiple comorbid conditions, including mental illness and 
substance use. Suicide is one of the leading causes of death among YEH34 with suicide attempt 
rates ranging from 12% to 48%.35-37 Rates of depression and post-traumatic stress among YEH 
range from 8%38 to 61%39 and 5% to 48%,40-42 respectively. Our recent research found that 42% 
of YEH are moderately to severely stressed, 48% experience mental distress, 48% have 
depression, and 23% have post-traumatic stress.43 Depression among YEH may be due to a 
lifetime of adversity, abuse, neglect, and housing instability,44,45 all of which can lead to riskier 
sexual decision making.46 Further, rates of substance use among YEH are twice those of 
housed youth.20,23 In one study, 86% of met the DSM-IV diagnostic criteria for a substance use 
disorder23 compared with only 15% in the general young adult population, and drug overdose is 
a leading cause of death among YEH.22 HIV prevention efforts must therefore address mental 
health and substance use issues and be incorporated into existing social service programs.47-49 
Interventions for YEH must address both their comprehensive needs and the full 
continuum of HIV. Barriers to HIV prevention and health seeking among YEH are compounded 
by mental illness, housing instability, and substance use,8 reinforcing the need to test 
interventions that comprehensively address the needs of YEH. Individuals impacted by mental 
illness, homelessness, and substance use have greater PrEP uptake and adherence when 
these broader issues are also addressed.8 Interventions for YEH must also provide the full 

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continuum of behavioral and biomedical HIV prevention including HIV and sexually transmitted 
infection (STI) screening and treatment, pre-exposure prophylaxis (PrEP), and non-occupational 
post-exposure prophylaxis (nPEP).7 To date, YEH have not accessed the continuum of HIV 
prevention strategies. As noted above, YEH often are unaware of effective prevention strategies 
like PrEP, and PrEP uptake50 and adherence are lower among homeless.51 Therefore, effective 
HIV prevention for YEH includes PrEP awareness, PrEP eligibility assessments, condom 
promotion, HIV/STI screening/treatment, as well as assisting in healthcare navigation and 
engagement for mental health and substance use issues,11-13 transportation and health 
insurance challenges. A strategy that may effectively address the multifaceted and complex 
health and social challenges of YEH is nurse case management. 
Nurse case management (NCM) is particularly suited to addressing the complex needs of 
YEH. Nurses, who have been voted 
the most trusted professionals in 
national Gallup opinion polls for the 
past 15 years,14 are well suited to 
work with YEH and are a part of most 
existing HIV programs for YEH. NCM 
is an effective intervention that can 
potentially address the complex 
comorbid conditions and effectively 
engage YEH in the full continuum of 
HIV prevention. NCM is based on the 
Comprehensive Health Seeking and 
Coping Framework (CHSCF; Figure 
1), which describes how the nurse 
and client work together to mutually 
develop goals and strategies to 
improve health in a context of non- 
judgmental acceptance. 
Accomplishment of goals occur by addressing cognitive appraisals (clarifying misconceptions), 
promoting health seeking, and addressing knowledge and coping behaviors that incorporate the 
situational, personal, social, and resource needs affecting health. NCM involves coordinated, 
individualized, comprehensive care delivered by a registered nurse (RN) that includes a 
comprehensive health assessment, mutual care plan development, prevention education, and 
health and social service navigation.52-55 A nurse-led intervention eliminates the need to refer 
YEH to other medical professionals for HIV prevention services (e.g., PrEP, nPEP, lab draws, 
STI testing/treatment), a step that may increase compliance. This is particularly important as 
being homeless can decrease effectiveness of linkages to care56 vs. providing care at the point- 
of-contact. NCM has been efficacious in reducing drug use among methadone users57 and 
YEH,54 improving hepatitis B vaccination rates,58 reducing repeat pregnancies, and facilitating 
HIV care coordination.59 NCM’s comprehensive approach of simultaneously addressing 
concomitant problems (e.g., mental health, substance use, and housing needs) and 
incorporating the full continuum of behavioral and biomedical HIV prevention in an integrated 
fashion is a promising strategy for engaging YEH. Nurses are part of nearly all current HIV 
programs for YEH; therefore, our intervention is sustainable and can be easily integrated into 
existing HIV prevention programs. 
We will strengthen NCM by integrating motivational interviewing (MI) and behavioral 
feedback. YEH are self-reliant, can be challenging to engage, and can become distrustful of 
adults due to past trauma and victimization on the streets.9,60 Therefore, we will integrate MI 
strategies into our NCM approach to strengthen the relationship between the YEH and RN and 

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to evoke participant driven goals.61 MI is a person-centered counseling style to strengthen a 
person’s motivation and commitment to change and addresses ambivalence about behavior 
change.15,16 MI has been successfully used with youth to improve uptake and adherence to 
health behaviors resulting in reduced alcohol62 and substance use63 and increased condom64 
and contraceptive use.65 We will also employ behavioral feedback technology to tailor and 
further engage YEH in the intervention. Specifically, we will include smartphone self-monitoring 
daily diaries for youth to monitor progress towards their behavioral goals. Instant feedback 
enhances cognitive appraisal of YEHs’ health seeking and coping behaviors and promotes 
motivation.61,66 Like many adolescents and young adults, YEH underestimate their HIV risk,67,68 
suggesting that self-monitoring may assist in aligning their behaviors with their perceived HIV 
risk. Immediate self-monitored behavior feedback has been found to increase condom use.61,69 
Leveraging the high number of youth who have phones and the technology use preferences of 
young adults70-72 in general and YEH,73-75 our intervention will include very brief daily diaries, 
with data from the daily diaries being used to provide instant visual feedback on their progress 
toward their goals (see Intervention Description for details). A review of 42 studies showed high 
daily diary monitoring rates (78%) among youth.76 Our prior studies have found similar high 
compliance (82-87%) with homeless and vulnerable populations (see Preliminary Studies 
section). We found that 67% of YEH have smartphones67 and that they frequently search the 
internet for health-related information, housing, and shelter. The most frequent searches were 
on healthcare services and medication information.67 
To further engage YEH, we will meet them “where they are”8 and implement the intervention in 
collaboration with existing health and social service providers. This strategy is particularly 
important given that past month use of a drop-in center predicts HIV/STI testing77 and being 
linked to a drop-in center is significantly associated with increased service utilization (p < 0.01) 
and improved HIV-related outcomes (p < 0.001).49 These findings support the potential of 
delivering HIV prevention in drop-in centers and shelters to connect healthcare underutilizing 
YEH. Moreover, drop-in centers may be the preferred HIV prevention service location of YEH.49 
By integrating the delivery of NCM4HIV into already established social services, we can 
enhance HIV prevention while improving access to mental health, substance use, and housing 
services. Because these service agencies also conduct weekly street outreach where we can 
recruit youth, we anticipate reaching disconnected youth who have yet to present for health or 
social services. 
Innovation 
 
While NCM and MI are established methods for behavioral change and care engagement 
among high-risk populations, nurses are underutilized as behavioral change agents.78 This 
early-stage and new-investigator R01 is innovative in the following ways: (1) it will take best 
advantage of the underutilized role of nurses, American’s most trusted professionals, in the HIV 
prevention team; (2) nurse provision of HIV prevention services will remove the need to refer 
YEH to other medical personnel, which can decrease compliance; (3) enhancing NCM with MI 
and behavioral feedback to increase YEHs’ motivation for adopting HIV prevention behaviors; 
(4) addressing the full continuum of behavioral and biomedical HIV prevention with YEH; and (5) 
the intervention can be applied to improve any existing YEH HIV prevention program. 
NCM4HIV capitalizes on the “come as you are” approach endorsed in the Clinical Guidelines79 
put forth by the National Healthcare for the Homeless Council (NHCHC) and aligns with NIH 
HIV/AIDS High Priority Research Area for reducing HIV through behavioral prevention and 
access to services in high HIV prevalence and substance-using populations. Additionally, NCM 
facilitates coordination with YEH service providers to meet mental health, substance use, and 
housing service needs and connects youth to the healthcare services at the Health Care for the 
Homeless Program (HCHP), such as HIV and STI testing and treatment. If efficacious, we will 

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partner with the NHCHC to disseminate the program across its approximately 300 programs 
and 3,300 clinics that provide care for people experiencing homelessness (see Letters of 
Support [LOS]). 
 
Objectives 
Aim 1: Determine whether the enhanced NCM intervention increases uptake of HIV prevention 
strategies (PrEP and nPEP uptake, HIV testing, STI screening and treatment, and condom use) 
when compared with wait list control youth (N=450; aged 16-25 years) at baseline, immediate 
post, and 3, 6, and 9 months 
H1: Youth receiving NCM will have greater improvements in these outcomes over 9 months 
than control youth 
Aim 2: Determine whether NCM4HIV improves mental health, substance use, and housing 
status when compared with wait list control youth at baseline, immediate post, and 3, 6, and 9 
months 
H2: Youth receiving NCM will have greater improvements in these outcomes over 9 months 
than control youth 
Exploratory Aim: Determine if health seeking, coping, HIV risk perception, PrEP/nPEP 
barriers/facilitators, and condom self-efficacy mediate intervention effects on PrEP/nPEP 
uptake, HIV/STI testing, and condom use 
 
Study Design 
Figure 2. Study Design 
Baseline 
Intervention 
3  Mon. 
6 Mon. 
9 Mon. 
Intervention 
Treatment arm 
O1 
X O2 
O3 
O4 
O5 
Wait list control 
O1 
O2 
O3 
O4 
O5 
X 
Figure 3. Study Design 
 
Measures. The baseline survey will include demographics such as age, sex (operationalized as 
the gender identity, not biological sex), race/ethnicity, sexual orientation, educational level, and 
employment. We will assess historical factors to characterize the sample, such as foster care 
history, adverse childhood experiences, age at the first episode of homelessness, and duration 
of current homelessness, all of which have been linked to sexual risks.114,115 PrEP/nPEP uptake 

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will be assessed through NCM report and medical chart verification of PrEP/nPEP prescription. 
Follow-up surveys will assess condom use at last sex and during the past 3 months, substance 
use,116 sexual behaviors,117 HIV and STI testing, mental health symptoms,118,119 and housing 
status. In alignment with CHSCF, we will assess possible intervention mediators including 
healthcare engagement,120 condom use self-efficacy,121 HIV risk perception,122 PrEP 
barriers/facilitators,123 health seeking, 124 and coping125,126 using validated measures. 
Outcome Measures by Study Aim 
Construct 
Scale/Measure 
Alpha 
Aim 1 Outcomes 
PrEP/nPEP Uptake 
PrEP uptake; nPEP uptake (NCM report, chart review) 
NA 
Condom Use 
Youth Risk Behavior Survey;128 (condom use at last sex) 
NA 
HIV/STI Test Uptake 
Rapid HIV test; Gonorrhea, Chlamydia, Syphilis test 
NA 
Aim 2 Outcomes 
Mental Health 
Brief Symptom Index-18118,119 
0.80 
Housing Status 
In a shelter, apt/house, with someone, outside, in a car…? 
NA 
Substance Use 
TCU Drug Screen II82,129 
0.89 
Exploratory Outcomes (possible mediators based on CHSCF; see Figure 1) 
Healthcare Engagement 
Healthcare clinic visit adherence120 
NA 
Condom Use Self-Efficacy 
Condom Use Self-Efficacy Scale121 
0.91 
HIV Risk Perception 
Perceived Risk of HIV scale122 
0.88 
PrEP Facilitators & Barriers 
Facilitators and Barriers to PrEP Use123 
NA 
Health Seeking 
General Help Seeking Questionnaire124 
0.83 
Coping 
Coping Inventory for Stressful Situations-Adolescent125,126 
0.92 
 
Study Population 
Inclusion Criteria. We will limit our sample to YEH ages 16-25 years to align with adolescent 
brain development,4,5 risk behavior,6 YEH literature, the current clinical and FDA guidelines for 
PrEP and nPEP use, and the extant literature suggesting that experiencing homelessness as a 
young adult under 26 is associated with heightened sexual risk behaviors and substance use.7 
Individuals will be included if they (1) engage in high-risk sexual activity or intravenous drug use, 
(2) are 16-25 years old, (3) speak English, (4) are experiencing homelessness, and (5) are not 
planning to move out of the metro area during the study. High-risk sexual activity will be defined 
as having condomless vaginal or anal sex in the past 6 months. While Houston has a high 
Hispanic population, only 1 of the 434 youth from Youth Count 2.0 preferred to take the survey 
in Spanish, and the large majority of Hispanic YEH in Houston prefer English. Therefore, we do 
not anticipate excluding otherwise eligible youth based on language by limiting to English 
speaking youth. Experiencing homelessness will be defined as having slept on the streets, in a 
place not meant for habitation, in a shelter, hotel/motel, or with someone where they cannot stay 
for more than 30 days (e.g., couch surfing). YEH may stay in emergency shelters or on the 
streets (e.g., parks and tent cities), in abandoned or vacant buildings or apartments, temporarily 
with friends, family, or acquaintances, or in rented hotel/motel rooms8 and go to great lengths to 
stay hidden from the dangers of victimization.9 This broader definition of homelessness aligns 
with the McKinney-Vento Homeless Assistance Act of 1987 which allows us to account for the 
transiency and instability of housing experienced by YEH, and increases the generalizability of 
the study findings. If a youth has low literacy based on the REALM-SF (scores < 4) they will be 
excluded due to the need to read at a 4th grade level for the daily dairies.2 Only 2 youth from 
Youth Count 2.0 were excluded based on their literacy level. While youth could access the 
survey using the audio-assisted feature of REDCap regardless of their literacy level, they may 

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not be able to read the daily diaries if they were assigned to the intervention arm. This set of 
criteria were used successfully in our prior studies. 
Exclusion Criteria. Youth outside of the age range (16-25) at the point of enrollment will be 
excluded. Youth who are very low literacy (scores < 4 on the REALM-SF health literacy 
assessment)2 will be excluded from participating in the study due to the need to independently 
read the daily diaries. Only 2 youth from Youth Count 2.0 were excluded based on their literacy 
level. While youth would be able to access the survey using the audio-assisted feature of 
REDCap regardless of literacy level, they may not be able to read the daily diaries if they were 
randomized to the NCM+behavioral feedback arm. A high proportion of homeless youth have a 
mental illness diagnosis or experience mental distress that is treatable. While we contemplated 
excluding youth with severe, acute mental symptoms to encourage them to first seek mental 
health services, we understand that they may also benefit from the intervention even if mental 
health is not a primary outcome. Youth who are noticeably intoxicated or experiencing acute 
mental distress will be encouraged to come back and be screened for enrollment at a later time 
point to assure safety and acute needs are met prior to enrollment. 
Recruitment. YEH in Houston, TX (N=450) will be recruited from drop-in centers, shelters, local 
YEH service locations, clinics, federally qualified healthcare centers in locations with a high 
concentration of homelessness, magnet (e.g., hot meal) events, mobile clinics, and street 
outreach to increase representation from both connected and disconnected YEH to increase 
generalizability of the findings (see LOSs). These recruitment sites serve young men, women, 
families, and LGBTQ youth. We will use group-based study introduction sessions, flyers, and 
recruitment letters at the agencies, clinics, street outreach, and the website and Facebook 
pages of the agencies and HYN, methods we successfully used in Youth Count 2.0 to recruit 
434 YEH in just 4 weeks.43 The RC and RA will maintain a consistent presence at the 
recruitment sites throughout the study to facilitate both recruitment and follow-up efforts. The 
RC and RA will approach youth to describe the study, screen for eligibility, and obtain informed 
consent (see Human Subjects section) in a quiet area (e.g., library or office space). Potential 
participants will be informed at each encounter that participation will have no effect on their 
ability to receive services such as housing, mental health, or healthcare. A nationally 
representative survey suggests that 3.5 million 18- to 25-year-olds experienced homelessness 
during the past year.103 In 2016 in Houston, TX, local homeless youth service providers served 
over 5000 unduplicated YEH.97 Given the aforementioned inclusion criteria and the high volume 
of YEH in Houston, we expect to have few challenges with enrolling our sample size of 450 
youth. Due to the transience of this population, we anticipate the need to recruit 600 youth for 
eligibility in order to reach out final sample size of 450 by the end of year 4. 
 
Due to the COVID-19 pandemic and subsequent closures/restrictions at recruitment sites, 
additional strategies will be used to supplement the delay of in-person recruitment. 
 
Participants who have completed the 2nd follow up data collection will be notified that they can 
refer peers to participate in the study. Referrals will be screened according to protocol and if 
eligible, will be invited to participate in the study. Participants who refer will receive a $10 gift 
card for each referral who successfully completes study enrollment (up to 5 referrals). 

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Successful completion of study enrollment includes consent process, baseline data collection, 
and issuance of group assignment and study cell phone, 
 
Study team will create a ResearchMatch profile. ResearchMatch.org is a free, publically 
available, and secure online tool created which allows individuals to find research studies 
for which they may be eligible. All interested individuals indicating interest will be screened 
by study staff per current protocol. 
 
Digital advertising (FB & Instagram ads) will be utilized to reach target population and will be 
targeted to 16-25 year olds within the Houston area, Individuals who respond to the ads via 
social media, phone, or email will be screened for eligibility by study staff and if eligible, will be 
invited to participate per current protocol. 
 
If risk level for coronavirus according to Harris County is 2 or 3, study staff will set up tables 
outside of shelters or drop-in centers to engage potentially eligible youth, with permission from 
the agencies. Youth will be screened for eligibility on-site and if eligible, will be invited to 
participate per current protocol. 
 
 
Study Procedures 
 
Protection of Human Subjects from Research Risks 
This Human Subjects research meets the definition of a clinical trial. 
 
Human Subjects Involvement, Characteristics, and Design. This proposed randomized 
controlled trial will test the efficacy of a nurse case management (NCM) HIV prevention 
intervention compared to usual care among homeless young adults aged 16-25 years old. We 
will follow participants for 9 months after the intervention for a total study period of 12 months. 
The intervention incorporates motivational interviewing strategies combined with nurse case 
management and a smartphone based daily diary to develop participant driven HIV prevention 
behavioral goals. Given the inclusion criteria and volume of youth served at the recruitment 
sites, we expect to recruit 50 youth in YR-1, 200 youth in YR-2, 150 in YR-3 and 50 in YR-4 for 
a total sample size of 450.Youth will be recruited in partnership with the Salvation Army that 
runs a Young Adults Resource Drop-in Center and street outreach (see LOS), the Covenant 
House Texas (CHT) youth shelter and their street outreach program (see LOS), and the 13 free- 
standing and shelter-based Healthcare for the Homeless Program clinics (Dr. Quadri is Medical 
Director and Co-I). As well, we will recruit from the 10 Legacy Federally Qualified Healthcare 
Center Clinics. 
 
Sources of Materials. 
Baseline and Follow-up Survey Data. 5 Surveys will be collected at baseline, immediate, 3-, 
6-, and 9-months post intervention using REDCap online surveys delivered on iPads or 
accessed remotely by participant smartphone or computer. Surveys will be provided in a quiet, 
private room at the drop-in center and shelter, and take about 30 minutes each to complete. In 
cases when a participant prefers to complete their survey at another location, the research 
assistant will find an agreed upon location to meet up with the youth to complete the survey 
such as a near-by library or coffee shop. For youth who leave the area during the data collection 
period, we will create an individualized survey link generated from REDCap. This web-based 

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link will be password protected and can be sent to the participant via text message or email. The 
RA will contact the participant to assure access to and completion of the survey. The survey can 
then be completed using the web browser on the study issued phone. We will finalize the pre- 
and post-surveys during YR-1 with input from the CAG and YWG. We will use survey items we 
have used in our previous studies with homeless youth to assess demographics (e.g., age at 
first homelessness, duration of homelessness, race/ethnicity, sexual orientation, gender 
identity), psychosocial factors, and behavioral outcomes (see Table 2). Additionally, the 
immediate post-survey for the intervention group will contain intervention process outcome 
items including what participants found the most and the least helpful, what made it easy to 
attend sessions and what made it hard. To report study process outcomes, we will calculate the 
number of eligible youth approached, participation refusal rate with reason for refusal, the 
number of sessions attended, follow-up survey response rates, and phone loss. For refusal rate, 
we will ask each youth we approach their age, race/ethnicity, gender and sexual orientation to 
allow for demographic comparisons by participation status to monitor potential sample bias. 
Participants will be notified that no survey data will be shared with shelter and drop-in center 
staff or their case workers. Data will be collected on encrypted iPads using a secured HIPPA 
and IRB compliant REDCap system for the baseline, follow-ups, and pre-post session surveys. 
In the event of unreliable W-FI, this data will be collected using REDCap offline in order to 
minimize concern over data. Offline data is stored on the hard drive of the encrypted iPad and 
uploaded to REDCap nightly at the UTHealth office or when Wi-Fi is detected. No data from 
REDCap is accessible from the iPads. The tablet will be encrypted and password protected so 
that no one except research staff are able to gain access to the information on the tablet and the 
tablet is rendered useless if stolen. iPads can be wiped to factory settings remotely by UTHeath 
IT department using AirWatch in the case of a missing or stolen device. Only research staff will 
have the passwords for the REDCap database and computer. Survey data cannot be accessed 
from the encrypted iPad tablet and is only accessible on the REDCap secure server. Data will be 
downloaded from REDCap after every data collection and saved on a secure, firewall protected 
hard drive. 
 
HIV/STI Test Specimens. As part of the study eligibility screening process, potentially eligible 
youth will be screened for HIV. Screening will take place in a private location in the shelter or 
drop-in center or library bathroom or private conference room. The RA, who will receive training 
in pre-and post-test counseling, will provide pre- and post-test counseling and coordinate follow- 
up care for confirmatory testing for participants with a positive HIV screening test. In the case of 
a participant who is HIV positive, the nurse will care for the youth as part of routine healthcare 
services provided by Healthcare for the Homeless which is part of the Harris Health System 
(https://www.harrishealth.org/en/our-community/outreach-services/pages/healthcare- 
homeless.aspx). Newly diagnosed youth who are not yet engaged in HIV care will be linked to 
HIV service provider at the Thomas Street Health Center using already in place protocols for 
homeless HIV positive clients. 
 
All study participants will be offered testing for HIV and STIs at baseline, immediate post- 
intervention, 3, 6, and 9 months post intervention. HIV and STI testing will be collected in a 
private location at the shelter or drop-in center. Any youth who have a positive STI test results 
will receive treatment and care coordination from the Healthcare for the Homeless Houston 
(HHH) program or their medical home if preferred. As mandated by law, positive results will also 
be reported to the Houston Health Department. Youth who test positive for HIV during the study 
will be linked to HIV care at the Thomas Street Health Center or another clinic of their choice 
using already in place protocols for homeless HIV positive clients by the nurse case manager. 

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For HIV testing, we will use the INSTI HIV-1/HIV-2 Rapid Antibody Test (99.9% sensitivity, 
100% specificity.) For Chlamydia and Gonorrhea, urine specimens will be collected in a sterile 
cup, refrigerated between 2°C to 8°C, and transported on the same day to Thomas Street Clinic, 
a Harris Health entity. Nurses will notify physician and Co-PI Dr. Quadri, who will order 
chlamydia and gonorrhea tests via the Harris Health lab. Results will be obtained by RNs 
credentialed by Harris Health via the electronic system, EPIC, and be shared with participants 
via phone call or in person. If collected at UTHealth, Chlamydia and Gonorrhea specimens will 
be processed via UTHealth clinic lab (LapCorp). For Syphilis testing, we will use the Syphilis 
Health Check, Syphilis Antibody Rapid Immunochromatographic Test. The assays will be run 
within 2 business days using the current laboratory procedures at Harris Health Systems (see 
Resources section). Specimens will be discarded based on the regulator laboratory procedures. 
Youth who test positive for an STI will be contacted to schedule a follow-up appointment to 
receive treatment as indicated. Reportable positive tests will be reported to the local health 
department to initiate partner notification procedures. Tests will be conducted in a private 
location in the drop-in center and shelter clinic area or private office space. 
 
Preferred method for HIV & STI testing is conducted by study staff at recruitment site for 
convenience of participant. However, due to COVID-19 pandemic, study team will offer 
additional methods to conduct HIV & STI depending on current COVID-19 risk level, availability 
of PPE, health of study staff, health of participant, and location of participant: 
1) With study staff at Cizik School of Nursing (6901 Bertner Ave. or 7000 Fannin) 
2) Covenant House clinic 
3) Harris Health clinic 
4) At-home test to take under supervision of a study staff via video call. 
 
At-home tests will be available for Syphilis, Chlamydia, and Gonorrhea using commercially 
available Everlywell tests. Study staff will mail test kits in a discreet envelope or hand-deliver 
the kits at a convenient public location (e.g., grocery store). Participants will register the kits on 
a private, secure platform and mail samples to Everlywell lab in a postage-paid envelope. 
Participant will be able to access results online. In the event of a positive result, a third party 
provider via Everlywell will contact participant and offer referrals for treatment. Study staff will 
follow up on treatment and make appropriate reports to Houston Health Department. Study 
staff will acquire results via the secure Everlywell Lens platform. 
 
Participants will receive an $20 gift card for completing each STI testing follow up in addition to 
incentive for surveys to cover the cost of transportation and time. 
 
If participants have been testing for HIV, chlamydia and gonorrhea, and/or syphilis in the last 2 
weeks and report no potential exposure, study staff will ask permission to obtain results from a 
partnering agency outlined in the consent form. 
 
Study staff will be equipped with PPE for all in-person visits in accordance with national (CDC & 
NIH), local (Harris County and City of Houston), and UTHealth clinical research guidelines. 
 
Sharing test results. Participants who request written documentation of test results will be 
provided with the Research Results Letter. Research staff who conducted the test will fill out 
testers name, date, location, time, test(s) conducted and results. Letter will specify that test was 
conducted as part of a research study and provide study contact information. 

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PrEP sub study. Participants who initiate PrEP during the study will be invited to take part in a 
PrEP sub study which includes a medication adherence test and interview. Separate protocol 
and consent form will be used for the sub study. 
 
Daily Diary Data. Participants in the intervention group will receive a brief daily diary during the 
3 months of the NCM intervention. The daily diary will ask about sexual risk behaviors, sexual 
urges, stress, affect, social interactions, coping, and circumstances the prior day (e.g. where did 
you stay last night, sexual activity, substance use). The daily diary will be pushed on the study- 
issued phone 30 minutes after waking as indicated on the participants’ intake form, and take 
less than 5 minutes to complete. Once completed, the data populates a simple interface 
accessible by password on the study issued smartphone. This interface provides a visual 
display based on the participant’s HIV prevention goals and their behaviors as reported in the 
daily diary. It allows the nurse and youth to review one’s current behaviors align with the health 
goals they established during the Nurse Case Management session. This feature is password 
protected on the phone. 
 
Community Advisory Group (CAG) and Youth Working Group (YWG). The CAG and YWG 
will meet throughout the study to ground it in the contextual experience and needs of YEH. The 
PI will work closely with the Homeless Youth Network (HYN) to create a study-specific CAG of 
health and social service providers and convene an YWG from existing community YEH 
advisory groups. CAG members (n=10) will be currently providing care to YEH recruited from 
the 150 members of the HYN. The PI will chair the CAG meetings. CAG will meet bi-monthly in 
Yr-1 and then biannually to provide input on study procedures, protocol implementation, and 
interpretation and dissemination of the findings to the community. Meetings will follow pre- 
scheduled HYN meetings, last about 1 hour, and take place at existing service locations to 
facilitate attendance. Refreshments will be provided in lieu of a monetary incentive, the norm for 
HYN. The CAG will finalize the local homeless resource guide to be given to all participants at 
the time of enrollment and pre-programmed into the study issued phones. This guide will 
contain location and contact information for shelters, meals, social, legal, and education 
services, and clinics. 
 
The YWG (n=10) will be currently or formerly YEH aged 16-25 years who will meet monthly in 
YR-1 then , if needed, to achieve the study aims and will be compensated at $25 per working 
session. Lunch will be provided during the sessions. YWG members will assist in the 
development of study procedures, survey items, and recruitment materials to provide the 
experiential context of HIV risk. The RC and PI will co-chair YWG sessions and they will last 1-2 
hours. 
 
Intervention Description 
 
Table 1. Differentiation between Usual Care and the NCM4HIV Intervention 
 
 
Expanded NCM4HIV Components 
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 
Current Usual Care Services 
Available 
Housing, food, and clothing needs, 
health assessment, basic 
healthcare, limited anticipatory 
guidance, mental health counseling, 
substance use treatment referrals, 
PrEP/nPEP referrals 

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An individual intervention design was chosen due to the heterogeneity of YEH and their risk 
behaviors and the challenges associated with group session designs including low 
attendance.104 
 
This intervention has 2 components: (1) 6 Face-to-Face NCM Sessions delivered by a nurse 
who will assist a participant to generate HIV prevention goal using Motivational Interviewing 
strategies and conduct an HIV risk profile and eligibility PrEP assessment. The nurse will meet 
the participant in a non-stigmatizing, trauma-informed way that respects where they are at in 
their current situation and evokes personal motivation for health promoting behaviors. Sessions 
are designed to meet the complex, multi-level health and social needs of homeless youth to 
align with the extant literature demonstrating the strong connection between HIV risk behaviors 
and mental health, substance use, and housing.1 Therefore, at each session, the nurse will 
assess mental health, substance use, and housing needs to establish a plan of care with the 
participant. The nurse will coordinate health and social service navigation with the social 
workers at the agencies as needed with permission of the participant. The nurse will review HIV 
acquisition and transmission risk factors with the participant at each session and inquire about 
engagement in sexual risk behaviors since the last NCM session. During each NCM session 
and as needed, youth will complete an HIV risk profile used in the clinic setting to assess for 
PrEP eligibility based on the extent of behavioral risk. A screening tool developed from the 
Centers for Disease Control and Prevention 2014 Clinical Practice Guidelines for PrEP use will 
be used to assess PrEP eligibility based on HIV risk behaviors at the beginning of each NCM 
session to determine whether recent behaviors warrant PrEP as a possible intervention for HIV 
prevention. This includes having a HIV-positive sexual partner, recent bacterial STI, a high 
number of sex partners, a history of inconsistent or no condom use, or commercial sex work, 
and IV drug use. Houston, TX is considered a high HIV prevalence area and homeless youth 
are considered a high prevalence network. The nurse will use MI strategies to evoke participant 
generated HIV prevention goals and strategies. In the event that a participant is unable to attend 
a session in person, they will be offered the option of attending the session via video chat or 
phone, or meeting at a public location that is convenient for them such as a neighborhood 
library. Due to COVID-19, nurse may elect to deliver the intervention via video call depending on 
current COVID-19 risk level, availability of PPE, health of study staff, health of participant, and 
location of participant. (2) Behavioral Feedback. Each session will entail HIV prevention 
education (i.e., risk behaviors and prevention strategies) and behavioral goal setting to align the 
participant’s goals with their current behaviors to evoke personal motivation to adopt and 
maintain HIV prevention strategies. Building on the goal setting of NCM using MI strategies, 
intervention youth will complete very brief daily diaries on their study-issued phone that 
populates an interface that provides visual feedback about how one’s current behaviors align 
with their health goals. These daily diaries take less than 5 minutes to complete each day. The 
nurse then can use this visual to facilitate discussion about the barriers and facilitators that 
impeded or enhanced one’s ability to actualize the uptake and adherence to HIV prevention 
strategies. The nurses will make monthly booster calls to intervention participants on the study 
issued phone in months 1-3 following the end of the face-to-face sessions. During this call, the 
nurse will inquire about the uptake and adherence to the HIV prevention strategies outlined 
during the NCM sessions, any other needs that they can address for the participant at that time, 
and will help the participant navigate services as needed. 
Table 2. Team Developed Enhanced NCM HIV Prevention Intervention Session 
Description 
# 
Session Title 
CHSCF Construct 
Motivational Interviewing Discussion 
Topics 
Session Goals 
1. 
Introduction & 
Situational, 
Review HIV risk behaviors & prevention 
Establish rapport; 

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Needs 
Assessment 
personal, social 
factors, & 
resources 
strategies (condoms, HIV/STI testing, 
treatment, PrEP, nPEP) knowledge, 
attitudes, beliefs, self-efficacy 
assess HIV risk, PrEP 
eligibility 
2. 
HIV Prevention 
Strategies & 
Goal Setting 
Nursing goals 
Review personal HIV risk; use MI to 
discuss strategies to increase the safety 
of sexual activity, evoke change talk 
Select HIV prevention 
behavioral goals and 
action plan 
3. 
Behavioral 
Feedback & 
Goal Alignment 
Health seeking & 
coping behaviors 
Identify gaps between goals & behaviors 
(e.g., self-management, coping, health 
care engagement), evoke change talk 
Revise/reinforce plan to 
meet/maintain HIV 
prevention goals 
4. 
Addressing 
Facilitators & 
Barriers 
Perceived 
behavior 
compliance & 
coping 
effectiveness 
Review goals and action plan; use MI to 
discuss personal HIV prevention 
behavioral change facilitators & barriers, 
evoke change talk 
Revise/reinforce HIV 
prevention goals and 
action plan to increase 
facilitators 
5. 
Establishing a 
Medical Home 
Immediate health 
outcomes 
Review goals and action plan; discuss 
local clinic preferences and schedule 
well-check as indicated, evoke change 
talk and behavioral maintenance 
Revise/reinforce HIV 
prevention goals, action 
plan, follow-up care plan 
6. 
Moving Toward 
Health & 
Wellbeing 
Long-term health 
outcomes 
Review goals and action plan; identify 
additional health, housing, work, and 
education needs/goals, evoke change 
talk and behavioral maintenance 
Reinforce HIV 
prevention behavioral 
goals and action plan 
 
HIV Prevention Goal Setting. The nurse will use MI strategies to evoke participant-generated 
HIV prevention goals and behavior change talk. Each session will entail HIV prevention 
education (i.e., HIV risk behaviors and prevention strategies) and behavior goal setting to align 
the participant’s goals with their current behaviors and evoke personal motivation to adopt and 
maintain HIV prevention strategies. For HIV positive youth and youth who test positive for HIV 
during the study period, the nurse will focus on linking youth to HIV care and promoting 
behaviors to reduce HIV transmission and promote medication adherence. For youth who are 
not PrEP eligible based on their current HIV risk, the nurse will promote the adoption of or 
encourage the maintenance of HIV prevention strategies. 
HIV Risk Profile and PrEP Eligibility Assessment. HIV status will be assessed at baseline 
using INSTI HIV-1/HIV-2 Rapid Antibody Test. Based on our prior studies, we estimate that 5- 
10% of youth will be HIV positive. During the first NCM4HIV session and at the beginning of 
each subsequent session, a screening tool developed from the Centers for Disease Control and 
Prevention 2014 Clinical Practice Guidelines for PrEP use that is current standard practice at 
the local HIV clinic. This screener will be used to assess PrEP eligibility based on their HIV risk 
behaviors (e.g., having an HIV-positive sexual partner, a recent bacterial STI, a high number of 
sex partners, a history of inconsistent or no condom use, intravenous (IV) drug use, or 
commercial sex work) to determine whether recent behaviors warrant PrEP as a possible 
intervention for HIV prevention. Houston, TX is considered a high HIV prevalence area and YEH 
are considered a high prevalence network. 
HIV positive or PrEP eligible youth, will be assigned to the PrEP/HIV RN who will follow PrEP 
and HIV clinical care guidelines and standing orders under the supervision of Dr. Paul in 
collaboration with the PrEP Navigator. This will be incorporated into the NCM sessions. The 
care plan will include coordinating access, uptake, and adherence to PrEP, and promoting HIV 
preventing behaviors (e.g., HIV/STI testing, condom use, reducing sexual partners, reductions 
in IV drug use, avoiding trade sex). For HIV negative, PrEP eligible youth, the nurse will discuss 
what PrEP is, how it works, its risks and benefits, and the implications of its use (e.g., follow-up 
lab work and appointment schedule) to promote shared decision making. If the participant is 
interested in receiving PrEP, the nurse will begin the lab work (e.g., 4th generation HIV test, 
kidney function, STI testing), and the PrEP Navigator will submit the patient assistance 
application to cover PrEP medication costs. To reduce medication delivery barriers, the PrEP 

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Navigator will deliver PrEP medications to the nurse to dispense to the participants at the NCM 
session. Owing to the established relationship between Drs. Paul (Co-I) and Flash (consultant) 
and the Gilead Patient Assistance Program, the turn-around time from getting lab work and 
submitting the assistance application to having PrEP medication in hand is approximately 3 
days. The nurse will follow standard clinical procedures for follow-up lab work. Our previous 
work suggests that approximately 84% of participants will be PrEP eligible based on the CDC 
Guidelines.6 While this is not a PrEP adherence study, it is important to measure adherence for 
those who uptake PrEP during the study. Therefore, we will measure PrEP adherence using 
UrSure, a urine test, at each follow-up time period for a subset of 60 youth in either arm who 
uptake PrEP during the study.. 
For youth who disclose a recent sexual assault, the nurse will coordinate with the Harris Health 
System for a sexual assault nurse exam. If the participant is within the 72-hour window where 
nPEP would be most effective for HIV prevention, the medication will be started with consent 
and the nurse will coordinate necessary follow-up care. Based on our prior work, we estimate 
that up to 24% of youth may experience sexual assault during the study period and be 
potentially eligible for nPEP.6 This nurse-led strategy provides direct access to PrEP/nPEP and 
HIV care versus linkages to care or referrals which are often less effective among individuals 
experiencing homelessness.56 
Booster Calls. After the completion of the 6 NCM sessions, the nurse will make monthly 
booster calls for another 3 months to gradually graduate participants from the project, an 
important feature with HIV positive homeless adults in SPINS.109 During these calls, the nurse 
will assess uptake and adherence to the youth’s HIV prevention goals and help the youth 
navigate needed health and social services. 
 
Exit Interviews. To qualitatively assess the mechanisms of change including assessment of the 
barriers and facilitators of adoption and maintenance of behavior change, we will conduct exit 
interviews with a subset of approximately 40 intervention youth (e.g., 20 youth with no/low 
reported behavior change, and 20 youth with uptake of PrEP). Specifically, we will ask youth 
what intervention feature they believe helped most in adopting the HIV prevention strategy, what 
made it hard to adopt or maintain the behavior change, and what made it easy to adopt or 
maintain the behavior change. 
 
Data and Safety Monitoring 
Nurse Training. Two nurses from will be hired by UTHealth and one existing Research Nurse 
from UTHealth will serve as the 3 nurse case managers under the direction of Co-Is Drs. Paul 
and Quadri (see LOSs). These nurses have the expertise to work with YEH in a non-judgmental 
and caring way that promotes acceptance and fosters trust. They will receive 2 weeks of training 
from the Co-Is and myself, including protection of human subjects certification, and a review of 
study protocols and procedures, trauma-informed care, adolescent brain development, HIV 
prevention, and PrEP/nPEP clinical management. They will also become knowledgeable of local 
resources relevant to HIV prevention and the social and housing needs of YEH. The nurses will 
also attend 4 days of MI training provided by a certified MI trainer specializing in homeless 
populations. The nurses MI skills will be assessed and their delivery of the 6-session content 
using role-play and retrained until skills are rated as excellent by the study team (see Human 
Subjects section). Once they have mastered session delivery with fidelity, they can meet with 
participants. 
Intervention Fidelity Checks. All intervention sessions will be audio recorded; 25% will be 
reviewed for NCM fidelity in duplicate by the Research Coordinators and myself and 25% will be 
reviewed by the MI trainer. Rating discrepancies will be discussed in bi-weekly team meetings. 

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The nurse will use a standardized fidelity checklist to self-rate adherence to the delivery of the 
general session content (see Table 2) at each NCM4HIV session, procedures the team has 
used in the past to assess intervention fidelity. Any nurse falling below 90% adherence will be 
retrained. The nurse will complete session notes on topics covered, environmental and 
situational influences that emerged, and updates on the participant’s behavior goals and 
cognitive appraisals. If any nurse has difficulty establishing rapport with an assigned participant, 
the team will discuss alternative solutions including reassignment to another team nurse. The 
team will also discuss any issues that arise with intervention delivery at the weekly check-in 
meetings and create individualized development plans as needed to assure the highest level of 
care and delivery of the intervention with fidelity. 
 
Data Safety and Monitoring Plan (DSMP) 
The DSM plan is in accordance of the Policy of the National Institute of Nursing Research for 
Data and Safety Monitoring of Extramural Clinical Trials set forth in 2014. As part of the DSM 
plan, we have convened a Safety Monitoring Committee (SMC) of which the organization, 
responsibilities, and operation are mandated by NIH and NINR policy. 
 
Trial Type/Level of Review. This study does not involve the testing of pharmacologic agents or 
any therapeutic treatments. Rather we are testing the efficacy of a nurse-led HIV prevention 
intervention. This study is classified as a Phase II of the Prevention Intervention Continuum – 
Methods Development, a minimal risk level study that dictates annual review by the IRB. To add 
additional safety measures for this study, we will convene a SMC. This study constitutes 
minimal psychological and physical risk and no legal or social risks. The risks are minimal since 
educational interventions generally promote good health, not endanger it. Our eligibility criteria 
are established to exclude individuals for whom the study procedures are not appropriate. 
 
Monitoring Entity 
Role of the PI and Investigative Team. Dr. Santa Maria will have primary responsibility for 
monitoring study research staff, who will receive training on the study design, recruitment, and 
protocol prior to study initiation. Research staff will receive formal training on the study protocol 
by Drs. Santa Maria, Flash, Quadri, and Paul, which will entail 2 weeks of intensive training 
session followed by additional training sessions as needed. The team will attend bi-weekly team 
meetings during data collection with the principal and co-investigators to discuss any study 
issues regarding recruitment and follow-up data collection and weekly meetings with Dr. Santa 
Maria. These meetings will be used to discuss experiences with the intervention participants, 
provide consultation, ascertain whether the research staff are following study protocols, 
evaluate and reinforce cultural competence, and identify any potential adverse reactions. Dr. 
Padhye, study statistician, will coordinate data management and analysis. He will oversee 
development of data entry screens and the database development, supervise data entry 
verification, and work with the investigators in conducting all data analyses. 
 
Role of the Safety Monitoring Committee. The SMC is responsible for oversight of the 
activities related to implementing the clinical trial to ensure patient safety, conformance to the 
clinical protocol, overall performance of the trial components, and integrity of the data being 
collected. The SMC will meet prior to participant enrollment and then meet quarterly to review 
adverse events and participant safety concerns and annually to review study progress (e.g., 
recruitment retention, and safety procedures). Data quality and completeness and timeliness will 
be provided to the SMC including total number participants screened, enrollment rates, 
exclusion rates and reasons, randomization numbers, completion of scheduled follow-ups, 
reasons for study withdrawal, referral site rates, adequacy of enrollment composition, 
demographic similarities/differences between intervention and control group, protocol deviations 

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and adherence, compromises in confidentiality. All meeting materials will be considered 
privileged by SMC members. This confidentiality should be maintained at all times to the extent 
permitted by law. 
 
The SMC will comprise 3 members with expertise in risk prevention, health communication, 
and/or homeless youth intervention research. These members have extensive expertise to 
review the scientific design and conduct of a study, to evaluate safety and risks to participants, 
to interpret data statistically, and to make recommendations concerning continuation, 
modification, suspension, or termination of a study. Dr. Sarah Narendorf, Social Work Scientist 
at the University of Houston Graduate College of Social Work; Dr. Emily Arnold, Anthropologist 
at the University of California San Francisco Center for AIDS Prevention Studies; and Dr. 
Christine Markham, Behavioral Scientist at the UTHeath School of Public Health will be the 
monitoring committee members (see Letters of Support). 
 
SMC meetings conducted quarterly will begin after the first week of data collection. In addition, 
should any adverse event occur, the monitoring committee will be informed immediately, and a 
special session will be scheduled to discuss strategies to deal with the event. The quarterly 
meeting will include a synopsis of protocol and design, discussion of the status of interventions 
and data collection procedures, a summary of subject contacts, discussion of any adverse 
events or potential adverse events, status of data entry and verification, and a summary of any 
descriptive and inferential statistics to date. Data quality and completeness and timeliness will 
be provided to the SMC including total number participants screened, enrollment rates, 
exclusion rates and reasons, randomization numbers, completion of scheduled follow-ups, 
reasons for study withdrawal, referral site rates, adequacy of enrollment composition, 
demographic similarities/differences between intervention and control group, protocol deviations 
and adherence, compromises in confidentiality. The SMC will meet in a closed session without 
the investigators. In this meeting, the committee will discuss the need for additional procedures 
to prevent adverse events or ensure data integrity. In the unlikely case that the study may need 
an early termination due to unexpected adverse events or inadequate conduct of the stud, the 
committee will make recommendations to the investigators. Recommendations from the 
monitoring committee meetings will be shared with the UTHealth IRB and NIH during annual 
reports and immediately if the monitoring committee identifies adverse events not previously 
reported or recommends early termination of the study. 
 
Role of the IRB. This study will be approved by the UTHealth IRB. The UTHealth IRB will be 
the primary oversight IRB for the study and the study PI (Dr. Santa Maria) will be responsible for 
reporting to the IRB about the status of the study. Annual progress reports and renewals will be 
completed for the IRBs and will include a summary of the recommendations of the monitoring 
committee. If adverse reactions related to study procedures are noted, they will be immediately 
reported to UTH IRB by Dr. Santa Maria so that the IRB is aware of any risks involved with the 
study. The IRB will be responsible for ensuring adequate and appropriate membership 
composition of the SMC as specified by NINR policy. 
 
Reporting to NINR. Dr. Santa Maria, the PI, will be responsible for submitting necessary 
reports to NINR. Summaries of the protocol and design, status of intervention group, data 
collection procedures, summary of subject contacts, discussion of any adverse reactions or any 
potential adverse reactions, status of data entry and verification, a summary of any descriptive 
statistics to date, and the recommendations of the monitoring committee will be included in each 
annual report to NINR. NINR will be notified within 7 days if the human subjects research or 
DSM plan is changed prior to or during implementation of the clinical trial for approval. In 
addition, should any adverse reaction occur or should the monitoring committee recommend 

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early termination of the study, the information will be immediately reported to the NINR program 
officer. All personal identifiers will be removed from any documentation sent to NINR. Timely 
reports to NINR will be generated for: 
• 
Unanticipated problems or unexpected serious adverse events that may be related to 
the study protocol 
• 
IRB-approved revisions to the study protocol that indicate a change in risk for 
participants 
• 
A summary of recommendations made by the SMC or other monitoring entity as 
appropriate and (if applicable) the action plan for response 
• 
Notice of any actions taken by the IRB or regulatory bodies regarding the research and 
any responses to those actions 
 
DSM Procedures 
Dr. Santa Maria will have primary responsibility for monitoring study research staff, who will 
receive training on the study design, recruitment, and protocol prior to study initiation. Research 
staff will receive formal training on the study protocol by Drs. Santa Maria, Flash, Quadri, and 
Paul, which will entail 2 weeks of intensive training session followed by additional training 
sessions as needed. The team will attend bi-weekly team meetings during data collection with 
the principal and co-investigators to discuss any study issues regarding recruitment and follow- 
up data collection and weekly meetings with Dr. Santa Maria. These meetings will be used to 
discuss experiences with the intervention participants, provide consultation, ascertain whether 
the research staff are following study protocols, evaluate and reinforce cultural competence, and 
identify any potential adverse reactions. Dr. Padhye, study statistician, will coordinate data 
management and analysis. He will oversee development of data entry screens and the 
database development, supervise data entry verification, and work with the investigators in 
conducting all data analyses. 
 
Follow-up face-to-face visits at 3, 6, 9, and 12-months will include a query of participants on 
whether they had “any serious health events that caused them to seek medical attention within 
the past 3 months” and if any of these resulted in “hospitalizations overnight.” Details of these 
events will be recorded. 
 
Data Management. The research coordinator will monitor study data for completeness and 
accuracy weekly. Ongoing training and weekly quality assurance checks will be performed to 
ensure adherence to all study protocols including confidentiality. Survey data will be stored on 
hard drives of encrypted tablets and then uploaded to a desktop microcomputer master file 
daily. Individual data files are automatically merged with the master data set via REDCap. 
Weekly backups of these survey data set will be stored as an encrypted file and in a secure 
area physically remote from the data management area. All study related paper forms, surveys, 
and data will be destroyed by shredding after seven years. All necessary firewall and password 
protections will be implemented to restrict access and ensure data confidentiality. 
 
Data Security. Unique passwords will be assigned to data management and data analysis team 
members, tracking staff, project coordinators, and investigators. Unique participant identifiers 
will be rigorously protected by team members. No names will be used in data analysis files or in 
reports. No names will be kept on the computer where the study data are collected or stored. 
Results of this study will be reported in the aggregate. Data collected in the study will be kept 
confidential except in cases when the research staff are provided with information that raises 
suspicion for abuse, neglect, harm to oneself, or harm to another. Participants will be made 
aware of the confidentiality of the data except in cases of safety concerns during the consent 

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and assent process. In order to minimize risk and ensure the quality of the data, research staff 
will receive extensive training. Research staff will attend biweekly supervision meetings where 
any problem will be discussed and solutions developed. Any breaches of protocol will be 
immediately reported to the PI, and in the case of breach of confidentiality or other event that 
would constitute a potential adverse event, they will be reported to the UTHealth IRB within 2 
business days. This would include situations where interviewers need to break confidentiality in 
cases of suspected concern for child abuse, suicide, or homicide. As stated above, research 
staff are extensively trained on handling such sensitive situations. No such events have 
happened in our previous studies with homeless youth. Such events are immediately reported 
to the PI, the appropriate authorities, and an adverse event report filed with the UTHealth IRB. 
 
Data at pre- and post-surveys will be collected on tablets using surveys programmed into 
REDCap. Computerized assessments are transferred electronically to UTHealth on a daily 
basis. We have used similar protocols with our previous homeless youth studies with success. 
REDCap is a well-tested computerized survey program. Our staff are experience withREDCap 
surveys, and this should reduce implementation, data management, and design problems. 
Participants entering data will be able to interrupt and resume sections in mid-course, review 
previously entered data, and back up to change prior entries. The quality of the data on these 
programs is enhanced, as REDCap will provide immediate feedback to the participant if 
unexpected data are entered. Only data analysis personnel connected with the study will have 
access to data files. Those files will be de-identified and not contain any identifying information. 
 
Paper Study Documents. To reduce the risk of transmission of infectious diseases, all 
documents will be programmed as forms in REDCap and accessible only to study staff. Paper 
documents will only be used as a back up and any collected hard copies will be saved in a 
secured and locked filing cabinet at the UTHealth Cizik School of Nursing for seven years. All 
study related forms, surveys, and data will be destroyed by shredding after seven years. In 
order to assure security of the data, we will make weekly backup copies of the REDCap data 
set. These copies will be stored in a secure area physically separate from the data management 
and analysis sections of the main project site. 
 
Phone Data Loss Prevention. Participants will be provided with a study-issued smart phone to 
allow them access to pre-programmed homeless youth resources and the behavior feedback 
interface for the intervention arm. The phone will also be equipped with capability to conduct 
video phone calls in the event that the intervention needs to be delivered remotely. As well, the 
phones will facilitate tracking of participants, in addition to our extensive tracking protocol, to 
enhance follow-up retention. In our previous study, we had a phone loss or damage rate of 
12%. If a phone is lost, it will be remotely wiped by UTHealth IT AirWatch system. No 
replacement phone will be provided to each participant in the event of a lost, stolen, or damaged 
phone. Paper versions of the daily diaries will also be available. Phone lines will be 
disconnected after 12 months or when study staff determines that the phone is lost, stolen, non- 
functional, or no longer being used for study purposes. 
 
 
Role of NIH.  Summaries of the protocol and design, status of intervention group, data 
collection procedures, summary of subject contacts, discussion of any adverse reactions or any 
potential adverse reactions, status of data entry and verification, a summary of any descriptive 
statistics to date, and the recommendations of the monitoring committee will be included in each 
annual report to NIH. In addition, should any adverse reaction occur or should the monitoring 
committee recommend early termination of the study, the information will be immediately 
reported to the program officer. 

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Drs. Santa Maria, Padhye, Lightfoot, Nyamathi, Quadri, and Paul will meet every other week (by 
phone and/or in person) to monitor study progress including data collected from participants on 
any serious health events that caused them to seek medical attention and if any of these 
resulted in hospitalizations overnight. Any adverse reactions noted by any of the team members 
will be immediately reported to the principal investigator, the UTHealth IRB, SMC, and NINR. All 
adverse events will be reviewed monthly by the research team and quarterly by the SMC. Also, 
in keeping with NIH guidelines, minority status and gender will be included in these reports to 
allow for detection of differential effects. 
 
Adverse Events and Unanticipated Problems 
While participants will be assured that their participation will not affect health and social services 
being provided at any location, some participants may feel concerned about or pressured to be 
part of the study. We will verbally assure participants at the beginning of each NCM session and 
at each follow-up that their participation is voluntary and that they can participate in all, part of, 
or none of the session and can withdraw from the study at any time for any reason without 
penalty. 
 
Adverse Event Identification. Survey questions and nurse case management sessions might 
create awkwardness or discomfort due to the potential for disclosing or discussing risk 
behaviors. A potential risk in participating in the proposed research is becoming more aware of 
and/or reporting past events, current circumstances, thoughts and feelings, and risk behaviors 
that may make participants feel uneasy. The research staff will receive 4 weeks of training prior 
to initiating recruitment procedures for this study to assure that all protocols and procedures are 
followed. Research staff will have ongoing supervision in how to handle awkwardness, 
embarrassment, or discomfort. Participants can choose whether to be in the study or not. They 
may withdraw at any time without consequences of any kind. They may also refuse to answer 
any questions they do not wish to answer and still remain in the study. It is possible that there 
may be occasions when study participants exhibit stronger and more serious signs of emotional 
distress; we may encounter individuals who express suicide intent, have psychiatric 
emergencies, or exhibit other indicators of acute distress. Research staff will be trained to 
identify signs of acute distress or suicidal ideation and trained how to respond if they occur. We 
will emphasize to research staff at all study team meetings that if a participant becomes upset, 
they should be offered the option of discontinuing participation in the study without penalty (i.e., 
still receiving payment) or continuing at a later time after a break. Further, the computer assisted 
survey administration limits participant exposure to potentially sensitive items. For example, 
participants who have not engaged in a certain risk behavior, such as substance use, are not 
exposed to more detailed questions about use. Participants will also be informed that they may 
skip any item that makes them feel uncomfortable. In the event of any acute emotional distress, 
research staff will remain with the participant until s/he is no longer distressed. 
 
The Covenant House Texas (CHT) shelter, where some of the NCM intervention sessions may 
be conducted when preferred by the participant, has 24-hour staff trained in managing acute 
episodes of distress and psychosis. CHT shelter has a clinic staff by Baylor College of Medicine 
Pediatric Resident in their Adolescent Fellowship on the premises with a clinical psychologist 
and a psychiatrist on staff. The Salvation Army (SA) drop-in center has social work staff 
available during business hours who are trained in managing acute episodes of distress and 
psychosis. SA has a Healthcare for the Homeless Program clinic that operates 1-2 days a week. 
We will follow the mental health safety protocols of the shelter and drop-in center to manage 
any participant needs including acute mental health needs that may arise during the study. 
Individuals who wish to pursue follow-up care will also be given a referral list specifically tailored 

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to the individual’s request. We will have prepared referral lists for perpetrators and victims of 
abuse as well as for common psychological issues. At the end of each assessment, all 
participants will be offered a list of relevant, local referrals. We will not be asking about suicidal 
ideation during the study, so it is unlikely that we will encounter acute suicidal ideation. 
However, given the risk of suicide and mental health issues within the population, we have strict 
protocols in place for handling mental health concerns that arise among subjects during the 
study. As well, anyone having direct involvement with the participants will be fully trained by the 
PI and the partnering recruitment agencies in procedures for assessment and intervention in 
cases where suicidal ideation is expressed. The nurse interventionists have additional 
institutional policies and procedures in place they will follow to assure swift and safe response to 
an acute mental health crisis. This may include both in-patient and out-patient follow-up mental 
healthcare. In case of an adverse mental health event, regardless of whether it is related to the 
study, research staff will be instructed to immediately contact the shelter or drop-in center staff 
to implement already in place protocols for managing youth expressing suicidal ideation and to 
contact the PI and take appropriate clinical action in these circumstances to assure participant 
and staff safety including referral to another level of clinical care. All study staff will be trained to 
immediately notify recruitment site staff and facilitate implementation of protocols for care in 
cases of acute mental distress. Our experienced MD supervisors (Drs. Quadri and Paul) and Dr. 
Santa Maria will be available for immediate consultation in the event of encountering an 
unexpected acute psychological issue; and as part of their training, research staff will be made 
familiar with referral resources and procedures for local psychological, social service, and other 
emergency care needs. 
 
Adverse Event Reviewing. Adverse events will be reviewed at each study team meeting to 
assure all participant safety and reporting protocols were followed. Reports of all Adverse 
Events and unanticipated problems will be The SMC will meet prior to participant enrollment and 
then meet quarterly to review reports on adverse events and unanticipated problems, discuss 
participant safety concerns, and review general study progress. 
 
Adverse Event Reporting. Study participants will be encouraged to immediately report any 
“emergencies or events” by calling the study contact number. These instructions will be included 
on all instructions that are sent to participants, programmed into the study issued cell phones, 
and on the consent forms. The study team will record all reported events in the adverse events 
and unanticipated problems log (including the subject’s name, date, and event description). All 
members of the study team will inform the principal investigator, Dr. Diane Santa Maria 
immediately, of any adverse events and unanticipated problems who will consult with co- 
investigators and the safety monitoring committee members on the action. The PI will report the 
incident to the UTHealth IRB within one week. The action and date of implementation will also 
be recorded in the adverse event unanticipated problems log. The entire investigative team and 
monitoring committee will participate in classifying events as “serious” or “non-serious” (see list 
below), as well as “non-attributable,” “possibly attributable” or “attributable” to the intervention 
(unlike a pharmaceutical trial where known side effects exist, the classification of “expected” vs. 
“unexpected” is inappropriate for this behavioral intervention). The SMC will advise the PI and 
the study team on actions to be taken to minimize further adverse events and unanticipated 
problems within 2 weeks of reviewing the reports. 
 
1. Serious events include any event or condition that is life threatening, results in a 
hospitalization, cancer or a physical or cardiac event serious enough to require medical 
attention. These events may be: 
a. Fatal 
b. Life threatening 

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c. Permanently disabling 
d. Required or prolonged hospitalization (Admission—not ER visit) 
e. Overdose 
f. 
Significant hazard to patient 
2. Non-Serious events includes all other events. 
 
A few potential minimal risks to subjects exist such as breach of confidentiality or normal risks 
associated with having a phone. Breach of confidentiality is not believed to present any 
significant risk given the data protections described above. However, to mitigate this risk we 
have outlined steps we will take to protect confidentiality in the Human Subjects sections, 
Safeguarding Confidentiality and Certificate of Confidentiality. Before data collection is 
initiated, researchers will obtain a Certificate of Confidentiality from NIH to protect participants 
from the requested release of study data. All participants will be informed that this certificate has 
been obtained, and what protections it affords them during the informed consent process. 
Participant data will not be released to any party outside the research team. 
 
Potential Risks. 
There are no physical risks associated with participation. The risk of psychological distress is 
related to the potential of receiving a positive HIV or STI test result. The types of study 
questions concerning past events, current circumstances, thoughts and feelings, sexual 
behaviors, substance use, and sexually transmitted infections may cause distress. Participants 
may find thinking about and answering questions about these issues upsetting; these questions 
will be asked in as sensitive a manner as possible. While participants will be assured that their 
participation will not affect health and social services being provided at any location, some 
participants may feel concerned about or pressured to be part of the study. Another potential 
risk is the loss of confidentiality or disclosure of information or data about the participant. While 
there were no reported adverse reactions to Nurse Case Management in our previous studies, 
there is the potential of stress and negative reactions from the self-reflection during the 
sessions. 
 
For data collection, participants may find thinking about thoughts and feelings that arise or 
answering questions about these issues upsetting; these questions will be asked in as sensitive 
a manner as possible. As well, if a participant answers no to a sexual activity question, they 
would not receive additional, more details questions about sex. By tailoring the questions, we 
minimize the exposure to sensitive questions and reduce the burden and fatigue that may arise 
from taking a survey. We use ACASI computer-based surveys to allow participants to read and 
answer the questions privately and not have to hear them aloud or tell another person, which 
may reduce any possible distress associated with answering the questions. While participants 
will be assured that their participation will not affect health and social services being provided at 
any location, some participants may feel concerned about or pressured to be part of the study. 
We will verbally assure participants at the beginning of each NCM session and at each follow-up 
that their participation is voluntary and that they can participate in all, part of, or none of the 
session and can withdraw from the study at any time for any reason without penalty. Another 
potential risk is the loss of confidentiality or disclosure of information or data about the 
participant. We have detailed below extensive measures to ensure confidentiality and decrease 
the risk for disclosure of private information. 
 
During data collection, participants may refuse to answer any questions that make them feel 
uncomfortable. Participants may discontinue participation in the study at any time. We anticipate 
that the types of adverse experiences that may occur, if any, may be associated with issues 

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arising during data collection. None of these risks are considered significant. Having a study 
phone poses no more risk than having a personal phone. 
 
This is a single site study. 
 
Ongoing assessments that may impact safety or ethics of the study 
The research team is active in HIV prevention research and will continue to monitor the 
literature, attend national and international conferences, and consult with colleagues to assure 
that we are aware of any emerging data that may impact safety or the ethics of the study. 
 
Advanced plans for interim/futility analysis 
One focus of the investigator meetings will be to continuously monitor and develop strategies to 
prevent adverse reactions, monitor the research staff, and protect data integrity. Accrual data 
will be reviewed by the team and the UTHealth IRB. The study team will make amendments to 
the protocol should accrual fall below 15% of the target, or should drop-outs exceed projections 
by 15%. This will include the addition of recruitment sites. 
 
Statistics 
Randomization. Participants will be randomly assigned to the intervention or wait list control 
arm using a computer-generated blocked 2:1 allocation; 300 participants will be in the 
intervention arm and 150 will be in the wait list control arm (see Figure 3). Participants will be 
told which group they are in after completing the baseline survey and will receive a study-issued 
phone with programmed YEH resources unless they prefer to use their own phone. In this case, 
the behavioral feedback app will be loaded onto their personal phone for those in the 
intervention arm, and these youth will be provided with a list of YEH services. 
 
Study Design. 
Baseline 
Intervention 
3 Mon. 
6 Mon. 
9 Mon. 
Intervention 
Treatment arm 
O1 
X O2 
O3 
O4 
O5 
Wait list control 
O1 
O2 
O3 
O4 
O5 
X 
 
Sample Size and Power Calculations. The primary endpoint is the efficacy of NCM to 
increase PrEP and nPEP uptake, HIV testing, STI screening, and condom use. Conservatively 
assuming an attrition rate of 30% at 9 months, the final sample size will be 315, with the 2:1 
randomization allocation providing for 210 participants in the intervention arm and 105 in the 
control arm. We estimate a retention rate of 70% based on study resources, community 
partnerships and support, the use of study-issued phones, the use of increasing follow-up 
incentives. This retention rate is substantially lower than the rate reported for other longitudinal 
YEH studies that have retained 88-89% 13,14 of youth to be very conservative in our retention 
estimation. 
 
Table1. Outcome Measures by Study Aim 
Construct 
Scale/Measure 
Alpha 
Aim 1 Outcomes 
PrEP/nPEP Uptake 
PrEP uptake; nPEP uptake (NCM report, chart review) 
NA 
Condom Use 
Youth Risk Behavior Survey;1 (condom use at last sex) 
NA 
HIV/STI Test Uptake 
Rapid HIV test; Gonorrhea, Chlamydia, Syphilis test 
NA 
Aim 2 Outcomes 
Mental Health 
Brief Symptom Index-182,3 
0.80 
Housing Status 
In a shelter, apt/house, with someone, outside, in a car…? 
NA 
Substance Use 
TCU Drug Screen II4,5 
0.89 

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Exploratory Outcomes (possible mediators based on CHSCF; see Figure 1) 
Healthcare Engagement 
Healthcare clinic visit adherence6 
NA 
Condom Use Self-Efficacy 
Condom Use Self-Efficacy Scale7 
0.91 
HIV Risk Perception 
Perceived Risk of HIV scale8 
0.88 
PrEP Facilitators & Barriers 
Facilitators and Barriers to PrEP Use9 
NA 
Health Seeking 
General Help Seeking Questionnaire10 
0.83 
Coping 
Coping Inventory for Stressful Situations-Adolescent11,12 
0.92 
 
For Aim 1, we anticipate having 87% power (95% CI: 84.8, 89.0) to detect the intervention effect 
on the reduction of condomless sex. Alpha was set at .05 and the power calculation was 
conducted using the SIMR package15 by 1000 Monte Carlo simulations with a generalized linear 
mixed model design that included a random intercept per participant. Data for the simulation 
were generated with compound symmetric covariance structure in the SIMSTUDY package by 
assuming that 79% of participants are sexually active and the probability of condomless sex will 
reduce modestly from 0.7 to 0.4 in the intervention group. The probability was conservatively 
assumed to decrease to 055 in the control group due to the potential for a placebo and/or 
contamination effect. The effect sizes and powers for HIV testing and STI screening and 
treatment outcomes are anticipated to be of similar magnitude to the condomless sex outcome. 
For the PrEP uptake outcome, it was assumed that rates would change from 2% to 4% in the 
control group and to 24% in the intervention group, for which the simulation resulted in 99% 
power (95% CI: 94.6, 99.9). Power analysis for the continuous instrument scores of Aim 2 
indicates that a sample size of n = 315 will provide 80% power for the interaction of time and 
arm in a repeated measures model when the effect size is f=.11, a small effect size. This 
calculation assumes a correlation between repeated measures of r = .50. 
Analysis Plan by Study Aim. Descriptive statistics will be calculated by study arm for baseline 
demographic characteristics, including age, gender identity, race/ethnicity, sexual orientation, 
educational level, and employment. However, random allocation of the participants to the 
intervention and control study arms will make it unlikely that there will be significant differences 
between the groups for baseline variables that could confound the results. Descriptive statistics 
will be calculated for all measures at each time point. We expect missing data to be minimal. 
Obvious errors will be corrected; those that cannot, will be set to missing. Missing data on the 
instruments will be replaced using single imputation with case mean substitution (i.e., replacing 
a participant’s missing items with that participant’s mean item score).16 Reliability estimates of 
the study instruments will be computed with Cronbach’s alpha (≥ .70 will be considered 
acceptable for internal consistency).17 Analysis for this study will be based on the intent-to-treat 
principle.18 Aim 1: Generalized estimating equation (GEE) analysis will be used to compare the 
groups’ changes over time in the dichotomous outcomes - PrEP uptake, nPEP uptake, condom 
use, and HIV/STI testing – assessed immediately post intervention and at 3-, 6-, and 9-months. 
The effects to be tested in the model will include time, study arm, and the interaction of time and 
study arm. Aim 2: GEE with normal distribution and identity link will be used to compare the 
intervention arm to the control arm over time with respect to mental health symptoms measured 
with the Brief Symptom Index, substance use, and number of homeless days in the past month. 
In case distributional assumptions are not met, Poisson link may be used for the number of 
homeless days and substance use days. The effects to be tested will include time, study arm, 
and the interaction of time and study arm. Time will be treated as a continuous variable unless 
nonlinearities are present, in which case it will be treated as a categorical variable. Hypothesis 
1: Intervention youth will have increased PrEP/nPEP uptake and adherence, condom use, 
STI/HIV testing and treatment compared to wait list control youth. Hypothesis 2: YEH 
Intervention youth will have decreased mental health symptoms and substance use and report 
fewer nights on the street compared to waitlist control youth. Exploratory Aim: To explore for 
mediation of the variables in the Comprehensive Health Seeking and Coping Framework, 

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𝑖𝑖𝑖𝑖 
𝑖𝑖𝑖𝑖 
instrument scores for the secondary outcomes including health seeking, coping, HIV/PrEP 
knowledge, and condom self-efficacy (see Table 2) will be examined as potential mediators in 
the path between the intervention and the outcome. Each of these indirect paths will be tested 
separately in multilevel (2-1-1) mediation models19 calculated in Mplus software.20 The within- 
subject level in the mediating variable and the outcome (condomless sex) will be collapsed by 
taking the mean difference centered on each subject’s baseline measurement. After collapsing 
the finest level, the intervention may be considered as a level 2 variable (i.e. between study 
arms) and the mediators and outcomes will be level 1 variables (subject-level). 
 
Sex as a variable. In each of the analyses for Aims 1, 2, and the exploratory aim, we will 
assess for differences by sex (operationalized as gender identity, not biological sex). If the 
power is not adequate to assess for sex differences, we will control for sex differences in the 
analyses. 
 
Equations for the models. 
GEE models for aims 1 and 2 may be expressed as: 
𝑔𝑔(𝜇𝜇𝑖𝑖𝑖𝑖) = 𝑋𝑋𝑘𝑘 𝛽𝛽𝑘𝑘, 
 
where 𝜇𝜇𝑖𝑖𝑖𝑖 is the mean response for subject i at time j, and g is a link function that is selected to 
be appropriate for the type of response variable (normal, binary, or Poisson). The predictors are 
denoted by 𝑋𝑋𝑘𝑘, where the index k is used to distinguish between each predictor. The predictors 
include the study arm (control/treatment), the time, and the interaction of time and study arm. 
Covariates, such as sex, may be included if the randomization has not resulted in uniform 
distributions in each study arm. Solution of the GEE estimating equation will result in estimated 
values of the coefficients 𝛽𝛽𝑘𝑘. 
 
 
Ethics 
Adequacy of Protection Against Risks. 
General Recruitment and Informed Consent. 
Participant recruitment will begin after obtaining UTHealth IRB approval. 
Our team has received IRB approval for several studies involving daily diary phone data 
collection and interventions with vulnerable populations of young people including young adults 
and minors experiencing homelessness. To encourage engagement and promote inclusivity, 
there will be a study logo contest at recruitment sites prior to study enrollment prior to study 
enrollment. It will be open to anyone at the recruitment sites. A $50 gift card will be given to the 
creator of the winning logo. The winning logo will be chosen by a vote to be conducted at a 
Youth Working Group (YWG) meeting (see YWG description on page 10). 
 
Flyers describing the study will be posted in the common area of local shelters, drop-in centers, 
and clinics as homeless youth often access services from multiple service providers and 
locations. We will pass out study information during street outreach events hosted by the 
partnering agencies. Local healthcare for the homeless providers, The Homeless Youth 
Network, and the Coalition for the Homeless will be informed about the study and flyers will be 
posted at local clinics with permission as well as coordinated access housing first locations 
(where youth can access housing services). Project staff will also approach youth who receive 
services at the Salvation Army and Covenant House Texas to screen for eligibility. Additionally, 
participants can contact research staff after seeing the flyers at other shelters, drop-in centers, 
or healthcare for the homeless clinics. The research staff will work with the shelter staff to 

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identify youth at the site each day who may be eligible. Research staff will also encourage youth 
to follow the study social media pages for updated information about how to be involved with the 
study.  We will recruit participants three days a week during regular business hours at the 
shelter and drop-in centers and during street outreach. The research staff will maintain a 
consistent presence at the agencies and will approach young people who present. In the event 
that the common room in the shelter or drop-in center is crowded, they will ask to speak to 
identified youth in a private office. The research staff will explain the study and complete the 
informed consent process with interested youth. All prospective participants will be assured that 
study participation will in no way affect their health and social services. Informed consent and 
contact information will be obtained from participants. For minors between 16-17 years of age 
who are seeking homeless services and are otherwise considered emancipated, we will also 
obtain written informed consent to participate in the study and seek a waiver of parental consent 
for minors based on Federal Rule 45 CFR 46.408(c). We have successfully obtained this waiver 
of parental consent for minors experiencing homelessness in our prior studies. Consent to 
Access Medical Records. During the informed consent process, study participants will give 
permission to access their medical records using the HIPAA Authorization Form for study 
purposes. 
 
Consent and Protection of Human Subjects. 
A step-wise screening process will be followed. First, we will screen potential participants for 
eligibility using a REDCap form. The survey will ask age, if they are sexually active, and if they 
are receiving homeless youth services. Wewill also administer the Rapid Estimate of Adult 
Literacy in Medicine-Short Form (REALM-SF) and enter the score into the eligibility form.2,3 See 
Appendix for REALM-SF. If they are within the age range, are receiving homeless services, and 
score greater than or equal to 4, then we will consent the participant. 
 
Informed Consent Procedures. Written informed consent will be received by all eligible youth 
interested in enrolling in the study as participants. Consent will be completed prior to data 
collection. The consent form will thoroughly describe risk assessment, data collection, and 
intervention procedures, as well as benefits and risks of study participation. Study staff will 
assess participants’ understanding of the consent form with a short checklist and clarify any 
areas of confusion. Once finalized, and prior to recruitment of any participants, consent forms 
will be thoroughly reviewed before approval by the UTHealth CPHS. The consent form will fulfill 
the requirements set out by the Committee for the Protection of Human Subjects (CPHS) from 
the University of Texas-Houston Health Science Center (UTHealth). Participants will be given 
the opportunity to refuse participation in the study and will be told that nonparticipation in the 
study will not affect services being provided by any health and social service providers. Once 
finalized, consent forms will be thoroughly reviewed before approval by the UTHealth CPHS. All 
study staff will complete the Protection of Human Subjects training at UTHealth prior to contact 
with potential participants. All study staff who will be recruiting youth will participate in project- 
specific training on project goals, procedures for recruitment, informed consent, data collection, 
and tracking, at which point they will have the opportunity to practice the recruitment and 
informed consent process. Research staff will also be shadowed during their first 3 recruitment 
sessions by the PI to assure that they are following the recruitment and informed consent 
process correctly. Retraining will be conducted as needed to correct consenting procedures. 
Consenting Minors: Written consent will be obtained for all participants. We will apply 
for a waiver of parental consent for minors who are unaccompanied by a parent based on 
Federal Rule 45 CFR 46.408(c). 
 
Due to the COVID-19 pandemic, informed consent process will also be available over the phone 
using the e-consent platform on REDCap. Study staff will inform interested individuals that they 

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must have access to text or email in order to complete the screening and e-consent (if eligible). 
Staff will screen over the phone using an online form and administer the REALM-SF test via text 
or email. Individuals will be asked to read the words over the phone and screener will score the 
REALM-SF according to current protocol. Screener will inform individual if they are eligible per 
current protocol. 
 
If eligible, study staff will invite the individual to participate and explain that consent process 
takes about 30 minutes over the phone. If individual agrees, they will be emailed or texted a link 
to the e-consent form and staff will proceed to review each section of the consent form per 
current protocol. If participant agrees and signs e-consent form, a copy of signed consent form 
will be saved in REDCap and emailed to participant. Study staff will proceed to complete the 
communication form and set up a time and place for baseline data collection and final study 
enrollment per current COVID-19 guidelines (see risk mitigation plan in Appendix D). 
 
Participant Tracking. Our team has a strong track record of retaining homeless youth in 
longitudinal studies. All participants will complete an extensive tracking form at the time of 
enrollment to collect participant contact information including personal phone number, 
alternative phone number (e.g., parent, sibling, or peer phone number), case manager phone 
number and email address, and social media information (e.g., Instagram and Facebook 
names). Youth will also be asked to sign a UTHealth media release and take a polaroid photo 
soley for the purpose of verifying participant identity during data collection and gift card 
distribution. This information is voluntary though youth will be instructed on the utility of 
providing this information to assist study staff in contacting youth for follow-up over the course of 
the study. These tracking procedures have been successful in our previous homeless youth 
studies and are supported by the literature.10-14 We have a strong participant tracking database 
in place using the REDCap data management system. To follow-up with participants, the RA will 
first send participants a text message reminder on their study-issued phone to schedule the in- 
person survey at 3, 6, and 9 months. In order to improve retention, RAs will inform participants 
that if they contact the study team to schedule their 3,6, and 9 month survey first, they will 
receive an extra $5 gift card incentive. If the RA is unable to reach the participant by text, they 
will then call the study phone and other contacts listed on the contact form (e.g. friends, family, 
and case manager). Finally, RAs will reach out to participants using the private message 
features on Instagram and Facebook to reach youth. RAs will also be on site at the drop-in 
center and shelter weekly and therefore be able to meet up with youth who are due for follow- 
up. Finally, as part of the tracking and consent forms, participants will be asked for permission 
to contact the social workers and shelter and drop-in center staff in a final attempt to get ahold 
of the participant if the above methods have not worked. The nurses will also discuss the date of 
the next sessions and preprogram the calendar of the participant’s study-issued phone with the 
dates of the 3, 6, and 9 month follow-ups. A smartphone calendar reminder will be set for 48 
hours prior to the appointment to prompt the participant to call study staff to schedule the visit in 
the case the RA has not been successful in contacting the participant and scheduling the follow- 
up visit. The RAs will stay engaged with the homeless youth population by being at the 
recruitment sites weekly and attending agency events monthly. 
 
Social media use. As mentioned in the tracking section, participants will be asked for social 
media information. In order to communicate with study participants via social media, study team 
must create pages. We will create Facebook, Instagram and Snapchat pages containing the 
project name CAYA. If team is unable to reach participant, they will send a private massage to 
the participants. In addition, social media platforms will be used as engagement tools. Social 
media platforms will not be restricted to participants, anyone will be able to follow the CAYA 
pages. However, measures to protect the privacy of current or potential participants will be in 

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place including hiding followers and not allowing external posts or comments. Research staff 
will post updates about the study, recruitment flyers, and health related information from 
credible institutions and motivational/inspiring content developed by the youth working group 
and research staff. All content will be approved by RC and PI prior to posting. Social media 
accounts will be managed in accordance with HOOP policy 219 and registered with the Office of 
Public Affairs per University guidelines. 
 
Protection Against Risks. Steps taken to minimize other potential risks include: 
 
Safeguarding Confidentiality. Data confidentiality is a high priority of the PI and research staff. 
All research staff will complete extensive training focused on each of the following topics: 1) 
project rationale and objectives, 2) the informed consent process, and 3) general data collection 
procedures (e.g., data collection, privacy). To assure participant confidentiality and accuracy of 
information, research staff will be extensively trained in standardized data collection procedures 
using a data collection manual of procedures. Unique participant identifiers will be rigorously 
protected by all research staff. Each participant will be assigned an ID number that will be 
utilized in place of names in all electronic and print data files. The file containing the links 
between participant names and identifiers will be kept in a separate password-protected file, 
which will be destroyed 12 months after the completion of the study. Informed consent will be 
stored in a locked filing cabinet in the Principal Investigator’s office. No information that would 
disclose the participant’s identity will be contained on any interview or survey research 
database. During the consent process the research staff will inform participants about 
restrictions on his/her ability to keep certain information confidential (i.e., by law, if the 
participant discloses intentions to hurt themselves or others). The staff member will report this 
information to shelter staff and the police when the risk for harm is immediate. This situation has 
never occurred in any of our past studies with homeless youth. Any adverse event will also be 
reported to the UTHealth IRB. Information from the study will not be shared with staff at the 
recruitment locations. The nurses and all study staff will receive HIPPA training on maintaining 
confidentiality. 
 
 
Certificate of confidentiality 
Per Section 2012 of the 21st Century Cures Act as implemented in the 2017 NIH Certificates of 
Confidentiality Policy, all ongoing or new research funded by NIH as of December 13, 2016 that 
is collecting or using identifiable, sensitive information is automatically issued a Certificate of 
Confidentiality (CoC). This CoC protects the privacy of research participants enrolled in this 
research study. With limited exceptions, researchers may not disclose names or any 
information, documents or biospecimens containing identifiable, sensitive information. The 
Certificate prohibits disclosure in response to legal demands, such as a subpoena. 
 
Certificates protect names or any information, documents, or biospecimens containing 
identifiable, sensitive information related to a research participant. This is defined as "covered 
information" in the policy. In addition, if there is at least a very small risk that information, 
documents, or biospecimens can be combined with other available data sources to determine 
the identity of an individual, then they are protected by the certificate. 
 
Participants will be asked to answer questions about private information that may have legal 
consequences if it were disclosed because homeless youth tend to interact with law 
enforcement more frequently and risk behaviors may be illegal. Therefore, all participants will be 
informed that this certificate has been obtained in the informed consent form, and what 

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protections it affords them during the informed consent process. Participant data will not be 
released to any party outside the research team. 
 
Minimizing Participant Discomfort. Survey questions and nurse case management sessions 
might create awkwardness or discomfort due to the potential for disclosing or discussing risk 
behaviors. A potential risk in participating in the proposed research is becoming more aware of 
and/or reporting past events, current circumstances, thoughts and feelings, and risk behaviors 
that may make participants feel uneasy. The research staff will receive 4 weeks of training prior 
to initiating recruitment procedures for this study to assure that all protocols and procedures are 
followed. Research staff will have ongoing supervision in how to handle awkwardness, 
embarrassment, or discomfort. Participants can choose whether to be in the study or not. They 
may withdraw at any time without consequences of any kind. They may also refuse to answer 
any questions they do not wish to answer and still remain in the study. It is possible that there 
may be occasions when study participants exhibit stronger and more serious signs of emotional 
distress; we may encounter individuals who express suicide intent, have psychiatric 
emergencies, or exhibit other indicators of acute distress. Research staff will be trained to 
identify signs of acute distress or suicidal ideation and trained how to respond if they occur. With 
respect to the assessments, we will emphasize to research staff that if a participant becomes 
upset, they should be offered the option of discontinuing without penalty (i.e., still receiving 
payment) or continuing at a later time after a break. Further, the computer assisted survey 
administration limits participant exposure to potentially sensitive items. For example, 
participants who have not engaged in a certain risk behavior, such as substance use, are not 
exposed to more detailed questions about use. Participants will also be informed that they may 
skip any item that makes them feel uncomfortable. In the event of any acute emotional distress, 
research staff will remain with the participant until s/he is no longer distressed. 
 
The Covenant House Texas (CHT) shelter, where some of the NCM intervention sessions may 
be conducted when preferred by the participant, has 24 hour staff trained in managing acute 
episodes of distress and psychosis. The Salvation Army (SA) drop-in center has social work 
staff available during business hours who are trained in managing acute episodes of distress 
and psychosis. We will follow the protocols of the shelter and drop-in center to manage any 
participant needs including mental health needs that may arise. CHT shelter has a clinic staff by 
Baylor College of Medicine Pediatric Resident in their Adolescent Fellowship on the premises 
with a clinical psychologist and a psychiatrist on staff. SA has a Healthcare for the Homeless 
Program clinic that operates 1-2 days a week. Individuals who wish to pursue follow-up care will 
also be given a referral list specifically tailored to the individual’s request. We will have prepared 
referral lists for perpetrators and victims of abuse as well as for other psychological problems. At 
the end of each assessment, all participants will be offered a list of relevant, local referrals. We 
will not be asking about suicidal ideation during the study, so it is unlikely that we will have to 
deal with acute suicidal ideation. As well, anyone having direct involvement with the participants 
will be fully trained by the PI in procedures for assessment and intervention in cases where 
suicidal ideation is expressed. Research staff will be instructed to immediately contact shelter or 
drop-in center staff to implement already in place protocols for managing youth expressing 
suicidal ideation and to contact the PI and take appropriate clinical action in these 
circumstances to assure participant and staff safety including referral to another level of clinical 
care. As well, recruitment will take place in shelters and drop-in centers staffed by trained 
clinical social workers, case managers, and healthcare providers. RAs will be able to notify 
recruitment site staff and facilitate implementation of protocols for care in cases of acute 
distress. Experienced supervisors and Dr. Santa Maria will be available for immediate 
consultation in the event of encountering an unexpected acute psychological problem; and as 
part of their training, research staff will be made familiar with referral resources and procedures 

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for local psychological, social service, and other emergency care needs. 
 
In order to minimize such risks that we may encounter in this study, extensive research staff 
training, and supervision will be developed. While the RAs in place have extensive experience 
with homeless youth, in the event of staff turnover, interview procedures will favor applicants 
with experience working with homeless youth or other vulnerable populations. UTHealth has 
staff and researchers highly experienced in research in vulnerable populations, sexual behavior, 
and mental health assessment interviewing. In our extensive research with homeless youth with 
our current RAs who are experienced and well trained in interview techniques related to 
sensitive material, we have rarely encountered participant reactions more adverse than mild 
discomfort, transient awkwardness, or embarrassment. RAs will be trained initially with ongoing 
supervision in how to handle such participant’s transient discomfort. The training will also 
include UTHealth IRB certifications, protection of human subjects training (e.g., CITI 
certification), and a detailed review of the research protocols, strategies for interacting with 
homeless youth, collection of accurate data, feedback on how to interact in a non-judgmental 
manner, ethical issues, emergency protocols, train-the trainer on intervention training for 
participants, adolescent development, trauma-informed care, maintaining appropriate 
boundaries, and general HIV prevention information. A minimum of biweekly supervision 
meetings will be conducted with research staff. 
 
Study Staff Training. RAs will be baccalaureate (nursing, social work, or public health) level 
professionals with experience working with homeless youth. RAs will receive a minimum of 2 
weeks of training from Dr. Santa Maria and the team, including IRB protection of human subject 
certification, review of study protocols and procedures, administering the Behavioral Symptom 
Index15 and REALM-SF during screening, trauma-informed non-violent communication skills, 
local health and social service resources, and HIV transmission and prevention. 
 
We will staff 3 nurses, credentialed with the Harris Health Systemto serve as the nurse case 
managers. These nurses have the expertise to work with homeless youth and other high HIV 
risk vulnerable and stigmatized populations in a non-judgmental and caring way that promotes 
acceptance and fosters a trusting relationship. They are knowledgeable of local resources 
relevant to HIV prevention and the social and situational needs of homeless youth. Nurses will 
be baccalaureate or masters level professionals with experience working with homeless youth. 
They will receive 4 weeks of training from the PIs and study team; IRB protection of human 
subjects certification (CITI training), review of study protocols and the manual of procedures, 
trauma-informed non-violent communication skills training, adolescent brain development, local 
homeless youth health and social services, HIV acquisition/transmission and prevention 
information, PrEP/nPEP clinical management. Additionally, the nurses will receive adolescent 
specific training to assure youth friendly, age appropriate case management of participants who 
are 16-17 years of age. the nurses will attend a 2-day intensive training provided by an expert in 
Motivational Interviewing (MI) in homeless populations. As part of the training process, nurses 
will be assessed on their MI skills and the delivery of the 6 session content using role-plays and 
retrained until skills are rated as excellent (see Human Subjects section). Once they have 
completed the skills check off successfully, they will be able to meet with participants. Once a 
nurse starts to meet with participants, a Motivational Interviewing Network of Trainers (MINT) 
trained Motivational Interviewing expert will conduct ongoing session assessments for the first 
year. All intervention sessions in YR-1 will be audio recorded; 25% will be reviewed for NCM 
fidelity in duplicate by the RA and the PI and 25% will be reviewed using the MITI by a MINT 
trained reviewer. Rating discrepancies will be discussed in bi-weekly team meetings. The nurse 
will use a standardized fidelity checklist for each face-to-face session and rate their adherence 
to the delivery of the general session content, procedures the team has used in the past to 

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assess intervention session delivery fidelity. Any nurse falling below 90% adherence will be 
retrained. The nurse will complete session notes on topics covered, environmental and 
situational influences that emerged, and care plan updates including the participant’s health 
goals and behavioral feedback appraisals. In the case of difficulty establishing participant 
rapport, the team will discuss alternative solutions including reassignment to another team 
nurse. The team will also discuss any issues that arise with the nurses and create individualized 
development plans as needed to assure the highest level of care and intervention fidelity. 
 
Social workers at the 2 largest recruitment sites provide care to youth seeking services. All staff 
at CHT and SA will be invited to receive a 2-hour in-service to assure basic knowledge of HIV 
transmission, HIV prevention strategies, and PrEP/nPEP service navigation for all participating 
and non-participating youth. This will allow all youth in both study arms to have potential access 
to basic HIV prevention education and services. This training will be offered annually to the 
shelter and drop-in center staff to account for the high staff turn-over often seen at these any 
other social service locations. 
 
Reducing the Risk for Coercion. To ensure that potential participants do not feel coerced to 
enter or remain in the study, research staff recruiting participants will follow a standardized 
script to ensure that all ethical issues are reviewed and that the study procedures are followed 
with fidelity. All protocols will be reviewed and approved by the UTHealth IRB prior to 
implementation. It will be made explicit in the informed consent document—both verbally and in 
writing—that participation in the study is voluntary, that it is unrelated to their access to health 
and social services, and that they can drop out of the research at any time for any reason. 
Participants will be verbally reminded at each follow-up that participation is voluntary and will not 
affect their ability to access any resources at the recruitment sites or at any other agency. 
Because of the potential for mistrust among youth experiencing homelessness, participants will 
be reminded at each session and follow-up visit that the data collected in the study and the 
information shared will be confidential unless they share that they are thinking of hurting 
themselves or someone else. Participants will be reminded that all study staff are mandatory 
reporters and are required to report if they suspect that a participant is at risk of hurting 
themselves or others. In addition, research staff reviewing the consent will be trained to probe 
for comprehension of the consent form and study procedures. Through our prior experience with 
homeless youth, the IRB, and homeless youth working group, we have also set the incentive 
levels at a modest amount that is commensurate with the amount of time youth will spend in the 
research study and not deemed to be coercive. 
 
Pre-programmed Smartphone Homeless Youth Resources. The PI and University of Texas 
Health Science Center have experience with mHealth and study issued smartphones used for 
research among vulnerable populations of youth and young adults experiencing homelessness. 
Despite the high rate of homeless youth with smartphones, all participants will receive a study- 
issued smart phone with a data plan in order to standardize the intervention and facilitate health 
seeking, engagement in care, and participant tracking for follow-up scheduling. Participants can 
use their personal phone for the daily dairies when preferred. All study phones will be 
preprogrammed with the contact information for local resources. These resources will display as 
a 1-click button such as “Need a place to stay?; Looking for a Healthcare Provider?; Hungry?”. 
Resources and contact information for services will be pre-programmed into the study-issued 
smartphones provided to participants. Resources will include contact information for 1) the 
National Sexual Assault hotline to access local trained sexual assault service providers, 2) the 
National Human Trafficking Resource Center to speak with a trained specialist, 3) the National 

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Runaway Safe Line for shelter resources, and 4) Sexual Assault Nurse Examiner locations. 
Participants will be shown how to access bedsider.org when they receive the phone to access 
local reproductive services. The phone will be pre-programmed with contact information for local 
homeless youth service providers including youth- and LGBTQ-friendly shelters, healthcare 
clinics (e.g., medical care, HIV/STI testing and treatment, and mental health services), and 
social service providers (e.g., meals, housing, education, jobs, ID, and legal services). Finally, 
the study staff “hotline” will be programmed into the phone. Study staff will be available to 
answer calls about the study throughout the business day and will return calls within 48 hours 
when received outside of the business day. Participants will also be able to text the study staff 
from their study phone. 
 
Potential Benefits of the Proposed Research to Human Subjects and Others. Potential 
benefits to study participation, which will be outlined in the consent forms, are that the 
participants may become more knowledgeable of HIV transmission and prevention strategies. 
Participants may become more aware of how thoughts and feelings can affect one’s behaviors 
and stress and how to uptake and adhere to HIV prevention goals. Our previous research and 
that of others suggests that young adults usually do not mind answering questions about their 
risk-taking behavior and knowledge, attitudes, and beliefs. In addition, research staff are 
provided with comprehensive lists of resources available to homeless youth and will receive 
extensive training on how to make referrals to appropriate resources if a participant indicates 
that s/he needs services they are not otherwise receiving. Finally, participants will have access 
to resources and contact information for services that will be pre-programmed into the study- 
issued smartphones provided to all participants throughout the duration of the study. 
Participants in the intervention arm may benefit from the linkages to care provided through the 
Nurse Case Management intervention. Through the HIV and STI testing offered to all 
participants, youth may become aware of a positive result and receive necessary treatment and 
linkages to care that they may not have otherwise have received. 
 
Importance of the Knowledge to be Gained. This study will provide essential HIV prevention 
intervention efficacy data that will advance the science of HIV prevention among homeless 
youth. Findings from the study may advance the science of prevention-based Nurse Case 
Management interventions among youth experiencing homelessness. The proposed study will 
significantly contribute to the field of HIV prevention in a marginalized and hard-to-reach 
population. The intervention is designed to be widely scalable within the practical parameters of 
care currently provided through the Healthcare for the Homeless programs across the nation. 
Therefore, if efficacious, this intervention has the potential to be disseminated to young people 
experiencing homelessness across the country without significant investments in infrastructure, 
equipment, or staff resources. 
 
Data handling and record keeping 
Data Management. The research coordinator will monitor study data for completeness and 
accuracy weekly. Ongoing training and weekly quality assurance checks will be performed to 
ensure adherence to all study protocols including confidentiality. Survey data will be stored on 
hard drives of encrypted tablets and then uploaded to a desktop microcomputer master file 
daily. Individual data files are automatically merged with the master data set via REDCap. 
Weekly backups of these survey data set will be stored as an encrypted file and in a secure 
area physically remote from the data management area. All study related paper forms, surveys, 
and data will be destroyed by shredding after seven years. All necessary firewall and password 
protections will be implemented to restrict access and ensure data confidentiality. 

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Data Security. Unique passwords will be assigned to data management and data analysis team 
members, tracking staff, project coordinators, and investigators. Unique participant identifiers 
will be rigorously protected by team members. No names will be used in data analysis files or in 
reports. No names will be kept on the computer where the study data are collected or stored. 
Results of this study will be reported in the aggregate. Data collected in the study will be kept 
confidential except in cases when the research staff are provided with information that raises 
suspicion for abuse, neglect, harm to oneself, or harm to another. Participants will be made 
aware of the confidentiality of the data except in cases of safety concerns during the consent 
and assent process. In order to minimize risk and ensure the quality of the data, research staff 
will receive extensive training. Research staff will attend biweekly supervision meetings where 
any problem will be discussed and solutions developed. Any breaches of protocol will be 
immediately reported to the PI, and in the case of breach of confidentiality or other event that 
would constitute a potential adverse event, they will be reported to the UTHealth IRB within 2 
business days. This would include situations where interviewers need to break confidentiality in 
cases of suspected concern for child abuse, suicide, or homicide. As stated above, research 
staff are extensively trained on handling such sensitive situations. No such events have 
happened in our previous studies with homeless youth. Such events are immediately reported 
to the PI, the appropriate authorities, and an adverse event report filed with the UTHealth IRB. 
Data at pre- and post-surveys will be collected on tablets using surveys programmed into 
REDCap. Computerized assessments are transferred electronically to UTHealth on a daily 
basis. We have used similar protocols with our previous homeless youth studies with success. 
REDCap is a well-tested computerized survey program. Our staff are trained in REDCap 
surveys, and our extensive experience should reduce implementation, data management, and 
design problems. Participants entering data will be able to interrupt and resume sections in mid- 
course, review previously entered data, and back up to change prior entries. The quality of the 
data on these programs is enhanced, as REDCap will provide immediate feedback to the 
participant if unexpected data are entered. Only data analysis personnel connected with the 
study will have access to data files. Those files will be de-identified and not contain any 
identifying information. 
 
Paper Study Documents. To reduce the risk of transmission of infectious diseases, all 
documents will be programmed as forms in REDCap and accessible only to study staff. Paper 
documents will only be used as a back up and any collected hard copies will be saved in a 
secured and locked filing cabinet at the UTHealth Cizik School of Nursing for seven years. All 
study related forms, surveys, and data will be destroyed by shredding after seven years. In 
order to assure security of the data, we will make weekly backup copies of the REDCap data 
set. These copies will be stored in a secure area physically separate from the data management 
and analysis sections of the main project site. 
 
Phone Data Loss Prevention. Participants will be provided with a study-issued smart phone to 
allow them access to pre-programmed homeless youth resources and the behavior feedback 
interface for the intervention arm. The phone will also be equipped with capability to conduct 
video phone calls in the event that the intervention needs to be delivered remotely. As well, the 
phones will facilitate tracking of participants, in addition to our extensive tracking protocol, to 
enhance follow-up retention. In our previous study, we had a phone loss or damage rate of 
12%. If a phone is lost, it will be remotely wiped by UTHealth IT AirWatch system. No 
replacement phone will be provided to the participant in the event of a lost, stolen, or damaged 
phone. Paper versions of the daily diaries will also be available. No data will be collected or 

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stored on the phones. Phone lines will be disconnected after 12 months or when study staff 
determines that the phone is lost, stolen, non-functional, or no longer being used for study 
purposes. 
 
 
Role of the PI and Investigative Team. Dr. Santa Maria will have primary responsibility for 
monitoring study research staff, who will receive training on the study design, recruitment, and 
protocol prior to study initiation. Research staff will receive formal training on the study protocol 
by Drs. Santa Maria, Flash, and Paul, which will entail 2 weeks of intensive training session 
followed by additional training sessions as needed. The team will attend bi-weekly team 
meetings during data collection with the principal and co-investigators to discuss any study 
issues regarding recruitment and follow-up data collection and weekly meetings with Dr. Santa 
Maria. These meetings will be used to discuss experiences with the intervention participants, 
provide consultation, ascertain whether the research staff are following study protocols, 
evaluate and reinforce cultural competence, and identify any potential adverse reactions. Dr. 
Padhye, study statistician, will coordinate data management and analysis. He will oversee 
development of data entry screens and the database development, supervise data entry 
verification, and work with the investigators in conducting all data analyses. 
 
Drs. Santa Maria, Padhye, Lightfoot, Nyamathi, Quadri, and Paul will meet every other week (by 
phone and/or in person) to monitor study progress. Any adverse reactions noted by any of the 
team members will be immediately reported to the principal investigator, the UTHealth IRB, 
Data Safety and Monitoring Board, and NIH. One focus of investigator meetings will be on 
developing strategies to prevent adverse reactions and to better monitor the research staff and 
data integrity. Accrual data will be reviewed by the UTHealth IRB. The study team will make 
amendments to the protocol should accrual fall below 15% of the target, or should drop-outs 
exceed projections by 15%. 
Quality control and assurance 
Role of the Safety Monitoring Committee. The SMC is responsible for oversight of the 
activities related to implementing the clinical trial to ensure patient safety, conformance to the 
clinical protocol, overall performance of the trial components, and integrity of the data being 
collected. The SMC will meet prior to participant enrollment and then meet quarterly to review 
adverse events and participant safety concerns and annually to review study progress (e.g., 
recruitment retention, and safety procedures). Data quality and completeness and timeliness will 
be provided to the SMC including total number participants screened, enrollment rates, 
exclusion rates and reasons, randomization numbers, completion of scheduled follow-ups, 
reasons for study withdrawal, referral site rates, adequacy of enrollment composition, 
demographic similarities/differences between intervention and control group, protocol deviations 
and adherence, compromises in confidentiality. All meeting materials will be considered 
privileged by SMC members. This confidentiality should be maintained at all times to the extent 
permitted by law. 
The SMC will comprise 3 members with expertise in risk prevention, health communication, 
and/or homeless youth intervention research. These members have extensive expertise to 
review the scientific design and conduct of a study, to evaluate safety and risks to participants, 
to interpret data statistically, and to make recommendations concerning continuation, 
modification, suspension, or termination of a study. Dr. Sarah Narendorf, Social Work Scientist 

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at the University of Houston Graduate College of Social Work; Dr. Emily Arnold, Anthropologist 
at the University of California San Francisco Center for AIDS Prevention Studies; and Dr. 
Christine Markham, Behavioral Scientist at the UTHeath School of Public Health will be the 
monitoring committee members (see Letters of Support). 
SMC meetings conducted quarterly will begin after the first week of data collection. In addition, 
should any adverse event occur, the monitoring committee will be informed immediately, and a 
special session will be scheduled to discuss strategies to deal with the event. The quarterly 
meeting will include a synopsis of protocol and design, discussion of the status of interventions 
and data collection procedures, a summary of subject contacts, discussion of any adverse 
events or potential adverse events, status of data entry and verification, and a summary of any 
descriptive and inferential statistics to date. Data quality and completeness and timeliness will 
be provided to the SMC including total number participants screened, enrollment rates, 
exclusion rates and reasons, randomization numbers, completion of scheduled follow-ups, 
reasons for study withdrawal, referral site rates, adequacy of enrollment composition, 
demographic similarities/differences between intervention and control group, protocol deviations 
and adherence, compromises in confidentiality. The SMC will meet in a closed session without 
the investigators. In this meeting, the committee will discuss the need for additional procedures 
to prevent adverse events or ensure data integrity. In the unlikely case that the study may need 
an early termination due to unexpected adverse events or inadequate conduct of the stud, the 
committee will make recommendations to the investigators. Recommendations from the 
monitoring committee meetings will be shared with the UTHealth IRB and NIH during annual 
reports and immediately if the monitoring committee identifies adverse events not previously 
reported or recommends early termination of the study. 
Role of the IRB. This study will be approved by the UTHealth IRB. The UTHealth IRB will be 
the primary oversight IRB for the study and the study PI (Dr. Santa Maria) will be responsible for 
reporting to the IRB about the status of the study. Annual progress reports and renewals will be 
completed for the IRBs and will include a summary of the recommendations of the monitoring 
committee. If adverse reactions related to study procedures are noted, they will be immediately 
reported to UTH IRB by Dr. Santa Maria so that the IRB is aware of any risks involved with the 
study. The IRB will be responsible for ensuring adequate and appropriate membership 
composition of the SMC as specified by NINR policy. 
 
Reporting to NINR. Dr. Santa Maria, the PI, will be responsible for submitting necessary 
reports to NINR. Summaries of the protocol and design, status of intervention group, data 
collection procedures, summary of subject contacts, discussion of any adverse reactions or any 
potential adverse reactions, status of data entry and verification, a summary of any descriptive 
statistics to date, and the recommendations of the monitoring committee will be included in each 
annual report to NINR. NINR will be notified within 7 days if the human subjects research or 
DSM plan is changed prior to or during implementation of the clinical trial for approval. In 
addition, should any adverse reaction occur or should the monitoring committee recommend 
early termination of the study, the information will be immediately reported to the NINR program 
officer. All personal identifiers will be removed from any documentation sent to NINR. Timely 
reports to NINR will be generated for: 

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• 
Unanticipated problems or unexpected serious adverse events that may be 
related to the study protocol 
• 
IRB-approved revisions to the study protocol that indicate a change in risk for 
participants 
• 
A summary of recommendations made by the SMC or other monitoring entity as 
appropriate and (if applicable) the action plan for response 
• 
Notice of any actions taken by the IRB or regulatory bodies regarding the 
research and any responses to those actions 
 
Publication Plan 
Dissemination Plan 
Drs. Santa Maria (PI) and Padhye at the University of Texas Health Science Center at Houston 
Cizik School of Nursing, Drs. Quadri and Paul at the Baylor College of Medicine, Dr. Lightfoot at 
the University of California San Francisco, and Dr. Nyamathi at the University of California Irvine 
are committed to the timely dissemination of the research findings. Dr. Santa Maria (PI) will 
ensure that this clinical trial will be registered on ClinicalTrials.gov (no later than 21 days after 
enrolling the first subject) and the updates (at least once every 12 months) and results (not later 
than one year after clinical trial completion date) are submitted to ClinicalTrials.gov according to 
the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information and in compliance 
with UTHealth policy requirements. Informed consent documents for the clinical trial will include 
a specific statement relating to posting of clinical trial information at ClinicalTrials.gov. Dr. Santa 
Maria will be responsible for ensuring that the timelines are met according to the NIH Policy. Dr. 
Santa Maria will also ensure that the informed consents at the University of Texas Health 
Science Center include a specific statement on the posting of clinical trial information to 
ClinicalTrials.gov and the protections afforded by the Certificate of Confidentiality. The 
University of Texas Health Science Center at Houston Committee for the Protection of Human 
Subjects has a policy posted on clinical trials registration and the reporting of the results are in 
compliance with NIH policy requirements. 
During the first biannual meeting with the co-investigators, we will create a plan regarding the 
dissemination of the protocol and preliminary and final results of this clinical trial. Included in this 
list of abstracts and papers will be potential journals and conferences these results will be 
disseminated to, and when. We will also include in the list the potential first authors of these 
abstracts and papers. The data generated from this study will be presented at national or 
international conferences and indexed journals in a timely manner. We will submit all final peer- 
reviewed manuscripts from the data generated by this clinical trial to the digital archive PubMed 
Central. 
Aggregated results in lay person terms will be shared with the participants, partnering agencies, 
and the larger community in addition to the scientific presentations and publications. 

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Beech BM, Myers L, Beech DJ, Kernick NS. Human immunodeficiency syndrome and 
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Robertson MJ, Clark RA, Charlebois ED, et al. HIV seroprevalence among homeless 
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Appendix A: REALM-SF 
 
 
Transience Resilience Cocaine Pregnancy Satisfied Temporary Identity Hepatitis Victimization 
 
 
 
 
Instructions for Administering the REALM-SF 
 
1. Show the youth the above words on the tablet (or a card). 
2. Say: 
"I want to see what format will work best for you to do the survey. I want to hear you 
read as many words as you can from this list. Begin with the first word and read aloud. When 
you come to a word you cannot read, do the best you can or say, 'blank' and go on to the next 
word." 
3. If the youth takes more than 5 seconds on a word, say "blank" and point to the next word, if 
necessary, to move the youth along. If the youth begins to miss every word, have him or her 
pronounce only known words. 
4. Enter REALM SCORE in box below 
(Score needed for youth to take survey alone=4; Interviewer: if youth scores 0,1,2,or 3 please administer 
survey with youth) 

IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
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Appendix B: NCM4HIV Study Timeline 
 
Year 1 
2019 
Year 2 
2019-2020 
Year 3 
2020-2021 
Year 4 
2021-2022 
Year 5 
2022-2023 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Finalize protocol, IRB approval 
x 
x 
Hire and train study staff 
x 
x 
x 
Recruit participants 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Conduct participant follow-ups 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Complete wait list control group 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Prepare and analyze data 
x 
x 
x 
x 
Prepare presentations, manuscripts 
x 
x 
 
 
1: Dec-Feb 
2: Mar-May 
3: Jun-Aug 
4: Sep-Nov 

IRB NUMBER: HSC-SN-18-0993 
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Appendix C: Letters of Support 

IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
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IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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IRB APPROVAL DATE: 03/09/2021 
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Appendix D: COVID-19 Risk mitigation plan 
 

IRB NUMBER: HSC-SN-18-0993 
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IRB APPROVAL DATE: 03/09/2021 
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IRB NUMBER: HSC-SN-18-0993 
IRB APPROVAL DATE: 03/09/2021 
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