Connecting Resources for Urban Sexual Health
Phase: NA
Conditions: HIV, Sexually Transmitted Infections
Sponsor: University of California, San Francisco

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.