Clinical trial NCT02183909
Conditions: HIV Sexually Transmitted Infections
Sponsor: University of California, San Francisco
Start date: 2013-05-01; Completion date: 2017-08-01
Enrollment: 378 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall goal of the CRUSH project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, targeting individuals and communities most vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key community-based organizations, are engaging in a participatory partnership to enhance and implement HIV services which target the East Bay's highest risk population- young men who have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a combination of program approaches to address the sexual health care needs of young gay men of color and their sexual partners by enhancing the current program activities of the Downtown Youth Clinic (DYC).

We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC services structure in two ways. We intend to expand HIV testing, and linkage to and retention in care for youth who test HIV positive, providing them with intensive risk-reduction counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further HIV transmission. And we intend for the first time to offer a comprehensive combination package of preventive services to HIV-negative youth, including routine accesses to HIV/STI screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).

The CRUSH Project will also have a substudy that will enroll HIV-negative participants who are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1 in Y/MSM of color.

Detailed description:
The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in the East Bay region. CRUSH has two major components:

1. Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at increasing the proportion of HIV positive Y/MSM who are in care, virologically suppressed, and receiving intensive risk reduction counseling.
2. Providing comprehensive sexual health services to high risk HIV-negatives, including but not limited to the provision of PrEP and PEP when clinically appropriate.

In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug, once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in treatment-naïve HIV-infected adults with estimated glomerular filtration rate ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a 3-drug regimen that has been approved for the treatment of HIV-1 infection

Arms: arm 1: None
Interventions: intervention 1: Testing and linkage to care for Y/MSM intervention 2: Engagement and retention for HIV-positive Y/MSM in care intervention 3: Engagement and retention for HIV-negative Y/MSM in sexual health services intervention 4: Stribild PEP Substudy
Intervention descriptions: intervention 1: Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies. intervention 2: Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff. intervention 3: Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming. intervention 4: A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).

Protocol documents:
Prot_000.pdf: 
S e pt e m b er 2 0 1 3  
U p d at e d D e c e m b er 1 7,  2 0 1 3 
 
C o n necti n g Res o urces f or Ur b a n Se x u al He alt h ( C R U S H)  
N C T 0 2 1 8 3 9 0 9 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 of 5 3  
C R U S H: C o n necti n g Res o urces f or Ur ba n Se x ual Healt h 
 
A De m o nstrati o n Pr oject  
F or  
E x pa n di n g Access t o  
 Se x ual Healt h Ser vices f or Y o u n g Me n w h o ha ve Se x wit h Me n ( Y/ M S M)  
I ncl u di n g pr o visi o n of 
HI V Pre -e x p os ure Pr o p h yla xis  
wit h Tr u va da ®  
 
C R U S H Pr ot oc ol  
 
Ver si o n 1 . 0 
 
A c oll a b or ati o n of  
East Ba y AI D S Ce nter,  
U C S F - Ce nter f or AI D S Pre ve nti o n St u dies,   
Gla dst o ne I nstit utes  
 
S p o ns ore d by 
Calif or nia HI V Researc h Pr o gra m 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 of 5 3  
  
I. I ntr o d ucti o n    
T he East Ba y AI D S Ce nter ( E B A C) i n Oa kla n d, Calif or nia has bee n pr o vi di n g c o m pre he nsi ve 
pri mar y care i ncl u di n g case ma na ge me nt, i n patie nt cli nical care, a n d p har mac y ser vices t o patie nts li vi n g 
wit h HI V f or o ver 2 5 years.  T he D o w nt o w n Y o ut h Cli nic ( D Y C), a di visi o n of E B A C, has de vel o pe d 
i n n o vati ve a p pr oac hes t o t he care of y o un g pe o ple wit h HI V, i ncl u di n g o pe n access, str uct ure d tra nsiti o n 
fr o m pe diatric setti n gs, a n d e xte nsi ve peer i n v ol ve me nt i n care. T he cli nicia ns a n d staff of E B A C/ D Y C 
ha ve c o nsi dera ble e x pertise i n t he ma na ge me nt of a ntiretr o viral me dicati o ns a n d t he cli nical care of 
p o p ulati o ns i nfecte d wit h  HI V, i ncl u di n g y o u n g me n w h o ha ve se x wit h me n ( M S M) of c ol or, a n d ha ve a 
str o n g i nterest i n a p pl yi n g t h ose s kills t o t he pre ve nti o n of HI V i nfecti o n.  Wit h t he assista nce of 
researc hers fr o m t he U C S F Ce nter f or AI D S Pre ve nti o n St u dies a n d t he Gla dst o ne I nstit ute of Vir ol o g y 
a n d I m m u n ol o g y, we pr o p ose t o br oa de n t he sc o pe of E B A C/ D Y C’s ser vices t o i ncl u de c o m pre he nsi ve 
HI V pre ve nti o n a n d se x ual healt h ser vices f or HI V -ne gati ve partici pa nts, i ncl u di n g t he pr o visi o n of pr e-
e x p os ure pr o p h yla xis ( Pr E P).   
T he o verall pr oject, C R U S H ( C o n necti n g Res o urces f or Ur ba n Se x ual Healt h), i ncl u des e n ha nce d 
treat me nt a n d li n ka ge t o care ( T L C +) f or HI V ser o p ositi ves, a n d c o m pre he nsi ve se x ual healt h ser vices f or 
b ot h HI V -p ositi ves a n d y o u n g a d ults w h o are HI V -ne gati ve b ut at hi g h ris k of HI V ac q uisiti o n.  O ne 
c o m p o ne nt of C R U S H will be t o offer Pr E P t o eli gi ble  hi g h ris k HI V - ne gati ves. T his ne w a n d e x pa n de d 
pr ot oc ol a p plicati o n a d dresses t he e x pa n de d researc h a n d pr o gra m e val uati o n acti vi ties w hic h will 
c o nstit ute t he C R U S H Pr oject, i ncl u di n g t he i m ple me ntati o n of pre -e x p os ure pr o p h ylactics ( Pr E P) f or 
eli gi ble HI V ne gati ve i n di vi d uals.  
Pr E P wit h Tr u va da ®  ( F T C/ T D F) has bee n de m o nstrate d i n cli nical trials t o re d uce rates of ne w 
HI V i nfecti o ns, 1 – 3 a n d has rece ntl y bee n a p pr o ve d b y t he F D A f or use i n M S M a n d ot her hi g h -ris k 
p o p ulati o ns. 4  T he C D C has iss ue d i nteri m g ui da nce o n t he use of Pr E P, e m p hasiz i n g t he i m p orta nce of 
parallel i nter ve nti o ns t o re d uce ris k f or ot her se x uall y tra ns mitte d i nfecti o ns ( S TIs), fre q ue nt HI V testi n g, 
a n d a d here nce s u p p ort t o ma xi mize t he be nefits a n d mi ni mize t he ris ks of Pr E P. 5, 6 A d diti o nal c o ncer ns 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 of 5 3  
re gar di n g i m ple me ntati o n i ncl u de t he li mite d k n o w n de ma n d f or Pr E P, partic ularl y a m o n g t he p o p ulati o n 
of y o u n g M S M of c ol or c urre ntl y at hi g hest ris k i n t he U nite d States; lac k of o verall cli nical ca pacit y; a n d 
p ote ntial c halle n ges of fitti n g t he i nter ve nti o n i nt o c urre nt cli nical m o dels. 7 
II. St u d y G o al a n d Ai ms  
T he o verall g oal of t he C R U S H pr oject is t o  e n ha nce a n d e xte n d a res p o nse t o t he l ocal HI V/ AI D S 
e pi de mic i n Ala me da C o u nt y wit h a set of i n n o vati ve, e vi de nce -base d i nter ve nti o ns acr oss t he c o nti n u u m 
of HI V pre ve nti o n a n d care, tar geti n g i n di vi d uals a n d c o m m u nities m ost v ul nera ble t o  HI V. T he East B a y 
AI D S Ce nter, i n part ners hi p wit h t he U ni versit y of Calif or nia Sa n Fra ncisc o’s Ce nter f or AI D S 
Pre ve nti o n St u dies, t he Gla dst o ne I nstit utes, a n d se veral ke y c o m m u nit y -base d or ga nizati o ns, are 
e n ga gi n g i n a partici pat or y part ners hi p t o e n ha nce a n d i m ple me nt HI V ser vices w hic h tar get t he East 
Ba y’s hi g hest ris k p o p ulati o n - y o u n g me n w h o ha ve se x wit h me n ( Y/ M S M) . S pecificall y, t he C R U S H 
Pr oject is desi g ne d t o e val uate a c o m bi nati o n of pr o gra m a p pr oac hes t o a d dress t he se x ual healt h care 
nee ds of y o u n g ga y me n of c ol or a n d t heir se x ual part ners b y e n ha nci n g t he c urre nt pr o gra m acti vities of 
t he D o w nt o w n Y o ut h Cli nic.  B y e n ha nci n g t his e xisti n g  m o del pr o gra m f or HI V -i nfected y o ut h, a n d 
a da pti n g/tail ori n g a n u m ber of i nter ve nti o n ele me nts t o a d dress t he pre ve nti o n nee ds of HI V ne gati ve 
y o ut h, we will e n ha nce li n ka ge t o a n d rete nti o n i n c o m pre he nsi ve care f or HI V p ositi ve y o ut h, a n d 
mea n w hile re d uce t he li keli h o o d of HI V ac q uisiti o n i n t h ose w h o are ne gati ve.  Fi g ure 1  prese nts a 
sc he matic of t he o verall pr oject pla n, i ncl u di n g t hree o verarc hi n g de m o nstrati o n ai ms.  
T he  pri mar y ai ms  of t his de m o nstrati o n pr oject  a n d ass ociate d i nter ve nti o ns are as f oll o w s:   
Ai m  1:  Test a n d li n k y o u n g M S M of c ol or t o se x ual healt h ser vices :  We will e x pa n d o ur c urre ntl y 
s uccessf ul HI V testi n g strate g y— c oll a b or ati o n s a n d syste ms of referr al of ne w c ases of HI V  fr o m 
existi n g p art ners — s o t hat referrals are als o recei ve d f or hi g h ris k ne gati ves t o recei ve se x ual healt h 
ser vices. We will als o i m ple me nt t w o ne w strate gies:  a n e n ha nceme nt we ha ve use d s uccessf ull y i n pri or 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 5 of 5 3  
pr ojects — s oci al net w or k testi n g; a n d a n i n n o vati ve strate g y deri ve d fr o m e vi de nce fr o m o ur pil ot 
st u d y— a y o ut h o utre ac h c or ps w or ki n g wit h e xisti n g a n d ne w  c o m m u nity p art ner  a ge ncies .  
Ai m 2:  E n ha nce a n d e val uate e n ga ge me nt a n d rete nti o n strate gies f or y o u n g M S M of c ol or i nfecte d wit h 
HI V :  We will pla n t o o pti mize t he c urre nt HI V care a n d treat me nt ser vices at D Y C b y a d di n g t hree ne w 
c o m p o ne nts: a p atie nt peer me nt ori n g c o m p o ne nt ; a li n k a ge a n d rete nti o n s peci alist ; a n d  psyc h os oci al 
s u p p ort f or pr o gr a m st aff.  
Ai m 3: E n ga ge a n d retai n HI V -u ni nfecte d y o u n g M S M of c ol or i n se x ual healt h ser vices, i ncl u di n g Pr E P:   
Fi nall y, at t he heart of t he C R U S H pr oject is o ur pla n t o b uil d a hi g hl y i n n o vati ve a n d m uc h nee de d 
m o del  of se x ual healt hcare t hat i nte grates se x ual healt h ser vices f or HI V -u ni nfecte d y o u n g M S M of c ol or 
i nt o a n HI V care 
setti n g.  T hese 
ser vices will re plicate 
t he de vel o p me ntall y 
a p pr o priate, 
c ult urall y se nsiti ve 
as pects of t he D Y C 
m o del t o offer a 
hi g hl y effecti ve 
c o m bi nati o n HI V 
pre ve nti o n strate g y, 
i ncl u di n g Pr E P, a n d 
als o:  w ar m -h a n d 
offs f or hi g h ris k 
D o w nt o w n Y o ut h Cli nic ( D Y C) *
P art n ers hi ps wit h existi n g 
y o ut h -s er vi n g cli nics
• C o nti n ui n g r ef errals f or 
n e w HI V -p ositi v es
• N e w r ef err als f or HI V -
n e g ati v es
C R U S H
•I nt a k e
•Tri a g e
S ex u al H e alt h S er vic es f or HI V N e g ati v es: 
• W ar m h a n d off t o pr e v e nti o n c as e m a n a g er
• Pr E P
• n P E P
• Pr e v e nti o n c o u ns eli n g
• R e p e at t esti n g ( HI V, S TI) e v er y 3 -6 m o nt hs
• Yo ut h f oc us e d a n d y o ut h r u n w or ks h o ps *
D Y C + E n h a nc e m e nts
• Assist e d discl os ur e a n d w ar m h a n d off
• Existi n g s ervic es *
• P e er m e nt ori n g
• Li n k a g e/ R et e nti o n s p eci alist
• St aff s u p p ort  
HI V N e g ati v e
HI V P ositi v e
s er oc o nv ersi o n
Ai m 1: Testi n g a n d Li n k a g e
C o n n ecti n g R es o urc es f or Ur b a n S ex u al H e alt h ( C R U S H)
Ai m 3: S ex u al H e alt h 
S er vic es f or Hi g h -Ris k 
HI V N e g ati v e Y o ut h 
Ai m 2: E n h a nc e d HI V 
Pri m ar y C ar e f or Y o ut h
• Existi n g m o d el/s ervic es
• S oci al n et w or k HI V 
t esti n g a n d li n k a g e
* S e e Existi n g S er vic es S ecti o n
C o m m u nit y e n g a g e m e nt 
wit h n e w p art n ers
• Yo ut h c or ps, e m b e d d e d 
o utr e ac h a n d t esti n g 
c o or di n at ors
• I nt er n et o utr e ac h


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 6 of 5 3  
ne g atives ; n o n -occ u p ati o n al p ost -e x p os ure pr o p hyl a xis  ( n P E P) w he n i n dic ate d; ris k re d ucti o n 
c o u nseli n g ; fre q ue nt HI V a n d S TI testi n g, i ncl u di n g testi n g a hig hly se nsitive met h o d of detecti n g 
e arly HI V i nfecti o n;  a n d y o ut h -f oc use d pr o gr a m mi n g.  
 
 
III. St u d y P o p ul ati o n  
We pr o p ose t o tar get y o u n g M S M of c ol or i n t he East Ba y f or a c o m pre he nsi ve i nter ve nti o n, w hic h 
b uil ds o n o ur e x perie nce a n d i ncl u des c ult urall y -c o m pete nt HI V testi n g, se x ual healt h ser vices i ncl u di n g 
pre -e x p os ure pr o p h yla xis ( Pr E P), a n d a n i nte grate d li n ka ge a n d rete nti o n pr o gra m i nt o se x ual healt h 
ser vices f or b ot h hi g h-ris k HI V-ne gati ve me n a n d HI V -p ositi ve me n.  M ore s pecificall y we will f oc us o n 
Afric a n A meric a n, C hic a n o/ L ati n o, a n d Asi a n/ P acific Isl a n der M S M  u n der 3 0 i n t he m ost hi g hl y 
affecte d cities of wester n C o ntra C osta C o u nt y a n d n ort her n Ala me da C o u nt y i ncl u di n g Oa kla n d, Sa n 
Pa bl o, Ber kele y, Ric h m o n d, a n d Sa n Lea n dr o.   
 III. 1 Eli gi bility of HI V P ositi ve I n di vi d u als  
•  
HI V p ositi ve i n di vi d uals bet wee n t he a ges of 1 8 -2 9.  
Ser o p ositi ves o utsi de t he tar get C R U S H a ge ra n ge will be referre d f or cli nical care as a p pr o priate at 
D Y C, E B A C, or else w here.  
 
III. 2 Eli gi bilit y of HI V Ne g ati ve I n di vi d u als  
A m o n g t h ose w h o are HI V ne gati ve, we s pecificall y ai m t o recr uit t he f oll o wi n g m ost hi g hl y i m pacte d 
c o m m u nities i n t he East Ba y:  
•  
M e n bet wee n t he a ges of 1 8 -2 9  w h o are e ver se x uall y acti ve wit h me n;  
•  
Tra ns ge n der fe males ( M 2 F) bet wee n t he a ges of 1 8 -2 9 w h o are se x uall y acti ve wit h me n; 
Tra ns ge n der males ( F 2 M) bet wee n t he a ges of 1 8 -2 9  wh o are se x uall y acti ve wit h me n; a n d  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 7 of 5 3  
•  
A n y HI V ne gati ve pers o n a ge d 1 8-2 9 , male or fe male, w h o has at least o ne k n o w n HI V 
p ositi ve (i.e. ser odisc or da nt)  se x ual part ner; 
. 
All HI V p ositi ves a n d ne gati ves w h o meet t he eli gi bilit y a b o ve a n d prese nt at t he cli nic will be 
offere d a v ol u ntar y o p p ort u nit y t o c o nse nt f or partici pati o n. Partici pa nts m ust meet eli gi bilit y 
criteria a n d m ust be w illi n g a n d a ble t o pr o vi de i nf or me d c o nse nt, u tilizi n g E n glis h or S pa nis h la n g ua ge. 
 
I V S pecific Rese arc h Acti vities   
We h y p ot hesize t hat we ca n re d uce t he i m pact of HI V a m o n g y o u n g M S M b y e x pa n di n g t he 
c urre nt D Y C  ser vices str uct ure i n t w o wa ys.  We i nte n d t o e x pa n d HI V testi n g, a n d li n ka ge t o a n d 
rete nti o n i n care f or y o ut h w h o test HI V +, pr o vi di n g t he m wit h i nte nsi ve ris k re d ucti o n c o u nseli n g a n d 
a ntiretr o viral treat me nt, a n d t here b y ulti matel y re d uci n g t he ris k of f urt her HI V tra ns missi o n.  A n d we 
i nte n d f or t he first ti me t o offer a c o m pre he nsi ve c o m bi nati o n pac ka ge of pre ve nti ve ser vices t o HI V 
ne gati ve y o ut h , i ncl u di n g r o uti ne accesses t o HI V/ S TI scree ni n g a n d treat me nt, a n d access t o HI V pre -
e x p os ure pr o p h yla xis  (Pr E P ). 
I n or der t o de m o nstrate a n d e val uate t he efficac y of t he C R U S H pr oject, we ha ve i de ntifie d 
s pecific pr o gra m ele me nts a n d researc h acti vities w hic h will be f urt her e x plai ne d as part of t his pr ot oc ol:  
•  
A u di o -c o m p uter-assiste d self-a d mi nistere d i nter vie wi n g ( A C A SI)  
•  
Peer -t o-Peer Me nt ori n g  
•  
S ocial Net w or ki n g HI V Testi n g  
•  
Q ualitati ve I nte r vie w Met h o ds: ke y i nf or ma nt a n d f oc us gr o u ps  
•  
Cli nical s u per visi o n a n d e val uati o n f or staff a n d c o m m u nit y part ners  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 8 of 5 3  
All HI V p ositi ve a n d ne gati ve partici pa nts eli gi ble t o partici pate i n C R U S H will be as ke d t o 
v ol u ntaril y c o nse nt t o partici pate i n t he a b o ve  acti vities, wit h t he e xce pti o n of ‘ Cli nical 
s u per visi o n a n d e val uati o n f or staff a n d c o m m u nit y part ners’, w hic h is a n i nter ve nti o n ai me d at 
C R U S H staff a n d c o m m u nit y part ner pers o n nel w h o  w or k directl y wit h t he C R U S H st u d y, a n d  
‘ Peer t o peer me nt ori n g, w hic h will be partic ularl y f oc use d o n HI V p ositi ve partici pa nts. 
I n a d diti o n t o t he a b o ve researc h ele me nts, t his pr ot oc ol o utli nes t he cli nical pr oce d ures of: 
• N ucleic aci d testi n g ( N A T) t o detect earl y i nfecti o n wit h HI V, H C V, or  H B V  
• n P E P, f or HI V ne gati ve i n di vi d uals w h o ha ve ha d a rece nt hi g h ris k e x p os ure;  
• Pr E P i m ple me ntati o n, f or eli gi ble HI V ne gati ves; a n d f or t h ose recei vi n g Pr E P:  
• Testi n g drie d bl o o d s p ots f or dr u gs le vels (te n of o vir a n d e mtricita bi ne); a n d  
• F or partici pa nts  w h o bec o me i nfecte d wit h HI V w hile recei vi n g Pr E P, allele -s pecific P C R-base d 
mi n or varia nt dr u g resista nce testi n g  
 V . Recr uit me nt  
T he C R U S H Pr oject will e m pl o y 3 mai n o utreac h a n d recr uit me nt strate gies t o p ote ntial st u d y 
partici pa nts:  
C o m m u nit y Base d O u treac h via a Y o ut h O utre ac h C or ps : We will be c olla b orati n g wit h c o m m u nit y 
part ners t o pr o vi de ve n ue a n d street base d o utreac h t o recr uit st u d y partici pa nts.  O ur f or mati ve 
e val uati o n pr o vi de d i nsi g ht i nt o t he nee d t o reac h o ut t o y o ut h i n n o n -tra diti o nal setti n gs i n or der t o 
pr o vi de access t o testi n g a n d li n ka ge t o care.  We will asse m ble a s mall gr o u p of o utreac h w or kers b y 
pr o vi di n g f u n ds f or staff i n 3 c o m m u nit y base d a ge ncies: R Y S E Y o ut h Ce nter i n Ric h m o n d, t he HI V 
E d ucati o n a n d Pre ve nti o n Pr oject of A la me da C o u nt y ( H E P P A C), a n d Asia n Healt h Ser vices ( A H S). 
Eac h or ga nizati o n will assi g n a part -ti me o utreac h w or ker, w h o will be s u per vise d t hr o u g h t heir 
res pecti ve a ge nc y pr o gra m ma na ger. Pr o gra m ma na gers a n d o utreac h w or kers w or k as a tea m a n d will 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 9 of 5 3  
atte n d m o nt hl y o utreac h meeti n gs f or t he C R U S H Pr oject, w here o utreac h strate gies, ve n ues, a n d e ve nts 
a n d l ocati o ns fre q ue nte d b y t he tar get p o p ulati o ns ca n be ma p pe d a n d s hare d, a n d pla ns f or o utreac h ca n 
be esta blis he d j oi ntl y. O utreac h a n d pr o m oti o nal materia ls f or t he C R U S H Pr oject will be de vel o pe d 
j oi ntl y wit h part ners, a n d re vie we d b y a c o m m u nit y a d vis or y b oar d. W hile n o s pecific data will be 
c ollecte d fr o m o utreac h acti vities f or p ur p oses of researc h, o utreac h staff will d oc u me nt wee kl y c o ntacts 
ma de f or C R U S H recr uit me nt, a n d p ote ntial partici pa nts, u p o n arri val, will be as ke d at c hec k -i n w here 
t he y lear ne d a b o ut t he C R U S H st u d y. 
Cli nic base d o utreac h : E B A C/ D Y C is c urre ntl y a referral ce nter f or M S M w h o test p ositi ve at l ocal HI V 
testi n g ce nters. U n der t he C R U S H pr oject, E B A C/ D Y C will c olla b orate wit h t hese l ocal pr o gra ms, a n d 
ot hers, t o i m ple me nt a parallel referral s yste m f or hi g h ris k i n di vi d uals w h o test HI V-ne gati ve a n d meet 
C R U S H  eli gi bilit y criteria. I n a d diti o n, c urre nt HI V -p ositi ve D Y C patie nts wi ll be i nf or me d of C R U S H 
st u d y acti vities b y  D Y C staff me m bers, a n d if eli gi ble, ma y als o partici pate i n t he st u d y. I n a d diti o n, 
i de ntifie d HI V-ne gati ve part ners of c urre nt E B A C/ D Y C clie nts , w h o are bet wee n t he a ges of 1 8 a n d 2 9 
a n d ot her wise meet st u d y el i gi bilit y criteria as descri be d i n secti o n  V, will be calle d t o deter mi ne w het her 
t he y are i ntereste d i n partici pati n g i n C R U S H .   
O n -li ne a n d I nter net O utreac h: We will create a n o n-li ne prese nce f or t he C R U S H Pr oject, utiliz i n g 
we bsites a n d s ocial me dia  pr o gra ms w hic h are p o p ular wit h t he tar get p o p ulati o n. All messa gi n g a n d use 
of o n li ne sites will be m o nit ore d b y t he C R U S H Pr oject Direct or, a n d i m ple me nte d t hr o u g h t he Y o ut h 
O utreac h C or ps.  
We will de vel o p a n d place ba n ner a d ds w hic h ha ve li n ks t o eli gi bilit y i nf or mati o n a b o ut t he 
C R U S H st u d y o n we bsites w hic h are fre q ue nte d b y t he tar get p o p ulati o n. T hese i ncl u de: Bl ack G ay C h at, 
A d a m 4 A d a m , a n d Me n 4 N o w , Gri n der, a n d J acke d. We will e m pl o y searc h e n gi ne o pti mizati o n t o ols t o 
e ns ure t hat o ur we bsite is ra n ke d hi g hl y f or searc hes s uc h as " Oa kla n d HI V" or " East Ba y  S T D  Testi n g " 
as researc h i n o ur area has s h o w n t hat ma n y y o ut h use we bsites li ke G o o gle a n d Y a h o o t o fi n d se x ual 
h ealt h i nf or mati o n.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 0  of 5 3  
We will de vel o p a pa ge o n Face b o o k . T he Face b o o k pa ge will be solel y mai ntai ne d b y C R U S H 
staff, a n d m o nit ore d b y t he Pr oject Direct or. N o i de ntif yi n g i nf or mati o n a b o ut patie nts or partici pa nts will 
be p u blis he d, a n d we will mai ntai n strict pri vac y setti n gs. O nl y  pict ures a n d q u otes fr o m C R U S H staff 
me m bers at D Y C, li n ks t o t he we bsite, li n ks t o ot her tr uste d s o urces of  healt h i nf or mati o n, i nf or mati o n 
a b o ut h o w t o te xt  or call  t o ma ke a n a p p oi nt me nt, a n d C R U S H eli gi bilit y criteria will be all o we d o n t he 
pa ge.  
E B A C/ D Y C will c o nti n ue t o pr o vi de cli nicall y a p pr o priate sex ual healt h ser vices t o pe o ple w h o 
eit her are i neli gi ble f or e nr oll me nt i n t he C R U S H pr oject, or c h o ose n ot t o partici pate. If i n di vi d uals 
recei vi n g ser vices at E B A C/ D Y C w h o are n ot e nr olle d i n C R U S H bec o me eli gi ble a n d i ntereste d i n 
partici pati n g, t he y ca n be e nr olle d i n t he st u d y .  Li ke wise, partici pa nts i n C R U S H ca n c h o ose t o c o nti n ue 
t o recei ve se x ual healt h ser vices, b ut decli ne or be i neli gi ble f or Pr E P. A n y HI V ne gati ve C R U S H 
partici pa nt ca n o pt at a n y ti me t o be e val uate d f or t he a p pr o priate ness of Pr E P; a n d a n y HI V p ositi ve 
i n di vi d ual c urre ntl y or ne wl y accessi n g ser vices at 
D Y C/ E B A C ma y o pt i n t o t he C R U S H st u d y.  
Fi g ure 1 de m o nstrates t he fl o w of t he C R U S H st u d y 
partici pati o n a n d cli nical ser vices f or HI V -ne gati ve a n d HI V -
p ositi ve partici pa nts w h o  d o or d o n ot c h o ose t o e nr oll as 
C R U S H researc h partici pa nts.  
 V I. St u dy Pr oce d ures 
V 1. 1 C o nse nt Pr oce d ures  
All  c o nse nt  pr oce d ures  a n d  acti vities  li n ke d  t o  t he 
st u d y  will  ta ke  place  at  t he  East  Ba y  AI D S  Ce nter. All 
p ote ntial st u d y partici pa nts will ha ve t he o p p ort u nit y t o meet 
wit h st u d y staff o ne -o n -o ne t o lear n a b o ut t he st u d y a n d as k 
Fi g ure 1: 
C R U S H St u d y 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 1  of 5 3  
q uesti o ns  f or  clarificati o n.    All  i nter vie ws  will  be  hel d  i n  a  o ne -o n -o ne  fas hi o n  i n  a  pri vate  setti n g.  
P artici pa nts  will  be  t ol d  t hat  t he y  are  bei n g  offere d  t he  o p p ort u n it y  t o  v ol u ntaril y  partici pate  i n  a 
c o nfi de ntial  st u d y  a b o ut  u n dersta n di n g  t he  best  wa ys  t o hel p  y o u n g  pe o ple i n  t he  East  Ba y access 
se x ual healt h care a n d sta y healt hier.  
 
I n di vi d uals w h o v ol u ntaril y c h ose t o partici pate i n st u d y acti vities w ill be as ke d t o si g n a c o nse nt 
f or m.  A st u d y c o or di nat or will e x plai n t he p ur p ose a n d  o bjecti ves of t he st u d y , a n d t he vari o us acti vities 
it  i n v ol ves.  Pers o ns  w h o  are  HI V-p ositi ve  will  ha ve  a  se parate  c o nse nt  pr oce d ure  fr o m  t h ose  w h o  are  
HI V - ne gati ve, t o e ns ure clarit y i n t he pr oce d ures t hat are s pecific t o ser ostat us. P artici pa nts will be t ol d 
clearl y t hat partici pati o n is c o m pletel y v ol u ntar y, a n d t hat t he y ca n decli ne t o a ns wer a n y q uesti o ns t hat 
t he y d o n ot wa nt t o a ns wer .  Pers o ns at hi g h ris k f or HI V i nfecti o n w h o decli ne researc h partici pati o n ca n 
n o net heless recei ve se x ual healt h ser vices at C R U S H, wit h referrals as a p pr o priate f or cli nical care. T he 
inf or me d c o nse nt pr ocess will als o i ncl u de a me dical rec or ds release a ut h orizati o n.  
If t he i n di vi d ual is eli gi ble a n d a grees t o partici pate, st u d y staff will e x plai n t he ter ms of 
t he  st u d y’s  c o nse nt  f or m.  T he  na mes  a n d  tele p h o ne  n u m bers  of  t he  i nter vie wer  a n d  pri nci pal 
i n vesti gat or/ pr oject  direct or  will  be  gi ve n  ver ball y  t o  all  partici pa nts,  a n d  s u m marize d  o n  t he 
c o nse nt f or m, a c o p y of w hic h will be pr o vi de d.   
O nce t he c o nse nt f or m is c o m plete d a n d si g ne d, acti vities descri be d f or t he i nitial st u d y 
visit will c o m me nce.   A $ 4 0 i nce nti ve will be gi ve n u p o n c o m pleti o n of t he i nitial st u d y 
i nter vie w a n d A C A SI.  Partici pa nts will recei ve $ 2 5 f or eac h a d diti o nal sc he d ule d st u d y f oll o w 
u p visit  a n d i nter vie w.   T here will be n o c o m pe nsati o n f or as -nee de d or dr o p -i n cli nical visits.   
All st u d y pers o n nel w h o will ha ve direct c o ntact wit h partici pa n ts (t he Pr oject Direct or, Pr oject 
C o or di nat or, Rete nti o n S pecialist, Me dical Assista nts, cli nicia ns, a n d D o w nt o w n Y o ut h Cli nic y o ut h 
a d v ocates staff) will be trai ne d i n c o nse nt pr oce d ures. All staff will ha ve o btai ne d CI TI h u ma n s u bjects 
trai ni n g certificates pri or t o st u d y start. 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 2  of 5 3  
 
VI. 2 A u di o -c o m p uter-assiste d self -a d mi nistere d i nter vie wi n g ( A C A SI)  
O nce a partici pa nt has bee n dee me d eli gi ble a n d has c o m plete d t he c o nse nt pr ocess, a u di o 
c o m p uter assiste d self -i nter vie wi n g ( A C A SI) s oft ware will be use d t o c ollect i nf or mati o n at baseli ne a n d 
at 1, 6 a n d 1 2 m o nt hs after e nr oll me nt.   A C A SI will be a d mi nistere d i n a pri vate s pace o n a la pt o p or 
ta blet c o m p uter.  St u d y staff will be a vaila ble t o a ns wer q uesti o ns or offer assista nce s h o ul d t he 
partici pa nts ha ve diff ic ult y wit h t he s oft ware.  A C A SI i nter vie ws will be i de ntifie d b y a st u d y n u m ber 
o nl y.   A C A SI i nter vie ws will be bac ke d u p at t he e n d of e ver y da y t o a sec ure ser ver wit h bac k u p 
rec or di n g ca pa bilities.  T he A C A SI will ha ve a bra nc h assess me nts b uilt i nt o i ts pr o gra m mi n g str uct ure, 
lea di n g partici pa nts i nt o t he set of q uesti o ns a da pte d f or ser o-stat us ( HI V-ne gati ve or HI V -p ositi ve). A 
draft q uesti o n naire is i ncl u de d, a p pe n di x 5. 
 
V 1. 3 Peer -t o-Peer Me nt ori n g f or HI V P ositi ves  
A Peer t o Peer Me nt ori n g strate g y  will be offere d t o ne wl y dia g n ose d HI V -p ositi ve partici pa nts 
of C R U S H, as well as t o t h ose c urre nt D Y C patie nts at ris k of falli n g o ut of care ( defi ne d as n ot ha vi n g 
see n a pr o vi der or pic ke d u p me dicati o ns i n t he pre vi o us 6 m o nt hs),  a n d t o o ut-of -care patie nts bei n g re -
li n ke d t o care. T he C R U S H L C S W will lea d t he m o nit ori n g of t his strate g y, i ncl u di n g trai ni n g a n d 
s u per visi o n of peers. “ Peer rea di ness” of p ote ntial peer me nt ors will be assesse d base d o n t he f oll o wi n g 
criteria:   
•  
S ta bl y i n care: o n a n d a dhere nt t o treat me nt, atte n da nce at r o uti ne me dical a p p oi nt me nts (at least 
3 i n a r o w);  
•  
C o mf orta ble wit h t heir se x ual i de n tit y, o ut a b o ut t heir se x ual i de ntit y;  
•  
G o o d i nter pers o nal s kills a n d ha ve esta blis he d relati o ns hi ps wit h D Y C pr o gra m staff.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 3  of 5 3  
T he staff  will n o mi nate u p t o 1 0 p ote ntial peer me nt ors. T hese patie nts will be a p pr oac he d wit h t he 
i dea of bec o mi n g a me nt or a n d as ke d t o partici pate. O nce a mi ni m u m of 3 me nt ors are sec ure d, trai ni n g 
will be sc he d ule d. T he me nt ori n g trai ni n g will be de v el o pe d b y t he C R U S H L C S W a n d base d i n part o n 
c o m p o ne nts of dia betes self -ma na ge me nt me nt or pr o gra m s, as well as t he B i g B r ot her/B i g S ister 
pr o gra m s. Me nt ors will be as ke d t o partici pate f or a mi ni m u m of 6 m o nt hs, a n d ma y partici pate f or t he 
d urati o n of t he pr oject . Res p o nsi bilities i ncl u de a willi n g ness t o meet face t o face, o nli ne or i n a gr o u p 
sit uati o n wit h me ntees . Me nt ors will gai n practice i n pr o vi di n g g ui da nce a n d liste ni n g s kills b y c o-
facilitati n g gr o u p w or ks h o ps or s u p p ort gr o u ps wit h t he cli nical s u per vis or. A n et hics of c o nfi de ntialit y 
will be a ke y c o m p o ne nt of eac h trai ni n g.  
Trai ne d peers will be matc he d wit h a n HI V -p ositi ve clie nt. B ot h peer a n d me ntees will ha ve 
c o m plete d i nitial c o nse nt t o partici pate i n t he peer pr o gra m.  
T he L C S W will esta blis h wee kl y gr o u ps a n d o ne -o n -o ne meeti n gs wit h peers a n d me nt ors. Case 
n otes will d oc u me nt e x perie nces of t he peers a n d t he me ntees, barriers a n d facilitat ors t o s u p p orti n g 
mai ntai ni n g t he care of y o ut h w h o are HI V p ositi ve, a n d satisfacti o n wit h t he me n t ori n g pr ocess. All case 
n otes a n d data c ollecte d will be stri p pe d of a n y i de ntif yi n g i nf or mati o n a b o ut me nt ors or me ntees, a n d t he 
L C S W will pr o vi de o nl y a n o n y mize d s u m mar y re p orts.  
We als o pla n t o c o n d uct f oc us gr o u ps a n d i n de pt h i nter vie ws wit h peers m e nt ors a n d me ntees as part 
of t he q ualitati ve data c ollecti o n acti vities (see bel o w, secti o n VI. 6)  
VI. 4 S ocial Net w or ki n g HI V Testi n g  
S ocial Net w or ki n g use d as a testi n g strate g y is a pr o ve n met h o d t o i ncrease access t o HI V testi n g 
i n har d t o reac h p o p ulati o ns.  T o c o n nect y o u n g M S M t o testi n g o p p ort u nities t hr o u g h a fa miliar a n d 
tr uste d pers o n wit hi n t heir o w n s ocial net w or ks, t he C R U S H st u d y will a da pt a n d tail or a strate g y b uil d 
lar gel y o n res p o n de nt dri ve n sa m pli n g, a n d o n C D C pil ot st u d y c o n d ucte d at multi ple sites acr oss t he 
U nite d States.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 4  of 5 3  
E nr oll me nt of s ocial net w or k recr uiters:  C R U S H staff me m bers will i nitiall y as k M S M of c ol or , 
a ges 1 8 t o 2 9,  w h o are c urre ntl y recei vi n g pri mar y care at D Y C , as well as t heir part ners, t o bec o me 
recr uiters. All par tici pa nts will be as ke d t o pr o vi de c o nse nt at t heir i nitial e nr oll me nt i nt o t he C R U S H 
st u d y t o p ossi ble partici pati o n i n s ocial net w or k recr uiti n g. P ote ntial recr uiters will be i ncl u de d o n t he 
basis of staff j u d g me nts a b o ut t heir li kel y i nterest a n d willi n g ness t o recr uit me m bers of t heir o w n s ocial 
net w or ks.  P ote ntial recr uiters will be e xcl u de d if t he y are o bser ve d t o be u n der t he i nfl ue nce of alc o h ol 
or ot her dr u gs , or a p pear  u na ble t o f ulfill t he re q uire me nts of t he pr o gra m f or a n y reas o n.   Staff will i n vite 
recr uiters t o c o ntact pers o ns t he y pers o nall y k n o w fr o m t heir s ocial, se x ual, or dr u g-usi n g net w or ks a n d 
e nc o ura ge t he m t o be teste d f or HI V.  As i n t he past, recr uiters will i ncl u de b ot h HI V -p ositi ve patie nts 
a n d t heir HI V -ne gati ve part ners , t o e nsure t hat partici pati o n d oes n ot i de ntif y a n y o ne as HI V -p ositi ve.  
Recr uiters will als o be e nc o ura g e d t o i de ntif y t he msel ves as C R U S H  v ol u nteers as a n a d diti o nal mea ns t o 
pre ve nt u n wa nte d discl os ure.   
Selecte d recr uiters will be as ke d t o partici pate i n a br ief trai ni n g sessi o n, d uri n g w hic h t he O utreac h 
C o or di nat or  will e x plai n s ocial net w or k testi n g, a n d will be re mi n de d of t he  i m p orta nce of mai ntai ni n g 
c o nfi de ntialit y.  
Recr uiters will recei ve $ 1 0 cas h ( or e q ui vale nt val ue gift certificate) f or eac h c o ntact  t he y refer w h o 
c o mes i n f or HI V testi n g,  u p t o te n el igi ble c o ntacts f or a ma xi m u m i nce nti ve of $ 1 0 0.  Eac h c o ntact w h o 
c o m pletes a n HI V ra pi d test sessi o n will als o recei ve $ 1 0 ( or e q ui vale nt). C o ntacts  will  bri n g i n a car d 
wit h a c o de d u ni q ue i de ntifier , pr o vi de d t o t he m b y t heir recr uiter, s o t hat b ot h recr uiter a n d c o ntact ma y  
recei ve t heir i nce nti ves.  T he recr uiter ma y acc o m pa n y t he c o ntact f or testi n g if b ot h prefer, b ut recr uiters 
nee d n ot acc o m pa n y  c o ntacts t o t he HI V testi n g a p p oi nt ment . C o ntacts will ha ve t he o pti o n t o dr o p  i n f or 
testi n g d uri n g cli nic h o urs or t o sc he d ule a n a p p oi nt me nt a hea d of ti me.   
 Eac h recr uiter will recei ve u p t o 1 0 car ds wit h a c o de d u ni q ue i de ntifier t o gi ve t o c o ntacts t hat t he y 
refer f or testi n g.  T he HI V testi n g c o or di nat or will c oac h eac h recr uiter o n h o w t o a p pr oac h p ote ntial 
c o ntacts a n d refer t he m f or HI V c o u nseli n g, testi n g, a n d referral ser vices.  T he O utreac h C o or di nat or  will 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 5  of 5 3  
rec or d t he na me a n d u ni q ue i de ntifier of eac h recr uiter e nr olle d i n t he social net w or k testi n g data base.  
T he HI V testi n g c o or di nat or will f oll o w u p wit h recr uiters peri o dicall y, i n pers o n or b y tele p h o ne, t o 
re vie w t heir pr o gress i n recr uiti n g c o ntacts a n d t o disc uss a n y iss ues t hat c o ncer n t he m.  F oll o wi n g t he 
first r o u n d of testi n g, ne w recr uiters will be c h ose n base d u p o n c haracteristics ass ociate d wit h referrals of 
lar ger n u m bers of hi g her ris k c o ntacts. I n ot her pr o gra ms f or s ocial net w or k testi n g, s uc h c haracteristics 
ha ve  i ncl u de d HI V-p ositi ve or HI V -ne gati ve pers o ns w h o  ( 1) ha d u n pr otecte d se x ual i nterc o urse or 
s hare d dr u g i njecti o n e q ui p me nt wit h a pers o n w h o was HI V p ositi ve or of u n k n o w n HI V stat us, ( 2) ha d 
e xc ha n ge d se x ual i nterc o urse f or dr u gs or m o ne y, or ( 3) were dia g n ose d wit h a n ot her se x uall y 
tra ns mitte d disease wit hi n t he last 1 2 m o nt hs.   
VI. 5 Cli nical S u per visi o n a n d E val uati o n f or Staff a n d Part ners  
T hr o u g h o ur c o m m u nit y part ners hi p wit h H E P P A C, C R U S H has c o ntracte d a lice nse d cli nical 
s ocial w or ker ( L C S W) t o pr o vi de s u p p ort t o t he me m bers of t he  C R U S H  staff an d part ner or ga nizati o n s, 
i ncl u di n g t he y o ut h c or ps, t he peer na vi gat ors, t he rete nti o n s pecialist, a n d t he peer me nt ors . T he L C S W 
will pr o vi de ps yc h os ocial s u p p ort a n d trai ni n g t o staff t hat i nteract directl y wit h hi g h ris k y o ut h, 
s u p p orti n g staff’s a bilit y t o a v oi d “ b ur n o ut ,” a n d assess i n g t heir trai ni n g nee ds. Wee kl y gr o u p meeti n gs 
will be c o n d ucte d  of a ncillar y staff , i ncl u di n g t he y o ut h c or ps, t he peer na vi gat ors, t he rete nti o n s pecialist 
a n d t he peer me nt ors ,  c o veri n g s uc h  t o pics as tra nsfere nce a n d c o u nter -tra nsfere nce i n pr o vi der-clie nt 
relati o ns hi ps. I n a d diti o n t o t hese wee kl y meeti n gs, t he cli nical s u per vis or will h ost “ office h o urs” f or o ne 
o n o ne dr o p -i n visits fr o m a n y of t he C R U S H staff me m bers, i ncl u di n g t he cli nicia ns. T he cli nical 
s uper vis or will d oc u me nt i n case n otes t he ke y iss ues w hic h arise i n t he gr o u ps a n d o ne -o n -o ne meeti n gs, 
w hic h will be use d t o s u p p ort C R U S H ai ms. N o na mes or i de ntif yi n g i nf or mati o n will be ke p t i n t he 
n otes, a n d t he L C S W will re m o ve all i de ntif yi n g staff inf or mati o n a n d pr o vi de o nl y s u m maries of n otes 
as part of re p orts. Staff will be i nf or me d d uri n g t he c o nse nt pr ocess t hat n o i nf or mati o n pr o vi de d as a part 
of t his pr ocess will i m pact t heir e m pl o y me nt.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 6  of 5 3  
T o assess t his strate g y, we will a da pt a n d utilize t he  Masla c h B ur n o ut I n ve nt or y ( M BI) .  T he M BI 
is a 2 2-ite m s ur ve y t hat assesses pr ofessi o nal b ur n o ut i n h u ma n ser vice, e d ucati o n, b usi ness, a n d 
g o ver n me nt pr ofessi o ns mai nl y i n t he f oll o wi n g t hree areas: ( 1) e m oti o n al ex h a usti o n  meas ures feeli n gs 
of bei n g e m o ti o nall y o vere xte n de d a n d e x ha uste d b y o ne's w or k; ( 2) de pers o n aliz ati o n  meas ures a n 
u nfeeli n g a n d i m pers o nal res p o nse t o war d reci pie nts of o ne's ser vice, care treat me nt, or i nstr ucti o n; a n d 
( 3) pers o n al acc o m plis h me nt  meas ures feeli n gs of c o m pete nce a n d s uccessf ul ac hie ve me nt i n o ne's w or k.  
( A p pe n di x 6)  
T he L C S W will a d mi nister t his scale o n se mi-a n n uall y. Staff will be as ke d t o v ol u ntaril y c o nse nt 
t o c o m plete t he s ur ve y, w hic h will be a d mi nistere d i n pri vate setti n gs d uri n g a sc he d ule d o ne -o ne o ne 
meeti n g wit h t he L C S W. Staff will be pr o vi de d a ra n d o mize d c o de w hic h ca n n ot be li n ke d t o na me or 
e m pl o y me nt hist or y, w hic h will be use d f or eac h s ur ve y. Data will be s u m marize d i n bi -variate a n d 
fre q ue nc y a nal ysis. 
VI. 6 Q ualitati ve I nter vie w Met h o ds: ke y i nf or m a nt a n d f oc us gr o u ps  
 
T hr o u g h o ut t he d urati o n of t he pr oject, q ualitati ve i nter vie wi n g will ta ke place wit h b ot h HI V -
p ositi ve a n d HI V -ne gati ve C R U S H partici pa nts, s ocial net w or k testi n g recr uiters, a n d staff a n d part ners 
partici pati n g i n cli nical s u per vis i o n wit h t he L C S W. Ple ase n ote: we will s u b mit m o dificati o n s t o t he 
I R B f or a n y i nter vie w g ui des, c o nse nt a n d recr uit me nt pr oce d ures, a n d a n y recr uit me nt materials t hat will 
be use d f or t he p ur p ose of q ualitati ve i nter vie wi n g.  
 
O ur q ualitati ve e val uati o n of t he C R U S H se x ual healt h ser vices f oc uses will f oc us o n t he 
f oll o wi n g o bjecti ves: 1) t o assess t he w het her a n d h o w t he C R U S H pr o gra m is meeti n g t he nee ds of 
Y M S M C; 2) t o i de ntif y t he be nefits a n d c halle n ges ass ociate d wit h t he se x ual healt h ser vices; 3) t o 
u n dersta n d t he e x perie nces of  t he C R U S H clie nts usi n g Pr E P.  We will c o n d uct f oc us gr o u p disc ussi o ns 
a n d i n-de pt h i nter vie ws wit h a sa m ple of C R U S H partici pa nts .  We will d oc u me nt t he e x perie nces of 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 7  of 5 3  
C R U S H partici pa nts o n Pr E P , a n d of t h ose w h o c h o ose t o f ore g o Pr E P.  We will assess t he e x perie nces 
of HI V  p ositi ve C R U S H partici pa nts  i n accessi n g r o uti ne care a n d se x ual healt h ser vices.  
F or t h ose partici pati n g i n peer me nt ori n g, we will c o n d uct i n -de pt h i nter vie ws wit h patie nts 
ser vi n g as me nt ors, a n d patie nts recei vi n g me nt ori n g ser vices , as well as wit h a s u bset of patie nts 
recei vi n g o utreac h fr o m t he rete nti o n s pecialist. F or t h ose C R U S H Staff a n d o utsi de part ners w h o are 
w or ki n g wit h t he L C S W, we will c o n d uct i n -de pt h i nter vie ws wit h C R U S H staff at t w o ti me p oi nts, 
bef ore e x p os ure t o t he cli nical s u per vis or a n d after. C R U S H staff will be as ke d t o descri be t heir 
e x perie nces wit h t he w or k -relate d stress a n d stress ma na ge me nt strate gies.  F or y o ut h w h o partici pate i n 
social net w or k testi n g, we will c o n d uct f oc us gr o u ps t o disc uss e x perie nces as s ocial net w or k recr uiters; 
we will elicit st ories a b o ut differe nt e pis o des of recr uiti n g.  
A me m ber of t he st u d y e val uati o n tea m will a p pr oac h C R U S H partici pa nts t o i n vite t he m t o 
partici pate i n a n eit her a n i n -de pt h i nter vie w i n pers o n or b y p h o ne, or a f oc us gr o u ps . C R U S H staff will 
refer all i ntereste d y o ut h t o call a st u d y p h o ne li ne t o be scree ne d. T he st u d y e val uati o n tea m me m ber 
c o n d ucti n g t he q ualitati ve i nter vie wi n g  will scree n p ote ntial partici pa nts a n d e ns ure  t hat b ot h c o mf orta ble 
a n d m oti vate d t o c olla b orate as eit her f oc us gr o u p partici pa nts or i n ot her p hases of t he researc h, as ke y 
i nf or ma nts. D uri n g t he scree ni n g pr ocess, we will clearl y e x plai n t he g oals of t he st u d y, a n d we will 
descri be t heir r ole as ke y i nf or ma nts rat her t ha n as passi ve st u d y partici pa nts.  
I n-de pt h i nter vie ws will be c o n d ucte d wit h all partici pa nts i n pers o n.   E ac h i nter vie w will be 
a p pr o xi matel y 4 5 - 9 0 mi n utes i n le n gt h a n d a u di o -rec or de d. F oc us gr o u p disc ussi o ns will be 
a p pr o xi matel y 9 0 mi n utes. A u di o -rec or di n gs of i nter vie ws a n d f oc us gr o u p disc ussi o ns will be 
tra nscri be d. Ver bati m tra nscri pti o ns will be ma na ge d usi n g Atlas.ti, a s oft ware pr o gra m desi g ne d t o assist 
wit h te xt ual, a u di o a n d/ or vi de o -base d datasets.  N o i de ntif yi n g i nf or mati o n will be i ncl u de d i n 
tra nscri pts- t he tra nscri ber will be n otifie d t o re m o ve na mes fr o m all tra nscri be d a u di o-rec or di n gs. 
 
As t he q ualitati ve researc h acti vities will be i n part g ui de d b y  t he e x perie nces ta ki n g 
place as part of o n g oi n g  i m ple me ntati o n of C R U S H , i nter vie w g ui des a n d pr oce d ures will be de vel o pe d 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 8  of 5 3  
s pecificall y t o areas of i nterest f or t he st u d y. As s uc h, t he e val uati o n tea m will a p pl y f or a m o dificati o n 
f or a d diti o nal researc h acti vities, a n d se parate c o nse nt s will be s u b mitte d f or a p pr o val.  
VII. Cli nic al St a n d ar d of C are Pr oce d ures f or C R U S H P artici p a nts  
St u d y staff will deter mi ne eli gi bilit y f or e nr oll me nt i n t he o verall C R U S H pr oject acc or di n g t o 
br oa der i ncl usi o n a n d e xcl usi o n criteria descri be d else w here. T h ose w h o are deter m i ne d t o be i neli gi ble 
or u ni ntereste d i n t he st u d y ma y c o nti n ue t o recei ve se x ual healt h ser vices at E B A C/ D Y C. We will as k 
partici pa nts w h o are eli gi ble b ut c h o ose n ot t o e nr oll i n C R U S H t o a ns wer q uesti o ns a b o ut t heir c h oice.  
T he y ma y c h o ose t o decli ne a ns weri n g t hese q uesti o ns a n d c o nti n ue t o recei ve se x ual healt h ser vices. 
I n di vi d uals electi n g n ot t o partici pate i n C R U S H, w h o later as k t o e nr oll, ma y be re-scree ne d a n d e nr oll at 
a later date. 
All C R U S H partici pa nts, re gar dless of HI V stat us, will be off ere d t he o p p ort u nit y t o recei ve se x ual 
healt h ser vices. C R U S H defi nes t he cli nical testi n g a n d scree ni n g se x ual healt h ser vices as t he f oll o wi n g:  
•  
HI V testi n g a n d treat me nt;  
•  
S y p hilis testi n g a n d treat me nt;  
•  
G o n orr hea testi n g a n d treat me nt;  
•  
C hla m y dia testi n g  a n d treat me nt;  
•  
He pati tis B scree ni n g a n d i m m u nizati o n; 
•  
Pr E P usi n g Tr u va da ® (f or eli gi ble HI V ne gati ve partici pa nts o nl y) 
 
VI 1. 1. Scree ni n g  Visit  ( all p artici p a nts) 
O n arri val t o t he cli nic wit h a n e x presse d i nterest t o lear n m ore a b o ut t he C R U S H st u d y, a n  
i n di vi d ual will meet wit h a st u d y c o or di nat or i n a pri vate r o o m a n d be scree ne d f or eli gi bilit y (as 
descri be d a b o ve). W he n eli gi bilit y is c o nfir me d, t he scree ni n g visit will be gi n. U p o n re vie wi n g a n d 
acce pta nce of a n i nf or me d c o nse nt f or partici pati o n with a st u d y c o or di nat or, a partici pa nt will si g n t w o 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 1 9  of 5 3  
c o pies, as well as si g n a me dical rec or ds release a ut h orizati o n. O nce writte n i nf or me d c o nse nt is o btai ne d, 
t he st u d y staff will c o n d uct t he HI V ra pi d test as part of scree ni n g visit pr oce d ures . W o me n w h o scree n as 
eli gi ble (a w o ma n w h ose has at least o ne k n o w n HI V p ositi ve se x ual part ner or is c urre ntl y i n a 
ser o disc or da nt part nershi p ), a n d of re pr o d ucti ve p ote ntial will ha ve a ra pi d uri ne pre g na nc y test at t he 
scree ni n g visit.  
I nitial HI V ra pi d p oi nt of care test is c o n d ucte d via oral fl ui d s peci me n e va l uate d f or HI V-1/ 2 
a nti b o dies. If t he res ult is p ositi ve, a c o nfir mat or y test will be or dere d a n d t he y t he partici pa nt will be 
resc he d ule d t o ret ur n t o t he cli nic i n 1 wee k f or t h ose res ults. C o u nseli n g will be perf or me d, b ut all ot her 
scree ni n g pr oce d ures will be deferre d t o t he s u bse q ue nt visit, w he n HI V ser ostat us will be  c o nfir me d.  If 
t he c o nfir mat or y test is p ositi ve, partici pa nts  will be offere d e nr oll me nt i n t h e T L C + ar m of t he C R U S H 
pr oject.  If t he c o nfir mat or y test is ne gati ve , f urt her cli nical e val uati o n i ncl u di n g HI V R N A testi n g will be 
i nitiate d.   
I n a d diti o n t o t he HI V ra pi d test, at scree ni ng, t he f oll o wi n g acti vities ca n  als o occ ur:  
•  
Me dical hist or y a n d f oc use d re vie w of s yste ms ;  
•  
S TI Ris k As sess me nt 
•  
Tar gete d P h ysical E xa m  (as nee de d b y a pr o vi der) 
•  
Ris k re d ucti o n c o u nseli n g, c o n d o m distri b uti o n 
•  
S TI scree ni n g a n d treat me nt, as nee de d  
 
All partici pa nts w h o ha ve c o nse nte d will be as ke d t o c o m plete a n A C A SI q uesti o n naire a n d i nitial 
scree ni n g visit. A C A SI is re peate d at 0, 4, 2 4, a n d 4 8 wee ks. F oll o w u p a p p oi nt me nts f or st u d y relate d 
acti vities are sc he d ule d wit h partici pa nts a n d m o nit ore d t hr o u g h t he Rete nti o n C o or di nat or.  
VII. 2 HI V  P ositi ve P artici p a nts: Tre at me nt a n d Li n k a ge t o C are ( T L C +)  
Partici pa nts w h ose HI V test is p ositi ve will be offere d e nr oll me nt i n t he e n ha nce d treat me nt a n d 
li n ka ge t o care (T L C +) ar m of t he C R U S H st u d y T h ose i n di vi d uals w h o meet t he eli gi bilit y criteria, a n d 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 0  of 5 3  
w h o are eit her k n o w n p ositi ves clie nts of t he D Y C, ha ve  bee n referre d b y a c o m m u nit y part ner as HI V 
p ositi ve, ha ve d oc u me ntati o n of a p ositi ve HI V test res ult  fr o m a lice nse d la b orat or y i n Calif or nia, will 
als o be offere d e nr oll me nt t o t he T L C + ar m.  
R o uti ne i nitial cli nical care of t he HI V -p ositi ve partic i pa nt will be acc or di n g t o t he c o m m u nit y 
sta n dar d of care, a n d g ui de d b y t he cli nical e x pertise of D Y C a n d E B A C cli nicia ns.  Partici pa nts will be 
assesse d f or a n y ur ge nt me dical or ps yc h os ocial nee ds; will ha ve a n i nta ke cli nical i nter vie w a n d baseli ne 
p h y sical e xa mi nati o n; a n d will ha ve la b orat or y s peci me ns se nt f or T cell s u bsets, HI V viral l oa d, a n d HI V 
ge n ot y pe (resista nce testi n g), r o uti ne bl o o d c he mistr y a n d he mat ol o g y, a n d scree ni n g f or viral he patitis, 
s y p hilis, a n d ot her S TIs. 
VII. 3 HI V Ne g ati ve P a rtici p a nts: Scree ni n g f or ac ute or e arl y HI V i nfecti o n  
I n a d diti o n t o ra pi d p oi nt-of -care HI V a nti b o d y testi n g, all HI V -ne gati ve C R U S H partici pa nts 
will ha ve bl o o d sa m ples se nt at e ver y visit ( w het her a sc he d ule d st u d y visit, or a n as -nee de d se x ual healt h 
visit) f or n ucleic aci d testi n g ( N A T)  t o detect ac ute or earl y i nfecti o n wit h HI V, a n d he patitis C a n d B 
vir uses ( H C V a n d H B V).  T his testi n g is offere d i n c olla b orati o n wit h S usa n Little, M D, of t he U ni versit y 
of Calif or nia, Sa n Die g o A nti viral  Researc h Ce nter ( A V R C) , w h o is st u d yi n g t he utilit y of N A T testi n g 
f or HI V i n si milar setti n gs i n S o ut her n Calif or nia.  S peci me ns will be se nt t o t he A merica n Re d Cr oss 
refere nce la b orat or y i n St. L o uis, M O f or N A T testi n g, a n d res ults t he n pr ocesse d t hr o ug h t he A V R C’s 
sec ure pr ocess.  Pr oce d ures f or o btai ni n g s peci me ns, N A T testi n g, a n d ha n dli n g a n d releasi n g res ults are 
detaile d i n A p pe n di x R.  O ur ai ms here are:  ( 1) t o st u d y w het her t his N A T testi n g pr ocess ca n detect 
earl y HI V i nfecti o n, d uri n g t he “ wi n d o w peri o d” i n w hic h HI V a nti b o d y testi n g re mai ns ne gati ve, b ut 
d uri n g w hic h t he partici pa nt ma y be hi g hl y i nfecti o us t o ot hers; a n d ( 2) t o e val uate t he i m pact of bei n g 
a ble t o deli ver b ot h ne gati ve a n d p ositi ve test res ults t o partici pa nts i n a ti mel y a n d pri vate fas hi o n VII. 4   
HI V Ne gati ve p ote ntial partici pa nts w h o o pt o ut of C R U S H Eli gi ble  HI V -ne gati ves w h o decli ne 
partici pati o n i n C R U S H will be referre d f or cli nical care as a p pr o priate t o ot her c o m m u nit y sites.  T he y 
ma y c o nti n ue t o recei ve r o uti ne se x ual healt h ser vices at t he C R U S H site, wit h o ut c o m pleti n g i nter vie ws 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 1  of 5 3  
or partici pati n g i n ot her researc h pr oce d ures.  R o uti ne se x ual healt h ser vices s hall ta ke place at visits o n 
a n as-nee de d basis, a n d s hall i ncl u de ra pi d p oi nt -of -care HI V a n ti b o d y testi n g, as well as testi n g f or S TIs 
as g ui de d b y ris k a n d/ or si g ns a n d s y m pt o ms, a n d treat me nt f or S TIs as cli nicall y a p pr o priate acc or di n g 
t o acce pte d g ui deli nes.  T his will i ncl u de e m piric treat me nt i n s o me cases, partic ularl y f or s us pecte d 
s y p hilis, her pes si m ple x, g o n orr hea, a n d/ or c hla m y dial i nfecti o ns, a n d i n ot her cases, treat me nt g ui de d b y 
test res ults.  All se x ual healt h e nc o u nters will i ncl u de ris k re d ucti o n c o u nseli n g.  A ntiretr o viral t hera p y 
eit her as Pr E P or P E P will n ot be r o uti nel y a vaila ble i n t his setti n g; at -ris k HI V-ne gati ves i ntereste d i n 
Pr E P or P E P b ut n ot wis hi n g t o partici pate i n C R U S H will be referre d t o ot her c o m m u nit y pr o vi ders.  
 
VII. 5 HI V  Ne g ati ve C R U S H P artici p a nts w h o o pt o ut of Pr E P  
Eli gi ble HI V -ne gati ves w h o acce pt  partici pati o n i n C R U S H , b ut w h o c h o ose n ot t o recei ve Pr E P 
or are dee me d i neli gi ble t o d o s o, will recei ve t he sa me r o uti ne se x ual healt h ser vices descri be d a b o ve.  I n 
a d diti o n  t o  accessi n g  as -nee de d  ser vices,  t he y  will  be  as ke d  t o  sc he d ule  re g ular  visits  f or  st u d y 
e val uati o ns a n d i nter vie ws at 1, 6, a n d 1 2 m o nt hs f oll o wi n g e nr oll me nt.  At eac h cli nical visit, w het her 
as-nee de d  or  sc he d ule d,  C R U S H  partici pa nts  will  u n der g o  N A T  testi n g  f or  detecti o n  of  earl y  HI V 
i nfecti o n.  T he y will als o be offere d partici pati o n i n peer s u p p ort gr o u ps, a n d ma y be as ke d t o ser ve as 
“see ds” f or s ocial net w or k recr uit me nt.  C R U S H cli nicia ns will pr o vi de r o uti ne se x ual healt h care as well 
as ot her basic a n d ur ge nt me dical care.  Partici pa nts wit h ot her c o m ple x me dical pr o ble ms will be assiste d 
b y C R U S H staff i n sec uri n g a p pr o priate referrals f or o n g oi n g cli nical care.  
 
 
HI V -ne gati ve partici pa nts wit h a n y  of t he f oll o wi n g will n ot be offere d Pr E P :  
•  
Hist or y of pat h ol o gical b o ne fract ures n ot relate d t o tra u ma;  
•  
Re nal disease or k n o w n a b n or mal ser u m creati ni ne;  
•  
Uri ne di pstic k wit h persiste nt pr otei n uria ≥2 +;  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 2  of 5 3  
•  
C o nc o mita nt partici pati o n i n a cli nical trial usi n g i n vesti gati o nal a ge nts, i ncl u di n g place b o -
c o ntr olle d cli nical trials usi n g s uc h a ge nts; or  
•  
A n y ot her c o n diti o n t hat w o ul d precl u de pr o visi o n of i nf or me d c o n se nt; ma ke partici pati o n i n t he 
pr oject u nsafe; c o m plicate i nter pretati o n of o utc o me data; or ot her wise i nterfere wit h 
ac hie vi n g t he pr oject o bjecti ves, base d o n t he o pi ni o n of t he i n vesti gat ors a n d/ or treati n g 
cli nicia n. 
•  
W o me n w h o are c urre ntl y breastfee d i n g. 
  
VII. 6 HI V  Ne g ati ve C R U S H P artici p a nts w h o o pt i n t o Pr E P  
Partici pa nts w h o ha ve a ne gati ve HI V 1/ 2 a nti b o d y p oi nt of care res ult will recei ve se x ual healt h 
pr o m oti o n c o u nseli n g at t he ti me t he y are pr o vi de d t heir res ults.  Partici pa nts will be as ke d if t he y w o ul d 
li ke t o recei ve Pr E P as part of t heir partici pati o n i n t he st u d y.  C R U S H partici pa nts w h o c h o ose n ot t o 
recei ve Pr E P at scree ni n g f or C R U S H ma y c h o ose t o i nitiate Pr E P at a later visit, if still eli gi ble.  
 
Sa m ples will be c ollecte d f or se x uall y tra ns mitte d i nfecti o ns ( S TI), ser u m HI V a nti b o d y, H Bs A g 
a n d H Bs A b testi n g.  All partici pa nts w h o are s u bse q ue ntl y f o u n d t o be b ot h H Bs A g a n d H Bs A b ne gati ve 
will be offere d t he he patitis B vacci nati o n series.  Partici pa nts f o u n d t o be H Bs A g p os iti ve ma y still 
recei ve Tr u va da ® Pr E P, b ut will i n a d diti o n be m o nit ore d acc or di n g t o a s pecific pr ot oc ol.  [ See 
A p pe n di x Q]  T h ose f o u n d t o be he patitis B a nti ge n p ositi ve, b ut w h o c h o ose n ot t o e nr oll i n Pr E P, will 
be referre d t o eit her t heir pri mar y care pr o vi der or a n ot her c o m m u nit y -base d cli nic f or treat me nt of 
he patitis B i nfecti o n.   
All HI V -ne gati ve partici pa nts, re gar dless of he patitis B stat us, w h o are i ntereste d i n recei vi n g Pr E P 
will recei ve f urt her c o u nseli n g o n Pr E P a n d, i n a d diti o n t o t he bl o o d w or k me nti o ne d a b o ve, will ha ve a n 
HI V N A T  se nt.  T he y will als o meet wit h a cli nicia n f or me dical hist or y, a tar gete d p h ysical e xa m a n d a n 
assess me nt of Pr E P eli gi bilit y acc or di n g t o criteria i n Secti o n I V. Assess me nt of eli gi bilit y will als o 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 3  of 5 3  
i ncl u de an e val uati o n f or s y m pt o ms of ac ute retr o viral s y n dr o me, i ncl u di n g s ore t hr oat, fe vers, s weats, 
hea dac hes, m yal gias or a rt hral gias, w hic h are n ot c o nsiste nt wit h seas o nal or c hr o nic patter ns.  If 
s y m pt o ms of ac ute retr o viral s y n dr o me are prese nt i n t he setti n g of a rece nt hi g h ris k e x p os ure, Pr E P will 
be deferre d u ntil t he res ults of t he HI V N A T  are bac k.  If t here has bee n a hi g h ris k e x p os ure i n t he past 
7 2 h o urs t o p ote ntiall y i nfecti o us b o d y fl ui ds fr o m a part ner w h o is HI V i nfecte d a n d w h o ha s a 
detecta ble or u n k n o w n viral l oa d (i.e., w h o d o n ot ha ve a m ost rece nt u n detecta ble HI V R N A bel o w t he 
li mit of q ua ntitati o n wit hi n t he pre vi o us 9 0 da ys), or w h o is at hi g h ris k f or bei n g HI V -i nfecte d, p ost-
e x p os ure pr o p h yla xis ( P E P) will be offere d usi n g a rec o m me n de d 3 dr u g re gi me n f or 2 8 da ys.  P referre d 
P E P re gi me ns  will be selecte d acc or di n g t o rece ntl y p u blis he d g ui deli nes of t he U S P H S f or occ u pati o nal 
P E P, a n d of t he Ne w Y or k State Tas k F orce.  
 
P E P s h o ul d be starte d as s o o n as p ossi ble, a n d bef ore t he res ults  of R N A testi n g  are k n o w n, a n d 
i n all cases wit hi n 7 2 h o urs of t he last p ossi ble e x p os ure t o HI V. If t he HI V R N A test res ult is ne gati ve, 
viral s y m pt o ms res ol ve, a n d re peat ra pi d a nti b o d y testi n g is n o n -reacti ve, P E P s h o ul d be disc o nti n ue d a n d 
t he partici pa nt ma y at t hat p oi nt be offere d Pr E P.  If t he HI V R N A test res ult is p ositi ve, t he partici pa nt 
will be i m me diatel y referre d t o t he T L C + ar m of C R U S H.  S o me p artici pa nts wit h n o hi g h ris k e x p os ures 
i n t he 7 2 h o ur P E P wi n d o w, b ut at o n g oi n g hi g h ris k a n d wit h s y m pt o ms a n d/ or si g ns hi g hl y s u g gesti ve 
of ac ute HI V i nfecti o n, ma y elect t o start pres u m pti ve hi g hl y a ntiretr o viral t hera p y ( H A A R T); t hese 
partici pa nts will be referre d i m me diatel y t o a n e x pert HI V cli nicia n.   
  
Creati ni ne testi n g will als o be perf or me d o n t he scree ni n g bl o o d sa m ple f or partici pa nts i nte n di n g 
t o recei ve Pr E P, a n d a uri ne di pstic k will be perf or me d t o assess f or pr otei n uria. Di pstic k pr otei n uria of 
2 + or greater will e xcl u de t he partici pa nt fr o m recei vi n g Pr E P; t hese partici pa nts will be  referre d f or 
cli nical e val uati o n.  If t he uri ne di pstic k is 1 +, Pr E P will be deferre d a n d t he partici pa nt will be as ke d t o 
ret ur n i n o ne wee k f or a re peat di pstic k. If a partici pa nt’s e nr oll me nt creati ni ne is n or mal a n d re peat 
di pstic k re mai ns < 2 +, s/ he ma y be gi n Pr E P.   


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 4  of 5 3  
If a Pr E P ca n di date has a n i de ntifia ble HI V-p ositi ve part ner, we will atte m pt t o o btai n ge n ot y pic 
i nf or mati o n a b o ut t he part ner’s vir us, i n or der t o a v oi d offeri n g Tr u va da ® Pr E P i n a sit uati o n of li kel y 
e x p os ure t o a vir us alrea d y resista n t t o b ot h c o m p o ne nt dr u gs of Tr u va da ®.   We will as k t he Pr E P 
ca n di date t o tr y t o o btai n a  de -i de ntifie d ge n ot y pe of t he ser op ositi ve part ner.   We will assist i n pr o vi di n g 
a release of c o nfi de ntial me dical i nf or mati o n f or m f or t his p ur p ose.  I n t he e ve nt that t he ser op ositi ve 
part ner is a patie nt at D Y C , we will as k t he ser op ositi ve part ner t o si g n a ‘ Release of I nf or mati o n’ 
all o wi n g t he Pr E P partici pa nt a n d t he C R U S H tea m  access t o his ge n ot y pe.  If a C R U S H  me dical 
pr o vi der has c o nfir me d d oc u me ntati o n t hat  t he ser op ositi ve part ner ’s vir us is resista nt t o b ot h dr u gs i n 
Tr u va da ® , or has reas o n t o belie ve t hat t his is li kel y t he case, t he n t he Pr E P patie nt will be e xcl u de d fr o m 
recei vi n g Tr u va da ® Pr E P as part of C R U S H, a n d will be referre d f or e x pert me dical c o ns ultati o n 
re gar di n g ot her o pti o ns. If we are u na ble t o o btai n a ge n ot y pe or resista nt rec or ds f or t he ser o p ositi ve 
part ner,  a n d ha ve n o reas o n t o belie ve t hat t w o-dr u g resista nce is li kel y, we will offer Tr u va da ® Pr E P as 
us ual .  
VII. 7 Pr E P  I niti ati o n 
T he  Pr E P i nitiati o n visit will ta ke place 1 -2 wee ks after scree ni n g, w he n all scree ni n g res ults are 
a vaila ble.  If t he partici pa nt is eli gi ble t o recei ve Pr E P, t he cli nicia n will re vie w all la b res ults d o ne at t he 
scree ni n g visit, re peat a ra pi d oral HI V a ntib o d y test, a n d o btai n a me dical hist or y al o n g wit h a f oc use d 
re vie w of s yste ms.  All partici pa nts w h o are deter mi ne d t o be H Bs A g ne gati ve a n d w h o d o n ot ha ve 
a nti b o dies t o he patitis B will be offere d t he he patitis B vacci nati o n series. If hi g h ris k e x p os ure, as 
descri be d i n secti o n VI 1. 1, or si g ns a n d/ or s y m pt o ms s u g gesti ve of ac ute retr o viral s y n dr o me ha ve 
occ urre d si nce t he scree ni n g visit, Pr E P will be wit h hel d a n d t he partici pa nt will be ma na ge d i n 
acc or da nce wit h t he g ui deli nes s pecifie d i n t he scree n i n g visit.  F urt her S TI testi n g will als o be d o ne if 
i n dicate d.   W o me n of re pr o d ucti ve p ote ntial will ha ve a ra pi d uri ne pre g na nc y test.  If n o 
c o ntrai n dicati o ns t o recei vi n g Pr E P ha ve bee n esta blis he d, t he ris ks a n d be nefits of F T C/ T D F ( Tr u va da ®) 
f or Pr EP will be re vie we d , a n d all q uesti o ns a n d c o ncer ns will be a d dresse d. T he partici pa nt will be 
i nstr ucte d t o ta ke F T C/ T D F dail y, at t he sa me ti me e ver y da y.  T he st u d y c o or di nat or or ot her D Y C staff 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 5  of 5 3  
me m ber will pr o vi de  ris k re d ucti o n c o u nseli n g, pr o vi de t he partici pa nt wit h c o n d o ms, a n d sc he d ule a 
f oll o w u p visit f or 4 wee ks. W he n all st u d y acti vities f or t he da y are c o m plete a n d d oc u me nte d o n a 
d is pe nsi n g chec klist, t he p har mac y will dis pe nse o ne b ottle ( 3 0 pills) of Tr u va da ® t o t he partici pa nt.    
Partici pa nts f o u n d t o be he patitis B a nti ge n p ositi ve, w h o c h o ose n ot t o ta ke Pr E P, will be referre d 
t o eit her t heir pri mar y care pr o vi der or a n ot her c o m m u nit y base d cli nic f or treat me nt of he patitis B 
i nfecti o n.  Partici pa nts w h o are H Bs A g-p ositi ve a n d w h o i nitiate Pr E P will be i nf or me d t hat st o p pi n g 
Pr E P c o ul d ca use a he patitis flare a n d/ or he patitis B dr u g resista nce. T he cli nical sta ge of t heir li ver 
disease will be assesse d at Pr E P i nitiati o n  (see A p pe n di x Q), i ncl u di n g testi n g f or A S T/ A L T, t otal 
bilir u bi n, al kali ne p h os p hatase, pr ot hr o m bi n ti me, a n d al b u mi n, a n d a cli nical e val uati o n f or sti g mata of 
cirr h osis. Partici pa nts w h o are H Bs A g p ositi ve a n d w h o recei ve Pr E P will ha ve t heir he patitis B D N A 
viral l oa d a n d t heir A S T/ A L T m o nit ore d f or t he d urati o n of t heir  Pr E P use  a n d f or 6 m o nt hs  f oll o wi n g 
disc o nti n uati o n of Pr E P . 
 
 VII. 8 O ne M o nt h Visit  
At t he 1 -m o nt h visit, partici pa nts will ha ve a ra pi d HI V a nti b o d y test, se x ual healt h pr o m oti o n 
c o u nseli n g, a n d Pr E P -s pecific c o u nseli n g. Partici pa nts will meet wit h t he st u d y cli nicia n f or a me dical 
hist or y a n d tar gete d p h ysical e xa m. F or partici pa nts w h o are still i ntereste d i n recei vi n g Pr E P, a bl o o d 
sa m ple will be dra w n f or creati ni ne a n d f or drie d bl o o d s p ot ( D B S) testi n g of dr u g le vels.   A d diti o nall y 
f or t h ose partici pa nts w h o are H Bs A g p ositi ve, bl o o d will be dra w n f or A L T/ A S T a n d he patitis B D N A.   
Partici pa nts w h o re mai n eli gi ble t o recei ve Pr E P will be pr o vi de d t w o b ottles ( 6 0 pills) at t his visit. 
W o me n of re pr o d ucti ve p ote ntial will ha ve a ra pi d uri ne pre g na nc y test.   
VI I. 9 S u bse q ue nt visits  
S u bse q ue nt visits will occ ur acc or di n g t o t he sc he d ule s h o w n i n t he ta ble of St u d y Pr oce d ures.  
F oll o wi n g t he 1 m o nt h f oll o w u p visit, partici pa nts will be as ke d t o ret ur n t o t he cli nic i n 2 m ore m o nt hs 
(at 3 m o nt hs of partici pati o n), a n d t he n e ver y 3 m o nt hs t hereafter f or st u d y visits (i.e., at m o nt hs 3, 6, 9 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 6  of 5 3  
a n d 1 2). T hese visits will be sc he d ule d wit hi n +/ -2 wee ks of t he tar get date base d o n Pr E P i nitiati o n .  
Partici pa nts w h o elect t o c o nti n ue Pr E P be y o n d 4 8 wee ks will c o n ti n ue t o be assesse d e ver y 3 m o nt hs f or 
t he d urati o n of t he pr oject peri o d, or u ntil t he y cease Pr E P. 
At q uarterl y visits, partici pa nts will recei ve ra pi d HI V testi n g  a n d c o u nseli n g , a n d will meet wit h a 
cli nicia n f or a me dical hist or y. If t he y re p ort a p o ssi ble S TI e x p os ure or ha ve s y m pt o ms of a n S TI, t he y 
will be teste d a n d treate d as a p pr o priate. Partici pa nts will als o recei ve Pr E P -s pecific c o u nseli n g, be as ke d 
t o pr o vi de a bl o o d sa m ple f or creati ni ne a n d f or drie d bl o o d s p ot ( D B S) dr u g le vel testi n g, a n d be 
dis pe nse d 3 b ottles ( 9 0 pills) of Pr E P. W o me n of re pr o d ucti ve p ote ntial will ha ve a ra pi d uri ne pre g na nc y 
test at all sc he d ule d visits. At se mia n n ual visits, i n a d diti o n t o t he q uarterl y pr oce d ures, partici pa nts will 
ha ve S TI a n d ser u m HI V a nti b o d y te sti n g d o ne, a tar gete d p h ysical e xa m will be perf or me d, a n d t he y will 
be as ke d t o c o m plete a n A C A SI q uesti o n naire. Partici pa nts w h o are H Bs A g p ositi ve will ha ve A L T/ A S T 
a n d H B V D N A viral l oa d testi n g d o ne.     
 
VIII. Assess me nts a n d I nter ve nti o ns  
Assess me nts a n d i nter ve nti o ns ta ki n g place at eac h visit are descri be d bel o w.  
        VII I. 1 Ris k assess me nt a n d cli nici a n c o u nseli n g 
Ris k assess me nts will be c o n d ucte d usi n g " Fi ve P's," a si m ple a p pr oac h t o ris k assess me nts f or 
cli nicia ns rec o m me n de d b y t he Calif or nia S T D Pre ve nti o n Bra nc h ( C A S T D Bra nc h, 2 0 1 1). 8  T he fi v e P's 
sta n d f or Part ners, se x ual Practices, Past S TIs, Pre g na nc y hist or y a n d pla ns (if rele va nt), a n d Pr otecti o n 
fr o m S TIs.  Se x ual ris k i nf or mati o n will be e ntere d i nt o t he cli nical n otes.  T he cli nicia n will d oc u me nt 
perf or ma nce of a ris k assess me nt o n t he Dis pe nsi n g C hec klist, a n d perf or m brief c o u nseli n g re gar di n g 
ris k re d ucti o n. 
VIII. 2 Pre g n a nc y  a n d bre astfee di n g assess me nt a n d c o u nseli n g  
Fe male partici pa nts of re pr o d ucti ve p ote ntial (a nat o micall y fe male, pre me n o pa usal, wit h a n i ntact 
uter us) will be scree ne d at eac h visit f or pre g na nc y, pla ns t o bec o me pre g na nt, a n d c urre nt breastfee di n g.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 7  of 5 3  
All w o me n w h o are pre g na nt at e nr oll me nt or bec o me pre g na nt d uri n g t heir partici pati o n will be 
i m me diatel y li n ke d t o pre natal care. T he cli nicia n will: 
a.      Deter mi ne if w o me n are pla n ni n g t o bec o me pre g na nt, are c urre ntl y pre g na nt, or are breastfee di n g;  
b.       Discl ose t o w o me n t hat safet y f or i nfa nts e x p ose d t o Tr u va da ® d uri n g pre g na nc y has n ot bee n 
f ull y assesse d b ut t hat n o har m has bee n re p orte d; 
c.      D o n ot offer ( or, if alrea d y be g u n, cease) Pr E P t o w o me n w h o are breastfee di n g;  
d.       C o n d uct a pre g na nc y test a n d d oc u me nt res ults; if pre g na nt, disc uss c o nti n ue d use of Pr E P wit h 
patie nt a n d pre natal care pr o vi der;  
e.      Bef ore dis pe nsi n g Pr E P, e ns ure t hat a uri ne pre g na nc y test is ne gati ve or, if pre g na nt, t hat t he 
patie nt has bee n i nf or me d a b o ut Tr u va da ® use d uri n g pre g na nc y; a n d  
f.       U p o n disc o nti n uati o n of Pr E P i n a pre g na nt partici pa nt, i nf or m pre natal care pr o vi der of 
T D F/ F T C us e i n earl y pre g na nc y a n d c o or di nate care t o mai ntai n HI V pre ve nti o n d uri n g 
pre g na nc y a n d breastfee di n g.  
 
VI II. 3 A d here nce assess me nt a n d c o u nseli n g 
A d here nce c o u nseli n g ( m oti vati o nal c o u nseli n g) will be perf or me d at e ver y visit w hile 
partici pa nts are recei vi n g Pr E P, as part of a n I nte grate d Ne xt -Ste p C o u nseli n g a p pr oac h 9. T his clie nt-
ce ntere d a p pr oac h will n ot be assess me nt -base d. T he c o u nseli n g c o n versati o n will f oc us o n facilitat ors 
a n d barriers t o pill -ta ki n g, a n d strate gies f or ma ke pill -ta ki n g m ore ma na gea ble f or t he partici pa nt.  I n t he 
sec o n d p orti o n of t he visit wit h t he st u d y c o or di nat or or ot her D Y C staff me m ber, a pill c o u nt will be 
c o n d ucte d.  Pill c o u nts will be c o m pare d t o t he e x pecte d n u m ber of pills re mai ni n g, a n d t he st u d y 
c o or di nat or will i nf or m t he partici pa nt of t he de gree of discre pa nc y.  If dr u g le vels are a vaila ble fr o m t he 
pri or visit’s drie d bl o o d s p ot ( D B S) testi n g, res ults will be s hare d wit h t he partici pa nt a n d disc usse d.  
A d here nce c o u nseli n g f oll o wi n g t he m o del a b o ve will be re pe ate d. 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 8  of 5 3  
A d here nce will be f urt her assesse d o n t he se mia n n ual A C A SI q uesti o n naire. A d diti o nall y, at t he 
ti me of eac h D B S c ollecti o n, partici pa nts recei vi n g Pr E P will be as ke d a b o ut t he ti mi n g of t heir m ost 
rece nt t hree Tr u va da ® d oses, i n or der t o ai d i n i nterpretati o n of D B S res ults. A n assess me nt t o ol use d i n 
c o nj u ncti o n wit h i nte grate d ne xt ste p c o u nseli n g is i ncl u de d i n a p pe n di x  1 0 . 
VII I. 4 Me dic al hist or y a n d f oc use d re vie w of s yste ms  
S y m pt o ms of S TIs i ncl u di n g ac ute HI V i nfecti o n will be assesse d a n d rec o r de d i n t he cli nical 
n otes acc or di n g t o us ual cli nic practice.  T he me dical hist or y will als o as k a b o ut p ote ntial si de effects of 
Tr u va da ®. T he cli nicia n will verif y t hat t here are n o s y m pt o ms of ac ute HI V o n t he Dis pe nsi n g 
C hec klist.  
VII I. 5 T ar gete d p h ysic al e x a m 
T he cli nicia n will perf or m a tar gete d e xa m as re q uire d base d u p o n t he me dical hist or y a n d 
f oc use d re vie w of s yste ms a n d rec or d t he res ults i n t he cli nical n otes. 
VI II. 6 Ris k Re d ucti o n/ Se x u al he alt h pr o m oti o n c o u nseli n g 
Se x ual healt h pr o m oti o n c o u n seli n g will be perf or me d at e ver y sc he d ule d visit f or all partici pa nts. 
T he c o u nseli n g a p pr oac h will f oll o w t he I nte grate d Ne xt -Ste p C o u nseli n g m o del. T he c o u nseli n g 
c o n versati o n will re vie w w hic h se x ual healt h pr o m oti o n strate gies t he partici pa nt uses, t heir facilitat ors 
a n d barriers t o t heir use, a n d a n a gree me nt o n w hic h strate gies t he partici pa nt w o ul d li ke t o c o nti n ue or 
tr y t o use.  
VI II. 7 L a b or at or y e v al u ati o n 
T he cli nicia n will or der a p pr o priate la b orat or y st u dies at t he c o ncl usi o n of t he visit, a n d  c hec k off 
w hic h la bs were or dere d o n t he Dis pe nsi n g C hec klist.  Pri or t o dis pe nsi n g, t he st u d y c o or di nat or or D Y C 
staff me m ber will verif y t hat all re q uire d la b s peci me ns were s u b mitte d t o t he o n-site cli nical la b. 
VI II. 8 Dr u g le vel ass a y: Drie d Bl o o d S p ot Testi n g 
Bl o o d will be dra w n, pr ocesse d, st ore d, a n d s hi p pe d f or drie d bl o o d s p ot ( D B S) testi n g of 
i ntracell ular le vels of te n of o vir a n d e mtricita bi ne, at ti me p oi nts as s h o w n i n t he sc he d ule of visits.  Dr u g 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 2 9  of 5 3  
le vel data ma y bec o me a vaila ble bef ore t he partici pa nt’s ne xt sc he d ule d st u d y visit.  If t hese data 
de m o nstrate li kel y i na de q uate a d here nce, t he partici pa nt will be c o ntacte d a n d br o u g ht i n f or a n 
a d diti o nal visit, w hic h  will f oc us o n a d here nce s u p p ort usi n g t he I nte grate d Ne xt -Ste p C o u nseli n g m o del . 
VI II. 9 S TI e v al u ati o n a n d tre at me nt 
Se x uall y tra ns mitte d i nfecti o ns will be e val uate d a n d treate d i n acc or da nce wit h us ual cli nic 
pr oce d ures, w hic h are c o nsiste nt wit h C D C g ui deli nes a n d i ncl u de scree ni n g f or as y m pt o matic i nfecti o ns 
a m o n g hi g h ris k gr o u ps ( i ncl usi ve of all st u d y partici pa nts), e vi de nce-base d treat me nt, e x pe dite d part ner 
t hera p y, a n d pr o m pt p u blic healt h re p orti n g. 
VI II. 1 0 P h ar m ace utic al dis pe nsi n g 
At Pr E P i nitiati o n a staff me m ber will pr o vi de t he p har mac y t he prescri pti o n f or Pr E P i nitiati o n 
a n d ha n d t he b ottle t o t he partici pa nt at t he visit. At s u bse q ue nt, sc he d ule d visits t he cli nicia n ma y fill a 
prescri pti o n pri or t o t he visit a n d dis pe nse it t o t he partici pa nt directl y after eli gi bilit y has bee n 
c o nfir me d.  
VI II. 1 1 P artici p a nt rete nti o n 
O ne wee k bef ore eac h sc he d ule d visit, t he st u d y c o or di nat or will c o ntact eac h partici pa nt t o re mi n d 
hi m/ her of t he date a n d ti me of t he ne xt a p p oi nt me nt a n d resc he d ule if necessar y. If a partici pa nt ca n n ot 
be c o ntacte d a n d misses a n a p p oi nt me nt, t he st u d y  c o or di nat or will use a d diti o nal c o ntact i nf or mati o n 
rec or de d i n t he me dical rec or d or at st u d y i nta ke t o atte m pt t o get i n t o uc h wit h hi m/ her. T o ma xi mize 
rete nti o n, t he st u d y c o or di nat or will als o c o ntact eac h partici pa nt at least o nce mi d-wa y bet wee n q u arterl y 
visits t o assess f or a n y ge neral pr o ble ms t hat ma y i nterfere wit h partici pati o n , i ncl u di n g a d here nce 
c halle n ges, healt h i ns ura nce c halle n ges, tra ns p ortati o n barriers, s ocial iss ues, etc.   
After u ns uccessf ul atte m pts t o c o ntact a partici pa nt f or ei t her a visit re mi n der or a mi d-wa y c hec k -i n, 
t he st u d y c o or di nat or will atte m pt t o f oll o w-u p a mi ni m u m of t hree ti mes. Atte m pts t o c o ntact t he 
partici pa nt will cease u p o n partici pa nt re q uest at a n y ti me.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 0  of 5 3  
VIII . 1 2   P artici p a nt Wit h dr a w al a n d St u d y C o m pleti o n  
Partici pa nts ma y v ol u ntaril y wit h dra w fr o m t he st u d y f or a n y reas o n at a n y ti me. O ne of t he 
i n vesti gat ors als o ma y wit h dra w partici pa nts fr o m t he st u d y i n or der t o pr otect t heir safet y, staff safet y, 
a n d/ or if partici pa nts are u n willi n g or u na ble t o c o m pl y wit h re q uire d st u d y pr oce d ures. Partici pa nts als o 
ma y be wit h dra w n if t he st u d y s p o ns or ter mi nates t he st u d y pri or t o its pla n ne d e n d date. T he st u d y 
c o or di nat or will a d mi nister t he St u d y E xit Q uesti o n naire i n pers o n if p ossi ble , a n d b y p h o ne if necessar y , 
t o all patie nts w h o wit h dra w fr o m t he st u d y.  If a d mi nistrati o n of t he St u d y E xit Q uesti o n naire is ref use d 
or n ot p ossi ble, t he st u d y c o or di nat or will rec or d a brief descri pti o n of t he circ u msta nces of eac h 
wit h dra wal.  
I X.  A d verse E ve nts a n d T o xicit y M a n a ge me nt  
S y m pt o ms a n d la b orat or y para meters ass ociate d wit h p ote ntial t o xicities of F T C/ T D F will be 
m o nit ore d as descri be d a b o ve. As is tr ue f or all patie nts of E B A C/ D Y C, st u d y partici pa nts will ha ve 
recei ve d i nstr ucti o ns f or c o ntacti n g t he cli nic t o rep ort a n y a d verse si g ns or s y m pt o ms t hat t he y 
e x perie nce. Gra de 3 or 4 a d verse e ve nts, as defi ne d b y t he D AI D S Ta ble f or Gra di n g t he Se verit y of 
A d ult a n d Pe diatric A Es, Versi o n 1. 0, Dece m ber, 2 0 0 4 ( Clarificati o n A u g ust 2 0 0 9) will be rec or de d o n 
t he A d verse E ve nt f or m.  All A d verse E ve nts will be e val uate d b y a n E B A C/ D Y C cli nicia n.  
S y m pt o matic Gra de 3 e ve nts a n d Gra de 4 a d verse e ve nts will be re p orte d t o C H R P a n d Gilea d Scie nces 
b y t he i n vesti gat ors re gar dless of relati o n t o t he st u d y dr u g.  
I X. 1. 1 Cre ati ni ne ele v ati o n 
F or a n esti mate d gl o mer ular filtrati o n rate (e G F R) less t ha n 6 0 ml/ mi n/ 1. 7 3 m 2, ser u m creati ni ne 
will be re peate d as s o o n as p ossi ble wit hi n 7 da ys. If t he e G F R re mai ns less t ha n 6 0, F T C/ T D F will be 
hel d u ntil t he e G F R is a gai n greater t ha n 6 0 , at w hic h p oi nt t he partici pa nt ma y be re-c halle n ge d wit h 
F T C/ T D F after c o ns ultati o n wit h t he Pri nci pal I n vesti gat or ( Dr. B urac k). If t he e G F R a gai n falls bel o w 
6 0 after t he dr u g is restarte d, F T C/ T D F will be per ma ne ntl y disc o nti n ue d, a n d t he partici pa nt will be 
m o nit ore d u ntil t he e G F R ret ur ns t o baseli ne or sta bilizes.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 1  of 5 3  
I X. 2 Uri ne pr otei n detecti o n 
A n y partici pa nt wit h pr otei n of 1 + or greater o n uri ne di pstic k a nal ysis will ha ve t he uri ne 
di pstic k re peate d wit hi n a wee k.  If t he creati ni ne is n or mal a n d  t he re peat di pstic k is < 2 + t he partici pa nt 
ma y re mai n o n Pr E P. Partici pa nts w h o ha ve  di pstic k of ≥ 2 + will ha ve Pr E P disc o nti n ue d a n d  will be 
referre d t o a ne p hr ol o gist. If t he ne p hr ol o gist d oes n ot rec o m me n d a gai nst restarti n g Pr E P, t he partici pa nt 
ca n restart.  Partici pa nts wit h e vi de nce of re nal t o xicit y attri b uta ble t o F T C/ T D F will ha ve t he st u d y dr u g 
st o p pe d 
I X. 3 HI V ac q uisiti o n /s us pecte d ac ute HI V i nfecti o n  
A n y i nitiall y HI V-ne gati ve partici pa nt wit h a p ositi ve HI V test of a n y t y pe d uri n g t he c o ur se of 
t he st u d y will be i nstr ucte d t o c o me i n i m me diatel y f or a n HI V + ( Ser oc o n versi o n) visit.  Patie nts 
ser oc o n verti n g w hile o n Pr E P will be offere d t he c h oice t o eit her ( 1) i nte nsif y t o a n a p pr o ve d 3 or 4 dr u g 
a ntiretr o viral re gi me n f or pres u m pti ve HI V treat me nt, as prescri be d b y a n e x pert HI V cli nicia n, or ( 2) 
st o p ta ki n g Pr E P.  At t he HI V + (ser oc o n versi o n) visit, t he partici pa nt will ha ve bl o o d dra w n f or 
c o nfir mat or y HI V Wester n bl ot a n d q ua ntitati ve HI V R N A P C R wit h refle x t o HI V -1 ge n ot y pe, as well 
as D B S testi n g f or dr u g le vels.  A d diti o nal bl o o d s peci me ns will be se nt t o t he U C S F la b orat or y of Teri 
Lie gler, M D, f or a n allele-s pecific P C R-base d assa y  f or detecti o n of mi n or varia nt dr u g resista nce at 
F T C/ T D F -selecti o n c o d o ns.  ( See A p pe n di x S.)  W o me n o f re pr o d ucti ve p ote ntial will ha ve a ra pi d uri ne 
pre g na nc y test.  A me dical hist or y, p h ysical e xa m, ris k assess me nt, ris k re d ucti o n c o u nseli n g, a d here nce 
assess me nt, a n d S TI e val uati o n will be perf or me d. T he partici pa nt will be as ke d t o ret ur n wit hi n o ne 
w ee k t o recei ve t he res ults of t he c o nfir mat or y HI V testi n g. F or t h ose c o nfir me d t o be HI V i nfecte d, 
E B A C/ D Y C will pr o vi de c o u nseli n g a n d i m me diate li n ka ge t o HI V pri mar y care acc or di n g t o us ual cli nic 
practice.  HI V i nfecte d partici pa nts w h o ha d electe d i n te nsificati o n t o hi g hl y acti ve a ntiretr o viral t hera p y 
( H A A R T) will be e nc o ura ge d t o c o nti n ue t heir treat me nt re gi me n u ntil HI V pri mar y care is esta blis he d.  
T h ose c o nfir me d t o be HI V u ni nfecte d will n ot res u me t he st u d y pr ot oc ol, a n d, if t he y ha ve electe d 
i nte nsificati o n t o H A A R T, will disc o nti n ue treat me nt.  So me patie nts w h o pr o ve t o be HI V u ni nfecte d 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 2  of 5 3  
ma y c h o ose t o restart Pr E P o utsi de t his pr ot oc ol, wit h m o nit ori n g as a p pr o priate f or t he cli nical 
circ u msta nces u n der t he g ui da nce of a n e x pert HI V cli nicia n.  
A n y partici pa nt wit h si g ns a n d s y m pt o ms at a n y st u d y visit s u g gesti ve of ac ute retr o viral 
s y n dr o me, i n t he setti n g of rece nt hi g h ris k be ha vi or, b ut wit h o ut ser ol o gic e vi de nce of HI V i nfecti o n t o 
date, will ha ve q ualitati ve HI V R N A testi n g se nt a n d will  be offere d i m me diate i nte nsificati o n t o a n 
a p pr o ve d 3 or 4 dr u g hi g hl y acti ve a ntiretr o viral t hera p y ( H A A R T) re gi me n as prescri be d b y a n e x pert 
HI V cli nicia n.  T his re gi me n will be c o nti n ue d, wit h cli nicall y a p pr o priate m o nit ori n g, u ntil res ults of 
R N A te sti n g are o btai ne d.  If HI V R N A testi n g is ne gati ve, t he patie nt will disc o nti n ue t he i nte nsificati o n 
a ge nt(s), a n d will be offere d c o nti n ue d Tr u va da ® pr o p h yla xis, as sc he d ule d o n t he Pr E P pr ot oc ol.   If 
HI V R N A testi n g is p ositi ve, t he patie nt will be i ns tr ucte d t o c o nti n ue H A A R T, a n d will be br o u g ht i n f or 
a n HI V + ( Ser oc o n versi o n) visit as a b o ve.  E B A C/ D Y C will pr o vi de c o u nseli n g a n d i m me diate li n ka ge t o 
HI V pri mar y care acc or di n g t o us ual cli nic practice.  
 
I X. 4 Pre g n a nc y 
W o me n w h o bec o me pre g na nt d uri n g t he st u d y ma y c o nti n ue Pr E P, partic ularl y si nce ris k of HI V 
ac q uisiti o n ma y be hi g her d uri n g t his peri o d.  T he cli nicia n will discl ose t o pre g na nt w o me n a n d t h ose 
pla n ni n g pre g na nc y t hat safet y f or i nfa nts e x p ose d t o Tr u va da ® d uri n g pre g na nc y is n ot f ull y assesse d, 
b ut t hat n o har m has bee n re p orte d .  Pre g na nt partici pa nts will be offere d t he o pti o ns of c o nti n ui n g or 
st o p pi n g Pr E P, a n d i n all cases will be referre d i m me diatel y f or pre natal care.  U p o n disc o nti n uati o n of 
Pr E P d uri n g  pre g na nc y, t he cli nicia n will i nf or m pre natal care pr o vi ders of T D F/ F T C use i n earl y 
pre g na nc y a n d will c o or di nate care t o mai ntai n HI V pre ve nti o n d uri n g pre g na nc y.  Partici pa nt 
i nf or mati o n will be s u b mitte d t o t he F D A’s A ntiretr o viral Pre g na nc y Re gistr y.   W o me n w h o gi ve birt h 
wil l be c o u nsele d n ot t o breastfee d, i n acc or da nce wit h U S g ui deli nes.  Pr E P will be disc o nti n ue d f or a n y 
w o ma n w h o i nte n ds t o breastfee d.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 3  of 5 3  
I X.. 5 S oci al h ar ms 
Partici pati o n i n t he st u d y c o ul d lea d t o s ocial har ms t hat ma y i ncl u de l oss of pri vac y, 
sti g matizati on, i nterfere nce wit h e m pl o y me nt, a n d c oerci o n. Partici pa nts w h o re p ort s ocial har ms will be 
referre d t o a cli nicia n. Pr E P ma y or ma y n ot be c o nti n ue d de pe n di n g u p o n t he prefere nce of t he patie nt 
a n d t he j u d g me nt of t he cli nicia n.  S ocial har ms lea di n g t o d isc o nti n uati o n of st u d y dr u g will be rec or de d 
o n a n A d verse E ve nt f or m a n d re p orte d t o C H R P a n d Gilea d Scie nces.  
 
X. D at a c ollecti o n a n d st or a ge  
T he st u d y c o or di nat or will mai ntai n a pass w or d -pr otecte d electr o nic list of st u d y partici pa nts o n a 
ser ver accessi ble o nl y t o cli nic staff at E B A C/ D Y C.  Data rec or de d o n t hat list will i ncl u de first a n d last 
na me, me dical rec or d n u m ber (f or partici pa nts k n o w n t o E B A C/ D Y C), a n d e nr oll me nt stat us ( p ote ntiall y 
i ntereste d, i neli gi ble, n ot i ntereste d, c urre ntl y e nr olle d, wit h dra w n, or c o m plete d). De m o gra p hic data, 
visit dates, cli nic n otes, a n d all la b orat or y data will be mai ntai ne d acc or di n g t o us ual cli nic practices i n 
E PI C , t he electr o nic me dical rec or d at E B A C/ D Y C.  Misse d visit data will als o be mai ntai ne d i n E PI C  
acc or di n g t o us ual cli nic practices . 
All f or ms will be file d i n a se parate secti o n i n t he pa per c hart reser ve d f or C R U S H case rec or d 
f or ms. At t he ti me of wit h dra wal or st u d y c o m pleti o n, data fr o m st u d y f or ms will be e ntere d i nt o a 
pass w or d -pr otecte d data ba se.  De m o gra p hic data, visit dates, a n d la b orat or y data a n d misse d visit data 
fr o m E PI C  will be li n ke d t o t he data base b y me dical rec or d n u m ber t o f or m t he data set f or a nal ysis. 
A n y data tra nsferre d o utsi de of t he E B A C s yste m will be se nt b y sec ure F T P pr ot oc ol or 
u pl oa de d directl y o nt o a n e ncr y pte d dri ve . 
 
XI.  
Refere nces  
1.  Gra nt, R. M. et al. Pree x p os ure c he m o pr o p h yla xis f or HI V pre ve nti o n i n me n w h o ha ve se x wit h 
me n. N. E n gl. J. Me d.  3 6 3 , 2 5 8 7– 2 5 9 9 ( 2 0 1 0) . 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 4  of 5 3  
2.  Baete n, J. M. et al. A ntiretr o viral Pr o p h yla xis f or HI V Pre ve nti o n i n Heter ose x ual Me n a n d 
W o me n. Ne w E n gl a n d J o ur n al of Me dici ne  3 6 7 , 3 9 9– 4 1 0 ( 2 0 1 2).  
3.  T hi g pe n, M. Dail y oral a nti -retr o viral use f or t he pre ve nti o n of HI V i nfecti o n i n heter ose x uall y 
acti ve y o u n g a d ults i n B ots wa na: res ults fr o m t he T D F 2 st u d y. ( 2 0 1 1).  
4.    Press A n n o u nce me nts > F D A a p pr o ves first dr u g f or re d uci n g t he ris k of se x uall y ac q uire d HI V 
i nfecti o n. at 
< htt p:// w w w.f da. g o v/ Ne ws E ve nts/ Ne wsr o o m/ Press A n n o u nce me nts/ uc m 3 1 2 2 1 0. ht m >  
5.   I nteri m G ui da nce f or Cli nicia ns C o nsi deri n g t he Use of Pree x p os ure Pr o p h yla xis f or t he 
Pre ve nti o n of HI V I nfecti o n i n Heter ose x uall y Acti ve A d ults. at 
< htt p:// w w w.c dc. g o v/ m m wr/ pre vie w/ m m wr ht ml/ m m 6 1 3 1a 2. ht m?s _ci d = m m 6 1 3 1a 2 _ w >  
6.    I nteri m G ui da nce: Pree x p os ure Pr o p h yla xis f or t he Pre ve nti o n of HI V I nfecti o n i n Me n W h o 
Ha ve Se x wit h Me n. at < htt p:// w w w.c dc. g o v/ m m wr/ pre vie w/ m m wr ht ml/ m m 6 0 0 3a 1. ht m >  
7.  Ar n ol d, E. et al. U n derst a n di n g t he fe asi bility a n d acce pt a bility of i m ple me nti n g Pre -Ex p os ure 
Pr o p hyl axis ( Pr E P) t o preve nt HI V a m o n g Afric a n A meric a n me n w h o h ave sex wit h me n a n d 
tr a ns ge n der pe o ple i n N ort her n C alif or ni a: Fi n al Pr o gress Re p ort. ( U C S F Ce nter f or AI D S 
Pre ve nti o n St u dies: Sa n Fra ncisc o, C A, 2 0 1 1).  
8.  Calif or nia De part me nt of P u blic Healt h Se x uall y Tra ns mitte d Diseases ( S T D) C o ntr ol Bra nc h i n 
c olla b orati o n wit h t he Calif or nia S T D/ HI V Pre ve nti o n Trai ni n g Ce nter A Cli nicia n’s G ui de t o 
Se x ual Hist or y Ta ki n g. ( 2 0 1 1). 
9.  A mic o, K R, Mc Ma ha n V, G oic oc hea P, Var gas L, Marc us J L, Gra nt R M, et al. 
S u p p orti n g st u d y pr o d uct use a n d acc urac y i n self-re p ort i n t he i Pr E x st u d y: ne xt ste p 
c o u nseli n g a n d ne utral assess me nt. AI D S a n d be ha vi or. 2 0 1 2 J ul; 1 6( 5): 1 2 4 3- 5 9.  
   
1 0. Gi or da n o, T. P. et al. Meas uri n g a d here nce t o a ntiretr o viral t hera p y i n a di verse p o p ulati o n usi n g 
a vis ual a nal o g ue scale. HI V cli nic al tri als  5 , ( 2 0 0 4). 
1 1 . A P H A: A d here nce t o HI V Treat me nt Re gi me ns. at 
< htt p:// w w w.a p ha. or g/ pr o gra ms/res o urces/ HI V + -+ AI D S/res hi vre gi me ns. ht m >  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 5  of 5 3  
 
 
 
 
 
 
 
A p pe n di x 1
 
C R U S H St u d y E nr oll me nt 
Pr ojecti o n


S e pt e m b er 2 0 1 3  
U p d at e d D e c e m b er 1 7,  2 0 1 3  
 
 
Ass u m es t h at  t w o t hir ds of p ositiv es a n d a 
q u art er of n e g ativ es ar e b ot h li nk e d t o 
C R U S H a n d willi n g t o p artici p at e i n st u dy 
d at a c oll ecti o n , a n d t h at 3 0 % of n e g ativ es 
will b e i nt er est e d i n Pr E P
Ass u mi n g a p ositivity of 2. 5 % f or 
c o m m u nity t esti n g a n d 1 0 % f or s oci al 
n et w or k t esti n g, a n d a n u nc h a n g e d r at e of 
n e wl y r ef err e d p ositiv e cli e nts fr o m ot h er 
a g e nci es ( 4 8 p er y e ar)
Ass u m es a n n u al t est v ol u m es as f oll o ws:
L a Cli nic a d e l a R az a 1 5 0
H Y F Y  2 5
B er k el ey B uil ds C a p acity
2 5
Asi a n H e alt h 1 5 0
H E P P A C 8 5
R Y S E 4 0
J o e H a wki ns/ O akl a n d Pri d e 1 5 0
S oci al n et w or k t esti n g
5 0
Als o ass u m es t h at e nr oll m e nt st arts 3 
m o nt hs aft er st u dy st art a n d e n ds 1 2 
m o nt hs pri or t o st u dy e n d f or 2. 7 5 y e ars 
of e nr oll m e nt
T ot al N e w HI V t ests
N = 1 8 5 7
S oci al n et w ork t esti n g = 1 3 8
C o m m u nity p art n ers = 1 7 1 9
N e wly r ef err e d HI V 
p ositiv es
1 8 9 
T ot al n u m b er of HI V 
p ositiv es e nr oll e d i n 
C R US H
N = 2 2 5
HI V p ositiv e cli e nts alr e a dy 
e n g a g e d at D Y C w h o 
c h o os e t o e nr oll N = 1 0 0
N e wly r ef err e d HI V 
n e g ativ es N = 1 8 0 0
HI V n e g ativ e cli e nts 
e nr oll e d 
N = 4 5 0
HI V n e g ativ e a n d n ot 
i nt er est e d i n Pr E P
N = 3 1 5
HI V n e g ativ e a n d 
i nt er est e d i n Pr E P
N = 1 3 5
St u d y E nr oll me nt f or t he C R U S H Pr oject  


S e pt e m b er 2 0 1 3  
U p d at e d D e c e m b er 1 7,  2 0 1 3 
 
 
 
 
 
 
A p pe n di x 2: 
 
a.  Calif or nia Patie nt Bill of 
Ri g hts 
 
b. HI P P A Patie nt I nf or mati o n 
Release F or m 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 8  of 5 3  
 
 
 
 
A p pe n di x 3: 
 
C o nse nt F or ms 
a. HI V Ne gati ves 
b.  HI V P ositi ves 
c. Staff a n d C o m m u nit y 
Part ner 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 3 9  of 5 3  
 
 
 
A p pe n di x 4: 
St u d y Visit Sc he d ule 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 0  of 5 3  
 
St u d y Visit Sc he d ule  (
W e e k  
S cr e e ni n g *  
0 
4 
1 2, 
2 4, 
3 6, 4 8  
  
St o p 
dr u g  
HI V 
A b +  
 
 
 
 
 
 
 
 
Cli ni c al A s s e s s m e nt s/I nt er v e nti o n s  
 
 
 
 
 
 
 
S cr e e n i n cl u si o n/ e x cl u si o n crit eri a  
x 
 
 
 
 
 
 
O bt ai n i nf or m e d c o n s e nt  
x 
 
 
 
 
 
 
M e di c al hi st or y a n d f o c u s e d 
r e vi e w of s y st e m s 
x 
x 
x 
x 
  
x 
x 
S TI Ri s k A s s e s s m e nt  
x 
x 
x 
x 
  
x 
x 
A d h er e n c e A s s e s s m e nt  
  
  
x 
x 
  
x 
x 
T ar g et e d P h y si c al E x a m  
x 
x 
x 
x 
  
x 
x 
A d h er e n c e c o u n s eli n g  
  
X 
x 
x 
  
x 
x 
Ri s k r e d u cti o n c o u n s eli n g, 
c o n d o m di stri b uti o n  
x 
X 
x 
x 
  
x 
x 
Dr u g di s p e n si n g  
  
X 
x 
x 
  
  
  
A C A SI ( w e e k s 0, 4, 2 4, 4 8 o nl y)  
 
X 
X 
x 
 
 
 
  
  
  
  
  
  
  
  
L a b o r at or y A s s e s s m e nt s 
  
  
  
  
  
  
  
Cr e ati ni n e  
x 
 
x 
x 
  
  
  
Uri n e di p sti c k pr ot ei n  
x 
X  
x 
x 
  
  
  
R a pi d uri n e pr e g n a n c y t e st (if 
r el e v a nt ) 
x 
X 
x 
x 
  
x 
x 
H B s A g ( a n d H B s A b if n ot 
d o c u m e nt e d)  
x 
  
  
  
  
  
  
A L T/ A S T (if H B s A g +)  
 
X 
x 
x 
 
x 
X 
H B V D N A + L F T s(if H B s A g +)  
 
X 
x 
x 
 
x 
x 
S er u m HI V A b EI A  
x 
  
  
  
  
x 
  
R a pi d Or al HI V A b  
x 
X 
x 
x 
  
x 
  
HI V A b W e st er n Bl ot  
  
  
  
  
  
  
x 
HI V R N A Q u alit ati v e P C R  
x 
 
  
  
  
  
  
HI V R N A Q u alit ati v e P C R (ri s k -
g ui d e d)  
  
  
x 
x 
  
x 
  
HI V R N A Q u a ntit ati v e P C R  
  
  
  
  
  
  
x 
HI V - 1 g e n ot y p e  
  
  
  
  
  
  
x 
S TI l a b or at or y e v al u ati o n  
x 
  
  
x 
  
x 
x 
D B S Dr u g L e v el T e sti n g  
  
  
x 
x 
  
x 
x 
*- 4 t o - 1 w e e k s  
  
  
  
  
  
  
  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 1  of 5 3  
 
 
 
A p pe n di x 5: 
 
D R A F T  
A C A SI Be ha vi oral 
Q uesti o n naire 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 2  of 5 3  
 
 
A p pe n di x 6: 
 
Maslac h B ur n o ut I n ve nt or y 
( M BI) 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 3  of 5 3  
 
 
A p pe n di x 7: 
  N o n-seri o us A d verse E ve nts 
& Si de Effects I n ve nt or y 
 


C o n n e c ti n g  R e s o u r c e s f o r  U r b a n  S e x u al  H e al t h  
C R U S H  Pr ot o c ol,  V er . 1 . 0 
S e pt e m b er  2 0 1 3  
P a g e  4 4  of  5 3  
 
N o n -s e ri o us  A d v e rs e  E v e nts  &  Si d e  Eff e cts I n v e nt o r y  
N o n -s e ri o us  A d v e rs e  E v e nts  &  Si d e  Eff e cts I n v e nt o r y                            S u bj e ct I D  : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
      Si d e  Eff e ct  
       Di a g n osis  
           (if  k n o w n) 
       
      or  
       
      Si g ns/  
      S y m pt o ms  
D at e  of  
O ns et  
 
O ut c o m e  
 
 
 
D at e  of  R es ol uti o n  
or  
 
â 
C h e c k if  c o nti n ui n g  
S e v erit y 1 
R el ati o ns hi p t o  St u d y  Dr u g  
R el ati o ns hi p t o  St u d y  Pr o c e d ur e  
A cti o n t a k e n  wit h  St u d y  Dr u g 2 
Ot h er   a cti o n t a k e n 3 
W as  E v e nt  S eri o us ?  
 
PI  
Initi als
/ D at e 
d d/ m m m/ y y y y  
✓  
d d/ m m m/  y y y y  
  
Y/ N   Y/ N   
  
  
Y/ N   
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
 
 
1 S e v erit y  
 
1 = Mil d  
2 = M o d e r at e  
3 = S e v e r e  
4 = Lif e -T h r e at e ni n g  
2 A cti o n t a k e n  wit h 
St u d y  Dr u g  
 
1 = N ot  c h a n g e d  
2 =I nt e r r u pt e d  
3 = Wit h d r a w n  
 
3Ot h e r  A cti o n  T a k e n  
 
1  =  N o n e  
2  =  M e di c ati o n 
R e q ui r e d *  
3  = 
H os pit ali z ati o n/ P r ol o n g e
d  H os pit ali z ati o n  
4  =  Ot h e r  T r e at m e nt  
R e q ui r e d  
 
* A n y  m e di c ati o n t a k e n f or 
a n  A E s h o ul d  b e r e c or d e d 
o n t h e  C o n c o mit a nt 
M e di c ati o n  L o g  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 5  of 5 3  
 
 
 
 
 
 
A p pe n di x 8: 
 
Seri o us A d verse E ve nt Re p ort F or m


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 6  of 5 3  
S E RI O U S A D V E R S E E V E N T R E P O R T F O R M 
 
F or t he p ur p oses o f t his f or m, a seri o us a d verse e ve nt is a n y u nt o war d me dical occ urre nce t hat 
res ults i n deat h, is life-t hreate ni n g, re q uires or pr ol o n gs h os pitalizati o n, ca uses persiste nt or si g nifica nt 
disa bilit y/i nca pacit y, res ults i n c o n ge nital a n o malies/ birt h defects,  or i n t he o pi ni o n of t he i n vesti gat ors 
re prese nts ot her si g nifica nt hazar ds or p ote ntiall y seri o us har m t o researc h s u bjects or ot hers.  A seri o us 
a d verse e ve nt is c o nsi dere d u ne x pecte d if it is n ot descri be d i n t he Pac ka ge I nsert or i n t he I n vesti gat or’s  
Br oc h ure (f or F D A i n vesti gati o nal a ge nts), i n t he pr ot oc ol, or i n t he i nf or me d c o nse nt d oc u me nt.  
 
I N S T R U C TI O N S: 
Please c o m plete t he i nf or mati o n re q ueste d bel o w a n d f or war d a c o p y t o t he I R B a n d t he s p o ns or as s o o n 
as p ossi ble, b ut n ot later t ha n se ve n ( 7)  da ys i n t he case of deat h or life -t hreate ni n g seri o us a d verse e ve nts 
or wit hi n fiftee n ( 1 5) da ys after t he occ urre nce of all ot her f or ms of seri o us a d verse e ve nts. I n a d diti o n, 
c o nti n ue t o f oll o w F D A a n d t he NI H Office of Bi otec h n ol o g y Acti vities ( O B A) re p orti n g re q uire me nts if 
y o ur researc h i n v ol ves a n I N D/I D E or ge ne tra nsfer.  
 
P R O T O C O L #: _ _ _ _ - _ _ _ _ - 
_ _ _ _ _ _ _ _ _ _ _  
P R O T O C O L TI T L E: C o n necti n g Res o urces f or Ur b a n Sex u al 
He alt h:  
P RI N CI P A L I N V E S TI G A T O R:  
Jeffrey H. B ur ack, M. D.  
 
East Ba y AI D S Ce nter         Office P h o ne:                       
Fa x:                                      E -mail:  
D A T E O F S E RI O U S A D V E R S E 
E V E N T:  
_ _ _ _/ _ _ _ _/ _ _ _ _ _  
S U B J E C T I D : 
 
 
W A S T HI S A N U N E X P E C T E D 
A D V E R S E E V E N T ?     
Yes [   ]     N o [   ]  
B RI E F D E S C RI P TI O N O F 
S U B J E C T( S)  ( D o N O T i ncl u de 
i de ntifiers.) 
 
 
 
 
S E X:   M/ F       A G E : _ _ _ _ _ _ _ _ _ _ _ 
Eve nt :  
B RI E F D E S C RI P TI O N O F T H E N A T U R E O F T H E S E RI O U S A D V E R S E E V E N T:  
 
 
 
 
 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 7  of 5 3  
C A T E G O R Y ( o utc o me) O F T H E 
S E RI O U S A D V E R S E E V E N T:  
[  ] deat h                      
[  ] disa bilit y/i nca pacit y 
[  ] life-threate ni n g               
[  ] c o n ge nital a n o mal y/ birt h defect 
[  ] h os pitalizati o n-i nitial or pr ol o n ge d 
[  ] re q uire d i nter ve nti o n t o pre ve nt 
per ma ne nt    i m pair me nt  
[  ] ot her 
 
R E L A TI O N S HI P O F S E RI O U S A D V E R S E E V E N T 
T O R E S E A R C H:  
 
[  ] 1 = u nrelate d (clearly n ot relate d t o t he researc h)  
[  ] 2 = u nli kel y ( d o u btf ull y relate d t o t he researc h) 
[  ] 3 = p ossi ble ( ma y be relate d t o t he researc h) 
[  ] 4 = pr o ba ble (li kel y relate d t o t he researc h) 
[  ] 5 = defi nite (clearl y relate d t o t he researc h) 
W h at ste ps d o y o u pl a n t o t a ke as a res ult of 
t he a dverse eve nt re p orte d a b ove ?  
 
 
 
 
 
 
 
[  ] n o acti o n re q uire d 
[  ] c o nti n ue st u d y dr u g 
[  ] disc o nti n ue st u d y dr u g 
[  ] ot her, descri be: 
R E P O R T E R’ S SI G N A T U R E:  
D A T E:   
I N V E S TI G A T O R’ S SI G N A T U R E: 
D A T E:   
 
 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 8  of 5 3  
 
 
 
 
A p pe n di x 9: 
Pr E P I nf or mati o nal Fact S heets 
f or Partici pa nt 
 
 
 
 
 
 
 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 4 9  of 5 3  
 
 
 
A p pe n di x 1 0: 
I nte grate d Ne xt Ste p 
C o u nseli n g Assess me nt T o ol 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 5 0  of 5 3  
A p pe n di x 1 1: M o nit ori n g of he p atitis B s urf ace a nti ge n ( H Bs A g) p ositi ve 
p artici p a nts o n Tr u v a d a ® Pr E P:  
•  C hec k b ot h H Bs A g a n d H Bs A b o n scree ni n g visit. 
•  If H Bs A g ne gati ve a n d H Bs A b ne gati ve, i m m u nize wit h H B V series ( 3 i njecti o ns o ver 6 
m o nt hs). Rec hec k H Bs A b at wee k 4 8 if i m m u nize d.  
•  If H Bs A g p ositi ve, c hec k at baseli ne:  A S T/ A L T, t otal bilir u bi n, al kali ne p h os p hatase, 
pr ot hr o m bi n ti me, al b u mi n, he patitis B D N A q ua ntitati ve P C R, a n d he patitis Be A g.  
Perf or m a cli nical e val uati o n f or sti g mata of cirr h osis. 
•  F or all H Bs A g p ositi ve partici pa nts, He patitis A t otal a nti b o d y a n d if i m m u nize ( 2 
vacci nes 6 m o nt hs a part) if ser o ne gati ve. 
•  F or all H Bs A g p ositi ve partici pa nts re gar dless of H Be A g stat us, c o u nsel partici pa nt 
re gar di n g ris k of H B V flare o n Pr E P; m o nit or H B V D N A q ua ntitati ve P C R a n d 
A L T/ A S T at 3, 6 a n d 1 2 m o nt hs or Pr E P, a n d t he n 6 m o nt hs after st o p pi n g Pr E P. 
•  If H Be A g p ositi ve at baseli ne, rec hec k H Be A g at 3, 6 a n d 1 2 m o nt hs of Pr E P, or u ntil 
H Be A g t ur ns ne gati ve. 
•  Flares i n A L T/ A S T , or e vi de nce of vir ol o gic brea kt hr o u g h b y H B V D N A, will be 
ma na ge d per sta n dar d cli nical pr ot oc ols acc or di n g t o A A S L D g ui deli nes. 
 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 5 1  of 5 3  
A p pe n di x 1 2: Pr oce d ures f or n u cleic aci d ( N A T) testi n g f or i nfecti o n wit h 
HI V, H C V, a n d H B V  
•  
C R U S H staff will c ollect bl o o d at all visits fr o m HI V -ne gati ve partici pa nts n ot recei vi n g Pr E P f or 
HI V/ H C V/ H B V N A T testi n g.  
•  
Eac h bl o o d sa m ple will be la bele d usi n g a u ni q ue, de -i de ntifie d, fi ve-di git n u m ber barc o de d 
stic ker pr o vi de d b y t he Re d Cr oss. Partici pa nts will als o be gi ve n t his 5-di git n u m ber s o t hat t he y 
ma y retrie ve t heir HI V test res ults (if ne gati ve) via t he we b or i nteracti ve v oice res p o nse s yste m 
t w o wee ks after t heir test date.  
•  
Sa m ples will be se nt i n batc hes directl y t o t he A merica n Re d Cr oss refere nce la b orat or y i n St. 
L o uis, M O f or N A T testi n g t hree ti mes a wee k, a n d C R U S H staff will n otif y t he U ni versit y of 
Calif or nia, Sa n Die g o A ntir viral Researc h Ce nter ( A V R C) staff via a s ec ure we b f or m t hat a 
N A T test was perf or me d ( o nl y 5 -di git c o de a n d test date e ntere d).  
•  
After t he Re d Cr oss c o m pletes N A T testi n g ( us uall y wit hi n 5 da ys), t he Re d Cr oss will se n d t he 
e ncr y pte d res ults electr o nicall y t o t he U C S D Ce nter f or AI D S Researc h ( C F A R) Bi oi nf or matics 
a n d I nf or mati o n Tec h n ol o gies ( BI T) C ore via sec ure F T P.  
•  
U p o n recei vi n g t he res ults fr o m t he Re d Cr oss, t he U C S D BI T C ore will a ut o maticall y decr y pt 
t he res ults a n d i m p ort t he m i nt o a sec ure data base l ocate d o n ser vers h oste d at t he U C SD Sa n 
Die g o S u perc o m p uti n g Ce nter ( S D S C) a n d A nti viral Researc h Ce nter ( A V R C).  
•  
T he decr y pte d res ults will be matc he d u p t o t he 5 -di git c o de pr o vi de d b y C R U S H staff t o t he 
A V R C via t he a b o ve -me nti o ne d we b f or m. T his matc hi n g all o ws t he BI T C ore t o m o nit or t he 
fl o w of data cl osel y s h o ul d a n y re p orti n g fail bet wee n Oa kla n d, t he Re d Cr oss a n d t he A V R C.  
•  
I n cases of ne gati ve HI V N A T res ults, partici pa nts ca n o btai n t heir res ults t w o wee ks after testi n g 
via we b or i nteracti ve v oice res p o nse usi n g t heir 5 -di git c o de, at t heearl ytest. ucs d.e d u 
•  
F or HI V p ositi ve res ults, A V R C staff a n d C R U S H staff will be a ut o maticall y n otifie d via e mail 
(i ncl u di n g o nl y 5-di git c o de, test date, a n d p ositi ve res ult) b y BI T C ore scri pts.  T his all o ws 


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 5 2  of 5 3  
s ufficie nt ti me f or cli nical staff to directl y c o ntact p ositi ve i n di vi d uals bef ore t he t w o -wee k 
ne gati ve res ults access wi n d o w o pe ns.  
•  
H C V a n d H B V ne gati ve res ults are n ot ma de a vaila ble t o partici pa nts t hr o u g h t he we b or 
i nteracti ve v oice res p o nse, b ut p ositi ve res ults will be re p orte d via e mail t o A V R C a n d C R U S H 
staff s o t hat t he y ma y directl y c o ntact partici pa nts. 
 
U C S D Ce nter f or AI D S Rese arc h ( C F A R) Bi oi nf or m atics a n d I nf or m ati o n Tec h n ol o gies ( BI T) C ore 
sec urity a n d priv acy fe at ures: 
T he BI T C ore has at its dis p osal 7 0 0 + pr ocess or Li n u x Be o w ulf M PI cl uster, se ve n rac k -m o u nte d 
we b ser vers, a n d t w o fa ult -t olera nt e ncr y pte d 1 6 T B R AI D 6 data st ora ge arra ys. All pri mar y pr o d ucti o n 
mac hi nes are l ocate d be hi n d a har d ware fire wall at t he S D S C o n t he U C S D mai n ca m p us i n a ser ver 
facilit y wit h bi o metric-base d restricte d access, te m perat ure a n d h u mi dit y m o nit ori n g, seis mic pr otecti o n, 
2 4/ 7 ge nerat or p o wer bac k u p, a n d c o nti n u o us C C T V ca mera s ur veilla nce. F or data a n d ser vice 
re d u n da nc y i n case of har d ware or p o wer fail ure at S D S C, sec o n dar y bac k u p mac hi nes are l ocate d be hi n d 
a har d ware fire wall at t he U C S D A nti viral Researc h Ce nter A V R C o n t he U C S D me dical ca m p us i n a 
ser ver r o o m wit h ke y car d-base d restricte d access, te m perat ure a n d h u mi dit y m o nit ori n g, a n d 2 4/ 7 C C T V 
ca mera s ur veilla nce.  


C o n n e cti n g R e s o ur c e s f or Ur b a n S e x u al H e alt h  
C R U S H Pr ot o c ol, V er . 1 . 0 
S e pt e m b er 2 0 1 3  
P a g e 5 3  of 5 3  
A p pe n di x 1 3: Allele -s pecific P C R-b ase d mi n or v ari a nt dr u g resist a nce ass a y  
T he de vel o p me nt of dr u g -resista nt vir us i n i n di vi d uals w h o  bec o me i nfecte d w hile ta ki n g  Pr E P is 
a c o ncer n t hat warra nts cl ose m o nit ori n g. W hile t he detecti o n of F T C -T D F selecte d dr u g resista nce i n 
cli nical trial partici pa nts w h o fail Pr E P is rare l y see n usi n g c o n ve nti o nal ge n ot y pi n g a n d ultrase nsiti ve 
assa ys, c o nti n ue d st u d y a n d m o nit ori n g is nee de d as F T C -T D F Pr E P use is e x pa n de d t o n o n -researc h 
setti n gs. O n g oi n g a n d pla n ne d de m o nstrati o n pr ojects prese nt a n i deal o p p ort u nit y t o m o nit or t he 
i nci de nce a n d nat ure of dr u g resista nce selecte d b y Pr E P.  
HI V -1 dr u g resista nce testi n g f or t he C R U S H Pr E P de m o nstrati o n pr oject will be perf or me d at 
U C S F’s  AI D S Researc h I nstit ute La b orat or y of Cli nical Vir ol o g y ( A RI -U C S F L C V) usi n g s peci me ns 
c ollecte d fr o m HI V i nfecte d partici pa nts at first e vi de nce of i nfecti o n. HI V -1 ge n ot y pic resista nce testi n g 
will be perf or me d b y b ul k se q ue nci n g of t he pr otease a n d re verse tra nscri ptase re gi o n usi n g t he F D A -
cleare d T R U G E N E ge n ot y pi n g kit u n der cli nical pr ot oc ols. I n di vi d ual dr u g resista nce m utati o ns  a n d dr u g 
s usce pti bilit y i nter pretati o ns are re p orte d. F or i ncrease d se nsiti vit y, a vali date d allele-s pecific P C R-base d 
mi n or varia nt dr u g resista nce assa y will be perf or me d f or detecti o n of mi n or varia nt dr u g resista nce at 
F T C/ T D F -selecti o n c o d o ns K 6 5 R, K7 0 E, a n d M 1 8 4 V/I t hat ma y be prese nt at a l o w le vel, a n d n ot 
detecte d b y t he se q ue nce -base d assa y. T he % dr u g resista nce c o d o n a b o ve t he bi ol o gic c ut off ( B C O) at 
eac h dr u g resista nce site is re p orte d.  
A si n gle  s peci me n is use d f or b ot h assa ys. S peci me ns of at least 1. 0 m L bl o o d plas ma will be 
o btai ne d fr o m partici pa nts, s p u n, a n d fr oze n, t he n se nt t o Dr. Lie gler’s la b, wit h n o i de ntif yi n g 
i nf or mati o n e xce pt f or a u ni q ue i de ntifier c o de n u m ber. A mi ni m u m HI V-1 viral l oa d of  5 0 0 c o pies/ m L 
b y  sta n dar d c o m mercial assa ys is re q uire d. Res ults will be re p orte d bac k t o C R U S H staff b y c o de 
n u m ber.    

SAP_001.pdf: 
Connecting Resources for Urban Sexual Health 
NCT02183909 
Document Date: December 17, 2013 
 
 
 


Statistical Analysis Plan 
 
Descriptive statistics (frequencies, means, medians) will be used to characterize endpoint 
variables.  Univariate tests of association (T test, Chi square) will be used to test for association 
between demographic variables and key endpoints such as adherence, early cessation of 
regimen, and frequency of adverse events, as well as between assigned PEP regimen and these 
endpoints.  Changes in quality of life will be tested for association with early regimen cessation 
and with assigned PEP regimen.  Changes in serum creatinine will be summarized with 
descriptive statistics (mean, standard deviation) and compared to historical data from clinical 
trials.  
  
Secondary Endpoints(s):  
o To assess the renal safety or Stribild® or Genvoya® or 
unbranded elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide PEP 
o To document the side effect profiles of Stribild® or Genvoya® or 
unbranded elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide given as PEP to 
HIV-1 seronegative adults 
o To assess adherence to Stribild® or Genvoya® or 
unbranded elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide PEP in a high risk 
population of HIV-1 seronegative adults 
• 
Early cessation of regimen  
• 
Frequency of adverse events  
• 
Change from baseline in quality of life  
• 
HIV-1 seroconversion  
• 
Change from baseline in serum creatinine and eGFR  
• 
Markers of proximal tubulopathy (glycosuria, proteinuria > 1+)  
• 
Self-reported adherence  
• 
Reasons for non-adherence