PART A (General Particulars)

1. Proposed Project Title: Health related Quality of ife and H!"#related $ti%&a a&on% the People i'in% (ith H!")A!*$ +. Principal !n'esti%ator: (Detail curriculum vitae is annexed) Dr. Ummul Khair Alam Medical officer, Department of Population dynamics, !P"#M ,. -o#in'esti%ator(s): (A copy of the curriculum vitae and list of pu$lications in respect of each colla$oratin% investi%ator is annexed) &. Dr. Md. Anisur 'ahman Professor ( )ead, Department of *pidemiolo%y !P"#M +. Dr. Md. 'i,-anul Karim Asst. Professor, Department of *pidemiolo%y, !P"#M .. Place of the study ) !nstitution(s): )ealth facilities and sentinel centers (.#/ .#) entitled to (authori,ed to) provide health services to people havin% )!0/A!D". /. $ponsorin% ) colla0oratin% a%ency: 1an%ladesh Medical research 2ouncil. 1. *uration: 3 (six) Months. 2. *ate of -o&&ence&ent: As soon as fund -ill $e availa$le. 3. *ate of -o&pletion: 4ithin six months from the date of startin%. 4. Total -ost: 56.78,99,999/7 15. 6ther $upport for Proposed Research: il (&) !s this research pro:ect $ein% "upported $y any other source< (+) )as an application for fundin% of (=) !s this pro:ect $een su$mitted to any other or%ani,ation(s)< ;es ;es ;es o o o

!f >;es> to &9(&) or &9(+) a$ove, please indicate the or%ani,ation(s) and amount of funds.

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11. *ate of $u0&ission:

+=/&9/ +9&=

1+. $i%nature of Principal !n'esti%ator:

????????????????????????? Dr. Ummul Khair Alam

1,. $i%nature of -o#!n'esti%ator(s) : ???????????????????????? &= Dr. Md. Anisur 'ahman &@ &8 &3 &A ???????????????????????? &B Dr. Md. 'i,-anul Karim

1.. 7ndorse&ent of the !nstitute Head: "i%nature: ???????????????????????? Prof. Dr. "aro: Kumar Ma,umder Desi%nation: Director, ational !nstitute of Preventive and "ocial Medicine. ( !P"#M)

#fficial "eal:

21

PART#8
PR!9-!PA !9"7$T!GAT6R($) !9:6R;AT!69 $H77T &. (i) ame: Dr. Umul Khair Alam (ii) Desi%nation: Medical #fficer, Department of Population Dynamics (iii) #fficial Address -ith telephone: Medical #fficer, Population Dynamics ational !nstitute of Preventive and "ocial Medicine Phone. 9+7CBCBACB, 9&A&&3=CCB= emailD ummul?upalEyahoo.com (iv) Present 'esidential Address -ith telephone: +/A7=, Property *nclave, 8@, e- *s6aton 'oad, Dha6a7&999 +. Academic $ac6%round

ame of the de%ree ""2 )"2 M11" MP) in 'eproductive and 2hild )ealth

;ear &CC3 &CCB +99@ +9&+

!nstitute 0iFarunnisa oon "chool 0iFarunnisa oon "chool and 2olle%e 1an%ladesh Medical 2olle%e ational !nstitute of Preventive and "ocial Medicine ( !P"#M)

1oard Dha6a Dha6a Dha6a Dha6a

'emar6s &st Division &st Division 'e%ular 'e%ular

=. @.

Gield *xperience: Hist is attached (it is in the resume of the principal investi%ator) (a) 'esearch *xperience Hist is attached (it is in the resume of the principal investi%ator) ($) #ther *xperiences: Hist is attached (it is in the resume of the principal investi%ator) Percenta%e of time to $e devoted to this pro:ect: =9I um$er of "cientific Pu$lications: Hist is attached (it is in the resume of the principal investi%ator)

8. 3.

21

PART # PR6<7-T

Health Related Quality of People i'in% (ith H!")A!*$

$=;;AR>

ife and H!"#related $ti%&a a&on% the

)ealth related Fuality of life and )!07related sti%ma are $ecomin% a %reat concern for the people livin% -ith )!0/A!D" for desi%nin% intervention to support them. 5he proposed cross sectional study -ill $e conducted -ith the primary aim to assess the level of health related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and determine their associated factors. 5he aim of the study -ill $e also to find out the association $et-een )'JoH and )!07related sti%ma amon% the respondents. )!0 positive patients attendin% in .overnment and non%overnment health facilities -ill $e selected purposively on the $asis of specific inclusion and exclusion criteria for this study. Appropriate research instruments comprisin% intervie-er administered semi structured Fuestionnaires -ill $e developed $y adoptin% K4)#J#H7 )!0 1'*G instrumentL for assessin% )JoH and validated K*nacted and perceived )!07 related sti%ma measurin% FuestionnaireL used $y other researchers, -ill $e used to collect data. Descriptive statistics includin% means, medians, standard deviations, ran%es, and minimum ( maximum for continuous data and freFuencies and proportion for cate%orical data -ill $e calculated. Gor inferential statistics, mainly t7test, one -ay A #0A and M+7test -ill $e used for uniivariate analysis. Ginally step-ise lo%istic re%ression model -ill $e constructed and ad:usted odds ratio of the statistically si%nificant predictors -ill $e reported -ith C8I confidence interval for the odds ratio. 5his study findin%s -ill $e used not only to assess the physical and medical needs of )!0/A!D" people, $ut also their psycholo%ic, social, environmental, and spiritual areas of life. Determination of these factors can help service providers to select the $est method of therapy thus -ill increase the efficacy of therapy.

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Part *
1. !9TR6*=-T!69 )!0/A!D" is a %lo$al pro$lem that endan%ers $oth individual and national -ell7$ein%. !t continues to spread and affect the lives of millions of people. 1y the end of +99A, ==.+ million people -orld-ide -ere livin% -ith )!0, +.A million people are ne-ly infected and +.9 million people died due to )!07related illness. 5he ma:ority of them are in "u$7 "aharan Africa -hich is estimated ++ million (+9.8 N +=.3 million), $ut epidemic are emer%in% in Asia and *astern *urope. Most infectious diseases affect the youn% and the old, $ut )!0/A!D", $y contrast, ta6es its lar%est toll on -or6in%7a%e populations. An estimated =9.B million people of -or6in% a%e %roup -ere livin% -ith )!0 -orld-ide in +99A.& *conomic development of a country depends on -or6in%7a%e population for a%riculture, education, industrial -or6 and other sectors of economic activity. Gor this reason, the economic conseFuences of A!D" are particularly de$ilitatin%.+ A!D" has devastatin% impact in all the facet of society. !t reduces the half of life expectancy in "u$7"aharan Africa.= 5he pro%ress of human development is lost $y more the + years -hen )!0 increases $y &I in a population. 4hen prevalence rises more than 3I, it ta6es a country && years lon%er to reach a particular level of human development. !ncreased )!0/A!D" in the society increases a$senteeism and staff turnover due to illness. !t also causes loss of tacit 6no-led%e, s6ill, declinin% moral. All these lead to loproductivity and lo-er investment and ultimately exert a ne%ative impact on macro7 economy. .ross Domestic product %ro-th has dropped $y +.3I in those countries havin% )!0 prevalence more than +9I. !n "u$7"aharan African .DP %ro-th has fallen $y +7 @I.+7=

1an%ladesh is still a lo- prevalence country for overall )!0 rates. 5he prevalence of )!0 from the first detection in &CBC up to +99A in the %eneral population of 1an%ladesh appears to $e at under 9.& percent.@5his prevalence is estimated to $e $elo- & per cent in all ris6 %roups except for in:ectin% dru% users (!DU), thou%ht to $e a relatively small %roup of people. 2urrent lo- prevalence situations can possi$ly mas6 an increasin% prevalence

21

in %eneral population due to hi%h ris6 factors in 1an%ladesh. 5he factors relatin% to hi%h prevalence of )!0 in the nei%h$orin% countries, existence of commercial sex and M"M -ith multiple clients, hi%h prevalence of "5!s amon%st the commercial sex -or6ers, spread of )!0 throu%h $rid%in% population (transport -or6ers, dru% users), the trend of rise of )!0 amon% (lDUs) in:ectin% dru% users (!n +993 it is found that the prevalence of )!0 amon% !DU in Dha6a 2ity had risen to A.9 percent), lo- condom use and lac6 of voluntary $lood donation, increased population movement $oth internal and external, lac6 of a-areness of )!0 infection, %ender ineFuities, poverty and %ap in health care delivery have $een identified as $ein% important factors in the spread of )!0 infection. At the same time factors li6e reli%ious and cultural values, family $onda%e and hi%h level of circumcision amon% man -hich help 1an%ladesh to remain a lo- prevalent country for )!0. @, 8

!n +998, === ne- cases of )!0 infection -ere reported, includin% &+8 ne- cases of A!D" and &@ deaths. and that some-here $et-een +.+ and =.C million more people -ere at elevated ris6 of acFuirin% )!0, includin% in:ectin% dru% users, female sex -or6ers and their clients, M"M, and internal mi%rants ( A"P/ Mo)G4, +998). @ 5ill Decem$er +9&9, there -ere +9BB reported cases of )!0 and B89 cases of A!D", amon% them +@& died. A$out A,899 people are livin% -ith )!0. !n recent United reported cases rose sharply. @ ations .eneral Assem$ly "pecial "ession on )!0/A!D" (U .A"") reportin% period, ho-ever, the num$er of

Grom its inception, the AcFuired !mmunodeficiency "yndrome (A!D") -as considered as su$7acute disease -ith a short life expectancy for patients after dia%nosis. Grom the next follo-in% decade, it has $ecome a chronic disease as a conseFuence of the advancement of in clinical test and treatment and implementation of ne- pro%ram for people livin% -ith )!0/A!D" (PH4)A). 3 Gor these reasons the survival of these patients has $een increased and the issue of )ealth related Fuality of life ()JoH) has increasin%ly %ained importance as an outcome measure of this disease.A )ealth related Juality of Hife -as introduced in the research on )!0/A!D" in &CC9. Juality of life (J#H) is a term that is popularly used

21

to convey an overall sense of -ell7$ein% and includes aspects such as happiness and satisfaction -ith life as a -hole. research.37C !t has $ecome an important facet of )!0/A!D"

0arious associations $et-een Khealth related Fuality if life ()JoH)L and other factors have $een reported in a num$er of studies of patients -ith )!0/A!D".
37&&

A study at the

University of 2incinnati, the 2incinnati 0A Medical 2enter, the 0A Pitts$ur%h )ealthcare "ystem, and .eor%e 4ashin%ton University Medical 2enter has found several factors that correlate the level of )'JoH of an individual. *mployment, si%nificant depressive symptoms, health -orries, financial -orries, )!0 mastery, provider trust, perceived social support, self7esteem, spirituality, symptom $other, and overall functionin% -ere associated -ith )'JoH.B "everal other factors -ere si%nificantly correlated -ith all $ut one of the )'JoH outcomes, and they included education, veteran status, duration of disease, history of A!D"7definin% conditions, disclosure -orries, or%ani,ed reli%ious activity, and ne%ative reli%ious copin%. &9 Another %roup of researchers found in their study that also conducted in developed country that -omen -ith )!0/A!D" report su$stantially poorer )JoH than men -ith )!0/A!D" in several )JoH domains.C )ealth 'elated Juality of Hife is severely comprised in PH4A in "ta%es = and @.
&9

A study -ith @@+ samples in a )!0 epidemic country of "outh *ast Asia, 5hailand,

has found a%e, social supportD antiretroviral treatment and self7care strate%ies had a si%nificant positive effect on the )JoH. Moreover social support and antiretroviralD treatment had an indirect effect on the )JoH via self7care strate%ies.&& As many of the )!0 patients stru%%le -ith numerous social pro$lems such as sti%ma, poverty, depression, su$stance a$use, and cultural $eliefs -hich can affect their J#H not only from the physical health aspect, $ut also from mental and social health point of vieand cause numerous pro$lems in useful activities and interests of the patients, assessin% health7related Fuality of life ()'J#H) is useful for documentin% the patients> perceived $urden of chronic disease, trac6in% chan%es in health over time, assessin% the effects of treatment and Fuantifyin% the return on health care investment. &&

21

"ti%ma is a discreditin% attri$ute that reduces individuals into de%raded persons. &+ People livin% -ith )!0/A!D" (PH4)A) employ diverse copin% mechanisms -hen their self -orth and net-or6s are disrupted $y sti%ma. "ti%ma can comes in many forms, includin% %ossip and ver$al a$use, :ud%ments and morally driven assumptions a$out ho- PH4)A acFuired the infection, violence and physical a$use, and loss of :o$s and livelihood. !n multivariate models of a study conducted in U"A found that enacted sti%ma -as associated -ith %ay/$isexual identity, symptomatic )!0 or A!D", and $arterin% sex. Perceived sti%ma -as associated -ith female %ender, symptomatic )!0 or A!D", $arterin% sex, lo-er in:ection dru% use, and fe-er friends and family 6no-in% serostatus. .ay/$isexual youn% people livin% -ith )!0/A!D" -ho -ere also )!0 symptomatic or A!D" dia%nosed experienced more )!07sti%ma than their heterosexual peers.
&+

"tudy

findin%s hi%hli%ht a %ender and rural7ur$an dichotomy that seems to influence the experience of )!0 felt sti%ma. &= !n the healthcare settin%, )!0 sti%ma and discrimination lead to PH)!0 $arriers in access to prevention, care, and treatment services. 5he association $et-een )!07sti%ma and )JoH are not -ell studies. A prospective in )on% Kon% -ith &@@ )!0 positive people found that )!07sti%ma had an independent ne%ative effect on )JoH.&@

!n an !ranian study J#H of )!0 positive people had noticed that %ender, marital status, level of education, 2D@ count, and clinical sta%e of the disease, had a si%nificant effect on the Fuality of life of the patients. !n multivariate analysis, the most important predictor of the Fuality of life -as clinical sta%e of disease.&8 )ealth related Fuality of life and )!07related sti%ma are the %reat concern for these lar%e %roups of people livin% -ith )!0/A!D" for desi%nin% intervention to support them, $ut unfortunately there is still relatively little empirical research on understandin% the level and factors associated health related Fuality of life and )!07related sti%ma of people livin% -ith )!0/A!D" in developin% country. Most of the studies -ere conducted in developed countries.
A7&9

Gindin%s of these studies may not $e al-ays relevant to

developin% countries. "o the current study aimed at to determine the level and associated factors of )JoH and )!07sti%ma.

21

+. 68<7-T!"7$ General o0jecti'e: 5o assess )ealth related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and to determine their associated factors.

$pecific o0jecti'es: &. 5o assess the health related Fuality of life ()'JoH) of people livin% -ith )!0 and A!D"D +. 5o measure the )!07related sti%ma amon% the respondentsD =. 5o determine the association $et-een )'JoH and )!07related sti%ma amon% the respondentsD @. 5o determine the influence of disease sta%e and antiretroviral therapy on )'JoH and )!07sti%ma of the respondentsD 8. 5o determine the influence of socio7demo%raphic characteristics on )!07sti%ma and )'JoH.

21

,. RAT!69A 7 5he increasin% pandemic of )!0/A!D" at present is one of the ma:or %lo$al concerns and a si%nificant development issue. 1ut recent advance in 6no-led%e a$out the disease, $etter dia%nostic methods, ne- treatments and stren%then of )!0 pro%ram have %reat hope for lon%er survival of )!0 positive people.
&8

Gor this reason )JoH of these lar%e num$er

people $ecome %reat concern. Measurement of )'J#H, -hich is often performed to identify pro$lems or assess outcomes, is also useful pro%nostically. )o-ever, little is 6no-n a$out the relation of )'J#H to survival amon% persons -ith )!0 throu%hout the -orld. )!07related sti%ma and discrimination remains a ma:or $arrier to fi%ht a%ainst )!0 and A!D" epidemic. )!07related sti%ma often prevents people from %ettin% tested, see6in% treatment for A!D" or from admittin% their )!0 status pu$licly. "ti%ma and discrimination are not only o$stacles to )!0 prevention, care and treatment for people livin% -ith )!0 $ut also expands terri$le conseFuences )!07related sti%ma are found in all parts of the -orld -ith varyin% manifestation from place to place. )!07sti%ma has $een increasin%ly reco%ni,ed as a 6ey factor impedin% )!0 identification, prevention, and treatment efforts.
&=

Gor this reasons it is o$viously needed to determine the level and

factors of )!07related sti%ma amon% the people livin% -ith )!0/A!D" in the society. 5he understandin% of the level and factors associated -ith health related Fuality of life and )!07related sti%ma amon% the people livin% -ith )!0/A!D" is crucial for desi%nin% interventions to support the people livin% -ith )!0/A!D" (PH)A). Determination of a valid and relia$le )JoH and )!07sti%ma measure is necessary that can $e used not only to assess the physical and medical needs of )!0/A!D" people, $ut also their psycholo%ic, social, environmental, and spiritual areas of life. Determination of these factors may help to select the $est method of therapy and doin% the $est to treat these patients. 5herefore, the efficacy of therapies -ill $e increased.

21

.. ;7TH6*6 6G> ..1. $tudy type: 5his study -ill $e desi%ned -ith the principal o$:ective of determinin% the level of health related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and their associated factors. 5he aim of the study -ill also $e to find out the association $et-een )'JoH and )!07related sti%ma amon% the respondents. !t -ill $e a cross7sectional study desi%n. ..+ $tudy place: All authori,ed .overnment and )!0/A!D" in 1an%ladesh .., $tudy population Patients -ith )!0/A!D" attendin% selected health facilities ... $a&ple si?e: =sin% for&ula
n= O + pF d+

on%overnment health facilities desi%nated to treat

All the )!0 positive people attendin% to authori,ed .#, .# health facilities durin% data collection period -ill $e our sample si,e of this study. (Approximately +89). 5he follo-in% selection criteria -ill $e employed: Inclusion criteria: All )!0 positive patients attendin% in selected centers durin% data collection period A%e a$ove &B years 4illin% to participate in this study

Exclusion criteria: Presence of any o$vious co7mor$id condition not associated -ith )!0/A!D" ot -illin% to participate in this study

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../ $a&plin% techni@ue Gacility $ased survey ..1 *ata collectin% instru&ent: A semi7structured pre7tested intervie-er administered Fuestionnaire in 1an%la and chec6 list -ill $e used for data collection. At first the varia$les -ill $e identified accordin% to the specific o$:ectives. 5hen indicators and appropriate scale of measurement for each varia$le -ill $e identified. After that an *n%lish Fuestionnaire -ill $e developed usin% some -ell accepted research tools and identified varia$les. "ocio7demo%raphic information -ill $e o$tained throu%h Fuestionnaire and K4)#J#H7)!0 1'*G instrumentL for assessin% )ealth related Fuality of life and K*nacted and perceived )!07related sti%ma measurin% FuestionnaireL adapted from those reported $y some other study for assessin% )!07related sti%ma. &=,&B,&C -ill also $e incorporated -ith the main Fuestionnaire. 5he *n%lish Fuestionnaire -ill $e translated into 1an%la -ith necessary correction and thorou%h chec6in%. Data on the sta%e of )!0 infection (no symptoms, symptoms/early )!0 disease, and A!D"), duration since dia%nosis of )!0, 2D@ count, sta%e of viral load (0H), co7mor$idities antiretroviral treatment -ill $e collected from record $oo6 usin% chec6list. and

5he Gollo-in% tools -ill $e used to prepare data collectin% instrument: Health related Quality of Life (HQOL) )'Jol -ere assessed $y usin% the =& items 4)#J#H7)!0 1'*G instrument. 5he 4orld )ealth #r%ani,ation Juality of Hife Juestionnaire for )!0 $rief version (4)#J#H7)!0 1'*G) -ill used to assess each patientPs Fuality of life. 5he 4)#J#H is a multidimensional, conceptuali,ed, %eneric, =&7item JoH instrument &3. !ts Fuestions cover the respondentPs perception of the overall Fuality of life -ithin the follo-in% 3 $road domains and -ithin each domain, there is a series of su$ domains (facets) of the Fuality of life that summari,es that particular domain: &. Physical health descri$es @ facets: +. Psycholo%ical state descri$es 8 facets

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=. Hevel of independence descri$es @ facets: @. "ocial relationships domain descri$es @ facets 8. *nvironment descri$es B facets 3. "pirituality, reli%ion and personal $eliefs descri$es @ facets 4)#J#H Fuestions are ans-ered on a 87point Hi6ert7 type scale ran%in% from & to 8. 5he mean score of items -ithin each domain is used to calculate the domain score. Mean scores are then multiplied $y @ in order to ma6e domain scores compara$le -ith the scores used in the 4)#J#H7&99, so that scores ran%e $et-een @ and +9. 4here @ indicates the lo-est Fuality of life or ne%ative perceptions and +9 indicates the hi%hest Fuality of life or positive perceptions. 5he Fuestionnaire has $een validated and used -idely in )!0 studies.&A HIV- Stigma: "ti%ma is defined as an attri$ute that is deeply discreditin%. &+ Much of the previous research on sti%ma uses a $road and va%ue concept of sti%ma. 'ecent concept of sti%ma distin%uishes t-o type of sti%ma i.e enacted and felt or perceived sti%ma. Enacted stigma: *nacted sti%ma refers to actual experience of discrimination and unaccepta$ility.
&+

*xperiences of )!07related sti%mas -ere assessed $y && yes (&) or

&+,&B

no (9) item adapted from those reported $y another research.

!tems include

someone refused to eat -ith you, someone refused to hu% -ith you, had children 6ept a-ay from you, $eaten up $y someone, $ein% hassled or threatened, physically a$used or losin% a friend, heard A!"D :o6e and shut out $y family mem$er K$ecause you are )!0Qve. 5hese items are cate%ori,ed into three dimension i.e avoidance dimension, a$use dimension and social re:ection dimension. Perceived stigma: Gelt or perceived sti%ma refers to fear or anticipation of discrimination, re:ection and internal sense of shame. Geelin%s and fears of )!07related sti%ma -as measured $y seven items five7point Hi6ert response scale ran%in% from Rnot at allP (9) to Ral-aysP (@). 5hese also adapted from those as6ed $y another research as6in% ho- often the respondent felt $lamed or ashamed, avoided, or feared losin%

21

family or friends K$ecause you are )!0QL durin% the past three months. &=,&B 5hese items are also cate%ori,ed into three dimension i.e avoidance dimension, re:ection dimension and shame dimension. ..2 *ata collection procedure After ta6in% -ritten consent from the research participants $y introducin% and informin% the study purpose and o$:ective, data -ill $e collected $y face to face intervie- ensurin% the privacy and confidentiality $y usin% an intervie-er administrated Fuestionnaire. "ome data -ill $e supplemented $y document revie- of patient medical records for treatment and clinical information. All the Fuestionnaires -ill $e chec6ed for consistency and completeness and a su$set of Fuestionnaires -ill $e re7chec6ed in the field for validity. ..3 *ata editin%: Data -ill $e edited $oth -hen they are collected and at sta%e $efore analysis. Data editin% -ill involve sortin% data, performin% Fuality7control chec6 and data processin%.

..4 *ata analysis: 2ollected data -ill $e entered usin% "P"" pro%ram and thereafter cleaned ( edited. Data -ill $e analysed $y univariate, $ivariate as -ell as multivariate statistics usin% the "tatistical Pac6a%e for "ocial "ciences ("P"" version &A) soft-are. "tatistical tests ( +) -ill $e performed to determine the association $et-een exposure and outcome varia$les. 5he result (;atePs corrected values) -ill $e considered si%nificant at a p value level S9.98. 2rude odds ratios (#') and C8I confidence intervals (2!) -ill $e used for the interpretation of the univariate analysis. !mportant predictors of univariate analysis -ill $e included in a step-ise lo%istic re%ression model to identify independent predictors. ..15 :actors in $tudy: Aey#'aria0les

21

5he varia$les that are dealt -ith this dissertation can $e cate%ori,ed as follo-in% division: "aria0le related to socioecono&ic and de&o%raphic characteristics: &. A%e +. .ender =. *ducation @. Place of residence 8. Place of $irth (District) 3. 'eli%ion A. Marital status B. C. o. of children o. of dependents

&9. #ccupation &&. Avera%e monthly family income &+. Gamily type "aria0les related to disease sta%e and treat&ent &. Months of dia%nosed -ith )!0 +. 2D2 sta%e of )!0 =. )/# #pportunistic infection @. "tatus of 2D@ count 8. "tatus of viral load (0H) 3. Antiretroviral (A'0) medication A. 5ime of antiretroviral (A'0) medication 6thers related 'aria0les &. Griends and or family 6no-in% serostatus +. )istory of 2hronic diseases =. Alcohol use @. !n:ection dru% use *ependent)6utco&e 'aria0les i. )ealth related Fuality of life

21

ii. )!07related sti%ma A) *nacted sti%ma 1) Perceived sti%ma /. =T! !BAT!69 6: R7$= T$ 5he understandin% of the level and factors associated -ith health related Fuality of life and )!07related sti%ma amon% the people livin% -ith )!0/A!D" is crucial for desi%nin% interventions to support the people livin% -ith )!0/A!D" (PH)A). Determination of a valid and relia$le )JoH and )!07sti%ma measure is necessary that can $e used not only to assess the physical and medical needs of )!0/A!D" people, $ut also their psycholo%ical, social, environmental, and spiritual areas of life. Determination of these factors -ill help us to select the $est method of therapy and doin% the $est to treat these patients. 5herefore, the efficacy of therapies -ill surely $e increased. 3. :A-! !T!7$ 1.1. :acilities a'aila0le: 5he study -ill $e done in the Department of *pidemiolo%y, !P"#M -hich is supported

$y necessary infrastructure ('oom, Gurniture, 2omputer and "ecretarial support etc.) 1.+. Additional facilities re@uired: Hu&an resourcesC Gunds for honorarium, stationeries, field -or6ers, transportation, documentations etc.

2. Appro'al of the Head of the *epart&ent)!nstitute Approved

3. : 6D -HART PR6P6$7* T!;7 ;A9AG7;79T P A9 :6R TH7 PR6<7-T

21

4. 7TH!-A !;P !-AT!69

$l. 9o. & + = Ti&e fra&e (;onth) 1st +nd ,rd .th /th 1th 2th 3th 4th 15th 11th 1+th

Acti'ities Hiterature revie'ecruitment pro:ect personnel of

5rainin% of the pro:ect personnel Gield testin% of data collectin% instrument and finali,ation Data collection and editin% Data analysis Preparation of report "u$mission of report

8 3 A B

!nstitutional 'evie- 1oard (!'1) -ill revie- the Protocol to ma6e sure that ethical issues are handled correctly. !nformed -ritten consent -ill $e ta6en. 5he respondents -ill $e informed a$out the o$:ectives, purpose of the study ( other relevant information of the study. Privacy and confidentiality -ill $e maintained strictly. 5hey -ill $e informed a$out their full ri%ht to participate or refuse to participate in the study. A complete assurance -ill $e %iven to them that all information provided $y them -ill $e 6ept confidential and their names or anythin% -hich can identify them -ill not $e pu$lished or exposed any-here. After completion of these procedures the intervie-ill $e started -ith their due permission. 5he researcher -ill assure the respondents that there -ill $e no invasive procedure in the study. 5he findin%s of the study -ill $e used to %uide the service providers and policy ma6ers for the modification and improvement of the current A!D" treatment %uideline. 5heir participation and contri$ution -ill $e ac6no-led%ed -ith due respect. )o-ever, prior to initiation of the study ethical clearance -ill $e ta6en from appropriate ethical committee.
15. R7:7R79-7$:

21

&.

5he Toint United

ation Pro%ram on )!0/A!D" /4orld )ealth #r%ani,ation, ation pro%ram on

Report on the global AIDS epidemic !!", :oint United )!0/A!D", .eneva. +99B +.
3.

1onnel, '. Economic Anal#sis o$ HIV%AIDS, 4orld 1an6,+99B 'osen, "ydney and Tonathon "imon. , Shi$ting the &urden o$ HIV%AIDS, 2enter for !nternational )ealth, 1oston University,+99B

@.

Ministry of )ealth and Gamily 4elfare.

!'! ()*ASS +ountr# Report $or

&angladesh submitted to ()AIDS, Dha6a: Directorate .eneral of )ealth "ervices, Ministry of )ealth and Gamily 4elfare. Decem$er, +9&9. 8. ational A!D"/"5D Pro%ramme. )ational HIV Serological Surveillance !!,!!-. "eventh 'ound 5echnical 'eport. Directorate .eneral of )ealth "ervices, Ministry of )ealth and Gamily 4elfare +99A 3. 'a,era G, Gerreira T and 1onami%o ''. Gactors associated -ith health7related Fuality7of7life in )!07infected 1ra,ilians. International /ournal o$ S0D 1 AIDS !!"2 &C: 8&CN8+= A. Hars *. *ri6sson, .un =+(8), &+&=V&++= B. Toseph M. Mrus Anthony 2. Heonard, Michael ". ;i, "usan gen intern med2 +993,+&:"=CN@A. . "herman ordstroUm et al. 5he health7related Fuality of life in a

"-edish sample of )!07infected persons, /ournal o$ Advanced )ursing3 +999,

K)ealth7'elated Juality of Hife in 0eterans and onveterans -ith )!0/A!D"L 4

21

C.

Mrus TM, 4illiams PH, 5sevat T, 2ohn "*, 4u A4. .ender differences in health7related Fuality of life in patients -ith )!0/A!D". 5ual 6i$e Res.2 !!,3 '7:789NC&.

&9.

)u%hes T, Telsma T, Maclean *, Darder M, 5inise W. K5he health7related Fuality of life of people livin% -ith )!0/A!D"L Disabil Rehabil. +99@, Mar &BD +3(3):=A&73.

&&.

5hitiarpha 5an%6a-anich et al.2ausal model of health: )ealth related Fuality of life in people livin% -ith )!0/A!D" in northern re%ion of 5hailand, /. nursing and health sciences +99B,&9,+&3 N ++&.

&+.

Dallas "-endem, Mary Tane Predictors of )!07related sti%ma amon% youn% people livin% -ith )!0L Health ps#chol3 !!-3 :ulyD+8(@):89&789C

&=.

0iolet

, ;e$ei M. Gelt sti%ma amon% the people livin% -ith )!0/A!D" in rural

and ur$al Kenya. A$rican Health Service ,+99B,0ol B o + Tune &@. 4innie Mar6 'ita Ha- et al. Attri$utional model of sti%ma on social support and Fuality of life amon% )!0 patients ' th Annual +on$erence o$ the International Societ# $or 5ualit# o$ 6i$e Research3+998 0olume &@ um$er C &8. Mar,ieh , Khatereh A. )ealth7'elated Juality of Hife in Patients -ith

)!0/A!D" Arch Iranian :edD +99B, && (3): 39B N 3&+.

&3.

'XXtel K, Pisarev ), Hoit )M, Uus6Xla A. Gactors influencin% Fuality of life of people livin% -ith )!0 in *stonia: a cross7sectional survey. Tournal of the !nternational A!D" "ociety +99CD&+:

21

&A.

irmal 1, Divya K', Doraira: 0", 0en6ates-aran K. Juality of life in )!0/A!D" patients: A cross7sectional study in south !ndia. !ndian T "ex 5ransm Dis +99BD +C:&87A.

&B.

"o-ell '1, Ho-enstein A et al.'esource, sti%ma and patterns of disclosure in rural -omen -ith )!0 infection. Pu$lic health nursin%. &CCAD &A(8): =9+7=&+.

&C.

1asavara: K),

avya MA, 'ashmi '. Juality of life in )!0/A!D". Indian

/ournal o$ Sexulla# 0ransmitted Diseases and AIDSDY+9&9, =&(+):A87B9

21

PART 7
8ud%et A. Total 8ud%et: TE 155C 555 8. *etailed 8ud%et "l. o. !tem & Personnel cost &.& Principal !nvesti%ator (P!) &.+ 2o7!nvesti%ator (2o7!) &.= 'esearch #fficer ('#) &.@ "upport "taff (MH"") + Gield *xpenses +.& )onorarium for 'esource Person for 5rainin% of '#, 0olunteers and data collectors +.+ 2ost of Data 2ollection +.= Hocal supervision cost +.@ 2ompensation for research participants = "upplies and Materials @ Patient 2ost 5ravel 8 2ost 8.& on7local field cost for P! ( 2o7! 8.+ on7local field cost for '# 8.= Hocal field cost for P! ( 2o7! Hocal field cost for '#/ Data 8.@ collectors 3 #ffice "tationeries 3.& 5oner 3.+ #ffset paper Pen/pencil/eraser/measurin% tape 3.= etc. A Data processin% and computer char%es A.& B Data entry, codin%, cleanin%

Unit cost 8999 =999 &9999 899 @89 8999 &999 +99

um$er & + + & @ B @ +99

Months/ times 3 3 = 3 + = = &

1D5 =9999 =3999 39999 =999 =399 &+9999 &+999 @9999

"u$7total

&+C999

&A8399 ot Applica$le ot Applica$le @999 &999 =99 +99 3999 @89 Hump sum Hump sum Hump sum Hump sum Hump sum Hump sum Hump sum = & = & & &3 & 3 +9 B9 & & &+999 3999 &B999 &3999 3999 A+99 &@999 +8999 +8999 8999 &9999 3999 +&999 89999 +A+99 8+999

A.+ Data analysis Printin% and reproduction/dissemination B.& B.+ B.= Printin% of Fuestionnaire 'eport preparation/ printin% Photocopy

C &9 &&

C.& Dissemination Miscellaneous (5elephone, internet, posta%e etc.) 0A5 ( !ncome 5ax (@I) .rand 5otal

&8999 &8999 &9+99 &9+99 +9999 +9999 1D5 899999.99 Z5a6a five lacs only[

21

!nstitute of pu0lic Health 9utrition *irectorate General of Health $er'ices Application for 7thical -learance 1. Principal !n'esti%ator(s): Dr. Ummul Khair Alam,MP)('2)) Medical officer, Department of Population dynamics, !P"#M Dr. Md. Anisur 'ahman Professor ( )ead, Department of *pidemiolo%y !P"#M Dr. Md. 'i,-anul Karim MP)(*pid) Asst. Professor, Department of *pidemiolo%y !P"#M ,. Place of the $tudy)!nstitution(s): .overnment and on%overnment health facilities entitled to provide )!0/A!D" treatment and or reha$ilitation. .. Title of $tudy: Health Related Quality of ife and H!"#related $ti%&a a&on% the People i'in% (ith H!")A!*$ /. Type of $tudy: 2ross sectional study 1. *uration: 2. Total -ost: 3 (six) Months 56.899,999/\

+.

-o#!n'esti%ator(s):

3. :undin% A%ency: Directorate .eneral of )ealth services

21

-ircle the appropriate ans(er to each of the follo(in% (If not Applicable write NA) 1. $ource of Population : (a) !ll "u$:ects ($) on] !ll "u$:ects ;es ;es ;es o o o ($) Procedures to $e follo-ed includin% alternatives used (c) Physical ris6s ;es ;es ;es ;es ;es ;es o o o o o o o (d) Private Fuestions (e) !nvasion of the 1ody (f) 1enefits to $e derived ;es o .. Are su0jects clearly infor&ed a0out: (a) ature and purposes of study ;es o

(c) Minors or persons under %uardianship +. *oes the study in'ol'e : (a) Physical ris6s to the su$:ects ($) "ocial 'is6s (c) Psycholo%ical ris6s to su$:ects (d) Discomfort to su$:ects (e) !nvasion of the $ody (f) !nvasion of Privacy

ot applica$le ;es o

ot applica$le ;es ;es o o

(%) 'i%ht to refuse to participate or to -ithdra- from study (h) 2onfidential handlin% of data (i)

;es

o o

(%) Disclosure of ;es information dama%in% to su$:ect or others ,. *oes the study in'ol'e : (a) Use of records, (hospital, medical, death, $irth or other) ($) Use of fetal tissue or a$ortus (c) Use of or%ans or $ody fluids ;es

2ompensation ;es -here there are ris6s or loss of -or6in% time or privacy is involved in any particular procedure

/. Dill si%ned consent for&)'er0al consent 0e re@uired : (a) Grom "u$:ects ;es o

;es ;es

o o

($) Grom parent or %uardian (if su$:ects are minors) 1. Dill precautions 0e taEen to protect anony&ity of su0jects

ot applica$le

;es

21

The 7thical Re'ie( -o&&ittee (7R-)

)ealth related Fuality of life and )!07related sti%ma are $ecomin% a %reat concern for the people livin% -ith )!0/A!D" for desi%nin% intervention to support them. 5he proposed cross sectional study -ill $e conducted -ith the primary aim to assess the level of health related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and determine their associated factors. 5he aim of the study -ill $e also to find out the association $et-een )'JoH and )!07related sti%ma amon% the respondents. )!0 positive patients attendin% in .overnment and non%overnment health facilities -ill $e selected purposively on the $asis of specific inclusion and exclusion criteria for this study. Appropriate research instruments comprisin% intervie-er administered semi structured Fuestionnaires -ill $e developed $y adoptin% K4)#J#H7)!0 1'*G instrumentL for assessin% )JoH and validated K*nacted and perceived )!07related sti%ma measurin% FuestionnaireL used $y other researchers, -ill $e used to collect data. 5his study findin%s -ill $e used not only to assess the physical and medical needs of )!0/A!D" people, $ut also their psycholo%ical, social, environmental, and spiritual areas of life. Determination of these factors can help service providers to select the $est method of therapy thus -ill increase the efficacy of therapy.

*ocu&ents su0&itted here(ith to co&&ittee: Um$rella proposal Proposal "ummary A$stract for *thical 'evie- 2ommittee as per attachment !nformed consent form for su$:ects Procedure for maintainin% confidentiality !ntervie- schedule and chec6list De a%ree to o0tain appro'al of the 7thical Re'ie( -o&&ittee for any chan%es in'ol'in% the ri%hts and (elfare of su0jects or any chan%es of the ;ethodolo%y 0efore &aEin% any such chan%es.

Principal !nvesti%ator

#ther !nvesti%ators

21

A8$TRA-T :6R 9R77thical !ssues: Principle: Patients are vulnera$le populations. 5herefore, the procedures -ill $e follo-ed durin% data collection and examination -ill $e in accordance -ith the 2!M#" %uidelines @, 8, 3, B, &8 and &B as updated in +99+.C 60jecti'es: 5he proposed cross sectional study -ill $e conducted -ith the primary aim to assess the level of health related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and determine their associated factors. 5he aim of the study -ill $e also to find out the association $et-een )'JoH and )!07related sti%ma amon% the respondents. Procedure: )!0 positive patients attendin% in .overnment and non%overnment health facilities -ill $e selected purposively on the $asis of specific inclusion and exclusion criteria for this study. Appropriate research instruments comprisin% intervie-er administered semi structured Fuestionnaires -ill $e developed $y adoptin% K4)#J#H7)!0 1'*G instrumentL for assessin% )JoH and validated K*nacted and perceived )!07related sti%ma measurin% FuestionnaireL used $y other researchers, -ill $e used to collect data Durin% re%istration, research assistants, not in hospital employee, -ill $rief o$:ectives, $enefits, ris6s and $urdens of this study to the patients and their close relatives accordin% to 2!M#" %uidelines B. #nly positive respondent and consistent to the selection criteria -ill $e recruited. Prior to conduction of this study, institutional permission -ill $e ta6en from the )ead of the department. !nfor&ed -onsent: 'esearch assistants, -ill ta6e -ritten informed consent from positive respondents only maintainin% full autonomy follo-in% the %uidelines @, 8 and 3. Model of informed consent form enclosed here-ith. *ata -ollection: 'esearch assistants -ill collect %eneral information and socioeconomic information of the selected patients follo-in% the Fuestionnaire. 'esident physician(s) or investi%ator(s) -ill ta6e intervie- in7depth and collect specific information a$out underlyin% factors follo-in% the Fuestionnaire. 5he reFuired time for examination -ill $e @8 minutes

21

approximately. Pri'acy and -onfidentiality: *ach of participants -ill $e intervie-ed in a separate room and their privacy as -ell as confidentiality -ill $e maintained strictly accordin% to the 2!M#" %uidelines &8 and &B. All relevant documents includin% Fuestionnaire -ill 6eep under control of the principal investi%ator or resident physician. authority in the due time. 8enefits: #utcomes of this study -ill $e of pu$lic importance and -ill $e of immense helpful to the medical practitioners. !t -ill also contri$ute in the preparation of national policy of effective treatment modality a%ainst )!0 treatment. $e %iven to the participants. RisEs: 5his study -ill not involve any mild, moderate or severe physical, mental or social ris6 to the participants. o -ed%e compensation -ill o individual information -ill $e supplied. 2ode num$er -ill $e used. Ginal report -ill $e su$mitted to the concerned

21

5hese issues -ill $e 6ept in concern -hile conductin% research process:

&. Any %roup -hose a$ility to %ive voluntary informed consent assumes Fuestiona$le -ill not $e
included

+.

o potential ris6s exists in desi%nin% this study

=. 1y follo-in% under mentioned steps confidentiality -ill $e maintained:

'esearch data -ill $e coded Data -ill $e stored in a loc6ed ca$inets #nly research personnel -ill $e allo-ed to access data. 5here is no physical, psycholo%ical, social and le%al ris6 durin% physical examination. Proper consent -ill $e ta6en. Gor safe%uardin% confidentiality and protectin% anonymity each of the patient -ill $e %iven a special !D no. A si%ned informed consent -ill $e ta6en from the patient/patientPs %uardians convincin% that privacy of the patient -ill $e maintained and he/she -ill $e compensated for loss of -or6 time if they -ants

A data collection sheet should (enclosed) $e prepared for -hich a short intervie- of &87=9 minutes -ill $e reFuired o dru% -ill $e used for this study o experimental ne- dru% -ill $e administrated o place$o -ill $e used here Use of hospital records (outdoor) -ill $e needed to fill up the patientPs data sheet.

@. 2onsent form -ill $e a -ritten statement 8. A $rief intervie- re%ardin% study varia$les -ill $e collected from the participants. 3. 5he study result -ill accrue the $enefit to the society $y providin% information re%ardin% the
association $et-een $iomass smo6e and ris6 to develop pulmonary tu$erculosis of our country.

A.

o experimental dru%, place$o -ill $e used.

Principal !nvesti%ator

21

INFORM CONSENT FORM FOR SUBJECTS Title of research study: ----------------------------------------------------------------------------------------------Name of artici a!t: ----------------------------------------------------------------------------------------------Name of i!"esti#ator: ----------------------------------------------------------------------------------------------1. I consent to participate in the research named above, the particulars of which-including details of interviews and questionnaires have been explained to me. A written copy of the information has been given to me to keep. . I authori!e the researcher to use with me the interviews and questionnaires referred to under "1# above. $. I acknowledge that% i. &he possible effects of the interviews and questionnaires have been explained to me to my satisfaction ii. I have been informed that I am free to withdraw from the research at any time without explanation or pre'udice and to withdraw any unprocessed data previously supplied( iii. &he pro'ect is for the purpose of research iv. I have been informed that the confidentiality of the information I provide will be safeguarded sub'ect to any legal requirements v. I have been informed regarding the interviews. I have also been informed that because of the number of people to be interviews in small( it is possible that some one may still be able to identify me on the basis of any references to personal information that might allow some one to guess my identity. )owever, I will be referred by pseudonym or identified by a different name in any publications arising from the research. *ignature +ate

----------------------------------------------------------------------------------------",articipant# *ignature +ate

----------------------------------------------------------------------------------------"-itness to consent#

21

The 7thical Re'ie( -o&&ittee (7R-)

)ealth related Fuality of life and )!07related sti%ma are $ecomin% a %reat concern for the people livin% -ith )!0/A!D" for desi%nin% intervention to support them. 5he proposed cross sectional study -ill $e conducted -ith the primary aim to assess the level of health related Fuality of life ()JoH) and )!07related sti%ma amon% the people livin% -ith )!0/A!D" and determine their associated factors. 5he aim of the study -ill $e also to find out the association $et-een )'JoH and )!07related sti%ma amon% the respondents. )!0 positive patients attendin% in .overnment and non%overnment health facilities -ill $e selected purposively on the $asis of specific inclusion and exclusion criteria for this study. Appropriate research instruments comprisin% intervie-er administered semi structured Fuestionnaires -ill $e developed $y adoptin% K4)#J#H7)!0 1'*G instrumentL for assessin% )JoH and validated K*nacted and perceived )!07related sti%ma measurin% FuestionnaireL used $y other researchers, -ill $e used to collect data. 5his study findin%s -ill $e used not only to assess the physical and medical needs of )!0/A!D" people, $ut also their psycholo%ical, social, environmental, and spiritual areas of life. Determination of these factors can help service providers to select the $est method of therapy thus -ill increase the efficacy of therapy.

*ocu&ents su0&itted here(ith to co&&ittee: Um$rella proposal Proposal "ummary A$stract for *thical 'evie- 2ommittee as per attachment !nformed consent form for su$:ects Procedure for maintainin% confidentiality !ntervie- schedule and chec6list De a%ree to o0tain appro'al of the 7thical Re'ie( -o&&ittee for any chan%es in'ol'in% the ri%hts and (elfare of su0jects or any chan%es of the ;ethodolo%y 0efore &aEin% any such chan%es.

Principal !nvesti%ator

#ther !nvesti%ators

21