Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa
Phase: NA
Conditions: HIV/AIDS
Sponsor: Johns Hopkins University

 
 
 
 
 
 
 
H o m e li n k
H o m e li n k : : 
P ost h os pit al c ar e t o r e d uc e HI V m ort alit y i n S o ut h Afric a
P ost h os pit al c ar e t o r e d uc e HI V m ort alit y i n S o ut h Afric a  
 
 
 
 
 
S h ort titl e:
S h ort titl e:  H o m e  Li nk 
Pr ot oc ol v ersi o n: 
Pr ot oc ol v ersi o n: 6 . 0 d at e d 0 3 A u g ust  2 0 2 2  
F u n d er:
F u n d er:  N ati o n al I nstit ut e of M e nt al H e alt h, U S A ( Gr a nt # 1 R 3 4 M H 1 1 8 9 9 8 ) 
I m pl e m e nti n g P art n er:
I m pl e m e nti n g P art n er: P H R U , S o ut h Afric a 
Pri nci p al I n v esti g at ors
Pri nci p al I n v esti g at ors : C hrist o p h er H off m a n n 
S o ut h Afric a n Pri nci p al I n v esti g at or
S o ut h Afric a n Pri nci p al I n v esti g at or : N eil M arti ns o n 
N C T 0 4 4 3 6 2 8 9  
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2  of 3 3  
 
St at e m e nt of C o m pli a nc e
St at e m e nt of C o m pli a nc e  
T h e st u d y will b e c arri e d o ut i n acc or d a nc e wit h t h e d esi g n a n d s p ecific pr o visi o ns of t his 
T h e st u d y will b e c arri e d o ut i n acc or d a nc e wit h t h e d esi g n a n d s p ecific pr o visi o ns of t his 
H u m a n s u bj ects et hics
H u m a n s u bj ects et hics -a p pr o v e d pr ot oc ol, wit h t h e et hic al pri nci pl es t h at ar e c o nsist e nt 
a p pr o v e d pr ot oc ol, wit h t h e et hic al pri nci pl es t h at ar e c o nsist e nt 
wit h G o o d Cli nic al Pr actic e ( G C P) a n d t h e a p plic a bl e r e g ul at or y r e q uir e m e nts b y t h e 
f oll o wi n g:
wit h G o o d Cli nic al Pr actic e ( G C P) a n d t h e a p plic a bl e r e g ul at or y r e q uir e m e nts b y t h e 
f oll o wi n g: 
•  
D ecl ar ati o n of H elsi nki  
•  
I C H G C P E 6 
•  
C o m pl eti o n of H u m a n S u bj ects Pr ot ecti o n Tr ai ni n g  
T h e Pri nci p al I nv esti g at or will ass ur e t h at n o d evi ati o n fr o m, or c h a n g es t o, t h e pr ot oc ol will t ak e 
pl ac e wit h o ut pri or a gr e e m e nt fr o m t h e s p o ns or a n d d oc u m e nt e d a p pr ov al fr o m t h e H u m a n 
R es e arc h Et hics C o m mitt e e , exc e pt w h er e n ec ess ary t o eli mi n at e a n i m m e di at e h az ar d(s) t o t h e 
tri al p artici p a nts. T h e Pri nci p al I nv esti g at or will pr o m ptly r e p ort t o H u m a n R es e arc h Et hics 
C o m mitt e e  a ny c h a n g es i n r es e arc h activity a n d all u n a ntici p at e d pr o bl e ms i nv olvi n g risk t o 
h u m a n s u bj ects or ot h ers.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 3  of 3 3  
 
 
S T U D Y S U M M A R Y
S T U D Y S U M M A R Y  
B ac k gr o u n d
B ac k gr o u n d : T his is a pil ot r a n d o miz e d cli nic al tri al ( R C T) t o d e m o nstr at e t h e f e asi bility a n d 
acc e pt a bility of a str uct ur al a n d b e h avi or al i nt erv e nti o n t o r e d uc e m ort ality f oll o wi n g h os pit al 
disc h ar g e f or p e o pl e wit h HI V ( P W H)  i n S o ut h Afric a. O ur pri or st u dy s h o w e d t h at a m o n g 1 2 1 
P W H disc h ar g e d, 5 4 % w er e r e a d mitt e d a n d 2 6 % h a d di e d by six m o nt hs f oll o wi n g disc h ar g e. I n 
t he pri or st u dy , w e i d e ntifi e d t h at missi n g cli nic visits aft er disc h ar g e w as  ass oci at e d wit h d e at h.  
H er e w e ar e s e eki n g t o ov erc o m e k ey b arri ers i n pil oti n g a h o m e -b as e d p ost -h os pit al c ar e 
i nt erv e nti o n. O ur a p pr o ac h is i nf or m e d by a c o nc e pt u al m o d el of k ey b arri ers t o t h e c ar e 
tr a nsiti o n al o n g wit h a b e h avi or al ex pl a n at ory m o d el, t h e B e h avi or al M o d el f or V ul n er a bl e 
P o p ul ati o ns.  
T h e ov er arc hi n g g o al of t his st u dy is t o t ail or a n d pil ot t h e i nt erv e nti o n t h at s hifts i niti al p ost-
disc h ar g e c ar e fr o m t h e o ut -p ati e nt cli nic t o t h e h o m e a n d pr ovi d es  p ati e nt -c e nt er e d c o u ns eli n g 
( H o m e Li nk i nt erv e nti o n). F or t h e i nt erv e nti o n t o pr ov e eff ectiv e it will n e e d t o s u bst a nti ally 
r e d uc e p ost-disc h ar g e m ort ality. S p ecific ally, i n t h e H o m e Li nk i nt erv e nti o n, a t e a m will c o n d uct 
h o m e visits t o ( 1) pr ovi d e a str uct ur e d cli nic al ass ess m e nt; ( 2) r ec o ncil e m e dic ati o ns, ( 3) pr ovi d e 
psyc h os oci al s u p p ort t hr o u g h p ati e nt -c e nt er e d c o u ns eli n g, a n d ( 4) ass ess h o m e n e e ds (f o o d 
s ec urity). T h es e visits will st art o n e w e ek aft er disc h ar g e a n d b e r e p e at e d ev ery t w o w e eks u ntil 
t h e p artici p a nt is st a biliz e d a n d r e a dy t o i niti at e l o w er i nt e nsity cli nic-b as e d s ervic es or t hr e e 
m o nt hs h av e el a ps e d.   
 
Ai ms
Ai ms : : T h e ai ms of t h e st u dy ar e t o pil ot a r a n d o miz e d cli nic al tri al of h o m e d eliv ery of h e alt h 
s ervic es d uri n g t h e p ost-h os pit al p eri o d f or P W H.  
 
M et h o ds
M et h o ds : T his pr oj ect is  a pil ot r a n d o miz e d cli nic al tri al ( R C T) t o r efi n e a n d t est t h e f e asi bility, 
acc e pt a bility, a n d pr eli mi n ary eff ectiv e n ess of t h e H o m eLi nk i nt erv e nti o n . At t h e c o ncl usi o n of 
t h e R 3 4 gr a nt p eri o d w e will h av e a pr ot oc ol a n d pr oc e d ur al m a n u al r e a dy f or a f ull R C T 
p o w er e d f or eff ectiv e n ess.  
 
Si g nific a nc e
Si g nific a nc e : T h e pr o p os e d st u dy is c o nsist e nt wit h NI H HI V/ AI D S hi g h est pri ority r es e arc h a n d 
t h e S o ut h Afric a n N ati o n al Str at e gic Pl a n o n HI V, T B, a n d S TIs 2 0 1 7-2 0 2 2. T h e r es e arc h a d dr ess es 
t h e HI V/ AI D S R es e arc h Pri ority of “r et e nti o n a n d e n g a g e m e nt i n t h es e s ervic es, a n d ac hi ev e m e nt 
a n d m ai nt e n a nc e of o pti m al pr ev e nti o n a n d tr e at m e nt r es p o ns es .”  
 
 
 
 
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 4  of 3 3  
 
K e y P ers o n n el
K e y P ers o n n el  
 
 
 
N a m e
N a m e  
R es p o nsi bilit y
R es p o nsi bilit y  
C o nt act
C o nt act  
P H R U
P H R U  
N eil M arti ns o n  
Sit e Pri nci p al i n v esti g at or 
Sit e Pri nci p al i n v esti g at or  
 
Pr oj ect m a n a g e m e nt, st ak e h ol d er 
e n g a g e m e nt, diss e mi n ati o n a n d 
m a n uscri pt pr e p ar ati o n.  
P h o n e:  + 2 7 1 1  9 8 9  9 8 3 8  
 
E m ail:  m arti ns o n @ p hr u.c o.z a  
E br a hi m V ari av a  
C o
C o -I n v esti g at or
I n v esti g at or 
 
Pr oj ect m a n a g e m e nt a n d cli nic al 
ov ersi g ht  
P h o n e :  + 2 7 0 8 4 -3 0 2 -6 0 5 9  
 
E m ail:  v ari av a @ w orl d o nli n e.c o.z a > 
J O H N S H O P KI N S U NI V E R SI T Y
J O H N S H O P KI N S U NI V E R SI T Y 
C hrist o p h er H off m a n n 
Pri nci p al I n v esti g at or
Pri nci p al I n v esti g at or  
 
D ev el o pi n g pr oc e d ur es,  pr ot oc ol,  
p r oj ect m a n a g e m e nt, st ak e h ol d er 
e n g a g e m e nt, diss e mi n ati o n a n d 
m a n uscri pt pr e p ar ati o n.  
P h o n e: + 1 ( 4 1 0) 6 1 4 -4 2 5 7   
M o bil e: + 1 ( 4 4 3) 6 0 2-2 2 1 0  
E m ail: c h off m a n n @j h mi. e d u 
J o n at h a n G ol u b 
C o
C o -I n v esti g at or
I n v esti g at or 
R es p o nsi bl e f or c o ntri b uti o n t o 
d esi g n a n d a n alysis  of R C T 
c o m p o n e nts. 
P h o n e:  + 1  
E m ail:  j g ol u b @j h mi. e d u 
K at e S h e ar er  
R es e arc h
R es e arc h  M a n a g er
M a n a g er  
St u dy d esi g n, pr ot oc ol writi n g, 
st u dy m a n a g e m e nt, st u dy 
i m pl e m e nt ati o n a n d ov ersi g ht.  
P h o n e: + 2 7 6 0 -8 7 6 -0 1 9 2  
E m ail: ks h e ar e 5 @j h u. e d u  
 
 
 
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 5  of 3 3  
 
 
C o nt e nts
C o nt e nts  
 
St at e m e nt of C o m pli a nc e
St at e m e nt of C o m pli a nc e  ................................................................................................................
................................................................................................................ 2 2  
1  
I N T R O D U C TI O N
I N T R O D U C TI O N .......................................................................................................................
....................................................................................................................... 8 8  
1. 1  
B ack gr o u n d  .......................................................................................................................... 8  
1. 2  
St u dy o bj ectiv es  ................................................................................................................ 1 0  
1. 3  
Si g nific a nc e  ........................................................................................................................ 1 0  
2  
M E T H O D S
M E T H O D S  .............................................................................................................................
............................................................................................................................. 1 0
1 0  
2. 1  
St u dy d esi g n  ...................................................................................................................... 1 0  
2. 2  
St u dy s etti n g  ...................................................................................................................... 1 1  
2. 2. 1  
Ts h e p o n g H os pit al  
1 1  
2. 2. 2  
D escri pti o n of t h e g e o gr a p hic al ar e as of st u dy i m pl e m e nt ati o n  
1 1  
2. 2. 3  
R ati o n al e f or s el ecti n g g e o gr a p hic al ar e as of st u dy i m pl e m e nt ati o n  
1 1  
2. 3  
St u dy P o p ul ati o n  ............................................................................................................... 1 1  
2. 3. 1  
I ncl usi o n crit eri a 
1 2  
2. 3. 2  
Excl usi o n crit eri a  
1 2  
2. 4  
S a m pli n g sc h e m e  .............................................................................................................. 1 2  
2. 4. 1  
P artici p a nt r ecr uit m e nt a n d i nf or m e d c o ns e nt  
1 2  
2. 4. 2  
R a n d o miz ati o n  
1 2  
2. 5  
Pr e -disc h ar g e st u dy pr oc e d ur es  ....................................................................................... 1 4  
2. 5. 1  
C ar e -as -us u al ( C A U) st u dy ar m  
1 4  
2. 5. 2  
H o m e Li nk st u dy ar m  
1 4  
2. 6  
V erific ati o n of h os pit al disc h ar g e d at e  ............................................................................. 1 5  
2. 7  
P ost -disc h ar g e f oll o w -u p  .................................................................................................. 1 5  
2. 7. 1  
C ar e v erific ati o n  
1 6  
2. 7. 2  
M ort ality  
1 6  
2. 7. 3  
Eff ectiv e n ess of H o m e Li nk  
1 7  
2. 7. 4  
Acc e pt a bility & F e asi bility  
1 7  
F or P W H: ≥1 HI V c ar e visit
F or P W H: ≥1 HI V c ar e visit  .............................................................................................................
............................................................................................................. 1 8
1 8  
S a m pli n g:  
2 1  
2. 8  
A n alysis  .............................................................................................................................. 2 1  
3  
D at a M a n a g e m e nt
D at a M a n a g e m e nt  ................................................................................................................
................................................................................................................ 2 2
2 2  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 6  of 3 3  
 
3. 1  
D at a c oll ecti o n t o ols  ......................................................................................................... 2 2  
3. 2  
St u dy s a m pl e siz e j ustific ati o n  .......................................................................................... 2 4  
3. 3  
Sc h e d ul e of c as e r e p ort f or ms  .......................................................................................... 2 4  
3. 4  
D at a b as e  ............................................................................................................................ 2 5  
3. 4. 1  
Str uct ur e of t h e d at a b as e  
2 5  
3. 4. 2  
D at a b as e acc ess  
2 6  
3. 4. 3  
L oc ki n g of fi n al d at a b as e 
2 6  
3. 4. 4  
D at a s ec urit y  
2 6  
3. 4. 5  
St u d y li mit ati o ns  
2 6  
4  
A p pr o pri at e c ar e i n r es p o ns e t o st u d y
A p pr o pri at e c ar e i n r es p o ns e t o st u d y -s p ecific fi n di n gs
s p ecific fi n di n gs .......................................................
....................................................... 2 7
2 7  
5  
Pr ot ecti o n of h u m a n p artici p a nts
Pr ot ecti o n of h u m a n p artici p a nts  .........................................................................................
......................................................................................... 2 7
2 7  
5. 1  
R e g ul at ory a p pr ov als  ........................................................................................................ 2 7  
5. 2  
Risks a n d b e n efits  .............................................................................................................. 2 7  
5. 3  
Cli nic al tri als r e gistr ati o n  .................................................................................................. 2 9  
5. 4  
C o nfi d e nti ality  ................................................................................................................... 2 9  
5. 5  
D at a s af ety a n d m o nit ori n g  .............................................................................................. 2 9  
6  
Pr oj ect G o v er n a nc e a n d M a n a g e m e nt
Pr oj ect G o v er n a nc e a n d M a n a g e m e nt  .................................................................................
................................................................................. 2 9
2 9  
6. 1  
R es e arc h t e a m  ................................................................................................................... 2 9  
6. 2  
P u blic ati o n p olicy  .............................................................................................................. 3 0  
6. 3  
P erf or m a nc e m o nit ori n g  ................................................................................................... 3 0  
7  
P artici p a nt r ei m b urs e m e nt
P artici p a nt r ei m b urs e m e nt  ...................................................................................................
................................................................................................... 3 0
3 0  
8  
F u n di n g
F u n di n g  ................................................................................................................................
................................................................................................................................. . 3 0
3 0  
9  
R ef er e nc es
R ef er e nc es  ............................................................................................................................
............................................................................................................................ 3 1
3 1  
 
 
 
 
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 7  of 3 3  
 
Gl oss ar y 
Gl oss ar y ofof  T er ms
T er ms  
AI D S  
 
Ac q uir e d I m m u n o -d efici e ncy Sy n dr o m e  
A R T  
 
A ntir etr ovir al T h er a py  
C A U  
 
C ar e as Us u al  
C B O  
 
C o m m u nity B as e d Or g a niz ati o n  
C C M D D  
C e ntr al C hr o nic M e dici n e Dis p e nsi n g a n d Distri b uti o n (syst e m or s ervic e)  
C R F  
 
C as e R e p ort F or m  
D O H  
 
S o ut h Afric a n D e p art m e nt of H e alt h  
HI V  
 
H u m a n I m m u n o d efici e ncy Vir us  
L T F U  
l oss t o f oll o w u p 
NI H  
 
N ati o n al I nstit ut es of H e alt h  
P H C  
 
Pri m ary H e alt h Cli nic  
P W H    
P e o pl e wit h  HI V  
PI S  
 
P artici p a nt I nf or m ati o n S h e et  
R C T  
 
R a n d o miz e d Cli nic al Tri al  
S A  
 
S o ut h Afric a  
S TI  
 
S ex u ally Tr a ns mitt e d Ill n ess es  
T B  
 
T u b erc ul osis  
W B O T   
W ar d -B as e d O utr e ac h T e a m  
 
List 
List ofof  T a bl es
T a bl es  
 
T a bl e 1. H o m e Li nk i nt erv e nti o n t e a m k ey m e m b ers  ..................................................................... 1 4  
T a bl e 2. Sc h e d ul e d visit wi n d o ws  .................................................................................................... 1 6  
T a bl e 3. Eff ectiv e n ess o utc o m es  ..................................................................................................... 1 7  
T a bl e 4. F e asi bility I n dic at ors  ........................................................................................................... 1 7  
T a bl e 5. M e as ur es a n d a n alysis f or f e asi bility, acc e pt a bility, a n d eff ects o n e n g a g e m e nt i n c ar e  1 9  
T a bl e 6. Eff ectiv e n ess o utc o m es  ..................................................................................................... 2 1  
T a bl e 7. M e as ur es a n d a n alysis f or f e asi bility, acc e pt a bility, a n d eff ects o n e n g a g e m e nt i n c ar e  2 1  
T a bl e 8. List of d at a c oll ecti o n t o ols a n d i nt e n d e d us e  ................................................................... 2 2  
T a bl e 9. P o w er by v aryi n g eff ect siz e o n r e d uci n g p ost -h os pit al m ort ality  .................................... 2 4  
T a bl e 1 0. Sc h e d ul e d st u dy visit wi n d o ws f or all p artici p a nts p ost -h os pit al  ................................... 2 4  
 
List 
List ofof  Fi g ur es
Fi g ur es  
 
Fi g ur e 1: Ts h e p o n g H os pit al & cli nics  .............................................................................................. 1 1  
Fi g ur e 2: Pr oj ect M a n a g e m e nt Str uct ur e  ........................................................................................ 3 0  
 
 
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 8  of 3 3  
 
1  I N T R O D U C TI O N
I N T R O D U C TI O N 
1. 1
1. 1  B ac k gr o u n d 
B ac k gr o u n d  
A. 3. S u b
A. 3. S u b -S a h ar a n Afric a HI V m ort alit y
S a h ar a n Afric a HI V m ort alit y  
I n 2 0 1 6 i n S o ut h Afric a a p pr oxi m at ely 1 5 4, 0 0 0 P W H di e d.1  Of t h es e d e at hs, 1 1 0, 0 0 0 h av e b e e n 
c h ar act eriz e d as exc ess m ort ality d u e t o HI V ( HI V ass oci at e d d e at hs). 2, 3 Ov er all, HI V -ass oci at e d 
d e at hs ar e ass oci at e d a dv a nc e d dis e as e d efi n e d by a l o w C D 4 c o u nt. 4 -6 
A. 4. I n
A. 4. I n -H os pit al a n d P ost
H os pit al a n d P ost -H os pit al M ort alit y i n Afric a
H os pit al M ort alit y i n Afric a  
I n p ati e nt m ort ality a m o n g p e o pl e wit h HI V ( P W H) i n Afric a is u nif or mly hi g h r a n gi n g fr o m 1 7. 2 t o 
2 9. 6 % acr oss t h e c o nti n e nt, i ncl u di n g i n S o ut h Afric a. 4 -6 F oll o wi n g disc h ar g e fr o m a n i n d ex 
h os pit aliz ati o n t h e m ort ality is als o hi g h. I n o ur pr eli mi n ary w ork w e h av e o bs erv e d a 2 6 % 
m ort ality i n t h e 6 m o nt hs aft er h os pit al disc h ar g e. T his o bs erv ati o n is c o nsist e nt wit h m ort ality 
fr o m ot h er r e p orts: 5 0 % m ort ality at t w elv e m o nt hs a n d 3 0 % a n d 3 1 % at six m o nt hs r e p ort e d 
fr o m T a nz a ni a, K e ny a, a n d S o ut h Afric a, r es p ectiv ely 7 ,8 
A. 5. T h e c o ntri b uti o n of P ost
A. 5. T h e c o ntri b uti o n of P ost -H os pit al M ort alit y t o O v er all D e at h a m o n g P e o pl e wit h HI V
H os pit al M ort alit y t o O v er all D e at h a m o n g P e o pl e wit h HI V  
I n S o ut h Afric a t h er e ar e a p pr oxi m at ely 8 4, 6 3 3 p u blic s ect or ac ut e c ar e h os pit al b e ds of w hic h 
a p pr oxi m at ely 2 5 % ar e a d ult m e dici n e b e ds. 9 By extr a p ol ati n g t h e p ost -disc h ar g e m ort ality w e 
o bs erv e d t o all disc h ar g es a m o n g P W H i n S o ut h Afric a w e c a n esti m at e t h e a n n u al m ort ality 
a m o n g P W H wit h a h os pit al disc h ar g e i n t h e p ast six m o nt hs.  C o nsi d eri n g t h e n ati o n al 
pr o p orti o n of all a d missi o ns t h at ar e f or P W H, t h e av er a g e l e n gt h of st ay, a n d t h e a n n u al 
r e a d missi o n r at e a n esti m at e d 2 4 0, 0 0 0 P W H ar e a d mitt e d t o m e dici n e w ar ds i n S o ut h Afric a 
a n n u ally. 1 0, 1 1 ,1 2, 1 3 A six -m o nt h p ost -h os pit al m ort ality of 2 6 % s u g g ests a t ot al of 6 2, 3 7 4 p ost -
h os pit al d e at hs a m o n g P W H. T his n u m b er of d e at hs r e pr es e nts 4 0 % of t h e a p pr oxi m at ely 
1 5 4, 0 0 0 t ot al a n n u al d e at hs a m o n g P W H i n S o ut h Afric a. 1, 2 A m o d est r e d ucti o n i n p ost -h os pit al 
d e at hs c o ul d s u bst a nti ally r e d uc e ov er all HI V m ort ality i n S o ut h Afric a.   
A. 6. C a us es of P ost
A. 6. C a us es of P ost -H os pit al D e at h
H os pit al D e at h  
S o m e p ost -h os pit al d e at hs m ay b e u n av oi d a bl e d u e t o a dv a nc e d or i nc ur a bl e dis e as e. Ot h er 
p ost -h os pit al d e at hs m ay b e av oi d a bl e wit h i m pr ov e d r et e nti o n i n c ar e. A st u dy fr o m 
J o h a n n es b ur g, S o ut h Afric a ass ess e d l oss fr o m c ar e f or HI V-T B c o -i nf ect e d p ati e nts; o nly 4 2 % of 
p ati e nts disc h ar g e d w er e k n o w n t o h av e b e e n t o a n HI V cli nic wit hi n 3 0 d ays of h os pit al 
disc h ar g e (t h e ti m e n e e d e d t o o bt ai n or r efill A R T pr escri pti o ns at t h e ti m e of t h e st u dy) 1 4 
Si mil arly i n o ur pr eli mi n ary st u dy, o nly 1 9 % of p artici p a nts att e n d e d a sc h e d ul e d f oll o w -u p visit. 
F ail ur e t o att e n d a sc h e d ul e d visit w as ass oci at e d wit h s u bs e q u e nt m ort ality i n o ur pr eli mi n ary 
st u dy a n d i n a r e p ort fr o m T a nz a ni a. 7 At pr es e nt, t h er e is li mit e d r es e arc h r e g ar di n g a p pr o ac h es 
t o r et ai ni n g P W H i n c ar e d uri n g t h e p ost-h os pit al tr a nsiti o n .4, 1 5 ,1 6   
A. 7. T h e H os pit al A d missi o n a n d R e
A. 7. T h e H os pit al A d missi o n a n d R e -a d missi o n C ost t o t h e M e dic al S yst e m
a d missi o n C ost t o t h e M e dic al S yst e m  
I n a d diti o n t o t h e h u m a n t oll of p ost-h os pit al m ort ality, t h er e is a s u bst a nti al c ost t o t h e h e alt h 
c ar e syst e m. T h e esti m at e d av er a g e c ost p er m e dic al a d missi o n i n S o ut h Afric a is U S D 1 4 2 6 
( U S D 3 6 4 p er d ay).1 7 R e d uci n g t h e fr e q u e ncy of r e a d missi o n a n d d e at h ( oft e n d uri n g 
r e a d missi o n) h as t h e p ot e nti al t o r e d uc e h e alt h syst e m c osts. A m o n g t h e 1 2 1 P W H w e o bs erv e d 
i n o ur pr eli mi n ary st u dy, 4 9 w er e r e a d mitt e d o nc e, 1 3 t wic e, a n d 2 t hr e e ti m es wit hi n six m o nt hs 
of d isc h ar g e f or a n esti m at e d h os pit al c ost of U S D 1 1 5, 5 0 6. I m pr ovi n g o ut p ati e nt e n g a g e m e nt i n 
c ar e m ay r e d uc e t his c ost.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 9  of 3 3  
 
A. 1 1. F act ors Ass oci at e d wit h Acc essi n g HI V C ar e i n Afric a
A. 1 1. F act ors Ass oci at e d wit h Acc essi n g HI V C ar e i n Afric a  
Alt h o u g h littl e h as b e e n d escri b e d r e g ar di n g e n g a g e m e nt i n c ar e f oll o wi n g h os pit aliz ati o n i n 
s o ut h er n Afric a, a gr e at d e al is k n o w n a b o ut f ail ur e t o li nk t o c ar e. St u dy t e a m m e m b ers a n d 
ot h er i nv esti g at ors i n t h e fi el d h av e i d e ntifi e d f act ors ass oci at e d wi t h li nk a g e t o c ar e a n d 
c o nti n u e d e n g a g e m e nt i n c ar e o n m ulti pl e s oci o -ec ol o gic al l ev els. 1 8, 1 9 O n a n i n divi d u al l ev el 
f e eli n g h e alt hy, n ot acc e pti n g a n HI V di a g n osis or all o p at hic c ar e, i nt er n aliz e d or a ntici p at e d 
sti g m a, f e ar, a n d f o o d i ns ec urity eit h er di mi nis h t h e p erc eiv e d v al u e of c ar e or i ncr e as e t h e 
p erc eiv e d c osts 1 9 -2 2 P ers o n al r esili e nc e a n d c o pi n g skills c a n r e d uc e s o m e of t h es e p ot e nti al 
c osts w hil e u n d erst a n di n g or r ec o g nizi n g t h e r ol e of A R T c a n i ncr e as e p erc e pti o ns of v al u e. O n 
a n i nt er p ers o n al l ev el, s oci al s u p p ort, acc e pt a nc e, a n d e nc o ur a g e m e nt of h e alt h s e eki n g  
b e h avi ors c a n c o ntri b ut e t o c ar e e n g a g e m e nt. Cli nic -l ev el c osts i ncl u di n g tr av el, n e e d f or r e p e at 
visits, l o n g w ait ti m es, n e e di n g t o arriv e v ery e arly i n t h e m or ni n g, e n act e d sti g m a, i n a dv ert e nt 
discl os ur e by att e n di n g a cli nic, a n d d e m e a ni n g b e h avi or fr o m h e alt h st aff ar e b arri ers t o c ar e 
e n g a g e m e nt. 2 3 -2 7S u p p ortiv e h e alt h c ar e w ork ers c a n i m pr ov e e n g a g e m e nt. Str e n gt hs -b as e d 
c o u ns eli n g a n d eli mi n ati n g str uct ur al b arri ers h av e h a d d e m o nstr at e d s ucc ess i n i ncr e asi n g 
li nk a g e t o c ar e.2 8 -3 3 F urt h er m or e, littl e is k n o w n a b o ut w h at i m p act, if a ny, C O VI D -1 9 h as h a d o n 
p ati e nt e n g a g e m e nt i n c ar e f oll o wi n g h os pit aliz ati o n.  
A. 8. H os pit al Tr a nsiti o n Pr o gr a ms i n Hi g h I nc o m e C o u ntri es
A. 8. H os pit al Tr a nsiti o n Pr o gr a ms i n Hi g h I nc o m e C o u ntri es . 
I n t h e a bs e nc e of h os pit al tr a nsiti o n i nt erv e nti o n st u di es fr o m s u b-S a h ar a n Afric a, st u di es fr o m 
hi g h i nc o m e c o u ntri es m ay pr ovi d e us ef ul l ess o ns. B est pr actic e g ui d eli n es r e g ar di n g h os pit al 
disc h ar g e ar e l ar g ely f oc us e d o n e d uc ati n g t h e p ati e nt a n d h o us e h ol d m e m b ers, m e dic ati o n 
r ec o ncili ati o n a n d p h ar m acy-b as e d i nt erv e nti o ns, a n d c o m m u nic ati o n b et w e e n t h e disc h ar gi n g 
h os pit al a n d a m b ul at ory c ar e pr ovi d ers. A d diti o n al r ec o m m e n d e d or t est e d str at e gi es i ncl u d e 
p ers o n al c o nt act vi a t el e p h o n e c alls, h o m e visits , or sc h e d ul e d cli nic visits s h ortly aft er h os pit al 
disc h ar g e. 3 4 S ev er al st u di es h av e ev al u at e d h o m e m e dic al visits f oll o wi n g disc h ar g e. A r ec e nt 
m et a -a n alysis of 4 7 r a n d o miz e d tri als r e p ort e d r e d uc e d r e a d missi o n i n fiv e st u di es; 4 of t h es e 
i ncl u d e d h o m e m e dic al visits.3 5, 3 6 P ost -h os pit al i nt erv e nti o ns t h at i ncl u d e d h o m e visits c o m p ar e d 
t o t h os e t h at di d n ot w er e m or e lik ely t o i m pr ov e o utc o m es. 
A. 9. H o m e
A. 9. H o m e -B as e d A R T I niti ati o n or M ai nt e n a nc e i n Afric a
B as e d A R T I niti ati o n or M ai nt e n a nc e i n Afric a  
H o m e -b as e d A R T h as b e e n st u di e d i n s u b -S a h ar a n Afric a t o i ncr e as e A R T i niti ati o n, i m pr ov e 
r et e nti o n, or d o b ot h. A st u dy i n U g a n d a r a n d o miz e d p artici p a nts t o c ar e at h o m e or at t h e 
h e alt h f acility st arti n g at t h e first visit aft er A R T i niti ati o n. Vir al l o a d s u p pr essi o n a n d m ort ality, t o 
2 4 m o nt hs, w as si mil ar by st u dy ar m. 3 7, 3 8 St u di es of h o m e A R T i niti ati o n i n M al a wi a n d L es ot h o 
r e p ort e d hi g h er A R T i niti ati o n a n d i m pr ov e d or si mil ar r et e nti o n i n c ar e wit h h o us e h ol d A R T 
i niti ati o n f oll o w e d by s u bs e q u e nt f acility-b as e d c ar e w h e n c o m p ar e d t o st a n d ar d f acility -b as e d 
A R T i niti ati o n. 2 9, 3 0 T h es e st u di es s u g g est t h e acc e pt a bility, f e asi bility, a n d p ot e nti al f or b ett er 
o utc o m es wit h h o m e -c ar e b as e d i nt erv e nti o ns.   
A. 1 0. P u blic H e alt h S ect or H o m e Visit M o d el i n S o ut h Afric a 
A. 1 0. P u blic H e alt h S ect or H o m e Visit M o d el i n S o ut h Afric a  
T h e N ati o n al D e p art m e nt of H e alt h, S o ut h Afric a, b e g a n a pr oc ess k n o w n as Pri m ary C ar e 
R e e n gi n e eri n g i n 2 0 1 0. A n i nt e gr al c o m p o n e nt of t his i niti ativ e is c o m m u nity a n d h o us e h ol d 
c ar e. S p ecific ally, e ac h of t h e > 5 0 0 0 pri m ary c ar e cli nics a n d c o m m u nity h e alt h c e nt ers will h av e 
a “ w ar d -b as e d o utr e ac h t e a m” or W B O T. T h e t e a ms ar e d esi g n e d t o b e l e d by a pri m ary c ar e 
n urs e a n d i ncl u d e e nr oll e d n urs es a n d l o w er l ev el c a dr es i ncl u di n g c o u ns el ors. T h e pri m ary 
m a n d at e of t h e W B O Ts is t o i m pr ov e h e alt h o utc o m es of S o ut h Afric a ns t hr o u g h pr ovisi o n of 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 0  of 3 3  
 
h o m e a n d c o m m u nity -b as e d h e alt h s ervic es. 3 9 At pr es e nt, t h er e is n o d efi n e d a p pr o ac h f or p ost -
h os pit al f oll o w -u p n or is t h er e a str uct ur e d syst e m of c o m m u nic ati o n b et w e e n t h e disc h ar gi n g 
h os pit al a n d cli nics or W B O T t e a ms. 4 0 T h e pr o p os e d i nt erv e nti o n fits wit hi n t h e c urr e nt i niti ativ e 
of t h e S o ut h Afric a n D e p art m e nt of H e alt h a n d h as t h e p ot e nti al t o pr ovi d e v al u a bl e n e w 
k n o wl e d g e t o g ui d e W B O T d e pl oy m e nt.  
1. 2
1. 2  St u d y 
St u d y o bj ecti v es
o bj ecti v es  
T h e o v er arc hi n g g o al of t his pr o p os al is t o d e m o nstr at e cli nic al tri al f e asi bilit y, acc e pt a bilit y, 
T h e o v er arc hi n g g o al of t his pr o p os al is t o d e m o nstr at e cli nic al tri al f e asi bilit y, acc e pt a bilit y, 
a n d pr eli mi n ar y effic ac y of str uct ur e d p ost
a n d pr eli mi n ar y effic ac y of str uct ur e d p ost -disc h ar g e m e dic al h o m e visits t o r e d uc e 
disc h ar g e m e dic al h o m e visits t o r e d uc e 
m ort alit y f oll o wi n g t h e tr a nsiti o n fr o m t h e h os pit al t o h o m e.
m ort alit y f oll o wi n g t h e tr a nsiti o n fr o m t h e h os pit al t o h o m e.  W e ar e pr o p osi n g a pil ot 
r a n d o miz e d cli nic al tri al ( R C T) t o d et er mi n e pr eli mi n ary effic acy, f e asi bility of tri al 
i m pl e m e nt ati o n a n d i nt erv e nti o n d eliv ery, acc e pt a bility of t h e i nt erv e nti o n, t h e eff ect of t h e 
i nt erv e nti o n o n b arri ers t o c ar e, a n d t o o bt ai n d et ail e d b a s eli n e psyc h os oci al a n d m e dic al n e e ds 
t o i nf or m i nt erv e nti o n r efi n e m e nt a n d ex pl ai n o utc o m es ( Fi g ur e 1).  
 
T h e pri m ary o bj ectiv es  of t his st u dy ar e:  
1.  T o esti m at e 6 m o nt h m ort ality r at es a n d ass ess f or evi d e nc e of effic acy of t h e H o m e Li nk 
i nt erv e nti o n c o m p ar e d t o c ar e as us u al. 
2.  T o d et er mi n e t h e f e asi bility, acc e pt a bility, a n d eff ect of t h e H o m e Li nk i nt erv e nti o n o n 
i d e ntifi e d b arri ers t o c ar e. 
3.  T o c h ar act eriz e m e dic al a n d b e h avi or al n e e ds a m o n g p artici p a nts i n t h e st u dy.  
 
T h e s ec o n d ary o bj ectiv es of t his st u dy ar e:  
1.  D et er mi n e p ost -h os pit al h e alt h c ar e o ut -of -p ock et c osts f or p artici p a nts  
2.  Ass ess r e -a d missi o n  
3.  Esti m at e 1 2 m o nt h m ort ality by st u dy ar m  
4.  T o u n d erst a n d ex p eri e nc es ar o u n d t h e ti m e of t h e p assi n g of t h e p artici p a nt fr o m t h e 
f a mily m e m b ers p ers p ectiv e  
1. 3
1. 3  Si g nific a nc e
Si g nific a nc e  
T h is st u dy fits wit h t h e S o ut h Afric a n N ati o n al Str at e gic Pl a n t o i ncr e as e eff ectiv e HI V tr e at m e nt. 
T h e st u dy is als o  c o nsist e nt wit h NI H HI V/ AI D S hi g h est pri ority r es e arc h a n d t h e S o ut h Afric a n 
N ati o n al Str at e gic Pl a n o n HI V, T B, a n d S TIs 2 0 1 7 -2 0 2 2. Giv e n t h e hi g h p ost -disc h ar g e m ort ality 
fi n di n gs fr o m t his st u dy c o ul d c o ntri b ut e t o a p pr o ac h es t o r e d uc e m ort ality f or P W H. 
 
2  M E T H O D S
M E T H O D S  
2. 1
2. 1  St u d y d esi g n
St u d y d esi g n  
T his is a pil ot r a n d o miz e d cli nic al tri al ( R C T) t o r efi n e a n d t est t h e f e asi bility, acc e pt a bility, a n d 
pr eli mi n ary eff ectiv e n ess of H o m e Li nk .  

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H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 2  of 3 3  
 
2. 3. 1  I ncl usi o n crit eri a 
- 
T est e d f or HI V  (c a n b e livi n g wit h HI V or HI V-u ni nf ect e d)  –  HI V n e g ativ e p artci p a nts 
s h o ul d h av e a d oc u m e nt e d t est fr o m wit hi n t h e pr evi o us 3 m o nt hs 
- 
R esi di n g wit hi n M atl os a n a s u b -district  
- 
A gr e e t o p ost -disc h ar g e f oll o w -u p  i ncl u di n g h o m e visit 
- 
A bl e t o pr ovi d e i nf or m e d c o ns e nt or , if l acki n g c a p acity at t h e ti m e of r ecr uit m e nt (if 
u n a bl e t o a ns w er b asic ori e nt ati o n q u esti o ns i ncl u di n g n a m e, m o nt h/y e ar, a n d r esi d e nc e 
l oc ati o n), as d et er mi n e d by t h e st u dy t e a m, h avi n g a n ext of ki n a bl e t o pr ovi d e i nf or m e d 
c o ns e nt  
2. 3. 2  E xcl usi o n crit eri a 
- 
< 1 8 y e ars of a g e  
- 
L e n gt h of st ay <2  ni g ht s 
- 
U nk n o w n HI V st at us at t h e p oi nt of st u dy scr e e ni n g a n d e nr oll m e nt  
- 
F ail ur e by t h e p ati e nt or n ext of ki n t o pr ovi d e i nf or m e d c o ns e nt t o b e f oll o w e d u p by 
st u dy st aff aft er disc h ar g e  
- 
R esi di n g o utsi d e of M atl os a n a s u b -district  
- 
N ot s p e aki n g a ny of t h e l a n g u a g es s p ok e n by t h e st u dy t e a m  
 
L at e excl usi o ns occ urri n g aft er e nr ol m e n t 
- 
D e at h  pri or t o h os pit al disc h ar g e  
- 
Disc h ar g e d t o o l at e f or t h e st u dy t e a m t o d eliv er t h e i nt erv e nti o n  
- 
Tr a nsf er t o a n ot h er h os pit al  
- 
R el oc ati o n o utsi d e of M atl os a n a s u b -district  at t h e p oi nt of disc h ar g e  or wit hi n 7 d ays of 
disc h ar g e  
 
2. 4
2. 4  S a m pli n g
S a m pli n g  sc h e m e
sc h e m e 
2. 4. 1  P artici p a nt r ecr uit m e nt a n d i nf or m e d c o ns e nt  
I n li ais o n wit h Ts h e p o n g H os pit al st aff, a list of n a m es of all m e dici n e w ar d p ati e nts will b e 
g e n er at e d o n r ecr uit m e nt d ays.  T his list will b e t h e n b e pl ac e d i n r a n d o m or d er (vi a r a n d o m 
n u m b er g e n er ati o n o n Exc el w orks h e et). R ecr uit m e nt will b e gi n wit h t h e first i n divi d u al a n d 
pr oc e e d d o w n t h e list u ntil t h e e nr oll m e nt t ar g et f or t h e d ay h as b e e n m et.  P ati e nts o n t h e list 
w h o ar e alr e a dy e nr oll e d, alr e a dy d ecli n e d, or d o n ot m e et e nr oll m e nt crit eri a will b e excl u d e d.  
P ati e nt s w h o m e et t h e e nr oll m e nt cri t eri a will b e i nvit e d t o p artici p at e ( A p p e n dix A: S 0 0 1 
Scr e e ni n g, eli gi bility a n d E nr ol m e nt).  T his pr oc ess will t ak e pl ac e a ny ti m e aft er a d missi o n a n d 
pri or t o r el e as e.  
2. 4. 2  R a n d o miz ati o n  
T h e t ot al s a m pl e siz e is 1 8 0 HI V -p ositiv e a n d 6 0 HI V -u ni nf ect e d a d ults. T h er e will b e a t ot al of 
f o ur st u dy ar ms c o m prisi n g of t w o ar ms f or HI V u ni nf ect e d a n d t w o ar ms f or P W H. W e will 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 3  of 3 3  
 
p erf or m i n divi d u al r a n d o miz ati o n bl ock e d by HI V -st at us t o e nr oll 3 0 HI V-u ni nf ect e d  a d ults  p er 
ar m a n d 9 0 P W H p er ar m  ( Fi g ur e 2).   
 
 
Fi g ur e 2: R a n d o miz ati o n St u d y Ar ms f or H o m e Li n k I nt er v e nti o n
Fi g ur e 2: R a n d o miz ati o n St u d y Ar ms f or H o m e Li n k I nt er v e nti o n  
 
1.  R a n d o miz ati o n of h os pit al p ati e nts f or r ecr uit m e nt: O n e ac h p artici p a nt r ecr uiti n g d ay, a 
list of all m e dic al w ar d p ati e nts will b e g e n er at e d, a n d e ac h p ati e nt will t h e n b e r a n d o mly 
list e d i n or d er of pl a n n e d r ecr uit m e nt. P ati e nts will b e a p pr o ac h e d at a ny ti m e aft er 
a d missi o n if t h ey ar e n ext o n t h e list f or r ecr uit m e nt  u ntil t h e e nr ol m e nt t ar g et is 
r e ac h e d f or t h at d ay.  A n e w list will b e g e n er at e d e ac h d ay i ncl u di n g o nly t h os e p ati e nts 
a d mitt e d 2 d ays pri or  ( or o n  T h urs d ay,  Fri d ay a n d S at ur d ay  o n M o n d ays ).  
2.  R a n d o miz ati o n t o st u dy ar m: Aft er i nf or m e d c o ns e nt a n d c o m pl eti o n of b as eli n e C R Fs 
t h e p artici p a nt will b e r a n d o miz e d t o c ar e as us u al or H o m e Li nk ar m.  
 
R a n d o miz ati o n will b e c o n d uct e d i m m e di at el y aft er eli gi bilit y crit eri a f or t h e p artici p a nt 
h as b e e n d oc u m e nt e d a n d i nf or m e d c o ns e nt h as b e e n si g n e d . P artici p a nts will b e 
r a n d o miz e d 1: 1 t o eit h er t h e c ar e as us u al or t h e H o m e Li n k i nt er v e nti o n ar ms usi n g 
c o m p ut er-g e n er at e d r a n d o m n u m b ers, str atifi e d b y HI V -st at us.   
 
A st u d y st aff m e m b er will S M S a d e dic at e d st u d y t el e p h o n e n u m b er –  st aff e d b y 
s o m e o n e n ot li n k e d t o a n y ot h er as p ect of t h e c o n d uct of t h e st u d y. D et ails of t h e 
eli gi bl e p artici p a nt , i ncl u di n g r a n d o miz ati o n gr o u p ( 1 =li vi n g wit h HI V; 2 =li vi n g wit h o ut 
HI V) , i niti als (first t w o l ett ers of t h e first n a m e a n d first t w o l ett ers of t h e s ur n a m e), a g e, 
a n d s ex, will b e s e nt vi a S M S t o t h e r a n d o mizi n g t e a m . A m e m b er of t h e r a n d o mizi n g 
t e a m will  t h e n r el a y t h e all oc ati o n d et ails ( wit hi n 1 5 mi n ut es) t o t h e st u d y st aff m e m b er 
2 4 0 
P A R TI CI P A N T S
1 8 0 HI V +
9 0 C A R E A S 
U S U AL 
9 0 H O M E 
LI N K
6 0 HI V -
3 0 C A R E A S 
U S U AL
3 0 H O M E 
LI N K

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 4  of 3 3  
 
w h o r e q u est e d t h e r a n d o miz ati o n vi a S M S. Pr o of of r a n d o miz ati o n will b e s e nt t o t h e 
st u d y st aff m e m b er w h o will pl ac e t h e pr o of i nt o t h e p artici p a nts’ st u d y fil e.  
 
2. 5
2. 5  Pr e
Pr e -disc h ar g e 
disc h ar g e st u d y pr oc e d ur es
st u d y pr oc e d ur es 
All p artici p a nts will h av e a b as eli n e d e m o gr a p hic h e alt h  a n d psyc h os oci al q u esti o n n air e  ( E 0 0 1, 
E 0 0 2) .  
2. 5. 1  C ar e -as -us u al ( C A U) st u dy ar m  
P artici p a nts will  r ec eiv e st a n d ar d disc h ar g e c ar e as pr ovi d e d at Ts h e p o n g H os pit al d uri n g t h e 
st u dy. T his c urr e ntly i ncl u d es disc h ar g e c o u ns eli n g fr o m a tr ai n e d disc h ar g e c o u ns el or  a n d will 
b e pr ovi d e d wit h a f oll o w -u p r et ur n d at e ( us u ally t w o  w e eks p ost -h os pit al). Disc h ar g e  c o u ns eli n g 
will  i ncl u d e a r evi e w of disc h ar g e m e dic ati o ns a n d i nstr ucti o ns r e g ar di n g f oll o w-u p c ar e visits.   
2. 5. 2  
H o m e  Li nk st u dy ar m 
T h e H o m e Li nk i nt erv e nti o n will b e d eliv er e d by a h o m e visit t e a m
h o m e visit t e a m  i ncl u di n g a pri m ary c ar e 
n urs e a n d c o u ns el or tr ai n e d i n p ati e nt -c e nt er e d c o u ns eli n g ( T a bl e 1 ). A r ot ati n g h os pit al-b as e d 
d oct or will  b e av ail a bl e f or pr e -h o m e visit cli nic al fil e r evi e w a n d p ost -visit disc ussi o n, vi a c ell 
p h o n e, f or d ecisi o n m aki n g a n d i n p ut o n p ati e nt c ar e d uri n g a h o us e h ol d visit . W e h av e t er m e d 
t his i n divi d u al a “disc h ar g e offic er
disc h ar g e offic er ”. T h e disc h ar g e offic er will b e a Ts h e p o n g cli nici a n w h o is 
w orki n g i n t h e h os pit al. S u p p orti n g H o m e Li nk is ex p ect e d t o t ak e < 3 0 mi n ut es of t h e p hysici a n’s 
ti m e d uri n g t h e d ay. T h e  t e a m will als o c o ns ult wit h a G C P -tr ai n e d, P H R U r es e arc h d oct or b as e d 
at Ts h e p o n g  H os pit al  pri or t o h o us e h ol d visits a n d f or a dvic e r e g ar di n g r ef err als, disc h ar g e fr o m 
h o m e -b as e d c ar e, a n d ot h er q u eri es . 
T a bl e 
T a bl e 1 . H o m e Li n k i nt er v e nti o n t e a m k e y m e m b ers
. H o m e Li n k i nt er v e nti o n t e a m k e y m e m b ers 
T e a m m e m b er  
Tr ai ni n g  
L oc ati o n of 
s ervic e 
R ol e  
Pri m ary C ar e N urs e  
Pr of essi o n al N urs e  
H o m e visit t e a m  
Cli nic al ass ess m e nt a n d m a n a g e m e nt  
C o u ns el or  
Hi g h sc h o ol di pl o m a  
H o m e visit t e a m  
P ati e nt -c e nt er e d c o u ns eli n g & h o m e 
n e e ds ass ess m e nt  
Disc h ar g e offic er  
M e dic al d oct or d e gr e e  
B as e d at 
h os pit al  
Cli nic al s u p p ort (vi a c ell p h o n e)  
P H R U r es e arc h 
d oct or  
M e dic al d oct or d e gr e e  
B as e d at 
h os pit al  
First p oi nt of c o nt act f or cli nic al s u p p ort 
T h e h o m e c ar e t e a m will tr av el vi a c ar t o t h e p artici p a nt’s h o us e o n e w e ek aft er disc h ar g e a n d 
ev ery t w o w e eks t h er e aft er u ntil c o m pl eti n g 6 visits or t h e p artici p a nt is disc h ar g e d fr o m t h e 
H o m e Li nk i nt erv e nti o n b as e d o n t h e cli nic al ass ess m e nts.  
H o m e visits:  Pri or t o t e a m d e p art ur e f or a p artici p a nt’s h o m e: t h e disc h ar g e offic er a n d P H R U 
r es e arc h d oct or will r evi e w t h e p artici p a nt’s m e dic al fil e, i ncl u di n g r etri evi n g l a b or at ory r es ults 
p e n di n g at t h e ti m e of disc h ar g e or t h e pri or h o m e visit, a n d a d d a ny p ati e nt s p ecific 
r ec o m m e n d ati o ns f or ass ess m e nts t o t h e P ati e nt Ass ess m e nt I nstr u m e nt ( A p p e n dix A) f or t h e 
n urs e t o us e at t h e h o us e h ol d.  
At t h e h o us e h ol d, t h e t e a m will us e t h e P ati e nt Ass ess m e nt I nstr u m e nt t o d oc u m e nt fi n di n gs 
a n d g ui d e d ecisi o n m aki n g i n t h e f oll o wi n g ar e as:  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 5  of 3 3  
 
Pri m arily pr ovi d e d by t h e pri m ary c ar e n urs e  
( a) Ass ess ill n ess s ev erity. T h e n urs e will ass ess f or sy m pt o ms of C O VI D-1 9 i nf ecti o n a n d activ e 
T B dis e as e as w ell as g e n er al ill n ess s ev erity usi n g t e m p er at ur e, bl o o d pr ess ur e, p uls e, 
r es pir ati o n r at e, p uls e oxi m etry, a n d ori e nt ati o n. Us e of t h es e si g ns will b e g ui d e d by a n 
al g orit h m ( A p p e n dix A) l e a di n g t o (i) disc h ar g e fr o m h o m e visits, (ii) r et ur n visit i n 2 w e eks, 
(iii) c o nt acti n g a cli nici a n at Ts h e p o n g H os pit al vi a c ell p h o n e f or f urt h er g ui d a nc e, or (iv) 
c alli n g f or r o uti n e m e dic al tr a ns p ort ( a m b ul a nc e s ervic e) t o tr a ns p ort t h e p artici p a nt t o 
Ts h e p o n g H os pit al f or ev al u ati o n a n d lik ely a d missi o n.  
( b) M e dic ati o n r ec o ncili ati o n: r evi e w m e dic ati o n t aki n g, m e dic ati o n av ail a bility, a n d pr escri b e d 
m e dic ati o n pl a n. C o u ns el o n a p pr o pri at e d osi n g a n d a d dr ess p ot e nti al a d h er e nc e b arri ers 
( e. g. l ack of u n d erst a n di n g, l ack of m e dic ati o n av ail a bility, n a us e a or ot her si d e eff ects).  
(c) O bt ai n l a b or at ory s p eci m e ns ( w h ol e bl o o d or uri n e , as r e q uir e d b as e d o n t h e disc h ar g e 
offic er ass ess m e nts ) f or tr a ns p ort t o t h e l a b or at ory a n d pr ovi d e m e dic ati o ns dis p e ns e d f or 
t h e p ati e nt fr o m t h e Ts h e p o n g H os pit al p h ar m acy as i n dic at e d f or a giv e n p artici p a nt. 
( d) Distri b ut e a ny m e dic ati o ns n e e d e d b as e d o n pr escri pti o n fr o m t h e disc h ar g e offic er ( b as e d 
o n a pri or h o us e h ol d visit ass ess m e nt).  
Pri m arily pr ovi d e d by c o u ns el or  
( e) H o us e h ol d ass ess m e nt: ass ess f or f o o d av ail a bility a n d h o m e s u p p ort; (i nv olv e s oci al w ork ers 
at Ts h e p o n g H os pit al if i n dic at e d) (c o m pl et e d d uri n g m e dic al ass ess m e nt) . 
(f) P ati e nt -c e nt er e d c o u ns eli n g t o a d dr ess r e a di n ess f or tr e at m e nt e n g a g e m e nt i ncl u di n g 
r e a di n ess t o acc e pt tr e at m e nt, r e a di n ess t o f ac e sti g m a a n d discl os ur e n e e ds, b uil di n g s elf-
effic acy f or c ar e e n g a g e m e nt , a n d pr ovi di n g c o u ns eli n g f or sy m pt o ms of d e pr essi o n a n d/ or 
alc o h ol a b us e i d e ntifi e d pri or t o h os pit al disc h ar g e or d uri n g h o m e visits .   
( g) P artici p a nts w h o h av e l o w f o o d s ec urity i d e ntifi e d pri or t o h os pit al disc h ar g e will b e pr ovi d e d 
wit h a f o o d s u p pl e m e nt/ p arc el  at t h e first h o m e visit.   
At t h e c o ncl usi o n of t h e h o m e visit, t h e t e a m will c o nt act ( p h o n e c all or t ext m ess a g e) t h e 
h os pit al -b as e d P H R U r es e arc h d oct or , if i n dic at e d, b as e d o n t h e P ati e nt Ass ess m e nt I nstr u m e nt 
or if t h e t e a m d esir es s p ecific g ui d a nc e. T h e P H R U d oct or  will h av e acc ess t o t h e h os pit al fil e ( all 
fil es p ull e d pri or t o t h e visit) a n d will pr ovi d e g ui d a nc e t o t h e t e a m. T h e g ui d a nc e will f all i nt o 
o n e of f o ur g e n er al c at e g ori es: 1) m ak e n o c h a n g es, 2) a dj ust m e dic ati o n t aki n g, 3) o bt ai n 
l a b or at ory s p eci m e ns, or 4) r ef er t o disc h ar g e offic er f or f urt h er g ui d a nc e a n d/ or h os pit al f or 
pr o b a bl e a d missi o n.  
T h e t ot al ti m e of t h e H o m e Li nk visit is a ntici p at e d t o b e 1 h o ur. T h e r evi e w wit h t h e d oct or  pri or 
t o d e p arti n g f or h o us e h ol d visits is ex p ect e d t o t ak e a b o ut 1 5 mi n ut es a n d t h e m o bil e p h o n e 
c o nt act wit h t h e P H R U r es e arc h d oct or  t o b e < 1 0 mi n ut es p er h o us e h ol d visit.  
2. 6
2. 6  V erific ati o n of 
V erific ati o n of h os pit al disc h ar g e d at e
h os pit al disc h ar g e d at e  
St u dy st aff will d et er mi n e w h e n st u dy p artici p a nts ar e disc h ar g e d fr o m t h e h os pit al i n or d er t o 
pl a n a n d sc h e d ul e d at a c oll ecti o n f oll o w-u p t o asc ert ai n o utc o m es a n d t o sc h e d ul e t h e H o m e 
Li nk i nt erv e nti o n h o m e visits (f or t h os e i n t h e H o m e Li nk ar m).  
2. 7
2. 7  P ost
P ost -disc h ar g e
disc h ar g e  f oll o w
f oll o w-u p
u p  
T h e pri m ary o utc o m e is m ort ality six m o nt hs aft er h os pit al disc h ar g e. S ec o n d ary o utc o m es 
i ncl u d e m ort ality 1 2 m o nt hs aft er h os pit al disc h ar g e, n u m b er of ni g hts s p e nt i n a h os pit a l, 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 6  of 3 3  
 
n u m b er of a m b ul at ory cli nic al e nc o u nt ers aft er t h e i n d ex h os pit aliz ati o n , a n d p ati e nt o ut-of -
p ock et c osts f or m e dic al c ar e . O utc o m es will b e ass ess e d t hr o u g h sc h e d ul e d c o nt act a n d 
c o m pl eti o n of a str uct ur e d q u esti o n n air e wit h t h e p artici p a nt or d esi g n at e d n ext of ki n ( eit h er 
t el e p h o nic or i n p ers o n if t el e p h o nic f ails) at 8, 12 , 2 6, a n d 5 2 w e eks. M ort ality will b e f urt h er 
asc ert ai n e d t hr o u g h a 2 6  a n d 5 2  w e ek r evi e w of t h e Ts h e p o n g H os pit al fil e (i ncl u di n g t h e 
affili at e d Kl erks d or p h os pit al fil es) a n d m atc hi n g  of  p artici p a nt n ati o n al i d e ntific ati o n n u m b ers t o 
t h e vit al st atistics r e gist er t hr o u g h c o ns ult ati o n wit h t h e D e p art m e nt of H o m e Aff airs . R e p e at 
h os pit aliz ati o n will b e asc ert ai n e d usi n g s elf -r e p ort / n ext of ki n r e p ort a n d h os pit al r ec or ds. 
M ost s u bs e q u e nt h os pit aliz ati o ns c a n b e ex p ect e d t o b e at Ts h e p o n g H os pit al d u e t o t h e 
s u bst a nti al dist a nc e t o r e ac h t h e n ext n e ar est h os pit al ( > 5 0 k m t o a l o w er l ev el f acility).  I n o ur 
pri or ex p eri e nc e w e h av e o bs erv e d r ar e us e of alt er n ativ e h os pit als. Cli nic visit d at a will b e 
asc ert ai n e d by s elf -r e p ort f oll o w e d by v erific ati o n t hr o u g h r evi e w of cli nic p a p er or el ectr o nic 
(ti er. n et) r ec or ds a n d N ati o n al H e alt h L a b or at ory S ervic e el ectr o nic r ec or ds ( Tr ack C ar e).  
 
T a bl e 
T a bl e 2 . . Sc h e d ul e d visit wi n d o ws
Sc h e d ul e d visit wi n d o ws  
Visit n a m e
Visit n a m e  
P eri o d
P eri o d  
Pri m ar y g o al
Pri m ar y g o al  
8 w e ek  f oll o w-u p  
2 0 –  7 0 d ays  
M ai nt ai n c o nt act wit h p artici p a nt  
1 2 w e ek  f oll o w-u p  
7 1 -1 5 0 d ays  
Ass ess c ar e e n g a g e m e nt, c ar e 
s atisf acti o n, m ort ality 
2 6 w e ek  f oll o w-u p  
1 5 1 –  2 4 5  d ays  
Ass ess c ar e e n g a g e m e nt, , m ort ality ; 
c o n d uct psyc h os oci al ass ess m e nt 
2 6 w e ek h os pit al fil e r evi e w  
> 2 6 w e eks p ost -h os pit al  
A bstr act c ar e visits, r e -a d missi o n, 
d e at h  
2 6 w e ek H o m e Aff airs vit al st at us 
r evi e w 
> 2 6 w e eks p ost -h os pit al  
M atc h S o ut h Afric a n I D n u m b ers  
2 6 w e ek c ar e v erific ati o n  
> 2 6 w e ek p ost -h os pit al  
Us e el ectr o nic a n d p a p er fil es t o 
v erify s elf-r e p ort e d cli nic visits 
5 2 w e ek  f oll o w-u p  
3 6 5 -4 5 5  d ays  
Ass ess c ar e e n g a g e m e nt, m ort ality  
5 2 w e ek h os pit al fil e r evi e w  
> 3 6 5 d ays  p ost -h os pit al  
A bstr act c ar e visits, r e -a d missi o n, 
d e at h  
5 2 w e ek H o m e Aff airs vit al st at us 
r evi e w 
> 3 6 5 d ays p ost -h os pit al  
M atc h S o ut h Afric a n I D n u m b ers  
 
2. 7. 1  C ar e v erific ati o n  
Cli nic al r ec or ds will b e acc ess e d t o d et er mi n e li nk a g e t o c ar e st at us, ti mi n g of li nk a g e t o c ar e, 
A R T c o nti n u ati o n, r et e nti o n i n c ar e, a n d r el ev a nt l a b or at ory r es ults.  T his will b e d o n e t hr o u g h 
r evi e wi n g p a p er cli nic c h arts, el ectr o nic cli nic d at a (ti er. n et), a n d el ectr o nic l a b or at ory d at a 
( N HL S Tr ackc ar e syst e m).  Li nk a g e b et w e e n p artici p a nts a n d r ec or ds will b e b as e d o n m atc hi n g 
s ur n a m e, first n a m e, d at e of birt h, sex,  a n d a p pr o pri at e d at e r a n g e . 
2. 7. 2  M ort ality  
M ort ality will b e asc ert ai n e d vi a:  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 7  of 3 3  
 
( 1) T el e p h o nic c o nt act wit h p artici p a nt ( aliv e) or n ext of ki n, as pr ovi d e d by t h e p artici p a nt, 
r e p orti n g a d e at h 
( 2) R evi e w of t h e Ts h e p o n g H os pit al p a p er fil e  
( 3) S o ut h Afric a n H o m e Aff airs vit al st atistics q u ery usi n g t h e p artici p a nt n ati o n al I D n u m b er  
M ort ality will b e ass ess e d aft er six m o nt hs a n d a g ai n aft er t w elv e m o nt hs.  
2. 7. 3  Eff ectiv e n ess  of H o m e Li nk  
 
T a bl e 
T a bl e 3 . . Eff ecti v e n ess o utc o m es
Eff ecti v e n ess o utc o m es  
Pri m ary o utc o m e  
M ort ality  at six m o nt hs  by ar m  
T est of p r o p orti o ns (c hi-s q u ar e) 
S ec o n d ary 
o utc o m es  
M ort ality at 1 2 m o nt hs  
T est of pr o p orti o ns (c hi -s q u ar e) 
Ti m e t o a ny n o n -ac ut e f oll o w -u p  
C ox pr o p orti o n al h az ar ds  
N u m b er of o ut p ati e nt f oll o w-u p c ar e e nc o u nt ers  
T est of m e di a ns ( Wilc ox o n r a nk s u m)  
N u m b er of ni g hts i n h os pit al  p ost -i niti al disc h ar g e 
T est of m e di a ns ( Wilc ox o n r a nk s u m)  
S elf -r e p ort e d c ost of c ar e 
T est of m e di a ns ( Wilc ox o n r a nk s u m)  
Pr oc ess o utc o m es  
Acc e pt a bility of i nt erv e nti o n  
 
 
F e asi bility of i nt erv e nti o n  
 
 
F e asi bility of cli nic al tri al  
 
2. 7. 4  Acc e pt a bility  & F e asi bility  
2. 7. 4. 1  F e asi bility of H o m e Li nk  
T h e g o al of t his ass ess m e nt is t o ev al u at e  t h e f e asi bility of i m pl e m e nti n g t h e H o m e Li nk  
i nt erv e nti o n a n d of e n d p oi nt asc ert ai n m e nt f or t h e cli nic al tri al of H o m e Li nk  i m pl e m e nt ati o n.  
S p ecific f e asi bility c o nsi d er ati o ns ar e:   
1)  T h e pr o p orti o n of p artici p a nts i n t h e H o m e Li nk ar m w h o r ec eiv e e ac h 
sc h e d ul e d/ ex p ect e d H o m e Li nk h o m e visits 
2)  S ucc ess of t h e st u dy t e a m t o asc ert ai n six m o nt h m ort ality  
W e will ass ess t h e tri al f e asi bility b as e d o n t h e pr o p orti o n of eli gi bl e i n divi d u als w h o e nr oll a n d 
t h e pr o p orti o n of p artici p a nts t h at w e ar e a bl e t o c oll ect f ull o utc o m e d at a o n. W e will ass ess t h e 
f e asi bility of i m pl e m e nti n g t h e i nt erv e nti o n o n t h e f ollo wi n g m e as ur es: t h e pr o p orti o n of 
pl a n n e d h o m e visits t h at ar e c o m pl et e d, t h e pr o p orti o n of h o m e m e dic al ass ess m e nts 
c o m pl et e d, t h e pr o p orti o n of h o m e m e dic ati o n r ec o ncili ati o n c o m pl et e d, t h e pr o p orti o n of 
p artici p a nts w h o r ec eiv e p ati e nt -c e nt er e d c o u ns elin g, a n d t h e pr o p orti o n of p artici p a nts wit h 
i d e ntifi e d f o o d i ns ec urity w h o r ec eiv e f o o d s u p pl e m e nt ati o n/ p arc els at t h e first h o m e visit . T h e 
pr o p orti o ns will b e c o nsi d er e d i n divi d u ally a n d wit h a c o m p osit e sc or e t o b e i nt er pr et e d i n t h e 
c o nt ext of t h e effic acy r es ults wit h a g e n er al t hr es h ol d t h at s u bst a nti ally m or e t h a n h alf of 
c o m p o n e nts ex p ect e d t o b e c o m pl et e d n e e d t o b e c o m pl et e d f or  t h e i nt erv e nti o n t o b e 
c o nsi d er e d f e asi bl e.   
S ucc ess will b e b as e d o n a pri ori  t ar g ets of ≥9 0 % of pl a n n e d h o m e visits c o m pl et e d , s ucc essf ul 
f oll o w-u p of ≥7 5 % of p artici p a nts, a n d vit al st at us asc ert ai n m e nt of > 9 0 % of p artici p a nts . 
 
T a bl e 
T a bl e 4 . 
4 . F e asi bilit y I n dic at ors
F e asi bilit y I n dic at ors  
N u m er at or
N u m er at or  
D e n o mi n at or
D e n o mi n at or  
M e as ur e
M e as ur e  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 8  of 3 3  
 
N u m b er wit h first H o m e Li nk  visit 
T ot al i n H o m e Li nk  ar m  
Pr o p orti o n  
N u m b er of c o m pl et e d H o m e Li nk visits  
N u m b er of pl a n n e d/ att e m pt e d  
H o m e Li nk  visits 
Pr o p orti o n  
N u m b er of h o m e m e dic al ass ess m e nts c o m pl et e d  
N u m b er of 
pl a n n e d/ att e m pt e d/c o m pl et e d 
H o m e Li nk visits  
Pr o p orti o n  
N u m b er of h o m e m e dic ati o n r ec o ncili ati o n c o m pl et e d  
N u m b er of 
pl a n n e d/ att e m pt e d/c o m pl et e d 
H o m e Li nk visits  
Pr o p orti o n  
N u m b er of p ati e nt -c e nt er e d c o u ns eli n g s essi o ns 
c o m pl et e d 
N u m b er of 
pl a n n e d/ att e m pt e d/c o m pl et e d 
H o m e Li nk visits  
Pr o p orti o n  
N u m b er of p artici p a nts w h o r ec eiv e d f o o d p arc els  
N u m b er of H o m e Li nk 
p artici p a nts wit h i d e ntifi e d f o o d 
i ns ec urity pr e -disc h ar g e  
Pr o p orti o n  
N u m b er  of p artici p a nts wit h 6  m o nt h vit al st at us 
asc ert ai n m e nt  
All st u dy p artici p a nts  
Pr o p orti o n  
N u m b er  of  p artici p a nts wit h 6 m o nt h c ar e e n g a g e m e nt 
asc ert ai n m e nt  
F or P W H : ≥1 HI V c ar e visit  
F or HI V -n e g ativ e p artici p a nts: ≥1 o ut p ati e nt cli n ic visit 
All st u dy p artici p a nts  
Pr o p orti o n  
N u m b er  of p artici p a nts wit h b as eli n e l a b or at ory a n d 
m e dic al ass ess m e nt c o m pl et e d   
All st u dy p artici p a nts  
Pr o p orti o n  
 
Acc e pt a bility  
Acc e pt a bility will b e ass ess e d a m o n g p artici p a nts i n t h e i nt erv e nti o n ar m a n d h e alt h st aff usi n g 
a n acc e pt a bility q u esti o n n air e a n d i n -d e pt h i nt ervi e ws. T h e  ( C R F F 0 0 4 ) q u esti o n n air e  b as e d o n 
t h e t h e or etic al fr a m e w ork of acc e pt a bility d ev el o p e d by S ek h o n et al. 4 1 t h at h as s ev e n c or e 
c o nstr ucts: attit u d e ( h o w a n i n divi d u al f e els a b o ut t h e i nt erv e nti o n wit h c o nfi d e nti ality a n d 
r ec ei pt of c ar e a n d m e dic al pr oc e d ur es s uc h as p hl e b ot o my occ urri n g at h o m e), b ur d e n ( eff ort 
r e q uir e d f or t h e i nt erv e nti o n), et hics (c o nc urr enc e wit h v al u e syst e m), c o h er e nc e ( h o w w ell t h e 
i nt erv e nti o n is u n d erst o o d), o p p ort u nity c osts, p erc eiv e d eff ectiv e n ess, a n d s elf-effic acy 
(c o nfi d e nc e i n p erf or mi n g or p artici p ati n g i n t h e i nt erv e nti o n). T h e acc e pt a bility sc or es will b e 
i nt er pr et e d i n t h e c o nt ext of t h e st u dy effic acy r es ults wit h a g e n er al t hr es h ol d of t h e m aj ority of 
p artici p a nts sc ori n g t h e c o nstr ucts as acc e pt a bl e (r es p o ns es o n Lik ert sc al e). Fi n di n gs fr o m t h e 
acc e pt a bility q u esti o n n air e will b e f urt h er ex pl or e d t hr o u g h i n -d e pt h i nt ervi e ws i n a s e q u e nti al 
ex pl a n at ory mix e d m et h o ds a p pr o ac h ( d escri b e d as f oll o ws).  
P ati e nt i n -d e pt h i nt ervi e w s: W e will i nt ervi e w u p t o 4 0 p ati e nts r ecr uit e d t hr o u g h a p ur p osiv e 
s a m pli n g str at e gy t o o bt ai n a m axi m u m v ari ati o n s a m pl e by n u m b er of H o m e Li nk visits r ec eiv e d 
a n d HI V st at us, ti mi n g of HI V di a g n osis ( d uri n g i n d ex h os pit aliz ati o n or pri or, f or t h os e livi n g wit h 
HI V ), h os pit al r e a d missi o n, s ex, a n d a g e gr o u p. I n-d e pt h i nt ervi e ws will b e c o n d uct e d by tr ai n e d 
r es e arc h assist a nts i n t h e p artici p a nt’s pr ef err e d l a n g u a g e. I nt ervi e ws will ex pl or e it e ms 
i d e ntifi e d i n t h e q u a ntit ativ e s urv ey f or f urt h er ex pl or ati o n a n d: i) p erc e pti o ns of a n d 
ex p eri e nc es wit h H o m e Li nk i ncl u di n g p artici p a nts p erc e pti o ns of ali g n m e nt of s ervic es wit h 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 1 9  of 3 3  
 
n e e ds (fr a m e d wit h t h e A n d ers e n B e h avi or al M o d el), ii) c o nfi d e nti ality , i m p act of C O VI D-1 9  or 
ot h er c o nc er ns wit h h o m e visits, a n d iii) p erc e pti o ns of q u ality of H o m e Li nk c ar e.  
H e alt h c ar e w ork er i nt ervi e ws : W e will i nt ervi e w u p t o 1 0 h e alt h c ar e w ork ers ( H o m e Li nk t e a m) 
t o u n d erst a n d t h eir p ers p ectiv es a n d ex p eri e nc es wit h d eliv eri n g t h e i nt erv e nti o n a n d t o ex pl or e 
w ays i n w hic h t h e m o d el c o ul d b e str e n gt h e n e d.  W e will als o ass ess t h e p erc eiv e d i m p act of 
C O VI D -1 9 o n t h e h o m e b as e d i nt erv e nti o n.  All a u di o -r ec or d e d i nt ervi e ws will b e tr a nscri b e d a n d 
tr a nsl at e d i nt o E n glis h ( as n ec ess ary). Tr a nscri pts will b e u pl o a d e d i nt o q u alit ativ e c o di n g 
s oft w ar e ( e. g. Atl as.ti , M ax Q D A) f or t h e pur p os es of c o di n g a n d a n alysis. H e alt h c ar e w ork ers will 
b e i nvit e d t o p artici p at e by l ett er.  F urt h er st u dy i nf or m ati o n a n d i nf or m e d c o ns e nt will b e 
pr ovi d e d i n priv at e.  T h e i nt ervi e ws will occ ur i n a priv at e s p ac e at a sc h e d ul e d ti m e c o nv e ni e nt 
t o t h e h e alt h c ar e w ork er. 
 
2. 7. 4. 2  B er e av e d F a mily m e m b ers  
 
I nt ervi e ws wit h t h e b er e av e d f a mily m e m b ers: W e will i nt ervi e w f a mily m e m b ers of u p t o 2 0 
d ec e as e d p artici p a nts t o u n d erst a n d t h eir ex p eri e nc es ar o u n d t h e ti m e of t h e p assi n g of t h e 
p artici p a nt, i ncl u di n g w h at c ar e t h e p artici p a nt s o u g ht, h o w l o n g t h ey w er e ill f or a n d w h at t h e 
f a mily m e m b ers t hi nk c o ul d h av e b e e n d o n e t o assist t h e p artici p a nt. I n-d e pt h i nt ervi e ws will b e 
c o n d uct e d by tr ai n e d r es e arc h assist a nts i n t h e p artici p a nt’s pr ef err e d l a n g u a g e. All a u di o -
r ec or d e d i nt ervi e ws will b e tr a nscri b e d a n d tr a nsl at e d i nt o E n glis h ( as n ec ess ary). Tr a nscri pts will 
b e u pl o a d e d i nt o q u alit ativ e c o di n g s oft w ar e ( e. g. Atl as.ti, M ax Q D A) f or t h e p ur p os es of c o di n g 
a n d a n alysis. F urt h er st u dy i nf or m ati o n a n d i nf or m e d c o ns e nt will b e pr ovi d e d i n priv at e.  T h e 
i nt ervi ews will occ ur i n a priv at e s p ac e at a sc h e d ul e d ti m e c o nv e ni e nt t o t h e p artici p a nt.  
 
2. 7. 4. 3  Eff ect of i nt erv e nti o n o n b arri ers t o c ar e e n g a g e m e nt  
W e will c o m p ar e, by st u dy ar m, c o nstr ucts a ntici p at e d t o b e eff ect e d by t h e i nt erv e nti o n: c ar e 
acc ess, b ur d e n of tr e at m e nt i ncl u di n g c ost t o t h e p ati e nt a n d ti m e  s p e nt by t h e p ati e nt, p ati e nt 
s atisf acti o n, c orr ect m e dic ati o n a d mi nistr ati o n, i nt er n aliz e d a n d ex p eri e nc e d HI V sti g m a, s oci al 
s u p p ort, a n d f o o d s ec urity ( T a bl e 5 ).  
Ti m e s p e nt a n d p ati e nt -l ev el fi n a nci al c ost of c ar e will b e asc ert ai n e d by p artici p a nt s elf-r e p ort 
usi n g a fi el d t e a m m e m b er a d mi nist er e d q u esti o n n air e wit h q u esti o ns f oc usi n g o n t h e l ast 
cli nic al c o nt act (cli nic or h o us e h ol d visit) si nc e h os pit al disc h ar g e, t h e t ot al n u m b er of c o nt acts 
(visits), t h e c ost of tr a ns p ort a n d i nci d e nt al ex p e ns es wit h g oi n g t o t h e cli nic a n d l ost w a g es. 
S p ecific c ost c h ar act eristics (s uc h as tr a ns p ort c ost a n d d at e of cli nic al c ar e visit) will b e v erifi e d 
usi n g o bj ectiv e m e as ur e s s uc h as l oc al mi ni-b us f ar es a n d m e dic al fil e a bstr acti o n ( at 2 6 w e eks 
aft er disc h ar g e).  
T a bl e 
T a bl e 5 . M e as ur es a n d a n al ysis f or f e asi bilit y, acc e pt a bilit y, a n d eff ects o n e n g a g e m e nt i n c ar e
. M e as ur es a n d a n al ysis f or f e asi bilit y, acc e pt a bilit y, a n d eff ects o n e n g a g e m e nt i n c ar e 
Ass ess m e nt  
Ass ess m e nt m et h o ds  
Ti mi n g  
St atistic al t est  
F e asi bility a n d Acc e pt a bility  
Tri al:  
F e asi bility  
Pr o p orti o n of e nr oll e d p artici p a nts a m o n g a p pr o ac h e d a n d 
eli gi bl e p ati e nts  
 
Pr o p orti o n of p artici p a nts wit h c o m pl et e f oll o w -u p  
b as e -
li n e 
 
1 y e ar  
Pr o p orti o n, t ot al st u dy  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 0  of 3 3  
 
I nt erv e nti o n: 
F e asi bility  
Pr o p orti o n of pl a n n e d h o m e visits s ucc essf ully c o m pl et e d, 
p ati e nt -c e nt er e d c o u ns eli n g s essi o ns c o m pl et e d, m e dic al 
ass ess m e nts, m e dic ati o n r ec o ncili ati o ns, a n d f o o d s ec urity 
m a n a g e m e nt  
3 m  
Pr o p orti o n, H o m e Li nk Ar m  
Acc e pt a bility  
Acc e pt a bility q u esti o n n air es wit h 7 acc e pt a bility d o m ai ns f or 
H C Ws  a n d  p artici p a nts  
3  m  
Pr o p orti o n, H o m e Li nk ar m  
Acc e pt a bility  
I n d e pt h i nt ervi e ws 
3  m  
T h e m atic a n alysis  
Eff ects o n c ar e e n g a g e m e nt b arri ers  
P ati e nt c ost  
Str uct ur e d q u esti o n n air e f or p artici p a nt s elf -r e p ort 
3 m , 6 m 
Wilc ox o n r a nk s u m  
C ar e s atisf acti o n  
A d a pt e d S o ut h Afric a n c ar e s atisf acti o n s urv ey4 4  
3 m  
Wilc ox o n r a nk s u m t est  
M e dic ati o n 
r ec o ncili ati o n 
R ec o ncili n g pl a n n e d m e ds o n disc h ar g e d act u al m e ds wit h 
p ati e nt & w ay t h at p ati e nt is t aki n g  
3 m  
Pr o p orti o n, H o m e Li nk ar m  
HI V sti g m a  
S h ort f or m HI V sti g m a sc al e 4 5, 4 6 
b as eli n e, 
6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
S oci al S u p p ort  
M OS s oci al s u p p ort i nstr u m e nt
4 7 
b as eli n e, 
6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
F o o d s ec urity  
T hr e e q u esti o n sc al e  
b as eli n e, 
6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
D e pr essi o n  
C ES -D (s h ort)  
B as eli n e, 
6 
m o nt hs  
Pr o p orti o n  
Alc o h ol us e  
Alc o h ol us e dis or d er i d e ntific ati o n t est ( A U DI T), s h ort e n e d 
v ersi o n 
B as eli n e, 
6 
m o nt hs  
Pr o p orti o n  
 
M e dic al c o n diti o ns a n d psyc h os oci al n e e ds will b e ass ess e d pri or t o h os pit al disc h ar g e a n d p ost -
h os pit al by usi n g H o m e Li nk visit a n d ot h er c ar e c o nt act r ec or ds.  
a.  M e dic al ass ess m e nt pri or t o h os pit al disc h ar g e : Cli nic al d at a will b e a bstr act e d or s p ecific ally 
o bt ai n e d f or t h e st u dy, if n ot i n t h e cli nic al r ec or d: HI V vir al l o a d, C D 4 c o u nt, HI V dr u g r esist a nc e 
t esti n g, X p ert Ultr a f or r a pi d T B di a g n osis , disc h ar g e di a g n os es, a n d disc h ar g e m e dic ati o ns. 
Bl o o d will b e dr a w n fr o m all p artici p a nts livi n g wit h HI V f or dr u g r esist a nc e t esti n g; h o w ev er, w e 
will o nly c o n d uct t h e dr u g r esist a nc e t est if t h e vir al l o a d r es ult is > 1 0 0 0 c o pi es/ mL. W e m ay us e 
l eft ov er s p eci m e n fr o m t h e dr u g r esist a nc e t est t o r e p e at t h e vir al l o a d a n d dr u g r esist a nc e t est 
usi n g a pl as m a s e p ar ati o n c ar d i n c oll a b or ati o n wit h t h e N ati o n al I nstit ut e f or C o m m u nic a bl e 
Dis e as es ( NI C D).  
b.  Psyc h os oci al ass ess m e nt pri or t o h os pit al disc h ar g e : s oci al s u p p ort, d e pr essi o n, ec o n o mic 
st at us, a n d HI V sti g m a will b e m e as ur e d. T h e 1 2-it e m HI V sti g m a sc al e4 5 (i ncl u di n g e n act e d, 
i nt er n aliz e d, a n d a ntici p at e d sti g m a c o m p o n e nts), C E S -D (s h ort)  d e pr essi o n sc al e, M O S s oci al 
s u p p ort i nstr u m e nt, f o o d s ec urity, a n d A U DI T alc o h ol us e i nstr u m e nt will b e a d mi nist er e d t o 
p artici p a nts pri or t o disc h ar g e ( E 0 0 2 ).  
c. P ost -h os pit al s ervic es d eliv er e d : All p ost-h os pit al ass ess m e nts ( H o m e Li nk visit cli nic al 
i nstr u m e nt (HL 0 0 1 ), p artici p a nt c h all e n g es i d e ntifi e d d uri n g p ati e nt -c e nt er e d c o u ns eli n g 
s essi o ns (fr o m str uct ur e d c o u ns el or n ot es), tri a g e d ecisi o ns fr o m t h e disc h ar g e offic er, fi n di n gs 
o n l a b or at ory t esti n g, a n d cli nic al ev al u ati o n d uri n g i n p ati e nt or a m b ul at ory c ar e t h at H o m e Li nk 
ar m p artici p a nts r ec eiv e will b e a bstr act e d fr o m  h os pit al or cli nic p a p er or el ectr o nic r ec or ds a n d 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 1  of 3 3  
 
t h e el ectr o nic N ati o n al H e alt h L a b or at ory S ervic e r ec or ds. T h es e d at a will b e or g a niz e d t o 
d escri b e t h e i nt e nsity of c ar e, psyc h os oci al n e e ds, cli nic al d ecisi o n m aki n g, a n d m ost c o m m o n 
cli nic al sc e n ari os. 
S a m pl i n g: All p artici p a nts will h av e i n -h os pit al l a b or at ory a n d psyc h os oci al ass ess m e nts. All 
p artici p a nts i n t h e H o m e Li nk ar m will b e i ncl u d e d i n t h e ass ess m e nt of p ost -disc h ar g e n e e ds 
a n d tri a g e o utc o m es.  
 
2. 8
2. 8  A n al ysis
A n al ysis  
2. 8. 1. 1  Eff ectiv e n ess  a n alysis  
T a bl e 
T a bl e 6 . . Eff ecti v e n ess o utc o m es
Eff ecti v e n ess o utc o m es  
Pri m ary o utc o m e  
M ort ality  at six m o nt hs by ar m  
T est of pr o p orti o ns (c hi -s q u ar e) 
S ec o n d ary 
o utc o m es  
M ort ality at 1 2 m o nt hs  
T est of pr o p orti o ns (c hi -s q u ar e) 
Ti m e t o a ny n o n -ac ut e f oll o w -u p  
C ox pr o p orti o n al h az ar ds  
N u m b er of o ut p ati e nt f oll o w -u p c ar e e nc o u nt ers  
T est of m e di a ns ( Wilc ox o n r a nk s u m)  
N u m b er of ni g hts i n h os pit al p ost -i niti al disc h ar g e 
T est of m e di a ns ( Wilc ox o n r a nk s u m)  
S elf -r e p ort e d c ost of c ar e 
T est of m e di a ns ( Wilc ox o n r a nk s u m) 
 
2. 8. 1. 2  F e asi bility  a n alysis  
T a bl e 
T a bl e 7 . M e as ur es a n d a n al ysis f or f e asi bilit y, acc e pt a bilit y, a n d eff ects o n e n g a g e m e nt i n c ar e
. M e as ur es a n d a n al ysis f or f e asi bilit y, acc e pt a bilit y, a n d eff ects o n e n g a g e m e nt i n c ar e 
Ass ess m e nt  
Ass ess m e nt m et h o ds
Ass ess m e nt m et h o ds  
Ti mi n g  
St atistic al t est  
F e asi bilit y a n d 
F e asi bilit y a n d Acc e pt a bilit y
Acc e pt a bilit y  
Tri al:  
F e asi bility  
Pr o p orti o n of e nr oll e d p artici p a nts a m o n g a p pr o ac h e d a n d 
eli gi bl e p ati e nts  
 
Pr o p orti o n of p artici p a nts wit h c o m pl et e f oll o w -u p  
b as e -li n e 
 
 
1 y e ar  
Pr o p orti o n, t ot al st u dy  
I nt erv e nti o n: 
F e asi bility  
Pr o p orti o n of pl a n n e d h o m e visits s ucc essf ully c o m pl et e d, 
p ati e nt -c e nt er e d c o u ns eli n g s essi o ns c o m pl et e d, m e dic al 
ass ess m e nts, m e dic ati o n r ec o ncili ati o ns, a n d f o o d s ec urity 
m a n a g e m e nt  
3 m  
Pr o p orti o n, H o m e Li nk 
Ar m  
Acc e pt a bility  
Acc e pt a bility q u esti o n n air es wit h 7 acc e pt a bility d o m ai ns f or 
H C Ws  a n d  p artici p a nts  
6 m  
Pr o p orti o n, H o m e Li nk 
ar m  
Acc e pt a bility  
I n d e pt h i nt ervi e ws 
6 m  
T h e m atic a n alysis  
Eff ects o n c ar e e n g a g e m e nt b arri ers  
C ost  of c ar e 
acc ess  
Str uct ur e d q u esti o n n air e f or p artici p a nt s elf -r e p ort 
3 m , 6 m 
Wilc ox o n r a nk s u m  
M e dic ati o n 
r ec o ncili ati o n 
R ec o ncili n g pl a n n e d m e ds o n disc h ar g e d act u al m e ds wit h 
p ati e nt & w ay t h at p ati e nt is t aki n g  
3 m  
Pr o p orti o n, H o m e Li nk 
ar m  
HI V sti g m a  
S h ort f or m HI V sti g m a sc al e 4 5, 4 6 
b as eli n e, 6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
S oci al S u p p ort  
M OS s oci al s u p p ort i nstr u m e nt
4 7 
b as eli n e, 6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
F o o d s ec urity  
T hr e e q u esti o n sc al e  
b as eli n e, 6 
m o nt hs  
Wilc ox o n r a nk s u m t est  
D e pr essi o n  
C ES -D (s h ort)  
B as eli n e, 6 
m o nt hs  
Pr o p orti o n  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 2  of 3 3  
 
Alc o h ol us e  
Alc o h ol us e dis or d er i d e ntific ati o n t est ( A U DI T), s h ort e n e d 
v ersi o n 
B as eli n e, 6 
m o nt hs  
Pr o p orti o n  
 
2. 8. 1. 3  Acc e pt a bility  a n alysis  
O ur a p pr o ac h t o t h e q u alit ativ e d at a will i nv olv e t h e m atic a n alysis a n d e m pl oy b ot h i n d uctiv e 
a n d d e d uctiv e c o di n g t ec h ni q u es. 4 2, 4 3 W e will first d ev el o p a n a pri ori  c o d e b o ok t h at r efl ects k ey 
a n alytic c o nc e pts of pr e dis p osi n g , e n a bli n g , a n d n e e d  c h ar act eristics fr o m t h e A n d ers e n 
B e h avi or al M o d el. D uri n g t h e pr oc ess of r e a di n g a n d c o di n g of tr a nscri pts usi n g t his i niti al c o di n g 
sc h e m e, a d diti o n al c o d es m ay b e a d d e d t o d oc u m e nt e m er gi n g t h e m es of i nt er est.  
A n alysis will b e l e d by c o -I K erri g a n a n d will b e assist e d by t h e ex p eri e nc e d q u alit ativ e P H R U 
t e a m. Q u alit ativ e a n alysis will pr oc e e d by first ex pl ori n g br o a d p att er ns a n d ex p eri e nc es of st u dy 
p artici p a nts, a n d t h e n ass essi n g p ossi bl e si mil ariti es a n d dif f er e nc es i n ex p eri e nc es b et w e e n 
diff er e nt ty p es of p ati e nts (i ncl u di n g diff er e nt a g es, g e n d er, l ev el a n d ty p e of c ar e e n g a g e m e nt, 
etc.) a n d pr ovi d ers ( diff er e nt ty p es). Giv e n str o n g g e n d er r ol es i n S o ut h Afric a, w e will 
s p ecific ally ex pl or e p ot e nti al  diff e r e nc es i n p erc e pti o ns of a n d ex p eri e nc es wit h i nt erv e nti o n  
s ervic es a m o n g  p ati e nts b as e d o n g e n d er  of t h e p artici p a nt.  
2. 8. 1. 4  S oci al a n d m e dic al n e e ds a n alysis  
W e will us e d escri ptiv e a n alysis t o d escri b e t h e pr o p orti o n of p artici p a nts wit h s p ecific fi n di n gs 
(cli nic al or psyc h os oci al) or tri a g e d ecisi o ns a n d o utc o m es f oll o wi n g t h at d ecisi o n p at h. L o gistic 
r e gr essi o n will b e us e d t o ass ess f or ass oci ati o ns b et w e e n p ost-h os pit al o utc o m es a n d i n -
h os pit al m e dic al a n d psyc h os oci al m e as ur es. A m ultiv ari a bl e m o d el will ass ess f or s p ecific 
ass oci ati o ns a n d i nt er acti o ns b et w e e n si g nific a nt f act ors. S ex, a g e, a n d tri al ar m will b e i ncl u d e d, 
a pri ori, i n l o gistic r e gr essi o n m o d eli n g. T h es e fi n di n gs will b e us e d t o r efi n e t h e list of fi el ds o n 
t h e H o m e Li nk cli nic al i nstr u m e nt a n d cli nic al al g orit h m. 
All p ost -h os pit al ass ess m e nts ( H o m e Li nk visit cli nic al i nstr u m e nt ( A p p e n dix) ), p artici p a nt 
c h all e n g es i d e ntifi e d d uri n g p ati e nt -c e nt er e d c o u ns eli n g s essi o ns (fr o m str uct ur e d c o u ns el or 
n ot es), tri a g e d ecisi o ns fr o m t h e disc h ar g e offic er, fi n di n gs o n l a b or at ory t esti n g, a n d cli nic al 
ev al u ati o n d uri n g i n p ati e nt or a m b ul at ory c ar e t h at H o m e Li nk ar m p artici p a nts r ec eiv e will b e 
a bstr act e d fr o m h os pit al or cli nic p a p er or el ectr o nic r ec or ds a n d t h e el ectr o nic N ati o n al H e alt h 
L a b or at ory S ervic e r ec or ds. T h es e d at a will b e or g a niz e d t o d escri b e t h e i nt e nsity of c ar e, 
psyc h os oci al n e e ds, cli nic al d ecisi o n m aki n g, a n d m ost c o m m o n cli nic al sc e n ari os.  
 
3  D at a M a n a g e m e nt
D at a M a n a g e m e nt  
D a ta w ill b e co ll ect e d t o rev i e w st u dy ass o cia t ed o u tco m es i n or d e r t o eva l ua te  th e ex te nt  t o 
w h ic h t h e c ase m a n a g e m e nt  g o a ls a n d ob je ctives  a re  b e in g  m e t. T o a chi e ve t his, d a ta w ill b e 
co llect e d i n  t h e H o m e Li nk a n d C ar e as Us u al ar ms . I n a d diti o n t o t his, d at a will als o b e c oll ect e d 
t o ass ess act u al pr o gr a m m e p erf or m a nc e a g ai nst pl a n n e d activiti es. 
3. 1
3. 1  D at a c oll ecti o n t o ols
D at a c oll ecti o n t o ols  
T a bl e 
T a bl e 8 . 
8 . List of d at a c oll ecti o n t o ols a n d i nt e n d e d us e
List of d at a c oll ecti o n t o ols a n d i nt e n d e d us e  
N a m e of t o ol
N a m e of t o ol  
P ur p os e
P ur p os e  
Sc h e d ul e
Sc h e d ul e  
St u d y ar m
St u d y ar m  
Scr e e ni n g F or m 
(S 0 0 1 ) 
T o d oc u m e nt scr e e ni n g pr oc ess a n d t h at 
p artici p a nt m e ets e nr oll m e nt crit eri a  
I n h os pit al  
H o m e Li nk &  
C A U  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 3  of 3 3  
 
E nr oll m e nt 
d e m o gr a p hics a n d 
hist ory f or m ( E 0 0 1)  
T o c oll ect m e dic al hist ory pri or t o h os pit al 
a d missi o n, f oc us e d o n HI V a n d T B  
 
I n h os pit al  
H o m e Li nk &  
C A U  
Psyc h o -s oci al 
ass ess m e nt ( E 0 0 2 ) 
T o ass ess d e pr essi o n, sti g m a, s oci al s u p p ort, a n d 
f o o d s ec urity (C E S -D  (s h ort), s h ort-f or m HI V 
sti g m a, M O S s oci al s u p p ort, f o o d s ec urity sc al e, 
A U DI T alc o h ol us e i nstr u m e nt)  
I n h os pit al; 
p ost -h os pit al   
H o m e Li nk &  
C A U  
L oc at or f or m (L 0 0 1) 
T o c oll ect t h e p artici p a nt’s p ers o n al i nf or m ati o n 
i m p ort a nt f or i d e ntifyi n g a n d c o nt acti n g t h e 
p artici p a nt f or f oll o w u p aft er r el e as e.  
I n h os pit al  
H o m e Li nk &  
C A U  
P ost r el e as e l oc at or 
(L 0 0 2) 
T o u p d at e  t h e p artici p a nt’s p ers o n al i nf or m ati o n 
i m p ort a nt f or i d e ntifyi n g a n d c o nt acti n g t h e 
p artici p a nt f or f oll o w u p aft er r el e as e.  
P ost -h os pit al  
H o m e Li nk &  
C A U  
H os pit al disc h ar g e or 
d e at h 
d oc u m e nt ati o n 
( D 0 0 1) 
D oc u m e nt ati o n of h os pit al o utc o m e a n d d at e of 
i n h os pit al d e at h or h os pit al disc h ar g e 
I n h os pit al  
H o m e Li nk & 
C A U  
Off St u dy  
/ T er mi n ati o n 
(T 0 0 1 ) 
T o d oc u m e nt disc o nti n u e d p artici p ati o n i n t h e 
st u dy d u e t o wit h dr a w al, l oss t o f oll o w u p or e n d 
of t h e st u dy pr oc e d ur es.  
P ost -h os pit al  
H o m e Li nk &  
C A U  
F oll o w -u p p artici p a nt 
or alt er n at e c o nt act 
( F 0 0 1) 
T o c oll ect m e dic al hist ory si nc e l ast st u dy c o nt act  
P ost -h os pit al  
H o m e Li nk &  
C A U  
P ost -h os pit al m e dic al 
n e e ds ( F 0 0 2)  
R ec or d m e dic al i nt erv e nti o ns a n d s ervic es 
r ec eiv e d p ost-h os pit aliz ati o n  
P ost -h os pit al  
H o m e Li nk &  
C A U  
P artici p a nt h e alt h 
r el at e d fi n a nci al 
c osts ( F 0 0 3) 
O bt ai n s elf -r e p ort r e g ar di n g h e alt h c osts 
(tr a ns p ort t o visits, m e dic ati o ns, cli nic c osts) 
P ost -h os pit al  
H o m e Li nk & 
C A U  
Acc e pt a bility ( F 0 0 4)  
Acc e pt a bility sc al e f or s u bs et of p ati e nt 
p artici p a nts a n d h e alt h c ar e w orks  
P ost -h os pit al  
H o m e Li nk & 
H C Ws  
C ar e s atisf acti o n 
( F 0 0 5) 
T o c oll ect i nf or m ati o n o n c ar e -s atisf acti o n 
P ost -h os pit al  
H o m e Li nk & 
C A U  
Cli nic Visit  
V erific ati o n  (C 0 0 1 ) 
T o c oll ect d et ails of s elf -r e p ort e d p artici p a nt cli nic 
visits. Ti er. n et; N HL S Tr ackc ar e; cli nic n ot e 
a bstr acti o n  
P ost -h os pit al  
H o m e Li nk &  
C A U  
H o m e Li nk h o m e visit 
ass ess m e nt f or m  
(HL 0 0 1 ) 
Str uct ur e d cli nic al a n d n e e ds ass ess m e nt f or m  
P ost -h os pit al  
H o m e Li nk  
H o m e Li nk fi d elity 
( HL 0 0 2) * 
D oc u m e nt t h e H o m e Li nk h o m e visit ( arriv al ti m e, 
i n divi d u als pr es e nt, s ervic es r e n d er e d, a n d 
d e p art ur e ti m e)  
P ost -h os pit al  
H o m e Li nk  
H o m e Li nk 
C o u ns eli n g ( HL 0 0 3)  
T o d oc u m e nt p ati e nt -c e nt er e d c o u ns eli n g at 
H o m e Li nk h o m e visits  
P ost -h os pit al  
H o m e Li nk  
Arc hiv e f oll o w -u p 
( A 0 0 1) 
T o a bstr act r e -a d missi o n, cli nic visits, a n d 
d oc u m e nt e d d e at h fr o m t h e h os pit al p a p er fil e  
P ost -h os pit al  
H o m e Li nk &  
C A U  
L a b or at ory T esti n g 
(L T 0 0 1)*  
T o d oc u m e nt c oll ecti o n of l a b s p eci m e ns a n d 
r es ults f or HI V R N A, cr e ati ni n e a n d C D 4 c o u nts.  
P ost -h os pit al  
H o m e Li nk &  
C A U  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 4  of 3 3  
 
H o m e Li nk  Tr a nsiti o n  
( T R 0 0 1)*  
T o d oc u m e nt disc h ar g e of p artici p a nt fr o m H o m e 
Li nk h o m e s ervic es.  
P ost -h os pit al  
H o m e Li nk  
I nt ervi e w G ui d e 1 
I nt ervi e w g ui d e f or p ati e nt p artici p a nts 
P ost -h os pit al  
H o m e Li nk  
I nt ervi e w G ui d e 2 
I nt ervi e w g ui d e f or h e alt h c ar e w ork ers 
P ost -h os pit al  
H C Ws  
 
3. 2
3. 2  St u d y s a m pl e siz e
St u d y s a m pl e siz e  j ustific ati o n
j ustific ati o n 
W e pr o p os e t o r ecr uit a s a m pl e of 2 4 0 p artici p a nts r a n d o miz e d 1: 1 i nt o c ar e as us u al a n d C ar e 
Li n k ar ms.  T h e p artici p a nts will b e bl oc k e d t o i ncl u d e 3 0 HI V -u ni nf ect e d a d ults a n d 9 0 p e o pl e 
li vi n g wit h HI V p er ar m.  T h e s a m pl e siz e h as b e e n d et er mi n e d t o b e f e asi bl e gi v e n ti m e a n d 
b u d g et li mit ati o ns w hil e still pr o vi di n g i nsi g ht i nt o t h e effic ac y.  Usi n g t h e b as e r at e of m ort alit y 
fr o m o ur pr eli mi n ar y st u d y of 2 6 % a n d a n al p h a of 0. 0 5 a n d a s a m pl e siz e of 1 2 0 s plit 1:1 i n 
c ar e as us u al a n d H o m e Li n k ar ms w e h a v e r e pr es e nt e d p o w er v ers us i nt er v e nti o n ar m 
m ort alit y , wit h s u b-gr o u p a n al ysis li mit e d t o P W H,  i n T a bl e 1 1 .  W e n ot e t h at t h e pri m ar y g o al is 
f e asi bilit y a n d acc e pt a bilit y. W e ar e a p pr o pri at el y p o w er e d o nl y f or a s u bst a nti al d ecr e as e i n 
m ort alit y fr o m 2 6 % t o 1 0 %.  
 
T a bl e 
T a bl e 9 . P o w er b y v ar yi n g eff ect siz e o n r e d uci n g p ost
. P o w er b y v ar yi n g eff ect siz e o n r e d uci n g p ost-h os pit al m ort alit y
h os pit al m ort alit y  
 
+ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - +  
  |    a l p h a    p o w e r        N       N 1       N 2    d e l t a       p 1       p 2  |  
  | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |  
  |      . 0 5    . 1 5 8 9      1 8 0       9 0       9 0     - . 0 6      . 2 6       . 2  |  
  |      . 0 5    . 2 5 2 7      1 8 0       9 0       9 0     - . 0 8      . 2 6      . 1 8  |  
  |      . 0 5    . 3 7 6 4      1 8 0       9 0       9 0      - . 1      . 2 6      . 1 6  |  
  |      . 0 5    . 5 2 1 2      1 8 0       9 0       9 0     - . 1 2      . 2 6      . 1 4  |  
  |      . 0 5    . 6 7 0 4      1 8 0       9 0       9 0     - . 1 4      . 2 6      . 1 2  |  
  |      . 0 5     . 8 0 3      1 8 0       9 0       9 0     - . 1 6      . 2 6       . 1  |  
  |      . 0 5    . 9 0 1 9      1 8 0       9 0       9 0     - . 1 8      . 2 6      . 0 8  |  
  + - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - +  
 
 
 
3. 3
3. 3  Sc h e d ul e of c as e r e p ort f or ms
Sc h e d ul e of c as e r e p ort f or ms  
T a bl e 
T a bl e 1 0
1 0 . . Sc h e d ul e d st u d y visit wi n d o ws f or all p artici p a nts p ost
Sc h e d ul e d st u d y visit wi n d o ws f or all p artici p a nts p ost -h os pit al
h os pit al  
C as e R e p ort F or m
C as e R e p ort F or m  
F or m
F or m  
C o d e
C o d e  
Visits:
Visits:  
Visit 
Visit 0  
0  
Disc h ar g e
Disc h ar g e  
Visit 
Visit 1  
1  
P ost
P ost -
disc h ar g
disc h ar g
e  
e  
Visit 
Visit 2  
2  
P ost
P ost -
disc h ar g
disc h ar g
e  
e  
Visit 
Visit 3  
3  
P ost
P ost -
disc h ar g e
disc h ar g e  
Visit 
Visit 4  
P ost
P ost -
disc h ar g e
disc h ar g e  
Ti m e si nc e 
Ti m e si nc e 
r el e as e:
r el e as e: 
Disc h ar g e
Disc h ar g e  
8 w k
8 w k  
1 2 w k
1 2 w k  
2 6 w k
2 6 w k  
5 2 w k
5 2 w k  
H os pit al disc h ar g e f or m  
D 0 0 1  
 
X  
 
 
 
 
Psyc h os oci al ass ess m e nt  
E 0 0 2  
 
 
 
 
X  
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 5  of 3 3  
 
Cli nic Visit  V erific ati o n   
C 0 0 1  
 
 
 
 
X  
X  
H o m e Li nk h o m e visit 
ass ess m e nt f or m   
HL 0 0 1  
At h o m e 
visits 
 
 
 
 
 
H o m e Li nk fi d elity  
HL 0 0 2  
At h o m e 
visits 
 
 
 
 
 
H o m e Li nk C o u ns eli n g  
HL 0 0 3  
At h o m e 
visits 
 
 
 
 
 
L a b or at ory T esti n g 
(L T 0 0 1) 
L T 0 0 1 
 
 
 
 
X  
X  
F oll o w -u p p artici p a nt or 
alt er n at e c o nt act  
F 0 0 1  
 
 
X  
X  
X  
X  
P ost -h os pit al m e dic al 
n e e ds ass ess m e nt  
F 0 0 2  
 
 
 
X  
X  
 
P ost -h os pit al fi n a nci al 
c osts  
F 0 0 3  
 
 
 
X  
X  
 
Acc e pt a bility  
F 0 0 4  
 
 
 
X  
 
 
C ar e s atisf acti o n  
F 0 0 5  
 
 
 
X  
 
 
Arc hiv e f oll o w -u p  
A 0 0 1  
 
 
 
 
X  
X  
H o m e Li nk Tr a nsiti o n  
T R 0 0 1  
At h o m e 
visits 
 
 
 
 
 
Off St u dy / T er mi n ati o n  
T 0 0 1  
 
[ X] 
[ X] 
[ X] 
[ X] 
[ X] 
X r e q uir e d C R F, [ X] m ay b e r e q uir e d if u p d at e d or as n ec ess ary  
 
3. 4
3. 4  D at a b as e
D at a b as e  
3. 4. 1   Str uct ur e of t h e d at a b as e  
T his st u d y will r el y o n t w o d at a b as es.  O n e will b e us e d t o c a pt ur e p artici p a nt c h ar act eristics 
a n d o utc o m es ( m ai n d at a b as e).  T h e ot h er d at a b as e will b e a st u d y a d mi nistr ati v e d at a b as e 
us e d f or m o nit ori n g of H o m e Li n k visits ( a d mi nistr ati v e d at a b as e).  M a i n st u d y d at a will b e 
c a pt ur e d i nt o a s ec ur e w e b b as e d R E D C a p ™ ( R es e arc h El ectr o nic D at a C a pt ur e) el ectr o nic 
d at a b as e. T h e R e dc a p d at a b as e pr o vi d es; a n i nt uiti v e i nt erf ac e f or v ali d at e d d at a e ntr y; a u dit 
tr ails f or tr ac ki n g d at a m a ni p ul ati o n a n d ex p ort pr oc e d ur es; a ut o m at e d ex p ort pr oc e d ur es f or 
s e a ml ess d at a d o w nl o a ds t o c o m m o n st atistic al p ac k a g es; a n d pr oc e d ur es f or i m p orti n g d at a 
fr o m ext er n al s o urc es. A s e p ar at e d at a b as e (a d mi nistr ati v e d at a b as e ) will b e d e v el o p e d  t o 
assist wit h tr ac ki n g of u pc o mi n g st u d y f oll o w -u p visits . D a ta e n tr y f or th e a d mi nistr ati v e 
d a t a ba s e wi ll b e m a in ta i ne d o n a d a il y b a sis f or r eal -tim e  us e o f d ata.  O n t h e d a y  of  e nr o lm e n t, 
t h e i d en tifica ti o n a n d  co nt a ct d e t ails will b e e n te re d i n to t h e  p a p er l oc at or C R F (L 0 0 1) w hic h 
will b e st or e d i n a l oc k e d c a bi n et i n a s ec ur e offic e a dj ac e nt t o Ts h e p o n g H os pit al.  T h e 
a d mi nistr ati v e  d a ta b a se  w ill b e u p d a te d wit hi n t hr e e d a ys of t h e p artici p a nt’s disc h ar g e d at e.   
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 6  of 3 3  
 
W e will d e v el o p a s e p ar at e d at a b as e f or m wit hi n R E D C a p f or e ac h p a p er c as e r e p ort f or m 
( C R F). All fi el ds will h a v e a p pr o pri at e r a n g e-c h ec ks f or v ali d ati o n d uri n g d at a-e ntr y.  Fi el d 
n u m b ers a n d n a m es i n t h e d at a b as e will c orr es p o n d t o n u m b ers a n d n a m es o n t h e C R F.  D at a 
will b e r ec or d e d eit h er o n p a p er C R Fs or dir ectl y i nt o R E D C a p. All p a p er d at a f or ms will b e 
i d e ntifi e d wit h t h e p artici p a nt st u d y i d e ntifi er a n d will n ot i ncl u d e a n y p ers o n al i d e ntifi er 
i nf or m ati o n ( exc e pt f or t h e scr e e ni n g a n d p ati e nt l oc at o r f or ms). P a p er f or ms will b e 
m ai nt ai n e d i n a l oc k e d c a bi n et i n a s ec ur e offic e a dj ac e nt t o Ts h e p o n g H os pit al.  F or all d at a n ot 
c a pt ur e d dir ectl y i nt o t h e d at a b as e s yst e m d uri n g p artici p a nt e nc o u nt ers, tr ai n e d d at a 
c a pt ur ers will e nt er d at a fr o m p a p er f or ms i nt o t h e d at a b as e.   
 
D at a e ntr y v ali d ati o n a n d a ut o m atic r a n g e c h ec ks will b e i nc or p or at e d i n m ost d at a fi el ds t o 
r e d uc e d at a e ntr y err ors.  I n a d diti o n, f or d at a c oll ect e d o n p a p er C R Fs a n d t h e n e nt er e d i nt o 
R E D C a p, a d at a m o nit or will c o m p ar e a p pr oxi m at el y 1 0 % of C R Fs wit h d at a wit hi n t h e 
d at a b as e.  T his will h el p t o i d e ntif y s yst e m atic err ors.  S uc h pr o bl e ms m a y l e a d t o a r e vi e w of a 
l ar g er pr o p orti o n of C R Fs. I n a d diti o n, bi-w e e kl y el ectr o nic c h ec ks f or i nc o nsist e n ci es wit hi n a n d 
acr oss f or ms will b e p erf or m e d f oll o w e d b y C R F r e vi e w of a n y d at a q u eri es t h at ar e g e n er at e d.   
3. 4. 2  D at a b as e acc ess  
Acc ess t o t h e d at a b as e ( d at a e ntr y, r e p orti n g, a n d extr acti o n) is c o ntr oll e d b y t h e D at a 
M a n a g er, St u d y M a n a g er , a n d t h e R E D C a p D at a b as e A d mi nistr at or. St u d y p ers o n n el r e q uiri n g 
acc ess t o t h e d at a b as e m ust c o m pl et e r e q uir e d d oc u m e nt ati o n a n d tr ai ni n g pri or t o r ec ei vi n g 
t h e n ec ess ar y us er n a m e a n d p ass w or d. 
3. 4. 3  L oc ki n g of fi n al d at a b as e 
T h e fi n al st u d y d at a b as e is l oc k e d t o c h a n g es aft er t h e cl e a n fil e f or m h as b e e n si g n e d. Fi n al 
st or a g e of t h e d at a b as e is wit h t h e pr o d ucti o n f ol d er str uct ur e t o g et h er wit h all t h e M et a d at a, 
s o urc e d at a a n d t h e us er writt e n pr o gr a ms a n d t h e v ersi o n of t h e s yst e m us e d t o pr o d uc e t h e 
d at a b as e. T h e f ol d er is gi v e n a s p eci al ic o n t o s h o w it is l oc k e d a n d t h e a v ail a bl e c h oic es ar e 
r estrict e d t o r e a di n g t h e d at a. 
3. 4. 4  D at a s ec urit y  
All p a p er st u d y r ec or ds ( e. g. c o ns e nt f or ms, scr e e ni n g l o gs) will b e k e pt i n a s ec ur e l oc ati o n 
acc essi bl e o nl y t o a ut h oriz e d  st u d y st aff, i n v esti g at ors, a n d m o nit ors.  N o p ers o n al i d e ntifi ers 
will b e c a pt ur e d o n R E D C a p a n d a ll p artici p a nts will b e iss u e d wit h a st u d y s p ecific n u m b er.   
3. 4. 5  St u d y li mit ati o ns  
T h e pr o p os e d i m pl e m e nt ati o n r es e arc h h as t h e f oll o wi n g li mit ati o ns:  
- 
P ar tici p an t se lf-r e p ort re g a rdi n g  l a pses  i n m e d ica tio ns  a n d e n tr y in t o ca re m a y  i ntro d uc e 
b ia s as p a rtici pa n ts m a y f a v o ur th e m ost  so ci all y a cc e pta b le r es p on s es. V e rifica tio n of  se lf-
r e p ort e d e n tr y-i nt o-c ar e us in g  clin ic r ecor ds w ill b e c o n d u ct e d, wh e re p oss ibl e,  fo r a ll 
p a rtici pa n ts. . 
- 
F oll o w u p a n d o bs er v ati o n of p artici p a nts i n t h e c ar e as  us u al ar m  ( m a y r es ult i n m o difi e d 
or i m pr o v e d p artici p a nt o utc o m es b ec a us e of t h e f act t h at t h e y ar e b ei n g c o nt act e d.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 7  of 3 3  
 
- 
A l o w pr o p orti o n p artici p ati n g w o ul d m ar k e dl y r e d uc e t h e g e n er aliz a bilit y of t h e r es ults.  
O ur ex p eri e nc e is wit h a n i nt er est a n d willi n g n ess of h os pit aliz e d p ati e nt s t o p artici p at e i n 
st u di es.  T h us w e d o n ot a ntici p at e t his t o b e a si g nific a nt li mit ati o n. 
 
4  A p pr o pri at e c ar e i n r es p o ns e t o st u d y
A p pr o pri at e c ar e i n r es p o ns e t o st u d y -s p ecific fi n di n gs
s p ecific fi n di n gs 
D uri n g all ev al u ati o ns i ncl u di n g pr e -disc h ar g e a n d p ost -disc h ar g e cli nic ally r el ev a nt i nf or m ati o n 
m ay b e c oll ect e d.  T his i nf or m ati o n i ncl u d es l a b or at ory t est r es ults, h e alt h scr e e ni n g 
i nf or m ati o n, a n d ass ess m e nts f or d e pr essi o n (C E S -D, s h ort ) a n d alc o h ol us e dis or d er ( A U DI T).  
Fi n di n gs fr o m all of t h es e will b e pr ovi d e d t o t h e “ disc h ar g e offic er”, a m e dic al d oct or, f or 
d et er mi n ati o n of acti o n. P ost -h os pit al cli nic al ass ess m e nts occ urri n g i n t h e H o m e Li nk ar m ar e 
r evi e w e d by t h e “ disc h ar g e offic er” as p art of t h e i nt erv e nti o n a n d t h e str uct ur e d ass ess m e nt 
c h ecklist wit h s p ecifi e d tri g g ers f or acti o n.  R es ults fr o m pr e -disc h ar g e t esti n g a n d psyc h o m etric 
t o ols f or t h e c ar e as us u al p artici p a nts will b e pr ovi d e d t o t h e “ disc h ar g e offic er” f or r evi e w a n d 
si g n-of f. R es ults i n dic ati n g cli nic al acti o n will b e a p pr o pri at ely r ef err e d ( e. g. micr o bi ol o gic t est 
r es ults i n dic ati n g i nf ecti o n, C E S -D (s h ort)  m e eti n g a t hr es h ol d f or d e pr essi o n, A U DI T s u g g esti n g 
alc o h ol us e dis or d er). R ef err als will b e m a d e t o t h e Ts h e p o n g s p e ci alty cli nics, Ts h e p o n g -b as e d 
cli nic al psyc h ol o gists, Ts h e p o n g -b as e d cli nic al s oci al w ork ers, or a pri m ary c ar e cli nic at w hic h a 
p ati e nt is r ec eivi n g c ar e will b e c o nt act e d wit h cli nic al r ec o m m e n d ati o ns.  T h es e 
r ec o m m e n d ati o ns m ay i ncl u d e m e dic al c ar e ( e. g. i niti at e T B tr e at m e nt b as e d o n p ositiv e T B 
r es ults) or psyc h ol o gic al ass ess m e nt at t h at cli nic. F or p artici p a nts i n t h e H o m e Li nk i nt erv e nti o n 
ar m wit h i n dic ati o ns of d e pr essi o n a n d/ or alc o h ol a b us e, c o u ns elli n g will b e pr ovi d e d d uri n g 
h o m e -b as e d visit s. 
 
5  Pr ot ecti o n of h u m a n p artici p a nts
Pr ot ecti o n of h u m a n p artici p a nts  
5. 1
5. 1  R e g ul at or y a p pr o v als
R e g ul at or y a p pr o v als  
T his st u dy will b e c o n d uct e d acc or di n g t o G o o d Cli nic al Pr actic e ( G C P) g ui d eli n es a n d c o m pl et e d 
i n c o m pli a nc e wit h i nt er n ati o n al a n d l oc al h u m a n s u bj ect r es e arc h g ui d eli n es. A p pr ov als will b e 
s o u g ht fr o m U niv ersity of t h e Wit w at ersr a n d H u m a n R es e arc h Et hics C o m mitt e e, N ort h W est 
Pr ovi nc e,  a n d t h e J o h ns H o pki ns U niv ersity I R B.  
 
5. 2
5. 2  Ris ks a n d b e n efits
Ris ks a n d b e n efits  
- 
T h e n at ur e of t his r es e arc h is f oc us e d o n i m pr ovi n g o utc o m es r e g ar di n g a sit u ati o n u ni q u e t o 
h os pit aliz e d i n divi d u als. T h e m aj ority of p ot e nti al b e n efit fr o m r es e arc h r es ults will i nf or m 
c ar e f or t his m e dic ally  v ul n er a bl e p o p ul ati o n.  T h e risk p os e d by t h e c o m p o n e nts of t his 
st u dy ar e e q u al t o or l ess t h a n t h at of d aily lif e.  T h e pri m ary risk will b e of i n a dv ert e nt 
discl os ur e of HI V st at us t hr o u g h c o nt act wit h st u dy st aff –  risks pr es e nt wit h o bt ai ni n g p u blic 
secti o n HI V c ar e i n S o ut h Afric a.  W hil e t his r isk is w h at is f ac e d i n p u blic s ecti o n c ar e, it is of 
s eri o us c o nc er n f or t h e st u dy a n d will b e a d dr ess e d t hr o u g h tr ai ni n g of st u dy st aff a n d 
discr eti o n d uri n g h o m e visits i ncl u di n g usi n g u n m ark e d v e hicl es.   
 
1.1.  N o exc essi v e i n d uc e m e nts f or p artici p ati o n.
N o exc essi v e i n d uc e m e nts f or p artici p ati o n.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 8  of 3 3  
 
P artici p a nts will n ot r ec eiv e s p ecific r e m u n er ati o n f or ov er all st u dy p artici p ati o n.  P ati e nt 
p artici p a nts will r ec eiv e R 1 0 0 f or ti m e a n d or tr av el f or i n -d e pt h i nt ervi e ws.  
 
2.2.  T h e i nf or m ati o n is pr es e nt e d i n l a n g u a g e t h at is u n d erst a n d a bl e t o t h e s u bj ect 
T h e i nf or m ati o n is pr es e nt e d i n l a n g u a g e t h at is u n d erst a n d a bl e t o t h e s u bj ect 
p o p ul ati o n.
p o p ul ati o n.  
T h e P artici p a nt I nf or m ati o n S h e et ( PI S) a n d ot h er st u dy r el at e d c o m m u nic ati o n is at t h e 
p artici p a nt l ev el. A d diti o n ally, t h e PI S will b e tr a nsl at e d i nt o t h e m ost c o m m o n l oc al l a n g u a g es 
s p ok e n i n t h e M atl os a n a ar e a.  
Writt e n i nf or m e d c o ns e nt will b e o bt ai n e d fr o m eli gi bl e p artici p a nts or t h eir n ext of ki n w hil e i n 
t h e h os pit al f or p ati e nt p artici p a nts a n d fr o m h e alt h w ork er p artici p a nts at ti m es c o nv e ni e nt t o 
t h e m. T h e c o ns e nt pr oc ess will b e d o n e i n a priv at e ar e a t o e ns ur e c o nfi d e nti ality. I nf or m e d 
writt e n c o ns e nt, usi n g Et hics C o m mitt e e/I R B -a p pr ov e d c o ns e nt f or ms, will b e o bt ai n e d by 
tr ai n e d st u dy p ers o n n el pri or t o p erf or mi n g a ny st u dy-s p ecific pr oc e d ur es. I nf or m e d c o ns e nt is a 
pr oc ess t h at will b e i niti at e d pri or t o t h e i n divi d u al’s a gr e ei n g t o p artici p at e i n t h e st u dy a n d will 
c o nti n u e t hr o u g h o ut t h e i n divi d u al’s st u dy p artici p ati o n. S h o ul d i nf or m e d c o ns e nt i niti ally b e 
o bt ai n e d fr o m t h e p ot e nti al p artici p a nt’s n ext of ki n, w e will a d diti o n ally c o ns e nt t h e p artici p a nt 
if a n d w h e n t h ey’r e a bl e t o d o s o. P ot e nti al p artici p a nts or t h eir n ext of ki n will r ec eiv e 
i nf or m ati o n a b o ut risks a n d p ossi bl e b e n efits of st u dy p artici p ati o n, st u dy o bj ectiv es a n d 
pr oc e d ur es. I nf or m e d c o ns e nt r e q uir es t h e l e g ally eff ectiv e si g n at ur e  or m ark of t h e s u bj ect  or 
t h eir n ext of ki n. A c o py of t h e si g n e d a n d d at e d i nf or m e d c o ns e nt d oc u m e nt will b e off er e d t o 
e ac h p artici p a nt f or his or h er r ec or ds.  T h e ri g hts a n d w elf ar e of t h e s u bj ects will b e pr ot ect e d 
by e m p h asizi n g t o s u bj ects t h at t h e tr e at m e nt by cli nici a ns will n ot b e a dv ers ely aff ect e d if t h ey 
d ecli n e t o p artici p at e i n t his st u dy, a n d t h at t h ey m ay wit h dr a w c o ns e nt at a ny ti m e. T h e 
i nv esti g at or will r et ai n a c o py of t h e si g n e d c o ns e nt f or ms, w hic h m ay b e i ns p ect e d at t h e 
m o nit or’s/ a u dit or’s r e q u est.  T h e i nv esti g at or will pr o m ptly r e p ort t o t h e Et hics C o m mitt e e/I R B 
of all c h a n g es i n t h e r es e arc h activity a n d all u n a ntici p at e d pr o bl e ms i nv olvi n g risks t o h u m a n 
s u bj ects or ot h ers, a n d will n ot m ak e c h a n g es i n t h e r es e arc h wit h o ut Et hics C o m mitt e e/I R B 
a p pr ov al, exc e pt w h er e n ec ess ary t o eli mi n at e a p p ar e nt i m m e di at e h az ar ds t o h u m a n s u bj ects.  
T h e i nf or m e d c o ns e nt pr oc ess will i ncl u d e a v er b al r evi e w of t h e st u dy, pr ovisi o n o n p artici p a nt 
i nf or m ati o n s h e ets i n r el ev a nt l a n g u a g es, r evi e w of t h e i nf or m ati o n s h e ets, a n d a ns w eri n g a n y 
q u esti o ns . P artici p a nts or t h eir n ext of ki n w h o ar e u n a bl e t o r e a d or writ e will b e ask e d t o m ak e 
a m ark or t h u m b pri nt i n t h e pr es e nc e of a wit n ess (v er b al c o ns e nt will n ot b e o bt ai n e d).  O nly 
writt e n i nf or m e d c o ns e nt will all o w f or st u dy p artici p ati o n.  
 
3.3.  H e alt h c ar e w ork er p artici p ati o n  
H e alt h s ervic e st aff i nv olv e d i n t h e disc h ar g e pr oc ess or H o m e Li nk i nt erv e nti o n will b e r ecr uit e d 
f or p artici p ati o n.  S el ect e d st aff m e m b ers will r ec eiv e an  i nvit ati o n wit h f oll o w-u p by a st u dy 
t e a m m e m b er r e g ar di n g i nt er est i n p artici p ati o n.  St u dy i nf or m ati o n will b e pr ovi d e d t o t h e 
p ot e nti al st aff p artici p a nt. St aff willi n g t o p artici p at e will b e ask e d t o si g n a writt e n i nf or m e d 
c o ns e nt d oc u m e nt i n d u plic at e.  O n e c o py will b e pr ovi d e d t o t h e st aff m e m b er a n d t h e ot h er 
will b e r et ai n e d i n st u dy fil es.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 2 9  of 3 3  
 
T h e c o ns e nt pr oc ess a n d d ecisi o n r e g ar di n g p artici p ati o n will r e m ai n c o nfi d e nti al fr o m h os pit al 
offici als, t h e st u dy PI, a n d st u dy c o -i nv esti g at ors.  I nt ervi e ws a m o n g st aff p artici p a nts will b e 
sc h e d ul e d t o t ak e pl ac e i n a priv at e s etti n g at a l at er ti m e an d d at e.  
 
5. 3
5. 3  Cli nic al tri als r e gistr ati o n
Cli nic al tri als r e gistr ati o n  
T h e st u dy will b e r e gist er e d wit h cli nic altri als. g ov.  K ey st u dy i nf or m ati o n a n d r es ults will h av e 
o p e n -acc ess av ail a bility o n t h e cli nic altri als. g ov w e bsit e.  T his is i n acc or d wit h f u n d er ( NI H) 
r e g ul ati o ns. 
5. 4
5. 4  C o nfi d e nti alit y
C o nfi d e nti alit y  
All st u dy r ec or ds will b e m a n a g e d i n a s ec ur e a n d c o nfi d e nti al f as hi o n. All r ec or ds will b e st or e d 
i n r es e arc h offic e s p ac e a dj ac e nt t o t h e Ts h e p o n g H os pit al i n l ock e d fili n g c a bi n ets a n d acc ess t o 
t h e r ec or ds will b e r estrict e d t o s p ecifi e d st u dy t e a m m e m b ers. C as e r e p ort f or ms a n d c as e 
m a n a g e m e nt d oc u m e nts will b e i d e ntifi e d usi n g t h e p artici p a nt’s st u dy n u m b er o nly, wit h 
l oc at or i nf or m ati o n st or e d s e p ar at ely.   
5. 5
5. 5  D at a s af et y a n d m o nit ori n g
D at a s af et y a n d m o nit ori n g  
A d at a s af ety a n d m o nit ori n g b o ar d will b e est a blis h e d t o r evi e w of t h e pr ot oc ol a n d m o nit ori n g 
pl a n pri or t o c o m m e nc e m e nt of e nr oll m e nt i nt o t h e R C T a n d m e et virt u ally  pri or t o c o m m e nci n g 
e nr oll m e nt a n d t h e n  ev ery 6 m o nt hs t o r evi e w of R C T pr o gr ess, e nr oll m e nt a n d o utc o m es d at a, 
a n d a ny p ot e nti al a dv ers e o utc o m es. T h e m e eti n gs will r evi e w s af ety t o s u g g est pr oc e d ur al 
c h a n g es a n d st u dy m o dific ati o ns. T h er e will b e n o crit eri a f or st u dy t er mi n ati o n b as e d o n 
eff ectiv e n ess b ec a us e t his is a pil ot f e asi bility s t u dy wit h a t ot al s a m pl e siz e t h at m ay n ot all o w 
cl e ar ass ess m e nt of diff er e nc e. T h e D S M B will i ncl u d e 3 -5 m e m b ers i ncl u di n g i n divi d u als wit h 
ex p eri e nc e wit h HI V c ar e, cli nic al o utc o m es r es e arc h, cli nic al tri als , a n d g o o d cli nic al pr actic e. 
 
6  Pr oj ect G o v er n a nc e a n d M a n a g e m e nt
Pr oj ect G o v er n a nc e a n d M a n a g e m e nt  
6. 1
6. 1  R es e arc h t e a m
R es e arc h t e a m  
- Dr. C hrist o p h er H off m a n n, M D, M P H, M Sc
Dr. C hrist o p h er H off m a n n, M D, M P H, M Sc  is a cli nici a n sci e ntist, Ass oci at e Pr of ess or at 
J o h ns H o pki ns U niv ersity. Dr. H off m a n n will pr ovi d e ov er all l e a d ers hi p f or st u dy 
i m pl e m e nt ati o n. 
- Pr of 
Pr of N eil M arti ns o n M B B C h, M P H is a cli nici a n sci e ntist a n d Ex ec uti v e Dir ect or of t h e 
N eil M arti ns o n M B B C h, M P H is a cli nici a n sci e ntist a n d Ex ec uti v e Dir ect or of t h e 
P eri n at al HI V R es e arc h U nit.  Pr of
P eri n at al HI V R es e arc h U nit.  Pr of  M arti ns o n is t h e S o ut h Afric a n PI a n d will pr o vi d e 
M arti ns o n is t h e S o ut h Afric a n PI a n d will pr o vi d e 
o v ersi g ht t o t h e S o ut h Afric a n t e a m.
o v ersi g ht t o t h e S o ut h Afric a n t e a m.  
 
T h e st u dy t e a m ( PI , S o ut h Afric a n PI, a n d c o -Is) will m e et bi w e ekly t o r evi e w st u dy pr o gr ess.  T h e 
PI will m e et w e ekly wit h t h e R es e arc h M a n a g er t o disc uss o p er ati o n al as p ects of t h e st u dy 
i m pl e m e nt ati o n.  Dr K erri g a n  will m e et as n e e d e d f or q u alit ativ e a n alysis c o m p o n e nts.  T h e PI 
will m ak e 3 –  4 visits a n n u ally t o st u dy sit es.  
 

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 3 0  of 3 3  
 
 
 
Fi g ur e 
Fi g ur e 2 : : Pr oj ect M a n a g e m e nt Str uct ur e
Pr oj ect M a n a g e m e nt Str uct ur e  
 
6. 2
6. 2  P u blic ati o n p olic y
P u blic ati o n p olic y  
T h e r es e arc h fi n di n gs will b e pr es e nt e d first t o n ati o n al st ak e h ol d ers, a n d diss e mi n at e d t o 
st ak e h ol d ers a n d p artici p a nts i n e ac h pr ovi nc e by m e a ns of l oc al m e eti n gs. T h e r es ults will b e 
writt e n u p as o n e or m or e articl es f or s u b missi o n t o a s uit a bl e sci e ntific j o ur n al.   
6. 3
6. 3  P erf or m a nc e m o nit ori n g
P erf or m a nc e m o nit ori n g  
T h e pri nci p al i nv esti g at or will c o m pl et e a m o nt hly pr o gr ess r e p ort t h at will f acilit at e m o nit ori n g 
of st u dy pr o gr ess a n d k e e pi n g t h e f u n d ers i nf or m e d. T h es e r e p orts will c a pt ur e vit al i nf or m ati o n, 
s uc h as I R B ti m eli n es, st at us of pr ot oc ol d ev el o p m e nt, e nr ol m e nt fi g ur es, a n d a ny iss u es/ d el ays 
t h at t h e PI m ay b e ex p eri e nci n g. 
 
7
 
7  P artici p a nt r ei m b urs e m e nt
P artici p a nt r ei m b urs e m e nt  
P artici p a nts will n ot r ec eiv e p ay m e nt f or p artici p ati o n i n t h e st u dy .  P ati e nt p artici p a nts will 
r ec eiv e R 1 0 0 f or ti m e a n d or tr av el f or i n-d e pt h i nt ervi e ws.  
8  F u n di n g
F u n di n g  
F u n di n g f or t his st u dy is pr ovi d e d by t h e N ati o n al I nstit ut e of M e nt al H e alt h, U S A,  Gr a nt 
N u m b er: 1 R 3 4 M H 1 1 8 9 9 8 . 
 
 
C o -Is 
G ol u b  
K erri g a n  
M arti ns o n  
Ki n g h or n  
V ariav a  
R es e arc h M a na g er  
( S h e ar er) 
 
R es e arc h Fi el d T e a m / 
D at a m a n a g e m e nt  
 
Pri nci p al I nv esti g at or  
( H off m a n n) 
 
D S M B Ov ersi g ht  
 
Sit e –  PI ( M arti ns o n)  
  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 3 1  of 3 3  
 
 
9  R ef er e nc es
R ef er e nc es  
 
1.  
St at s S A. M ort alit y a n d c a u s e s of d e at h i n S o ut h Afri c a, 2 0 1 5. I n: Afri c a S S, e d. Pr et ori a, S o ut h 
Afri c a: G o v er n m e nt of S o ut h Afri c a; 2 0 1 7.  
2.  
U N AI D S. C o u ntr y: S o ut h Afri c a. 2 0 1 8; 
htt p:// w w w. u n ai d s. or g/ e n/r e gi o n s c o u ntri e s/ c o u ntri e s/ s o ut h afri c a . 
3.  
U N AI D S. U N AI D S D at a 2 0 1 7.  V ol 2 0 1 7. S wit z erl a n d: J oi nt U nit e d N ati o n s Pr o gr a m m e o n 
HI V/ AI D S; 2 0 1 7.  
4.  
O u sl e y J, Ni yi bi zi A A, W a nj al a S, et al. Hi g h Pr o p orti o n s of P ati e nt s Wit h A d v a n c e d HI V Ar e 
A ntir etr o vir al T h er a p y E x p eri e n c e d: H o s pit ali z ati o n O ut c o m e s Fr o m 2 S u b -S a h ar a n Afri c a n Sit e s. 
Cli n I nf e ct Di s. 2 0 1 8; 6 6( s u p pl _ 2): S 1 2 6 -S 1 3 1.  
5.  
Sii k a A, M c C a b e L, B w a k ur a -D a n g ar e m bi zi M, et al. L at e Pr e s e nt ati o n Wit h HI V i n Afri c a: 
P h e n ot y p e s, Ri s k, a n d Ri s k Str atifi c ati o n i n t h e R E A LI T Y Tri al. Cli n I nf e ct Di s. 
2 0 1 8; 6 6( s u p pl _ 2): S 1 4 0 -S 1 4 6.  
6.  
P o st F A, S z u b ert A J, Pr e n d er g a st A J, et al. C a u s e s a n d Ti mi n g of M ort alit y a n d M or bi dit y A m o n g 
L at e Pr e s e nt er s St arti n g A ntir etr o vir al T h er a p y i n t h e R E A LI T Y Tri al. Cli n I nf e ct Di s. 
2 0 1 8; 6 6( s u p pl _ 2): S 1 3 2 -S 1 3 9.  
7.  
P e c k R N, W a n g R J, Mt ui G, et al. Li n k a g e t o Pri m ar y C ar e a n d S ur vi v al Aft er H o s pit al Di s c h ar g e 
f or HI V-I nf e ct e d A d ult s i n T a n z a ni a: A Pr o s p e cti v e C o h ort St u d y. J o ur n al of a c q uir e d i m m u n e 
d efi ci e n c y s y n dr o m e s. 2 0 1 6; 7 3( 5): 5 2 2 -5 3 0.  
8.  
M ur p h y R A, S u n p at h H, T a h a B, et al. L o w u pt a k e of a ntir etr o vir al t h er a p y aft er a d mi s si o n wit h 
h u m a n i m m u n o d efi ci e n c y vir u s a n d t u b er c ul o si s i n K w a Z ul u -N at al, S o ut h Afri c a. T h e i nt er n ati o n al 
j o ur n al of t u b er c ul o si s a n d l u n g di s e a s e : t h e offi ci al j o ur n al of t h e I nt er n ati o n al U ni o n a g ai n st 
T u b er c ul o si s a n d L u n g Di s e a s e. 2 0 1 0; 1 4( 7): 9 0 3 -9 0 8.  
9.  
D e p art m e nt of H e alt h R o S A. R e g ul ati o n s r el ati n g t o c at e g ori e s of h o s pit al s. I n: D e p art m e nt of 
H e alt h R o S A, e d. Pr et ori a: G o v er n m e nt of S o ut h Afri c a; 2 0 1 2.  
1 0.  
M ei ntj e s G, K er k h off A D, B urt o n R, et al. HI V -R el at e d M e di c al A d mi s si o n s t o a S o ut h Afri c a n 
Di stri ct H o s pit al R e m ai n Fr e q u e nt D e s pit e Eff e cti v e A ntir etr o vir al T h er a p y S c al e -U p. M e di ci n e 
( B alti m or e). 2 0 1 5; 9 4( 5 0): e 2 2 6 9.  
1 1.  
St u art -Cl ar k H, V or aj e e N, Z u m a S, et al. T w el v e -m o nt h o ut c o m e s of p ati e nt s a d mitt e d t o t h e 
a c ut e g e n er al m e di c al s er vi c e at Gr o ot e S c h u ur H o s pit al. S o ut h Afri c a n m e di c al j o ur n al = S ui d -
Afri k a a n s e t y d s krif vir g e n e e s k u n d e. 2 0 1 2; 1 0 2( 6): 5 4 9 -5 5 3.  
1 2.  
St a nl e y A, Gr a h a m N, P arri s h A. A r e vi e w of i nt er n al m e di ci n e r e -a d mi s si o n s i n a p eri -ur b a n 
S o ut h Afri c a n h o s pit al. S o ut h Afri c a n m e di c al j o ur n al = S ui d -Afri k a a n s e t y d s krif vir g e n e e s k u n d e. 
2 0 0 8; 9 8( 4): 2 9 1 -2 9 4.  
1 3.  
R o c h e S, D e Vri e s E. M ulti m or bi dit y i n a l ar g e di stri ct h o s pit al: A d e s cri pti v e cr o s s -s e cti o n al 
st u d y. S o ut h Afri c a n m e di c al j o ur n al = S ui d -Afri k a a n s e t y d s krif vir g e n e e s k u n d e. 
2 0 1 7; 1 0 7( 1 2): 1 1 1 0 -1 1 1 5.  
1 4.  
V o s s D e Li m a Y, E v a n s D, P a g e -S hi p p L, et al. Li n k a g e t o c ar e a n d tr e at m e nt f or T B a n d HI V 
a m o n g p e o pl e n e wl y di a g n o s e d wit h T B or HI V -a s s o ci at e d T B at a l ar g e, i n n er cit y S o ut h Afri c a n 
h o s pit al. Pl o S o n e. 2 0 1 3; 8( 1): e 4 9 1 4 0.  
1 5.  
O sl er M, Hil d er br a n d K, G o e m a er e E, et al. T h e C o nti n ui n g B ur d e n of A d v a n c e d HI V Di s e a s e 
O v er 1 0 Y e ar s of I n cr e a si n g A ntir etr o vir al T h er a p y C o v er a g e i n S o ut h Afri c a. Cli n I nf e ct Di s. 
2 0 1 8; 6 6( s u p pl _ 2): S 1 1 8 -S 1 2 5.  
1 6.  
H ol m e s C B, Si k a z w e I, Si k o m b e K, et al. E sti m at e d m ort alit y o n HI V tr e at m e nt a m o n g a cti v e 
p ati e nt s a n d p ati e nt s l o st t o f oll o w -u p i n 4 pr o vi n c e s of Z a m bi a: Fi n di n g s fr o m a m ulti st a g e 
s a m pli n g -b a s e d s ur v e y. P L o S m e di ci n e. 2 0 1 8; 1 5( 1): e 1 0 0 2 4 8 9.  
1 7.  
W H O. C H O o si n g I nt er v e nti o n s t h at ar e C o st Eff e cti v e ( W H O -C H OI C E). 2 0 1 8; 
htt p:// w w w. w h o.i nt/ c h oi c e/ c o u ntr y/ z af/ c o st/ e n/ . A c c e s s e d 4/ 2 7/ 2 0 1 8, 2 0 1 8. 
1 8.  
H off m a n n C J, M a b ut o T, M c C art h y K, M a ul s b y C, H olt gr a v e D R. A Fr a m e w or k t o I nf or m 
Str at e gi e s t o I m pr o v e t h e HI V C ar e C o nti n u u m i n L o w - a n d Mi d dl e -I n c o m e C o u ntri e s. AI D S E d u c 
Pr e v. 2 0 1 6; 2 8( 4): 3 5 1 -3 6 4.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 3 2  of 3 3  
 
1 9.  
A h m e d S, A utr e y J, K at z I T, et al. W h y d o p e o pl e li vi n g wit h HI V n ot i niti at e tr e at m e nt ? A 
s y st e m ati c r e vi e w of q u alit ati v e e vi d e n c e fr o m l o w - a n d mi d dl e -i n c o m e c o u ntri e s. S o c S ci M e d. 
2 0 1 8; 2 1 3: 7 2 -8 4.  
2 0.  
K at z I T, E s si e n T, M ari n d a E T, et al. A ntir etr o vir al t h er a p y r ef u s al a m o n g n e wl y di a g n o s e d HI V -
i nf e ct e d a d ult s. AI D S. 2 0 1 1; 2 5( 1 7): 2 1 7 7 -2 1 8 1.  
2 1.  
T o p p S M, M w a m b a C, S h ar m a A, et al. R et hi n ki n g r et e nti o n: M a p pi n g i nt er a cti o n s b et w e e n 
m ulti pl e f a ct or s t h at i nfl u e n c e l o n g -t er m e n g a g e m e nt i n HI V c ar e. Pl o S o n e. 
2 0 1 8; 1 3( 3): e 0 1 9 3 6 4 1.  
2 2.  
M u k u m b a n g F C, M w al e J C, v a n W y k B. C o n c e pt u ali si n g t h e F a ct or s Aff e cti n g R et e nti o n i n C ar e 
of P ati e nt s o n A ntir etr o vir al Tr e at m e nt i n K a b w e Di stri ct, Z a m bi a, U si n g t h e E c ol o gi c al 
Fr a m e w or k. AI D S R e s Tr e at. 2 0 1 7; 2 0 1 7: 7 3 5 6 3 6 2.  
2 3.  
W ar e N C, W y att M A, G e n g E H, et al. T o w ar d a n u n d er st a n di n g of di s e n g a g e m e nt fr o m HI V 
tr e at m e nt a n d c ar e i n s u b-S a h ar a n Afri c a: a q u alit ati v e st u d y. P L o S m e di ci n e. 
2 0 1 3; 1 0( 1): e 1 0 0 1 3 6 9; di s c u s si o n e 1 0 0 1 3 6 9.  
2 4.  
M a b ut o T, C h ar al a m b o u s S, K e n n e d y C, H off m a n n C J. P er c e pti o n s of V al u e a n d C o st of HI V 
C ar e E n g a g e m e nt F oll o wi n g Di a g n o si s i n S o ut h Afri c a. AI D S a n d b e h a vi or. 2 0 1 8.  
2 5.  
J ai n K, M s h w e s h w e -P a k el a N T, C h ar al a m b o u s S, M a b ut o T, H off m a n n C J. E n h a n ci n g v al u e a n d 
l o w eri n g c o st s of c ar e: a q u alit ati v e e x pl or ati o n of a r a n d o mi z e d li n k a g e t o c ar e i nt er v e nti o n i n 
S o ut h Afri c a. AI D S C ar e. 2 0 1 8: 1 -8.  
2 6.  
R e nj u J, M o s h a b el a M, M c L e a n E, et al. ' Si d e eff e ct s' ar e ' c e ntr al eff e ct s' t h at c h all e n g e r et e nti o n 
i n HI V tr e at m e nt pr o gr a m m e s i n si x s u b-S a h ar a n Afri c a n c o u ntri e s: a m ulti c o u ntr y q u alit ati v e 
st u d y. S e x Tr a n s m I nf e ct. 2 0 1 7; 9 3( S u p pl 3).  
2 7.  
M a u g h a n -Br o w n B, K u o C, G al arr a g a O, et al. St u m bli n g Bl o c k s at t h e Cli ni c: E x p eri e n c e s of 
S e e ki n g HI V Tr e at m e nt a n d C ar e i n S o ut h Afri c a. AI D S a n d b e h a vi or. 2 0 1 8; 2 2( 3): 7 6 5 -7 7 3.  
2 8.  
R o s e n S, M a s k e w M, F o x M P, et al. I niti ati n g A ntir etr o vir al T h er a p y f or HI V at a P ati e nt' s Fir st 
Cli ni c Vi sit: T h e R a pI T R a n d o mi z e d C o ntr oll e d Tri al. P L o S m e di ci n e. 2 0 1 6; 1 3( 5): e 1 0 0 2 0 1 5.  
2 9.  
M a c P h er s o n P, L all o o D G, W e b b E L, et al. Eff e ct of o pti o n al h o m e i niti ati o n of HI V c ar e f oll o wi n g 
HI V s elf -t e sti n g o n a ntir etr o vir al t h er a p y i niti ati o n a m o n g a d ult s i n M al a wi: a r a n d o mi z e d cli ni c al 
tri al. J A M A. 2 0 1 4; 3 1 2( 4): 3 7 2 -3 7 9.  
3 0.  
L a b h ar dt N D, Ri n g er a I, L ej o n e TI, et al. Eff e ct of Off eri n g S a m e -D a y A R T v s U s u al H e alt h 
F a cilit y R ef err al D uri n g H o m e -B a s e d HI V T e sti n g o n Li n k a g e t o C ar e a n d Vir al S u p pr e s si o n 
A m o n g A d ult s Wit h HI V i n L e s ot h o: T h e C A S C A D E R a n d o mi z e d Cli ni c al Tri al. J A M A. 
2 0 1 8; 3 1 9( 1 1): 1 1 0 3 -1 1 1 2.  
3 1.  
H off m a n n C J M, T.; Gi ni n d z a, S.; Fi el di n g, K. L.; K u b e k a, G.; D o w d y, D.; C h ur c h y ar d, G. J.; 
C h ar al a m b o u s, S. A r a n d o mi z e d tri al t o a c c el er at e HI V c ar e a n d A R T i niti ati o n f oll o wi n g HI V 
di a g n o si s. C o nf er e n c e o n R etr o vir u s e s a n d O p p ort u ni sti c Ill n e s s e s; F e br u ar y 2 2 -2 6, 2 0 1 6; 
B o st o n, M A.  
3 2.  
Cr a w J A, G ar d n er LI, M ar k s G, et al. Bri ef str e n gt h s -b a s e d c a s e m a n a g e m e nt pr o m ot e s e ntr y 
i nt o HI V m e di c al c ar e: r e s ult s of t h e a ntir etr o vir al tr e at m e nt a c c e s s st u d y-II. J 
A c q uirI m m u n e D efi c S y n dr. 2 0 0 8; 4 7( 5): 5 9 7 -6 0 6.  
3 3.  
M c N air y M L, L a m b M R, G a c h u hi A B, et al. Eff e cti v e n e s s of a c o m bi n ati o n str at e g y f or li n k a g e 
a n d r et e nti o n i n a d ult HI V c ar e i n S w a zil a n d: T h e Li n k 4 H e alt h cl u st er r a n d o mi z e d tri al. P L o S 
m e di ci n e. 2 0 1 7; 1 4( 1 1): e 1 0 0 2 4 2 0.  
3 4.  
B o ut w ell A G, F.; H w u, S.; S h a n n o n, D. Eff e cti v e I nt er v e nti o n s t o R e d u c e R E h a o s pit ali z ati o n s: A 
C o m p e n di u m of 1 5 Pr o mi si n g I nt er v e nti o n s. C a m bri d g e, M A: I n stit ut e f or H e alt h c ar e 
I m pr o v e m e nt; 2 0 0 9. 
3 5.  
L e p pi n A L, Gi o nfri d d o M R, K e s sl er M, et al. Pr e v e nti n g 3 0 -d a y h o s pit al r e a d mi s si o n s: a 
s y st e m ati c r e vi e w a n d m et a -a n al y si s of r a n d o mi z e d tri al s. J A M A I nt er n M e d. 2 0 1 4; 1 7 4( 7): 1 0 9 5 -
1 1 0 7.  
3 6.  
S hi p p e e N D, S h a h N D, M a y C R, M air F S, M o nt ori V M. C u m ul ati v e c o m pl e xit y: a f u n cti o n al, 
p ati e nt -c e nt er e d m o d el of p ati e nt c o m pl e xit y c a n i m pr o v e r e s e ar c h a n d pr a cti c e. J Cli n 
E pi d e mi ol. 2 0 1 2; 6 5( 1 0): 1 0 4 1 -1 0 5 1.  
3 7.  
J aff ar S, A m ur o n B, F o st er S, et al. R at e s of vir ol o gi c al f ail ur e i n p ati e nt s tr e at e d i n a h o m e -b a s e d 
v er s u s a f a cilit y -b a s e d HI V -c ar e m o d el i n Ji nj a, s o ut h e a st U g a n d a: a cl u st er -r a n d o mi s e d 
e q ui v al e n c e tri al. L a n c et. 2 0 0 9; 3 7 4( 9 7 0 7): 2 0 8 0 -2 0 8 9.  

 
 
H o m e Li nk Pr ot oc ol v6 . 0 0 3  A u g ust  2 0 2 2  
Li nk 0 0 1 
P a g e 3 3  of 3 3  
 
3 8.  
W o o d d S L, Gr o s s k urt h H, L e vi n J, et al. H o m e -b a s e d v er s u s cli ni c -b a s e d c ar e f or p ati e nt s 
st arti n g a ntir etr o vir al t h er a p y wit h l o w C D 4( +) c ell c o u nt s: fi n di n g s fr o m a cl u st er -r a n d o mi z e d tri al. 
AI D S. 2 0 1 4; 2 8( 4): 5 6 9 -5 7 6.  
3 9.  
D e p art m e nt of H e alt h R o S A. Pr o vi n ci al G ui d eli n e s f or t h e I m pl e m e nt ati o n of t h e T hr e e Str e a m s 
of P H C R E -E n gi n e eri n g. I n: H e alt h, e d. Pr et ori a 2 0 1 1.  
4 0.  
N ai d o o N R, J.; J o b s o n, G; M atl a k al a, N; M ari n c o wit z, G; M cI nt yr e, J A; Str ut h er s, H E; P et er s, 
R P H. M a ki n g w ar d -b a s e d o utr e a c h t e a m s a s eff e cti v e c o m p o n e nt of h u m a n i m m u n o d efi ci e n c y 
vir u s pr o gr a m m e s i n S o ut h Afri c a. S o ut h er n Afri c a n J o ur n al of HI V M e di ci n e. 2 0 1 8; 1 9( 1): 1 -6.  
4 1.  
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r e vi e w s a n d d e v el o p m e nt of a t h e or eti c al fr a m e w or k. B M C H e alt h S er v R e s. 2 0 1 7; 1 7( 1): 8 8.  
4 2.  
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P u bli c ati o n s; 2 0 1 3.  
4 3.  
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4 4.  
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s er vi c e s at pri m ar y h e alt h -c ar e f a ciliti e s i n t h e Fr e e St at e, S o ut h Afri c a --a t w o -y e ar st u d y u si n g 
f o ur w a v e s of cr o s s-s e cti o n al d at a. B M C H e alt h S er v R e s. 2 0 0 8; 8: 2 1 0.  
4 5.  
R ei ni u s M, W ett er gr e n L, Wi kl a n d er M, S v e d h e m V, E k str o m A M, Eri k s s o n L E. D e v el o p m e nt of a 
1 2 -it e m s h ort v er si o n of t h e HI V sti g m a s c al e. H e alt h Q u al Lif e O ut c o m e s. 2 0 1 7; 1 5( 1): 1 1 5.  
4 6.  
B er g er B E, F err a n s C E, L a s hl e y F R. M e a s uri n g sti g m a i n p e o pl e wit h HI V: p s y c h o m etri c 
a s s e s s m e nt of t h e HI V sti g m a s c al e. R e s N ur s H e alt h. 2 0 0 1; 2 4( 6): 5 1 8 -5 2 9.  
4 7.  
S h er b o ur n e C D, St e w art A L. T h e M O S s o ci al s u p p ort s ur v e y. S o c S ci M e d. 1 9 9 1; 3 2( 6): 7 0 5 -7 1 4.