Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
Phase: NA
Conditions: Cervical Cancer
Sponsor: University of Miami

 
Pr ot oc ol Title: Acce pta bilit y of H P V self -sa m pli n g 
t o ols f or cer vical ca ncer pre ve nti o n i n Ja maica n 
w o me n: A t he or y- base d a p pr oac h t o c ult urall y-
tail ore d messa ge desi g n. 
 
Versi o n : 1 A  
 
Versi o n D ate:  A pril 2 7, 2 0 1 8  
 
N C T N u m ber: N C T 0 3 6 1 3 4 9 3  
 

I R B St u d y N u m ber: 2 0 1 8 0 0 3 3 
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1)  Pr ot oc ol Title  
Acce pta bilit y of H P V self -sa m pli n g t o ols f or cer vical ca ncer pre ve nti o n i n 
Ja maica n w o me n: A t he or y-base d a p pr oac h t o c ult urall y -tail ore d messa ge desi g n. 
2)  I R B Re vie w Hist or y * 
N/ A  
 
3)  O bjecti ves *  
T he p ur p ose of t he pr o p ose d st u d y is t o i ncrease H P V scree ni n g be ha vi ors i n Ja maica n 
w o me n b y e xa mi ni n g t he acce pta bilit y of H P V D N A self-sa m pli n g t o ols, a n d deter mi ne 
t he m ost c ult urall y a p pr o priate a n d effecti ve messa ge desi g n f or pr o m oti n g s uc h a t o ol i n 
t his c o nte xt.  
 
S pecific Ai m: E val uate c ult ural l y-tail ore d H P V D N A self-sa m pli n g t o ol kit.  
 
H 1: W o me n w h o recei ve c ult urall y tail ore d messa gi n g will e x hi bit i m pr o ve d scree ni n g, 
scree ni n g-rele va nt k n o wle d ge, attit u des, a n d percei ve d-efficac y. 
 
4)  B ac k gr o u n d *  
L o w scree ni n g c o vera ge is relate d t o healt h s yste m barriers, as well as w o me n’s 
attit u des a n d k n o wle d ge a b o ut cer vical ca ncer scree ni n g. I n a st u d y c o n d ucte d b y 
t he Mi nistr y of Healt h a n d E n vir o n me nt of Ja maica i n 2 0 0 8, lac k of u pta ke was 
f o u n d t o be i nfl ue nce d t o a si g nifica nt de gree b y fears a n d misc once pti o ns o n t he 
part of Ja maica n w o me n, i ncl u di n g i deas t hat t he h u ma n pa pill o ma vir us ( H P V) 
test ca uses da ma ge t o t he cer vi x. I n a d diti o n, ot her fact ors i m pe di n g w o me n i n 
Ja maica i ncl u de c o ncer ns a b o ut pri vac y, belief t hat t he pr oce d ure was 
e m barrassi n g, i g n ora nce a b o ut w here t o get a pa p test, a n d lac k of s ufficie nt 
i nf or mati o n, fear of pai n, fear of cer vical ca ncer dia g n osis, a n d lac k of s ufficie nt 
ti me wit h t heir d oct ors.  
T he U S F o o d a n d Dr u g A d mi nistrati o n has desi g nate d H P V scree ni n g as a best 
practi ce i n i de ntif yi n g ris k of cer vical ca ncer, o ver a n d a b o ve pa p test scree ni n g, 
beca use of its hi g h efficac y, aff or da bilit y, a n d c o n ve nie nce, si nce it ca n be 
a da pte d f or vari o us setti n gs. T he H P V self-sa m pli n g t o ol has bee n s h o w n t o 
a d dress iss ues s uc h as pr i vac y, a n d st u dies ha ve s h o w n t hat w o me n feel m ore 
c o mf orta ble wit h t his o pti o n a n d e x presse d willi n g ness t o rec o m me n d t he t o ol t o 
ot hers. T his a da pta bilit y has bec o me a dri vi n g f orce i n a d v ocates s u p p ort f or t he 
t o ol i n har d-t o-reac h a n d p o or areas.  H P V self-sa m pli n g has bee n teste d i n ma n y 
c o nte xts, i ncl u di n g res o urce-li mite d c o u ntries, a n d has bee n f o u n d t o be 
efficaci o us a n d c ost -effecti ve. Wit h t his n o w fairl y well -esta blis he d i n t he 
literat ure, researc h q uesti o ns ha ve n o w f oc use d o n t he best strate gies f or diff usi o n 
of t he t o ols. It has bee n s u g geste d t hat C o m m u nit y Healt h W or kers ( C H Ws), 
c o u ple d wit h C o m m u nit y- base d Partici pat or y Researc h ( C B P R) met h o ds are t he 
i deal ve hicle t o e ns ure o pti mal u pta ke i n c o m m u nit y-setti n gs. O n t he ot her ha n d, 
ot her st u dies ha ve pr o p ose d t hat a maile d a p pr oac h is preferre d. 

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T his c urre nt pr o p osal ai ms t o deter mi ne h o w c ult urall y a p pr o priate messa gi n g 
wit hi n o ne c o nte xt (Ja maica), al o n gsi de a n i n n o vati o n (self- sa m pli n g H P V test), 
mi g ht i ncrease u pta ke of scree ni n g be ha vi or s. 
5)  I ncl usi o n a n d E xcl usi o n Criteri a * 
Rati o nale f or i ncl usi o n/e xcl usi o n criteria: T his st u d y will i n v ol ve t he c ollecti o n of 
data fr o m Ja maica n w o me n. Eli gi ble partici pa nts will be acce pte d t o t he st u d y o n 
a first-c o me - first-ser ve basis. A prescree ni n g s ur ve y i n pers o n or o ver t he p h o ne 
(see A p pe n di x A), as well as t he data fr o m t he baseli ne s ur ve y (see A p pe n di x B), 
w hic h will i ncl u de a de m o gra p hic secti o n w hic h will i ncl u de self-re p orti n g of a ge 
etc. (liste d bel o w) w hic h will be a n a d diti o nal c hec k f or c o nfir mi n g eli gi bilit y f or 
t he st u d y. 
I ncl usi o n criteri a: Ja maica n w o me n, a ge d 3 0 t o 6 5.  
E xcl usi o n criteri a : w o me n w h o re p ort ha vi n g ha d a h ysterect o m y, ha ve ha d a 
hist or y of cer vical ca ncer, W o me n w h o are c urre ntl y u p- t o-date o n cer vical ca ncer 
scree ni n g ( ha ve ha d a Pa p i n t he last 3 years or ha ve ha d a Pa p s mear/ H P V c o-test 
wit hi n t he past 5 years), a d ults u na ble t o c o nse nt, c hil dre n, pre g na nt w o me n a n d 
pris o ners. 
6)  N u m ber of S u bjects *  
T otal e x pecte d: a p pr o xi matel y 3 6 0 partici pa nts, ( 3 5 0 f or t he i nter ve nti o n; 1 0 i nter vie ws) 
 
7)  St u d y -Wi de Recr uit me nt Met h o ds *
 
Ja maica n w o me n will be recr uite d f or partici pati o n i n t w o differe nt p hases of t his 
researc h pr oject. Eff orts will be ma de t o i ncl u de w o me n fr o m r ural areas, ur ba n 
areas, a n d var yi n g s oci o ec o n o mic a n d c ult ural bac k gr o u n ds. Recr uit me nt will 
occ ur i n t hree i de ntifie d l o w- scree ni n g re gi o ns i n Ja maica ( usi n g nati o nal 
statistical data o n scree ni n g rates per paris h i n Ja maica), a n d e nr ol me nt will ta ke 
place t hr o u g h l ocal c o m m u nit y or ga nizati o ns as well as at c o m m u nit y e ve nts s uc h 
as healt h fairs. 
8)  St u d y Ti meli nes *  
A n i n di vi d ual s u bject i n t he researc h is e x pecte d t o partici pate u p t o ma xi m u m of 4 
m o nt hs. E nr olli n g st u d y s u bjects is e x pecte d t o n ot e xcee d o ne m o nt h pri or t o t he act ual 
st u d y date. T he esti mate d date f or t he i n vesti gat ors t o c o m plete t his st u d y is Se pte m ber 
3 0, 2 0 1 8. T he pri mar y data a nal ysis will be c o m plete d b y Oct o ber 3 1, 2 0 1 8. Ot her 
st u dies t hat ha ve utilize d c o m m u nit y a n d g o ver n me nt part ners ha ve bee n s uccessf ul at 
recr uiti n g a si milar n u m ber of partici pa nts o ver a s h ort ti me. F or e xa m ple ( Barrett & 
H uff ma n, 2 0 1 1) c ollecte d t heir e ntire dataset i n 3 wee ks i n Oct o ber 2 0 0 7 ( 2 7 6 Ja maica n 
a d olesce nts). A n ot her e xa m ple is ( Le wis -Bell et a l., 2 0 1 3), a cr oss-secti o nal st u d y t hat 

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t o o k place i n A pril –J ul y 2 0 1 0 wit h 8 5 2 se x uall y-acti ve Ja maica n w o me n, 1 6 – 4 9 years of 
a ge. 
 
9)  St u d y E n d p oi nts *  
 
T he pri mar y st u d y e n d p oi nts are: 
●  De vel o p me nt of messa ges a n d desi g n of H P V self -sa m pli n g t o ol kit. 
 
Base d  o n f or mati ve res ults fr o m i nter vie ws (see A p pe n di x C f or i nter vie w scri pt), 
messa ges will be desi g ne d t hat are c ult urall y a p pr o priate a n d tail ore d f or a n y 
a u die nce se g me nts w hic h e mer ge fr o m t he data. Fee d bac k will be use d t o desi g n a 
c ult urall y a da pte d H P V D N A self - sa m pli n g t o ol kit f or t his c o nte xt. 
 
● E val uati o n of c ult urall y -tail ore d H P V D N A self-sa m pli n g t o ol kit. 
E nr olle d partici pa nts will c o m plete a pre -test/ baseli ne q uesti o n naire w hic h will be base d 
o n t he t he oretical c o nstr ucts i de ntifie d, a n d w hic h will als o be assesse d i n t he p osttest. 
T he i nter ve nti o n will be c o nsi dere d a s uccess w he n: 1) t he maj orit y of w o me n tar gete d 
o pt t o ret ur n t heir sa m ple, as i nstr ucte d o n t he t o ol kit, f or testi n g a n d, 2) u p o n e val uati o n 
(p osttest  - See A p pe n di x C), w o me n re p ort hi g her le vels of, k n o wle d ge, self-efficac y a n d 
res p o nse efficac y or p ositi ve c ha n ges i n attit u des t o war d scree ni n g t ha n at baseli ne. 
 
 
1 0)  Pr oce d ures I n v ol ve d *  
 
I nter vie ws 
Deter mi n ati o n of eli gi bilit y: T he Ja maica Ca ncer S ociet y (J C S) will pr o vi de 
s u p p ort t o select 1 0 i n di vi d uals f or i nter vie ws usi n g t heir data base ( p ur p osi ve 
sa m pli n g) fr o m at least 2 of t heir cli nic- base d l ocati o ns. Eli gi bilit y will be 
deter mi ne d acc or di n g t o t he i ncl usi o n/e xcl usi o n criteria o utli ne d as well as d uri n g 
t he pre-scree ni n g pr ocess ( A p pe n di x A). 
Pr oce d ure: Partici pa nts w h o e x press a n i nterest will be scree ne d, c o nse nte d a n d 
gi ve n t he baseli ne s ur ve y t o c o m plete, b y a l ocal st u d y c o or di nat or or t he C o-I. 
T he y will t he n be gi ve n t he self-sa m pler t o ol t o use at h o me. A date, ti me a n d 
l ocati o n t o ret ur n t he t o ol a n d partici pate i n t he i nter vie w pr ocess ( wit hi n t he 
sa me wee k) will be deter mi ne d wit h t he partici pa nt at t he ti me of c o nse nt. 
Partici pa nts will be re mi n de d of t his b y at least o ne tele p h o ne call u p t o t he da y of 
t he i nter vie w. After t he i nter vie ws, partici pa nts will als o c o m plete t he baseli ne 
s ur ve y. T he i nter vie ws will f u ncti o n as a pil oti n g of t he baseli ne a n d p osttest 
q uesti o n naires as well as a  pretest of t he c ollecti o n of self -sa m ples ( descri be d 
bel o w), si nce partici p a nts will act uall y use a n d ret ur n a self -sa m pli n g t o ol bef ore 
c o n d ucti n g t he i nter vie w. T he l ocati o n f or t he i nter vie ws will be at t he J C S. T he 
partici pa nts will recei ve t heir h p v test res ults wit hi n 6 wee ks of t he i nter vie ws.  

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N arr ati ve i nter vie ws : F or t h e p ur p ose of s ocial scie nce researc h, narrati ve 
i nter vie ws are u nstr uct ure d a n d i n-de pt h a n d as k partici pa nts t o rec o nstr uct a 
partic ular e ve nt t hat is i m p orta nt t o t he m a n d t heir s ocial c o nte xt, i n t he f or mat of 
a st or y, f or a n i nter vie wer ( R o hle der & Gi b s o n, 2 0 0 5). T he met h o d see ks t o 
u n dersta n d h o w pe o ple’s narrati o n of st ories als o de m o nstrates pe o ple’s wa ys of 
t hi n ki n g or t heir " u nc o nsci o us l o gic" ( H oll wa y, 2 0 0 1, p. 1 5). M o vi n g be y o n d t he 
tra diti o nal q uesti o n-res p o nse f or mat, narrati ve i nter vie wers ha ve a di mi nis he d 
r ole. I nstea d t he i nter vie w relies o n certai n e x pecte d sc he ma i n st or ytelli n g t o 
elicit t he s o u g ht -after ric h data. T his sc he ma dictates t hat t he res p o n de nt will 
nat urall y s hare t he m ost perti ne nt i nf or mati o n, pr o vi de s ufficie nt detail, a n d 
i ncl u de a str uct ure t hat i ncl u des a be gi n ni n g, mi d dle a n d e n d of t he mai n sit uati o n 
or occ urre nce bei n g descri be d. After t he partici pa nts are as ke d t o tell t heir st or y, 
t he i nter vie w ma y n ot i nterr u pt at a n y p oi nt t o as k f or f urt her e x pla nati o ns or t o 
e x press a n y o pi ni o ns; t he i nter vie wee ma y o nl y as k w hat ha p pe ne d ne xt 
( R o hle der & Gi bs o n, 2 0 0 5). See A p pe n di x C f or i nter vie w scri pt. 
T ail ori n g t he self -s a m pler mess a ges ( p ac k a ge a n d i nstr ucti o ns): T he 
pa rtici pa nt res p o nses will pr o vi de i nsi g ht i nt o l ocal w o me n's’ perce pti o ns, 
la n g ua ge, e x perie nce usi n g t he t o ol, w hic h will f urt her ai d messa ge desi g n. T he 
i nter vie ws will pr o vi de i nsi g ht o n t he partici pa nts e x perie nce usi n g t he t o ol kit a n d 
h o w t his is e x presse d li n g uisticall y. F or e xa m ple, i n t heir o w n w or ds h o w di d 
t he y use t he self-sa m pler t o ol. T his will i nf or m f urt her t he la n g ua ge a n d w or di n g 
c h oices f or t he c ult urall y -tail ore d c o n diti o n.  
 
C ollecti o n of Self -S a m ples : 
Deter mi n ati o n of eli gi bilit y: Partici pa nts i n t he f ull i nter ve nti o n ( 3 5 0 w o me n) 
will be scree ne d f or eli gi bilit y b y t he C O -I or a l ocal st u d y c o or di nat or. T he  C o -
I/l ocal st u d y c o or di nat or will a d mi nister a brief scree ni n g q uesti o n naire pri or t o 
o btai ni n g i nf or me d c o nse nt ( A p pe n di x A). T he scree ni n g q uesti o n naire will c o ver 
t he i ncl usi o n/e xcl usi o n criteria liste d a b o ve. F or w o me n w h o scree n p ote ntiall y 
eli gi ble, t he C O-I/l ocal st u d y c o or di nat or will f urt her descri be t he st u d y. Eli gi ble 
p ote ntial partici pa nts will be t ol d t hat we are c o n d ucti n g a researc h st u d y t o 
u n dersta n d h o w ne w i n n o vati o ns li ke a n at- h o me H P V self-sa m pli n g t o ol w o ul d 
be acce pte d b y y o u a n d i n y o ur c o m m u nit y. T he st u d y will i n v ol ve c o m pleti o n of 
a baseli ne s ur ve y ( A p pe n di x B) a b o ut t heir se x ual a n d re pr o d ucti ve practi ces a n d 
cer vical self-sa m pli n g.  
 
I n o ur researc h, we pla n t o use a self-sa m pli n g de vice de vel o pe d b y Pre ve nti ve 
O nc ol o g y I nter nati o nal ( P OI) a n d t he Nati o nal I nstit utes of Healt h ( NI H). T he 
P OI/ NI H self -sa m pler is c o nsi dere d a n o n-si g nifica nt ris k de vice a n d has bee n 
a p pr o ve d f or researc h c o n d ucte d b y NI H fac ult y t hr o u g h o ut t he U nite d States a n d 
i n vari o us i nter nati o nal setti n gs. T his de vice is ma n ufact ure d b y P urita n Me dical 
Pr o d ucts, a n d is t h o u g ht t o reflect a n i m pr o ve me nt o ver ot her self-sa m plers, gi ve n 
a lar ger C ollecti o n S wa b ti p, w hic h e na bles a w o ma n t o c ollect cells fr o m m ore of 

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t he cer vi x’s t otal s urface area wit h less eff ort. T he P OI/ NI H self-sa m pler is a 2 0 
c m i n dia meter, w hic h is si milar t o a re g ular -size d ta m p o n. T his sa m pler is eas y t o 
use.  A w o ma n i nserts t he de vice i nt o her va gi na u ntil s he feels sli g ht resista nce. 
T he partici pa nt t he n h ol ds t he pa d dle e n d of t he C ollecti o n S wa b a n d r otates it 
fi ve ti mes.  S he t he n wit h dra ws t he C ollecti o n S wa b. O nce t he C ollecti o n S wa b is 
f ull y re m o ve d fro m t he va gi na, t he partici pa nt places t he C ollecti o n S wa b i nt o 
li q ui d cell preser vati ve a n d r otates it fi ve ti mes. T he partici pa nt ca n t he n dis p ose 
of t he s wa b i n a h o use h ol d tras h ca n a n d sec ure t he vial li d. T he partici pa nt 
s h o ul d ret ur n t he vial b y mail (s he will be pr o vi de d a pre-a d dresse d, sta m pe d 
e n vel o pe) or i n pers o n t o a s pecifie d ret ur n l ocati o n. T he C O- I/l ocal st u d y 
c o or di nat or will be res p o nsi ble f or st ori n g a n d s hi p me nt of t he sa m ples t o t he 
S C C C f or testi n g.  
Partici pa nts will recei ve t he H P V self -sa m pler at t he ti me t he y c o m plete t he 
baseli ne s ur ve y wit h t he C o- I/l ocal st u d y c o or di nat or. T he H P V self-sa m pler kit 
will i ncl u de t he c ollecti o n s wa b a n d t he vial f or c ollecti n g a n d st ori n g t he 
s peci me n, a n d a n i nstructi o nal s heet t hat vis uall y de picts t he ste ps f or self -
sa m pli n g. 1 1 5 w o me n will recei ve a c ult urall y -tar gete d, fear a p peal messa ge f or 
t he H P V self-sa m pler kit; 1 1 5 w o me n will recei ve o nl y a fear a p peal messa ge, n ot 
tar gete d f or t he Ja maica n p o p ulace; a n d 1 1 5 w o me n will recei ve o nl y t he self-
sa m pler t o ol wit h n o messa ge a p peal ( plai n pac ka gi n g). ( A p pe n di x G & J ). T he 
C o -I/l ocal st u d y c o or di nat or will offer t he H P V self-sa m pler acc o m pa nie d b y a n 
i nstr ucti o n s heet o n h o w t o use t he self-sa m pler. At t his p oi nt partici pa nts will 
recei ve s o me se nsitizati o n o n t he t o pic, w hic h will i ncl u de: 1) healt h e d ucati o n o n 
t he i m p orta nce of cer vical ca ncer scree ni n g usi n g a s h ort i nter ve nti o n/e d ucati o nal 
scri pt ( A p pe n di x H) a n d 2) m oti vati o n t o e nc o ura ge w o me n t o ha ve scree ni n g 
usi n g t he H P V self- sa m pler. W o me n will als o be i nf or me d of t he f oll o wi n g: 1) 
H P V i nfecti o n us uall y is n ot detecta ble or har mf ul; 2) nearl y e ver y o ne w h o has 
ha d se x ual i nterc o urse has bee n e x p ose d t o H P V a n d i nfecti o n is ver y c o m m o n; 
3) a p ositi ve H P V test res ult d oes n ot i n dicate t he prese nce of ca ncer a n d t hat n ot 
all w o me n w h o test p ositi ve f or a n H P V i nfecti o n will n ot de vel o p a d va nce d 
ca ncer. It will als o be stresse d t o w o me n t hat if t he y ha ve n ot see n a d oct or 
rece ntl y t he y will still nee d t o see a pr o vi der t o a d dress ot her healt h iss ues, w hic h 
ma y i ncl u de a g y nec ol o gic e xa m. T he y will als o be a d vise d t hat if H P V o btai ne d 
t hr o u g h self-sa m pli n g is p ositi ve, t he y will nee d f oll o w-u p me dical care at cli nical 
sites (a list of p ossi ble sites will be pro vi de d).  a n d t o pac ka ge a n d ret ur n it b y 
mail or t o t he a d dress pr o vi de d. A brief s ur ve y o n i nte nti o ns will t he n be 
a d mi nistere d ( A p pe n di x K) . Partici pa nts will be as ke d t o use t he t o ol at h o me b y 
f oll o wi n g t he i nstr ucti o ns, T he l ocal st u d y c o or di nat or will f oll o w u p wit h 
partici pa nts w h o d o n ot ret ur n t he kit wit hi n 1 wee k via S M S messa gi n g. All 
partici pa nts will recei ve t he f oll o wi n g messa ge: “ Please re me m ber t o ret ur n y o ur 
H P V self -sa m pler kit t o X l ocati o n d uri n g t he f oll o wi n g ti mes: X Y, a n d Z. Please 
i g n ore t his messa ge if y o u ha ve alrea d y ret ur ne d t he kit. T ha n k y o u.” 

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P osttest I nter vie w:  All partici pa nts will be as ke d t o c o m plete a p osttest s ur ve y 
w hic h ma y be a d mi nistere d b y p h o ne or i n pers o n, if c o n ve nie nt ( A p pe n di x D) 
u p o n ret ur n of t he self- sa m pler kit.  
C o m pe ns ati o n: All partici pa nts will be pr o vi de d a o ne- ti me s mall i nce nti ve of 
a p pr o xi matel y $ 2 1 U S D ( $ 2, 5 0 0 Ja maica n d ollars) i m me diatel y u p o n c o m pleti o n 
of t he narrati ve i nter vie ws (f or t he i nter vie w partici pa nts), a n d u p o n c o m pleti o n 
of t he p osttest i nter vie ws (f or t he messa ge desi g n e x peri me nt partici pa nts).  
Re p ort of H P V L a b Res ults: T he C o -I will recei ve test res ults fr o m la b a n d 
pr o vi de i nf or mati o n t o t he l ocal st u d y c o or di nat or. T he C o-I/l ocal st u d y 
c o or di nat or will call partici pa nts wit hi n 4- 6 wee ks t o n otif y t he m of t heir test 
res ults w he n t he y are recei ve d.  
Partici pa nts w h o test ne gati ve will be e nc o ura ge d t o f oll o w- u p wit h t heir d oct or 
a n d rescree n i n 3 6 m o nt hs, base d o n t he U S Pre ve nti ve Ser vices Tas k F orce 
( U S P S T F) g ui deli nes. Partici pa nts w h ose test res ults i n dicate i ns ufficie nt sa m ple 
(i ns ufficie nt cell ular q ua ntit y f or a nal ysis) w o ul d be as ke d if t he y ha d a 
h ysterect o m y. If n o, t he partici pa nt will ha ve t he o pti o n of pr o vi di n g a sec o n d 
sa m ple if t he y are l ocate d wit hi n reas o na ble dista nce fr o m a l ocal pr oject part ner, 
a n d a n a p p oi nt me nt will be sc he d ule d b y C o- I/l ocal st u d y c o or di nat or t o eit her 
deli ver t he kit or f or t he partici pa nt t o pic k u p. Partici pa nts w h o test p ositi ve f or 
H P V will be na vi gate d t o a p pr o priate f oll o w- u p care wit h o ur c o m m u nit y part ners 
a n d/ or T he Mi nistr y of Healt h Ja maica wit hi n 3 0 da ys of recei vi n g t he res ult. T he 
C o -I will w or k wit h Mi nistr y of Healt h staff t o e ns ure t hat w o me n wit h a b n or mal 
fi n di n gs recei ve ti mel y f oll o w u p. T he C o-I/l ocal st u d y c o or di nator will f oll o w u p 
wit h partici pa nts w h o d o n ot ret ur n t he kit wit hi n 3 0 da ys.  
F or i n di vi d uals w h o scree n eli gi ble b ut decli ne d c o nse nt/e nr oll me nt, t he brief 
de m o gra p hic i nf or mati o n c ollecte d d uri n g t he eli gi bilit y scree n (a ge, et h nicit y) 
will be ke pt wit h o ut a n y i de ntifia ble i nf or mati o n s o t hat we ma y c o m pare 
res p o n ders vers us n o n-res p o n ders. F or i n di vi d uals w h o c h o ose t o partici pate i n 
t he st u d y, t he C O-I/l ocal st u d y c o or di nat or will o btai n c o nse nt (see A p pe n di x F), 
c o m plete t he baseli ne s ur ve y ( A p pe n di x B) a n d gi ve t he self -sa m pli n g t o ol ( or 
sc he d ule a ti me t o d o s o at a ti me or l ocati o n c o n ve nie nt f or t he partici pa nt).  
 
1 1)  D at a a n d S peci me n B a n ki n g *  
T he l ocal st u d y c o or di nat or will tra ns p ort a n y sa m ples fr o m t he fiel d t he n batc h-
s hi p pe d t o U M S yl vester C o m pre he nsi ve Ca ncer Ce nter ( S C C C) via D H L.  T he 
st u d y c o or di nat or will be i n c har ge of t he l o gistics relate d t o recei vi n g t he 
sa m ples fr o m t he fiel d, st ori n g t he m a n d s hi p pi n g t he m (t his c orres p o n ds wit h 
ot her pr ojects t hat ha ve s uccessf ull y use d t hese met h o ds i n t he c ollecti o n of H P V 
d na sa m ples (see ( Le wis- Bell et al. 2 0 1 3) . We will s hi p t he self-sa m ple d 
s peci me ns t o t he S C C C f or hi g h-ris k H P V detecti o n a n d H P V viral ge n ot y pi n g. 
Cer vical s peci me ns will be la bele d wit h a n u m ber t hat matc hes t he n u m ber 
assi g ne d t o t he partici pa nt d uri n g t he st u d y i nta ke. T he s peci me ns will be 

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pr ocesse d a n d res ults w ill be re p orte d bac k t o C o-I wit hi n 2 wee ks, w h o will 
o btai n si g nat ure fr o m Dr. Matt Sc hl u m brec ht. He will si g n a n d date la b res ult 
s heet. C o pies of res ults will be file d a n d ke pt i n l oc ke d ca bi net a n d u pl oa de d t o 
R E D Ca p. C o pies of a nal ysis will be gi ve n t o t he st u d y tea m w h o will be file d a n d 
ke pt i n l oc ke d ca bi net a n d u pl oa de d t o Re d Ca p. 
1 2)  D at a M a n a ge me nt *  
All st u d y data will be ca pt ure d b y R E D Ca p ( htt p:// pr oject -re dca p. or g/), a n d Vel os 
( vel os. me d. mia mi.e d u), w hic h pr o vi des b ot h sec ure data ca pt ure f or cli nical 
researc h st u dies. T he R E D Ca p ( Researc h Electr o nic Data Ca pt ure) s yste m 
( pr oject-re dca p. or g/) is a we b-base d cli nical researc h ma na ge me nt a p plicati o n 
t hat is desi g ne d s pecificall y f or i n vesti gat ors a n d t heir researc h tea ms.  It s u p p orts 
pr ocesses f or p atie nt recr uit me nt, patie nt sc he d uli n g, b u d geti n g, i n v oici n g, a n d 
milest o ne ma na ge me nt, data safet y m o nit ori n g, a d verse e ve nt re p orti n g, s yste m 
i nte grati o n, data c ollecti o n a n d st u d y e xec uti o n.  Data safet y c hec ks, re d u n da nc y, 
a n d s ki p patter ns ca n all be easil y pr o gra m me d.  A maj or stre n gt h f or o ur 
pr o p osal is t hat R E D C A p all o ws all st u d y relate d i nf or mati o n t o be ce ntralize d 
yet be accesse d t hr o u g h t he i nter net fr o m a n y w here t hr o u g h e ncr y pte d a n d 
pass w or d pr otecte d access gra nte d o nl y t o a ut h orize d pers o n nel as desi g nate d b y 
t he st u d y PIs. It is eas y t o use, relia ble, f ull y HI P A A c o m plia nt a n d c o m pletel y 
sec ure. A maj or a d va nta ge of usi n g t his s yste m is t hat U M pr o vi des t his i m p orta nt 
res o urce t o U M a n d ass ociates (s uc h as n o n-U M c o m m u nit y researc h part ner s) at 
n o c ost.  T his i ncl u des tec h nical s u p p ort a n d eff ort of R E D Ca p tea m staff w h o 
assists i n vesti gat ors i n u pl oa di n g all t heir s ur ve ys a n d q uesti o n naires i nt o 
R E D Ca p.  I n t his st u d y, all of t he data c ollecte d at t he ti me of i nter vie w or site 
visit b y t he  C o -I/l ocal st u d y c o or di nat or will be u pl oa de d i n real ti me i nt o 
R E D Ca p s yste m usi n g i Pa ds.  H o we ver, t he C o-I will als o ha ve pa per versi o ns of 
t he i nstr u me nt f or t he a ntici pate d b ut h o pef ull y rare occasi o ns w he n tec h n ol o gical 
glitc hes occ ur.  I n t hese cases t he C o -I/l ocal st u d y c o or di nat or w o ul d i n p ut t he 
data at a later ti me.  
 
All data will be i ns pecte d f or q ualit y ass ura nce pri or t o a nal ysis. Pri or t o 
perf or mi n g statistical a nal ysis o n q ua ntitati ve data, t he data will be c hec ke d, 
scree ne d a n d verifie d. Data c hec ki n g is critical t o e ns ure t he i nte grit y of t he 
data base. Ra n ge c hec ks will be r o uti nel y perf or me d, a n d ra n d o m ite ms fr o m t he 
ra w data will be c hec ke d a gai nst t he e ntere d data s o t hat mista kes ca n be 
i de ntifie d. t he sa m pli n g strate g y f or o ur st u d y ma y be descri be d as p ur p osi ve a n d 
s n o w ball sa m pli n g. W o me n will n ot be n ot ra n d o ml y selecte d as t he st u d y was 
i nte n de d t o ca pt ure a c o m m u nit y-base d p o p ulati o n t hat meets s pecific selecti o n 
criteria. Data will be a nal yze d fr o m i nter vie ws usi n g t he c o nsta nt  c o m paris o n 
met h o d ( C or bi n & Stra uss, 2 0 0 8). F or t he messa ge desi g n e x peri me nt, a paire d t-
test will be c o n d ucte d t o deter mi ne t he differe nce bet wee n pre a n d p osttests i n 
scree ni n g be ha vi or after e x p os ure t o t he self-sa m pli n g t o ol; me diati o n a nal yses 
will be c o n d ucte d t o deter mi ne if c ha n ge i n scree ni n g k n o wle d ge, attit u des a n d 
percei ve d -efficac y me diate d c ha n ges i n scree ni n g o utc o mes. Me diati o n a nal yses 

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will be perf or me d usi n g or di nar y least s q uares re gressi o n, usi n g tec h ni q ues 
rec o m me n de d f or wit hi n-s u bject desi g ns (J u d d, Ke n n y, & Mc Clella n d, 2 0 0 1). 
 
T o mai ntai n partici pa nt c o nfi de ntialit y, st u d y s pecific I D c o des are use d i n all 
st u d y trac ki n g a n d a nal yses. O nl y t he C o -I/l ocal st u d y c o or di nat or will ha ve 
access t o t he files li n ki n g partici pa nts wit h st u d y I D n u m bers.  
1 3)  Pr o visi o ns t o M o nit or t he D at a t o E ns ure t he S afet y of S u bjects *  
All st u d y data c ollecte d will be u pl oa de d i nt o t he R E D Ca p s yste m. As pre vi o usl y 
state d, t he C o -I a n d l ocal c o or di nat or have access t o t his s yste m t o e nter 
partici pa nt data usi n g a n i Pa d or pa per-base d met h o ds d uri n g i nter vie ws a n d site 
visits , a n d i n real ti me d uri n g t he e val uati o n p h o ne call.  
F urt her m ore, q ualit y a n d c o m plete ness of data e ntr y will be s yste maticall y 
c hec ke d b y a data ma na ger at re g ular i nter vals f or t he d urati o n of t he st u d y. O nl y 
t he C o -I has access t o t he ra w data files e ntere d b y t he C o -I/l ocal st u d y 
c o or di nat or . De-i de ntifie d data files t hat ha ve bee n clea ne d a n d a p pr o priatel y 
gr o u pe d a n d cate g orize d will be ma de a vaila ble t o st u d y pers o n nel re q uesti n g 
s uc h data. 
A d diti o nall y, all st u d y staff a n d t he PI  will meet m o nt hl y t o re vie w st u d y 
pr o gress, as well as disc uss a n y a d verse e ve nts a n d fee d bac k fr o m partici pa nts 
re gar di n g st u d y pr oce d ures. Fi nall y, st ud y data is re vie we d o n a re g ular basis t o 
e ns ure pr o per e ntr y a n d st ora ge pr oce d ures. 
1 4)  Wit h dr a w al of S u bjects *
 
A n y partici pa nt ma y c h o ose t o wit h dra w fr o m t he st u d y at a n y ti me. If a 
partici pa nt c h o oses t o wit h dra w,  t heir data will be destr o ye d, a n d t heir reas o n f or 
wit h dra wal rec or de d. Partici pa nts ma y wit h dra w b y c o ntacti n g t he C o -I/l ocal 
st u d y c o or di nat or. 
 
1 5)  Ris ks t o S u bjects *  
Partici pa nts i n t he st u d y will be as ke d a series of q uesti o ns a b o ut t heir beliefs, 
attit u des, a n d practices relate d t o t heir se x ual  a n d re pr o d ucti ve hist or y a n d healt h 
see ki n g be ha vi ors. T here is n o ris k of p h ysical i nj ur y fr o m a ns weri n g t hese 
q uesti o ns. H o we ver, t he t o pic is se nsiti ve i n nat ure, a n d partici pa nts ma y feel 
u nc o mf orta ble a ns weri n g s o me q uesti o ns a b o ut t heir pers o nal feeli n gs a n d 
beliefs, a n d a b o ut t he details of t heir be ha vi or. Partici pa nts ma y als o fi n d 
t he msel ves o pe ni n g u p a b o ut healt h iss ues a n d c o ncer ns t hat t he y ha ve pre vi o usl y 
ke pt pri vate, w hic h ma y ca use s o me e m oti o nal disc o mf ort. 
 
Re gar di n g t he cer vical self -sam pli n g de vice, t he t w o m ost c o m m o n pri or 
pr o ble ms of self- sa m pli n g were:  1) placi n g t he sa m pler i n a n i nc orrect o pe ni n g 
(e. g., t he a n us); a n d 2) I nj ur y t o t he va gi na or cer vi x d ue t o a g gressi ve sa m pli n g.  

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Als o, a partici pa nt ma y e x perie nce cer vical blee d i n g a n d i nfla m mati o n fr o m 
e xcessi ve press ure a p plie d d uri n g t he r otati o n of t he de vice.  If a partici pa nt 
e x perie nces c o nti n u o us a n d hea v y blee di n g, t he y are a d vise d t o st o p usi n g t he 
de vice a n d c o ntact t he st u d y tea m i m me diatel y.   H o we ver, b ot h of t hese hazar ds 
are u nli kel y t o occ ur wit h t he c urre nt de vice.  I n trials wit h m ore t ha n 2 0, 0 0 0 
w o me n w he n eit her pr o ble m has occ urre d, t he y di d n ot ca use seri o us i nj ur y. 
Rat her, t he y res ulte d i n mi ni mal patie nt disc o mf ort.  T h us, it is c o nsi dere d a n o n-
si g nifica nt ris k de vice.  
T here are ps yc h ol o gical ris ks ass ociate d wit h recei vi n g a n a b n or mal test res ult 
fr o m self-sa m pli n g. Partici pa nts ma y i nter pret a n a b n or mal res ult as a dia g n osis 
of ca ncer rat her t ha n a n i nfecti o n wit h H P V. T he partici pa nt ma y feel h o peless i n 
res p o nse t o a n a b n or mal res ult, belie vi n g t hat t here is n ot hi n g t hat ca n hel p. As a 
me m ber of a n u n derser ve d gr o u p s he ma y feel t hat a de q uate healt h ser vices are 
n ot a vaila ble or accessi ble t o her. S he ma y als o feel g uilt y t hat s he has d o ne 
s o met hi n g wr o n g or s o me o ne has wis he d ill healt h u p o n her. S he ma y feel 
e m barrasse d t o tell her frie n ds, fa mil y, a n d ot her o nes, fearf ul of h o w t he y ma y 
j u d ge her a n d reflect u p o n her dia g n osis. 
If t he partici pa nt deci des t hat t he y d o n ot wis h t o partici pate i n t he stu d y after it 
has starte d, t he y will be a d vise d t o tell t he C o -I or l ocal st u d y c o or di nat or. T he y 
will be a d vise d t hat t here is n o pe nalt y i m p ose d if t he y deci de t o e n d t heir 
partici pati o n earl y a n d/ or ref use t o a ns wer a n y q uesti o n.  
A d verse E x perie nce Re p o rti n g: If a n y partici pa nt w h o c h o oses t o use t he H P V 
self-sa m pler i n dicates t o t he l ocal st u d y c o or di nat or or C o-I t hat a disc o mf ort is 
persiste nt or s o met hi n g else has occ urre d, t he C o -I s h o ul d c o ntact directl y t he 
Pri nci pal I n vesti gat or a n d o versi g ht c o m mittee of t he st u d y. Partici pa nts w h o  
e x perie nce a n y a d verse effect or  st u d y-relate d i nj ur y will be na vi gate d t o 
a p pr o priate f oll o w - u p care wit h o ur c o m m u nit y part ners a n d/ or T he Mi nistr y of 
Healt h Ja maica i m me diatel y f or f oll o w- u p care.  
 
1 6)  P ote nti al Be nefits t o S u bjects *  
A p ote ntial be nefit f or all partici pa nts is t he o p p ort u nit y t o be scree ne d. T here are 
n o ot her direct be nefits t o partici pa nts fr o m ta ki n g part i n t he st u d y. 

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1 7)   V ul ner a ble P o p ul ati o ns *  
T his researc h d oes n ot i n v ol ve i n di vi d uals w h o are v ul nera ble t o c oerci o n or 
u n d ue i nfl ue nce or v ul nera ble p o p ulati o ns. 
1 8)  M ulti -Site Rese arc h *  
N/ A  
 
1 9)  C o m m u nit y -B ase d P artici p at or y Rese arc h *  
T his pr oject s hares s o me ele me nts of c o m m u nit y -e n ga ge d researc h.  
Firstl y, t he c o m m u nit y will be i n v ol ve d i n t he c o n d uct of t he st u d y as 
partici pa nts, t o i m pr o ve t h e utilizati o n of l ocal k n o wle d ge i n t he 
de vel o p me nt of a n effecti ve i nter ve nti o n or pr o gra m at a nati o nal le vel. 
Sec o n dl y, we will c olla b orate wit h l ocal i nstit uti o ns t o pla n t he researc h  
pr oject a n d f or assista nce i n t he recr uit me nt of partici pa nts.  
2 0)  S h ari n g of Res ults wit h S u bjects *  
After partici pa nts ret ur n t heir tests b y mail ( or d o n ot), res ults will be a nal yze d 
wit hi n 6 wee ks a n d se nt t o t he l ocal st u d y c o or di nat or, w h o will call partici pa nts 
t o gi ve t he res ults of t heir tests. T h ose w h o d o n ot ret ur n t heir kit will als o be 
calle d. All w o me n w h o test p ositi ve f or hi g h- ris k H P V will recei ve i nf or mati o n 
o n f oll o w- u p pr oce d ures, w hic h will be a vaila ble at l ocal healt h facilities.  
I n a d diti o n t o disse mi nati n g o ur fi n di n gs t hr o u g h j o ur nals, c o nfere nces, a n d ot her 
sta n dar d aca de mic c ha n nels, o ur c o m m u nit y part ners will o versee t he 
disse mi nati o n of researc h fi n di n gs wit hi n o ur tar get c o m m u nities.  
2 1)  Setti n g  
T he C o -I/l ocal st u d y i n vesti gat or will i de ntif y a n d recr uit p ote ntial s u bjects at 
vari o us c o m m u nit y ve n ues or N G Os (s uc h as t he Ja maica Ca ncer S ociet y) t hat 
t he y dee m a p pr o priate a n d at w hic h w o me n te n d t o c o n gre gate.  T hese ma y 
i ncl u de, b ut are n ot li mited t o: c h urc hes, healt h cli nics, mar kets healt h fairs a n d 
ot her e ve nts. Paris hes t hat ha ve bee n i de ntifie d as l o w -scree ni n g areas will be 
tar gete d. A d diti o nall y, partici pa nts will be as ke d t o refer ot hers t o t he st u d y b y 
pr o vi di n g t he na mes a n d p h o ne n u m bers of u p t o t hree a d diti o nal w o me n.  
I nter vie ws will be c o n d ucte d at a l ocati o n c o n ve nie nt f or t he partici pa nt or i n a 
pri vate l ocati o n t o be i de ntifie d (e. g. Ja maica Ca ncer S ociet y office). 
2 2)  Res o urces A v ail a ble  
 
● S or o ya J ulia n Mc Farla ne, P h D Ca n di date,  C o- I n vesti gat or,  Sc h o ol of 
C o m m u nicati o n, U ni versit y of Mia mi. S or o ya will be res p o nsi ble f or all 
as pects of t he researc h i m ple me ntati o n, i ncl u di n g: data c ollecti o n a n d/ or 
ma na ge me nt, st u d y c o or di nati o n, data a nal ysis a n d/ or statistics, partici pa nt 
scree ni n g/recr uit me nt, s ocial a n d/ or be ha vi oral assess me nt, i nter vie ws. 

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Mc Farla ne’s aca de mic a n d pr ofessi o nal e x perie nce has bee n s pecificall y f oc use d 
o n healt h c o m m u nicati o n f or healt h dis parit y p o p ulati o ns i n Lati n A merica a n d 
t he Cari b bea n. S he has a Bac hel or’s de gree i n Me dia a n d C o m m u nicati o n 
( U ni versit y of t he West I n dies, Ja maica), wit h a s pecializati o n i n S ocial 
Mar keti n g. Her Master’s de gree is i n P u blic Healt h: Healt h Pr o m oti o n ( Lee ds 
Metr o p olita n U ni versit y, U nite d Ki n g d o m). F or t he past 8 years s he has w or ke d 
as a C o m m u nicati o ns S pecialist i n p u blic healt h i ncl u di n g t o pics relate d t o se x ual 
a n d re pr o d ucti ve healt h, mater nal healt h a n d HI V/ AI D S. S he has w or ke d i n 
Ja maica wit h i nter nati o nal, g o ver n me ntal a n d n o n- g o ver n me ntal or ga nizati o ns 
t here. S he is kee n o n pr o perl y u n dersta n di n g tar get a u die nces i n or der t o de vel o p 
e vi de nce base d, c ult urall y a p pr o priate ca m pai g ns a n d e val uati o n i nstr u me nts t o 
i m ple me nt effecti ve i nter ve nti o ns at differe nt le vels. 
 
P h D C o m mittee:  
 
● S usa n E. M or ga n, P h D,  A d vis or of C o -I, P h D C o m mittee C hair,  
Ass ociate Pr o v ost f or Researc h De vel o p me nt a n d Strate g y, Pr ofess or, 
De part me nt of C o m m u ni cati o n St u dies , U ni versit y of Mia mi  
se m or ga n @ mia mi.e d u  
 
As Ass ociate Pr o v ost f or Researc h a n d as a Pr ofess or i n t he de part me nt of 
C o m m u nicati o n St u dies at t he U ni versit y of Mia mi, Dr. M or ga n has c o nsi dera ble 
e x pertise i n c o n d ucti n g researc h o n messa ge desi g n i n healt h c o m m u nicati o n 
ca m pai g ns f or s pecific a u die nces. I ha ve a str o n g trac k -rec or d of sc h olarl y 
pr o d ucti vit y a n d o ver $ 9 mill i o n i n fe derall y-f u n de d gra nts t hat ha ve le d t o 
i m pactf ul fi n di n gs. M y pre vi o us researc h has f oc use d o n t he de vel o p me nt of 
effecti ve healt h be ha vi or c ha n ge messa ges i n t he area of or ga n d o nati o n. T his 
w or k has de m o nstrate d c o nsiste nt a n d si g nifica nt p o p ula ti o n effects as a res ult of 
t hese t he or y-base d ca m pai g ns. M y c urre nt, de vel o pi n g area of researc h i n ca ncer 
c o m m u nicati o n i ncl u des a f oc us o n creati n g i nf or mati o n a b o ut cli nical trials t hat 
is easil y accessi ble a n d u n derst o o d b y li mite d literac y a u die nces, as well as 
c o m m u nicati o n pr ot oc ols t hat ca n be use d b y me dical pr ofessi o nals a n d researc h 
st u d y staff w he n recr uiti n g p ote ntial partici pa nts f or cli nical trials a n d researc h 
st u dies. 
 
● Wa n hsi u Tsai, P h. D, Ass ociate Pr ofess or, Sc h o ol of 
C o m m u nicati o n, U ni versit y of Mia mi, wa n hsi u @ mia mi.e d u   
●  Nic k Carci o p p ol o, Assista nt Pr ofess or, Sc h o ol of C o m m u nicati o n, 
U ni versit y of Mia mi n.carci o p p ol o @ mia mi.e d u  
● Matt he w Sc hl u m brec ht, M D, M P H, F A C O G, Ass ociate Direct or 
f or t he G y nec ol o gic O nc ol o g y Fell o ws hi p a n d t he C o-Di rect or of 
Ca ncer C o ntr ol a n d Pre ve nti o n f or G y nec ol o gic O nc ol o g y wit hi n 
t he S yl vester C o m pre he nsi ve Ca ncer Ce nter, , U ni versit y of Mia mi 

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msc hl u m brec ht @ mia mi.e d u    
 
A d diti o nal o versi g ht:  
 
● Eri n K o betz, P h. D., M. P. H., Se ni or Ass ociate Dea n f or Healt h 
Dis parities, Ass ociate Direct or, P o p ulati o n Scie nces a n d Ca ncer 
Dis parit y, U M S yl vester, U ni versit y of Mia mi 
e k o betz @ me d. mia mi.e d u      
●  Eliza bet h U n ger, P h D, M D, C hief of t he C hr o nic Viral Diseases 
Bra nc h. Ce nters f or Disease C o ntr ol a n d Pre ve nti o n ( C D C), 
Atla nta, G A er u 0 @c dc. g o v    
● Ka y Rattra y, Rattra y, M B B S, D M ( O & G), F R C O G, F A C O G, 
Hea d of De part me nt, De part me nt of O bstetrics & G y naec ol o g y, 
T he U ni versit y of t he West I n dies, M o na Ca m p us, Ja maica 
ka y.rattra y @ g mail.c o m  
 
 T his pr oject ma y utilize a st u d y c o or di nat or w h o is i n di ge n o us t o Ja maica t o 
recr uit partici pa nts, t o c ollect, st ore a n d s hi p ret ur ne d self-sa m ples, a n d t o 
disse mi nate res ults. T he l ocal st u d y c o or di nat or will ha ve pers o nal c o n necti o ns 
a n d c ult ural c o m pete ncies wit hi n t he Ja maica n c o nte xt, a n d will be fa miliar wit h 
t he n or ms a n d n ua nces ass ociate d wit h disc ussi n g se nsiti ve t o pics li ke se x ual a n d 
re pr o d ucti ve healt h a n d c ollecti n g sa m ples, a n d ca n a p pr oac h t he w or k fr o m a 
place of u n dersta n di n g a n d k n o wle d ge. A d diti o nall y, t he l ocal c o or di nat or will be 
certifie d t o c o n d uct researc h b y t he U M I nstit uti o nal Re vie w B oar d (I R B).  
 
Fi nall y, t he pr oject i n v ol ves c olla b orati o n wit h l ocal part ners. We ma y w or k wit h 
t he Ja maica Ca ncer S ociet y a n d t he U ni versit y of t he West I n dies De part me nt f or 
G y naec ol o g y t o e ns ure t hat i nter ve nti o ns are a p pr o priate f or t he l ocal c o nte xt. 
 
 
2 3)  Pri or A p pr o v als  
 
T he st u d y will als o gai n et hical a p pr o val fr o m t he Mi nistr y of Healt h Ja maica Et hics 
C o m mittee.  
 
2 4)  Recr uit me nt Met h o ds  
I nter vie w partici pa nts will be recr uite d t hr o u g h p ur p osi ve sa m pli n g fr o m a pri or f oc us 
gr o u p st u d y (I R B # 2 0 1 7 0 8 0 2). T he C O- I/c o m m u nit y v ol u nteer will place a f oll o w u p call 
t o eac h i de ntifie d i nter vie w partici pa nt t o re mi n d t he m a b o ut t he u pc o mi n g meeti n g.  
 
Recr uit me nt f or t he self -sa m pler i nter ve nti o n  will occ ur i n t hree i de ntifie d l o w -scree ni n g 
re gi o ns i n Ja maica ( usi n g nati o nal statistical data o n scree ni n g rates per paris h i n 
Ja maica). Recr uit me nt will ta ke place t hr o u g h l ocal c o m m u nit y or ga nizati o ns s uc h as 
c h urc hes as well as at c o m m u nit y e ve nts s uc h as healt h fairs, vari o us c o m m u nit y ve n ues, 
i ncl u di n g la u n dr o mats, healt h cli nics, a n d flea mar kets. A des k ma y be set u p at a n e ve nt 

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wit h a recr uit me nt p oster t o attract w o me n ( A p pe n di x I). Alter nati vel y, the C o -I/l ocal 
st u d y c o or di nat or will a p pr oac h p ote ntiall y -eli gi ble i n di vi d uals at c o m m u nit y ve n ues, 
i ntr o d uce t he msel ves, a n d e x plai n t heir r ole i n t he pr oject. T he C o -I/l ocal st u d y 
c o or di nat or will als o rel y hea vil y o n t heir o w n s ocial net w or ks a n d t h ose of t he 
c o m m u nit y lea ders, t o i de ntif y p ote ntia ll y eli gi ble partici pa nts. Fr o m t his i nitial 
c o n ve nie nce sa m ple of partici pa nts recr uite d at c o m m u nit y l ocati o ns, t he y will re q uest 
referrals ( na mes a n d p h o ne n u m bers) f or p ote ntiall y eli gi ble partici pa nts. T h us, t he 
sa m pli n g strate g y f or o ur st u d y ma y als o be descri be d as s n o w ball sa m pli n g. We will 
st o p recr uiti n g after 3 5 0 eli gi ble  w o me n  ha ve bee n c o nse nte d a n d e nr olle d. Part neri n g 
or ga nizati o ns a n d N G Os me m bers ma y  als o pr o m ote o ur researc h a ge n da t hr o u g h 
c ult urall y-a p pr o priate c o m m u nicati o n c ha n nels, s uc h as ra di o a n d w or d of m o ut h, a n d 
ca n hel p ge nerate c o m m u nit y i nterest i n, a n d s u p p ort f or t he pr o p ose d researc h. 
 
2 5)  L oc al N u m ber of S u bjects  
A mi ni m u m of 3 5 0 t otal s u bjects is e x pecte d t o be accr ue d l ocall y.  
2 6)  C o nfi de nti alit y  
M ulti ple ste ps will be ta ke n t o g uara ntee c o nfi de ntialit y. All pa per -base d s ur ve ys 
a n d f or ms will be e ntere d a n d u pl oa de d usi n g R E D Ca p. All R E D Ca p data is 
sec urel y h oste d b y t he U ni versit y of Mia mi’s I T De part me nt.  
Researc h I T a d mi nisters pr oject creati o n , user acc o u nt ma na ge me nt, a n d 
m o ve me nt of pr ojects fr o m de vel o p me nt t o pr o d ucti o n. A ut he nticati o n is 
perf or me d via Ca neI D A ut he nticati o n Ser vice ( C A S), t he sa me i nstit uti o n -wi de 
s yste m use d f or a variet y of a p plicati o ns s uc h as m y U M. 
 
A n y electr o nic data will be st ore d i n pass w or d -pr otecte d files t hat o nl y t he PI -I, 
C o -I a n d st u d y staff will be a ble t o access. T here are m ulti ple le vels of sec urit y 
o nce place d o n t he l ocal net w or k. Pa per c o pies will si milarl y be st ore d i n a l oc ke d 
file dra wer t hat o nl y st u dy staff will be a ble t o access.  
 
All st u d y pers o n nel will be certifie d t o c o n d uct h u ma n s u bjects’ researc h b y t he 
U ni versit y of Mia mi I nstit uti o nal Re vie w B oar d.  
 
T he st u d y i n vesti gat ors a n d t heir staff will c o nsi der all rec or ds c o nfi de ntial t o t he 
e xte nt per mitte d b y la w. T he U. S. De part me nt of Healt h a n d H u ma n Ser vices 
( D H H S) ma y re q uest t o re vie w a n d o btai n c o pies of a n y rec or ds. Rec or ds ma y 
als o be re vie we d f or a u dit p ur p oses b y a ut h orize d U ni versit y e m pl o yees or ot her 
a ge nts w h o are b o u n d b y t he pr o visi o ns of c o nfi de ntialit y. 
 
2 7)  Pr o visi o ns t o Pr otect t he Pri v ac y I nterests of S u bjects  
Partici pa nts will be i nf or me d t hat t he y d o n ot ha ve t o a ns wer a q uesti o n if t he y d o 
n ot wa nt t o. T he y are als o all o we d t o wit h dra w fr o m t he st u d y at a n y m o me nt. All 
c orres p o n de nce wit h partici pa nts will be b y direct c o ntact. All electr o nic s ur ve ys 

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a n d f or ms will be e ntere d a n d u pl oa de d usi n g Researc h Electr o nic Data Ca pt ure 
( R E D Ca p), w hic h is sec urel y h oste d b y t he U ni versit y of Mia mi’s I T De part me nt. 
T o pr otect t he st u d y’s s u bjects’ pri vac y i nterests, i nter vie ws wit h partici pa nts will 
ta ke place i n a l ocati o n t hat offers e n o u g h pri vac y, s o t hat t he y d o n ot ha ve t o 
w orr y a b o ut bei n g see n e nteri n g a place t hat t he y feel mi g ht sti g matize t he m, or 
a b o ut bei n g o ver hear d w he n a ns weri n g se nsiti ve q uesti o ns or disc ussi n g pri vate 
me dical i nf or mati o n wit h ot her t ha n t heir p h ysicia ns or g y nec ol o gists. T o ma ke 
t he partici pa nts m ore c o mf orta ble wit h t he researc h, t he data c ollecti o n will be 
li mite d t o o nl y t he mi ni m u m a m o u nt of i nf or mati on necessar y t o acc o m plis h t he 
st u d y’s p ur p oses. M ore o ver, t he q uesti o ns will be as ke d b y fe male researc hers t o 
ma ke t he s u bjects feel at ease wit h t he sit uati o n.  
 
2 8)  C o m pe ns ati o n f or Rese arc h -Rel ate d I nj ur y  
All researc h i n v ol ves a ris k of researc h -relate d har m t o partici pa nts. W hile we d o 
n ot e x pect a n y p h ysical i nj ur y relate d t o t his st u d y, we ma y e nc o u nter 
ps yc h ol o gical, s ocial or ec o n o mic ris ks, i n s pite of all safet y meas ures. If s uc h 
pr o ble ms occ ur, t he researc hers will refer partici pa nts t o t he res o urces of t he 
Mi nistr y of Healt h f or f urt her care a n d atte nti o n. T he U ni versit y of Mia mi has n ot 
set asi de f u n ds t o pa y f or a n y s uc h reacti o ns, or f or a n y relate d care. 
2 9)  Ec o n o mic B ur de n t o S u bjects  
T he s u bjects ma y be res p o nsi ble f or t he l ocal tra ns p ortati o n e x pe nses relate d t o 
arri vi n g t o t he researc h l ocati o ns. Refres h me nts will be pr o vi de d f or t he f oc us 
gr o u p partici pa nts. 
3 0)  C o nse nt Pr ocess  
Writte n I nf or me d c o nse nt will be o btai ne d b y t he C o- I/l ocal st u d y c o or di nat or 
after pre-scree ni n g. C o nse nt will be o btai ne d i n a pri vate area fr o m i n di vi d uals 
w h o are eli gi ble a n d a gree t o partici pate after t he C o -I/l ocal st u d y c o or di nat or 
descri bes t he st u d y. P ote ntial partici pa nts will be t ol d t hat we are c o n d ucti n g a 
researc h st u d y t o u n dersta n d h o w i n n o vati o ns li ke a n h pv self -sa m pli n g t o ol 
w o ul d be acce pte d b y y o u a n d i n y o ur c o m m u nit y.  
Partici pa nts are gi ve n t he o p p ort u nit y t o o pt o ut of selecte d st u d y pr oce d ures. 
I nf or me d c o nse nt will be pr o vi de d i n E n glis h. 
A wai ver of si g ne d c o nse nt is re q ueste d f or scree ni n g acti vi ties. T his researc h 
prese nts n o m ore t ha n mi ni mal ris k of har m t o s u bjects a n d i n v ol ves n o 
pr oce d ures f or w hic h writte n c o nse nt is n or mall y re q uire d o utsi de of t he researc h 
c o nte xt. 

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3 1)  Pr ocess t o D oc u me nt C o nse nt i n Writi n g  
 
We will be f oll o wi n g t he S O P H R P -0 9 0 I nf or me d C o nse nt Pr ocess f or Researc h w he n 
o btai ni n g c o nse nt.