Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities
Phase: NA
Conditions: SARS-CoV2 Infection
Sponsor: Michigan State University

 
 
 
 
 
Cover Page for Study Protocol 
 
Official Title: 
Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling 
Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities 
 
NCT Number: 
NCT04957082 
 
Date: 
 
December 1, 2022 

 
 
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B a si c St u d y  I nf or m ati o n 
 
  
 
1. * S h ort  titl e: 
Pr o m oti n g S A R S -C o V -2 a nti b o d y t e sti n g t hr o u g h eff e cti v e c o m m u ni c ati o n  
 
2.  * Bri ef  d e s cri pti o n:  
Afri c a n A m eri c a n s w er e i nf e ct e d a n d di e d fr o m S A R S -C o V -2 m or e t h a n a n y ot h er r a ci al 
gr o u p i n U nit e d St at e s, i n cl u di n g citi e s s u c h a s Fli nt, MI. Y et, c o n n e cti o n s t o i nfl a m m at or y 
bi ol o gi c al pr o c e s s e s i n C O VI D -1 9 di s p ariti e s r e m ai n s u n k n o w n. T hi s st u d y ai m s t o 
i d e ntif y a n d c o m p ar e i nfl a m m ati o n a m o n g t h o s e wit h a n d wit h o ut c o nfir m e d S A R S-C o V - 
2 i nf e cti o n vi a a nti b o d y t e sti n g & c o n d u ct cr o s s -r a c e c o m p ari s o n s of i nfl a m m at or y 
f a ct or s. T h e m ai n o bj e cti v e i s t o e n c o ur a g e u n d er st a n di n g a n d u pt a k e of a nti b o d y 
t e sti n g. T h e c e ntr al h y p ot h e si s i s t h at Afri c a n A m eri c a n s will b e r e c e pti v e t o a nti b o d y 
t e sti n g w h e n b e n efit s a n d li mit ati o n s ar e c o m m u ni c at e d i n a c ult ur all y eff e cti v e  m a n n er.  
W e will pr o vi d e a n o p p ort u nit y t o e n g a g e i n s ali v ar y a nti b o d y s cr e e ni n g - a n o n -i n v a si v e 
r o ut e t o a nti b o d y t e sti n g t h at i s hi g hl y s uit e d t o di s p ariti e s-ori e nt e d C O VI D -1 9 r e s e ar c h.  
 
3.  * W h at ki n d of st u d y i s  t hi s ? 
I R B S u b mi s si o n 
 
4.  * Will a n e xt er n al I R B a ct a s t h e I R B of r e c or d f or t hi s  st u d y ?  
Y e s  
N o  
 
5.  * L o c al pri n ci p al  i n v e sti g at or: 
T o d d Willi a m L u c a s  
 
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6.  * D o e s t h e i n v e sti g at or h a v e a fi n a n ci al i nt er e st r el at e d t o t hi s 
r e s e ar c h ? 
Y e s  
N o  
 
7.  * I s t h e a cti vit y a s y st e m ati c i n v e sti g ati o n, i n cl u di n g r e s e ar c h 
d e v el o p m e nt, t e sti n g a n d e v al u ati o n, d e si g n e d t o d e v el o p or 
c o ntri b ut e t o g e n er ali z a bl e  k n o wl e d g e ?  
Y e s  
N o  
 
 
 
8.  * D o e s t h e a cti vit y i n v ol v e a li vi n g i n di vi d u al a b o ut w h o m a n 
i n v e sti g at or ( w h et h er pr of e s si o n al or st u d e nt) c o n d u cti n g r e s e ar c h 
o bt ai n s d at a t hr o u g h i nt er v e nti o n or i nt er a cti o n wit h t h e i n di vi d u al, or 
i d e ntifi a bl e pri v at e i nf or m ati o n ? 
Y e s  
N o  
 
9.  * I s t hi s pr oj e ct b ei n g c o n d u ct e d t o f ulfill t h e r e q uir e m e nt of a n 
e d u c ati o n/tr ai ni n g  pr o gr a m ?  
Y e s  
N o  
 
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St u d y S c o p e  
 
 
1. * D o e s t h e st u d y s p e cif y t h e u s e of a n a p pr o v e d dr u g or bi ol o gi c, u s e  
a n u n a p pr o v e d dr u g or bi ol o gi c, or u s e a f o o d or di et ar y s u p pl e m e nt 
t o di a g n o s e, c ur e, tr e at, or miti g at e a di s e a s e or c o n diti o n ?  
Y e s  
N o  
 
2.  * D o e s t h e st u d y e v al u at e t h e s af et y or eff e cti v e n e s s of a d e vi c e or 
u s e a h u m a nit ari a n u s e d e vi c e  ( H U D) ? 
Y e s  
N o  
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Additional Study Information 
 
 
 
1. * Describe the research procedures that involve obtaining 
information or biospecimens about a living person through 
interaction or intervention and/or by obtaining their identifiable 
private information or identifiable biospecimens. If subjects will 
participate in or undergo an intervention, fully describe the 
intervention. 
Human subjects in the proposed research will be engaged in an experimental study 
involving exposure to either standard (i.e., generally applicable) or culturally-targeted 
informational videos materials about salivary testing for SARS-CoV-2 antibody. These 
brief videos in conjunction with the survey questions will be distributed via Qualtrics to 
the Flint community. The Flint Registry will provide contact information and 
demographics of eligible subjects to the SeroNet team. The SeroNet team will be 
recruiting participants via email/phone/mail. In collaboration with leading salivary 
bioscience experts, we will also furnish an opportunity to engage in salivary antibody 
screening – a non-invasive route to SARS-CoV-2 antibody testing that is highly suited to 
disparities-oriented COVID-19 research. Video materials will be developed in 
collaboration with clinical and community advisory committees that are highly suited to 
the proposed research, and we will present materials as professionally prepared online 
modules. Participants will also have the option to complete a spit kit in which their 
collected saliva will be used to enable assays for a dozen salivary cytokines, which we 
will link to antibody status. 
 
 
 

 
 
 
2. * Describe the subject population. 
This study will recruit both male and female participants who are Black/African-American 
or White/Caucasian and enrolled in the Flint Registry. All participants will be 18 and over. 
We aim to recruit a total sample size of 500 individuals. We will stratify by age and recruit 
even sample sizes of N = 167 children 18-21, young adults 22-40; and older adults 40 
and above (see Inclusion of Individuals Across the Lifespan). Each age group will be 
further stratified by race and gender. We will recruit a two-thirds African American sample 
(N = 110), and a one-third White sample (N = 57), both of which will be one-third to one- 
half male. The inclusion of both a one-third White sample and a one-third male sub-
sample will ensure that we are able to conduct effective race and gender comparisons. 
 
3. * Select the age range (select one). 
Adults who are 18 or older 
 
4. Identify if your project involves any of the following: (check all that 
apply) 
 
A ctivities That May Require Additional MSU Reviews: 
 
Biospecimens from humans (e.g. human blood, tissue, cell lines, buccal swab) 
 
 
Activities That May Utilize MSU Resources 
There are no items to display 
 
Activities That May Be Subject To Additional Federal Requirements 
Certificate of Confidentiality 
 
Registration and/or reporting with clinicaltrials.gov (by you or the sponsor) 
 

 
 
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A cti viti e s T h at M a y B e S u bj e ct T o A d diti o n al R e q uir e m e nt s B a s e d O n 
R e cr uit m e nt  
T h er e ar e n o it e m s t o di s pl a y  
 
 
A cti viti e s T h at M a y B e S u bj e ct T o I nt er n ati o n al R e q uir e m e nt s  
T h er e ar e n o it e m s t o di s pl a y  
 
5.  * I s t hi s a r e s e ar c h st u d y i n w hi c h o n e or m or e h u m a n s u bj e ct s ar e 
pr o s p e cti v el y a s si g n e d t o o n e or m or e i nt er v e nti o n s ( w hi c h m a y 
i n cl u d e pl a c e b o or ot h er c o ntr ol) t o e v al u at e t h e eff e ct s of t h e 
i nt er v e nti o n s o n  bi o m e di c al  or  b e h a vi or al  h e alt h -r el at e d o ut c o m e s ?  
Y e s  
N o  
 
* Pl e a s e s el e ct o n e of t h e o pti o n s b el o w:  
Ot h er  
 
6.  * Will a n y s u bj e ct' s i n s ur a n c e b e bill e d a s p art of t hi s  pr oj e ct ?  
Y e s  
N o  
 
7.  * Ar e y o u a w ar e of a n y i n di vi d u al w h o h a s a fi n a n ci al i nt er e st w hi c h 
m a y cr e at e a n or g a ni z ati o n al c o nfli ct of i nt er e st ? S e e H R P P p oli c y 
1 0 -1,  C o nfli ct  of  I nt er e st, f or d efi niti o n s  a n d  a d diti o n al  i nf or m ati o n. 
Y e s  
N o  
 
8.  * H a s a n y fi n a n ci al arr a n g e m e nt, i n cl u di n g c o m p e n s ati o n, o w n er s hi p 
i nt er e st, st o c k o pti o n s, or ot h er o w n er s hi p i nt er e st, ( e. g., 
c o m p e n s ati o n t h at i s: e x pli citl y gr e at er f or a f a v or a bl e r e s ult; i n t h e 
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f or m of a n e q uit y i nt er e st i n t h e s p o n s or of a c o v er e d st ud y; or i n t h e 
f or m of c o m p e n s ati o n ti e d t o s al e s of t h e pr o d u ct, s u c h a s a r o y alt y 
i nt er e st) b e e n e st a bli s h e d w h er e b y t h e v al u e of c o m p e n s ati o n or  
o w n er s hi p i nt er e st t o i n v e sti g at or s c o n d u cti n g t h e st u d y c o ul d b e 
i nfl u e n c e d b y t h e o ut c o m e of t h e st u d y ? 
Y e s  
N o  
 
9.  * D o a n y i n v e sti g at or s or r e s e ar c h st aff h a v e a fi n a n ci al i nt er e st 
r el at e d t o t h e r e s e ar c h t h at h a s n ot ot h er wi s e b e e n di s cl o s e d 
el s e w h er e i n t hi s  s u b mi s si o n ?  
Y e s  
N o  
 
1 0. * Will t h e r e s e ar c h b e c o n d u ct e d o ut si d e t h e U nit e d   St at e s ? 
Y e s  
N o  
 
11. * Will s u bj e ct s b e c o m p e n s at e d f or p arti ci p ati o n i n t h e st u d y ( e. g. 
m o n e y, gift c ar d s, c o u p o n s f or fr e e  f o o d) ? 
Y e s  
N o  
 
* Pr o vi d e d et ail s c o n c er ni n g p a y m e nt, i n cl u di n g t h e a m o u nt a n d 
s c h e d ul e of p a y m e nt s i n cl u di n g a n y t er m s a n d c o n diti o n s a n d w h o 
will pr o vi d e p a y m e nt ( e. g. M S U, a n ot h er i n stit uti o n). P a y m e nt s h o ul d 
b e pr o p orti o n at e t o p arti ci p ati o n.  
W e will r e cr uit 5 0 0 p arti ci p a nt s t o c o n d u ct t h e pr o p o s e d r e s e ar c h. E a c h p arti ci p a nt will 
b e c o m p e n s at e d $ 5 0 f or o n e o nli n e s e s si o n l a sti n g a p pr o xi m at el y 4 5 -6 0 mi n ut e s. T hi s 
s e s si o n will i n cl u d e c o m pl eti n g pr e s cr e e ni n g, vi e wi n g e d u c ati o n al m at eri al s, a n d filli n g 
o ut a n i niti al i m m e di at e o ut c o m e s ur v e y m e a s ur e. P arti ci p a nt s c a n b e c o m p e n s at e d a n 
a d diti o n al $ 5 0 f or c o m pl eti n g a s ali v ar y a s s a y kit f or a nti b o d y t e sti n g, a n d f or 
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infl a m m at or y pr ofil e s.  
1 2. * Will y o ur r e s e ar c h li k el y r e q uir e n o n -e x e m pt ( e x p e dit e d or f ull
b o ar d)  r e vi e w ?
Y e s  
N o  
*  ( 1) D e s cri b e  th e  crit eri a for w h o will  b e  i n cl u d e d or  ex cl u d e d fr o m 
t he st u d y,  i n cl u di n g h o w  su bj e ct s  will b e scr e e n e d  f or eli gi bilit y.
T h e f or m al  in cl u si o n crit eri a br o a dl y  e n co m p a s s  Fli nt are a  c om m u nit y  me m b er s  wh o ar e 
Bl a c k/ Afri c a n -A m eri c a n or  Whit e/ C a u c a si a n,  1 8 y e ar s  a nd a b o v e,  an d e nr oll e d i n t h e 
Fli nt  R egi str y.  W e will  e x clu d e  p arti ci p a nt s wh o d o n ot  m e et  ag e or  r a c e crit eri a. Alt h o u g h 
w e will  n ot int e nti o n all y  e xcl u d e t h e m,  our  sa m pl e will  in cl u d e i n di vi d u al s  fr o m t h e Fli nt 
c o m m u nit y  w h o h a v e r e a d y a cc e s s  to i nt ern e t – t h e pri m ar y m o d e of  e nrolli n g i n t h e Fli nt 
R e gi str y.  
*  ( 2) I d e ntif y m at eri al s t h at will be u s e d  t o re cr uit  su bj e ct s  (s el e ct  all  
 th at  a p pl y):
     L ett er, e m ail, fl y er, p o st c ar d s, C D, D V D  
U s e of w e b sit e s or A p p s ( e. g. F a c e b o o k, R e s e ar c h M at c h) 
Ot h er  
* D e s cri b e:
St u d y t e a m m a y al s o r e cr uit p arti ci p a nt s vi a t e xt m e s s a g e/ p h o n e.  
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