Piloting a Naloxone Intervention in an Emergency Response Community to Reduce Opioid Overdoes in Philadelphia
Conditions: Opioids; Harmful Use
Sponsor: Drexel University

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 1	 of	 34
Revised:	 January	 09,	 2014
1) Protocol	 Title
Piloting	 	 a	 	 naloxone	 	 intervention	 	 in	 	 an	 	 emergency	 	 response	 	 community	 	 to	 	 reduce	 	 opioid	 
overdoses	 in	 Philadelphia	 
2) IRB	 Review	 History
Does	 not	 apply	 
3) Objectives
We	 propose	 a	 study	 to	 develop	 and	 pilot	 test	 a	 pragmatic	 community	 intervention	 enabling	 rapid	 
naloxone	 	 delivery	 	 by	 	 stakeholders	 	 including	 	 non-medical	 	 opioid	 	 users	 	 (NMOU)	 	 –	 	 persons	 
misusing	 	 prescription	 	 opioids/heroin	 	 -	 	 and	 	 good	 	 Samaritan	 	 community	 	 members	 	 (CM)	 	 during	 
overdose	 emergencies.	 Opioid-related	 overdose	 is	 a	 major	 public	 health	 problem	 and	 a	 leading	 
cause	 of	 mortality.
1–4	 The	 timely	 use	 of	 naloxone	 in	 opioid	 overdose	 situations	 can	 be	 crucial.
5	 
Health	 policy,	 legislation,	 and	 research	 funding	 have	 converged	 in	 support	 of	 community-based	 
opioid	 	 Overdose	 	 Prevention	 	 Programs	 	 (OPP)	 	 
that	 	 distribute	 	 naloxone,	 	 an	 	 opioid	 	 antagonist.6–8	 
We	 observe	 three	 apparent	 tendencies	 in	 populations	 commonly	 studied	 for	 overdose	 behavior:	 
(a)	 	 delays	 	 or	 	 a	 	 reluctance	 	 to	 	 call	 	 Emergency	 	 Medical	 	 Services/911	 	 –	 	 even	 	 in	 	 light	 	 of	 	 the	 
legislative	 	 changes	 	 of	 	 recent	 	 years;	 	 (b)	 	 a	 	 willingness	 	 amongst	 	 bystanders	 	 and	 	 victims	 	 
to	 	 seek	 
and/or	 	 administer	 	 naloxone	 	 
in	 	 an	 	 overdose	 	 situation;	 	 and	 	 
(c)	 	 
the	 	 growing	 	 use	 	 of	 	 OPPs	 	 
to	 	 both	 
distribute	 	 naloxone	 	 and	 	 conduct	 	 support	 	 group	 	 sessions.	 	 A	 	 recent	 	 study9	 	 reports	 	 
that	 	 
injection	 
drug	 	 users	 	 participating	 	 in	 	 OPP	 	 express	 	 significant	 	 concerns	 	 with	 	 attracting	 	 police,	 	 with	 	 the	 
victim	 	 calling	 	 911	 	 
in	 	 only	 	 23%	 	 of	 	 overdose	 	 events.	 	 Findings	 	 of	 	 drug	 	 user	 	 studies	 	 consistently	 
connect	 the	 reluctance	 or	 delay	 in	 calling	 and	 involving	 911/EMS	 with	 the	 critical	 time-response	 
factor.
10	 The	 documented	 existence	 of	 the	 ‘buddy	 ethic’	 between	 drug	 users	 who	 ‘watch	 out	 for	 
each	 other’	 when	 using	 drugs	 presents	 a	 behavioral	 model	 that	 can	 be	 leveraged	 for	 broader	 pro-
social	 intervention.
11	 This	 proposed	 new	 intervention	 leverages	 the	 growing	 success	 of	 naloxone	 
distribution	 	 programs	 	 and	 	 will	 	 empower	 	 NMOU	 	 communities	 	 to	 	 provide	 	 rapid,	 	 secure,	 	 and	 
effective	 emergency	 response	 to	 support	 each	 other	 in	 the	 event	 of	 overdose.	 This	 intervention	 is	 
designed	 to	 augment	 EMS	 by	 potentially	 delivering	 naloxone	 to	 overdose	 victims	 more	 rapidly	 
using	 a	 smartphone	 application	 (app).	 Emergency	 Response	 Communities	 (ERC)	 are	 specialized	 
smartphone-based	 social	 networks	 in	 which	 members	 are	 approved	 carriers	 and/or	 potential	 users	 
of	 a	 specific	 medication	 or	 treatment.12	 The	 ERC	 approach	 is	 ideally	 suited	 to	 support,	 facilitate,	 
and	 	 encourage	 	 naloxone	 	 administration	 	 in	 	 opioid	 	 overdose	 	 emergencies.	 	 ERC	 	 uses	 	 a	 	 shared-
condition	 	 membership	 	 model	 	 in	 	 which	 	 available	 	 members	 	 in	 	 possession	 	 of	 	 a	 life-preserving	 
medication	 	 and	 	 smartphone	 	 are	 	 alerted	 	 to	 	 respond	 	 to	 	 emergency	 	 requests	 	 made	 	 by	 	 other	 
members.	 	 This	 	 model	 	 combines	 	 GPS	 	 and	 	 IP-location	 	 
tracking	 	 plus	 	 an	 	 underlying	 	 
information	 
system	 	 to	 	 automatically	 	 identify	 	 potential	 	 responding	 	 members,	 	 simulates	 	 a	 	 pharmaco-spatial	 
response	 area	 around	 a	 person	 in	 need,	 and	 guides	 those	 agreeing	 to	 respond	 to	 the	 intervention	 
target.	 ERC	 effectiveness	 is	 predicated	 on	 the	 observation	 that	 while	 most	 community	 members	 
will	 	 not	 	 comply	 	 and	 	 carry	 	 
their	 	 prescribed	 	 medication	 	 (naloxone)	 	 at	 	 all	 	 
times,	 	 within	 	 a	 	 given	 
population	 at	 any	 one	 time,	 there	 will	 be	 a	 sufficient	 number	 of	 compliant	 individual	 members	 to	 
elicit	 a	 positive	 response	 within	 minutes.
12,13	 ERCs	 can	 increase	 event	 driven	 access	 to	 naloxone	 
in	 overdose	 situations,	 which	 may	 have	 a	 significant	 public	 health	 impact.	 Towards	 this	 end,	 we	 	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 2	 of	 34	 
Revised:	 January	 09,	 2014	 
are	 proposing	 to	 utilize	 an	 ERC	 in	 the	 development	 and	 pilot	 testing	 of	 a	 smartphone	 app-based	 
naxolone	 intervention	 (ERC-NAX).	 Research	 is	 required	 to	 understand	 the	 needs	 and	 barriers	 in	 
NMOU	 	 communities	 	 that	 	 will	 	 enable	 	 effective	 	 design,	 	 adaption,	 	 and	 	 implementation	 	 of	 	 the	 
proposed	 ERC-NAX	 app.	 
Aim	 	 1:	 	 Identify	 	 barriers	 	 and	 	 facilitators	 	 of	 	 acceptance	 	 and	 	 use	 	 of	 	 a	 	 smartphone-based	 	 ERC	 
naloxone	 intervention	 program.	 Finalize	 the	 initial	 ERC-NAX	 app	 design	 based	 on	 stakeholder	 
inputs	 for	 key	 features	 and	 functionality;	 and	 implement	 the	 app	 prototype.	 
Aim	 	 2:	 	 Pilot	 	 
test	 	 
the	 	 
implementation	 	 of	 	 ERC-NAX	 	 
in	 	 an	 	 ERC	 	 consisting	 	 of	 	 55	 	 non-medical	 
opioid	 	 users	 	 and	 	 55	 	 community	 	 members.	 	 Develop	 	 and	 	 apply	 	 metrics	 	 
that:	 	 measure	 	 perceived	 
usability	 and	 usefulness;	 online	 and	 physical	 proximity/availability;	 alert	 and	 response	 behaviors;	 
and	 drug	 use	 and	 overdose	 risk	 behaviors.	 
Aim	 3:	 Synthesize	 the	 knowledge	 acquired	 in	 Aims	 1	 and	 2	 to	 (a)	 revise	 the	 pilot	 app	 design	 and	 
specifications;	 	 (b)	 	 determine	 	 which	 	 metrics	 	 were	 	 useful	 	 and	 	 effectively	 	 collected;	 	 (c)	 	 confirm	 
efficacy	 	 of	 	 recruitment	 	 procedures,	 	 retention/adherence,	 	 and	 	 assessment	 	 procedures;	 	 and	 	 (d)	 
develop	 a	 field	 study	 implementation	 manual;	 all	 of	 which	 will	 be	 used	 in	 a	 subsequent	 study	 to	 
conduct	 a	 large-scale,	 multi-site	 implementation	 trial.	 
This	 3-year	 study	 will	 provide	 us	 with	 actionable	 evidence	 regarding	 the	 viability	 and	 acceptance	 
of	 an	 app-based	 naloxone	 intervention	 following	 the	 ERC	 model.	 It	 will	 enable	 us	 to	 discover	 the	 
barriers	 	 and	 	 motivators	 	 for	 	 app	 	 use	 	 amongst	 	 community	 	 members,	 	 and	 	 fine-tune	 	 NMOU	 	 and	 
other	 stakeholder	 requirements.	 To	 achieve	 Aim	 1,	 we	 will	 modify	 and	 validate	 our	 current	 ERC	 
design	 	 by	 	 conducting	 	 qualitative	 	 
interviews	 	 and	 	 
focus	 	 groups	 	 with	 	 
stakeholders,	 	 which	 	 will	 	 be	 
followed	 	 by	 	 rapid	 	 development	 	 of	 	 the	 	 app.	 	 In	 	 Aim	 	 2,	 	 we	 	 will	 	 pilot	 	 the	 	 ERC-NAX	 	 app	 	 in	 
partnership	 with	 an	 OPP	 in	 a	 geographically	 defined	 urban	 area	 of	 Philadelphia	 by	 distributing	 
the	 	 app	 	 
to	 	 a	 	 
test	 	 population	 	 of	 	 NMOU	 	 and	 	 community	 	 support	 	 members	 	 and	 	 providing	 	 
initial	 
training	 	 and	 	 technical	 	 assistance.	 	 This	 	 will	 	 lead	 	 us	 	 towards	 	 with	 	 the	 	 goal	 	 of	 	 assessing	 	 the	 
acceptability	 	 and	 	 effective	 	 use	 	 of	 	 the	 	 app	 	 by	 	 stakeholders.	 	 In	 	 Aim	 	 3,	 	 we	 	 will	 	 prepare	 	 the	 
groundwork	 for	 a	 study	 across	 larger	 populations	 enabling	 us	 to	 measure	 the	 endpoint	 impacts	 of	 
the	 	 intervention,	 	 which	 	 include	 	 the	 	 potential	 	 positive	 	 effect	 	 on	 	 adherence	 	 levels	 	 (naloxone	 
carrying);	 and	 provision	 of	 naloxone	 in	 overdose	 emergencies.	 
	 
4)	 Background	 	 
SIGNIFICANCE	 
Fatal	 and	 non-fatal	 opioid	 overdose	 is	 a	 significant	 national	 public	 health	 problem.	 The	 U.S.	 
is	 amidst	 an	 escalating	 drug	 overdose	 epidemic.	 In	 2014,	 47,055	 people	 died	 from	 drug	 overdose	 
in	 the	 United	 States	 that	 exceeds	 the	 number	 of	 overdose	 deaths	 in	 any	 other	 previous	 year	 on	 
record.
4	 From	 2000	 to	 2014,	 the	 age-adjusted	 rates	 of	 overdose	 deaths	 have	 risen	 137%,	 from	 6.2	 
per	 100,000	 in	 2000	 to	 14.7	 per	 100,000	 in	 2014.4	 In	 2014,	 drug	 overdose	 deaths	 in	 the	 United	 
States	 outnumbered	 deaths	 from	 motor	 vehicle	 crashes	 by	 approximately	 one	 and	 a	 half	 times.4	 
Illicit	 	 and	 	 prescription	 	 opioids,	 	 
including	 	 heroin	 	 and	 	 opioid	 	 pain	 	 
relievers,	 	 have	 	 contributed	 	 
to	 
the	 majority	 (61%)	 of	 drug	 overdoses	 in	 2014.
4	 From	 2000	 to	 2014,	 death	 rates	 from	 overdoses	 
involving	 any	 opioid	 has	 increased	 200%.4	 The	 societal	 burden	 of	 opioid-related	 premature	 	 
	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 3	 of	 34	 
Revised:	 January	 09,	 2014	 
mortality	 is	 substantial:	 opioid-related	 deaths	 accounted	 for	 an	 estimated	 500,000	 potential	 years	 
of	 	 
life	 	 
lost	 	 each	 	 year14;	 	 more	 	 
than	 	 $18	 	 billion	 	 
future	 	 earnings	 	 were	 	 estimated	 	 
to	 	 be	 	 
lost	 	 due	 	 
to	 
overdose	 	 in	 	 2009.15	 	 Non-fatal	 	 overdose	 	 is	 	 also	 	 a	 	 significant	 	 burden	 	 for	 	 public	 	 health	 
infrastructure;	 in	 the	 United	 States,	 an	 estimated	 1.1	 million	 emergency	 department	 visits	 were	 
made	 each	 year	 for	 drug	 poisoning	 during	 2008-11.16	 
Fatal	 	 and	 	 non-fatal	 	 opioid	 	 overdose	 	 
is	 	 a	 	 significant	 	 public	 	 health	 	 problem	 	 
in	 	 Philadelphia.	 	 
Death	 	 due	 	 to	 	 drug	 	 overdose	 	 is	 	 a	 	 significant	 	 and	 	 rising	 	 cause	 	 of	 	 mortality	 	 and	 	 morbidity	 	 in	 
Philadelphia.	 In	 2015,	 almost	 700	 drug	 overdose	 deaths	 were	 reported	 in	 Philadelphia	 –	 twice	 as	 
many	 	 as	 	 deaths	 	 
from	 	 homicide.17	 	 Public	 	 health	 	 officials	 	 are	 	 predicting	 	 
that	 	 overdose	 	 deaths	 	 
in	 
2016	 	 are	 	 
likely	 	 
to	 	 
reach	 	 900.18	 	 On	 	 one	 	 day	 	 
in	 	 November	 	 2016,	 	 50	 	 overdoses	 	 were	 	 
reported	 	 
(5	 
fatal).
18	 In	 December	 2016,	 an	 unprecedented	 35	 fatal	 overdoses	 occurred	 in	 a	 36	 hour	 period.
18	 
Heroin	 and	 prescription	 opioids	 are	 key	 drugs	 involved	 in	 overdose19	 and	 readily	 available	 on	 the	 
local	 	 black	 	 market.
20	 	 Importantly,	 	 Philadelphia	 	 is	 	 located	 	 along	 	 a	 	 primary	 	 drug	 	 trafficking	 
corridor	 that	 has	 historically	 offered	 the	 purest	 and	 cheapest	 heroin	 on	 the	 East	 Coast.
20	 During	 
2009-2014,	 	 43%	 	 increase	 	 in	 	 drug	 	 overdose	 	 deaths	 	 in	 	 Philadelphia	 	 was	 	 accompanied	 	 by	 	 45%	 
increase	 	 
in	 	 overdose	 	 deaths	 	 
related	 	 
to	 	 heroin.
21	 	 A	 	 
recent	 	 outbreak	 	 
in	 	 overdose	 	 deaths	 	 has	 	 been	 
linked	 	 
to	 	 
the	 	 non-medical	 	 use	 	 of	 	 fentanyl,	 	 a	 	 prescription	 	 opioid	 	 50	 	 
to	 	 100	 	 
times	 	 as	 	 potent	 	 as	 
morphine22;	 	 fentanyl-related	 	 deaths	 	 have	 	 risen	 	 more	 	 
than	 	 600%	 	 between	 	 2013	 	 and	 	 2015.
23	 	 In	 
Philadelphia,	 for	 each	 opioid-related	 death,	 there	 were	 12	 emergency	 department	 visits	 for	 opioid	 
overdose	 in	 2015.17	 The	 share	 of	 ED	 visits	 for	 opioid	 overdoses	 among	 all	 ED	 visits	 has	 grown	 
from	 0.4%	 in	 2007	 to	 0.7%	 in	 2015.
17	 	 	 
Naloxone	 	 
is	 	 
increasingly	 	 available	 	 as	 	 a	 	 
tool	 	 
to	 	 combat	 	 opioid	 	 overdoses	 	 
in	 	 Philadelphia.	 	 In	 
November	 2014,	 Pennsylvania	 passed	 Act	 139,	 a	 state’s	 version	 of	 Good	 Samaritan	 Law.24	 Prior	 
to	 	 Act	 	 139,	 	 only	 	 paramedics	 	 and	 	 intermediate	 	 level	 	 emergency	 	 medical	 	 technicians	 	 were	 
authorized	 to	 administer	 naloxone.
25	 The	 law	 expanded	 access	 to	 naloxone	 for	 law	 enforcement	 
officers	 and	 firefighters.	 Act	 139	 also	 allowed	 medical	 professionals	 to	 prescribe,	 dispense,	 and	 
distribute	 	 naloxone	 	 –	 	 directly	 	 or	 	 
through	 	 a	 	 
standing	 order	 	 
-	 	 
to	 	 
laypersons,	 	 
including	 	 persons	 	 at	 
risk	 of	 opioid-related	 overdose,	 family	 members,	 friends,	 or	 other	 persons	 with	 close	 contact	 to	 
those	 	 at	 	 risk	 	 for	 	 opioid	 	 overdose.	 	 Pursuant	 	 to	 	 Act	 	 139,	 	 in	 	 2015,	 	 Pennsylvania’s	 	 Physician	 
General	 	 signed	 	 a	 	 standing	 	 order	 	 prescription	 	 
for	 	 naloxone,	 	 available	 	 as	 	 Standing	 	 Order	 	 DOH-
002-2015,26	 and	 later	 Standing	 Order	 DOH-002-2016.
27	 The	 standing	 order	 allows	 any	 person	 to	 
request	 	 intranasal	 	 naloxone	 	 or	 	 intramuscular	 	 naloxone	 	 administered	 	 by	 	 auto-injector	 	 at	 	 a	 
pharmacy	 that	 carries	 this	 medication.	 
Bystanders	 are	 willing	 to	 respond	 to	 drug	 overdoses.	 There	 is	 emerging	 literature	 on	 willingness	 
and	 	 effectiveness	 	 of	 	 bystanders	 	 to	 	 respond	 	 to	 	 an	 	 overdose	 	 event	 	 and	 	 administer	 	 naloxone.	 	 A	 
2015	 review	 of	 data	 from	 four	 studies	 found	 bystander	 naloxone	 administration	 to	 be	 associated	 
with	 increased	 odds	 of	 recovery	 for	 overdose	 victims.10	 Walley	 et	 al.	 (2016)	 found	 that	 among	 
community	 responders	 trained	 in	 overdose	 prevention	 and	 naloxone	 administration,	 help-seeking	 
(calling	 	 911	 	 and/or	 	 EMS	 	 present)	 	 
increased	 	 over	 	 
time	 	 and	 	 was	 	 more	 	 
likely	 	 when	 	 response	 	 
to	 
naloxone	 took	 longer	 or	 naloxone	 didn’t	 work.28	 Bagley	 et	 al.	 (2015)	 demonstrated	 that	 family	 
members	 of	 drug	 users	 have	 high	 motivation	 for	 uptake	 of	 overdose	 trainings	 and	 they	 will	 use	 
naloxone	 in	 case	 of	 overdose	 emergency.29	 
	 
	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 4	 of	 34	 
Revised:	 January	 09,	 2014	 
Ecological	 	 Momentary	 	 Assessments,	 	 effective	 	 
in	 	 gathering	 	 real-time	 	 data	 	 on	 	 drug	 	 users,	 	 set	 
the	 	 stage	 	 for	 	 Ecological	 	 Momentary	 	 Interventions	 	 to	 	 deliver	 	 just-in-time	 	 emergency	 	 health	 
response	 for	 overdose.	 	 By	 2015,	 64%	 of	 Americans	 owned	 a	 smartphone.
30	 Innovations	 in	 the	 
application	 of	 technology	 to	 areas	 of	 smartphone	 users’	 lives	 have	 led	 to	 the	 rise	 of	 mobile	 health	 
(mHealth)	 technology,	 which	 is	 increasingly	 being	 used	 to	 deliver	 public	 health	 interventions.
31	 
A	 	 promising	 	 methodology	 	 is	 	 the	 	 use	 	 of	 	 ecological	 	 momentary	 	 assessment	 	 (EMA)	 	 to	 	 capture	 
multiple	 	 observations	 	 of	 	 a	 	 user’s	 	 health	 	 behavior.32	 	 EMA	 	 allows	 	 
researchers	 	 
to	 	 
receive	 	 
regular	 
reports	 	 from	 	 research	 	 participants	 	 on	 	 behaviors	 	 or	 	 experiences	 	 close	 	 to	 	 real	 	 time,	 	 leading	 	 to	 
improved	 	 accuracy	 	 in	 	 measurement	 	 and	 	 decreasing	 	 recall	 	 bias.
33	 	 EMA	 	 methods	 	 have	 	 been	 
successfully	 	 applied	 	 
to	 	 different	 	 populations,	 	 
including	 	 people	 	 with	 	 mental	 	 or	 	 physical	 	 
illness	 
and	 people	 who	 use	 drugs.
34,35	 	 EMA	 can	 be	 used	 to	 explore	 contextual	 factors	 related	 to	 drug	 
use	 	 such	 	 as	 	 location	 	 of	 	 use,	 	 triggers	 	 and	 	 factors	 	 influencing	 	 variations	 	 in	 	 patterns	 	 of	 	 use.32,33	 
Preliminary	 applications	 of	 EMA	 with	 people	 who	 inject	 drugs	 are	 promising,
36,37	 however,	 there	 
is	 	 an	 	 even	 	 greater	 	 need	 	 to	 	 shift	 	 from	 	 assessment	 	 to	 	 intervention,	 	 in	 	 the	 	 form	 	 of	 	 Ecological	 
Momentary	 Interventions	 (EMI).	 EMI	 has	 yet	 to	 be	 studied	 to	 understand	 the	 context	 of	 opioid	 
overdose	 and	 response.	 	 	 
EMI	 	 are	 	 
typically	 	 designed	 	 with	 	 a	 	 
focus	 	 on	 	 
individuals	 	 by	 	 using	 	 
their	 	 personal	 	 smartphone	 	 
to	 
deliver	 tailored	 health	 interventions.	 EMI	 is	 being	 used	 by	 our	 team	 in	 the	 study	 of	 epinephrine	 
delivery	 in	 anaphylaxis	 events.12,38	 The	 proposed	 study	 builds	 on	 our	 successful	 use	 of	 EMI	 at	 
the	 	 individual	 	 level,	 	 and	 	 connects	 	 smartphone	 	 users	 	 to	 	 one	 	 another	 	 to	 	 build	 	 a	 	 network	 	 that	 
collectively	 	 supports	 	 health	 	 intervention.	 	 Smartphones	 	 are	 	 increasingly	 	 being	 	 utilized	 	 for	 
innovative	 	 approaches	 	 to	 	 support	 	 emergency	 	 response	 	 because	 	 their	 	 sensors	 	 can	 	 be	 	 used	 	 to	 
transmit	 	 
the	 	 user’s	 	 
location	 	 and	 	 other	 	 critical	 	 
information.
39,40	 	 The	 	 use	 	 of	 	 smartphone	 	 systems	 
that	 connect	 users	 and	 collectively	 mobilize	 them	 to	 respond	 to	 a	 critical	 health	 event	 has	 been	 a	 
new	 development	 across	 the	 world	 in	 recent	 years,41-43	 but	 research	 in	 this	 area	 is	 in	 its	 infancy.	 
Research	 	 
is	 	 needed	 	 
to	 	 provide	 	 evidence	 	 for	 	 feasibility,	 	 appropriate	 	 design,	 	 and	 	 dissemination,	 
and	 to	 measure	 impact	 on	 response	 efforts	 and	 health	 outcomes.	 
The	 Food	 and	 Drug	 Administration	 (FDA)	 launched	 a	 Naloxone	 App	 Competition	 in	 2016.	 To	 
highlight	 	 
the	 	 significance	 	 and	 	 demand	 	 for	 	 
the	 	 proposed	 	 mobile	 	 phone	 	 app,	 	 
the	 	 FDA	 	 recently	 
announced	 	 a	 	 competition	 	 towards	 	 the	 	 “development	 	 of	 	 a	 	 low-cost,	 	 scalable,	 	 crowd-sourced	 
mobile	 	 phone	 	 application	 	 
that	 	 helps	 	 
increase	 	 
the	 	 
likelihood	 	 
that	 	 opioid	 	 users,	 	 
their	 	 
immediate	 
personal	 	 networks,	 	 and	 	 first	 	 responders	 	 are	 	 able	 	 to	 	 identify	 	 and	 	 react	 	 to	 	 an	 	 overdose	 	 by	 
administering	 	 naloxone.”
44	 	 The	 	 winning	 	 application	 	 will	 	 receive	 	 $40,000	 	 to	 	 help	 	 in	 	 the	 
development	 of	 the	 naloxone	 application.	 The	 FDA	 announcement	 was	 released	 after	 we	 began	 
developing	 	 the	 	 proposed	 	 application	 	 in	 	 early	 	 2016.	 	 While	 	 we	 	 are	 	 encouraged	 	 by	 	 the	 	 FDA	 
announcement,	 we	 believe	 an	 interdisciplinary,	 community-engaged,	 evidence-based	 approach	 is	 
needed	 to	 develop	 a	 successful	 and	 scalable	 naloxone	 app.	 
	 
INNOVATION	 
A	 new	 class	 of	 Ecological	 Momentary	 Intervention	 (EMI)	 will	 be	 piloted	 to	 reduce	 overdose	 in	 
a	 high	 risk	 population.	 mHealth	 apps	 have	 ushered	 in	 a	 new	 age	 of	 participatory	 medicine	 and	 
led	 to	 a	 sharp	 increase	 in	 the	 availability	 of	 apps	 supporting	 medically	 motivated	 real-world	 	 
	 

Emergency	 Response	 Communities	 
(ERC)	 will	 amplify	 the	 potential	 for	 naloxone	 to	 reverse	 opioid	 overdose	 by	 enabling	 
immediate	 availability	 during	 an	 overdose	 event

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This	 	 EMI	 	 utilizes	 	 GPS	 	 and	 	 IP-location	 	 tracking	 	 to	 	 identify	 	 potential	 	 responding	 	 members,	 
modeling	 a	 pharmaco-spatial	 response	 area	 around	 a	 person	 in	 need	 (Figure	 2),	 and	 guiding	 those	 
agreeing	 to	 respond	 to	 the	 intervention	 target.	 
Opioid	 	 users	 	 can	 	 be	 	 empowered	 	 to	 	 help	 	 each	 	 other.	 	 ERC	 	 leverages	 	 known	 	 low	 	 adherence	 
levels,	 predicated	 on	 the	 observation	 that	 while	 most	 community	 members	 will	 not	 comply	 and	 
carry	 	 
their	 	 prescribed	 	 medication	 	 at	 	 all	 	 
times,	 	 within	 	 a	 	 given	 	 population	 	 at	 	 any	 	 one	 	 
time	 	 
there	 
will	 be	 a	 sufficient	 number	 of	 compliant	 individual	 members	 to	 elicit	 a	 positive	 response	 within	 
minutes	 –	 often	 faster	 than	 EMS/911	 arrival	 times.12,13,38	 	 Preliminary	 research	 has	 resulted	 in	 the	 
development	 	 of	 	 the	 	 ERC	 	 Effectiveness	 	 Model	 	 to	 	 assess	 	 the	 	 potential	 	 of	 	 condition-specific	 
communities	 	 based	 	 on	 	 population	 	 density	 	 and	 	 prescription	 	 distribution	 	 characteristics.
13,57,58	 
Studies	 	 in	 	 shared	 	 identity	 	 and	 	 ‘buddy	 	 behavior’	 	 show	 	 high	 	 levels	 	 of	 	 willingness	 	 to	 	 help.59-61	 
These	 results	 support	 that	 responding	 to	 opioid	 overdose	 emergencies	 can	 be	 a	 highly	 effective	 
intervention	 of	 an	 ERC.	 
A	 	 ERC-NAX	 	 app	 	 will	 	 be	 	 developed	 	 and	 	 
tested	 	 
in	 	 partnership	 	 with	 	 
two	 	 community	 	 partners	 
with	 extensive	 experience	 in	 overdose	 prevention	 –	 Prevention	 Point	 Philadelphia	 and	 Angels	 
in	 	 Motion.	 	 Prevention	 	 Point	 	 Philadelphia	 	 
(PPP),	 	 a	 	 multi-service	 	 harm	 	 
reduction	 	 agency	 	 
in	 	 
the	 
Kensington	 area	 of	 Philadelphia,	 began	 offer	 trainings	 in	 overdose	 prevention	 from	 2006.	 Angels	 
in	 	 Motion,	 	 a	 	 Philadelphia-based	 	 grassroots	 	 group	 	 of	 	 community	 	 members	 	 devoted	 	 to	 	 helping	 
people	 	 suffering	 	 from	 	 drug	 	 addiction,	 	 was	 	 established	 	 
in	 	 2015	 	 by	 	 parents	 	 of	 	 people	 	 who	 	 use	 
drugs.	 Drawing	 upon	 the	 years	 of	 experience	 accrued	 by	 the	 members	 and	 clients	 of	 these	 two	 
organizations	 	 will	 	 
infuse	 	 a	 	 
real-world	 	 utility	 	 
to	 	 
the	 	 design	 	 and	 	 development	 	 of	 	 
the	 	 ERC-NAX	 
app.	 
	 
5)	 Inclusion	 and	 Exclusion	 Criteria	 
	 
Inclusion	 criteria	 for	 NMOU	 and	 CM	 are	 found	 in	 Table	 1.	 “Stakeholders”	 will	 be	 either	 NMOU	 
or	 	 CM.	 	 NMOU	 	 will	 	 be	 	 active	 	 heroin/opioid	 	 users	 	 whereas	 	 CM	 	 will	 	 know	 	 active,	 	 former,	 	 or	 
deceased	 	 NMOU.	 	 Both	 	 groups	 	 will	 	 
live	 	 one	 	 of	 
four	 	 zip	 	 code	 	 areas	 	 –	 	 adjacent	 	 sections	 	 in	 	 the	 
eastern	 	 part	 	 of	 	 the	 	 Kensington	 	 section	 	 of	 
Philadelphia	 	 –	 	 that	 	 encompass	 	 the	 	 residential	 
areas	 	 with	 	 the	 	 highest	 	 drug	 	 overdose	 	 rates	 	 in	 
city.	 	 Both	 	 groups	 	 will	 	 own	 	 a	 	 smartphone	 	 and	 
maintain	 	 an	 	 ongoing	 	 cellphone	 	 data	 	 package.	 
Participants	 	 will	 	 be	 	 asked	 	 to	 	 produce	 	 a	 	 smartphone,	 	 e.g.,	 	 Apple,	 	 Android,	 	 and	 	 demonstrate	 
competent	 	 use	 	 at	 	 enrollment.	 	 Participants	 	 who	 	 do	 	 not	 	 will	 	 be	 	 excluded.	 Exclusion	 	 criteria	 	 for	 
both	 NMOU	 and	 CM	 include:	 live	 outside	 four	 zip	 codes	 in	 Table	 1,	 younger	 than	 18	 years	 old,	 
and	 	 does	 	 not	 	 speak/read	 	 English.	 	 For	 	 NMOU,	 	 an	 	 additional	 	 exclusion	 	 criteria	 	 
is:	 	 did	 	 not	 	 use	 
heroin	 or	 prescription	 opioid	 in	 the	 past	 12	 months.	 For	 CM,	 an	 additional	 exclusion	 criteria	 is:	 
does	 not	 know	 active,	 former,	 or	 deceased	 NMOU.	 
	 
	 
	 
Table	 1	 –	 Study	 Enrollment	 Criteria	 
Non-Medical	 Opioid	 Users	 (NMOU)	 
Community	 Members	 (CM)	 
1.	 Week
ly	 m
isuse	 of	 hero
in	 and/or	 rx	 
op
io
id	 dur
ing	 past	 30	 days	 	 
2.	 Current
ly	 
l
ives	 
in	 z
ip	 codes	 19122,	 
19125,	 19133,	 19134	 	 
3.	 18	 years	 o
ld	 or	 o
lder	 
4.	 Speaks/reads	 Eng
l
ish.	 
1.	 Knows	 act
ive,	 former,	 or	 
deceased	 NMOU	 	 
2.	 Current
ly	 
lives	 
in	 z
ip	 codes	 
19122,	 19125,	 19133,	 19134	 	 
3.	 18	 years	 o
ld	 or	 o
lder	 
4.	 Speaks/reads	 Eng
l
ish.	 

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No	 special	 vulnerable	 populations	 will	 be	 included	 in	 the	 study	 as	 indicated	 below:	 
☐	 	 	 	 Adults	 unable	 to	 consent	 
☐	 	 	 	 Individuals	 who	 are	 not	 yet	 adults	 (infants,	 children,	 teenagers)	 
☐	 	 	 	 Pregnant	 women	 
☐	 	 	 	 Prisoners	 
☒	 	 Not	 Applicable	 	 
	 
6)	 Study	 Timelines	 
The	 duration	 of	 an	 individual	 subject’s	 participation	 in	 the	 study:	 	 
•	 Year	 1:	 10	 stakeholders	 -	 participants	 of	 focus	 groups	 (1	 hour),	 qualitative	 interviews	 (1	 
hour),	 and	 usability	 testing	 (1	 hour)	 -	 will	 be	 enrolled	 for	 3	 hours.	 	 
•	 Year	 	 2:	 	 110	 	 subjects	 	 who	 	 will	 	 participate	 	 in	 	 training	 	 (30	 	 min),	 	 quantitative	 	 baseline	 
assessment	 (45	 min),	 brief	 follow-up	 assessments	 (11	 times	 X	 10	 min),	 retrospective	 use	 
assessment	 (30	 min)	 and	 post-trial	 qualitative	 interviews	 (60	 min)	 will	 be	 enrolled	 for	 3-5	 
hours.	 
The	 duration	 anticipated	 to	 enroll	 all	 study	 subjects:	 	 
The	 	 anticipated	 	 duration	 	 for	 	 
the	 	 enrollment	 	 of	 	 all	 	 study	 	 subjects	 	 constitutes	 	 20	 	 months.	 	 
	 	 This	 
includes	 	 1)	 	 6	 	 months	 	 
for	 	 stakeholder	 	 
focus	 	 group,	 	 qualitative	 	 
interviews,	 	 and	 	 usability	 	 
testing,	 
and	 	 2)	 	 14	 	 months	 	 
involving	 	 
recruitment,	 	 
training,	 	 pilot	 	 
field	 	 
testing	 	 of	 	 ERC-Nax	 	 
system,	 	 post-
intervention	 qualitative	 interviews,	 and	 post-trial	 qualitative	 user	 interviews.	 
The	 estimated	 date	 for	 the	 investigators	 to	 complete	 primary	 analyses	 for	 this	 study	 is	 July,	 2019.	 	 
7)	 Study	 Endpoints	 
The	 primary	 endpoints	 of	 this	 study	 include	 the	 following:	 
1)	 	 Identifying	 	 barriers	 	 and	 	 facilitators	 	 of	 	 acceptance	 	 and	 	 use	 	 of	 	 a	 	 smartphone-based	 	 ERC	 
naloxone	 intervention	 program;	 	 
2)	 Developing	 and	 testing	 the	 ERC-NAX,	 a	 smartphone	 app-based	 naxolone	 intervention;	 
3)	 Preparing	 groundwork	 for	 conducting	 a	 large-scale,	 multi-site	 implementation	 trial	 to	 measure	 
the	 	 impacts	 	 of	 	 the	 	 intervention,	 	 including	 	 the	 	 potential	 	 positive	 	 effect	 	 on	 	 adherence	 	 levels	 
(naloxone	 carrying);	 and	 provision	 of	 naloxone	 in	 overdose	 emergencies.	 
	 
8)	 Procedures	 or	 Methods	 Involved	 
Screening	 
All	 participants	 will	 be	 screened	 at	 Prevention	 Point	 Philadelphia	 and	 meetings	 held	 by	 Angels	 in	 
Motion.	 	 Interested	 	 individuals	 	 will	 	 be	 	 screened	 	 for	 	 study	 	 eligibility	 	 by	 	 an	 	 interviewer	 	 using	 	 a	 

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Figure	  4:	  Alternative	  alert	  design	  
scripted	 	 screening	 	 form.	 	 	 	 Individuals	 	 who	 	 meet	 	 the	 	 enrollment	 	 criteria	 	 and	 	 are	 	 interested	 	 in	 
participating	 	 will	 	 be	 	 consented.	 	 baseline,	 	 
study	 	 applicants	 	 will	 	 be	 	 	 	 asked	 	 a	 	 
series	 	 of	 	 
screening	 
questions	 to	 determine	 their	 eligibility	 and	 safety	 of	 their	 participation	 in	 this	 study.	 While	 half	 of	 
the	 sample	 will	 be	 active	 drug	 users,	 applicants	 who	 are	 clearly	 intoxicated	 will	 not	 be	 enrolled	 in	 
the	 study.	 	 
At	 this	 stage,	 no	 identifying	 information	 will	 be	 collected	 and	 the	 answers	 to	 the	 questions	 will	 
not	 be	 recorded.	 If	 the	 subject	 is	 deemed	 eligible,	 he	 or	 she	 will	 be	 asked	 if	 they	 are	 interested	 in	 
participating	 in	 a	 longitudinal	 study	 that	 will	 involve	 one	 baseline	 assessment,	 11	 follow	 ups,	 and	 
periodic	 retrospective	 follow	 ups.	 
If	 	 
the	 	 person	 	 
is	 	 
interested	 	 
in	 	 participating,	 	 he	 	 or	 	 she	 	 will	 	 be	 	 consented	 	 with	 	 an	 	 
IRB-approved	 
informed	 	 consent	 	 
form.	 	 Upon	 	 enrollment,	 	 
the	 	 
interviewer	 	 will	 	 create	 	 a	 	 coded	 	 
identifier	 	 
for	 	 
the	 
participant.	 No	 personally	 identifying	 information	 will	 be	 collected	 from	 subjects	 to	 create	 this	 
identifier.	 
	 
Screener	 	 data	 	 will	 	 be	 	 collected	 	 
to	 	 compare	 	 persons	 	 who	 	 qualify	 	 and	 	 enroll	 	 compared	 	 
to	 	 
those	 
who	 qualify	 and	 refuse.	 	 Additionally,	 data	 on	 reasons	 for	 refusal	 will	 be	 collected.	 
Aim	 1	 	 
Qualitative	 	 Interviews.	 	 We	 	 will	 	 conduct	 	 qualitative	 	 interviews	 	 with	 	 10	 	 stakeholders	 	 -	 	 5	 	 non-
medical	 	 opioid	 	 users	 	 (NMOU)	 	 and	 	 5	 	 community	 	 members	 	 (CM)	 	 –	 to	 	 determine	 	 features	 	 
that	 
users	 want	 built	 into	 the	 app.	 Qualitative	 interviews	 will	 include	 questions	 focusing	 on	 the	 use	 of	 
smartphones	 and	 smartphone	 applications,	 concerns	 about	 being	 part	 of	 an	 Emergency	 Response	 
Community,	 	 concerns	 	 about	 	 using	 	 the	 	 ERC-NAX	 	 app	 	 during	 	 an	 	 overdose	 	 event,	 	 expected	 
behaviors	 in	 different	 OD/response	 scenarios,	 and	 ideas	 for	 developing	 an	 optimal	 app.	 	 
Focus	 	 Groups.	 	 Three	 	 small	 	 focus	 	 groups	 	 will	 	 be	 	 held	 	 with	 
combinations	 	 of	 	 3	 	 NMOU	 	 and	 	 3	 	 CM	 	 from	 	 the	 	 original	 	 10	 
stakeholders	 at	 various	 points	 in	 the	 app	 development	 process	 so	 
that	 	 stakeholders	 	 can	 	 provide	 	 feedback	 	 prior	 	 to	 	 finalizing	 	 the	 
app.	 	 During	 	 focus	 	 groups,	 	 participants	 	 will	 	 be	 	 presented	 	 with	 
application	 screen	 mockups	 to	 elicit	 user-requirements	 specific	 to	 
the	 	 target	 	 populations.	 	 Data	 	 collection	 	 will	 	 be	 	 done	 	 using	 
tablet/laptop	 	 computers.	 	 In	 	 addition,	 	 stakeholders	 	 will	 	 also	 	 be	 
presented	 	 with	 	 a	 	 series	 	 of	 	 storyboard	 	 scenarios	 	 depicting	 	 ERC-
NAX	 	 use	 	 in	 	 order	 	 
to	 	 gauge	 	 pre-pilot	 	 willingness	 	 
to	 	 participate	 
and	 other	 key	 factors.	 One	 example	 of	 an	 interface	 question	 to	 be	 
tested	 during	 focus	 groups	 is	 willingness	 to	 respond	 if	 others	 are	 
responding	 (diffusion	 of	 responsibility),	 and	 how	 this	 should	 be	 
reflected	 in	 the	 design.	 Figure	 4	 shows	 an	 alternative	 alert	 screen	 
in	 	 which	 	 subjects	 	 are	 	 presented	 	 a	 	 map	 	 showing	 	 other	 	 members	 
responding,	 in	 contrast	 to	 limiting	 information	 to	 just	 the	 location	 
of	 	 
the	 	 victim	 	 (Figure	 	 1	 	 Panel	 	 C).	 	 Knowledge	 	 
that	 	 more	 	 people	 
will	 	 be	 	 there	 	 to	 	 help	 	 may	 	 encourage	 	 participation	 	 (based	 	 on	 

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Revised:	 January	 09,	 2014	 
shared	 identity	 theory),	 create	 impetus	 to	 ‘get	 there	 first’,	 or	 suppress	 urgency.	 Other	 scenarios	 
will	 be	 tested	 if	 users	 prefer	 that	 the	 Talk	 button	 communicates	 only	 with	 the	 signaling	 victim,	 or	 
created	 an	 open	 channel	 across	 all	 responders	 to	 this	 event.	 Scenario-based	 questions	 will	 allows	 
us	 	 to	 	 control	 	 and	 	 manipulate	 	 alternative	 	 app	 	 designs	 	 with	 	 key	 	 variable	 	 interfaces,	 	 e.g.,	 	 show	 
member	 profile	 photos	 to	 identify	 responder,	 provide	 sound-beacon	 functions	 to	 locate	 victim	 at	 
close	 range.	 	 This	 is	 a	 relatively	 fast	 data	 collection	 method	 which	 requires	 fewer	 resources	 than	 
a	 prototype	 and	 allows	 us	 to	 explore	 a	 wider	 range	 of	 design	 issues.
75	 Storyboarding	 is	 widely	 
used	 as	 a	 technique	 to	 demonstrate	 system	 interfaces	 and	 contexts	 of	 use	 in	 a	 design	 process.76,77	 
Similar	 	 approaches	 	 have	 	 been	 	 taken	 	 in	 	 the	 	 design	 	 of	 	 emergency	 	 medical	 	 information	 
systems.
78,79	 	 Additional	 	 features,	 	 such	 	 as	 	 a	 	 screen	 	 view	 	 through	 	 which	 	 NMOU	 	 can	 	 view	 	 the	 
potential	 naloxone-carrying	 responders	 in	 their	 proximity	 (similar	 to	 Figure	 2)	 will	 be	 presented	 
to	 	 determine	 	 
interest	 	 
in	 	 possible	 	 modification	 	 of	 	 pre-use	 	 behavior,	 	 which	 	 answers	 	 
the	 	 
inherent	 
question	 ‘If	 I	 enter	 a	 state	 of	 OD	 and	 require	 help,	 is	 there	 anyone	 close	 by?’.	 
Usability	 	 
testing.	 	 Heuristic	 	 evaluation	 	 will	 	 be	 	 performed	 	 with	 	 expert	 	 evaluators	 	 
to	 	 
identify	 	 and	 
resolve	 	 potential	 	 usability	 	 issues	 	 before	 	 pilot	 	 testing	 	 begins.	 	 In	 	 addition,	 	 user	 	 testing	 	 will	 	 be	 
performed	 with	 at	 least	 five	 NMOU	 and/or	 CM	 end	 users,	 who	 will	 be	 asked	 to	 perform	 a	 series	 
of	 easy,	 medium,	 and	 difficult	 tasks	 while	 thinking	 aloud.	 One	 evaluator	 will	 facilitate	 the	 user	 
tests	 	 while	 	 a	 	 second	 	 evaluator	 	 observes	 	 and	 	 takes	 	 notes.	 	 User	 	 tests	 	 will	 	 conclude	 	 with	 	 open-
ended	 	 questions	 	 
to	 	 gauge	 	 satisfaction	 	 with	 	 
the	 	 application	 	 and	 	 willingness	 	 
to	 	 use	 	 
it	 	 
in	 	 a	 	 real-
world	 	 
scenario.	 	 Data	 	 
from	 	 user	 	 
tests	 	 will	 	 be	 	 analyzed	 	 by	 	 both	 	 evaluators	 	 and	 	 
solutions	 	 will	 	 be	 
proposed	 and	 prioritized	 together	 with	 all	 investigators,	 based	 on	 how	 critical	 and	 how	 difficult	 
each	 identified	 usability	 or	 technical	 issue	 will	 be	 to	 fix.	 	 	 
	 
The	 primary	 goal	 of	 this	 phase	 is	 increased	 pilot	 suitability	 to	 both	 task	 and	 user	 population	 by	 
improving	 usability	 and	 design	 of	 interface.	 Data	 will	 be	 put	 to	 immediate	 use	 to	 modify	 ERC-
NAX	 design	 prior	 to	 pilot	 development.	 At	 the	 end	 of	 this	 stage,	 we	 will	 have	 a	 validated	 app	 
design	 in	 support	 of	 expected	 behavior.	 
	 
Aim	 2	 
Following	 development	 of	 the	 ERC-NAX	 app	 we	 will	 initiate	 a	 structured	 and	 monitored	 launch	 
of	 the	 system.	 	 
	 
911	 Alerts	 and	 ethical	 considerations.	 For	 the	 current	 study	 we	 propose	 to	 test	 an	 interface	 that	 
automatically	 alerts	 911	 concurrent	 with	 the	 community	 alert.	 It	 is	 important	 to	 note	 that	 in	 no	 
case	 does	 the	 pilot	 study	 bypass	 or	 eliminate	 response	 by	 EMS/First	 Responders.	 	 The	 guiding	 
principles	 of	 the	 app	 design	 include	 automatic	 EMS	 alert	 by	 the	 app	 irrespective	 of	 expected	 
ERC	 response.	 This	 functionality	 helps	 responders	 meet	 the	 apparent	 legal	 obligation	 to	 inform	 
911	 upon	 providing	 naloxone.	 	 According	 to	 the	 current	 Standing	 Order	 for	 Pennsylvania,86	 a	 
person	 administering	 naloxone	 is	 “…immune	 from	 liability	 for	 giving	 naloxone	 if	 you	 believed	 
the	 person	 was	 suffering	 from	 an	 opioid	 overdose	 (heroin	 or	 prescription	 pain	 medication)	 and	 
you	 called	 for	 medical	 help/911	 after	 giving	 the	 medication.”
86	 	 Through	 the	 ‘Good	 Samaritan’	 
provision	 of	 PA	 State	 Act	 139,	 bystanders	 are	 “encouraged	 to	 call	 911	 for	 emergency	 medical	 
services	 in	 the	 event	 an	 overdose	 is	 witnessed	 and	 to	 stay	 with	 the	 individual	 until	 help	 arrives.	 
The	 provision	 offers	 certain	 criminal	 and	 civil	 protections	 to	 the	 caller	 so	 that	 they	 cannot	 get	 in	 
trouble	 for	 being	 present,	 witnessing	 and	 reporting	 an	 overdose.”
86	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 10	 of	 34	 
Revised:	 January	 09,	 2014	 
App	 	 Diffusion	 	 and	 	 ERC-NAX	 	 Membership	 	 Requests.	 	 Active	 	 participation	 	 
in	 	 
the	 	 pilot	 	 will	 	 be	 
limited	 to	 the	 110	 subject	 directly	 recruited	 and	 trained.	 However,	 it	 is	 important	 to	 understand	 
effective	 ways	 to	 grow	 membership	 and	 app	 usage,	 determine	 how	 the	 app	 might	 diffuse	 from	 an	 
initially	 	 seeded	 	 group	 	 of	 	 users,	 	 and	 	 collect	 	 
location	 	 data	 	 
from	 	 potentially	 	 active	 	 members.	 	 For	 
that	 	 reason,	 	 
the	 	 app	 	 will	 	 support	 	 open	 	 downloads	 	 and	 	 registrations	 	 but	 	 registrants	 	 outside	 	 
the	 
subject	 	 pool	 	 will	 	 be	 	 informed	 	 that	 	 their	 	 app	 	 is	 	 pending	 	 activation.	 	 Registrant	 	 data	 	 will	 	 be	 
collected	 for	 potential	 full	 participation	 in	 follow-on	 studies.	 
	 
App/Opioid	 Overdose	 Prevention	 Training.	 Following	 study	 enrollment	 and	 informed	 consenting	 
process,	 overdose	 prevention	 training	 for	 all	 participants	 will	 occur	 at	 
Prevention	 	 Point	 	 Philadelphia.	 	 Trainings,	 	 which	 	 will	 	 last	 	 approximately	 	 30	 	 minutes,	 	 will	 	 be	 
delivered	 by	 PPP	 staff	 and	 consist	 of:	 overdose	 risk	 factors,	 steps	 
to	 	 take	 	 in	 	 a	 	 witnessed	 	 overdose,	 	 and	 	 use	 	 of	 	 naloxone	 	 (Table	 	 3).	 
Participants	 	 will	 	 receive	 	 a	 	 doctor’s	 	 prescription	 	 for	 	 naloxone,	 	 an	 
instruction	 card,	 and	 two	 doses	 of	 NARCAN	 nasal	 spray	 (naloxone	 
HCI,	 	 4mg).	 	 	 	 During	 	 the	 	 same	 	 session,	 	 ERC-NAX	 	 app	 	 training	 
sessions,	 	 which	 	 will	 	 
last	 	 approximately	 	 30	 	 minutes,	 	 will	 	 be	 	 held	 
for	 all	 study	 participants.	 In	 these	 sessions	 we	 will:	 validate	 proper	 installation	 of	 the	 app	 on	 each	 
participant’s	 	 smartphone;	 	 explain	 	 the	 	 alert	 	 mode	 	 operation	 	 of	 	 the	 	 app;	 	 explain	 	 the	 	 responder	 
mode	 operation	 of	 the	 app;	 explain	 the	 EMS/911	 functionality;	 have	 each	 participant	 initiate	 and	 
alert	 and	 a	 response	 using	 the	 app’s	 test	 mode.	 
	 
Quantitative	 	 Baseline	 	 Assessment	 	 
(QBA).	 	 The	 	 QBA,	 	 which	 	 
take	 	 approximately	 	 45	 	 minutes	 	 
to	 
administer,	 will	 consist	 of	 6	 modules	 that	 capture	 key	 elements	 to	 be	 tracked	 over	 the	 course	 of	 
the	 	 study	 	 (Table	 	 4).	 	 Main	 	 predictors	 	 and	 	 outcomes	 
will	 	 be	 	 assessed	 	 with	 	 validated	 	 standardized	 
measures:	 	 psychological	 	 health	 	 [Brief	 	 Symptoms	 
Inventory	 	 (BSI)];
91	 physical	 	 health	 	 [12	 	 Item	 	 Short	 
Form	 	 Health	 	 Survey	 	 (SF-12)];92	 	 and	 	 Overdose	 	 Risk	 
Behavior	 	 Scale.93	 	 Opioid	 	 and	 	 other	 	 drug	 	 misuse	 	 will	 
be	 assessed	 with	 self-report	 questions	 that	 have	 been	 
effective	 	 in	 	 prior	 	 studies.
89,94	 	 Community	 	 members	 
with	 	 limited	 	 drug	 	 use	 	 histories	 	 will	 	 skip	 	 sections	 	 of	 
modules	 3,	 4,	 and	 5.	 The	 QBA	 will	 be	 scripted	 using	 
REDCap	 	 software,	 	 pre-tested,	 	 and	 	 administered	 
during	 face-to-face	 interviews	 on	 a	 laptop	 computer.	 
	 
	 
Brief	 	 Follow-Up	 	 Assessment	 	 
(BFA).	 	 Following	 	 
the	 	 QBA,	 	 BFA	 	 will	 	 be	 	 administered	 	 once	 	 per	 
month	 for	 11	 months.	 The	 BFA	 will	 consist	 of	 a	 brief	 set	 of	 questions	 from	 modules	 3	 through	 6	 
of	 	 
the	 	 QBA	 	 covering	 	 
recent	 	 opioid	 	 use,	 	 other	 	 drug	 	 use,	 	 experiencing/witnessing/responding	 	 
to	 
overdose,	 	 current	 	 possession	 	 of	 	 naloxone,	 	 and	 	 overdose	 	 risk	 	 behaviors.	 	 In	 	 addition,	 	 questions	 
will	 focus	 on	 use	 of	 the	 app,	 such	 as	 rationale	 for	 use/nonuse	 during	 witnessed	 or	 experienced	 
overdose	 	 events.	 	 Responders	 	 will	 	 receive	 	 vignettes	 	 that	 	 assess	 	 their	 	 ability	 	 to	 	 respond	 	 to	 	 a	 
simulated	 	 overdose	 	 event.	 	 They	 	 will	 	 receive	 	 information	 	 such	 	 as:	 	 time	 	 of	 	 day,	 	 weather	 
Table	 3:	 OD	 Prevention	 Training	 
1.	 R
isk	 factors	 for	 overdose	 
2.	 Reduc
ing	 r
isk	 for	 overdose	 
3.	 Recogn
iz
ing	 an	 overdose	 
4.	 Steps	 to	 take	 
if	 w
itness
ing	 an	 
overdose:	 sternum	 rub,	 ca
l
l	 911,	 prov
ide	 
rescue	 breath
ing,	 adm
in
ister	 na
loxone	 
5.	 Use	 of	 na
loxone	 
Table	 4:	 Quantitative	 Baseline	 Assessment	 (QBA)	 
Modules	 &	 Select	 Key	 Measures	 (not	 exhaustive	 list	 of	 
measures)	 
1.	 Demographics	 –	 age,	 gender,	 race/ethn
ic
ity,	 SES,	 
educat
iona
l,	 emp
loyment	 h
istory,	 cr
im
ina
l	 
just
ice	 h
istory,	 	 
2.	 Psychological/Physical	 Health	 History	 –	 Chron
ic	 Pa
in	 
Sca
le,	 BSI	 
3.	 Opioid	 Use	 History/Practices	 –	 Age	 of	 
in
it
iat
ion,	 30/90	 
day	 use,	 forms/doses,	 modes	 of	 adm
in
istrat
ion	 	 
4.	 Other	 Drug	 Use	 History/Practices	 –	 Age	 of	 
in
it
iat
ion	 of	 
i
l
lega
l/prescr
ipt
ion	 drugs,	 tobacco	 and	 a
lcoho
l,	 30/90	 day	 use,	 
modes	 of	 adm
in
istrat
ion,	 po
lydrug	 use,	 drug	 treatment	 h
istory	 
5.	 Overdose	 History/Overdose	 Risk	 –	 Persona
l	 overdose,	 
l
i
fet
ime	 w
itnessed	 overdose,	 Overdose	 R
isk	 Behav
ior	 Sca
le	 
6.	 Intentions	 to	 Use	 App	 –	 Intent
ions	 to	 use	 app	 as	 ca
l
ler,	 
responder,	 or	 both	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 11	 of	 34	 
Revised:	 January	 09,	 2014	 
conditions,	 	 
location,	 	 distance,	 	 estimated	 	 walking	 	 
time,	 	 gender,	 	 availability	 	 of	 	 other	 	 
responders.	 
Closed-ended	 	 items	 	 will	 	 assess	 	 ability	 	 to	 	 respond	 	 and	 	 barriers	 	 to	 	 respond	 	 if	 	 they	 	 are	 
unavailable/unwilling.	 For	 example,	 we	 will	 explore	 geographic	 barriers	 (e.g.	 distance	 to	 user),	 
characteristics	 of	 user	 (e.g.	 gender,	 age,	 race/ethnicity),	 time	 of	 event	 (i.e.	 unwilling	 to	 respond	 
in	 	 
the	 	 evening	 	 when	 	 
it’s	 	 dark	 	 or	 	 unwilling	 	 
to	 	 go	 	 
to	 	 a	 	 private	 	 
residence),	 	 etc.	 	 The	 	 BFA	 	 will	 	 be	 
launched	 via	 the	 ERC-NAX	 app	 and	 will	 offer	 participants	 a	 user	 friendly	 and	 intuitive	 interface	 
for	 	 completing	 	 the	 	 brief	 	 via	 	 a	 	 secure	 	 project	 	 website.	 	 The	 	 BFA	 	 will	 	 take	 	 approximately	 	 10	 
minutes	 to	 complete.	 
	 
Retrospective	 	 Use	 	 of	 	 App	 	 Assessment	 	 (RUA).	 	 During	 	 the	 	 live	 	 pilot	 	 activity,	 	 the	 	 system	 	 will	 
maintain	 a	 complete	 log	 of	 all	 user	 activity.	 We	 briefly	 describe	 the	 operation	 of	 the	 live	 system	 
(complete	 details	 appear	 in	 the	 report	 by	 Schwartz	 
and	 	 Khalemsky
63).	 	 With	 	 the	 	 app	 	 installed	 	 and	 
activated,	 	 the	 	 location	 	 of	 	 study	 	 participants	 	 is	 
monitored	 at	 all	 times	 and	 securely	 stored	 in	 cloud	 
servers.	 	 At	 	 any	 	 point	 	 in	 	 time,	 	 a	 	 participant	 	 can	 
press	 	 the	 	 app’s	 	 alert	 	 button	 	 initiating	 	 an	 
intervention/urgent	 	 request	 	 for	 	 naloxone.	 	 Due	 	 to	 
the	 	 nature	 	 of	 	 opioid	 	 overdose,	 	 we	 	 expect	 	 that	 
often	 	 
this	 	 alert	 	 will	 	 be	 	 
initiated	 	 by	 	 a	 	 
‘buddy’	 	 NMOU	 	 
rather	 	 
than	 	 by	 	 
the	 	 overdosing	 	 
individual.	 	 
The	 	 app	 	 will	 	 acknowledge	 	 receipt	 	 of	 	 the	 	 alert	 	 and	 	 will	 	 instantly	 	 determine	 	 potential	 	 ERC	 
members	 (both	 NMOU	 and	 CM)	 in	 the	 vicinity	 of	 relevant	 response.	 The	 alert	 will	 be	 sent	 to	 all	 
available	 members	 with	 a	 request	 to	 respond.	 Members	 agreeing	 to	 respond	 will	 be	 guided	 to	 the	 
member	 	 who	 	 initiated	 	 the	 	 alert.	 	 All	 	 alert	 	 and	 	 response	 	 activity	 	 (Table	 	 5)	 	 will	 	 be	 	 logged	 
automatically	 	 by	 	 the	 	 system	 	 for	 	 later	 	 analysis.	 
Following	 	 each	 	 alert	 	 event,	 	 the	 	 participating	 
members	 will	 be	 contacted	 for	 a	 Retrospective	 Use	 
Assessment	 	 regarding	 	 their	 	 participation	 	 in	 	 the	 
event	 	 and	 	 outcomes,	 	 including	 	 reactions	 	 to	 
receiving	 	 alerts,	 	 such	 	 as	 	 response	 	 barriers	 	 and	 
motivators	 	 for	 	 responders	 	 (Table	 	 6)	 	 and	 	 event-
precipitating	 factors	 for	 persons	 who	 overdose,	 such	 as	 quantity	 of	 drugs	 consumed,	 location	 of	 
use,	 	 syringe	 	 sharing.	 	 Retrospective	 	 use	 	 assessments	 	 will	 	 be	 	 administered	 	 4-48	 	 hours	 	 after	 	 
the	 
event.	 	 Participants	 will	 receive	 a	 text	 message	 prompting	 them	 to	 initiate	 data	 entry	 	 
beginning	 	 4	 	 hours	 	 after	 	 
the	 	 event.	 	 An	 	 alert	 	 will	 	 cue	 	 
them	 	 
to	 	 respond	 	 every	 	 4	 	 hours	 	 until	 	 
the	 
assessment	 	 is	 	 completed	 	 or	 	 48	 	 hours	 	 have	 	 passed	 	 and	 	 the	 	 data	 	 entry	 	 window	 	 has	 	 close.	 
Additionally,	 this	 data	 will	 enable	 us	 to	 identify	 users	 with	 different	 participation	 profiles	 to	 be	 
further	 explored	 in	 end-of-trial	 qualitative	 interviews.	 
	 
Qualitative	 	 Interviews.	 	 
	 	 Over	 	 the	 	 course	 	 of	 	 the	 	 12-month	 	 pilot	 	 of	 	 the	 	 app,	 	 we	 	 anticipate	 	 that	 
participants	 	 will	 	 fall	 	 
into	 	 four	 	 groups	 	 based	 	 upon	 	 
their	 	 use	 	 of	 	 
the	 	 app:	 	 caller;	 	 responder;	 	 both	 
caller	 and	 responder;	 and	 neither	 caller	 or	 responder.	 	 We	 will	 conduct	 20	 qualitative	 interviews	 
to	 	 understand	 	 and	 	 describe	 	 use	 	 (or	 	 lack	 	 of	 	 use)	 	 of	 	 the	 	 app:	 	 callers	 	 (n=5);	 	 responders	 	 (n=5);	 
caller/responders	 (n=5);	 neither	 callers/responders	 (n=5).	 	 These	 20	 individuals	 will	 be	 selected	 
from	 the	 larger	 sample	 of	 110	 participants.	 	 Depending	 upon	 the	 numbers	 in	 each	 group,	 efforts	 
Table	 5:	 Select	 Key	 Data	 Items	 collected	 per	 alert	 event	 from	 app	 
(not	 exhaustive	 list	 of	 data	 items)	 
1.	 a
lert-t
ime:	 date,	 t
ime	 	 
2.	 a
lert-locat
ion:	 (x,y);	 street	 address
	 
3.	 a
lert
ing-member	 ID	 
4.	 v
iab
le-members:	 set	 of	 IDs;	 set	 of	 
locat
ions	 
5.	 agree
ing-members:	 set	 of	 IDs;	 set	 of	 
locat
ions	 
6.	 respond
ing-members:	 set	 of	 IDs;	 set	 of	 
locat
ions	 
7.	 comp
let
ing-members:	 set	 of	 IDs;	 set	 of	 
locat
ions	 
8.	 event-reso
lut
ion-t
ime:	 date/t
ime	 
Table	 6:	 Retrospective	 Use	 Assessment	 
RESPONDER	 
1.	 Ca
l
ler	 or	 responder	 
2.	 Na
loxone	 de
l
ivered	 	 
3.	 CBR	 de
l
ivered	 
4.	 EMS	 arr
iva
l	 
5.	 Mot
ivators	 to	 respond	 
6.	 Barr
iers	 to	 respond	 
PERSONS-OVERDOSE	 
1.	 Drugs	 consumed	 	 
2.	 Route	 of	 adm
in
istrat
ion	 
3.	 Locat
ion	 of	 use	 
4.	 Syr
inge/parapherna
l
ia	 shar
ing	 
5.	 Mot
ivators	 to	 use	 app	 
6.	 Barr
iers	 to	 use	 app	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 12	 of	 34	 
Revised:	 January	 09,	 2014	 
will	 	 be	 	 made	 	 
to	 	 select	 	 participants	 	 
for	 	 qualitative	 	 
interviews	 	 
to	 	 obtain	 	 diversity	 	 across	 	 gender,	 
race/ethnicity,	 	 and	 	 age.	 	 	 	 Interview	 	 topics	 	 will	 	 focus	 	 on	 
experiences	 using	 the	 app,	 motivators/barriers	 to	 using	 the	 app,	 
and	 	 impact	 	 of	 	 using	 	 the	 	 app	 	 on	 	 drug	 	 use	 	 (see	 	 Table	 	 7).	 
Qualitative	 	 interviews	 	 will	 	 be	 	 conducted	 	 face-to-face	 	 in	 	 a	 
private	 	 or	 	 semi-private	 	 
location,	 	 e.g.,	 	 Prevention	 	 Point,	 	 
that	 	 
is	 
convenient	 for	 the	 participant.	 Interviewees	 will	 receive	 a	 $50	 
incentive	 for	 participation.	 	 
	 
9)	 Data	 Banking	 
Following	 the	 completion	 of	 the	 study,	 data	 will	 be	 stored	 for	 three	 years	 on	 password-protected	 
and	 digitally	 encrypted	 computers.	 Data	 analysis	 will	 also	 be	 performed	 on	 the	 same	 computers.	 	 
Only	 	 PIs	 	 and	 	 IRB-approved	 	 research	 	 staff	 	 will	 	 have	 	 access	 	 to	 	 research	 	 datasets.	 	 
	 After	 	 three	 
years	 from	 the	 completion	 of	 the	 study,	 digitally-recorded	 screening	 survey	 forms	 and	 interview	 
transcripts	 	 will	 	 be	 	 destroyed.	 	 Data	 	 will	 	 be	 	 stored	 	 for	 	 this	 	 amount	 	 of	 	 time	 	 to	 	 allow	 	 for	 	 the	 
generation	 of	 publishable	 works	 from	 this	 research.	 
10)	 Data	 Management	 
	 
Aim	 1	 
Qualitative	 	 Interviews	 	 and	 	 Focus	 	 Groups.	 	 	 	 Individual	 	 and	 	 group	 	 interviews	 	 will	 	 be	 	 digitally	 
recorded	 and	 transcribed.	 Qualitative	 data	 from	 interview	 transcripts	 will	 be	 entered	 into	 Atlas.ti	 
(a	 	 qualitative	 	 software)	 	 and	 	 analyzed	 	 using	 	 
inductive	 	 
thematic	 	 analysis	 	 
to	 	 
identify	 	 
themes	 	 
that	 
represent	 the	 most	 common	 opportunities	 and	 needs	 to	 be	 addressed	 during	 app	 development.	 
	 
Usability	 testing	 
Descriptive	 quantitative	 data	 from	 user	 tests	 -	 five	 NMOU	 and/or	 CM	 –	 will	 be	 generated	 and	 
analyzed.	 	 Solutions	 	 for	 	 app	 	 development	 	 will	 	 be	 	 proposed	 	 and	 	 prioritized	 	 together	 	 with	 	 all	 
investigators,	 based	 on	 how	 critical	 and	 how	 difficult	 each	 identified	 usability	 or	 technical	 issue	 
will	 be	 to	 fix.	 	 	 
	 
Aim	 2	 
Quantitative	 Baseline	 Assessment	 (QBA).	 SPSS	 and	 SAS	 will	 be	 used	 for	 data	 management	 and	 
analysis.	 	 Procedures	 	 to	 	 clean	 	 quantitative	 	 data	 	 will	 	 include	 	 univariate	 	 analyses	 	 (e.g.,	 	 mean,	 
standard	 deviation)	 and	 patterns	 of	 correlation	 and	 covariance.	 	 Univariate	 statistics	 will	 be	 used	 
to	 	 broadly	 	 examine	 	 the	 	 characteristics	 	 of	 	 the	 	 sample	 	 population	 	 and	 	 bivariate	 	 analyses	 	 (e.g.,	 
correlation	 	 analyses)	 	 will	 	 examine	 	 relationships	 	 among	 	 variables	 	 of	 	 interest.	 	 The	 	 quantitative	 
baseline	 assessment	 data	 will	 be	 used	 in	 multiple	 ways	 to	 gain	 a	 descriptive	 understanding	 of	 the	 
sample.	 	 For	 instance,	 a	 key	 goal	 is	 to	 describe	 different	 types	 of	 app	 users.	 By	 the	 end	 of	 the	 12-
month	 	 pilot,	 	 data	 	 will	 	 allow	 	 
the	 	 sample	 	 
to	 	 be	 	 divided	 	 
into	 	 
four	 	 groups:	 	 callers	 	 –	 	 persons	 	 who	 
used	 the	 app	 to	 call	 for	 help;	 responders	 –	 persons	 who	 responded	 to	 a	 call;	 caller/responders	 –	 
persons	 	 who	 	 both	 	 called	 	 and	 	 
responded;	 	 and	 	 non-responders	 	 –	 	 persons	 	 who	 	 neither	 	 called	 	 nor	 
responded.	 Participants	 will	 be	 sorted	 into	 these	 four	 groups	 and	 analyses	 will	 be	 conducted	 to	 
characterize	 	 each	 	 group	 	 demographically	 	 and	 	 based	 	 on	 	 drug	 	 use	 	 history.	 	 	 	 The	 	 baseline	 
Table	 7:	 Qualitative	 Interview	 Modules	 
1.	 Exper
iences	 us
ing	 the	 app	 
2.	 Mot
ivators	 to	 us
ing	 the	 app	 	 
3.	 Barr
iers	 to	 us
ing	 the	 app	 
4.	 Impact	 of	 us
ing	 app	 on	 patterns	 of	 drug	 
use	 
5.	 Suggest
ions	 for	 app	 
improvement	 
	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 13	 of	 34	 
Revised:	 January	 09,	 2014	 
assessment,	 along	 with	 brief	 follow-up	 assessments,	 will	 be	 used	 to	 determine	 changes	 in	 app-
related	 behavior	 of	 users	 over	 time.	 	 
	 
Brief	 Follow-Up	 Assessment	 (BFA).	 Analyses	 will	 focus	 on	 understanding	 the	 extent	 to	 which	 
the	 	 app	 	 was	 	 used	 	 when	 	 naloxone	 	 was	 	 needed	 	 and	 	 facilitators/barriers	 	 
to	 	 
its	 	 use.	 	 We	 	 will	 	 also	 
examine	 	 participant	 	 engagement	 	 across	 	 key	 	 endpoints	 	 in	 	 overdose	 	 prevention	 	 including:	 	 (1)	 
overdose	 	 risk	 	 (2)	 	 overdose	 	 experiences	 	 in	 	 which	 	 the	 	 app	 	 was	 	 not	 	 employed	 	 (3)	 	 witnessing	 
overdose	 	 (4)	 	 administering	 	 naloxone,	 	 (5)	 	 app	 	 use	 	 while	 	 responding	 	 to	 	 an	 	 overdose;	 	 and	 	 (6)	 
naloxone	 	 possession/refill.	 	 These	 	 endpoints	 	 
represent	 	 critical	 	 moments	 	 when	 	 
the	 	 app	 	 could	 	 be	 
deployed	 	 
to	 	 prevent	 	 overdose.	 	 A	 	 separate	 	 analysis	 	 will	 	 be	 	 conducted	 	 for	 	 each	 	 endpoint	 	 using	 
summary	 	 statistics	 	 
(frequency	 	 and	 	 percent	 	 with	 	 associated	 	 error	 	 
terms).	 	 For	 	 each	 	 outcome,	 	 we	 
will	 	 assess	 	 facilitators/barriers	 	 to	 	 identify	 	 factors	 	 that	 	 could	 	 be	 	 targeted	 	 with	 
behavioral/educational	 interventions	 to	 increase	 app	 use	 at	 each	 stage.	 	 Combining	 quantitative	 
baseline	 	 and	 	 
follow-up	 	 assessments	 	 will	 	 provide	 	 a	 	 self-reported,	 	 
longitudinal	 	 dataset.	 	 The	 	 data	 
contains	 repeating	 observation	 on	 users,	 and	 enables	 a	 complete	 (all-users)	 study	 of	 behavior	 and	 
expectation	 changes	 over	 time	 (compared	 to	 the	 baseline).	 Given	 the	 structure	 and	 completeness	 
of	 the	 data,	 we	 can	 assess	 learning	 curves,	 engagement	 patterns,	 and	 perspectives	 (enthusiasm	 or	 
exhaustion	 	 over	 	 time)	 	 while	 	 controlling	 	 for	 	 type	 	 of	 	 users	 	 (responders/	 	 callers/	 	 both),	 
demographics,	 and	 drug	 use	 history.	 	 	 These	 data	 will	 enable	 us	 to	 establish	 patterns	 of	 drug	 use	 
and	 associations	 with	 overdose	 as	 well	 as	 facilitators/barriers	 to	 using	 the	 app	 in	 situations	 when	 
naloxone	 is	 needed.	 
	 
Qualitative	 	 Interviews.	 	 All	 	 qualitative	 	 interviews	 	 will	 	 be	 	 transcribed	 	 by	 	 project	 	 staff	 	 and	 
converted	 	 
to	 	 Word	 	 documents.	 	 The	 	 analysis	 	 will	 	 
involve:	 	 1)	 	 
the	 	 development	 	 of	 	 a	 	 descriptive	 
coding	 	 frame;	 	 2)	 	 memoing	 	 (writing	 	 down	 	 ideas	 	 as	 	 data	 	 are	 	 collected	 	 and	 	 analyzed);	 	 3)	 
comparison	 	 of	 	 memos	 	 with	 	 data	 	 collected	 	 
from	 	 qualitative	 	 
interviews;	 	 and	 	 4)	 	 
theory	 	 building.	 
The	 	 coding	 	 frame	 	 will	 	 be	 	 developed	 	 through	 	 a	 	 series	 	 of	 	 a	 	 priori	 	 codes	 	 linked	 	 to	 	 interview	 
questions,	 	 e.g.,	 	 barriers	 	 
to	 	 using	 	 
the	 	 app,	 	 and	 	 open	 	 codes	 	 based	 	 upon	 	 probing	 	 questions	 	 
linked	 
emergent	 	 responses,	 	 e.g.,	 	 stigma	 	 within	 	 user	 	 groups.	 	 Transcribed	 	 interviews	 	 (n=20)	 	 will	 	 be	 
analyzed	 using	 ATLAS.ti	 software.	 The	 coding	 framework	 will	 be	 applied	 to	 developing	 broader	 
themes	 	 connected	 	 
to	 	 use	 	 of	 	 
the	 	 app	 	 during	 	 
the	 	 12-month	 	 period.	 	 
	 	 For	 	 
instance,	 	 since	 	 sampling	 
will	 	 divide	 	 respondents	 	 into	 	 four	 	 groups	 	 –	 	 callers,	 	 responders,	 	 caller/responders,	 	 and	 	 non-
responders	 	 –	 	 qualitative	 	 analysis	 	 will	 	 be	 	 directed	 	 towards	 	 characterizing	 	 each	 	 group	 	 and	 
determining	 differences	 between	 groups.	 	 The	 theme	 of	 “fear”	 or	 “trust”	 may	 be	 articulated	 by	 
each	 group	 but	 in	 different	 ways	 –	 fear	 that	 police	 disrupt	 the	 scene	 among	 callers	 or	 fear	 that	 
strangers	 may	 enter	 the	 scene	 among	 non-responders	 -	 that	 will	 impact	 use	 or	 non-use	 of	 the	 app.	 
	 
Retrospective	 analysis	 of	 app	 registration	 and	 usage	 data.	 Event	 data,	 combined	 with	 the	 member	 
location	 	 log,	 	 will	 	 allow	 	 behavioral	 	 and	 	 geospatial	 	 analysis	 	 of	 	 ERC-NAX	 	 usage	 	 providing	 
insights	 into	 efficacy,	 ease	 of	 use,	 member	 availability,	 willingness	 to	 respond	 and	 other	 items	 
important	 in	 advance	 of	 an	 R01.
	 With	 ERC-NAX	 registration	 and	 usage	 data	 we	 will	 construct	 a	 
comprehensive	 	 picture	 	 of	 	 participant	 	 alert	 	 and	 	 response	 	 behaviors,	 	 app	 	 diffusion,	 	 support	 
network	 	 growth,	 	 and	 	 intervention	 	 potential.	 	 This	 	 includes	 	 a	 	 complete	 	 geo-location	 	 log	 	 of	 	 all	 
participants	 over	 the	 full	 trial	 period,	 and	 details	 of	 each	 ERC	 alert	 event	 (sample	 of	 data	 items	 in	 
Table	 5).	 	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
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Revised:	 January	 09,	 2014	 
	 
The	 	 
log	 	 data	 	 contains	 	 
information	 	 of	 	 
the	 	 actual	 	 use	 	 of	 	 
the	 	 application	 	 by	 	 users,	 	 
including	 	 (1)	 
participation	 	 events:	 	 call	 	 open,	 	 call	 	 response,	 	 (2)	 	 geo-location	 	 upon	 	 use,	 	 and	 	 (3)	 	 demographic	 
location	 of	 users.	 The	 combination	 of	 these	 data	 allow	 the	 analysis	 of	 actual	 use	 pattern,	 such	 as	 
what	 type	 of	 users	 choose	 to	 open	 calls,	 at	 what	 time	 and	 condition,	 who	 responds	 to	 that	 call	 and	 
when.	 Moreover,	 this	 data	 can	 be	 used	 to	 analyze	 nonusers,	 or	 users	 that	 respond	 to	 certain	 type	 
of	 	 calls	 	 only,	 	 based	 	 on	 	 geographic	 	 proximity,	 	 
temporality,	 	 or	 	 demographic	 	 match	 	 between	 	 
the	 
caller	 	 and	 	 responder.	 	 Relevant	 	 statistical	 	 analysis	 	 on	 	 log	 	 data	 	 includes	 	 survival	 	 analysis	 
(unstructured	 	 
repeating	 	 behavior):	 	 probability	 	 of	 	 call/response	 	 of	 	 users	 	 at	 	 a	 	 certain	 	 
time	 	 point,	 
given	 their	 type,	 and	 demographics.	 	 
	 
Aim	 3	 
In	 	 advance	 	 of	 	 a	 	 R01	 	 multi-site	 randomized	 	 trial	 	 we	 	 will	 	 synthesize	 	 the	 	 results	 	 of	 	 the	 	 initial	 
design,	 implementation,	 and	 pilot	 test.	 For	 each	 type	 of	 user	 (NMOU/CM),	 we	 will	 delineate	 the	 
barriers	 and	 facilitators	 impacting	 adoption	 and	 use.	 Using	 system	 log	 usage	 data,	 we	 will	 group	 
users	 	 into	 	 high/mid/low-usage	 	 cohorts	 	 (where	 	 low-usage	 	 includes	 	 users	 	 identified	 	 as	 	 having	 
uninstalled	 	 or	 	 never	 	 activated	 	 the	 	 app)	 	 and	 	 analyze	 	 the	 	 interview	 	 data	 	 based	 	 on	 	 the	 	 cohort	 
groupings.	 	 The	 	 efficacy	 	 of	 	 data	 	 collection	 	 
through	 	 
the	 	 app	 	 and	 	 EMI	 	 assessments	 	 will	 	 also	 	 be	 
examined	 for	 lessons-learned	 leading	 to	 R01	 modifications.	 Analysis	 of	 the	 pilot	 data	 will	 guide	 
and	 	 
inform	 	 modifications	 	 
to	 	 
the	 	 
intervention	 	 design.	 	 A	 	 detailed	 	 study	 	 
implementation	 	 manual	 
will	 	 be	 	 drafted	 	 to	 	 support	 	 future	 	 multi-site	 	 studies.	 	 This	 	 will	 	 include	 	 sections	 	 on:	 	 participant	 
recruitment;	 	 suggested	 	 retention	 	 strategies;	 	 app	 	 implementation	 	 and	 	 registration	 	 management;	 
EMI	 methodology;	 survey	 methodology;	 log	 data	 collection	 procedures;	 and	 analytical	 models	 to	 
be	 applied	 to	 data	 collected.	 Specific	 attention	 will	 be	 paid	 to:	 	 
	 
Recruitment.	 	 A	 fundamental	 aspect	 of	 Aim	 2	 is	 the	 recruitment	 of	 110	 individuals	 into	 the	 study	 
to	 pilot	 test	 the	 ERC-NAX	 app.	 	 As	 indicated,	 we	 will	 recruit	 55	 non-medical	 opioid	 users	 (who	 
we	 anticipate	 will	 be	 the	 primary	 callers)	 and	 55	 community	 members	 (who	 we	 expect	 will	 be	 
the	 	 primary	 	 responders).	 	 In	 	 both	 	 cases,	 	 individuals	 	 will	 	 need	 	 to:	 	 be	 	 trained	 	 in	 	 administering	 
naloxone;	 	 carry	 	 naloxone;	 	 and	 	 own/carry	 	 smartphones.	 	 	 	 Assessing	 	 the	 	 ease	 	 of	 	 recruiting	 
individuals	 in	 both	 groups	 in	 the	 targeted	 neighborhoods	 will	 be	 an	 indicator	 of	 broader	 interest	 
and	 uptake	 of	 the	 app	 for	 the	 R01	 study.	 	 Ultimately,	 the	 success	 of	 the	 app	 is	 contingent	 upon	 
recruitment	 	 of	 	 both	 	 groups	 	 –	 	 persons	 	 witnessing	 	 an	 	 overdose	 	 who	 	 are	 	 willing	 	 to	 	 signal,	 	 and	 
persons	 carrying	 naloxone	 who	 are	 willing	 to	 respond.	 	 Screener	 data	 will	 be	 used	 to	 determine	 
characteristics	 	 of	 	 study	 	 participants	 	 vs.	 	 non-participants,	 	 and	 	 
reasons	 	 
for	 	 
refusing	 	 participation	 
will	 be	 analyzed.	 	 This	 quantitative	 data	 will	 be	 used	 to	 understand	 challenges	 towards	 recruiting	 
a	 larger	 sample	 for	 a	 R01	 study.	 We	 will	 also	 develop	 insights	 regarding	 app	 diffusion	 based	 on	 
download	 	 and	 	 registration	 	 patterns	 	 beyond	 	 the	 	 initial	 	 110	 	 subjects	 	 which	 	 will	 	 be	 	 useful	 	 in	 
designing	 the	 diffusion	 strategy	 for	 the	 R01	 study.	 
	 
Intervention	 Implementation.	 A	 critical	 success	 factor	 for	 the	 piloted	 intervention	 is	 the	 extent	 to	 
which	 	 the	 	 subjects	 	 actually	 	 use	 	 the	 	 app,	 	 which	 	 generally	 	 depends	 	 on	 	 their	 	 perceptions	 	 of	 
usefulness	 	 and	 	 ease	 	 of	 	 use.	 	 A	 	 fundamental	 	 goal	 	 of	 	 Aim	 	 1	 	 was	 	 
to	 	 adapt	 	 
the	 	 
initial	 	 app	 	 design	 
based	 	 on	 	 subject	 	 inputs	 	 to	 	 meet	 	 these	 	 goals.	 	 The	 	 activities	 	 of	 	 Aim	 	 2	 	 focused	 	 on	 	 assessing	 
effectiveness	 of	 the	 app	 as	 reported	 by	 members	 in	 BFA	 and	 qualitative	 interviews.	 In	 Aim	 3,	 we	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 15	 of	 34	 
Revised:	 January	 09,	 2014	 
revisit	 the	 design	 decisions	 made	 during	 the	 stages	 of	 Aim	 1	 in	 light	 of	 the	 results	 from	 Aim	 2.	 	 
This	 	 will	 	 enable	 	 modification	 	 of	 	 the	 	 app	 	 features	 	 and	 	 functions	 	 to	 	 hone	 	 suitability	 	 during	 
emergency	 	 events,	 	 increase	 	 ease	 	 of	 	 use	 	 and	 	 perceived	 	 usefulness,	 	 and	 	 improve	 	 intervention	 
implementation	 for	 the	 R01	 study.	 
	 
Retention/Adherence.	 	 Retaining	 both	 NMOU	 and	 CM	 in	 the	 study	 will	 be	 a	 key	 study	 outcome	 
since	 the	 success	 of	 the	 app	 is	 contingent	 upon	 an	 ongoing	 critical	 mass	 of	 persons	 being	 able	 
and	 willing	 to	 respond	 to	 an	 overdose	 when	 alerted.	 	 We	 anticipate	 a	 10%	 attrition	 rate.	 Several	 
necessary	 preconditions	 for	 responding	 to	 an	 overdose	 alert	 include:	 carrying	 naloxone;	 having	 a	 
cellphone	 turned	 on;	 being	 located	 close	 enough	 to	 the	 event	 to	 respond	 in	 a	 timely	 manner;	 and	 
being	 	 willing	 	 to	 	 respond	 	 to	 	 a	 	 stranger	 	 and/or	 	 unknown	 	 location.	 	 	 	 Qualitative	 	 interview	 	 data	 
focusing	 on	 participants’	 experiences	 using	 the	 app,	 motivations	 to	 use	 the	 app,	 and	 barriers	 to	 
using	 the	 app	 will	 illuminate	 factors	 pertaining	 to	 retention	 in	 study	 and	 ongoing	 use	 of	 the	 app.	 
This	 	 qualitative	 	 data	 	 will	 	 be	 	 used	 	 to	 	 understand	 	 factors	 	 pertaining	 	 to	 	 study	 	 retention	 	 and	 
adherence	 in	 using	 the	 app	 for	 the	 R01	 study.	 
	 
Assessment	 Processes	 
Interviews.	 	 	 Completion	 	 of	 	 the	 	 Brief	 	 Follow-Up	 	 interviews	 	 will	 	 be	 	 important	 	 to	 	 determine	 
outcomes	 	 relating	 	 
to	 	 drug	 	 use	 	 and	 	 overdose	 	 risk,	 	 possession	 	 of	 	 naloxone,	 	 and	 	 use	 	 of	 	 
the	 	 app.	 	 
Similarly,	 use	 of	 follow-up	 interviews	 would	 be	 a	 crucial	 part	 of	 a	 larger	 R01	 study.	 	 Follow-up	 
interview	 completion	 rates	 will	 be	 examined	 for	 each	 of	 the	 110	 participants.	 Statistical	 analysis	 
will	 	 be	 	 used	 	 
to	 	 determine	 	 characteristics	 	 of	 	 participants	 	 who	 	 complete	 	 
follow-ups	 	 compared	 	 
to	 
those	 	 who	 	 do	 	 not.	 	 
	 	 This	 	 quantitative	 	 data	 	 will	 	 be	 	 used	 	 
to	 	 
improve	 	 completion	 	 
rates	 	 
in	 	 
the	 	 R01	 
study.	 	 
	 
App	 usage.	 Analysis	 of	 the	 usage	 log	 data	 will	 be	 important	 to	 determine	 community	 behavior,	 
response	 	 times	 	 and	 	 distances	 	 for	 	 responders,	 	 and	 	 potential	 	 for	 	 intervention	 	 based	 	 on	 	 member	 
location	 for	 non-responders.	 This	 data	 will	 be	 used	 to	 study	 physical	 geographic	 distribution	 of	 
members	 	 
(both	 	 
responders	 	 and	 	 non-responders)	 	 under	 	 
the	 	 different	 	 conditions	 	 
logged	 	 
for	 	 each	 
event.	 This	 quantitative	 data	 will	 be	 used	 to	 set	 baseline	 expectations	 for	 response	 behavior	 in	 the	 
R01	 study	 and	 inform	 the	 inclusion	 of	 new	 motivators	 in	 the	 R01	 to	 extend	 the	 limits	 of	 response	 
behavior.	 
	 
Data	 	 Collection	 	 Efficacy.	 	 Quantitative	 	 data	 	 collected	 
from	 study	 instruments,	 such	 as	 the	 	 
Baseline	 Assessment,	 Brief	 Follow-Up,	 Retrospective	 
Use	 	 of	 	 App,	 	 as	 	 well	 	 as	 	 logged	 	 alert	 	 and	 	 response	 
activity,	 will	 be	 examined	 to	 determine	 the	 feasibility	 
of	 	 collecting	 	 
these	 	 data	 	 on	 	 
larger	 	 scale	 	 for	 	 
the	 	 R01.	 	 
For	 instance,	 data	 from	 the	 Retrospective	 Use	 of	 App,	 
which	 will	 be	 administered	 following	 use	 of	 the	 app,	 
will	 be	 examined	 for	 missing	 data	 and	 data	 quality	 to	 
determine	 	 the	 	 ideal	 	 period	 	 to	 	 administer	 	 the	 	 survey	 
following	 an	 event.	 	 
	 
Table	 9:	 	 Working	 hypotheses	 for	 R01	 	 
H1	 	 
Intervention.	 Adopt
ion	 	 of	 	 
the	 	 ERC-NAX	 	 app	 	 by	 	 an	 
OPP	 	 
(tr
ia
l)	 	 group	 	 w
i
l
l	 	 
resu
lt	 
	 
in	 	 h
igher	 	 
rates	 	 of	 	 na
loxone	 
use	 than	 in	 an	 OPP	 (contro
l)	 group	 w
ith	 an	 informat
ion-
on
ly	 app.	 
H2	 	 Acceptance.	 W
i
l
l
ingness	 	 
to	 	 summon	 	 ERC	 	 member	 
he
lp	 
	 in	 	 an	 	 overdose	 	 s
ituat
ion	 	 w
i
l
l	 	 resu
lt	 
	 in	 
	 increased	 
emergency	 use	 of	 na
loxone.	 
H3	 	 Participation.	 Ava
i
lab
i
l
ity	 	 of	 	 the	 	 ERC-NAX	 
app
l
icat
ion	 
	 
in	 	 a	 	 spec
if
ic	 	 commun
ity	 	 w
i
l
l	 	 
resu
lt	 
	 
in	 	 h
igher	 
leve
ls	 	 of	 	 na
loxone	 	 OPP	 	 program	 	 part
ic
ipat
ion	 	 for	 	 that	 
commun
ity.	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 16	 of	 34	 
Revised:	 January	 09,	 2014	 
This	 proposal	 does	 not	 examine	 specific	 hypotheses	 that	 will	 become	 the	 subject	 of	 the	 planned	 
R01	 	 study	 	 to	 	 follow.	 	 However,	 	 it	 	 does	 	 validate	 	 the	 	 research	 	 constructs	 	 and	 	 methods	 	 through	 
which	 	 
the	 	 R01	 	 hypotheses	 	 will	 	 be	 	 
tested.	 	 For	 	 
that	 	 
reason,	 	 we	 	 present	 	 a	 	 
list	 	 of	 	 
several	 	 working	 
hypotheses	 	 
in	 	 Table	 	 9.	 	 Aim	 	 3	 	 will	 	 specifically	 	 address	 	 
the	 	 ability	 	 of	 	 an	 	 R01	 	 
trial	 	 
to	 	 study	 	 
the	 
working	 hypotheses	 given	 the	 results	 of	 the	 pilot	 study.	 	 
	 
Security	 of	 data	 
	 
The	 study	 design	 will	 yield	 four	 primary	 types	 of	 data:	 quantitative	 data	 from	 the	 Quantitative	 
Baseline	 and	 Follow-Up	 Assessments;	 qualitative	 data	 from	 the	 Qualitative	 Interviews	 and	 Focus	 
Groups;	 retrospective	 data;	 smartphone	 use/app	 data;	 and	 participant	 tracking	 information.	 
The	 	 Quantitative	 	 Baseline	 	 and	 	 Follow-Up	 	 Assessments	 	 will	 	 yield	 	 a	 	 data	 	 
file	 	 
in	 	 REDCap	 	 
that	 
will	 	 be	 	 converted	 	 
into	 	 an	 	 SPSS	 	 or	 	 SAS	 	 file	 	 during	 	 data	 	 analysis.	 	 The	 	 data	 	 file	 	 will	 	 primarily	 
consist	 of	 coded	 numerical	 response	 to	 questions	 from	 the	 interview.	 The	 follow-up	 assessment	 
will	 be	 launched	 via	 the	 ERC-NAX	 app	 and	 will	 offer	 participants	 a	 user	 friendly	 and	 intuitive	 
interface	 for	 completing	 the	 brief	 via	 a	 secure	 project	 website.	 	 
Retrospective	 	 data.	 	 No	 	 participant	 	 identifying	 	 information	 	 will	 	 be	 	 stored	 	 in	 	 the	 	 smartphone.	 	 
Retrospective	 	 responses	 	 will	 	 be	 	 directly	 	 entered	 	 into	 	 a	 	 secure	 	 study	 	 server	 	 through	 	 a	 	 project	 
website	 with	 a	 standard	 web	 browser	 via	 an	 encrypted	 connection	 and	 any	 information	 entered	 
will	 not	 be	 retained	 on	 the	 smartphone.	 	 
Smartphone	 	 use/app	 	 data.	 	 All	 	 app	 	 usage	 	 data	 	 will	 	 be	 	 automatically	 	 collected	 	 
through	 	 
the	 	 app	 
which	 	 is	 	 purpose-built	 	 to	 	 gather	 	 relevant	 	 indicators.	 	 	 	 HIPAA-compliant	 	 servers	 	 will	 	 log	 	 all	 
activity	 	 and	 	 ensure	 	 security	 	 of	 	 Protected	 	 Health	 	 Information	 	 (PHI).	 	 Secure-server	 	 stored	 	 data	 
includes	 	 geolocation	 	 and	 	 emergency	 	 alert/response	 	 information	 	 referenced	 	 only	 	 by	 	 unique	 
subject	 identifiers	 and	 containing	 no	 identifiable	 private	 information	 (IPI).	 A	 single	 system	 table	 
linking	 identifiers	 to	 IPI	 will	 be	 maintained	 and	 secured	 separately	 following	 the	 most	 stringent	 
data	 security	 standards.	 No	 event	 history	 data	 will	 be	 stored	 on	 individual	 smartphones.	 	 
Qualitative	 	 data	 	 from	 	 qualitative	 	 interviews	 	 and	 	 focus	 	 groups.	 	 All	 	 the	 	 qualitative	 	 and	 	 focus	 
groups	 interviews	 will	 be	 digitally	 recorded.	 Interviews	 will	 be	 transcribed	 by	 a	 New	 York-based	 
company	 (Transcript	 Divas)	 within	 one	 month	 of	 the	 interview	 and	 converted	 into	 an	 electronic	 
Word	 	 document.	 	 
	 	 During	 	 
the	 	 
transcription	 	 process,	 	 all	 	 
identifying	 	 
information	 	 
revealed	 	 by	 	 
the	 
subject	 –	 about	 his/herself	 or	 others	 -	 will	 be	 removed.	 	 The	 digital	 file	 will	 be	 destroyed	 after	 
determining	 	 
that	 	 an	 	 accurate	 	 
transcript	 	 has	 	 been	 	 created	 	 
from	 	 
the	 	 digital	 	 
recording	 	 
(within	 	 one	 
month	 of	 developing	 the	 transcript).	 	 The	 electronic	 transcript	 may	 also	 be	 printed	 as	 a	 hard	 copy	 
or	 paper	 copy	 for	 analysis.	 	 Each	 paper	 copy	 will	 be	 labeled	 with	 the	 coded	 identifier	 assigned	 at	 
the	 time	 of	 interview,	 stored	 in	 an	 individual	 folder,	 and	 locked	 in	 a	 file	 cabinet	 when	 not	 in	 use.	 
Each	 interview	 note	 will	 be	 labeled	 with	 the	 coded	 identifier	 assigned	 at	 the	 time	 of	 interview,	 
stored	 in	 an	 individual	 folder,	 and	 locked	 in	 a	 file	 cabinet	 when	 not	 in	 use.	 The	 digital	 file	 will	 be	 
destroyed	 	 after	 	 determining	 	 that	 	 accurate	 	 notes	 	 have	 	 been	 	 created	 	 from	 	 the	 	 digital	 	 recording	 
(within	 one	 month	 of	 developing	 the	 transcript).	 	 
Participants	 	 will	 	 be	 	 asked	 	 to	 	 provide	 	 contact	 	 information	 	 including:	 	 current	 	 residence;	 	 home,	 
office,	 	 and	 	 cellular	 	 phone	 	 numbers;	 	 pager	 	 number;	 	 email/Facebook	 	 addresses;	 	 and	 	 
the	 	 names,	 
addresses,	 and	 phone	 number	 of	 immediate	 relatives	 and	 of	 an	 unrelated	 friend.	 	 This	 contact	 and	 	 
	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 17	 of	 34	 
Revised:	 January	 09,	 2014	 
locating	 	 information	 	 will	 	 be	 	 entered	 	 and	 	 stored	 	 in	 	 a	 	 password-protected	 	 Access	 	 database	 	 and	 
updated	 throughout	 the	 project	 period.	 Tracking	 information	 will	 be	 collected	 at	 baseline	 onto	 a	 
paper	 tracking	 form.	 The	 paper	 copy	 will	 be	 destroyed	 after	 the	 information	 has	 been	 stored	 	 
electronically.	 	 
Access	 	 
to	 	 Individually	 	 Identifiable	 	 Private	 	 Information.	 Only	 	 
individuals	 	 at	 	 Drexel	 	 will	 	 have	 
access	 	 
to	 	 
individual	 	 
identifiable	 	 private	 	 
information.	 	 At	 	 Drexel,	 	 
the	 	 following	 	 
individuals	 	 will	 
have	 access:	 Lankenau	 (Principal	 Investigator);	 Roth	 (Co-Investigator);	 Marcu	 (Co-Investigator)	 
and	 	 TBN	 	 (Data	 	 Manager).	 	 All	 	 research	 	 staff	 	 will	 	 be	 	 trained	 	 on	 	 the	 	 proper	 	 procedures	 	 for	 
handling	 confidential	 data.	 	 	 
	 
11)	 Provisions	 to	 Monitor	 the	 Data	 to	 Ensure	 the	 Safety	 of	 Subjects	 
An	 external	 Data	 and	 Safety	 Monitoring	 Board	 (DSMB)	 will	 be	 established	 to	 oversee	 the	 safety	 
of	 	 participants	 	 as	 	 part	 	 of	 	 the	 	 overall	 	 Data	 	 and	 	 Safety	 	 Monitoring	 	 Plan.	 	 The	 	 DSMB	 	 will	 	 be	 
established	 within	 the	 first	 two	 months	 of	 the	 study	 start	 date	 and	 will	 consist	 of	 three	 members	 
with	 the	 following	 expertise:	 a	 clinician	 (MD)	 with	 experience	 running	 clinical	 trials;	 a	 bioethicist;	 
and	 	 a	 	 community	 	 member	 	 with	 	 direct	 	 experience	 	 with	 	 the	 	 problem	 	 of	 	 opioid	 	 misuse	 	 and/or	 
overdose.	 	 Any	 	 potential	 	 adverse	 	 events	 	 (AE)	 	 relating	 	 to	 	 use	 	 of	 	 the	 	 ERC-NAX	 	 app	 	 will	 	 be	 
documented	 and	 reported	 to	 the	 Principal	 Investigators	 and	 DSMB.	 The	 DSMB	 will	 review	 any	 
potential	 	 AE	 	 to	 	 determine	 	 if	 	 they	 	 meet	 	 criteria	 	 for	 	 serious	 	 adverse	 	 events	 	 (SAE).	 	 Any	 	 SAE,	 
whether	 or	 not	 related	 to	 ERC-NAX	 app,	 will	 be	 reported	 to	 the	 Principal	 Investigators,	 the	 IRB,	 
and	 NIDA.	 The	 DSMB	 will	 convene	 at	 least	 twice	 during	 the	 12-month	 data	 collection	 period	 to	 
query	 the	 Principal	 Investigators	 about	 participant	 safety	 if	 no	 AE	 are	 reported.	 
	 
12)	 Withdrawal	 of	 Subjects	 
A	 	 study	 	 participant	 	 may	 	 be	 	 asked	 	 
to	 	 withdraw	 	 from	 	 
the	 	 study	 	 due	 	 
to	 	 a	 	 serious	 	 adverse	 	 event	 
(SAE)	 if	 the	 Principal	 Investigator	 determines	 it	 is	 the	 best	 interest	 of	 the	 participant’s	 safety.	 In	 
case	 a	 participant	 either	 withdraws	 from	 the	 study	 or	 PI	 decides	 to	 discontinue	 a	 participant,	 the	 
participant	 will	 have	 appropriate	 follow-up.	 Monitoring	 will	 continue	 until	 the	 problem	 has	 been	 
resolved	 	 or	 	 stabilized	 	 with	 	 no	 	 further	 	 change	 	 expected,	 	 or	 	 is	 	 clearly	 	 unrelated	 	 to	 	 study	 
intervention.	 
In	 the	 event	 of	 participant	 withdrawal,	 at	 any	 point	 during	 survey	 or	 interview	 process,	 data	 will	 
be	 	 
immediately	 	 destroyed.	 	 If	 	 
the	 	 participant	 	 wishes	 	 
to	 	 stop	 	 survey	 	 or	 	 
interview,	 	 but	 	 does	 	 not	 
want	 data	 from	 survey	 or	 interview	 destroyed,	 collected	 data	 will	 used,	 but	 a	 survey	 or	 interview	 
will	 be	 considered	 incomplete.	 	 
If	 a	 participant	 takes	 part	 in	 an	 interview,	 but	 later	 decides	 to	 withdraw	 her	 data,	 the	 interview	 
will	 be	 destroyed.	 
	 
	 
	 
	 
	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 18	 of	 34	 
Revised:	 January	 09,	 2014	 
13)	 Risks	 to	 Subjects	 
	 
The	 	 possible	 	 risks	 	 to	 	 subjects	 	 involved	 	 in	 	 this	 	 research	 	 include	 	 the	 	 potential	 	 loss	 	 of	 
confidentiality,	 potential	 distress	 caused	 by	 interview	 questions,	 and	 potential	 distress	 caused	 by	 
responding	 to	 a	 drug	 overdose.	 	 	 
Drug	 	 users	 	 engage	 	 
in	 	 a	 	 variety	 	 of	 	 
illegal	 	 activities	 	 apart	 	 
from	 	 use	 	 of	 	 
illicit	 	 substances,	 	 such	 	 as	 
drug	 	 selling,	 	 violent	 	 behaviors,	 	 and	 	 other	 	 crimes,	 	 which	 	 could	 	 be	 	 recorded	 	 during	 	 
interviews.	 	 
These	 	 individuals	 	 could	 	 be	 	 at	 	 risk	 	 for	 	 arrest	 	 from	 	 police	 	 or	 	 retribution	 	 from	 	 others	 	 if	 	 the	 
confidentiality	 	 of	 	 the	 	 data	 	 were	 	 to	 	 be	 	 compromised.	 	 Subjects	 	 will	 	 also	 	 provide	 	 self-reported	 
information	 about	 their	 HIV	 status	 and	 HIV-related	 risk	 behavior.	 	 There	 is	 a	 risk	 that	 others	 not	 
involved	 in	 the	 study	 could	 learn	 this	 sensitive	 information	 if	 the	 confidentiality	 of	 the	 interviews	 
is	 compromised.	 However,	 no	 data	 will	 be	 stored	 on	 participant’s	 smartphones	 or	 through	 EMA	 
data	 collection	 methods.	 Our	 research	 shows	 that	 active	 drug	 users	 perceive	 few	 potentials	 harms	 
and	 many	 benefits	 associated	 with	 participation	 in	 a	 longitudinal	 EMA	 study	 of	 drug	 use.
69	 
To	 protect	 against	 a	 loss	 of	 confidentiality,	 all	 interview	 data,	 and	 tracking	 data	 will	 be	 identified	 
by	 the	 coded	 identifiers,	 password-protected,	 and/or	 stored	 in	 locked	 filing	 cabinets.	 	 Identifying	 
information	 	 will	 	 be	 	 removed	 	 from	 	 qualitative	 	 interviews.	 	 All	 	 staff	 	 will	 	 be	 	 trained	 	 in	 
confidentiality	 	 procedures.	 	 The	 	 project	 	 will	 	 obtain	 	 a	 	 Federal	 	 Certificate	 	 of	 	 Confidentiality,	 	 and	 
interviewers	 	 will	 	 carry	 	 it	 	 at	 	 all	 	 times	 	 when	 	 conducting	 	 research.	 	 	 	 In	 	 our	 	 past	 	 NIH	 	 studies	 
involving	 similar	 high-risk	 populations,	 these	 procedures	 have	 proven	 effective,	 and	 we	 have	 not	 
had	 any	 adverse	 events	 to	 report	 to	 the	 IRB.	 	 	 
Another	 	 potential	 	 
risk	 	 
to	 	 subjects	 	 
is	 	 
the	 	 experience	 	 of	 	 emotional	 	 distress	 	 
that	 	 may	 	 
result	 	 
from	 
responding	 	 to	 	 a	 	 drug	 	 overdose.	 	 However,	 	 our	 	 prior	 	 research	 	 on	 	 bystanders	 	 responding	 	 to	 
overdose	 	 events	 	 with	 	 naloxone	 	 did	 	 not	 	 indicate	 	 any	 	 adverse	 	 events.9,60	 The	 	 study	 	 staff	 	 who	 
conduct	 	 interviews	 	 will	 	 refer	 	 emotionally	 	 distressed	 	 study	 	 participants	 	 to	 	 a	 	 qualified	 	 case	 
manager	 	 or	 	 mental	 	 health	 	 worker	 	 for	 	 assessment	 	 and	 	 care.	 	 
	 	 A	 	 similar	 	 protocol	 	 
is	 	 currently	 	 
in	 
place	 for	 a	 current	 R01	 study	 of	 young	 drug	 users.	 	 	 
For	 the	 current	 study	 we	 propose	 to	 test	 an	 interface	 that	 automatically	 alerts	 911	 concurrent	 with	 
the	 	 community	 	 alert.	 	 It	 	 is	 	 important	 	 to	 	 note	 	 that	 	 in	 	 no	 	 case	 	 does	 	 the	 	 pilot	 	 study	 	 bypass	 	 or	 
eliminate	 response	 by	 EMS/First	 Responders.	 	 The	 guiding	 principles	 of	 the	 app	 design	 include	 
automatic	 EMS	 alert	 by	 the	 app	 irrespective	 of	 expected	 ERC	 response.	 This	 functionality	 helps	 
responders	 meet	 the	 apparent	 legal	 obligation	 to	 inform	 911	 upon	 providing	 naloxone.	 
During	 the	 course	 of	 retrospective	 qualitative	 interviews,	 follow-up	 interviews,	 or	 assessments,	 
interviewers	 and/or	 data	 analyst	 will	 check	 for	 events	 relating	 to	 use	 of	 the	 ERC-NAX	 that	 had	 
any	 	 adverse	 	 consequence	 	 
for	 	 
the	 	 
study	 	 participant	 	 or	 	 others	 	 using	 	 
the	 	 app.	 	 
	 All	 adverse	 	 events	 
(AE)	 occurring	 during	 the	 course	 of	 the	 study	 will	 be	 collected,	 documented,	 and	 reported	 to	 the	 
Principal	 	 Investigator	 	 within	 	 24	 	 hours	 	 of	 	 discovering	 	 the	 	 event.	 	 Each	 	 week	 	 the	 	 Principal	 
Investigator	 	 will	 	 review	 	 AE	 	 from	 	 the	 	 prior	 	 week	 	 for	 	 events	 	 that	 	 were	 	 reported	 	 as	 	 new	 	 or	 
continuing.	 The	 study	 investigators	 will	 follow	 all	 AE	 to	 the	 point	 of	 a	 satisfactory	 resolution.	 In	 
any	 addition,	 quantitative	 and	 qualitative	 data	 will	 be	 monitored	 by	 random	 inspection	 monthly	 
to	 ascertain	 any	 possible	 AE	 that	 went	 unreported	 to	 the	 PI.	 
All	 AE	 will	 be	 assessed	 to	 determine	 if	 they	 meet	 criteria	 for	 serious	 adverse	 events	 (SAE).	 SAE	 
will	 	 be	 	 systematically	 	 evaluated.	 	 Any	 	 SAE,	 	 whether	 	 or	 	 not	 	 
related	 	 
to	 	 ERC-NAX	 	 app,	 	 will	 	 be	 
reported	 to	 the	 Drexel	 IRB	 and	 NIDA.	 The	 initial	 SAE	 report	 will	 be	 followed	 by	 submission	 of	 

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a	 	 completed	 	 SAE	 	 
report	 	 
to	 	 both	 	 
institutions.	 Outcome	 	 of	 	 SAE	 	 will	 	 be	 	 periodically	 	 
reported	 	 
to	 
NIDA.	 	 A	 	 summary	 	 of	 	 
the	 	 SAE	 	 
that	 	 occurred	 	 during	 	 
the	 	 previous	 	 year	 	 will	 	 be	 	 
included	 	 
in	 	 
the	 
annual	 progress	 report	 to	 the	 Drexel	 IRB	 and	 NIDA.	 
Dr.	 	 Lankenau	 	 will	 	 be	 	 
responsible	 	 
for	 	 
reporting	 	 adverse	 	 events.	 	 
	 	 Adverse	 	 events	 	 deemed	 	 
to	 	 be	 
serious	 	 and	 	 unexpected	 	 and	 	 possibly	 	 related	 	 to	 	 participation	 	 in	 	 the	 	 study	 	 will	 	 be	 	 reported	 
promptly	 to	 the	 IRB.	 	 If	 it	 is	 believed	 that	 the	 reported	 events	 merit	 change	 to	 the	 consent	 form,	 
then	 the	 Dr.	 Lankenau	 will	 submit	 a	 revised	 consent	 form	 to	 the	 IRB	 for	 review	 and	 approval.	 	 	 
Dr.	 Lankenau	 and	 co-investigators	 are	 experienced	 researchers	 who	 are	 accustomed	 to	 working	 
with	 	 high-risk	 	 populations,	 	 including	 	 persons	 	 at	 	 risk	 	 for	 	 overdose.	 	 All	 	 interviewers	 	 will	 	 be	 
trained	 	 by	 	 Dr.	 	 Lankenau	 	 to	 	 screen	 	 for	 	 intoxicated	 	 individuals	 	 and	 	 how	 	 to	 	 identify	 	 emotional	 
distress.	 	 
	 	 This	 	 information	 	 will	 	 be	 	 discussed	 	 during	 	 staff	 	 meetings,	 	 and	 	 staff	 	 training	 	 will	 	 be	 
ongoing.	 	 	 	 In	 	 the	 	 event	 	 that	 	 a	 	 research	 	 subject	 	 becomes	 	 emotionally	 	 distressed	 	 during	 	 an	 
interview,	 interviewers	 will	 stop	 the	 interview	 immediately	 and	 the	 interviewer	 will	 provide	 an	 
escort	 	 
to	 	 whatever	 	 emergency	 	 services	 	 are	 	 necessary.	 	 
	 	 Whenever	 	 specifically	 	 
requested	 	 by	 	 
the	 
subject,	 interviewers	 will	 provide	 a	 direct	 telephone	 referral	 and	 escort	 the	 subject	 to	 appropriate	 
services	 in	 the	 community.	 
Overall,	 	 
the	 	 risks	 	 are	 	 similar	 	 
to	 	 anyone	 	 who	 	 volunteers	 	 
to	 	 be	 	 
trained	 	 
in	 	 overdose	 	 prevention,	 
carries	 	 naloxone,	 	 and	 	 responds	 	 to	 	 an	 	 overdose.	 	 We	 	 believe	 	 that	 	 these	 	 planned	 	 procedures	 	 in	 
conjunction	 with	 the	 potential	 benefits	 of	 this	 study	 outweigh	 the	 potential	 risks.	 
	 
14)	 Potential	 Benefits	 to	 Subjects	 
There	 is	 no	 direct	 benefit	 to	 subjects;	 however	 we	 anticipate	 that	 this	 research	 will	 be	 beneficial	 
for	 	 those	 	 enrolled	 	 in	 	 the	 	 study	 	 in	 	 several	 	 indirect	 	 ways.	 	 The	 	 ERC-Nax	 	 and	 	 related	 	 overdose	 
prevention	 training	 has	 the	 potential	 to	 save	 lives	 of	 enrolled	 participants,	 persons	 in	 their	 social	 
network,	 	 or	 	 
strangers.	 	 During	 	 
the	 	 
interview	 	 process	 	 
it	 	 
is	 	 possible	 	 
that	 	 participants	 	 will	 	 
identify	 
behaviors	 or	 circumstances	 that	 increase	 their	 risk	 for	 negative	 health	 outcomes,	 which	 can	 lead	 
to	 behavior	 change.	 Interviewers	 will	 provide	 a	 direct	 referral	 and/or	 escort	 to	 appropriate	 mental	 
health	 and	 social	 services	 if	 requested.	 
15)	 Vulnerable	 Populations	 
Does	 not	 apply	 
	 
16)	 Multi-Site	 Research	 
Does	 not	 apply	 	 
17)	 Community-Based	 Participatory	 Research	 
Our	 	 approach	 	 will	 	 
involve	 user-centered	 design,72	 participatory	 design,73	 and	 community-based	 
participatory	 research74	 to	 engage	 end	 users	 and	 stakeholders	 in	 the	 design	 of	 the	 ERC-NAX	 app.	 
Guided	 by	 emergent	 themes	 from	 qualitative	 data	 collection	 and	 analysis,	 ERX-NAX	 mockups	 
and	 	 prototypes	 	 will	 	 be	 	 generated	 	 using	 	 a	 	 rapid	 	 iteration	 	 process.	 	 Two	 	 community-based	 
organizations,	 	 Angels	 	 in	 	 Motion	 	 and	 	 Prevention	 	 Point	 	 Philadelphia,	 will	 assist	 	 with	 	 the	 
recruitment	 	 of	 	 community	 	 members	 	 
(CM)	 	 and	 	 non-medical	 	 opioid	 	 users	 	 
(NMOU)	 	 
in	 	 both	 	 
the	 
development	 	 of	 	 
the	 	 ERC-NAX	 	 app,	 	 e.g.,	 	 stakeholders,	 	 as	 	 well	 	 as	 	 during	 	 recruitment	 	 of	 	 study	 

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participants	 to	 test	 the	 app.	 Starting	 with	 low-fidelity	 prototypes,	 feedback	 will	 be	 solicited	 from	 
stakeholders	 	 on	 	 an	 	 ongoing	 	 basis	 	 and	 	 
iteration	 	 will	 	 continue	 	 until	 	 a	 	 high-fidelity	 	 prototype	 	 has	 
been	 	 generated	 	 that	 	 stakeholders	 	 do	 	 not	 	 identify	 	 issues	 	 with,	 	 and	 	 that	 	 provides	 	 enough	 
specification	 to	 guide	 software	 development.	 These	 approaches	 ensure	 that	 the	 resulting	 solution	 
and	 interface	 will	 be	 usable,	 feasible,	 and	 adoptable.	 End	 users	 and	 stakeholders	 will	 co-create	 an	 
app	 that	 meets	 their	 needs	 relating	 to	 overdose	 response	 and	 realistically	 fits	 into	 their	 everyday	 
lives.	 Using	 an	 iterative	 process,	 data	 collection	 and	 analysis	 will	 occur	 concurrently	 during	 Year	 
1	 	 to	 	 support	 	 the	 	 development	 	 of	 	 the	 	 app	 	 and	 	 will	 	 involve	 	 several	 	 components,	 	 including	 
qualitative	 interviews,	 focus	 groups,	 and	 usability	 testing.	 
18)	 Sharing	 of	 Results	 with	 Subjects	 
Presentations	 on	 study	 results	 will	 be	 conducted	 at	 both	 Prevention	 Point	 Philadelphia	 
and	 Angels	 in	 Motion.	 Study	 participants	 will	 be	 contacted	 and	 encouraged	 to	 attend	 
these	 presentations	 for	 their	 insight	 and	 feedback	 on	 study	 results.	 
19)	 Setting	 
Recruitment	 of	 NMOU	 will	 be	 facilitated	 by	 Prevention	 Point	 Philadelphia	 (PPP)	 and	 conducted	 
at	 	 
their	 	 Kensington	 	 facility.	 PPP	 	 serves	 	 
the	 	 most	 	 vulnerable	 	 and	 	 hard-to-reach	 	 populations	 	 of	 
Philadelphia,	 	 including	 	 people	 	 who	 	 use	 	 drugs	 	 and	 	 sex	 	 workers.	 	 	 	 The	 	 agency	 	 takes	 	 a	 	 harm	 
reduction	 	 approach	 	 
to	 	 high	 	 risk	 	 behavior	 	 by	 	 providing	 	 safety	 	 measures	 	 for	 	 people	 	 who	 	 are	 	 at	 
high	 	 risk	 	 for	 	 contracting	 	 HIV/AIDS,	 	 hepatitis	 	 C,	 	 and	 	 other	 	 blood-borne	 	 diseases,	 	 including	 
overdose	 	 prevention	 	 
trainings.	 CM	 	 will	 	 be	 	 
recruited	 	 
through	 	 Angels	 	 
in	 	 Motion,	 	 a	 	 community-
based	 group	 located	 in	 Kensington	 that	 is	 comprised	 of	 individual	 community	 members	 and	 hold	 
bimonthly	 meetings.	 	 
20)	 Resources	 Available	 
Two	 community-based	 organizations,	 Angels	 in	 Motion	 and	 Prevention	 Point	 Philadelphia,	 will	 
assist	 	 with	 	 
the	 	 
recruitment	 	 of	 	 55	 	 community	 	 members	 	 
(CM)	 	 and	 	 55	 	 non-medical	 	 opioid	 	 users	 
(NMOU).	 	 Feasibility	 	 of	 	 recruitment	 	 is	 	 assured	 	 by	 	 the	 	 fact	 	 that	 	 both	 	 Angels	 	 in	 	 Motion	 	 and	 
Prevention	 	 Point	 	 Philadelphia	 	 have	 	 members	 	 or	 	 clients	 	 that	 	 greatly	 	 exceed	 	 the	 	 number	 	 of	 
subjects	 	 enrolled	 	 to	 	 be	 	 enrolled	 	 in	 	 the	 	 study.	 	 The	 	 Executive	 	 Director	 	 of	 	 Prevention	 	 Point	 
Philadelphia	 	 (Jose	 	 Benitez)	 	 and	 	 the	 	 President	 	 of	 	 Angels	 	 in	 	 Motion	 	 (Carol	 	 Rostucher)	 	 have	 
reviewed	 the	 study	 aims	 and	 support	 for	 this	 research	 (see	 Appendix	 -	 Letters	 of	 Support).	 
	 
Staff	 
Research	 	 Team:	 	 An	 	 experienced	 	 
interdisciplinary	 	 
team	 	 brings	 	 
together	 	 
the	 	 diverse	 	 knowledge	 
and	 skills	 required	 for	 this	 proposal.	 Addiction	 sociology	 and	 public	 health	 (Prof.	 Lankenau	 and	 
Dr.	 	 Roth),	 	 
information	 	 systems,	 	 mHealth	 	 systems,	 	 and	 	 online	 	 social	 	 networks	 	 
(Prof.	 	 Schwartz	 
and	 Dr.	 Yahav),	 mobile	 app	 design	 and	 human-computer	 interaction	 (Prof.	 Marcu),	 each	 play	 a	 
fundamental	 	 part	 	 of	 	 
this	 	 effort.	 	 Qualitative	 	 and	 	 quantitative	 	 data	 	 collected	 	 and	 	 analyzed	 	 
in	 	 
this	 
project	 require	 techniques	 involving	 EMA/EMI,	 social	 network	 analysis,	 data	 clustering	 and	 geo-
spatial	 	 analysis.	 	 The	 	 team	 	 will	 	 conduct	 	 weekly	 	 skype	 	 meetings,	 	 semi-annual	 	 face-to-face	 
sessions,	 and	 utilize	 a	 secure	 document/data-sharing	 and	 collaboration	 platform.	 

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Dr.	 Stephen	 Lankenau	 is	 a	 Professor	 in	 the	 Department	 of	 Community	 Health	 and	 Prevention	 
at	 Drexel	 University’s	 Dornsife	 School	 of	 Public	 Health.	 	 A	 sociologist	 by	 training,	 his	 research	 
focuses	 on	 the	 use	 and	 misuse	 of	 substances	 at	 the	 forefront	 of	 current	 public	 health	 concerns,	 
including	 marijuana	 and	 opioids,	 and	 associated	 morbidities,	 such	 as	 overdose,	 HIV,	 HCV,	 and	 
drug	 dependence.	 The	 problem	 of	 opioid	 overdose	 and	 prevention	 has	 been	 a	 focal	 point	 of	 his	 
studies	 conducted	 in	 Philadelphia	 and	 Los	 Angeles	 since	 2009.	 	 Dr.	 Lankenau’s	 methodological	 
approach	 	 to	 	 public	 	 health	 	 research	 	 combines	 	 qualitative	 	 and	 	 quantitative	 	 techniques	 	 into	 
integrated	 	 mixed	 	 method	 	 designs.	 	 	 	 Dr.	 	 Lankenau	 	 will	 	 lead	 	 the	 	 data	 	 collection	 	 of	 	 study	 
participants	 in	 Philadelphia,	 lead	 the	 qualitative	 analysis,	 and	 be	 responsible	 for	 human	 subjects	 
protection.	 Dr.	 Lankenau	 will	 be	 supported	 15%	 time	 in	 Years	 1-3.	 
Dr.	 	 David	 	 Schwartz	 	 is	 	 director	 	 of	 	 the	 	 Social	 	 Intelligence	 	 Lab	 	 and	 	 Professor	 	 of	 	 Information	 
Systems	 	 at	 	 Bar-Ilan	 	 University,	 	 Israel,	 	 where	 	 he	 	 leads	 	 the	 	 Emergency	 	 Response	 	 Community	 
(ERC)	 	 initiative.	 	 The	 	 ERC	 	 program,	 	 initiated	 	 in	 	 2013,	 	 leverages	 	 the	 	 convergence	 	 of	 	 mobile	 
smartphone	 	 technologies	 	 and	 	 social	 	 networks	 	 to	 	 build	 	 and	 	 study	 	 location-aware	 	 emergency	 
response	 platforms	 –	 a	 novel	 form	 of	 ecological	 momentary	 intervention.	 A	 number	 of	 leading	 
medical	 experts	 have	 joined	 the	 initiative,	 providing	 medical	 guidance,	 including	 Prof.	 Dr.	 Abdel	 
Bellou	 	 (former	 	 president	 	 of	 	 the	 	 European	 	 Society	 	 for	 	 Emergency	 	 Medicine	 	 and	 	 currently	 
Disaster	 Medicine	 Fellow	 at	 BIDMC/Harvard),	 and	 Prof.	 Dr.	 Nikos	 Papadopoulos	 (president	 of	 
the	 European	 Association	 for	 Allergy	 and	 Clinical	 Immunology).	 The	 supply	 of	 adrenaline	 auto-
injectors	 	 
in	 	 
incidents	 	 of	 	 anaphylaxis	 	 became	 	 
the	 	 first	 	 
targeted	 	 application	 	 of	 	 ERC,	 	 which	 	 Dr.	 
Schwartz	 	 will	 	 continue	 	 to	 	 study	 	 and	 	 develop	 	 alongside	 	 this	 	 new	 	 overdose-reversal	 	 study.	 	 Dr.	 
Schwartz	 	 will	 	 lead	 	 the	 	 design	 	 efforts	 	 to	 	 adapt	 	 the	 	 app	 	 specification	 	 and	 	 system	 	 architecture,	 
ensure	 that	 the	 pilot	 follows	 the	 principles	 established	 for	 ERCs,	 contribute	 to	 the	 study	 of	 app	 
usage	 	 barriers/motivators,	 	 and	 	 
lead	 	 quantitative	 	 geo-spatial	 	 analysis	 	 of	 	 data	 	 
logs.	 	 Dr.	 	 Schwartz	 
will	 be	 supported	 at	 15%	 in	 Years	 1-3.	 
Dr.	 Alexis	 Roth	 is	 an	 Assistant	 Professor	 in	 the	 Department	 of	 Community	 Health	 &	 Prevention	 
at	 Drexel	 University’s	 Dornsife	 School	 of	 Public	 Health.	 Her	 research	 is	 focused	 on	 individual,	 
social	 and	 environmental	 factors	 that	 influence	 health	 disparities	 among	 vulnerable	 populations	 
living	 in	 urban	 settings.	 She	 has	 extensive	 experience	 in	 the	 use	 of	 mobile	 phone	 technology	 to	 
monitor	 event-level	 HIV	 risk	 and	 drug	 use,	 mixed	 methods	 research,	 and	 the	 development	 and	 
evaluation	 	 of	 	 structural	 	 interventions	 	 to	 	 improve	 	 healthcare	 	 utilization	 	 among	 	 populations	 
unlikely	 	 
to	 	 seek	 	 clinical	 	 care.	 	 Additionally,	 	 she	 	 has	 	 expertise	 	 
in	 	 
the	 	 ethical	 	 considerations	 	 for	 
using	 ecological	 momentary	 assessment	 with	 vulnerable	 populations,	 including	 opioid	 users.	 Dr.	 
Roth	 will	 be	 supported	 at	 10%	 in	 Years	 2-3.	 
Dr.	 Inbal	 Yahav	 is	 an	 Assistant	 Professor	 at	 the	 Graduate	 School	 of	 Business	 Administration,	 
Bar-Ilan	 	 University,	 	 Israel.	 	 Her	 	 research	 	 interests	 	 lie	 	 in	 	 the	 	 areas	 	 of	 	 statistical	 	 modeling	 	 and	 
social	 	 media,	 	 with	 	 a	 	 focus	 	 on	 	 users
'	 	 behavior	 	 in	 	 social	 	 networks,	 	 interactions	 	 and	 	 dynamics	 
between	 users,	 and	 statistical	 modeling	 of	 heterogeneous	 behaviors.	 Her	 research	 to-date	 focuses	 
on	 two	 domains.	 The	 first	 is	 cyber	 security	 and	 privacy,	 and	 in	 specific	 privacy	 unawareness	 and	 
unintentional	 information	 leakage	 in	 social	 networks.	 The	 second	 is	 statistical	 modeling	 of	 sub-
populations	 	 in	 	 Big	 	 Data.	 	 She	 	 has	 	 presented	 	 her	 	 work	 	 at	 	 multiple	 	 Information	 	 Systems	 
conferences	 and	 published	 papers	 in	 books	 and	 journals.	 She	 is	 currently	 serving	 as	 an	 Associate	 
Editor	 of	 the	 Decision	 Sciences	 Journal	 and	 the	 Big	 Data	 Journal.	 Dr.	 Yahav	 will	 be	 supported	 at	 
10%	 in	 Years	 1-3.	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 22	 of	 34	 
Revised:	 January	 09,	 2014	 
Dr.	 Gabriela	 Marcu	 is	 an	 Assistant	 Professor	 in	 the	 College	 of	 Computing	 and	 Informatics	 and	 
Research	 	 Fellow	 	 with	 	 the	 	 A.J.	 	 Drexel	 	 Autism	 	 Institute.	 	 She	 	 has	 	 8	 	 years	 	 of	 	 experience	 	 with	 
community-based	 	 participatory	 	 
research	 	 
for	 	 
the	 	 development	 	 of	 	 novel	 	 behavioral	 	 
interventions	 
delivered	 	 via	 	 mobile	 	 devices.	 	 She	 	 is	 	 currently	 	 PI	 	 or	 	 Co-PI	 	 on	 	 three	 	 projects	 	 in	 	 which	 	 she	 	 is	 
responsible	 for	 leading	 the	 design,	 development,	 and	 evaluation	 of	 mobile	 applications,	 including	 
ecological	 	 momentary	 	 
interventions.	 	 Additionally,	 	 she	 	 was	 	 principal	 	 designer	 	 of	 	 a	 	 smartphone	 
intervention	 for	 the	 treatment	 of	 bipolar	 disorder,	 which	 was	 successfully	 used	 in	 a	 clinical	 trial.	 
Dr.	 	 Marcu	 	 directs	 	 the	 	 Empathic	 	 Design	 	 and	 	 Technology	 	 Research	 	 Group,	 	 a	 	 multidisciplinary	 
group	 	 of	 	 software	 	 developers,	 	 interface	 	 designers,	 	 and	 	 qualitative	 	 social	 	 scientists	 	 who	 	 work	 
collaboratively	 	 on	 	 mHealth	 	 development	 	 projects	 	 from	 	 beginning	 	 to	 	 end	 	 of	 	 the	 	 software	 	 life	 
cycle.	 Dr.	 Marcu	 will	 be	 supported	 at	 20%	 during	 the	 summer	 months	 in	 Years	 1-3.	 
Facilities	 
At	 Drexel	 University,	 the	 PI	 and	 Co-Investigator	 each	 have	 300	 sq.	 ft.	 office	 is	 located	 on	 the	 4th	 
floor	 	 of	 	 
the	 	 Nesbitt	 	 Building,	 	 which	 	 
is	 	 home	 	 
to	 	 
the	 	 School	 	 of	 	 Public	 	 Health’s	 	 Department	 	 of	 
Community	 	 Health	 	 and	 	 Prevention.	 	 It	 	 is	 	 equipped	 	 with	 	 chairs,	 	 desk,	 	 bookcases,	 	 two	 	 locking	 
filing	 	 cabinets,	 	 and	 	 hardwired	 	 high-speed	 	 internet	 	 access.	 	 Each	 	 member	 	 of	 	 the	 	 research	 	 team	 
each	 has	 a	 60	 sq.	 ft.	 cubicle	 equipped	 with	 chairs,	 desk,	 locking	 filing	 cabinets,	 and	 high-speed	 
internet	 access.	 All	 computers	 are	 connected	 to	 laser	 printers.	 These	 facilities	 ensure	 that	 the	 PI	 
and	 	 research	 	 
team	 	 have	 	 
the	 	 necessary	 	 space	 	 and	 	 equipment	 	 
to	 	 store	 	 data,	 	 analyze	 	 results,	 	 and	 
prepare	 manuscripts	 for	 publication.	 
	 
At	 	 Bar-Ilan	 	 University,	 	 
the	 	 PI	 	 and	 	 Co-investor	 	 each	 	 have	 	 160	 	 sq.	 	 
ft.	 	 offices	 	 
located	 	 on	 	 
the	 	 3rd	 
floor	 of	 the	 Daniel	 S.	 Abraham	 Center	 of	 Economics	 and	 Business	 Building,	 which	 is	 home	 to	 
the	 	 Graduate	 	 School	 	 of	 	 Business	 	 Administration’s	 	 Information	 	 Systems	 	 Department.	 	 Each	 	 is	 
equipped	 	 with	 	 chairs,	 	 desk,	 	 bookcases,	 	 
two	 	 
locking	 	 filing	 	 cabinets,	 	 and	 	 hardwired	 	 high-speed	 
internet	 access.	 All	 computers	 are	 connected	 to	 laser	 printers.	 These	 facilities	 ensure	 that	 the	 has	 
the	 	 necessary	 	 space	 	 and	 	 equipment	 	 
to	 	 store	 	 data,	 	 analyze	 	 results,	 	 and	 	 prepare	 	 manuscripts	 	 for	 
publication.	 
Prevention	 	 Point	 	 Philadelphia	 	 
is	 	 an	 	 excellent	 	 setting	 	 
for	 	 drug	 	 users’	 	 screening,	 	 surveying,	 	 and	 
interviewing.	 	 
	 	 The	 	 agency	 	 has	 	 8	 	 private	 	 rooms	 	 usually	 	 used	 	 for	 	 case-management	 	 sessions	 	 or	 
medical	 services	 (for	 example,	 HIV	 or	 Hepatitis	 C	 testing);	 one	 of	 these	 rooms	 or	 another	 private	 
space	 	 in	 	 the	 	 PPP	 	 office	 	 will	 	 be	 	 available	 	 for	 	 survey	 	 or	 	 interviewing.	 	 	 	 PPP	 	 is	 	 staffed	 	 with	 
experienced	 case-managers	 who	 can	 assist	 study	 participants	 in	 case	 of	 emotional	 distress.	 	 PPP	 
also	 	 houses	 	 a	 	 clinic	 	 with	 	 medical	 	 staff	 	 able	 	 
to	 	 assist	 	 participants	 	 with	 	 acute	 	 health	 	 problems.	 
Additionally,	 	 the	 	 agency’s	 	 staff	 	 and	 	 the	 	 student	 	 researcher	 	 herself	 	 are	 	 trained	 	 to	 	 recognize	 
overdose	 	 signs	 	 and	 	 administer	 	 naloxone	 	 
(opioid	 	 antidote)	 	 
in	 	 case	 	 
there	 	 
is	 	 overdose	 	 emergency	 
during	 survey	 or	 interviewing.	 	 In	 case	 the	 interview	 will	 be	 scheduled	 outside	 of	 the	 PPP	 office,	 
a	 mutually	 acceptable	 location	 (café	 or	 chain-restaurant)	 will	 be	 chosen	 within	 walking	 distance	 
from	 the	 PPP	 office	 or	 mobile	 van,	 so	 that	 the	 student	 researcher	 is	 able	 to	 promptly	 reach	 PPP	 
qualified	 staff	 in	 case	 of	 a	 medical	 emergency	 
	 
Medical/Psychological	 Resources/Training	 
Dr.	 Lankenau	 and	 co-investigators	 are	 experienced	 researchers	 who	 are	 accustomed	 to	 working	 
with	 high-risk	 populations,	 including	 persons	 at	 risk	 for	 overdose.	 All	 interviewers	 will	 be	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 23	 of	 34	 
Revised:	 January	 09,	 2014	 
trained	 by	 Dr.	 Lankenau	 to	 screen	 for	 intoxicated	 individuals	 and	 how	 to	 identify	 emotional	 
distress.	 This	 information	 will	 be	 discussed	 during	 staff	 meetings,	 and	 staff	 training	 will	 be	 
ongoing.	 In	 the	 event	 that	 a	 research	 subject	 becomes	 emotionally	 distressed	 during	 an	 interview,	 
interviewers	 will	 stop	 the	 interview	 immediately	 and	 the	 interviewer	 will	 provide	 an	 escort	 to	 
whatever	 emergency	 services	 are	 necessary.	 Whenever	 specifically	 requested	 by	 the	 subject,	 
interviewers	 will	 provide	 a	 direct	 telephone	 referral	 and	 escort	 the	 subject	 to	 appropriate	 services	 
in	 the	 community.	 All	 adverse	 events	 (AE)	 occurring	 during	 the	 course	 of	 the	 study	 will	 be	 
collected,	 documented,	 and	 reported	 to	 the	 Principal	 Investigator	 within	 24	 hours	 of	 discovering	 
the	 event.	 
	 
21)	 Prior	 Approvals	 
	 
Approvals	 	 from	 	 Drexel	 	 University’s	 	 Institutional	 	 Review	 	 Board	 	 and	 	 a	 	 Federal	 	 Certificate	 	 of	 
Confidentiality	 	 will	 	 be	 	 obtained	 	 prior	 	 
to	 	 commencing	 	 recruitment	 	 and	 	 data	 	 collection	 	 for	 	 
this	 
research.	 
	 
22)	 Recruitment	 Methods	 
	 
Recruitment	 	 Plan.	 	 Participants	 	 (non-medical	 	 opioid	 	 users	 	 and	 	 community	 	 members)	 	 will	 	 be	 
sampled	 	 using	 	 targeted	 	 and	 	 chain	 	 referral	 	 sampling,
87,88	 	 which	 	 was	 	 deployed	 	 effectively	 	 in	 
previous	 	 PI	 	 studies.89,90	 	 Targeted	 	 sampling	 	 focuses	 	 on	 	 particular	 	 locations	 	 containing	 	 the	 
population	 of	 interest.	 In	 this	 case,	 Prevention	 Point	 Philadelphia	 and	 Angels	 in	 Motion	 will	 be	 
targeted	 to	 enroll	 NMOU	 and	 CM,	 respectively.	 Community	 members	 may	 also	 be	 enrolled	 from	 
PPP	 staff.	 Chain-referral	 sampling,	 which	 utilizes	 currently	 enrolled	 participants	 to	 refer	 others	 
within	 	 
their	 	 network,	 	 consciously	 	 attempts	 	 
to	 	 sample	 	 from	 	 multiple	 	 networks	 	 
to	 	 
increases	 	 
the	 
diversity	 	 of	 	 
the	 	 sample.	 	 A	 	 key	 	 strength	 	 of	 	 
this	 	 sampling	 	 methodology	 	 
is	 	 controlling	 	 screening	 
and	 enrollment	 so	 that	 the	 sample	 is	 diverse	 in	 terms	 of	 gender,	 race,	 and	 age.
89	 	 
Payments:	 
•	 Each	 individual	 screened	 will	 receive	 a	 $3	 gift	 card.	 	 
•	 Enrolled	 participants	 will	 receive	 $25	 for	 the	 baseline	 interview	 and	 participation	 in	 the	 
OPP.	 	 
•	 Participants	 will	 receive	 $5	 for	 each	 completed	 BFA	 
•	 Qualitative	 interviewees	 will	 receive	 a	 $50	 incentive	 for	 participation.	 
23)	 Number	 of	 Subjects	 
10	 stakeholders	 will	 take	 part	 in	 qualitative	 interviews,	 including	 5	 non-medical	 opioid	 users	 
(NMOU)	 and	 5	 community	 members	 (CM).	 Of	 the	 10	 stakeholders,	 6	 people	 (3	 NMOU	 and	 3	 
CM)	 will	 participate	 in	 focus	 groups.	 
110	 participants	 (55	 NMOU	 and	 55	 CM)	 will	 take	 part	 in	 Quantitative	 Baseline	 Assessments	 
(QBA),	 Brief	 Follow-Up	 Assessments	 (BFA),	 and	 Retrospective	 Use	 Assessment	 (RUA)	 
following	 use	 of	 the	 app.	 	 A	 subset	 of	 the	 110	 participants,	 20	 people,	 will	 be	 recruited	 for	 a	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 24	 of	 34	 
Revised:	 January	 09,	 2014	 
Qualitative	 Interview	 based	 upon	 use	 of	 the	 app	 including	 5	 callers,	 5	 responders,	 5	 
caller/responders,	 and	 5	 people	 who	 are	 neither	 callers/responders.	 
Retention	 	 Strategies	 	 for	 	 Follow-Up	 	 and	 	 Attrition.	 	 Study	 	 investigators	 	 fully	 	 appreciate	 	 the	 
challenges	 associated	 with	 tracking	 and	 retaining	 participants	 in	 a	 longitudinal	 study,	 particularly	 
drug	 users.	 We	 are	 practiced	 at	 successfully	 retaining	 participants	 for	 follow-up	 interviews	 based	 
upon	 employing	 tracking	 protocols	 in	 previous	 studies,90	 in	 which	 many	 subjects	 were	 hard-to-
reach	 	 due	 	 to	 	 substance	 	 use.	 	 Key	 	 retention	 	 strategies	 	 include:	 	 collecting	 	 extensive	 	 tracking	 
information	 	 at	 	 baseline,	 	 
including	 	 email	 	 and	 	 social	 	 media	 	 
info;	 	 storing	 	 
tracking	 	 
information	 	 
in	 
retrievable	 	 Access	 	 database;	 	 conducting	 	 monthly	 	 follow-up	 	 interviews	 	 with	 	 incentives	 	 ($5);	 
training	 staff	 on	 the	 importance	 of	 retention.	 Despite	 these	 tracking	 efforts,	 we	 are	 anticipating	 
some	 participant	 attrition.	 	 Based	 upon	 our	 previous	 studies,	 we	 are	 predicting	 10%	 attrition	 over	 
the	 course	 of	 the	 year-long	 study	 resulting	 in	 a	 final	 sample	 of	 100.	 
	 
24)	 Confidentiality	 
Does	 not	 apply	 (not	 a	 multi-site	 study)	 
	 
25)	 Provisions	 to	 Protect	 the	 Privacy	 Interests	 of	 Subjects	 
Subjects’	 privacy	 interests	 will	 be	 protected	 through	 the	 use	 of	 informed	 consent	 process,	 as	 well	 
as	 	 by	 	 not	 	 collecting	 	 their	 	 identifying	 	 data.	 	 	 	 The	 	 interviewees	 	 will	 	 be	 	 assured	 	 that	 	 sensitive	 
information	 about	 their	 drug	 use,	 overdose	 experiences,	 street-related	 activities,	 and	 violence	 in	 
their	 lives	 is	 expected	 to	 be	 offered	 voluntarily	 and	 will	 be	 treated	 with	 strict	 confidentiality.	 The	 
participants	 will	 be	 informed	 of	 their	 rights,	 including	 the	 right	 to	 withdraw	 from	 the	 study	 at	 any	 
point	 and	 not	 answer	 questions	 the	 participant	 chooses	 not	 to.	 	 
Additionally,	 	 
it	 	 
is	 	 expected	 	 
that	 	 
the	 	 majority	 	 of	 	 qualitative	 	 
interviews	 	 will	 	 be	 	 held	 	 at	 	 a	 	 private	 
room	 at	 the	 PPP	 office	 that	 should	 also	 help	 participants	 feel	 at	 ease.	 	 In	 cases	 when	 participants	 
are	 recruited	 at	 the	 PPP	 van	 and	 available	 for	 interview	 immediately	 after	 survey,	 a	 quiet	 semi-
private	 	 
location	 	 
(café	 	 or	 	 chain	 	 
restaurant)	 	 will	 	 be	 	 chosen	 	 
for	 	 
interview.	 	 
	 	 
If	 	 
the	 	 participant	 	 does	 
not	 feel	 comfortable	 at	 that	 place,	 she	 will	 be	 scheduled	 an	 interview	 at	 the	 PPP	 office	 or	 other	 
mutually	 accepted	 location	 at	 another	 time/day.	 	 
The	 research	 team	 (PI	 and	 the	 student	 researcher)	 will	 not	 be	 permitted	 to	 access	 any	 sources	 of	 
information	 about	 the	 subjects.	 
	 
26)	 Compensation	 for	 Research-Related	 Injury	 
Does	 not	 apply	 (the	 research	 does	 not	 involve	 more	 than	 minimal	 risk).	 
	 
27)	 Economic	 Burden	 to	 Subjects	 
The	 participation	 in	 the	 research	 does	 not	 involve	 any	 economic	 burden	 to	 
participants.	 	 Interviews	 for	 eligible	 participants	 will	 be	 held	 at	 their	 convenience.	 

PROTOCOL	 TITLE:	 Piloting	 a	 naloxone	 intervention	 in	 an	 emergency	 response	 community	 to	 
reduce	 opioid	 overdoses	 in	 Philadelphia	 
Protocol	 Version	 Date:	 05/10/17	 
SBE	 Version	 
Page	 25	 of	 34	 
Revised:	 January	 09,	 2014	 
28)	 Consent	 Process	 
Participants	 will	 be	 consented	 with	 one	 of	 two	 consent	 forms.	 One	 consent	 form	 will	 be	 used	 to	 
10	 	 consent	 	 participants	 	 for	 	 stakeholder	 	 interviews	 	 during	 	 Year	 	 1.	 	 This	 	 form	 	 will	 	 consent	 
participants	 to	 engage	 in	 the	 following	 research	 activities:	 focus	 groups,	 qualitative	 interviews,	 
and	 usability	 testing.	 A	 second	 consent	 form	 will	 be	 used	 to	 consent	 110	 participants	 during	 Year	 
2	 to	 engage	 in	 the	 following	 research	 activities:	 Quantitative	 Baseline	 Assessment	 (QBA);	 Brief	 
Follow-Up	 Assessment	 (BFA);	 Retrospective	 Use	 Assessments;	 and	 Qualitative	 Interviews.	 
Prior	 	 
to	 	 enrolling	 	 a	 	 subject	 	 
in	 	 Year	 	 1	 	 or	 	 Year	 	 2	 	 activities,	 	 study	 	 
interviewer	 	 will	 	 conduct	 	 
the	 
consent	 process	 using	 a	 Consent	 Form.	 The	 interviewer	 will	 read	 the	 Consent	 Form	 out	 loud	 and	 
ask	 	 the	 	 participant	 	 to	 	 follow	 	 along.	 	 	 	 The	 	 interviewer	 	 will	 	 ask	 	 questions	 	 about	 	 the	 	 subject’s	 
comprehension	 	 during	 	 this	 	 process	 	 and	 	 will	 	 ensure	 	 that	 	 all	 	 the	 	 subject’s	 	 questions	 	 have	 	 been	 
answered	 	 before	 	 asking	 	 the	 	 subject	 	 one	 	 final	 	 time	 	 whether	 	 he/she	 	 wants	 	 to	 	 participate	 	 in	 	 the	 
study.	 	 
	 	 The	 	 consenting	 	 participant	 	 will	 	 sign	 	 
the	 	 Consent	 	 Form	 	 as	 	 will	 	 
the	 	 
interviewer.	 	 
	 	 Both	 
participant	 	 and	 	 interviewer	 	 will	 	 keep	 	 a	 	 copy	 	 of	 	 the	 	 signed	 	 Consent	 	 Form.	 	 	 	 Following	 	 the	 
interview,	 the	 interviewer	 will	 place	 the	 consent	 form	 in	 a	 locked	 filing	 cabinet	 at	 Drexel.	 	 
In	 all	 cases,	 the	 process	 of	 obtaining	 informed	 consent	 will	 only	 occur	 after	 the	 potential	 subject	 
has	 been	 given	 a	 description	 of	 the	 project,	 has	 been	 screened	 for	 eligibility,	 and	 a	 semi-private	 
interviewing	 location	 has	 been	 secured.	 	 Trained	 interviewers	 will	 obtain	 verbal	 consent	 from	 all	 
subjects	 who	 participate	 in	 interviews.	 	 Consent	 forms	 will	 contain	 a	 discussion	 of	 the	 following:	 
the	 	 study	 	 sponsor;	 	 
the	 	 goals	 	 and	 	 objective	 	 of	 	 
the	 	 study;	 	 
responsibilities	 	 of	 	 participating	 	 
in	 	 
the	 
study;	 	 the	 	 use	 	 and	 	 outcome	 	 of	 	 study	 	 data;	 the	 	 risks	 	 involved	 	 in	 	 participation;	 	 the	 	 benefits	 	 of	 
participation;	 	 
the	 	 compensation	 	 
for	 	 participation;	 	 
the	 	 content	 	 of	 	 
information	 	 provided	 	 
to	 	 others	 
(confidentiality);	 	 the	 	 voluntary	 	 nature	 	 of	 	 participation;	 	 and	 	 the	 	 rights	 	 of	 	 study	 	 participants.	 
Interviewers	 will	 provide	 each	 subject	 with	 a	 consent	 form	 and	 read	 through	 the	 entire	 document.	 	 
After	 the	 subject	 indicates	 that	 he	 or	 she	 understands	 all	 sections	 of	 the	 consent	 form,	 he	 or	 she	 
will	 indicate	 his/her	 verbal	 consent	 to	 participate,	 and	 the	 interviewer	 will	 document	 this	 verbal	 
consent.	 	 The	 	 
interviewer	 	 will	 	 offer	 	 a	 	 copy	 	 of	 	 
the	 	 consent	 	 
form	 	 
to	 	 
the	 	 enrolled	 	 subject.	 	 At	 	 
that	 
point,	 the	 subject	 will	 be	 formally	 enrolled	 in	 the	 study,	 and	 the	 interviewer	 will	 proceed	 with	 the	 
interview.	 	 This	 	 consent	 	 form	 	 will	 	 provide	 	 consent	 	 for	 	 the	 	 baseline	 	 and	 	 subsequent	 	 follow-up	 
interviews.	 	 Participants	 will	 be	 reminded	 of	 their	 rights	 as	 research	 participants	 during	 follow-up	 
interviews	 in	 the	 scripted	 online	 interview	 or	 verbally	 during	 face-to-face	 interviews.	 
Non-English	 Speaking	 Subjects	 
Does	 not	 apply	 
	 
Waiver	 or	 Alteration	 of	 the	 Consent	 and	 Authorization	 Process	 (consent	 will	 
not	 be	 obtained,	 required	 information	 will	 not	 be	 disclosed,	 or	 the	 research	 
involves	 deception)	 
Does	 not	 apply	 
	 

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Subjects	 who	 are	 not	 yet	 adults	 (infants,	 children,	 teenagers)	 
Does	 not	 apply	 
	 
Cognitively	 Impaired	 Adults	 
Does	 not	 apply	 
	 
Adults	 Unable	 to	 Consent	 
Does	 not	 apply	 
29)	 Process	 to	 Document	 Consent	 in	 Writing	 
The	 study	 will	 be	 following	 SOP:	 Written	 Documentation	 of	 Consent	 (HRP-091).	 
	 
	 
	 

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BIBLIOGRAPHY	 AND	 REFERENCES	 CITED	 
	 
1.	 	 Compton	 WM,	 Boyle	 M,	 Wargo	 E.	 	 Prescription	 opioid	 abuse:	 problems	 and	 responses.	 
Prev	 Med.	 2015;80:5–9.	 
2.	 	 U.S.	 	 Department	 	 of	 	 Health	 	 and	 	 Human	 	 Services.	 	 
	 	 Opioid	 	 abuse	 	 
in	 	 
the	 	 U.S.	 	 and	 	 HHS	 
actions	 to	 address	 opioid-drug	 related	 overdoses	 and	 deaths.	 ASPE	 Issue	 Brief.	 	 March	 26,	 2015.	 
Available	 	 	 at:	 	 	 https://aspe.hhs.gov/sites/default/files/pdf/107956/ib_OpioidInitiative.pdf.	 
Accessed	 December	 7,	 2016.	 
3.	 	 Hawk	 KF,	 Vaca	 FE,	 D’Onofrio	 G.	 Reducing	 fatal	 opioid	 overdose:	 prevention,	 treatment	 
and	 harm	 reduction	 strategies.	 Yale	 J	 Biol	 Med.	 2015;88:235–245.	 
4.	 	 Rudd	 	 RA,	 	 Aleshire	 N,	 	 Zibbell	 	 
JE,	 	 Gladden	 	 RM.	 	 
Increases	 	 
in	 	 drug	 	 and	 	 opioid	 	 overdose	 
deaths	 —	 United	 	 States,	 	 2000–2014.	 	 MMWR	 	 Morb	 	 Mortal	 	 Wkly	 	 Rep.	 	 2016;64(50-51):1378–
1382.	 
5.	 	 Volkow	 ND.	 Naloxone—a	 potential	 lifesaver.	 Nora’s	 Blog	 -	 National	 Institute	 on	 Drug	 
Abuse.	 	 March	 	 4,	 2014.	 	 	 	 Available	 	 at:	 	 	 	 https://www.drugabuse.gov/about-nida/noras-
blog/2014/02/naloxone-potential-lifesaver.	 	 Accessed	 December	 7,	 2016.	 
6.	 	 Wheeler	 	 E,	 	 Jones	 	 S,	 	 Gilbert	 	 MK,	 	 Davidson	 	 PJ.	 	 Opioid	 	 overdose	 	 prevention	 	 programs	 
providing	 	 naloxone	 	 to	 	 laypersons	 —	 United	 	 States,	 	 2014.	 	 MMWR	 	 Morb	 	 Mortal	 	 Wkly	 	 Rep.	 
2015;64(23):631–635.	 
7.	 	 Rowe	 	 C,	 	 Santos	 	 GM,	 	 Vittinghoff	 	 E,	 	 Wheeler	 	 E,	 	 Davidson	 	 P,	 	 Coffin	 	 PO.	 	 Predictors	 	 of	 
participant	 	 engagement	 	 and	 	 naloxone	 	 utilization	 	 
in	 	 a	 	 community	 based	 	 naloxone	 	 distribution	 
program.	 Addiction.	 2015;110(8):1301-1310.	 
8.	 	 Clark	 	 AK,	 	 Wilder	 	 CM,	 	 Winstanley	 	 EL.	 	 A	 	 systematic	 	 review	 	 of	 	 community	 	 opioid	 
overdose	 prevention	 and	 naloxone	 distribution	 programs.	 J	 Addict	 Med.	 2014;8(3):153–163.	 
9.	 	 Lankenau	 	 SE,	 	 Wagner	 	 KD,	 	 Silva	 	 K,	 	 et	 	 al.	 	 Injection	 	 drug	 	 users	 	 trained	 	 by	 	 overdose	 
prevention	 programs:	 responses	 to	 witnessed	 overdoses.	 J	 Community	 Health.	 2013;38(1):133–
141.	 
10.	 	 Giglio	 RE,	 Li	 G,	 DiMaggio	 CJ.	 Effectiveness	 of	 bystander	 naloxone	 administration	 and	 
overdose	 education	 programs:	 a	 meta-analysis.	 Inj.	 Epidemiol.	 2015;2:2–10.	 
11.	 	 Lagu	 	 T,	 	 Anderson	 	 BJ,	 	 Stein	 	 M.	 	 Overdoses	 	 among	 	 friends:	 	 drug	 	 users	 	 are	 	 willing	 	 to	 
administer	 naloxone	 to	 others.	 J	 Subst	 Abuse	 Treat.	 2006;30(2):129–133.	 
12.	 	 Schwartz	 	 DG,	 	 Bellou	 	 A,	 	 Garcia-Castrillo	 	 L,	 	 Muraro	 	 A,	 	 Papadopoulos	 	 NG.	 	 Towards	 
chronic	 	 emergency	 	 response	 	 communities	 	 for	 	 anaphylaxis.	 	 
	 	 In:	 	 2014	 	 IEEE	 	 15th	 	 International	 
Conference	 	 	 on	 	 	 Information	 	 	 Reuse	 	 	 and	 	 	 Integration	 	 	 (IRI).	 	 	 2014:98–103.	 	 
doi:10.1109/IRI.2014.7051878.	 	 
13.	 	 Khalemsky	 	 M.	 	 Emergency	 	 Response	 	 Communities	 	 Effectiveness	 	 Model.	 	 Bar-Ilan	 
University.	 2015.	 
14.	 	 Gomes	 T,	 Mamdani	 MM,	 Dhalla	 IA,	 Cornish	 S,	 Paterson	 JM,	 Juurlink	 DN.	 The	 burden	 
of	 premature	 opioid	 related	 mortality.	 Addiction.	 2014;109(9):1482-1488.	 

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reduce	 opioid	 overdoses	 in	 Philadelphia	 
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15.	 	 Inocencio	 TJ,	 Carroll	 NV,	 Read	 EJ,	 Holdford	 DA.	 The	 economic	 burden	 of	 opioid-related	 
poisoning	 in	 the	 United	 States.	 Pain	 Med.	 2013;14(10):1534–1547.	 
16.	 	 
	 	 Albert	 	 M,	 	 McCaig	 	 LF,	 	 Uddin	 	 S.	 	 Emergency	 	 department	 	 visits	 	 
for	 	 drug	 	 poisoning:	 	 United	 
States,	 2008-2011.	 US	 Department	 of	 Health	 and	 Human	 Services,	 Centers	 for	 Disease	 Control	 
and	 	 Prevention,	 	 National	 	 Center	 	 for	 	 Health	 	 Statistics.	 	 2015.	 	 Available	 	 at:	 
http://www.cdc.gov/nchs/data/databriefs/db196.htm.	 	 Accessed	 December	 7,	 2016.	 
17.	 	 Philadelphia	 	 Department	 	 of	 	 Public	 	 Health.	 	 Overdose	 	 deaths	 	 involving	 	 opioids	 	 in	 
Philadelphia.	 	 
CHART.	 	 
2016;1(1):1-8.	 	 
Available	 	 
at:	 
http://www.phila.gov/health/pdfs/chartv1e1.pdf.	 	 Accessed	 December	 7,	 2016.	 
18.	 	 Sapatkin	 	 D,	 	 Farr	 	 S.	 	 Overdose	 	 surge	 	 may	 	 have	 	 killed	 	 35.	 	 	 	 The	 	 Philadelphia	 	 Inquirer.	 	 
December	 	 9,	 	 2016.	 	 
	 	 Available	 	 at:	 	 http://www.philly.com/philly/health/Medical-examiner-Phila-
overdose-surge-may-have-killed-35-over-5-days.html.	 	 Accessed	 December	 9,	 2016.	 	 	 
19.	 	 Lim	 	 ST,	 	 Lamb	 	 RC,	 	 Levine	 	 MF.	 	 
	 	 
	 	 Drug	 	 Use	 	 
in	 	 Philadelphia,	 	 Pennsylvania:	 	 2012.	 	 
	 	 In:	 
National	 	 Institute	 	 on	 	 Drug	 	 Abuse.	 	 	 	 Epidemiologic	 	 Trends	 	 in	 	 drug	 	 abuse:	 	 Proceedings	 	 of	 	 the	 
Community	 	 Epidemiology	 	 Work	 	 Group,	 	 Volume	 	 II,	 	 June	 	 2013.	 	 	 	 March	 	 2014:	 	 232-247.	 	 
Available	 	 at:	 	 https://www.drugabuse.gov/sites/default/files/files/June_2013_Vol_2_508_2.pdf.	 	 
Accessed	 December	 7,	 2016.	 
20.	 	 U.S.	 	 Department	 	 of	 	 Justice,	 	 Drug	 	 Enforcement	 	 Administration.	 	 	 	 2011	 	 Heroin	 	 Domestic	 
Monitor	 	 Program.	 	 	 	 March	 	 2013.	 	 Available	 	 at:	 	 https://info.publicintelligence.net/DEA-
HeroinDMP-2011.pdf.	 	 Accessed	 December	 7,	 2016.	 
21.	 	 Drug	 	 Enforcement	 	 Administration	 	 Philadelphia	 	 Field	 	 Division.	 	 
	 	 DEA	 	 Intelligence	 	 Report:	 
(U)	 Analysis	 of	 Drug-Related	 Overdose	 Deaths	 in	 Pennsylvania,	 2014.	 	 July	 2015.	 Available	 at:	 
https://info.publicintelligence.net/DEA-PhiladelphiaOverdoses-2013-2014.pdf.	 	 	 	 Accessed	 
December	 7,	 2016.	 
22.	 	 National	 	 Institute	 	 on	 	 Drug	 	 Abuse.	 	 	 	 Fentanyl.	 	 	 	 Updated	 	 June	 	 2016.	 	 	 	 Available	 	 at:	 
https://www.drugabuse.gov/drugs-abuse/fentanyl.	 	 Accessed	 December	 7,	 2016.	 
23.	 	 Mitman	 H.	 	 Philadelphia	 taking	 fentanyl	 fight	 to	 the	 streets.	 	 Philly	 Voice.	 August	 19,	 2016.	 	 
Available	 	 at:	 	 http://www.phillyvoice.com/philadelphia-taking-fentanyl-fight-to-the-streets/.	 	 
Accessed	 December	 7,	 2016.	 
24.	 	 Pennsylvania	 General	 Assembly.	 2014	 Act	 139.	 	 Controlled	 Substance,	 Drug,	 Device	 And	 
Cosmetic	 	 Act	 	 -	 	 Drug	 	 Overdose	 	 Response	 	 Immunity.	 	 	 	 Available	 	 at:	 	 
http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2014&sessInd=0&act=139	 	 
.	 	 
Accessed	 December	 7,	 2016.	 
25.	 	 
	 	 The	 	 Network	 	 
for	 	 Public	 	 Health	 	 Law.	 	 Drug	 	 overdose	 	 prevention	 	 
in	 	 Philadelphia.	 	 Act	 	 139	 
Fact	 	 Sheet.	 	 	 	 January	 	 2015.	 	 	 	 Available	 	 at:	 	 https://www.networkforphl.org/_asset/9r6xcz/PA-
overdose-prevention.pdf.	 	 Accessed	 December	 7,	 2016.	 
26.	 	 Pennsylvania	 Department	 of	 Health.	 Standing	 Order	 DOH-002-2015.	 Naloxone	 Prescription	 
for	 	 
Overdose	 	 
Prevention.	 	 
	 	 
Available	 	 
at:	 	 
http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/A-
D/Documents/Naloxone%20Standing%20Order%20for%20General%20Public%20(2).pdf.	 	 
Accessed	 December	 7,	 2016.	 	 

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27.	 	 Pennsylvania	 	 Department	 	 of	 	 Health.	 	 Standing	 	 Order	 	 DOH-002-2016.	 	 Naloxone	 
Prescription	 	 
for	 	 
Overdose	 	 
Prevention.	 	 
Available	 	 
at:	 	 
http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/A-
D/Documents/ACT%20139/Naloxone%20Standing%20Order%20DOH-
General%20PublicMarch2016.pdf.	 	 Accessed	 December	 7,	 2016.	 
28.	 	 
Walley	 AY,	 Sisti	 J,	 Forman	 L,	 et	 al.	 	 Help-seeking	 among	 community	 responders	 trained	 
in	 overdose	 prevention	 and	 naloxone	 administration.	 CPDD	 78th	 Annual	 Meeting,	 Palm	 Springs,	 
CA.	 	 
	 	 
2016	 	 
Abstracts.	 	 
	 	 
Available	 	 
at:	 	 
	 	 
http://cpdd.org/wp-
content/uploads/2016/06/CPDD2016_Abstracts-FINAL.pdf.	 	 Accessed	 December	 7,	 2016.	 
29.	 	 Bagley	 SM,	 Peterson	 J,	 Cheng	 DM,	 et	 al.	 Overdose	 education	 and	 naloxone	 rescue	 kits	 
for	 family	 members	 of	 individuals	 who	 use	 opioids:	 Characteristics,	 motivations,	 and	 naloxone	 
use.	 Subst	 abuse.	 2015;36(2):149-154.	 
30.	 
Smith	 A.	 U.S.	 smartphone	 use	 in	 2015.	 Pew	 Research	 Center.	 April1,	 2015.	 	 Available	 at:	 
http://www.pewinternet.org/2015/04/01/us-smartphone-use-in-2015/.	 	 	 	 Accessed	 	 December	 	 7,	 
2016.	 
31.	 	 Payne	 HE,	 Lister	 C,	 West	 JH,	 Bernhardt	 JM.	 Behavioral	 functionality	 of	 mobile	 apps	 in	 
health	 	 interventions:	 	 a	 	 systematic	 	 review	 	 of	 	 the	 	 literature.	 	 JMIR	 	 MHealth	 	 UHealth.	 
2015;3(1):e20.	 
32.	 	 Labrique	 AB,	 Kirk	 GD,	 Westergaard	 RP,	 Merritt	 MW.	 Ethical	 issues	 in	 mHealth	 research	 
involving	 	 persons	 	 living	 	 with	 	 HIV/AIDS	 	 and	 	 substance	 	 abuse.	 	 AIDS	 	 Res	 	 Treat.	 
doi:10.1155/2013/189645.	 Epub	 2013	 Sep	 19.	 
33.	 	 
Moskowitz	 DS,	 Young	 SN.	 Ecological	 momentary	 assessment:	 what	 it	 is	 and	 why	 it	 is	 a	 
method	 of	 the	 future	 in	 clinical	 psychopharmacology.	 J	 Psychiatry	 Neurosci.	 2006;31(1):13–20.	 
34.	 	 Shiffman	 	 S.	 	 Ecological	 	 momentary	 	 assessment	 	 (EMA)	 	 in	 	 studies	 	 of	 	 substance	 	 use.	 	 
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technology	 into	 psychosocial	 and	 health	 behaviour	 treatments.	 Br	 J	 Health	 Psychol.	 	 2010;15:1–
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36.	 	 Kirk	 	 GD,	 	 Linas	 	 BS,	 	 Westergaard	 	 RP,	 	 et	 	 al.	 	 The	 	 exposure	 	 assessment	 	 in	 	 current	 	 time	 
study:	 implementation,	 feasibility,	 and	 acceptability	 of	 real-time	 data	 collection	 in	 a	 community	 
cohort	 of	 illicit	 drug	 users.	 AIDS	 Res	 Treat.	 doi:10.1155/2013/594671.	 Epub	 2013	 Nov	 6.	 	 	 	 
37.	 	 Cook	 	 PF,	 	 McElwain	 	 CJ,	 	 Bradley-Springer	 	 LA.	 	 Brief	 	 report	 	 on	 	 ecological	 	 momentary	 
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38.	 	 Schwartz	 	 DG,	 	 Bellou	 	 A,	 	 Garcia-Castrillo	 	 L,	 	 Muraro,	 	 A.	 	 (forthcoming).	 	 Papadopoulos	 
NG.	 	 Exploring	 	 mHealth	 	 Participation	 	 for	 	 Emergency	 	 Response	 	 Communities.	 	 Australas	 	 J	 	 Inf	 
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39.	 	 	 	 Mitra	 	 P,	 	 Poellabauer	 	 C.	 	 Emergency	 	 response	 	 in	 	 smartphone-based	 	 Mobile	 	 Ad-Hoc	 
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Available	 at:	 http://ieeexplore.ieee.org/document/6364839/.	 	 Accessed	 December	 7,	 2016.	 

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reduce	 opioid	 overdoses	 in	 Philadelphia	 
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40.	 	 Ringh	 M,	 Rosenqvist	 M,	 Hollenberg	 J,	 et	 al.	 Mobile-phone	 dispatch	 of	 laypersons	 for	 CPR	 
in	 out-of-hospital	 cardiac	 arrest.	 N	 Engl	 J	 Med.	 2015;372(24):2316-2325.	 
41.	 	 NSW	 Government,	 Emergency	 New	 South	 Wales.	 Smartphone	 app	 to	 improve	 emergency	 
response.	 	 Ministerial	 	 media	 	 release.	 	 	 	 December	 	 6,	 	 2013.	 	 	 	 Available	 	 at:	 
https://www.emergency.nsw.gov.au/media-releases/2013/smartphone-app-to-improve-
emergency-response.html.	 	 Accessed	 December7,	 2016.	 
42.	 	 
	 	 National	 	 Science	 	 Foundation.	 	 Researchers	 	 Reveal	 	 Next-Generation	 	 Emergency	 	 Response	 
Technology.	 	 Press	 	 release	 	 13-104.	 	 June	 	 12,	 	 2013.	 	 	 	 Available	 	 at:	 
https://www.nsf.gov/news/news_summ.jsp?cntn_id=128252.	 	 Accessed	 December	 7,	 2016.	 
43.	 	 
	 	 Hasselqvist-Ax	 	 I,	 	 Riva	 	 G,	 	 Herlitz	 	 J,	 	 et	 	 al.	 	 Early	 	 cardiopulmonary	 	 resuscitation	 	 
in	 	 out-of-
hospital	 cardiac	 arrest.	 N	 Engl	 J	 Med.	 2015;372(24):2307-2315.	 
44.	 	 U.S.	 	 Food	 	 and	 	 Drug	 	 Administration.	 	 	 	 2016	 	 Naloxone	 	 App	 	 Competition.	 	 	 	 Available	 	 at:	 	 
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm520943.htm.	 	 	 	 Accessed	 	 December	 	 7,	 
2016.	 	 	 
45.	 	 Swan	 	 M.	 	 Emerging	 	 patient-driven	 	 health	 	 care	 	 models:	 	 an	 	 examination	 	 of	 	 health	 	 social	 
networks,	 consumer	 personalized	 medicine	 and	 quantified	 self-tracking.	 Int	 J	 Environ	 Res	 Public	 
Health.	 2009;6(2):492–525.	 	 
46.	 	 Sakai	 T,	 Iwami	 T,	 Kitamura	 T,	 et	 al.	 Effectiveness	 of	 the	 new	 ‘Mobile	 AED	 Map’to	 find	 
and	 retrieve	 an	 AED:	 a	 randomised	 controlled	 trial.	 Resuscitation.	 2011;82(1):69-73.	 
47.	 	 Rea	 	 T,	 	 Blackwood	 	 J,	 	 Damon	 	 S,	 	 Phelps	 	 R,	 	 Eisenberg	 	 M.	 	 A	 	 link	 	 between	 	 emergency	 
dispatch	 	 and	 	 public	 	 access	 	 AEDs:	 	 potential	 	 
implications	 	 
for	 	 early	 	 defibrillation.	 	 Resuscitation.	 	 
2011:82(8):995–998.	 
48.	 	 
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49.	 	 Folke	 	 F,	 	 Lippert	 	 FK,	 	 Nielsen	 	 SL,	 	 et	 	 al.	 	 	 	 Location	 	 of	 	 cardiac	 	 arrest	 	 in	 	 a	 	 city	 	 center	 
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50.	 	 Peberdy	 	 MA,	 	 Van	 	 Ottingham	 	 L,	 	 Groh	 	 WJ,	 	 et	 	 al.	 	 Adverse	 	 events	 	 associated	 	 with	 	 lay	 
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2006;70(1):59-65.	 	 
51.	 	 Cappato	 R,	 Curnis	 A,	 Marzollo	 P,	 et	 al.	 Prospective	 assessment	 of	 integrating	 the	 existing	 
emergency	 	 medical	 	 system	 	 with	 	 automated	 	 external	 	 defibrillators	 	 fully	 	 operated	 	 by	 	 volunteers	 
and	 laypersons	 for	 out-of-hospital	 cardiac	 arrest:	 the	 Brescia	 Early	 Defibrillation	 Study	 (BEDS).	 
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52.	 	 Elsner	 	 J,	 	 Meisen	 	 P,	 	 Ewert	 	 D,	 	 Schilberg	 	 D,	 	 Jeschke	 	 S.	 	 	 	 Prescient	 	 profiling–AI	 	 driven	 
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597-607.	 	 

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53.	 	 Elsner	 J,	 Meisen	 P,	 Thelen	 S,	 Schilberg	 D,	 Jeschke	 S.	 	 EMuRgency	 –	 a	 basic	 concept	 for	 
an	 	 AI	 	 driven	 	 volunteer	 	 notification	 	 system	 	 
for	 	 
integrating	 	 
laypersons	 	 
into	 	 Emergency	 	 Medical	 
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54.	 	 Groh	 	 WJ,	 	 Birnbaum	 	 A,	 	 Barry	 	 A,	 	 et	 	 al.	 	 	 	 Characteristics	 	 of	 	 volunteers	 	 responding	 	 to	 
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55.	 	 Capriola	 	 A.	 	 
	 	 DHF	 	 partners	 	 with	 	 HelpAround	 	 
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	 	 A	 	 Monte	 	 Carlo	 
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67.	 	 Unertl	 KM,	 Weinger	 MB,	 Johnson	 KB,	 Lorenzi	 NM.	 Describing	 and	 modeling	 workflow	 
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70.	 	 Roth	 	 AM,	 	 Hensel	 	 DJ,	 	 Fortenberry	 	 JD,	 	 Garfein	 	 RS,	 	 Gunn	 	 JKL,	 	 Wiehe	 	 SE.	 	 Feasibility	 	 and	 
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moderates	 	 the	 	 relationship	 	 between	 	 partner	 	 type	 	 and	 	 condom	 	 use	 	 among	 	 women	 	 engaging	 	 in	 
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73.	 Marcu	 G,	 Dey	 AK,	 Kiesler	 S.	 Parent-Driven	 Use	 of	 Wearable	 Cameras	 for	 Autism	 Support:	 
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75.	 	 Bardram	 	 JE,	 	 Frost	 	 M,	 	 Szántó	 	 K,	 	 Marcu	 	 G.	 	 The	 	 MONARCA	 	 self-assessment	 	 system:	 	 a	 
persuasive	 	 personal	 	 monitoring	 	 system	 	 for	 	 bipolar	 	 patients.	 	 In:	 	 Proceedings	 	 of	 	 the	 	 2nd	 	 ACM	 
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electronic	 	 self-monitoring	 	 of	 	 subjective	 	 and	 	 objective	 	 symptoms	 	 in	 	 bipolar	 	 disorder—the	 
MONARCA	 	 trial	 	 protocol	 	 (MONitoring,	 	 treAtment	 	 and	 	 pRediCtion	 	 of	 	 bipolAr	 	 disorder	 
episodes):	 	 a	 	 randomised	 	 controlled	 	 single-blind	 	 trial.	 	 BMJ	 	 Open.	 	 2013;3(7):e003353.	 
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using	 	 smartphones–	 	 the	 	 MONARCA	 	 II	 	 trial	 	 protocol:	 	 a	 	 randomized	 	 controlled	 	 single-blind	 
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78.	 	 Norman	 	 DA,	 	 Draper	 	 SW,	 	 eds.	 	 User	 	 centered	 	 
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80.	 	 Minkler	 	 M,	 	 Wallerstein	 	 N,	 	 eds.	 	 Community-based	 	 participatory	 	 research	 	 for	 	 health:	 	 From	 
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81.	 	 Rosson	 	 MB,	 	 Carroll	 	 JM.	 	 Scenario	 	 based	 	 design.	 	 
	 	 
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84.	 Salman	 YB,	 Cheng	 HI,	 Patterson	 PE.	 Icon	 and	 user	 interface	 design	 for	 emergency	 medical	 
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86.	 Gov.	 Wolf	 announces	 naloxone	 standing	 order	 to	 combat	 heroin	 epidemic	 (+FAQs).	 	 October	 
28,	 	 2015.	 	 Updated	 	 with	 	 FAQs:	 	 October	 	 29,	 	 2015.	 	 	 	 Available	 	 at:	 
https://www.governor.pa.gov/naloxone-standing-order/.	 	 Accessed	 December	 8,	 2016.	 
87.	 	 Clatts	 	 MC,	 	 Davis	 	 WR,	 	 Atillasoy	 	 A.	 	 	 	 Hitting	 	 a	 	 Moving	 	 Target:	 	 The	 	 use	 	 of	 	 ethnographic	 
methods	 	 
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the	 	 evaluation	 	 of	 	 AIDS	 	 outreach	 	 programs	 	 
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89.	 Lankenau	 SE,	 Schrager	 SM,	 Silva	 K,	 et	 al.	 Prescription	 and	 illicit	 drug	 use	 among	 high-risk	 
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92.	 	 Ware	 	 JE,	 	 Kosinski	 	 M,	 	 Keller	 	 SD.	 	 
	 	 A	 	 12-item	 	 Short-Form	 	 Health	 	 Survey:	 	 Construction	 	 of	 
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93.	 	 Pouget	 	 ER,	 	 Bennett	 	 AS,	 	 Elliott	 	 L,	 	 Golub	 	 A,	 	 Rosenblum	 	 A.	 	 Preliminary	 	 reliability	 	 and	 
validity	 	 of	 	 an	 	 opioid	 	 overdose	 	 risk	 	 behavior	 	 scale	 	 in	 	 a	 	 community-based	 	 sample	 	 of	 	 recent	 
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94.	 Lankenau	 SE,	 Sanders	 B,	 Bloom	 JJ,	 et	 al.	 	 First	 injection	 of	 ketamine	 among	 young	 injection	 
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Appendix	 –	 Letters	 of	 Support	 
	 
1.	 Prevention	 Point	 Philadelphia	 
2.	 Angels	 in	 Motion	 
	 

	 
	 
	 
	 
	 
	 
	 
November	 30,	 2016	 
	 
	 
Stephen	 E	 Lankenau,	 PhD	 
Dornsife	 School	 of	 Public	 Health	 	 
Drexel	 University	 
3215	 Market	 Street,	 Room	 411	 	 
Philadelphia,	 PA	 19104	 
	 
Dear	 Steve,	 
	 
This	 letter	 is	 in	 support	 of	 your	 R34	 application	 entitled	 “Piloting	 a	 naloxone	 intervention	 in	 an	 
emergency	 response	 community	 to	 reduce	 opioid	 overdoses	 in	 Philadelphia.”	 	 Angels	 in	 Motion	 
is	 a	 community-based	 organization	 located	 in	 Philadelphia	 that	 has	 been	 providing	 street	 outreach	 
support	 to	 persons	 suffering	 from	 drug	 addiction	 since	 2015.	 Angels	 in	 Motion	 holds	 twice-
monthly	 community	 meetings	 to	 help	 spread	 awareness	 about	 drug	 addiction	 and	 offers	 support	 
to	 families,	 friends,	 and	 loved	 ones	 that	 have	 been	 effected	 by	 this	 disease.	 	 The	 problem	 of	 drug	 
overdose	 has	 been	 a	 particular	 focus	 of	 our	 outreach	 efforts.	 
	 
Angels	 in	 Motion	 do	 a	 majority	 of	 their	 street	 outreach	 in	 the	 Kensington	 neighborhood	 of	 
Philadelphia,	 which	 has	 a	 long-standing	 problem	 of	 heroin	 use	 and	 drug	 overdose.	 	 Angels	 in	 
Motion	 volunteers	 are	 trained	 in	 overdose	 prevention,	 carry	 naloxone,	 and	 own	 smartphones.	 
Since	 our	 volunteers	 service	 the	 targeted	 area	 of	 your	 proposed	 study	 and	 are	 trained	 in	 the	 use	 of	 
naloxone,	 we	 can	 assist	 you	 and	 your	 team	 in	 recruiting	 community	 members	 (CM)	 for	 both	 the	 
pilot	 and	 implementation	 phase	 of	 the	 naloxone	 application	 trial.	 	 Given	 our	 assistance,	 I	 am	 very	 
confident	 that	 your	 team	 will	 be	 able	 to	 recruit	 and	 interview	 the	 requisite	 number	 of	 community	 
members	 into	 the	 study.	 
	 
Over	 the	 past	 year,	 I	 have	 been	 discussing	 aspects	 of	 this	 study	 with	 you	 and	 am	 optimistic	 about	 
its	 potential	 towards	 saving	 lives.	 	 I	 am	 hopeful	 that	 proposed	 mobile	 naloxone	 application	 could	 
increase	 the	 response	 time	 to	 drug	 overdoses	 in	 our	 community	 and	 encourage	 more	 community	 

members	 to	 receive	 overdose	 prevention	 training.	 	 I	 see	 this	 as	 an	 innovative	 proposal	 since	 it	 
utilizes	 the	 concept	 of	 Emergency	 Response	 Community	 (ERC)	 and	 applies	 it	 to	 community	 
members	 who	 are	 trained	 in	 overdose	 response	 and	 carry	 naloxone.	 The	 ERC	 approach	 is	 ideally	 
suited	 to	 support,	 facilitate,	 and	 encourage	 naloxone	 use	 for	 overdose	 reversal.	 Helping	 
community	 members	 respond	 to	 drug	 overdoses	 through	 the	 proposed	 mobile	 naloxone	 
application	 is	 an	 important	 step	 in	 addressing	 the	 problem	 of	 overdose	 in	 Philadelphia.	 
	 
I	 have	 enjoyed	 getting	 to	 know	 you	 over	 the	 past	 year	 through	 meetings	 at	 Prevention	 Point	 and	 
while	 attending	 meetings	 for	 the	 recently	 created	 Overdose	 Prevention	 Task	 Force.	 	 I	 see	 this	 
grant	 application	 as	 opportunity	 to	 develop	 a	 new	 collaboration	 with	 you	 and	 Drexel	 University	 
and	 look	 forward	 to	 working	 together	 on	 this	 project.	 
	 
Sincerely,	 
	 
	 
	 
Carol	 Rostucher	 
President/	 Founder