Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Phase: NA
Conditions: Substance Use, Sexual Risk
Sponsor: Hunter College of City University of New York

 
 
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Young Men’s Health Project (YMHP):  
Examining community-based effectiveness of a 
substance use and HIV risk reduction intervention 
for young men of color (YMHP-CBO)  
 
 
 
Sponsor: 
National Institute on Drug Abuse (NIDA) 
 
 
 
 
 
 
R01DA041262 
 
 
 
Study Lead:  
 
 
 
Tyrel Starks 
PRIDE Research Consortium (PRIDE) 
Hunter College of the City University of 
New York (CUNY) 
New York, NY, USA 
 
 
 
Analyst: 
 
 
 
 
Tyrel Starks, Ph.D. 
 
 
 
 
 
 
PRIDE, Hunter College 
 
 
NCT Number:  
 
 
 
NCT03488914 
 
 
Study Procedure Guide Version Date: 
October 1, 2021 
 
 
 

 
 
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STUDY PROCEDURE GUIDE VERSION AND AMENDMENT TRACKING 
 
 
Revision History 
Revision 
# 
Page(s) 
Description of Changes 
Revised 
By 
Effective 
Date 
1 
All 
Reformatted and revised to match 
YMHP ATN SPG. Edited for clarity 
and consistency. Updated Background 
section.   
L. Kelman 
05.18.2018 
2 
All 
Reformatting and review of procedural 
changes 
S. Gurung 
06.06.2018 
3 
All 
Revised assessment diagram, revised 
background section, added acronym 
list, updated TOC 
L. Kelman 
06.08.2018 
4 
 
Inserted data flow diagram  
L. Kelman 
07.03.2018 
5 
 
Updated to reflect change in eligibility 
criteria 
L. Kelman 
01.29.2019 
6 
 
Accepted Liz’s previous edits, 
addressed Sitaji’s questions and 
comments, changed all mentions of 
CHEST to PRIDE, updated as per 
study changes e.g. BAC / 12MFU, 
added qual interview to 4.2 Schedule 
of Assessments & 4.6 Incentives and 
Compensation, updated stratification 
language in Study Abstract, included 
most up to date consent form in 
appendix, added positive HIV test 
results protocol to 4.5.3 
Now Version 2.0 
S. Samrock 
5.15.2020 
7 
 
Updated Statistical Analytic Plan 
D.Cain 
10.1.2021 
 
 
 
 
Version Number/Amendment 
Approval Date 
 
 

 
 
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SCALE IT UP STUDY PROCEDURE GUIDE APPROVAL 
 
Study Procedure Guide Version: 2.0  
Date: 5/13/2020 
Principal Investigator:  Tyrel Starks, Ph.D. 
Title of Study Procedure Guide:  Young Men’s Health Project (YMHP): Examining 
community-based effectiveness of a substance use and HIV risk reduction intervention for young 
men of color (YMHP-CBO)           
 
 
 
 
 
 
            
 
 
____________________ 
 
 
 
 
Protocol Lead 
 
 
Signature 
 
 
 
Date 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
LIST OF ABBREVIATIONS AND ACRONYMS .....................................................................1 
STUDY ABSTRACT ..................................................................................................................2 
STUDY DESIGN (as of 2018) ....................................................................................................4 
STUDY TIMELINE (as of 2018) ................................................................................................1 
1.0 BACKGROUND AND SIGNIFICANCE ..............................................................................1 
1.1 MYMSM are disproportionately at risk for HIV and STIs ..........................................1 
1.2 Substance Use and HIV Risk among YMSM .............................................................2 
1.3 The CBO Setting .......................................................................................................3 
1.4 Motivational Interviewing ..........................................................................................4 
1.5 Intervention Delivery by Health Educators .................................................................5 
2.0 STUDY OBJECTIVES .........................................................................................................5 
2.1 Specific Aims ............................................................................................................6 
2.2 Research Overview ....................................................................................................6 
3.0 STUDY POPULATION ........................................................................................................7 
3.1 
Inclusion and Exclusion Criteria ............................................................................7 
3.2 
Recruitment and Screening ....................................................................................7 
3.3 
Contact Information...............................................................................................8 
4.0 STUDY PROCEDURES .......................................................................................................9 
4.1 
Enrollment Procedures ..........................................................................................9 
4.1.1 
Informed Consent ..................................................................................................9 
4.1.2 CASI ......................................................................................................................... 10 
4.1.3 
STI Testing .......................................................................................................... 10 
4.1.4 
Randomization .................................................................................................... 11 
4.2 
Schedule of Assessments ..................................................................................... 11 
4.3 
Managing and Tracking Study Visits ................................................................... 13 
4.4 
Retention and Follow Up ..................................................................................... 15 
4.5 
Specimen Collection and HIV/STI Test Reporting ............................................... 16 
4.5.1 CBO specimen collection .......................................................................................... 16 
4.5.2 Alternative means of specimen collection .................................................................. 17 
4.5.3 HIV/STI Test Result Delivery ................................................................................... 17 
4.5.4 HIV/STI Test Reporting ............................................................................................ 18 

 
 
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4.6 
Incentives and Compensation .............................................................................. 18 
4.7 Criteria for Premature Discontinuation ..................................................................... 19 
4.8 
Measures ............................................................................................................. 19 
4.8.1 
Self-Management Model Measures ...................................................................... 23 
PRIDE5.0 
INTERVENTION PROCEDURES ...................................................................... 23 
5.1 
Intervention Design and Procedures ..................................................................... 23 
5.1.1 
Four Sessions of YMHP ...................................................................................... 23 
5.2 
Intervention Training and Supervision ................................................................. 25 
5.2.1 
Initial and Pre-Trial Training ............................................................................... 25 
5.2.2 
Booster Trainings ................................................................................................ 26 
5.2.3 
Ongoing Monitoring and Supervision .................................................................. 26 
6.0 
DATA MANAGEMENT AND ANALYSIS PLAN ...................................................... 27 
6.1 
Data Management and Data Quality .................................................................... 27 
6.2 
Quantitative Analysis Plan ................................................................................... 27 
6.2.2 
Equivalency Checks Grant language vs ATN language ........................................ 28 
6.2.3    Equivalency Tests................................................................................................... 29 
6.3 
Cost-Effectiveness Analysis Plan ......................................................................... 29 
6.3.1 
YMHP Program Cost Analysis ............................................................................ 30 
6.3.2 
Data Collection for YMHP Cost Analysis ............................................................ 31 
7.0 SAFETY MONITORING PLAN ........................................................................................ 34 
7.1      Data and Safety Monitoring Board ...................................................................... 34 
7.2      Adverse Events Reporting ................................................................................... 34 
7.3  
NIH Reporting ..................................................................................................... 35 
8.0 
ETHICAL CONSIDERATIONS ................................................................................... 35 
8.1 
Regulatory and Ethical Compliance ..................................................................... 35 
8.2 
Informed Consent Process ................................................................................... 35 
8.3 
Responsibilities of the Site PI .............................................................................. 35 
8.4 
Early Termination of the Study ............................................................................ 36 
9.0 
STUDY ORGANIZATION ........................................................................................... 36 
10.0 
DATA ACCESS AND SHARING ................................................................................ 36 
11.0 
PUBLICATIONS POLICY: OVERVIEW ..................................................................... 36 
12.0 
REFERENCES .............................................................................................................. 37 
 

 
 
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LIST OF ABBREVIATIONS AND ACRONYMS 
 
AE 
 
Adverse Event 
BAC 
 
Bridging Access to Care, Inc. 
 
CAS 
Condomless Anal Sex 
 
CASI 
Computer-Assisted Self-Interview 
 
CBO 
Community Based Organization 
 
CET 
Comparative Effectiveness Trial 
 
PRIDE 
Center for HIV Educational Studies & Training 
 
CT 
Chlamydia trachomatis 
 
C&T  
(HIV) Counseling and Testing 
 
DATCAP 
Drug Abuse Treatment Cost Analysis Program 
 
DSMB 
Data Safety Monitoring Board 
 
DSMP 
Data Safety Monitoring Plan 
 
eTAU 
Enhanced treatment as usual  
 
GC  
Neisseria gonorrhea 
 
GMM 
Growth Mixture Modeling 
 
HIPAA 
Health Insurance Portability and Accountability Act 
 
IDU 
Injection Drug Use 
 
IP  
Immediate Post-Test Assessment 
 
ITT 
Intent-to-treat 
 
MAR 
Missing at Random 
 
MI 
Motivational Interviewing 
 
MITI  
Motivational Interviewing Treatment Integrity 
 
MSM 
Men who have sex with men 
 
MYMSM 
Racial and ethnic minority young men who have sex with men 
 
OMS 
Online Master Screener 
 
PHI 
Protected Health Information 
 
PD 
Project Director 
 
PI 
Principal Investigator 
 
PrEP 
Pre-Exposure Prophylaxis 
 
Rating Form 
MI Coach Rating Scale 
 
RPPR 
Research Performance Progress Report 
 
SAE 
Serious Adverse Events 
 
STI 
Sexually Transmitted Infection 
 
YMHP 
Young Men’s Health Project 
 
YMSM  
Young men who have sex with men (ages 15-24 unless otherwise 
specified) 
 
 

 
 
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STUDY ABSTRACT 
 
PURPOSE: 
The purpose of this study is to adapt and test the effectiveness 
of the Young Men’s Health Project (YMHP) motivational 
interviewing (MI) intervention as delivered in community 
based organizations (CBOs), in an effort to reduce human 
immunodeficiency virus (HIV) and sexually transmitted 
infection (STI) disparities among racial and ethnic minority 
young men who have sex with men (MYMSM).  
 
DESIGN:  
This study will use a comparative effectiveness trial (CET) 
design with two intensities of treatment to be offered following 
field-based HIV counseling and testing -- the YMHP 
intervention and an enhanced “treatment as usual” (eTAU) 
condition involving HIV prevention services provided at two 
CBOs -- to test their relative effectiveness in reducing substance 
use and sexual risk behavior among HIV-negative MYMSM. 
Phase I will include conducting focus groups with CBO staff 
including HIV counseling and testing (C&T) staff, counselors, 
and others to obtain implementation feedback about the delivery 
of the YMHP intervention and intervention components to 
ensure 
culturally 
competent, 
feasible, 
and 
scalable 
implementation in CBO settings. Phase II will include the 
recruitment and enrollment of 260 MYMSM aged 15-29 (130 
per condition). Intervention sessions will be recorded for 
Motivational Interviewing Treatment Integrity (MITI) fidelity 
coding, and Health Educators and supervisors will be given 
implementation support throughout the full trial. [TBD: Prior to 
implementation, immediately at the conclusion of the
intervention delivery phase, and one year post-intervention, the 
PRIDE Health Research Consortium (PRIDE) will conduct 
interviews with counselors, supervisors, and CBO leaders to 
obtain information about the barriers to and facilitators of 
implementation and sustainment of YMHP.] 
 
DURATION: 
The overall study duration is 36 months. There will be 
approximately 8 months of focus groups, adaptation, and 
training; 13 months for recruitment and enrollment; and 15 
months of follow-up assessments with study participants. 
Assessment of intervention outcomes will be at immediate 
post-test (IP), 3-, 6-, 9-, and 12-month time points (12M 
removed May 2020). An optional qualitative interview will be 
conducted at any point after the immediate post. 
 
 

 
 
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STUDY SITES: 
Boom! Health – Bronx, NY 
Bridging Access to Care – Brooklyn, NY (BAC ended 
participation May, 2019. BAC participants complete their 
intervention, follow-up assessments, and STI testing at Hunter 
College research offices (142 W 36th Street, New York, NY 
10018) or Boom!Health ) 
 
SAMPLE SIZE: 
 
We will enroll 260 HIV-negative MYMSM (130 per 
condition) 
 
POPULATION:  
We will screen HIV-negative MYMSM aged 15-29 who seek 
HIV/STI testing at the CBOs or via mobile testing. Enrollment 
will be limited to HIV-negative YMSM who report recent 
substance use and condomless anal sex (CAS) or a positive 
STI test result in the past 90 days. 
  
STRATIFICATION:  
Participants will be randomized and scheduled to receive their 
first YMHP session directly following their baseline 
assessment. The study will employ a stratified block 
randomization procedure with strata for substance use and 
each interventionist using Qualtrics. Randomization is 
stratified by substance use including (marijuana alone). For the 
purposes of stratification, any alcohol and/or tobacco use is not 
considered.    
 
DATA 
COLLECTION: 
Intervention sessions will occur approximately once per week 
for four weeks, beginning one week after completion of the 
baseline assessment. There will be a 12-week window for 
intervention completion, i.e. all 4 sessions must be completed 
within 12 weeks of the baseline assessment. The IP will occur 
3 months after baseline. Subsequent follow ups will be 
scheduled every 3 months thereafter, ending with the 12-
month post-intervention (i.e., 15 months post-baseline) 
assessment. Baseline, 3-month, and 9-month assessments 
consist of self-report data collection (CASI) plus HIV and STI 
testing. The IP, 6-month, and 12-month follow-up assessments 
require only the CASI and can be completed remotely.  
 
OBJECTIVES 
1) To adapt the YMHP intervention for delivery in CBOs by 
Health Educators 
2) To test the effectiveness of the YMHP intervention 
delivered at two CBOs in high HIV incidence neighborhoods 
in NYC  
3) To assess the cost-effectiveness of YMHP 

 
 
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STUDY DESIGN (as of 2018) 
 
YMHP 
Screening
Ineligible
Eligible
Baseline
Randomized
(Enrolled)
4 YMHP 
Sessions
Immediate 
Post-Test
3MFU
6MFU
9MFU
12MFU
(removed 5/20)
1 eTAU Session
Immediate 
Post-Test
3MFU
6MFU
9MFU
12MFU
(removed 5/20)

STUDY TIMELINE (as of 2018) 
 
 
 
 

 
1.0 BACKGROUND AND SIGNIFICANCE 
1.1 MYMSM are disproportionately at risk for HIV and STIs  
 
The annual number and rate of new HIV infection diagnoses in the United States decreased 
between 2011 and 2016 [1]. However, the number of infections attributed to male-to-male sexual 
contact did not decrease [1]. In 2016, 70% of new HIV infections were attributed to sexual 
contact between men [1]. Additionally, the annual number and rate of HIV diagnoses both 
increased among young adults aged 25-29, while decreasing or remaining stable for other age 
groups [1]. People aged 25–29 had the highest rate of new diagnoses (34.8%) in 2016, followed 
by those aged 20–24 (30.3%) [1]. Rates of new HIV diagnoses were greatest among 
blacks/African-Americans (43.6%) and Latinos (17%); the rate amongst whites was the lowest of 
all racial and ethnic groups (5.2%) [1]. According to the Centers for Disease Control and 
Prevention (CDC), black YMSM (aged 13 - 24 years) account for more new diagnoses 
nationwide than any other subgroup by race/ethnicity, age and sex [2]. CDC projects that “if 
current rates persist” one in two black MSM and one in four Latino MSM are at risk of an HIV 
diagnosis in their lifetime [2]. 
 
Rates of HIV diagnoses also vary geographically across the US. The Northeast has the highest 
rate of people living with diagnosed HIV (418 per 100,000 people) and the second-highest rate 
of HIV diagnosis (11.2 per 100,000 people) in the US [3]. New York City remains the epicenter 
of the domestic HIV epidemic, and reflects even stronger disparities in incidence by sexual 
orientation, age and race/ethnicity. In 2016, MSM made up at least 71.4% of men newly 
diagnosed with HIV in New York City, with those aged 20-29 making up the greatest number of 
new diagnoses (39.8%) [4]. While the number of annual new HIV diagnoses has decreased 
across all age groups since 2001, the estimated annual percent decrease in new diagnoses for the 
20-29 age group (0.87) is a fraction of the decrease for the other age groups (which range from 
2.53 amongst New Yorkers over 60 to 22.6 amongst those under 13) [4]. MYMSM in NYC are 
the most affected; 78.7% of all YMSM diagnosed with HIV between 2012 and 2016 were black 
and/or Latino [5]. In 2016, MSM aged 20-29 made up 37.6% of all new HIV diagnoses amongst 
blacks/African-Americans, and 36.1% of all new HIV diagnoses amongst Latinos; together, 
MYMSM aged 20-29 comprised 20.0% of all new HIV diagnoses in NYC in 2016 [6].  
 
Young males ages 15-24 are vastly overrepresented in rates of STIs, with similar disparities by 
race/ethnicity and sexual behavior. In 2016, 15-24 year old males accounted for 52% and 38% of 
all male cases of Chlamydia trachomatis (CT) and of Neisseria gonorrhea (GC) infection, 
respectively [7, 8]. According to the CDC, in 2016 young black/African American men ages 15-
19 and 20-24 had a rate of CT infection 8.8 and 4.9 times higher than whites, respectively. GC 
rates showed similar racial disparities nationwide: black/African American men aged 20–24 
years and 25–29 years had a GC rate 9.1 times and 7.4 times that of white men in the same age 
group, respectively [9]. 2015 NYC trends in STI incidence by race/ethnicity were similar; black 
non-Latino young men aged 15-19, 20-24, and 25-29 reported GC at 8.4, 2.8, and 2.9 times the 
rate (per 100,000 population) as their white counterparts. Nearly half of new GC diagnoses 
among males in 2015 were among men ages 20-29 [10]. In 2016, MSM accounted for 81% of all 

 
 
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primary and secondary (P&S) syphilis cases diagnosed in the US, with 47.0% of those MSM co-
infected with HIV [9]. Considering all race, ethnicity, sex, and age categories, rates of reported 
P&S syphilis cases were highest among Black men aged 20–24 years and 25–29 years. The rates 
among black men aged 20–24 and 25-29 years were 6.4 times and 6.2 times those for their white 
counterparts [9].  
 
The NYC DOHMH found that between 2012 and 2016, male P&S syphilis case rates increased 
81%, with the overwhelming majority (88%) of 2016 cases amongst MSM. Even more 
concerning is the high rate of HIV co-infection among MSM with P&S syphilis: 43.4% in 2016 
[11]. Syphilis and HIV co-infection raises the risk of transmission to sexual partners [12]. 
Similarly, a study of HIV-negative MSM diagnosed with rectal CT/GC at NYC STI clinics from 
2008 to 2010 showed that rectal CT/GC infections greatly increase HIV incidence. Among those 
with CT/GC infections, 1 in 15 was diagnosed with HIV within one year, with HIV incidence 
highest among YMSM and Black MSM [13]. 
 
1.2 Substance Use and HIV Risk among YMSM 
 
MSM, including YMSM, use recreational drugs and alcohol at higher rates than their 
heterosexual counterparts [14-18]. Substance use increases the likelihood of engaging in sexual 
risk behavior and HIV seroconversion among MSM [19-21]. Some have even argued that 
methamphetamine-using MSM are fueling the HIV epidemic [22]. Polydrug use is common 
among YMSM [14, 23, 24], and “club drugs” like cocaine, ketamine, methamphetamine, ecstasy, 
and gamma hydroxybutyrate (GHB), are commonly used, often in association with sexual 
activity [25-27]. Substance use is especially prevalent amongst MSM in urban areas [18]. A 
recent study of Black MSM in 6 US cities found that 38% reported stimulant use and 57% 
marijuana use. 48% reported substance use during their last anal sex encounter [28]. Similarly, a 
study in Boston found that 34% of black MSM reported using stimulants during sex at least 
monthly in the previous year [29]. Nearly half of Black MSM with newly diagnosed HIV 
infection (48%) reported substance use during their last anal sex encounter [30].  
 
YMSM who use recreational drugs are particularly susceptible to HIV infection. PRIDE’s own 
research using event-level data for the previous 30 days has found that YMSM’s substance use 
strongly and significantly predicts CAS: CAS was twice as likely on a day that any drug was 
used [31]. Among Latino YMSM, street drug and methamphetamine use are strongly correlated 
with sexual risk; among Black MSM higher rates of marijuana use are linked to sexual risk [32].  
 
Given these statistics, there is a critical need for brief, culturally appropriate, effective behavioral 
interventions that improve self-management to reduce new HIV infections among substance-
using YMSM, and MYMSM in particular. 
 
 
 

 
 
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1.3 The CBO Setting 
 
CDC supports routine HIV testing in clinical settings and targeted HIV testing in nonclinical 
settings. The nonclinical setting includes community-based organizations, whose location within 
a community makes their services more accessible and comfortable for populations that might 
have limited or irregular access to medical care. CBOs successfully engage populations that are 
at high risk for HIV infection and are difficult for traditional clinical settings to reach [33]. HIV 
testing, counseling and prevention provided by CBOs address many key barriers that these 
populations face, including lack of health insurance, stigma, medical mistrust, and lack of 
confidentiality in insurance billing statements. Young people who are covered as dependents on 
a parent or partner’s health insurance plan, for example, may seek testing from a CBO so that the 
test does not appear on an Explanation of Benefits sent from their insurance company to the 
policyholder, as it would if they received testing in a clinical setting using their insurance. Unlike 
the clinical setting, CBOs rely on counselors and lay health workers, with a focus on C&T and 
social services rather than routine healthcare.  
 
Community-based organizations that offer targeted HIV testing usually conduct same-day rapid 
HIV tests, active recruitment to reach out to high-risk populations for HIV testing, and offer HIV 
prevention services, including “structural or behavioral interventions and social services” [33]. 
Co-locating HIV prevention and substance use treatment at CBO sites is an especially effective 
strategy for providing accessible HIV prevention services to high-risk populations [34]. CBO 
partner Boom!Health’s harm reduction center is an example of integrated, co-located services: 
the center includes a syringe exchange program, HIV and HCV testing, care management, 
common harm reduction support services, primary care, mental health services, suboxone 
treatment, and pharmacy services [35]. CBO partner Bridging Access to Care (BAC) co-locates 
HIV primary care services in its behavioral health clinics, including rapid HIV testing onsite for 
any interested client [36].  
 
Agencies often provide HIV testing and prevention services at multiple venue types in order to 
better identify high-risk clients, meet the needs of their target populations, and offer a broader 
range of services. “Offering testing in these venues allows providers to strategically target their 
services to individuals at highest risk of becoming HIV infected in their community. By 
providing clients access to prevention, medical, and social services on-site or through external 
agencies, non-clinical testing programs can expand access to a wide range of medical and social 
services that can help stem HIV transmission improve health, enhance the quality of life, and 
prolong life” [37]. BAC, for example, offers C&T at several of their offices, as well as through 
mobile units and partnerships with churches, schools, and other organizations [38].  
 
BOOM!Health (formerly CitiWide Harm Reduction and Bronx AIDS Services) delivers a range 
of HIV prevention, behavioral health and wellness services to those at highest risk in the Bronx, 
a community with some of the highest HIV concentrations in NYC. In January 2015, 
BOOM!Health opened a 35,000 square-foot Wellness Center with health care services focusing 
on the unique needs of sexual minorities and youth in the Bronx. BOOM!Health provides HIV 
testing onsite and via mobile vans, as well as evidence-based HIV prevention interventions and 

 
 
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related services to a large population of MYMSM in the Bronx, making it an ideal collaborating 
site for testing the effectiveness of YMHP in the field.  
 
Bridging Access to Care, Inc. (formerly Brooklyn AIDS Task Force) (BAC ended participation 
as a site in May 2019.) is Brooklyn’s oldest nonprofit prevention, treatment and health service 
organization. They provide comprehensive HIV/AIDS, mental health, and substance use services 
to underserved racial and ethnic minority communities in Brooklyn, as well as HIV testing and 
prevention outreach across New York City. BAC’s Brooklyn Men (K)onnect program 
specifically serves MYMSM. BAC’s offices are located in Flatbush, Crown Heights and 
Williamsburg, which have the three highest HIV incidence rates in Brooklyn and together 
comprise 14.7% of all new HIV diagnoses in NYC [6].  
  
Given the success of HIV testing and counseling in the CBO setting, this study places the YMHP 
intervention in the CBO setting, to directly follow a client’s negative HIV test result. YMHP has 
the potential to be a powerful tool for HIV prevention amongst MYMSM, and the CBO setting is 
ideal for the intervention to reach this population. The youth population served by BAC and 
Boom!Health is almost entirely Black and Hispanic, and both CBOs have targeted outreach to 
YMSM. Boom!Health and BAC are well known and trusted in their communities, which have 
disproportionately high rates of poverty and HIV incidence. Our study utilizes staff indigenous to 
the CBO setting to build capacity for implementation of the YMHP intervention. Lay health 
workers are commonly integrated into CBOs, and often play a central role in providing HIV 
prevention services, including C&T. We will be studying the effectiveness of YMHP delivery by 
trained lay Health Educators in these community-based settings, with a focus on intervention 
sustainment and scalability. 
 
1.4 Motivational Interviewing 
 
Motivational Interviewing (MI) has the potential to improve self-management behaviors in terms 
of promoting sexual health and reducing substance use among MYMSM. Meta-analyses of MI in 
medical care settings found that MI had a significant impact on behaviors such as alcohol and 
substance use, sexual risk behavior, and HIV viral load over and above those who did not receive 
MI [39-41]. There is strong evidence that MI is a culturally appropriate and effective approach 
for working with racial and ethnic minority populations [42] who are disproportionately affected 
by HIV and other STIs. One meta-analysis of MI found greater effect among minorities [43]. MI 
has been recommended as particularly effective when working with MYMSM [44]. MI promotes 
increased intrinsic motivation to change and, when paired with information regarding health risk 
behaviors, reinforces the individuals’ right and capacity to make well-informed health self-
management decisions for themselves [45]. The autonomy-reinforcing nature of MI may be 
particularly culturally appropriate for African-American/Black and Latino youth; one study of 
HIV+ MYMSM found that minority youth who did not feel respected during care encounters 
were at greater risk of being lost to care [46].  
 
YMHP was the first trial of a structured and manualized MI intervention that also included 
personalized feedback and problem-solving skills building to reduce CAS and substance use in 

 
 
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YMSM. We found that YMSM randomized to receive the YMHP sessions were 24% less likely 
to engage in CAS and 18% less likely to use recreational drugs than those who received content-
matched educational sessions [47].  
 
1.5 Intervention Delivery by Health Educators 
 
Lay health workers are as effective as clinicians in providing high quality MI, and clients are 
more likely to be retained in HIV care when working with the lay health workers [48]. Health 
Educators are commonly integrated into community-based health clinics, and often play a central 
role in providing HIV prevention services, including HIV C&T. Training lay health workers to 
deliver evidence-based interventions is a critical step towards realistic and cost-effective 
implementation[49, 50]. Research has established that in order to obtain MI fidelity, initial 
training must be reinforced by ongoing coaching [51-54]. Such training can be costly when 
relying on outside trainers. Thus, a “train the trainer” model, where expert trainers provide local 
supervisors with MI coaching skills, may be more sustainable [55]. CDC has called for expanded 
use of lay health workers in services for preventing and managing chronic disease, including 
leading and supporting self-management programs; CDC suggests comprehensive state policy 
approaches to supporting lay health workforce, as Massachusetts and Minnesota have done [56].  
 
Lay health workers have long been the cornerstone of integrating support services into HIV-
related prevention efforts [57]. The “Hybrid 2” design of this YMHP CET study tests both 
clinical and implementations interventions/strategies [58]; this allows us to determine which 
treatment works better as well as answer implementation science questions about the potential 
barriers and facilitators to a treatment’s widespread and continued implementation. 
  
In summary, this study examines the implementation of a brief efficacious intervention that 
addresses an important problem (high rates of substance use and increasing HIV/STI incidence) 
among a population experiencing multiple vulnerabilities and health disparities. Given the 
absence of effective behavioral interventions in reducing both substance use and sexual risk 
outcomes in HIV-negative MYMSM, this CET is the crucial next step in determining the 
effectiveness of the YMHP intervention in real-world contexts, i.e. as delivered by frontline staff 
to their clients.   
2.0 STUDY OBJECTIVES 
 
In collaborating with two CBOs (Boom!Health and BAC(BAC ended participation in May 
2019)), our goals are to better understand substance use and sexual health-related outcomes 
among HIV-negative MYMSM who are unlikely to be treatment-seeking and to implement the 
YMHP intervention in a way that will maximize portability and scalability. Working 
collaboratively with the CBOs will help to address practical problems at the frontline of service 
provision to pave the way for a comprehensive program to reduce substance use and HIV 
infection among MYMSM.  

 
 
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2.1 Specific Aims 
 
Aim 1: Adapt the YMHP intervention for delivery in CBOs by Health Educators. We will 
conduct focus groups with site staff to obtain further input on the best ways to implement YMHP 
in CBO settings to maximize feasability, acceptability, and sustainability. 
Aim 2: Test the effectiveness of the YMHP intervention delivered in two CBOs situated in high 
HIV incidence neighborhoods in NYC using a CET. We will test YMHP – an efficacious, MI-
based intervention – versus enhanced treatment as usual (eTAU) condition (standard HIV C&T 
and prevention services with information about PrEP) in reducing substance use and CAS among 
HIV-negative MYMSM. 
Aim 3: Assess the cost-effectiveness of YMHP. In order to enhance the likelihood of uptake if 
effective, we will conduct analyses to assess the cost-effectiveness of YMHP compared to 
eTAU.  
 
2.2 Research Overview 
 
We will achieve our aims over two phases of the study. 
Phase I: We will conduct focus groups with staff, including HIV C&T counselors, Health 
Educators, counselors and others. We will train a mininum of 2 Health Educators and 1 
supervisor at each CBO. Once Health Educators demonstrate competence according to the MITI, 
we will move to Phase 2. 
Phase II: We will recruit and enroll 260 MYMSM, aged 15-29, 130 per condition. Enrollment 
will be limited to HIV-negative YMSM who report recent substance use and either CAS or a 
positive STI result. Participants will be randomized to receive either the 4-session YMHP 

 
 
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intervention, or one session of eTAU. YMHP sessions will be audio-recorded for MITI fidelity 
coding, and counselors and supervisors will be given implementation support throughout. [TBD: 
Prior to implementation, immediately at the conclusion of the intervention delivery phase, and 
one year after, PRIDE will conduct interviews with counselors, supervisors, and CBO leaders to 
obtain information about the barriers to and facilitators of YMHP implementation and 
sustainment.] 
3.0 STUDY POPULATION 
3.1 
Inclusion and Exclusion Criteria 
 
Patients who express interest in YMHP must demonstrate the following inclusion criteria to be 
enrolled in the study: 
• HIV-negative test result from the past 90 days 
• 15-29 years of age 
• Currently identifies as male (regardless of birth sex) 
• Sex with men in the past 90 days 
• Self-report ≥ 3 days of substance use (including heavy drinking) in the past 90 
days 
• Self-report ≥ 1 episode of CAS in the past 90 days, or a positive STI test result in 
the past 90 days 
• Living in NYC metropolitan area 
• Able to communicate in English 
 
Participants will be excluded from the study if they any indicate the following: 
• ≥5 days of injection drug use (IDU) in the past 90 days 
• Currently taking Truvada as pre-exposure prophylaxis (PrEP) 
• Mental, physical or emotional capacity that does not permit them to complete the 
protocol as written. 
 
We expect a study population that is close to 100% black and Hispanic, based on the client 
population at the partner CBO sites. However, we will not exclude young men of other ethnic or 
racial backgrounds from the study if they meet inclusion criteria. Given the racial and ethnic 
breakdown of YMSM clients at BOOM!Health and BAC, we estimate that 44% of our sample 
will identify as Black/African-American, 48% as Hispanic/Latino, and 8% as “other.” 
3.2 
Recruitment and Screening 
 
Recruitment and screening will be integrated into the HIV testing practices of both collaborating 
CBOs. BOOM!Health and BAC will continue to conduct HIV testing at their home offices and 
in the field as usual. YMSM that are tested and receive an HIV-negative result will be offered the 
opportunity to participate in YMHP. If interested, the HIV tester will ask the potential participant 
to complete a brief screener via an iPad. If eligible, the potential participant’s contact info will be 

 
 
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collected and passed on to the Research Coordinator who will contact them in order to schedule a 
baseline appointment. 
 
CBO study personnel will also attempt to screen YMSM who have previously received an HIV-
negative test result at BOOM!Health or BAC. To do so, CBO study personnel will reach out to 
YMSM who have received a recent negative HIV test result in the last 90 days. After giving an 
explanation of the YMHP study, the potential participant will be asked if he would like to answer 
the screener questions for the study over the phone. If he declines, the study personnel will thank 
him for his time and end the call. If they agree to answer the questions, the study personnel will 
deliver the study screener over the phone. 
 
The study will be advertised in the form of flyers, brochures, and cards displayed in public areas 
of the BOOM!Health and BAC offices frequented by clients, plus their mobile testing units, 
alongside materials promoting the organizations’ other services. These materials will be given to 
potential participants to encourage HIV testing as well as promote the YMHP study. 
 
PRIDE will assist in identifying potentially eligible participants through its existing ongoing 
online recruitment efforts. PRIDE utilizes the Hunter College IRB-approved Online Master 
Screener (OMS) to preliminarily screen individuals who are interested in participating in PRIDE 
studies. When the OMS determines an individual to be preliminarily eligible for a study, they are 
asked to provide their contact information to PRIDE for follow-up. For this study, the OMS will 
be used to recruit, inform, and phone-screen potentially eligible YMSM to YMHP. PRIDE staff 
will conduct phone screens of potential participant identified by the OMS. If a YMSM screens 
preliminarily eligible for YMHP, they will be referred via email to BOOM!Health or BAC for 
free HIV testing to finalize eligibility. This referral email will contain additional information 
about the study. PRIDE will not provide the contact information collected through the OMS to 
the CBOs; however, the CBOs will be made aware that a potentially eligible YMSM has been 
screened for the study and added to the study database for follow up HIV testing.  
 
We anticipate enrollment of 10 participants per site per month. We estimate that 80% of enrolled 
participants will be racial/ethnic minorities.  
 
3.3 
Contact Information  
 
Once deemed eligible by the screener, participants will be routed to an online, Qualtrics version 
of the Locator Form. The information provided on the online Locator Form will be printed or 
pulled up by CBO staff for review in-person. The Locator Form asks participants to provide a 
street address, cell phone number, alternative phone number, and valid email address at which 
they can be reached. Participants will also be asked to provide valid phone numbers for two 
contacts who can be called in the event the participant cannot be reached by phone or email. 
Participants will be asked if voicemail messages can be left at the numbers provided. Site study 
staff will not leave messages unless expressly permitted to do so by the participant, as 
documented on this form. If permission is given to leave messages, site study staff will assure 
participants that messages left with a family member or friend will only ask the participant to 

 
 
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contact study staff and will not include any protected health information or information related to 
study participation. Participants will also be asked for permission to contact them via text 
message, and given the option to list any additional methods of contact including social media 
(Facebook, Twitter, Tumblr, Instagram). The Locator Form data will be maintained off-line in a 
password-protected file on a secure server, separate from all study records, with access limited to 
designated research personnel. A record that will link unique identification codes with names and 
contact information for participants will be accessible only to study staff and maintained off-line 
in a password-protected file on a secure server. Participants’ names, addresses, email addresses, 
and social media information will not be collected in the survey, interview, or counseling 
sessions. 
4.0 STUDY PROCEDURES 
4.1 
Enrollment Procedures 
 
Participants are randomized to YMHP or eTAU after completing the baseline session, which 
includes the YMHP screener, completion of the Locator Form. After randomization, they are 
counted as officially enrolled in the study. Once enrolled, the participant should complete the 
session (YMHP #1 or eTAU, as assigned) immediately. The Research Coordinator will be 
responsible for tracking the visit as completed in REDCap. PRIDE will then verify that the 
baseline assessment was completed and follow up with the Research Coordinator if there are any 
data which need clarification.  
 
4.1.1 Informed Consent  
 
Given that some of the participants will be under the age of 18, adequate provisions will be made 
for soliciting informed consent. At each site, the Research Coordinator will review the consent or 
assent forms to make a formal assessment of every youth's decision-making capacity to consent 
prior to signing, using a 2-step process. In the first step, the Research Coordinator will determine 
whether the person understands the goals by asking "Can you tell me what this study is about?" 
In the second step, s/he will ask questions designed to assess the potential participant’s capacity 
to understand, appreciate, reason with, and express a choice about participation in our specific 
protocol. We will use a modified version of the widely used Evaluation to Sign Consent Form. 
Subjects will be asked to:  
1. Name things they will be expected to do during the study,  
2. Explain what they would do if they no longer wished to participate in the study, 
3. Explain what they would do if they experienced distress during the study, and  
4. Identify potential risks for participating in the study.  
Participants will be enrolled only once they are able to provide clear and correct answers to each 
of these items, with assistance and clarification from the research staff member as needed. If the 
research staff member feels there is a question about the need for more formal assessment of the 
decisional capacity of a potential participant s/he will contact the Principal Investigator (PI) to 
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Consent will be discussed and documentation obtained in person at subjects' baseline visits prior 
to any data collection or other study procedures.  The consent form (Appendix A) will be signed 
and dated by the individual obtaining the informed consent and by the participant at the 
beginning of the baseline assessment. A copy of the signed consent form will be given to the 
participant and the original(s) will be kept securely with each participant’s research records. 
Signed consent forms will be filed and stored securely, and securely stored separately from other 
assessment materials because they contain the full names of participants. 
 
The Research Coordinators will be trained on the protocol and the consent process, as well as 
receive Collaborative Institutional Training Initiative (CITI) training. CITI certificates will be 
submitted to the Hunter College IRB. The Research Coordinators will not engage in any research 
activity until they are registered as YMHP Research Staff with the Hunter College IRB and IRB 
approval is granted for their role on the research project. It is also possible for other site staff 
members (e.g., Health Educators) to be trained and cleared to obtain consent.  
 
Sites will use a local authorization to release protected health information (PHI) to PRIDE as per 
their institutional policy. Participants will also sign a research authorization for use and 
disclosure of PHI as required by the IRB. 
  
4.1.2 CASI 
After obtaining informed consent, participants will complete a confidential computer-based 
survey (CASI) at the CBO site that will ask about their substance use, sexual behavior, and 
general thoughts and feelings. CBO study staff will administer the baseline CASI survey on a 
study-designated iPad or computer and ensure the participant can complete the survey in a quiet 
place. The participant will be able to reach the assessor if they have any questions or encounter 
errors completing the survey, but the assessor will not be in the room so that the participant 
completes the CASI in private. The baseline CASI will take about 45 minutes to complete. 
Participants who screen ineligible based upon CASI responses will be dropped from the study 
and all relevant databases. They will be given a $25 gift card for completing the CASI. This was 
changed in August, 2019 because too many participants were incorrectly answering study 
eligibility questions on the BL CASI. After that point, Study eligibility was determined at 
screening.  
 
4.1.3 STI Testing 
If eligible to continue based on the CASI, participants will proceed to STI testing, which will 
consist of a urine sample, an anal self-swab of rectal mucosa, and a syphilis test (type dependent 
on participant’s history of syphilis). The syphilis tests used in this study do not require a 
phlebotomist. The STI testing process will take about 15 minutes.  

 
 
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All participants will have already taken an HIV test in the last 90 days, with a negative test 
result. This is the baseline HIV status. The next HIV test will occur as part of the 3 Month Follow 
Up Visit. 
See Section 4.6 for specimen collection and STI test result reporting procedures.  
 
4.1.4 Randomization 
Participants will be randomized at the end of their baseline assessment into one of two 
intervention conditions: 1) delivery of the 4-session YMHP intervention or 2) delivery of a single 
eTAU session. Each participant’s condition will be tracked in the REDcap database maintained 
by the Research Coordinator.  
 
To assign condition, the study employs a stratified block randomization procedure with strata for 
interventionist and substance use. Interventionists are crossed by condition rather than nested, 
allowing for a more statistically powerful design. The assigned interventionist will be used for 
these particular strata. The substance use strata will randomize based on whether the participant 
used only marijuana in the past 3 months versus use of another drug in the past 3 months. After a 
participant completes the CASI, the assessor will open the randomizer in Qualtrics. The assessor 
will enter the participant’s ID, the assigned interventionist, and select either “marijuana-only” or 
“other substance use” into the randomizer. The block randomization procedure will select the 
condition. 
4.2 
Schedule of Assessments 
 
Baseline (first) visit: After providing informed consent, completing the CASI, and collecting 
specimens for STI testing, participants will complete their first session of YMHP, or their first 
and only session of eTAU, depending on their randomization. If randomized to receive the 
YMHP intervention, this first session will take 40-50 minutes to complete, focusing on either 
sexual risk or substance use, and will be audio recorded. If randomized to receive eTAU, the 
session will take 30-45 minutes, and will also be audio recorded. After this first visit, there are no 
additional treatment sessions as part of eTAU.  
 
Additional YMHP sessions: Participants randomized to YMHP will have the first YMHP 
session immediately after completion of the baseline assessment, and then they will return to the 
CBO to receive the remaining 3 intervention sessions, focused on sexual risk and substance use. 
Intervention sessions should occur approximately once per week for a total of four weeks, 
inclusive of the baseline visit. There is a 12 week window for intervention completion, i.e. all 4 
YMHP sessions must be completed within 12 weeks of the baseline assessment. Thus, if 
participants need to miss a week periodically, for any reason, they should have ample time to 
complete the four sessions during the 12 week window.  
 
Immediate post-test assessment: After completing all 4 YMHP sessions, or the single eTAU 
session, participants will be scheduled to complete an immediate post-test assessment. This 
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post-baseline). During this assessment participants will complete a confidential computer-based 
survey about their substance use, sexual behavior and general thoughts and feelings. In addition 
to assessing the primary outcomes of the intervention, participants will also respond to process 
measures. Specifically, participants will be asked to provide an evaluation of their health 
educator, as well as the health care climate of the YMHP intervention. This survey can be 
completed at the clinic or through a survey link, which will be sent to participants electronically, 
and will take about 45 minutes to complete. 
 
Follow-up assessments: There will be four additional follow-up assessments for participants to 
complete. These follow-up assessments will occur in three-month intervals until 12 months after 
their post-intervention assessment (i.e. 3 months, 6 months, 9 months, 12, and 15 months post 
BL).  
The 3 month and 9 month follow-up assessments include completing a confidential computer-
based survey (CASI) on an iPad and require confidential HIV and STI testing. The HIV and STI 
testing should be performed at the CBO clinic but other options are available such as getting tests 
performed at an outside lab (e.g. Quest Diagnostics) or by using a self-test kit which will be 
mailed to the participant if they choose. If participants do not complete the 3 month or 9 month 
HIV and STI testing they will be asked to complete these tests at their next assessment.  
The 6 month and 12 month assessments do not require HIV and STI testing (unless testing is 
missed at a previous visit) so these assessments can be completed remotely. Participants can use 
an electronic link provided to them or they can complete the CASI at the CBO site if they 
choose. The CASI assessment will be similar to the one administered at baseline and will take 
about 45 minutes for the participant to complete. 
The immediate post-test and follow-up assessments will be administered by a Research 
Coordinator or a trained and cleared Health Educator. No Health Educators may administer an 
assessment to a participant to whom they administered eTAU or YMHP sessions.    
Optional Qualitative Interview: In an effort to understand barriers and facilitators to YMHP 
program participation, we are adding an optional qualitative interview with study participants 
post intervention. It can be completed at the immediate post or at any time after the intervention 
window has closed (3 months post BL). The qualitative interview will be conducted over the 
phone between a PRIDE Staff member and the participant and should take approximately 30 
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Screening 
 Baseline 
 IP 
3M FU 
6M FU 
 9M FU 
12M FU 
Informed Consent 
 
X 
 
 
 
X 
 
CASI 
 
X 
X 
X 
X 
X 
X 
HIV Testing 
X 
 
 
X 
 
X 
 
STI Testing 
 
X 
 
X 
 
X 
 
Randomization 
 
X 
 
 
 
 
 
 
Refer to “Study Design” for a visual representation of the schedule of assessments. 
 
4.3 
Managing and Tracking Study Visits 
 
All participant tracking and retention activities are managed at the two CBO sites, since 
participants are mainly recruited at these sites. There are two different types of databases 
(Contact and Tracking) housed on REDCap, an online application, used to log staff contact with 
participants and participant progress in the study. This system allows both site Research 
Coordinators and PRIDE to monitor the completion of study visits and surveys, and generate 
reports on enrollment and retention as needed. The Research Coordinators are expected to track 
all completed study components in REDCap immediately after completing an assessment or 
upon receiving of e-mail notification of session completion no later than the end of the business 
day. 
 
Intervention Visits: Intervention tracking includes database entries of all YMHP sessions 
completed by the participants. Intervention sessions will be largely managed by the Health 
Educators with their individual study participants. The tracking mainly involves four components 
– delivery of the YMHP session, completion of the Clinical Session Note Form, uploading audio 
files, and sending an e-mail notification to the study team. Using the central study e-mail 
account, Health Educators will notify their CBO’s Research Coordinator and PRIDE of whether 
sessions were completed for tracking purposes, submit electronic Clinical Session Form, and 
upload audio files to the study Dropbox folder as per study procedures. PRIDE will notify the 
Health Educators to acknowledge receipt of the Clinical Session Form or to remind them to 
complete the form. The Health Educators will be responsible for scheduling the YMHP sessions 
2-4 for participants randomized into YMHP.  
 
Intervention visits include all YMHP sessions between enrolled study participants and MI-
trained Health Educators. Intervention visits will be largely managed by the Health Educators 
with their individual study participants. Health Educators will notify site study staff of whether 

 
 
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visits were completed for tracking purposes, provide receipts for session compensation to site 
study staff, and upload audio files to Dropbox as per study procedures. The 1st YMHP 
appointment or one-time eTAU occurs directly after the baseline appointment.  
 
Assessment Tracking: Assessment tracking includes entries of the baseline visit, the immediate 
post-test assessment, and all four follow-up assessments in REDCap. All participants, regardless 
of randomized condition, are expected to complete the six assessments as part of full 
participation in the study.  
 
For each assessment, the participant will complete the CASI using an iPad (if completed in 
person at the clinic) or using a phone, tablet, or other computer device (for assessments that can 
be completed at home). Research Coordinators will schedule participants for in-person 
assessments during times that they will be available. Research Coordinators will also ensure that 
there is available space at clinic sites to conduct these assessments. Research Coordinators are 
expected to keep in touch with participants and remind them of the upcoming visit and 
reschedule if/when needed. A reminder call should be made one business day before a 
participant is due to come in for a study visit (i.e. the Friday before a Monday visit). Participants 
who wish to forego an in-person visit to the clinic site have the option of completing follow-up 
assessments online (i.e. without coming to the clinic) for visits which do not require HIV and 
STI testing (6-Month Follow-Up and 12-Month Follow-Up). These assessments consist only of 
an online CASI. Participants may contact Research Coordinators by phone or email about any 
questions or concerns that arise while completing these surveys. The Study Data Flow is 
presented below.  
 
 

 
 
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4.4 
Retention and Follow Up 
 
We estimate that retention for the IP and the 3, 6, 9, and 12-month Follow Up assessments will 
be about 97%, 94%, 91%, 88%, and 85%, respectively, based on our prior work on YMHP. 
Through the REDCap Tracking Database, PRIDE YMHP staff will generate weekly reports 
listing all participants who are due for follow-up assessments. PRIDE will provide extensive 
training to the CBO Research Coordinators on retention efforts. 
 
Session Retention: For patients who are actively taking part in the YMHP intervention and 
working with Health Educators, site study staff will not add an additional level of outreach to the 
procedures. Health Educators will be instructed to adhere to the already-present procedures of 
the CBO for contacting and re-scheduling patients. Research Coordinators should prioritize the 
completion of intervention sessions before the first follow-up assessment, and should not 
schedule this follow-up less than 12 weeks after baseline if a participant is available to complete 
any additional sessions first. 
 

 
 
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Assessment Retention: A target date for completing each follow-up will be established at every 
12-week point from the baseline. Research Coordinators should aim to schedule and complete 
these follow-ups as close as possible to each target date. Given that this is an effectiveness trial 
in a real-world setting, assessment windows are liberal. To keep track of longitudinal data 
collection dates, assessment windows will be programmed to 30 days prior and after the target as 
“in window.” If Research Coordinators attempt to assess a participant 60 or more days before or 
after the established target date, then they should contact PRIDE to authorize the assessment 
prior to compensating the participant. 
 
Research Coordinators are to maintain strong and consistent relationships with study 
participants, and should contact study participants by phone at least once per month. During this 
phone outreach, Research Coordinators can verify existing contact information and inquire as to 
whether the participant foresees any potential changes in the near future. Research Coordinators 
should take note of participants who are less stable in terms of housing/phone numbers, and 
devote outreach efforts toward these participants strategically. Retention success/challenges will 
be based on outreach and assessment reporting from Research Coordinators at each site to 
PRIDE via Qualtrics. PRIDE will generate weekly reports using REDCap and distribute them to 
staff at each site. PRIDE and the Research Coordinators will meet regularly to discuss 
recruitment and retention efforts, based on these reports and any other relevant feedback. 
 
4.5 
Specimen Collection and HIV/STI Test Reporting 
4.5.1 CBO specimen collection  
Sites will use standard protocols for specimen collection for this study, as outlined in the 
Standard Operating Procedure guide for STI Specimen Collection and summarized below.  
 
HIV testing (performed at follow-up appointments only) will be performed using the OraQuick 
rapid test. The test result should be recorded in the participant’s health record 
 
[For BAC only] For syphilis serologic testing, the Research Coordinator will use the Syphilis 
Health Check™ Antibody Rapid Immunochromatographic Test from Diagnostics Direct. This 
test involves a finger prick blood draw, and the test takes 10 minutes to incubate before results 
are ready to be read. During this time, the Research Coordinator should have the participant 
collect his urine and rectal swab specimens. BAC visits with a phlebotomist will do syphilis 
testing via venipuncture as part of a full panel. In all cases, the participant’s syphilis test result 
will be recorded in their health record. Note: Participants who indicate a past syphilis infection 
will not be tested for syphilis at baseline or follow-up visits, except if doing a full panel at BAC 
with the phlebotomist.  
 
 
STI testing supplies for Boom!Health will be ordered by PRIDE staff through Quest Diagnostics. 
BAC will order its own STI testing supplies through LabCorp.  
 

 
 
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CBO study staff will escort the participant to the participant restroom with the printed 
instructions on specimen collection and all labeled specimen collection devices and containers. 
They will instruct the participant where to place specimens when collection is completed, as well 
as where they can be found after completion of the specimen collection process, and will leave 
the participant to carry out the procedure in private. Once specimens are obtained, the study staff 
will ensure that urine and rectal swab samples are labeled correctly and will place them in the 
appropriate area in the laboratory designated for specimen pick-up. 
BAC samples will be picked up and processed by LabCorp. Boom!Health samples will be picked 
up and processed by Quest Diagnostics. The Research Coordinators will track participants’ STI 
results on RedCap and complete the Test Results Form on Qualtrics.  
All positive HIV and STI test results will be conveyed to participants by CBO site staff 
using their standard protocols, and participants will be provided with access to 
treatment.  
 
PRIDE will provide STI testing supplies to Boom!Health. CBO study staff may pick up the 
supplies from the PRIDE office, or PRIDE will deliver as-needed. STI test kit supplies include: 
• Anal swabs 
• Pee cups 
• Beakers 
• Test tubes (for urine and rectal swab samples) 
• Syphilis Health Check™ kits (each with 20 test devices, 20 pipettes, and 5 ml diluent in a 
dropper bottle) 
• OraQuick rapid tests 
 
4.5.2 Alternative means of specimen collection 
When participants move away or are otherwise unable to complete specimen collection at the 
clinic site, specimens may be collected via at-home testing or testing at central lab facilities (e.g. 
Quest Diagnostics). At-home testing kits may be mailed to a home address with instructions for 
use. YMHP research staff at PRIDE may be asked to ship kits to an alternate location deemed as 
a safe space, such as a youth center, and will require youth to speak with a trained PRIDE staff 
member to ensure these arrangements are both safe and allowable. 
4.5.3 HIV/STI Test Result Delivery 
All HIV and STI test results will be delivered following the CBOs’ existing protocols for 
delivery of HIV/STI test results. Test results for participants who utilized at-home testing kits 
will by delivered following the corresponding PRIDE protocol for delivery of HIV or STI test 
results. Participants utilizing at-home testing kits determined to be HIV-positive at a follow up 
YMHP assessment will receive the results from a member of the PRIDE clinical team who is 
trained in HIV C&T, following the PRIDE protocol for delivering HIV positive test results. If a 
HIV/ STI test results in a positive test result, then a participant’s results will be reported to State 
Health Departments in New York for surveillance purposes. Participants will be informed that 
their results will be shared with health departments in the site-specific consent form. 

 
 
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All participants who test positive for HIV will be referred for services, including referral for a 
confirmatory HIV test if needed.  Similarly, all participants testing positive for an STI will be 
offered a referral for STI treatment.  
 
4.5.4 HIV/STI Test Reporting 
Upon receiving the test results from Quest/LabCorp, generally within 3 days, the CBO Research 
Coordinators will complete the Qualtrics STI Test Results reporting form for these and the rapid 
test results already recorded for that visit in the participant’s CBO health record (HIV and 
syphilis).  
Reporting to the NYCDOHMH will occur using existing standard protocols at each CBO, or by 
existing standardized protocols at PRIDE or the participant’s testing provider for specimen 
collection done outside of the clinic setting.  
 
4.6 
Incentives and Compensation 
For taking part in this study, participants will be paid for both the treatment sessions and 
assessments as follows, up to $245 in gift cards if the participant completes the whole study: 
 
 
 
 
 
 
 
 
 
Visit 
Compensation amountok  
Baseline survey, STI and 
HIV testing, and YMHP 
Session 1 or eTAU session  
$50 in gift cards ($25 gift card for completing the computer 
based survey and $25 gift card for completing first YMHP or 
Treatment as Usual session, HIV and STI tests).  
Program Sessions 2-4 
(ONLY if randomized into 
YMHP) 
 
MetroCard ($5.50 value) and food voucher ($7 value) for each 
of the three additional YMHP sessions.  If the baseline and 
three additional YMHP sessions are complete participant will 
receive an additional $20 gift card. 
Post-test assessment (IP) 
$25 gift card (CASI-only assessment) 
3-month assessment 
$50 in gift cards ($25 gift card for completing the CASI plus $25 
gift card for completing HIV and STI testing). 
6-month assessment 
$25 gift card (CASI-only assessment) 
9-month assessment 
$50 in gift cards ($25 gift card for completing the CASI plus $25 
gift card for completing HIV and STI testing). 
12-month assessment 
$25 gift card (CASI-only assessment) 
Optional Qualitative 
Interview 
$25 gift card (phone interview-only assessment) 

 
 
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4.7 Criteria for Premature Discontinuation 
 
Dropping participants simply means we have stopped following them but they remain enrolled. 
This is for two reasons: (1) Participants should not be dropped after randomization in any trial, in 
order to remain consistent with the guidelines for intention-to-treat (ITT) analyses; and (2) These 
situations reflect the reality of implementing an intervention in a real world setting and make 
meaningful data points in an effectiveness trial. The only legitimate reason to drop an individual 
from the total number of enrolled participants is if someone is found to be ineligible at the time 
of randomization. Anyone marked as “Withdrew from Study” for IRB purposes should be 
included in the IRB continuation, Data Safety Monitoring report, and the Research Performance 
Progress Report (RPPR).  
Below are the categories of “dropping” participants along with their definitions. These categories 
should be accurately used in the site’s tracking materials if one of the conditions below occurs. 
4.8 
Measures 
 
All measures except HIV and STI Testing are administered at study assessments using a web-
based CASI survey on an iPad at each site. See below for the CASI measures and schedule of 
measures by visit.  
 
Primary Outcomes 
• Substance Use/Abuse  
o ASSIST 
o PRIDE Grid 
o Cannabis Use – Perceptions of Criminality 
• Sexual Risk Behavior  
o Main and Casual Partners 
o Harmonized Sexual Risk Behavior 
• Pre-Exposure Prophylaxis (PrEP) Uptake 
o Motivational PrEP Cascade  
o General PrEP Experiences and Acceptability  
o Decisional Balance for PrEP Use  
o PrEP Treatment Adherence  
o Perceived Risk of HIV scale (only 2 questions) 
o The Contemplation Ladder: PrEP Use  
Other Self-Reported Measures 
• Demographics/Socioeconomic Characteristics 
• Subjective Social Status 
• Condoms during Anal Sex Contemplation Ladder  
• Drug Use Contemplation Ladder 
• STI Testing  

 
 
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• HIV Testing 
• Patient Health Questionnaire for Anxiety and Depression (PHQ-8, GAD-7)  
• Visual Analog Scale for Self-Efficacy of Five Outcome Behaviors 
• Unmet Physical or Behavioral Health Care Needs 
• ATN Social Support Measure  
• Poor Family Management 
• Parenting Style Questionnaire  
• Comfort in Sexual Communication with Parents  
• The Parent-Teen Sexual Risk Communication Scale 
• Brief Perceived Ethnic Discrimination Questionnaire Community Version 
• Group Membership Questionnaire  
• Everyday Discrimination- Race and Ethnicity  
• Everyday Discrimination- Sexual Orientation  
Client Evaluation of Intervention 
• Health-Care Climate Questionnaire 
• Client Evaluation of Counseling 
• Client Satisfaction Questionnaire 
Self-Management Measures 
• Behavior Rating Inventory of Executive Functions (BRIEF-A) 
• Patient Activation Measure (PAM) 
See schedule of measures by visit on next page. 
 

 
 
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Brief CASI on iPad 
Baseline Immediate
Post-Test 
Follow-
Up 
Primary Outcomes 
Substance Use/Abuse  
ASSIST + PRIDE Grid 
√ 
√ 
√ 
Cannabis Use Perceptions of Criminality 
√ 
 
 
Sexual Risk Behavior 
Sexual Risk Behavior Main Partner 
√ 
√ 
√ 
Sexual Risk Behavior Casual Partner 
√ 
√ 
√ 
Harmonized Sexual Risk Behavior 
√ 
√ 
√ 
Pre-exposure Prophylaxis (PrEP) uptake 
Motivational PrEP Cascade  
√ 
√ 
√ 
General PrEP Experiences & Acceptability  
√ 
√ 
Decisional Balance for PrEP Use  
√ 
 
√ 
PrEP Treatment Adherence  
 
√ 
√ 
Perceived Risk of HIV scale  
√ 
√ 
√ 
The Contemplation Ladder: PrEP Use  
√ 
√ 
√ 
Other Self-
Reported 
Measures 
Demographics/Socioeconomic Characteristics 
√ 
 
 
Subjective Social Status Scale 
√ 
 
 
Condoms during Anal Sex Contemplation Ladder 
√ 
√ 
√ 
Drug Use Contemplation Ladder 
√ 
√ 
√ 
STI Testing (in past 3 months) 
√ 
√ 
√ 

 
 
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HIV Testing 
 
√ 
√ 
Patient Health Questionnaire Anxiety and Depression 
(PHQ-8,GAD-7) 
√ 
√ 
√ 
Visual Analog Scale for Self-Efficacy of Five Outcome 
Behaviors  
√ 
√ 
√ 
Unmet Physical or Behavioral Health Care Needs 
√ 
√ 
√ 
ATN Social Support Measure 
√ 
 
√ 
Poor Family Management 
√ 
 
 
Parenting Style Questionnaire  
√ 
 
 
Comfort in Sexual Communication with Parents  
√ 
 
 
The Parent-Teen Sexual Risk Communication Scale 
√ 
 
 
Brief Perceived Ethnic Discrimination Questionnaire 
Community Version 
√ 
 
 
Group Membership Questionnaire  
√ 
 
 
Everyday Discrimination- Race and Ethnicity  
√ 
 
 
Everyday Discrimination- Sexual Orientation  
√ 
 
 
Client 
Evalu
ation 
Client Evaluation of Counseling 
 
√ 
 
Client Satisfaction Questionnaire 
 
 
√ 
Healthcare Climate Questionnaire  
 
√ 
 
S
M
M 
PAM 
√ 
√ 
√ 
BRIEF-A 
√ 
 
 
 
 
 

 
 
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4.8.1 Self-Management Model Measures 
The AC will develop and apply analytic approaches to assess the Five Components of Self-
Management Model1-2 as a synergistic model within and across the Scale It Up projects, and how 
these components vary over time, are directly improved by interventions, and mediate 
intervention effects. Four components are considered predictive variables, and the AC will 
choose measures in collaboration with project leads and PRIDE PI. Sample measures, which 
were all used in the PIs’ previous trials, include the Behavior Inventory of Executive Function 
for Problem Solving and Decision Making, Services and Support measure for Resource 
Utilization, and the Measures of Processes of Care for Provider Relationship. We hypothesize 
that these will predict the fifth component, patient self-management action. 
 
 
5.0 
INTERVENTION PROCEDURES 
 
5.1 
Intervention Design and Procedures 
 
YMHP is a CDC Best Evidence Intervention [59] that utilizes MI and personalized feedback to 
reduce CAS and substance use among YMSM. The YMHP intervention will be delivered by MI-
trained Health Educators employed at each of the two CBOs. Participants will be randomized to 
receive either the intervention or an eTAU session with the Health Educator. The intervention 
condition involves completion of 4 YMHP sessions and the delivery of PrEP information and 
navigation services to interested participants. The control condition involves the completion of a 
single session eTAU that reviews the array of services offered by the CBO and also provides an 
overview of PrEP and PrEP-related services.  
 
5.1.1 Four Sessions of YMHP 
 
Session One: Engagement; Focusing & Evoking on the First Target Behavior 
In Session 1, participants will choose which behavior to discuss first (sexual risk or substance 
use), and the Health Educator will elicit the client’s view of the problem using standard MI 
techniques, building motivation for change by eliciting and reinforcing change talk and 
clarifying the youth’s own personal priorities (through a structured values card sort activity). 
Basic information on PrEP efficacy will be provided using the ask-ask-tell-ask-reflect approach. 
The Health Educator will discuss options for a behavior change plan, and, if the client is willing 
to proceed, the client will set goals. The session ends with MI strategies to evoke the client’s 
ideas about how to take steps towards change, consolidate their commitment to the plan, and 
problem-solving. 
• Opening statement – Provide information as appropriate; set the stage for collaboration; 
introduce target behaviors 
• Background and Priority Card Sort Activity – Use Open Questions and Reflections to 
understand what is truly important for each participant  

 
 
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• Ask permission to discuss the first target behavior; ask the client which one they would 
like to begin with and summarize participant’s concerns 
• Use strategies for eliciting change talk & managing discord 
• At the end of the session, offer a closing summary highlighting any change talk or steps 
towards change; evoke commitment to attend future sessions 
 
Session Two: Second Target Behavior; Continue Focusing & Evoking 
Session 2 follows the same format as Session 1, but revolves around the second target behavior. 
• Opening statement – highlight any change talk or plan from previous session; introduce 
second target behavior and collaborate on setting session agenda with client  
• Briefly revisit last session’s topic and check for any changes or recent events since you 
last met  
• Ask permission to discuss second target behavior 
• Use strategies for eliciting change talk and managing discord 
• Offer a closing summary at the end of the session, highlighting change talk and any steps 
taken towards change  
 
Session Three: Consolidating Change Plan/Considering PrEP 
In Session 3, the Health Educator will review the change plan, continue to elicit and reinforce 
change talk, problem-solve barriers, consolidate commitment, and address maintenance of 
behavior change. 
• Opening statement: Highlight and integrate change talk on both target behaviors and any 
ideas or goals the client has articulated around these behaviors; work collaboratively to 
set the agenda for the session 
• Ask the client where they would like to go from here; or, ask permission to discuss 
collaborating on a change plan together 
• Evoke client’s ideas about change; build on past success; evoke and reinforce self-
efficacy for taking steps towards change 
• If appropriate, use the Ask-ask-tell-ask-reflect approach [60] for offering information or 
suggestions about PrEP education and work together on a navigation plan if appropriate; 
if offering suggestions be sure to reinforce client autonomy and offer a menu of options 
• Collaborate with the client to build a change plan that reflects their goals, priorities and 
readiness to change; elicit the client’s ideas about how the plan could be carried out, 
when the steps will occur – and why these changes are important; and how PrEP may or 
may not fit into change plans the participant has already made for their substance use and 
sexual health  
• Offer a closing summary highlighting change talk and briefly reiterating the basic plan; 
reinforce client autonomy; remind the client that the next session will be focused on 
moving ahead independently (as it is the final YMHP session)   
 
 

 
 
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Session Four: Consolidating Commitment; Relapse Prevention/Termination 
• Opening Statement: Summarize the plan developed previously and collaborate on setting 
the session agenda; introduce termination / last YMHP session;  
• Check in on how the plan has been going since you last met; use strategies for evoking 
change talk / managing discord as appropriate; affirm client for any steps towards 
change; 
• Evoke client’s ideas about how to improve or adapt the plan; evoke and reinforce 
commitment for maintaining the plan moving forward 
• Evoke client’s ideas about what to do should problems arise in the future; develop a 
‘backup plan’ as appropriate 
• Summarize progress over the 4 sessions and address termination  
 
5.2 
Intervention Training and Supervision 
 
YMHP training will occur prior to the initiation of Phase 2, with ongoing coaching and 
supervision and training of new interventionists, as required. The interventionist training team 
consists of trainers from PRIDE’s clinical team. The training procedure includes:  
1. Initial 3-day training for Health Educators and their supervisors;  
2. A 2-3 month training period of role-play practice, coding and feedback, and supervision 
modeling, including mock sessions with “standardized clients” role-played by PRIDE 
Research Assistants;  
3. 1 hour weekly supervision sessions between the Health Educators and their supervisors;  
4. Monthly supervision calls between supervisors and trainers from the PRIDE clinical 
team, including a quarterly Skype booster training (see Booster Trainings below); and  
5. Ongoing quality assurance and feedback using MITI coding.  
All materials (e.g., slides, training exercises, supervisory tools) will be packaged for potential 
dissemination. Any copyrighted media will be removed from these materials prior to 
dissemination. 
 
5.2.1 Initial and Pre-Trial Training 
The 3-day training will be held at PRIDE and follows a curriculum developed for our previous 
NIH-funded effectiveness trials. Health Educators and supervisors participate together. Days 1 
and 2 include introductions to YMHP and MI, followed by an overview of how to deliver each of 
the 4 YMHP sessions. The full third day is dedicated to mocks, supervision, and introduction to 
the MITI. PRIDE will provide external MITI coding for the supervisor to use as feedback. 
Following the in-person 3-day training workshop, all Health Educators and supervisors will each 
mock the intervention with a “standardized client” (played by a trained PRIDE RA) and submit 
the 4 roleplayed sessions to PRIDE. Then, supervisors will complete one supervision session 
with each Health Educator, with audio recordings uploaded into the study Dropbox. After each 
audio recording is uploaded to Dropbox, the Health Educator and supervisor will notify PRIDE 

 
 
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via the study email account. All mock sessions should be saved in the Dropbox sub-folder named 
“Pre-Trial.” All audio recordings uploaded to Dropbox will be downloaded to the PRIDE 
multimedia (M:) drive. They will be tracked in an Excel spreadsheet for MITI coding 
assignment. PRIDE will delete audio files from Dropbox monthly, and notify sites in advance via 
email each time.   
The mock sessions will be MITI coded and PRIDE trainers will provide coaching and feedback. 
PRIDE trainers will use MITI thresholds for fidelity flagging. Those criteria include percent 
reflection, percent complex reflection, technical global, relational global, and MI non-adherent 
codes. For clearance, trainees should score in the “fair” range on all 5 elements by their final 
mock. If they are below in 1 or 2 domains, they will not have to redo the mock. However, by the 
4th mock they should score at least “fair” to be cleared.  
If there is staff turnover for any reason (e.g., staff leave the clinic, staff are unable to be cleared 
to see participants due to quality of delivery), then additional training will be provided to new 
staff members. 
   
5.2.2 Booster Trainings 
The PRIDE Clinical Team will lead quarterly boosters via group Skype for supervisors. Prior to 
each quarterly booster, supervisors will submit a recording of a supervision session for review. 
Boosters will cover successes and challenges, MITI scores, updated MI Skill Development plans 
for each Health Educator, and role-plays of supervision skills. Someone from the PRIDE Clinical 
Team will join supervision sessions via Skype if MITI scores fall below competency without 
remediation. PRIDE will also lead annual in-person booster trainings covering MI skills and 
specific delivery of YMHP for supervisors and Health Educators.  
 
5.2.3 Ongoing Monitoring and Supervision 
Once beginner competency is met, the supervisors will take over weekly individual supervision 
of the Health Educators. To prepare for these weekly meetings, supervisors are expected to listen 
to at least one session recording per week and review MITI coding when available. In cases of 
flagged sessions, supervisors are expected to review the MITI scores with the Health Educator 
and discuss ways to address fidelity concerns. If multiple sessions take place in the week of the 
meeting, the supervisors should work with the Health Educator to identify which session they 
would like to go over in the supervision meeting.  If no sessions take place in the week of the 
meeting, the supervisor should use the meeting time to review and practice MI skills with the 
Health Educator, and/or review past sessions that were not discussed.    
The MITI coding randomizer should flag for additional review any session where the Health 
Educator falls below “fair” on more than 2 domains. 10% of each Health Educator’s recordings 
will be randomly selected for MITI coding. These randomly coded sessions will be shared with 
the supervisors as a way to reinforce their internal barometers for “good enough” MI, rather than 
MITI only being used for comparing unsatisfactory delivery of MI. Ongoing fidelity issues may 
result in a Health Educator being required to attend additional training and/or removed from 
active session delivery until fidelity is achieved.   

 
 
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After reviewing a supervisee’s session and before supervision, supervisors will complete the MI 
Coach Rating Scale (“Rating Form”) via Qualtrics. 
Each Health Educator will submit an electronic Clinical Session Form via Qualtrics upon 
completion of each non-mock YMHP session. PRIDE will notify the sites acknowledging the 
receipt of the Clinical Session Form or send a reminder to complete the form.  
Supervisors will have monthly 30-minute supervision calls with trainers from the PRIDE 
Clinical Team to discuss ongoing implementation issues at their sites. Each monthly call will be 
audio recorded.  If circumstances prevent a supervisor from attending a call, they are expected to 
review the recording. PRIDE staff will be available to answer questions as needed  
6.0 
DATA MANAGEMENT AND ANALYSIS PLAN 
 
6.1 
Data Management and Data Quality 
PRIDE will be handling data management. Data will be entered directly by participants through 
Qualtrics. Data dictated by participants who request assistance completing surveys may also be 
entered by the Research Coordinators. The database, data structure, and data quality will be 
routinely reviewed by PRIDE. Where indicated, we will use full-information maximum 
likelihood estimation to account for missing data under Missing at Random (MAR) assumptions. 
 
6.2 
Quantitative Analysis Plan 
 
Primary Outcome Measures: 
• Days of Illicit Drug Use (past 30 days) 
• Days of Marijuana Use (past 30 days) 
• Condomless Anal Sex Acts (past 30 days) 
 
Secondary Outcome Measure:  
• Days of Alcohol Use (past 30 days) 
 
 
Phase 1  
The primary purpose of data analysis in Phase 1 is to inform the adaptation of the YMHP 
intervention for delivery by Health Educators in CBO settings, and the development of CET 
implementation protocols. Focus group dialogue will be transcribed by a team of 10-15 
undergraduate and graduate student interns at PRIDE, thematically coded by the Research 
Scientist and Principal Investigator using NVivo, and analyzed following procedures outlined by 
Miles and Huberman and Patton for thematic analysis. Our focus will be on factors that can 
enhance intervention acceptability and sustainability, both from the perspective of the peer 
counselors and participants.  
 
Phase 2 

 
 
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Qualitative analysis: Interviews will be transcribed prior to data analysis. The team will use 
NVivo to conduct thematic content analyses to identify implementation barriers and facilitators. 
Using constant comparison analytic methods, a preliminary codebook will be developed both 
deductively and inductively. Research Scientist and another member of the team will code each 
interview. Divergent coding will be discussed, decision trails will be created at key decision-
making junctures, and consensus-building strategies will resolve discrepancies. Findings will be 
used to inform revisions of the YMHP implementation package. 
 
Statistical analysis: The primary hypothesis is that participants randomized to receive YMHP 
will demonstrate significant reductions in sexual risk behavior and associated health outcomes as 
well as substance use frequency and severity when compared to those who randomized to eTAU. 
We will utilize stratified block randomization with substance use and interventionist as the strata 
in order to assign all participants to a condition.  
 
A series of bivariate analyses within SPSS (version 27) evaluated the success of randomization 
and the presence of differential attrition. With respect to randomization, χ2 tests of independence 
evaluated between-condition differences across demographic characteristics (race and ethnicity, 
sexual identity, relationship status, education, income, and age). Where cell sizes for categorical 
variables were too small (n < 5) to permit chi-square tests, we utilized a Fisher’s exact test.  The 
generalized linear model function in SPSS – which permits the specification of Poisson and 
negative binomial outcome variable distributions –  was used to evaluate between group 
differences in baseline frequency of primary (marijuana use days, other illicit drug use instances, 
and CAS with male partners) and secondary (alcohol use days) outcomes. Likewise, χ2 analyses 
were used to evaluate whether the probability of retention at each follow-up was associated with 
site, condition or categorical demographic factors; meanwhile, the generalized linear model 
component of SPSS was used to test whether retention at follow-up was associated with baseline 
primary or secondary outcome frequency.  
 
Outcome analyses were conducted using piece-wise latent growth curve (LGC) models 
following procedures outlined by Chou et al., (Chou et al., 2010) and used previously in similar 
studies (Flora, 2008; Kohli et al., 2013; Li et al., 2001; Naar-King et al., 2009; Naar et al., 2020). 
Growth trajectories over-time following the delivery of an intervention may be characterized by 
a large initial response followed by a more sustained trajectory with a less dramatic slope. Piece-
wise LGC models quantify this kind of trajectory through the use of two slopes. Slope 1 
quantifies the change from baseline to the immediate post-test (3-month follow-up). Meanwhile, 
Slope 2 quantifies the trajectory over the post-intervention follow-up period.  
 
All primary (marijuana use, other illicit drug use, and CAS with male partners) and secondary 
(alcohol use) outcomes were modeled as negative binomial distributions. All models were 
estimated using full-information maximum likelihood estimation in MPlus Version 8.0. This 
permitted the retention of all randomized cases consistent with a true intent to treat paradigm. 
Many commonly used indices of model fit are not available for growth models with count-
distributed outcomes (i.e., root-mean square error of approximation (RMSEA) ≤ 0.05, Tucker-
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evaluated using a robust log-likelihood χ2 test (Satorra & Bentler, 2001) comparing the log-
likelihood of the specified model to a null-model – in which all structural coefficients associated 
with the regression of latent growth factors on condition and site were constrained to be zero. 
 
6.2.2 Equivalency Checks  
PRIDE will ensure that randomization is stratified by substance use (including marijuana). 
Further, we will monitor randomization to ensure that condition is not associated with 
characteristics that would require adjustment in proposed analyses. 
 
6.2.3    Equivalency Tests 
A series of bivariate analyses will be conducted to examine between condition differences at 
baseline and evaluate the success of randomization procedures.  We will utilize chi square tests 
of independence, t-tests, ANOVA and Spearman’s rho correlations as appropriate to examine 
whether intervention conditions differed significantly with respect to key demographic variables 
and outcome variables at baseline.  In the event that significant baseline differences are observed, 
these demographic factors will be incorporated into subsequent outcome analyses. 
 
6.2.4    Power Analysis 
We will enroll a total of 260 substance-using MYMSM (130 per condition) engaged in HIV risk 
behavior; this will be 1.8 times more participants than in the original efficacy trial, providing 
adequate power to detect differences in this real-world setting. We conducted a series of 
simulations using SAS 9.2 PROC GLIMMIX to examine power to detect intervention effects on 
primary outcomes. In each simulation, 500 draws were requested and effects averaged across 
samples assuming 260 enrolled participants with retention of 85% at 12-month follow-up (n = 
221). All models included a random effect for counselor assuming approximately 12 peer 
counselors across sites by the end of the study. Consistent with existing CDC and NYCDOH 
data on 12month STI incidence among MYMSM,141 we allowed the proportion of positive 
diagnoses in the eTAU/YMHP groups to vary between 0.15/0.04 and 0.20/0.07, respectively, and 
found 81.0% average power (i.e., 1 – β) to detect statistically significant differences at α = 0.05 
(i.e., 95% confidence). Utilizing the effect sizes found within the original YMHP efficacy trial 
(that utilized an intensive attention-control group), we set the proportion of individuals in the 
eTAU group who engaged in CAS at follow-up to 0.50 and to 0.30 in the YMHP group and 
found 85.4% power to detect significant differences at α = 0.05, suggesting effects of this 
magnitude or larger will be sufficiently powered. Finally, examining substance use, assuming 
that the proportion of individuals in the eTAU group who persist in substance use over time is 
.80, we will have power to detect proportions of .62 or smaller in the YMHP group as 
statistically significant with power of 83.0% or greater at α = 0.05. 
 
6.3 
Cost-Effectiveness Analysis Plan 
 

 
 
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In order to enhance the likelihood of uptake if effective, the AC will conduct analyses to assess 
the cost-effectiveness of two delivery models of YMHP in reducing sexual risk and substance 
use utilizing CDC’s guidelines for cost effectiveness analysis on HIV infections averted.  
 
Interventions such as YMHP are intended to prevent infection in HIV-negative YMSM. 
Therefore, YMHP can be evaluated to determine the number of infections prevented that would 
have otherwise occurred had it not been provided at our sites. We will model our analyses based 
on the framework for a cost-utility analysis of addiction treatment, with emphasis on the 
Holtgrave and Kelly model  [61-65] because they also examined a behavioral health intervention 
to prevent HIV infection [66]. 
 
Our economic analysis will have two components: 1) a cost analysis of the YMHP intervention; 
and 2) an incremental cost effectiveness analysis that compares the value of clinic-delivery of 
YMHP over remote delivery. 
 
6.3.1 YMHP Program Cost Analysis 
In order to enhance the likelihood of uptake if effective, we will conduct analyses to assess the 
cost-effectiveness of YMHP in reducing substance use and sexual risk behaviors compared to 
eTAU utilizing CDC’s guidelines for cost effectiveness analysis on HIV infections averted [67]. 
Our economic analysis will have two components: 1) a cost analysis of the YMHP intervention; 
and 2) an incremental cost effectiveness analysis that compares the value of YMHP to eTAU.  
 
We will use a modification of The Drug Abuse Treatment Cost Analysis Program (DATCAP) 
[63, 68] plus study contact and expenditure records, to estimate the cost of the YMHP and eTAU 
conditions. Using both conditions will increase the stability of the measurements. The DATCAP 
is a standardized data collection instrument that estimates the economic cost of addiction 
treatment programs. Administration of the DATCAP is generally a collaborative effort involving 
an economist (Dr. Simpson) and various members of the intervention staff (Health Educators, 
administrators, accounting/finance personnel, etc.). The DATCAP organizes program resources 
into personnel, buildings and facilities, supplies and materials, and miscellaneous resources. 
Client case flow data are incorporated to determine the average annual cost per client for each 
service type. Other useful computations include weekly cost per client, average cost per 
intervention episode (based on length of stay in the program), and marginal cost per contact [69-
71][76-78][71-73][71-73][71-73][70-72][69-71]. 
 
We will first estimate the marginal costs of delivering YMHP as compared to eTAU. Using data 
from the modified DATCAP and study contact and expenditure records, key statistics from the 
cost evaluation will include total annual economic cost for the program, weekly economic cost 
per client, and total economic cost per intervention [episode/session]. To highlight the relative 
contribution of the various cost components and necessary future budgeting, we will also 
perform a descriptive analysis of the cost accounted for by resource category.  
 
The mean aggregate cost of the interventions will be used as inputs in the cost effectiveness 
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using the results from the clinical trial combined with published HIV infection risk rates for the 
specific risk behaviors. These data will be combined in a mathematical model structured as a 
decision tree with a long-term follow-up component using a Markov model structure. This 
combined structure will best capture the complexity of the clinical trial data and well as the 
uncertainty embedded in the HIV risk prediction equations, and minimize the number of 
assumptions required for the cost effectiveness estimate.    
 
Cost-effectiveness will be modeled for YMHP as compared to eTAU and for the differences in 
CAS and predicted through Markov modeling for 5 and 10 years and over a lifetime using 
varying assumptions about decay of the effect of the intervention over time. Modeling will be 
performed from the perspectives of 1) a third party payer, 2) the medical care system, and 3) 
society. 
 
Model Structure. We will use an HIV mathematical model with clinical findings from the 
study, YMHP cost data, clinical and epidemiological data from published studies, and cost data 
from archival databases. The model uses a combined decision tree and Markov approach to 
estimate treatment effects of CAS on HIV infection rates. Crystal Ball Monte Carlo estimation 
software will be used to simulate outcomes for a patient cohort under varying assumptions about 
the distribution of the data for the model parameters.  
 
Model Parameters: Critical data in the model will come from the clinical parameters (substance 
use and CAS) and the study intervention cost data. Incidence of HIV infection projections after 
the end of the study will be based on analysis of epidemiologic data from large patient cohorts or 
on reported values in the literature. Quality of life weights are based on literature reports and 
archival data. Direct intervention costs for YMHP and eTAU will be estimated as described 
above. Cost of medical care will be based on Medicaid data; other costs will be based on the 
literature or archival data. The effects of different costing perspectives will be assessed. Both 
cost and years of life will be discounted by 3% when cost effectiveness is examined.  
 
Model Outputs: The model will estimate 5-year and 10-year flow of fund differences to 
example individuals, Medicaid, private insurers, and other payers under specific assumptions, as 
well as overall cost effectiveness and cost utility estimates. Differences in expected population 
survival, quality of life, and costs attributable to YMHP will also be reported. We will perform 
sensitivity analysis using a Monte Carlo simulation. 
 
Limitations: We will minimize the effects of data variation by using several data sources, boot-
strapping, and sensitivity analysis with a Monte Carlo approach to examine the effect of 
variations in parameters and differences in distributional assumptions in our model. 
 
6.3.2 
Data Collection for YMHP Cost Analysis 
Data will be collected for two distinct purposes: 
1. To collect treatment site cost data for a cost analysis to capture the cost of the 
intervention used in the study. 

 
 
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2. To collect subject resource use data to be used to estimate the cost differences of events 
between treatment groups.  
 
In addition, records will be made to obtain cost data for the following: 
A. Cost of Adaptation of YMHP for clinic delivery months 1 to 3 
1. Cost to conduct focus groups with staff  
a. Number of attendees 
b. Time 
c. Venue 
d. other 
2. Adapting YMHP for clinic delivery  
 
B. Cost of training a minimum of 2 Health Educators at each clinic at time of training 
1. Development of training materials 
2. Training time 
3. Numbers trained 
a. Initial 3-day training for Health Educators and local supervisors;  
b. A 2-3 month training period of role-play practice, coding and feedback, and 
supervision modeling, including mock sessions with “standardized clients” role 
played by PRIDE Research Assistants;  
c. 1 hour weekly supervision sessions between local supervisors and Health 
Educators;  
d. Monthly supervision calls between local supervisors and the investigator team, 
including a yearly Skype booster training; and  
e. Ongoing quality assurance and feedback using MITI coding.  
 
Treatment site cost data collection: Cost of delivery at 6 months after initiation of YMHP 
Treatment site cost data collection will be based on the approach described by Kim et al. (2015) 
for the economic evaluation of the Positive Charge multisite program aimed at linking HIV-
infected youth to care [72]. Data collection will be completed for this component by having each 
CBO site’s financial management contact fill out a standard Excel spreadsheet, which contains 
resource use categories relevant to calculation the cost of the intervention. Not all categories will 
be relevant to each site or to each intervention. To minimize the burden of data collection on the 
sites, we will contact a designated site Financial Management Contact (FMC). The FMC and Dr. 
Simpson will discuss the content of the spreadsheet and agree which data elements in the 
spreadsheet are relevant to the site. .  
 
However, these will be tailored to each site’s financial information system and collected using an 
Excel standardized spread sheet:  All information provided in the spreadsheet will be treated as 
confidential, with any site-identifying information removed and replaced with a site code as soon 
as the spreadsheet is returned to Dr. Simpson. Examples of data elements that might be collected 
from a site are provided below. 
 
Clinic Cost Structure 
Year of Report:  
  

 
 
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Staff/Personnel 
Hourly Wage 
Fringe Rate 
Case managers 
  
Counselors 
  
Nurses 
  
Peer-opinion leaders working as staff 
  
Outreach workers 
  
Providers who conduct training 
  
Staff support/clerical 
  
Other project supervision 
  
Other staff 
  
  
  
Materials and Other Consumables 
Unit 
 Cost per Unit  
Staff/personnel (not client) travel costs 
  
Travel tokens (not already entered above) 
  
Equipment devoted intervention services 
  
Other equipment 
  
Brochures/handouts/other printed materials 
  
Incentives 
  
Risk reduction supplies 
  
Printing 
  
Computer supplies 
  
Office supplies 
  
General supplies 
  
Postage and handling 
  
Rent 
  
Phone 
  
Other materials and consumables 
  
  
Rate 
Standard overhead rate not included in above services 
 
Site charge code list with 2017 charges by CPT or billing codes 
  
 
Study Subject Resource Use Data: Healthcare resources used by study subjects will be tracked 
via REDcap. The data collection units will be the number and types of contacts used for the 
interventions such as in-person sessions, telephone contacts or text messages sent. Costs or 
payments to participants should not be collected. The resources will be recorded and aggregated 
at the level of the individual subject. These resource counts will be converted to cost by using a 
set of standard cost weights developed from pooled data from both study sites and/or mean 
payment data estimated from archival data sets containing Medicaid payment for similar 
services. The following resource use data will be collected for each subject: 
 
A. Visits (YMHP or eTAU) with CPT code (or visit clinic charge code if CPT codes are not 
available).  
B. Telephone contacts 
C. Actively produced text messages (not automatic messages) 

 
 
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D. Other type(s) of resources that are either very frequent or rare but very time consuming 
that are specific to each intervention may also be recorded. Any such resources will be 
specified by the PI. 
E. Transportation demands: To assess how financial barriers related to transportation may 
differ by site, we will compare the public transportation cost to the Uber cost by site. We 
will capture the costs by identifying the distance between the participant's home address 
(or school address depending) and the clinic site and then applying an Uber rate to 
estimate the costs of getting to and from the clinic. The cost-effectiveness analysis of the 
YMHP program would utilize the Uber values for the sites with poor public 
transportation and the public transport cost for the site that use this approach. 
 
7.0 SAFETY MONITORING PLAN 
 
7.1      Data and Safety Monitoring Board 
 
The study will be conducted under the supervision of an independent DSMB.  All DSMB 
members have extensive experience in either clinical trials and/or management of HIV or HIV 
prevention experience. The study team will draft a Data Safety Monitoring Plan (DSMP) and 
update it as-needed. The DSMB will be responsible for ongoing review of the research study and 
for making recommendations concerning the continuation, modification, and termination of the 
study. 
 
7.2      Adverse Events Reporting 
 
Adverse events in this study are not anticipated as this is a comparative effectiveness trial. The 
Site PI is responsible for the detection and documentation of events meeting the criteria and 
definition of an AE or SAE. Data for monitoring participants’ safety will be captured within the 
REDCap database as part of the required study data. Site study staff may ask questions 
concerning adverse events via email, but must formally report them via REDCap. Information on 
unexpected events including serious adverse effects (SAEs) will be reported as per the policy of 
the IRB. 
 
Information to be collected includes the nature, date of onset, stop date, intensity, duration, 
treatment, causality, and outcome of the event. Site PIs should follow usual clinical practices at 
their institutions for reporting serious, unexpected events related to standard of care. SAEs that 
occur after 30 days after completion of the study will be collected only if they are considered by 
the PI to be related to study participation. In addition, any AE resulting in potential participant 
withdrawal must been reported to PRIDE prior to participant withdrawal when possible. 
 

 
 
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Site PIs must report any Adverse Event within one business day of learning of it. PRIDE will 
then report all SAEs to the IRB within 3 business days and all AEs within 5 business days, upon 
learning of them from site study staff. 
 
7.3  
NIH Reporting 
 
The PRIDE team will complete the annual Research Performance Progress Report (RPPR). The 
PI will submit it electronically to the NIH according to NIH policies and procedures.   
 
8.0 
ETHICAL CONSIDERATIONS 
 
8.1 
Regulatory and Ethical Compliance 
 
Study Procedure Guidelines are designed and shall be implemented in accordance with the HHS 
45 CFR Part 46. 
8.2 
Informed Consent Process 
 
Site PIs must ensure that participants are fully informed about the purpose, responsibilities of 
participating and potential risks or other critical issues related to participation in YMPH. Written 
informed consent or assent must be obtained from every participant or, in those situations where 
consent cannot be given by participants, their legally acceptable representative, prior to clinical 
study participation.  
 
A waiver of parental permission has been obtained for minors choosing to participate with 
parental permission.   
 
The rights, safety, and well-being of study participants are the most important considerations and 
should prevail over interests of science and society. If there is any question that the prospective 
participant will not reliably comply with study procedures and/or follow-up, they should not be 
enrolled in YMHP. 
8.3 
Responsibilities of the Site PI 
 
Study materials will be reviewed and approved by a single Institutional Research Board (sIRB), 
as needed. A signed and dated statement that these materials were approved by the sIRB will be 
sent to each participating CBO site before site initiation occurs. Prior to study start, a Reliance 
Agreement was received from each site confirming their agreement to conduct the study in 
accordance with the sIRB approval.  Site PIs are to give access to all relevant data and records to 
monitors, auditors, quality assurance representatives, sIRB and regulatory authorities as required. 
Site PIs also agree to apply due diligence to avoid protocol deviations. 

 
 
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8.4 
Early Termination of the Study 
 
The Principal Investigator retain the right to terminate the study, a study site or a Site PI at any 
time. The PI will monitor the progress of the study. If warranted, the study may be suspended or 
discontinued early if there is an observation of safety concerns posing an unreasonable risk to the 
study population. If the study is terminated early, the PI will provide a written statement to the 
IRB and the Site PI to enable notification to study participants. The PI may terminate enrollment 
activity at a site, or participation in the study by the Site PI and/or site if there is evidence of a 
Site PI’s failure to maintain adequate standards or failure to comply with the protocol. 
Notification of enrollment suspension or termination of the study or study site/Site PI will be sent 
to the Site PI and the IRB. 
9.0 
STUDY ORGANIZATION 
 
YMHP is sponsored by the NIH. The PI maintains responsibility for the overall conduct of the 
study.  Each CBO site will be responsible for site management, site monitoring, and recruitment, 
enrollment, and retention. The data team at PRIDE will be responsible for Data Management and 
data analysis, while the PD and PI will be responsible for reporting and research dissemination. 
10.0 
DATA ACCESS AND SHARING 
 
The Leadership Team will authorize access to study data. Site PIs and members of auxiliary 
committees must submit a proposal requesting approval to access study data. 
11.0 
PUBLICATIONS POLICY: OVERVIEW 
 
Primary and secondary reports of study findings will be published in peer-reviewed journals. 
Proposals for presentations and publications incorporating data obtained from participants 
involved in YMHP must be submitted for review by the PI. The primary publication will be 
authored by the trial’s writing committee. No site is permitted to present or publish data 
obtained during the conduct of this trial without prior approval from the PI.  
 
 

 
 
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12.0 
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