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Lim)8.2(ited empirical evidence )]TJ 22.8689 0 TD .0012 Tc .0002 Tw [(suggests that econom)8.5(ic interventions i)5.8(n)-1.5( com)8.5(b)-1.5(ination )]TJ -22.8689 -1.153 TD [(with ps)7.8(y)-7(c)2.4(ho-)6.3(social support)5.8( have greater im)8.5(pact )]TJ 19.1858 0 TD .0001 Tw [(than either t)5.9(y)-6.9(pe of i)5.9(n)-1.4(tervention ta)8(ken singl)5.9(y)-6.9(.)]TJ 7.02 0 0 7.02 463.56 450.72 Tm 0 Tc 0 Tw (i)Tj 10.98 0 0 10.98 465.54 445.74 Tm ( )Tj 7.02 0 0 7.02 468.24 450.72 Tm .0042 Tc (ii)Tj 10.98 0 0 10.98 472.2 445.74 Tm 0 Tc ( )Tj 7.02 0 0 7.02 474.96 450.72 Tm .0042 Tc (iii)Tj 10.98 0 0 10.98 480.9 445.74 Tm 0 Tc ( )Tj -38.5519 -1.153 TD ( )Tj 9 0 0 9 57.6 422.4 Tm (***** )Tj 0 -1.1467 TD ( )Tj 10.98 0 0 10.98 57.6 399.72 Tm .0004 Tc .001 Tw [(Because this is such a novel approach, there are )-5.4(many)-7.8( )]TJ 21.8361 0 TD .0011 Tc .0003 Tw [(unanswered questions on how an intervention )5.5(using s)7.7(u)-1.6(ch )]TJ -21.8361 -1.1475 TD .0012 Tc .0002 Tw [(an approach could )5.5(be or s)7.8(hould be )5.5(designed. Wh)]TJ 21.0109 0 TD .0007 Tc .0007 Tw [(at )5.5(is the appropr)5.8(iate target population? Adolescents? )]TJ -21.0109 -1.153 TD .0009 Tc .0005 Tw [(Geographical hot spot)5.5( areas? Set within)3.6( residential )]TJ 20.8634 0 TD .0008 Tc .0006 Tw [(communities or within social networks? )5.5(What is the )]TJ -20.8634 -1.153 TD .0011 Tc .0003 Tw [(appropriate am)8.4(ount of cash to dispense)7.8(? What i)5.7(n)-1.6(terval )]TJ 22.3388 0 TD .0012 Tc .0002 Tw [(of testing/)5.8(pay)-7(m)8.5(ent is needed? For )5.5(ho)3.9(w long sho)3.9(u)-1.5(l)5.8(d)-1.5( the )]TJ -22.3388 -1.153 TD .0001 Tw [(intervention r)6.4(un? )5.5( What ha)8(ppens when t)5.9(h)-1.4(e m)8.6(oney)-6.9( run)4(s)2.5( )]TJ 22.1694 0 TD .0003 Tc .0011 Tw [(out?)-3.9( What are the risks?)-3.9( )5.5(How do the risks differ in )]TJ -22.1694 -1.153 TD .0013 Tc .0001 Tw [(different potential target po)4(pulation )5.5(grou)4(ps? Wh)]TJ 19.6503 0 TD .0006 Tc .0008 Tw [(at epide)-3.6(m)7.9(iologic setting is m)7.9(o)-2.1(st appropriate? )]TJ -19.6503 -1.153 TD 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0003 Tc .0011 Tw [(These are )-5.4(absolutely)-7.9( critical questions that have never )]TJ 21.9235 0 TD .0009 Tc .0005 Tw [(been exam)8.2(ined in term)8.2(s of )-5.4(CCTs & STIs/HIV prevention, )]TJ -21.9235 -1.153 TD .0006 Tc .0008 Tw [(which is why we are castin)-7.6(g a wide net in this first )]TJ 21.2077 0 TD -.0001 Tc .0015 Tw [(study)-8.3( and are focusing on an )]TJ 11.7322 0 TD .0009 Tc .0005 Tw [(epidem)8.2(iological context that )]TJ -32.9399 -1.153 TD .0005 Tc .0009 Tw [(is typical)-5.3( of)5.6( the East Afri)-5.8(can areas wh)-7.7(ere y)-7.7(outh are at higher-risk of HIV. )]TJ T* 0 Tc 0 Tw ( )Tj T* .0009 Tc .0005 Tw (We have been careful in the design of)Tj 15.1639 0 TD .0006 Tc .0008 Tw [( this study)-7.6( to ensure that we exp)]TJ 12.8852 0 TD .0009 Tc .0005 Tw [(licitl)5.5(y)-7.3( cons)7.5(ider each of these fundam)8.2(e)-3.3(ntal )]TJ -28.0492 -1.1475 TD .0005 Tc .0009 Tw [(questions and ensure that we are using the best e)-3.7(m)7.8(piri)-5.8(cal)]TJ 22.7814 0 TD [( evidence )-5.4(available. In some)]TJ 11.377 0 TD -.0001 Tc .0069 Tw [( )5.4(ca)-4.3(ses, )5.4(th)-8.3(at m)7.2(eans we have )]TJ -34.1585 -1.153 TD .0008 Tc .0006 Tw [(been able to draw on em)8.1(pirical work in other areas; in)]TJ 21.6339 0 TD .0005 Tc .0009 Tw [( )-5.4(other cases it )-5.4(means that we have built the question into )]TJ -21.6339 -1.153 TD .0003 Tc .0011 Tw [(the study)-7.9( our)5.4(selves because there is little ev)]TJ 17.5519 0 TD .0011 Tc .0003 Tw [(idence to guide interve)7.8(n)-1.6(tion )5.5(design )5.5(decisions. )]TJ -17.5519 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0007 Tc .0007 Tw [(In this study, )5.5(we will i)-5.6(m)8(plement the intervention f)5.8(o)-2(r one y)]TJ 23.4044 0 TD .0008 Tw [(ear in tw)6.9(o districts in )5.5(southern Tanzania and evaluate )]TJ -23.4044 -1.153 TD .0008 Tc .0006 Tw [(its i)-5.5(m)8.1(pact by)-7.4( )5.5(random)8.1(ly)-7.4( assigning 18-)5.9(30 )5.5(y)-7.4(ear old parti)5.4(c)]TJ 21.918 0 TD .0006 Tc .0008 Tw (ipants and their spouses to receive either the CCT )Tj -21.918 -1.1475 TD [(intervention )5.5(or STI testing/treat)-5.7(ment alone. A follo)]TJ 20.6995 0 TD .0007 Tw [(w-up assessmen)-7.5(t)-.2( will be conducted 12-m)8(onths after the )]TJ -20.6995 -1.153 TD .0009 Tc .0005 Tw [(intervention e)7.6(nds. This two-y)-7.3(ear random)8.2(ized trial thus )]TJ 22.0328 0 TD .0001 Tc .0013 Tw [(has two main ar)-5.7(m)7.4(s)1.3(: a tr)-5.7(eat)-6.2(ment ar)-5.7(m)7.4( )-5.4(which receives th)-8.1(e )]TJ -22.0328 -1.153 TD .0009 Tc .0005 Tw [(CCT intervention for )5.5(1 )5.5(y)-7.3(ear starting after baseline, and )]TJ 22.2568 0 TD [(a control ar)6(m)8.2( )-5.4(which does not. Bo)3.6(th st)5.5(ud)3.6(y)-7.3( arm)8.2(s)2.1( will )]TJ -22.2568 -1.153 TD .0007 Tc .0007 Tw [(receive STI t)-5.6(esting, basic STI/HIV counseling, and t)5.3(r)]TJ 21.3388 0 TD .0001 Tc .0013 Tw [(eat)-6.2(ment five times over the 2-y)-8.1(ear period, as well as t)-6.2(h)-2.6(e )]TJ -21.3388 -1.153 TD .0008 Tc .0006 Tw [(psy)-7.4(c)2(hosocial /group-couns)7.4(eling intervention for t)5.4(h)-1.9(e fi)5.4(rst )]TJ 22.8087 0 TD .0009 Tc .0005 Tw [(y)-7.3(ear. Indi)5.5(viduals in the t)5.5(r).6(eatment arm)8.2( )-5.4(will then be )]TJ -22.8087 -1.1475 TD [(random)8.2(ly)-7.3( assigned to receive either a Tsh 10,000 or T)5.2(s)]TJ 22.0328 0 TD .0016 Tc -.0002 Tw [(h 20,000 \(roughl)6.2(y $10 or )5.5($20, )]TJ 12.3115 0 TD .0005 Tc .0009 Tw [(as referred to in t)5.1(h)-2.2(is )]TJ -34.3443 -1.153 TD .0008 Tc .0006 Tw [(protocol\) cash reward group. This will )5.5(further allow sub-st)]TJ 23.5137 0 TD .0004 Tc .001 Tw [(udy)-7.8( )5.5(of t)5(h)-2.3(e effect of vary)-7.8(ing sizes of cash transfers. )]TJ -23.5137 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0003 Tc .0011 Tw [(We have 3 pri)-6(m)7.6(ary)-7.9( researc)-3.9(h)-2.4( objectives: )5.5( )]TJ T* 0 Tc 0 Tw ( )Tj ET endstream endobj 4 0 obj <> endobj 5 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 6 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD .0002 Tc .0002 Tw [( )-29045.1(Page 3 o)-5.5(f)2.4( 29)]TJ /TT4 1 Tf 12 0 0 12 338.28 30.6 Tm 14.61 Tc 0 Tw ( )Tj 10.98 0 0 10.98 75.6 736.6801 Tm .0027 Tc (1.)Tj /TT2 1 Tf .7541 0 TD 0 Tc ( )Tj /TT4 1 Tf .8852 0 TD .0006 Tc .0008 Tw [(Evaluate the im)7.9(p)-7.6(act of the co)-7.6(m)7.9(b)-2.1(ined CCT/counseli)]TJ 20.5301 0 TD .0012 Tc .0002 Tw [(ng )5.5(intervention )5.5(o)3.9(n)-1.5( STI inciden)3.9(ce overall and b)3.9(y)-1.5( )]TJ -20.5301 -1.153 TD .0008 Tc .0006 Tw [(specific subgroups )5.5(during the interventi)5.4(on period. This)]TJ 22.7541 0 TD .0005 Tc .0009 Tw [( will enable a characterization of t)5.1(h)-2.2(e immediate )]TJ -22.7541 -1.153 TD .0008 Tc .0006 Tw [(and short-term)8.1( )-5.4(effects of the inte)]TJ 13.1038 0 TD .001 Tc .0004 Tw [(rvention and to ident)5.6(i).1(fy responsiv)]TJ 13.5191 0 TD .0006 Tc .0008 Tw [(eness in different potential )5.5(target )]TJ -26.623 -1.153 TD [(groups. Econom)7.9(i)-5.7(c outcomes will be evaluated as well. )]TJ -3.2787 -1.153 TD 0 Tc 0 Tw ( )Tj 1.6393 -1.1475 TD .0027 Tc (2.)Tj /TT2 1 Tf .7541 0 TD 0 Tc ( )Tj /TT4 1 Tf .8852 0 TD .0012 Tc .0002 Tw [(Exam)8.5(ine the long-term)8.5( effects of the intervention )5.5( )]TJ 20.8142 0 TD .0009 Tc .0005 Tw [(an)3.6(d its withdrawal on STI )5.5(incidence and econom)8.2(ic )]TJ -20.8142 -1.153 TD .0012 Tc .0002 Tw [(outcom)8.5(e)-3(s by)-7( )5.5(conducting)3.9( a final roun)3.9(d of)6.3( STI testi)]TJ 19.9235 0 TD .0016 Tc -.0002 Tw [(ng and surve)8.3(y)-6.6(in)4.3(g )5.5(in the sam)8.9(e)2.8( populatio)4.3(n 12-)6.7(m)8.9(onths )]TJ -19.9235 -1.153 TD .0006 Tc .0008 Tw [(after the intervention )5.5(has ended. )]TJ -3.2787 -1.153 TD 0 Tc 0 Tw ( )Tj 1.6393 -1.153 TD .0027 Tc (3.)Tj /TT2 1 Tf .7541 0 TD 0 Tc ( )Tj /TT4 1 Tf .8852 0 TD .0007 Tc .0007 Tw [(Co)-7.5(m)8(p)-2(are the )-5.4(i)-5.6(m)8(pact of the CCT intervention in the hi)]TJ 21.5082 0 TD .0004 Tc .001 Tw [(gh-value cash transfer ar)-5.4(m)7.7( )-5.4(to)]TJ 11.6831 0 TD ( that in the low-value )Tj -33.1913 -1.1475 TD .0005 Tc .0009 Tw [(cash transfer )-5.4(ar)-5.3(m)7.8(.)-.9( This wil)-5.8(l)-.4( perm)7.8(it us to better )]TJ 18.8033 0 TD .0009 Tc .0005 Tw [(understand thresholds and non-li)5.5(nearities in the price )]TJ -18.8033 -1.153 TD [(effects, )-5.4(and the findings will have im)8.2(portant im)8.2(plic)]TJ 20.5301 0 TD .0012 Tc .0002 Tw [(ations for how the interventi)5.8(on coul)5.8(d be brought)5.8( to )]TJ -20.5301 -1.153 TD .0008 Tc .0006 Tw (scale, if found to be effective. )Tj -3.2787 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0009 Tc .0005 Tw [(In addition, t)5.5(h)-1.8(e Control-R)6.7(4)-1.8( sam)8.2(p)-1.8(le to be newly)-7.3( recruited )]TJ 22.9836 0 TD [(at round )5.5(4 \(not i)5.5(n)-1.8(itiall)5.5(y envisioned )5.5(as part of the study)-7.3(\)).6( )]TJ -22.9836 -1.153 TD .0008 Tc .0006 Tw [(will be used to test the im)8.1(p)-7.4(act of enrollment in the or)5.9(ig)]TJ 22.0109 0 TD .0007 Tc [(inal Control group. Spec)7.4(ifically)-7.5(, t)5.3(h)-2(e Control-R4 sa)7.4(m)8(p)-2(l)-5.6(e)1.9( )]TJ -22.0109 -1.1475 TD .0008 Tw [(will allow testing of t)5.2(h)-2.1(e effects of the extensive access to)]TJ 22.8689 0 TD .0011 Tc .0003 Tw [( counseling, testing and treatm)8.4(e)2.3(nt provided t)5.7(o)-1.6( ori)5.7(g)-1.6(inal )]TJ -22.8689 -1.153 TD .0008 Tc .0006 Tw [(Control subje)7.5(c)2(ts in the mai)-5.5(n)-1.9( study)-7.4(.)4.9( The )5.5(main study w)]TJ 21.6776 0 TD .0007 Tc (as designed to test the effects of cash rewards, over and )Tj -21.6776 -1.153 TD [(above the effects of such counseling/test)5.3(ing/treatment, )]TJ 22.0601 0 TD [(thus the ori)5.3(g)-2(i)5.3(n)-2(al Control )5.5(group itself received extensive )]TJ -22.0601 -1.153 TD .0009 Tc -.005 Tw [(intervention. This )-5.5(original Control )-5.5(gr)6(oup )-5.5(interventi)]TJ 20.7322 0 TD .0011 Tc .0003 Tw [(o)3.8(n)3.8( has so far included baselin)3.8(e, 4-m)8.4(onth, and 8-m)8.4(onth )]TJ -20.7322 -1.153 TD .0007 Tc .0007 Tw [(counseling/testing/treat)-5.6(m)8(e)-3.5(nt, as well as )-5.4(a y)-7.5(ear of m)8(onthl)5.3(y)-7.5( gr)5.8(oup counseling. T)5(h)-2(i)5.3(s)1.9( package of services to )]TJ 0 -1.1475 TD .0005 Tc .0009 Tw (baseline participants is expected to)Tj 13.9617 0 TD .0003 Tc .0011 Tw [( result in decreased)-7.9( STI incidence based)]TJ 16.0765 0 TD .0006 Tc .0008 Tw [( on prior research, but the extent )5.5(of )]TJ -30.0383 -1.153 TD [(that prior research is li)-5.7(m)7.9(ite)-3.6(d, thus there is considerable)]TJ 21.9454 0 TD .0005 Tc .0009 Tw [( scientific va)-3.7(lue in quantify)-7.7(i)5.1(ng the STI )5.5(benefits of this )]TJ -21.9454 -1.153 TD .0007 Tc .0007 Tw [(precise package of preventi)5.3(ve efforts. The Control-R)6.5(4)-2( w)]TJ 22.8907 0 TD [(ill serve as a co)-7.5(m)8(p)-2(ariso)-7.5(n)-2( group to thi)5.3(s)1.9( original Control )]TJ -22.8907 -1.153 TD .0011 Tc .0003 Tw [(group,)5.2( allowing estimation of the STI i)5.7(m)8.4(proveme)]TJ 19.8907 0 TD .0015 Tc -.0001 Tw [(nt due to ori)6.1(g)-1.2(ina)8.2(l).6( Control enr)6.6(o)-1.2(llm)8.8(ent. )]TJ -19.8907 -1.153 TD 0 Tc 0 Tw ( )Tj /TT10 1 Tf 0 -1.1585 TD .0006 Tc .0008 Tw (Study area )Tj /TT2 1 Tf 7.98 0 0 7.98 57.6 397.92 Tm 0 Tc 0 Tw ( )Tj /TT4 1 Tf 10.98 0 0 10.98 57.6 385.92 Tm .0003 Tc .0011 Tw [(This study)-7.9( will take place in two rural districts in s)]TJ 20.306 0 TD .0009 Tc .0005 Tw [(outhern Tanzania, Kilo)-7.3(m)8.2(b)-1.8(ero and Ulanga, located in the )]TJ -20.306 -1.1475 TD .001 Tc .0004 Tw [(region of M)4.9(o)3.7(rogoro.)5.1( The I)6.1(f).7(akara Health Research )]TJ 20.4372 0 TD .0006 Tc .0008 Tw [(an)-7.6(d Development Center \(IHRDC\) )-5.4(manages the Ifakara )]TJ -20.4372 -1.153 TD .0009 Tc .0005 Tw [(Dem)8.2(ographic Surveillance Sy)-7.3(stem)8.2( \(DSS\) in this region)]TJ 22.2076 0 TD .001 Tc .0004 Tw [(. The Ifakara DSS site was incepted in Septem)8.3(ber 1996 )]TJ -22.2076 -1.153 TD .0008 Tc .0006 Tw [(and is am)8.1(ong )5.5(the largest dem)8.1(ographic su)-7.4(rveillance sy)-7.4(stem)]TJ 23.3333 0 TD [( in all of Africa, collecting basic sociodem)8.1(ographic )]TJ -23.3333 -1.153 TD .0012 Tc .0002 Tw [(household-le)7.9(vel inform)8.5(ation o)3.9(n)-1.5( births, )5.5(pregnancies, deaths)]TJ 23.5082 0 TD .0008 Tc .0006 Tw [(, and migration o)3.5(n)-1.9( a )5.5(quarterly)-7.4( )5.5(basis. Basic data )-5.4(on )]TJ -23.5082 -1.153 TD .0006 Tc .0008 Tw [(asset owner)-5.2(s)1.8(hip, ethnicit)5.2(y)-7.6(, )5.5(education levels, and econom)7.9(i)-5.7(c)]TJ 23.4426 0 TD [( activity)-7.6( )5.5(is also collect)-5.7(ed, although )5.5(at less frequent )]TJ -23.4426 -1.153 TD .0005 Tc .0009 Tw [(intervals. A baseline census was conducted between )]TJ 21.3934 0 TD .0009 Tc .0005 Tw [(Septem)8.2(ber an)-7.3(d Decem)8.2(b)-7.3(er )-5.4(1996, and each household )5.5(has )]TJ -21.3934 -1.1475 TD .0006 Tc .0008 Tw [(been visited once every)-7.6( four m)7.9(onths )]TJ 14.7978 0 TD .001 Tc .0004 Tw [(ever since. A total of 56 )5.5(village)7.7(s are covered )-5.4(with a popula)7.7(tion of about )]TJ -14.7978 -1.153 TD .0019 Tc -.0005 Tw [(95,0)4.6(00 peo)4.6(p)-.8(l)6.5(e)3.1( in 20,)6(000 )5.5(h)4.6(ouseholds.)6( )]TJ 10.02 0 0 10.02 57.6 273.0601 Tm 0 Tc 0 Tw ( )Tj 10.98 0 0 10.98 57.6 260.58 Tm .0007 Tc .0007 Tw [(In Tanzania and ot)5.3(her East African countries, the )-5.4(m)8(a)]TJ 21.1585 0 TD .0012 Tc .0002 Tw [(jo)-7(rity of new HIV infections occur am)8.5(ong youn)3.9(g peop)3.9(le, )]TJ -21.1585 -1.1475 TD .0016 Tc -.0002 Tw [(aged 15-30)4.3(,)]TJ 7.02 0 0 7.02 109.5 252.9601 Tm .0042 Tc 0 Tw (iv)Tj 10.98 0 0 10.98 115.02 247.9801 Tm .0008 Tc .0006 Tw [( a)-3.4(nd the Kilom)8.1(b)-1.9(ero/Ulanga district appears to be)]TJ 19.5027 0 TD .0001 Tc .0013 Tw [( strongly)-8.1( affected. Th)]TJ 8.8743 0 TD 0 Tc (e infection rates in the )Tj -33.6066 -1.153 TD .0008 Tc .0006 Tw [(Morogor)5.9(o region as a whol)5.4(e are higher than m)8.1(a)2(ny)-7.4( other parts )]TJ 24.8361 0 TD .0003 Tc .0011 Tw [(of the countr)5.4(y)-7.9(. At t)4.9(h)-2.4(e district level, accurate d)-7.9(a)1.5(ta )]TJ -24.8361 -1.153 TD [(are often lacking, but the )5.5(data that are av)-7.8(ailable suggest )]TJ 22.4973 0 TD .0005 Tc .0009 Tw [(a consisten)-7.7(t)-.4( pattern. Results of an ant)5.1(e)1.7(natal survey)-7.7( )5.5(of )]TJ -22.4973 -1.153 TD .0011 Tc .0003 Tw [(youn)3.8(g m)8.4(o)-1.6(thers conducted i)5.7(n)-1.6( 20)3.8(03 revealed an overall HI)]TJ 22.8087 0 TD .0006 Tc .0008 Tw [(V prevalen)-7.6(ce of 13.0%)3( for the Kilombero/Ulanga )]TJ -22.8087 -1.153 TD .0004 Tc .001 Tw [(district as a w)-4.2(hole. In Kilom)7.7(b)-7.8(ero, overall HIV prev)]TJ 20.7814 0 TD [(ale)-3.8(n)-2.3(ce was 19.2%, co)-7.8(m)7.7(p)-2.3(ared )-5.4(to 9.8% in Ulanga \(with )]TJ -20.7814 -1.153 TD .0007 Tc .0007 Tw (apparent hot spots in a few areas e.g. Lupiro\).)Tj 7.02 0 0 7.02 276.96 189.66 Tm 0 Tc 0 Tw (v)Tj 10.98 0 0 10.98 280.5 184.6801 Tm .0007 Tc .0007 Tw [( In a)7.4(ddition, a 2006 study)-7.5( )]TJ 10.7432 0 TD 0 Tc .0014 Tw [(conducted by)-8.2( our resear)-5.8(ch team)7.3( )]TJ -31.0437 -1.1475 TD .001 Tc .0004 Tw [(found an aggr)6.1(egate STI prevalence rate o)-7.2(f).7( 19% am)8.3(ongs)]TJ 22.306 0 TD .0009 Tc .0005 Tw [(t 500 )5.5(youth r)6(a)2.1(ndom)8.2(ly)-7.3( selected fro)-7.3(m)8.2( five villages in the )]TJ -22.306 -1.153 TD .0011 Tc .0003 Tw [(Kilo)-7.1(m)8.4(b)-1.6(ero/Ulanga DSS region.)]TJ 10.02 0 0 10.02 196.62 159.42 Tm 0 Tc 0 Tw ( )Tj 10.98 0 0 10.98 199.08 159.42 Tm ( )Tj -12.8852 -1.153 TD ( )Tj T* .0011 Tc .0003 Tw [(In the last qu)3.8(arter of 2005,)5.2( IHRDC added a )5.5(y)-7.1(out)5.7(h )]TJ 20.1202 0 TD .0008 Tc .0006 Tw [(sex)3.5(ual and repro)3.5(ductive health m)8.1(odule to a socio-)]TJ -20.1202 -1.153 TD .0007 Tc [(dem)8(ographic survey)-7.5( adm)8(i)-.2(nistered within the DSS area)]TJ 21.8689 0 TD .0013 Tc .0001 Tw [(. 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Ideall)-5.4(y)-1.8(, the)7.6(y)-7.3( are de)]TJ 21.1967 0 TD .0006 Tc .0008 Tw [(signed to com)7.9(p)-2.1(l)-5.7(e)-3.6(ment, rather than replace, the )-5.4(m)7.9(o)-2.1(re )]TJ -21.1967 -1.153 TD .0005 Tc .0009 Tw [(fam)7.8(iliar suppl)5.1(y)-7.7(-).2(side invest)-5.8(ments which channel res)]TJ 21.4426 0 TD .0004 Tc .001 Tw [(ources direct)-5.9(ly towards schools, clinics, and service )]TJ -21.4426 -1.153 TD .0012 Tc .0002 Tw [(providers. )5.5( )]TJ 0 -1.1475 TD 0 Tc 0 Tw ( )Tj /TT2 1 Tf 10.02 0 0 10.02 57.6 397.14 Tm ( )Tj 0 -1.1497 TD -.0024 Tw [(Interna)5.3(t)-2.3(ional)8.4( collaborativ)5.3(e team)8.9( )]TJ /TT4 1 Tf 10.98 0 0 10.98 75.6 373.32 Tm 0 Tw ( )Tj 0 -1.153 TD .0004 Tc .001 Tw [(This resear)-5.4(ch collaboration brings together investigat)]TJ 21.3333 0 TD [(ors fro)-7.9(m)7.6( the Ifakara He)-3.9(alth and Resear)-5.5(ch Developmen)-7.9(t )]TJ -22.9727 -1.153 TD .0008 Tc .0006 Tw (Centre \(IHRDC\) in Tanzania, the Univ)Tj 15.6339 0 TD [(ersity)-7.4( of Calif)5.9(ornia, Berkeley)-7.4(, an)3.5(d the W)4.8(o)-1.9(rld Bank. T)5.1(h)3.5(is stud)3.5(y)-7.4( is bei)5.4(ng )]TJ -15.6339 -1.153 TD .0004 Tc .001 Tw [(reviewed by)-7.8( the IRBs at both the local \(IHRDC\) )-5.4(and nati)]TJ 22.8634 0 TD .0006 Tc .0008 Tw [(onal \(National Institute for Medical Resear)-5.2(ch\) level)-5.7(s)1.8( in )]TJ -22.8634 -1.153 TD (Tanzania. )Tj T* 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0007 Tc .0007 Tw [(This resear)-5.1(ch will be conducted in villa)7.4(ges in the Kilom)8(b)]TJ 22.9454 0 TD .0005 Tc .0009 Tw [(ero/Ul)-5.8(anga districts in southern Tanzania, in close )]TJ -22.9454 -1.153 TD .0004 Tc .001 Tw [(collaboration )5.5(with resear)-5.4(chers at the Ifak)-7.8(a)1.6(ra He)-3.8(alth )]TJ 20.776 0 TD .0005 Tc .0009 Tw [(and Resear)-5.3(ch D)-4.1(e)1.7(velopment Centre \(IHRD)-4.1(C\). 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The only inclusion )]TJ -22.4481 -1.153 TD .0001 Tc .0013 Tw [(criteria ar)-5.7(e att)-6.2(e)1.3(ndance at the study)-8.1( station during the ti)-6.2(m)7.4(e)]TJ 23 0 TD .001 Tc .0004 Tw [( of sub-stud)3.7(y)-7.2( recruitm)8.3(ent and consen)3.7(ting to)3.7( participate )]TJ -23 -1.153 TD .0009 Tc .0005 Tw [(in bot)5.5(h interviews, but we will im)8.2(pose quotas by)]TJ 19.5082 0 TD .0011 Tc .0003 Tw [( gender, )-5.4(m)8.4(a)2.3(rital status and study )5.5(arm)8.4(.)-5.7( )]TJ -19.5082 -1.153 TD 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0014 Tc [(Round )5.5(4 Con)4.1(t).5(rol Group \()8.1(Control-R4\) )]TJ ET 57.6 64.38 174.78 .54001 re f BT 10.98 0 0 10.98 57.6 53.4601 Tm .0008 Tc .0006 Tw [(At the 12-m)8.1(o)-7.4(nth \(round )5.5(4\) )5.5(follow-up study)-7.4( point we )5.5(will )]TJ 23.0383 0 TD .0011 Tc .0003 Tw [(recruit a sm)8.4(all additional control gr)6.2(oup \(t)5.7(o be termed )]TJ -23.0383 -1.153 TD .0007 Tc .0007 Tw [(Control-R4\) to com)8(p)-2(are )-5.4(against our original control gr)]TJ 22.7322 0 TD .0014 Tc 0 Tw [(oup)4.1( enroll)6(ed at the roun)4.1(d 1 )]TJ 11.0765 0 TD .0007 Tc .0007 Tw [(baseline \(we now term)8( )-5.4(this )]TJ ET endstream endobj 16 0 obj <> endobj 17 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 18 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD .0002 Tc .0002 Tw [( )-29045.1(Page 7 o)-5.5(f)2.4( 29)]TJ /TT4 1 Tf 12 0 0 12 338.28 30.6 Tm 14.61 Tc 0 Tw ( )Tj 10.98 0 0 10.98 57.6 736.6801 Tm .0008 Tc .0006 Tw [(original contr)5.9(o)-1.9(l group recruited at round 1 Control-R)6.6(1)-1.9(\))]TJ 22.9508 0 TD .0006 Tc .0008 Tw [(. 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Assum)8(i)-.2(ng)-7.5( a refusal/ineligibilit)5.3(y rate of 20%, we will )]TJ -21.1749 -1.153 TD .0012 Tc .0002 Tw [(recruit 3600 i)5.8(ndivid)3.9(u)-1.5(als. )]TJ T* 0 Tc 0 Tw ( )Tj T* .0007 Tc .0007 Tw [(By)-7.5( co)3.4(nventio)3.4(n, STI preven)3.4(tion trials are often powered)]TJ 22.1475 0 TD .0008 Tc [( to detect a magnitude of )5.5(30%)3.2( difference in STI )]TJ -22.1475 -1.1475 TD .0002 Tc .0012 Tw [(incidence acr)-5.6(oss study)-8( arms. 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In roun)]TJ 14.7432 0 TD .0009 Tc .0005 Tw [(d 2 we )5.5(will include five additional)5.5( )]TJ -29.2678 -1.153 TD [(interviews: three )-5.4(men and two wo)-7.3(m)8.2(e)2.1(n who have tested positiv)]TJ 25.0219 0 TD .0007 Tc .0007 Tw [(e aft)5.3(e)1.9(r 4 m)8(onths will be asked to participate in an )]TJ -25.0219 -1.153 TD .0005 Tc .0009 Tw [(in-depth interview the wee)-3.7(k)-2.2( after receivi)-5.8(ng test results. )]TJ ET endstream endobj 19 0 obj <> endobj 20 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 21 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD .0002 Tc .0002 Tw [( )-29045.1(Page 8 o)-5.5(f)2.4( 29)]TJ /TT4 1 Tf 12 0 0 12 338.28 30.6 Tm 14.61 Tc 0 Tw ( )Tj 10.98 0 0 10.98 57.6 736.6801 Tm 0 Tc ( )Tj 0 -1.153 TD .0014 Tc [(Round )5.5(4 Con)4.1(t).5(rol Group \()8.1(Control-R4\) )]TJ ET 57.6 722.28 174.78 .53998 re f BT 10.98 0 0 10.98 57.6 711.36 Tm .0011 Tc .0003 Tw [(In Round 4 w)7.4(e)2.3( plan to enroll approxim)8.4(a)2.3(t)-5.2(e)2.3(ly)-7.1( )5.5(400 )5.5(new i)]TJ 21.7596 0 TD .0006 Tc .0008 Tw [(ndividuals int)5.2(o)-2.1( the Control-R4 study)-7.6( group. 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Pr)6(ospective participants will be identified )]TJ -21.8087 -1.1475 TD .0006 Tc .0008 Tw [(through the D)6.9(SS database. The DSS collects basi)-5.7(c soci)]TJ 22.0055 0 TD .0009 Tc .0005 Tw [(o-dem)8.2(ograp)-7.3(hic househol)5.5(d-level information on )5.5(births, )]TJ -22.0055 -1.153 TD .001 Tc .0004 Tw [(pregnancies, deaths, and migration from)8.3( all household)3.7(s)]TJ 22.1421 0 TD .0006 Tc .0008 Tw [( in the DSS area on a quarterly)-7.6( )5.5(basis, making it an )]TJ -22.1421 -1.153 TD .0012 Tc .0002 Tw [(excellent platform)8.5( for drawing random)8.5( sam)8.5(p)-1.5(les. To )]TJ 21.1694 0 TD .0009 Tc .0005 Tw [(minim)8.2(i)0(ze spillover effects )]TJ 11.377 0 TD .0004 Tc .001 Tw (across the intervention and )Tj -32.5464 -1.153 TD .0007 Tc .0007 Tw [(control gr)5.8(oups \(where 1 non-marital sex)-7.5(ual )]TJ 17.5847 0 TD [(partner is in one arm)8( & )-5.4(the other part)5.3(ner is in the other arm)8(\)).4(, we will )]TJ -17.5847 -1.153 TD .001 Tc .0004 Tw [(enroll not m)8.3(o)-1.7(re than 30% of age-eligible youth from)8.3( an)]TJ 22.224 0 TD .0004 Tc .001 Tw [(y)-7.8( one village, and we will designate some villages as )]TJ -22.224 -1.1475 TD .0007 Tc .0007 Tw (high treatment penetration villages and others as low )Tj 22.7541 0 TD [(treat)-5.6(ment penetration villages, by vary)-7.5(i)5.3(ng t)5.3(h)-2(e percent )]TJ -22.7541 -1.153 TD .0009 Tc .0005 Tw [(of the eligible)7.6( population w)7.2(ho is enrolled in the treatment arm)8.2(.)-5.9( )]TJ T* 0 Tc 0 Tw ( )Tj T* .0005 Tc .0009 Tw [(Following a )5.5(phase of co)-7.7(mm)7.8(unity)-7.7( sensitization, fieldworkers)]TJ 24.0601 0 TD .0007 Tc .0007 Tw [( will visit the households of the )5.5(random)8(ly)-7.5(-selected )]TJ -24.0601 -1.153 TD .0009 Tc .0005 Tw [(young m)8.2(e)2.1(n & women to invite them)8.2( to participate in the st)]TJ 23.4481 0 TD .0008 Tc .0006 Tw [(udy)-7.4(.)-.6( P)5(o)-1.9(t)5.4(e)2(ntial participants)]TJ 10.7377 0 TD .0013 Tc .0001 Tw [( will be given an invi)5.9(tation )]TJ -34.1858 -1.153 TD .0011 Tc .0003 Tw [(that contains inform)8.4(ation about t)5.7(h)-1.6(e stud)3.8(y, plus t)5.7(h)-1.6(e inf)6.2(o)-1.6(rm)]TJ 23.0656 0 TD [(ed consent form)8.3( to read)-7.2(, and instructi)5.6(ons to com)8.3(e)2.2( to a )]TJ -23.0656 -1.1475 TD .0005 Tc .0009 Tw [(nearby)-7.7( study station)-5.3( )5.5(the following week for screeni)]TJ 21.224 0 TD .0007 Tc .0007 Tw [(ng & potential )5.5(enrollment if they are interested in )]TJ -21.224 -1.153 TD .0005 Tc .0009 Tw [(participating )5.5(\(see below fo)-7.7(r deta)]TJ 12.9618 0 TD .0003 Tc .0011 Tw [(ils on the study)-7.9( stations\). )]TJ -12.9618 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0006 Tc .0008 Tw (Qualitative sub-study )Tj ET 57.6 357.54 94.38 .53998 re f BT 10.98 0 0 10.98 57.6 346.62 Tm .0004 Tc .001 Tw [(We will recru)-7.8(it participants for the qualit)5(ative study)-7.8( at)]TJ 21.7596 0 TD .001 Tc .0004 Tw [( )5.5(two points i)5.6(n)-1.7( )5.5(time using the same recruitm)8.3(ent )-5.4(m)8.3(e)2.2(thods. )]TJ -21.7596 -1.1475 TD .0006 Tc .0008 Tw [(The first recr)-5.2(uitm)7.9(ent will t)-5.7(a)1.8(ke place during the baseline visit )]TJ 24.4863 0 TD [(to the)7.3( study)-7.6( station. 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These partic)]TJ 22.1093 0 TD .001 Tc .0004 Tw [(ipants will be asked if they would )5.5(be willing to )]TJ -22.1093 -1.153 TD .0003 Tc .0011 Tw [(participate in the qualitative sub-study)-7.9(.)-1.1( )5.5( )]TJ /TT6 1 Tf 0 -1.0929 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 0 -1.1858 TD .0014 Tc [(Round )5.5(4 Con)4.1(t).5(rol Group \()8.1(Control-R4\) )]TJ ET 57.6 142.8 174.78 .53999 re f BT 10.98 0 0 10.98 57.6 131.88 Tm .0008 Tc .0006 Tw [(The Control-)5.9(R4 group will)5.4( be selected and recruited us)]TJ 22.082 0 TD [(ing the sam)8.1(e)-3.4( procedures described above as were used )]TJ -22.082 -1.153 TD .0007 Tc [(for the origi)5.3(n)3.4(al baseline sam)8(p)-2(l)-5.6(e)1.9(. Potentially)-7.5( eligible )]TJ 21.2295 0 TD .001 Tc .0004 Tw [(i)5.6(ndividuals will be identifie)7.7(d in the existi)5.6(ng Dem)8.3(ographic )]TJ -21.2295 -1.153 TD .0009 Tc .0005 Tw [(Surveillance Surve)7.6(y)-7.3( com)8.2(puterized da)]TJ 14.9891 0 TD .0005 Tc .0009 Tw [(tabase of village residents; st)-5.8(udy)-7.7( )]TJ 13.3333 0 TD .0012 Tc .0002 Tw [(personnel will visit the)7.9(i).3(r househol)5.8(d t)5.8(o)-1.5( )]TJ -28.3224 -1.1475 TD .0006 Tc .0008 Tw [(explain the study)-7.6( and verif)5.7(y)-2.1( eligibilit)5.2(y; )5.5(and eligibles will )]TJ 23.0109 0 TD .0011 Tc .0003 Tw [(be invite)7.8(d to com)8.4(e)2.3( to the study)-7.1( stati)5.7(on the foll)5.7(owing )]TJ -23.0109 -1.153 TD .0005 Tc .0009 Tw [(week to co)-7.7(mplete inform)7.8(e)-3.7(d)-2.2( consen)]TJ 14.0219 0 TD .0008 Tc .0006 Tw [(t and enroll if the)7.5(y)-1.9( so choose. )]TJ /TT6 1 Tf 12.3224 0 TD 0 Tc 0 Tw ( )Tj /TT2 1 Tf 10.02 0 0 10.02 57.6 69.48 Tm ( )Tj 0 -1.1497 TD ( )Tj 0 -1.1437 TD .0003 Tc -.0027 Tw [(Recr)6.2(uitmen)6.3(t Materials)5.6( )]TJ ET endstream endobj 22 0 obj <> endobj 23 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 24 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD .0002 Tc .0002 Tw [( )-29045.1(Page 9 o)-5.5(f)2.4( 29)]TJ /TT4 1 Tf 12 0 0 12 338.28 30.6 Tm 14.61 Tc 0 Tw ( )Tj 10.98 0 0 10.98 75.6 736.6801 Tm 0 Tc ( )Tj -1.6393 -1.153 TD .0015 Tc -.0001 Tw [(Main stud)4.2(y)-6.7( a)8.2(nd Contr)6.6(o)-1.2(l-R4 sam)8.8(p)-1.2(le )]TJ ET 57.6 722.28 155.22 .53998 re f BT 10.98 0 0 10.98 57.6 711.36 Tm .0008 Tc .0006 Tw [(Recruit)-5.5(m)2.7(ent invitations wil)5.4(l)-.1( be delivered to the househol)]TJ 22.7869 0 TD .0007 Tc [(ds of selected indivi)5.3(dual)5.3(s)1.9( a few day)-7.5(s)1.9( before the stud)3.4(y)-7.5( )]TJ -22.7869 -1.153 TD .0008 Tw [(team)7.9( arrives f)-5.2(o)-2.1(r enrollm)7.9(ent)-5.7( and baseline study)-7.6( activities. Th)]TJ 24.0656 0 TD .0007 Tw [(ese invitations will inform)8( r)-5.1(ecipien)-7.5(ts that the)7.4(y)-7.5( ha)7.4(ve )]TJ -24.0656 -1.153 TD .0008 Tc [(been random)8.1(ly selected to participate in a new study)-7.4(.)4.9( )]TJ 21.5301 0 TD .0005 Tc .0009 Tw [(The invitations will also specify)-7.7( where and when the )]TJ -21.5301 -1.1475 TD .001 Tc .0004 Tw [(recruit should go to m)8.3(e)-3.2(et with the study t)5.6(e)2.2(am)8.3( for )]TJ 19.8033 0 TD .0005 Tc .0009 Tw [(possi)-5.8(ble enrollm)7.8(en)-7.7(t and baseline data collecti)-5.8(on. )5.5( )]TJ -19.8033 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0005 Tc .0009 Tw [(The purpose )5.5(of the study )5.5(will be descri)-5.8(b)-2.2(ed briefly)-7.7(,)-.9( el)]TJ 21.1967 0 TD .0007 Tc .0007 Tw (igibility criteria will be de)Tj 10.459 0 TD .0008 Tc [(tailed, and the)7.5( names and )]TJ -31.6557 -1.153 TD .0005 Tc .0009 Tw [(institutional a)7.2(ffiliations of the resear)-5.3(cher)-5.3(s will be given.)]TJ 22.4262 0 TD .0008 Tc .0006 Tw [( The nam)8.1(e)2( )-5.4(and contact inform)8.1(ation for the in-village )]TJ -22.4262 -1.153 TD .0001 Tc .0013 Tw [(study)-8.1( representative as well as the IHR)-5(D)1(C study)-8.1( contact )]TJ 23.5847 0 TD .0011 Tc .0003 Tw (person will be provided. )Tj 10.7486 0 TD .0005 Tc .0009 Tw [(The invitation will list )5.5(the )]TJ -34.3333 -1.1475 TD .0007 Tc .0007 Tw [(same key)-7.5( p)3.4(o)-2(i)5.3(n)-2(ts about stu)3.4(d)3.4(y)-2( participatio)3.4(n that are lis)]TJ 21.082 0 TD .0015 Tc -.0001 Tw [(ted in the inf)6.6(o)4.2(rm)8.8(ed consent form)8.8( \(and co)-6.7(m)8.8(p)-1.2(rehension )]TJ -21.082 -1.153 TD .0006 Tc .0008 Tw (assessment\). The same language will )Tj 15.0765 0 TD .0003 Tc .0011 Tw [(be used to ensur)5.4(e)1.5( consistency)-7.9( across all co)-7.9(mmunication materi)-6(als.)-6.5( )]TJ -15.0765 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0006 Tc .0008 Tw (Qualitative sub-study )Tj ET 57.6 570.48 94.38 .53998 re f BT 10.98 0 0 10.98 57.6 559.5601 Tm .0007 Tw (Potential participants will be verbally recru)Tj 17.3333 0 TD .0009 Tc .0005 Tw [(ited using )5.5(the attached recruit)-5.4(m)8.2(ent script. )5.5( )]TJ /TT2 1 Tf 10.02 0 0 10.02 57.6 547.74 Tm 0 Tc 0 Tw ( )Tj /TT4 1 Tf 10.98 0 0 10.98 57.6 535.4401 Tm ( )Tj /TT2 1 Tf 10.02 0 0 10.02 57.6 523.6201 Tm ( )Tj 0 -1.4012 TD ( )Tj ET 56.1 520.92 499.8 .47998 re f 56.1 519.96 499.8 .48004 re f BT 10.02 0 0 10.02 57.6 498.12 Tm -.0012 Tc -.0012 Tw (SECTION 4: IN)Tj 7.1557 0 TD .0007 Tc -.0091 Tw [(FORME)9(D)-1.7( CO)6.1(NSENT)6.8( )]TJ /TT4 1 Tf 10.98 0 0 10.98 57.6 485.76 Tm 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0015 Tc -.0001 Tw [(Main stud)4.2(y)-6.7( a)8.2(nd Contr)6.6(o)-1.2(l-R4 sam)8.8(p)-1.2(le )]TJ ET 57.6 471.42 155.22 .53998 re f BT 10.98 0 0 10.98 57.6 460.5 Tm .0007 Tc .0007 Tw [(The main study)-7.5( will invol)5.3(ve inform)8(ed )]TJ 15.4645 0 TD .0008 Tw [(consent for study)-7.6( enrollm)7.9(ent. The c)]TJ 14.4973 0 TD [(onsent will also ask for agreem)7.9(en)-7.6(t for )]TJ -29.9617 -1.153 TD .001 Tc .0004 Tw [(long-term)8.3( speci)-5.3(m)8.3(en storage and possible )5.5(future research )]TJ 22.8361 0 TD .0008 Tc .0006 Tw [(testing, as well as for linking t)5.4(o)-1.9( DSS )5.5(data for futur)5.9(e)2( )]TJ -22.8361 -1.153 TD -.0001 Tc 0 Tw [(resea)-4.3(rch. )]TJ T* 0 Tc ( )Tj T* .0006 Tc .0008 Tw [(All potential )5.5(study)-7.6( participants )-5.4(m)7.9(u)-2.1(st pr)]TJ 15.6612 0 TD .0012 Tc .0002 Tw [(ovide written inform)8.5(ed consent to enro)]TJ 15.6175 0 TD .0005 Tc .0009 Tw [(ll i)5.1(n)-2.2( the m)7.8(a)1.7(in st)-5.8(udy)-7.7(.)-.9( Participa)7.2(n)-2.2(ts )]TJ -31.2787 -1.1475 TD [(are not required to consent )5.5(to long-term)7.8( )-5.4(speci)-5.8(men storag)]TJ 22.6393 0 TD .0002 Tc .0012 Tw [(e and DSS data acc)-4(ess; p)-8(a)1.4(rticipants )-5.4(may)-8( choose not to )]TJ -22.6393 -1.153 TD .0009 Tc .0005 Tw [(consent to the)7.6(se future research activities and still be )]TJ 21.3934 0 TD .0007 Tc .0007 Tw [(enrolled in )5.5(the )5.5(study)-7.5(.)-.7( Inf)5.8(o)-2(rmed consent form)8(s will be )]TJ -21.3934 -1.153 TD .0008 Tc (written and reviewed with participants in Kiswahili, th)Tj 21.8689 0 TD .0006 Tc .0008 Tw [(e local language. Form)7.9(s )-5.4(will be translated into Kiswahili )]TJ -21.8689 -1.153 TD .001 Tc .0004 Tw (and back-translated into English )Tj 13.1913 0 TD .0015 Tc -.0001 Tw [(before stud)4.2(y)-6.7( im)8.8(plem)8.8(entation. )5.5( )]TJ -13.1913 -1.153 TD 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0004 Tc .001 Tw [(Please note that we have ad)-7.8(opted m)7.7(a)1.6(ny)-7.8( best practice)-3.8(s)-3.9( )]TJ 22.5628 0 TD .001 Tc .0004 Tw [(for obtaining inform)8.3(ed c)-3.2(onsent and view infor)-4.8(m)8.3(ed )]TJ -22.5628 -1.153 TD .0006 Tc .0008 Tw [(consent as a process: involving the communities at outs)7.2(e)1.8(t, )]TJ 23.4754 0 TD .0008 Tc .0006 Tw [(buildi)5.4(ng participants)-5( unders)]TJ 11.5191 0 TD .001 Tc .0004 Tw [(tanding )5.5(of the study over )]TJ -34.9945 -1.153 TD .0006 Tc .0008 Tw [(time before obtaining written inform)7.9(ed c)-3.6(onsent, assess)-3.7(i)]TJ 22.1694 0 TD .0007 Tw [(ng participants)-5.1( understandi)]TJ 11.1858 0 TD [(ng within the inform)8(ed )]TJ -33.3552 -1.153 TD .0009 Tc .0005 Tw [(consent forms, using visua)7.6(l)0( aids to enha)7.6(nce par)]TJ 18.9126 0 TD .0017 Tc -.0058 Tw [(ticipants understanding)4.4(, )-5.5(and )]TJ 11.8634 0 TD .0014 Tc 0 Tw [(m)8.7(onitorin)4.1(g)-1.3( part)6(icipants )]TJ -30.776 -1.153 TD .0007 Tc .0007 Tw [(understanding and perceived risks throughout)5.3( the study)-7.5(. )]TJ 22.7049 0 TD .001 Tc .0004 Tw [(Specific activities relating to t)5.6(h)-1.7(e inform)8.3(ed consent )]TJ -22.7049 -1.1475 TD .0003 Tc .0011 Tw [(process are d)-7.9(e)1.5(tailed below. )]TJ /TT2 1 Tf 10.02 0 0 10.02 57.6 258.9601 Tm 0 Tc 0 Tw ( )Tj /TT8 1 Tf 10.98 0 0 10.98 57.6 246.5401 Tm .0007 Tc .0007 Tw (Community sensitization phase )Tj /TT4 1 Tf T* .0008 Tc [(The process of obtaining informed consent will begin )5.5(w)]TJ 22.4262 0 TD [(ith a period )5.5(of comm)8.1(unit)-5.5(y)-1.9( sensitization several weeks )]TJ -22.4262 -1.153 TD .0006 Tc .0008 Tw [(before recruitment begins. In each study)-7.6( )5.5(village, st)]TJ 20.2787 0 TD .0007 Tw (udy staff will work with village leaders to build )Tj -20.2787 -1.1475 TD .0008 Tw [(understanding of and support for the study)-7.6( within )5.5(the )5.5(v)]TJ 22.0656 0 TD .0005 Tc .0009 Tw [(illages. 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Participants)]TJ 22.6448 0 TD .0007 Tw ( will be tested for each of the following six STIs during )Tj -22.6448 -1.153 TD .001 Tc .0004 Tw [(the five roun)3.7(ds of STI testing: )]TJ /TT8 1 Tf 12.306 0 TD [(Chlamyd)3.7(i).1(a trachomati)5.6(s)2.2(, Neisseria )]TJ 13.9618 0 TD .0012 Tc -.0053 Tw (gonorrhoeae, Trichom)Tj 9.071 0 TD .0014 Tc -.0055 Tw [(onas vaginalis, )]TJ -35.3388 -1.153 TD .0054 Tw [(M)3.8(ycoplasma genitalium)]TJ /TT4 1 Tf 9.6612 0 TD .0015 Tc -.0001 Tw [( [)6.6(R)1.8(ound)4.2( 1 testin)4.2(g was not pos)8.1(sible])]TJ /TT8 1 Tf 14.1202 0 TD .001 Tc .0004 Tw (, Treponema pallidum )Tj /TT4 1 Tf 9.1311 0 TD .0008 Tc .0006 Tw [(\(sy)-7.4(phi)5.4(lis\), )5.5(and HSV-2 \(herpes )]TJ -32.9126 -1.153 TD .0006 Tc .0008 Tw [(si)-5.7(m)7.9(p)-2.1(lex II\). Participants wi)-5.7(ll not )5.5(be tested for s)7.2(y)-7.6(philis)]TJ 21.5683 0 TD .0004 Tc .001 Tw [( )5.5(and HSV-2 in rounds )5.5(2 and 3. 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We an)Tj 24.0055 0 TD .0008 Tc .0006 Tw [(ticipate the use of a pooling prot)5.4(ocol for som)8.1(e)2( of the )]TJ -24.0055 -1.153 TD -.0006 Tc 0 Tw [(NAAT)-7.2(s. )]TJ T* 0 Tc ( )Tj T* .0007 Tc .0007 Tw [(Blood specimens will be tested for herpes sim)8(p)-2(lex II virus \(HSV-2\), )]TJ /TT8 1 Tf 27.5956 0 TD .0015 Tc -.0001 Tw [(T. palli)6.1(dum )]TJ /TT4 1 Tf 4.8743 0 TD .0004 Tc .001 Tw [(\()5.5(s)1.6(y)-7.8(p)3.1(hilis\), and HIV. For HSV-)]TJ -32.4699 -1.153 TD [(2, we will use the Focus HerpeSelect HS)-6.3(V-2 ELISA Ig)]TJ 22.0874 0 TD [(G assay)-7.9( \(Focus Technologies, Cy)-7.9(press, CA\) to detect )]TJ -22.0874 -1.1475 TD .0008 Tc .0006 Tw [(seru)-7.4(m)8.1( antibodies. 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For HIV,)-6.2( we will use rapid )]TJ -22.5956 -1.153 TD .0009 Tc .0005 Tw [(test for initial results, confirm)8.2(a)2.1(tion of positives, and tie-breaking. )]TJ T* 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0006 Tc .0008 Tw [(For each participant, specimens will be )-5.4(labeled with a da)]TJ 22.7541 0 TD .0005 Tc .0009 Tw [(ted barcode that will link their sam)7.8(p)-7.7(l)-.4(es \(and test r)-5.3(esults\) )]TJ -22.7541 -1.153 TD .0008 Tc .0006 Tw [(to their study )5.5(identification )5.5(code in the la)7.5(boratory)-7.4( computer)]TJ 23.9235 0 TD .0005 Tc .0009 Tw [( database. All laboratory)-7.7( test results will be stored in )]TJ -23.9235 -1.153 TD .0006 Tc .0008 Tw [(a password-protected data)-3.6(base on a com)7.9(puter in the )]TJ 20.9727 0 TD .0004 Tc .001 Tw [(laboratory)-7.8(,)-1( separate fro)-7.8(m)7.7( a)-3.8(ll other study )5.5(data. The )]TJ -20.9727 -1.153 TD .0006 Tc .0008 Tw [(laborator)5.7(y)-7.6( test result reports will be automatically)-7.6( gene)]TJ 22.1202 0 TD .0011 Tc .0003 Tw [(rated \(using standard laboratory)-7.1( m)8.4(a)2.3(nagem)8.4(e)2.3(nt software\) )]TJ -22.1202 -1.153 TD .0006 Tc .0008 Tw [(for each study participant )5.5(once all tests )-5.4(have been com)7.9(p)]TJ 22.388 0 TD [(l)-5.7(e)1.8(ted for their village in a given round. These reports )]TJ -22.388 -1.1475 TD .0003 Tc .0011 Tw [(will then be double-checked by)-7.9( laboratory)-7.9( staff for ac)7(cu)]TJ 22.4699 0 TD .0005 Tc .0009 Tw [(racy)-7.7( and t)5.1(h)3.2(en returned to study)-7.7( partici)5.1(p)-2.2(ants in a )]TJ -22.4699 -1.153 TD .0006 Tc .0008 Tw (standardized format. )Tj T* 0 Tc 0 Tw ( )Tj T* .0005 Tc .0009 Tw [(As part of the accuracy)-7.7( checking of STI )5.5(result reports ge)]TJ 22.694 0 TD .0003 Tc .0011 Tw [(nerated for study)-7.9( participan)]TJ 11.0437 0 TD [(ts, several )-5.4(procedures have )]TJ -33.7377 -1.153 TD .001 Tc .0004 Tw [(been im)8.3(ple)-3.2(m)-2.6(ented: )]TJ /F1 1 Tf 0 -1.2186 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0005 Tc .0009 Tw [(The com)7.8(puter)-5.3( program)7.8(s tha)-3.7(t)-.4( translate res)-3.8(u)-2.2(lts into)]TJ 19.6995 0 TD .0004 Tc .001 Tw [( reports have been extensively)-7.8( )5.5(bug-checked. )5.5( )]TJ /F1 1 Tf -21.3388 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0006 Tc .0008 Tw [(The data entry interface has been )-5.4(m)7.9(odified so as to )]TJ 20.6393 0 TD .0007 Tw [(reduce the possibility)-7.5( )5.5(of results being entered into )]TJ -20.6393 -1.153 TD .0005 Tc .0009 Tw [(incorrect fiel)-5.8(ds, and also to prevent invalid res)]TJ 18.5792 0 TD .0008 Tc .0006 Tw [(ponses \(such as bla)-3.4(nk spaces\) fr)-5(om)8.1( being entered. )]TJ /F1 1 Tf 12 0 0 12 57.6 227.3401 Tm 0 Tc 0 Tw ()Tj /TT2 1 Tf .46 0 TD ( )Tj /TT4 1 Tf 10.98 0 0 10.98 75.6 227.3401 Tm .0009 Tc .0005 Tw [(In addition to lab staff double-checking any)-7.3( )5.5(da)]TJ 18.7268 0 TD .0008 Tc .0006 Tw [(ta entry for accuracy, the lab dire)7.5(ctor m)8.1(u)-1.9(st)]TJ 12 0 0 12 468.06 227.3401 Tm .0005 Tc -.0005 Tw [( ha)-5.6(nd-check )]TJ -32.705 -1.15 TD .0006 Tc -.0016 Tw [(every positive report ag)5.6(ainst a raw )]TJ 14.055 0 TD .0001 Tc -.0001 Tw [(printout of lab results, and sign a flow sheet each tim)7.9(e he does )]TJ -14.055 -1.15 TD .0002 Tc 0 Tw (so. )Tj /F1 1 Tf -1.5 -1.225 TD 0 Tc ()Tj /TT2 1 Tf .46 0 TD ( )Tj /TT4 1 Tf 1.04 0 TD .0008 Tc -.0015 Tw [(The local If)3.8(akara direc)4.6(t)-1.4(or)3.8( of)3.8( the If)3.8(akara Health )]TJ 18.995 0 TD .0009 Tc -.0009 Tw [(In)5.9(stitu)5.9(te will s)5.1(pot-che)4.7(ck th)5.9(e result pr)3.9(intouts f)3.9(o).9(r )]TJ -18.995 -1.145 TD .0006 Tc -.0013 Tw [(study participants agains)4.8(t raw resu)5.6(lt printou)5.6(t)-1.6(s. T)6.4(h).6(is)]TJ 20.72 0 TD -.0018 Tw [( will b)5.7(e)-.5( d)5.7(one prior to results being)5.7( delivered to)5.7( )]TJ -20.72 -1.15 TD .0001 Tc -.0001 Tw (subjects each week. )Tj 10.98 0 0 10.98 57.6 144.6001 Tm 0 Tc 0 Tw ( )Tj 0 -1.153 TD ( )Tj /TT12 1 Tf T* .0009 Tc .0005 Tw (HIV/STI post-counseling )Tj /TT10 1 Tf 10.6885 0 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf .2514 0 TD ( )Tj -10.9399 -1.1475 TD .0008 Tc .0006 Tw (Participants will be asked to return )Tj 14.1913 0 TD .0002 Tc .0012 Tw [(to the study)-8( station at a specified tim)]TJ 14.7049 0 TD .0008 Tc .0006 Tw (e to receive their test results and )Tj -28.8962 -1.153 TD .0006 Tc .0008 Tw [(HIV/STI post-test counseling. A trained )5.5(study)-7.6( counselor w)]TJ 23.5902 0 TD .0005 Tc .0009 Tw [(ill return )5.5(the results to the )]TJ 10.5738 0 TD .0007 Tc .0007 Tw (participant in a private, )Tj -34.1639 -1.153 TD .0011 Tc .0003 Tw [(soundpr)6.2(oof ar)6.2(ea of the study station. P)5.3(o)3.8(st-test counseling )]TJ 23.4317 0 TD .0006 Tc .0008 Tw [(will diffe)7.3(r depending on whether the result is negative )]TJ -23.4317 -1.153 TD .0008 Tc .0006 Tw [(or positive. H)7.1(o)-1.9(wever, all post-test counseli)]TJ 17.1639 0 TD .0006 Tc .0008 Tw [(ng will contain the following core elements: )-5.4( )]TJ -15.5246 -1.153 TD 0 Tc 0 Tw ( )Tj /TT2 1 Tf T* .0003 Tc (- )Tj /TT4 1 Tf 1.6393 0 TD .001 Tw [(Confirmation of participant)-5.4(s readiness to receive the HIV/STI test )-5.4(result )]TJ ET endstream endobj 40 0 obj <> endobj 41 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 42 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD -.0001 Tc .0005 Tw [( )-29045.1(Page 15 )-7.5(of 29)]TJ /TT4 1 Tf 12 0 0 12 342.72 30.6 Tm 14.24 Tc 0 Tw ( )Tj /TT2 1 Tf 10.98 0 0 10.98 75.6 736.62 Tm .0003 Tc (- )Tj /TT4 1 Tf 1.6393 0 TD .0009 Tc .0005 Tw [(Provision )5.5(of )5.5(HIV/STI test )-5.4(results and time for reflection. )5.5( )]TJ /TT2 1 Tf -1.6393 -1.1585 TD .0003 Tc 0 Tw (- )Tj /TT4 1 Tf 1.6393 0 TD .0006 Tc .0008 Tw [(Assessment of individual)-5.2(s com)7.9(p)-2.1(r)-5.2(e)1.8(hensi)-5.7(on of r)]TJ 18.9016 0 TD .0007 Tw [(esults )5.5(and additional explanation )5.5(if necessary)-7.5(.)4.8( )]TJ /TT2 1 Tf -20.541 -1.1585 TD .0003 Tc 0 Tw (- )Tj /TT4 1 Tf 1.6393 0 TD .0014 Tc [(Discussion of support s)8(y)-6.8(ste)8.1(m)8.7(. )]TJ /TT2 1 Tf -1.6393 -1.153 TD .0003 Tc (- )Tj /TT4 1 Tf 1.6393 0 TD .0009 Tc .0005 Tw [(Discussion of partner testing and n)3.6(o)-1.8(tification. )5.5( )]TJ /TT2 1 Tf -1.6393 -1.1585 TD .0003 Tc 0 Tw (- )Tj /TT4 1 Tf 1.6393 0 TD .001 Tw [(Explanation )5.5(of active )-5.4(m)7.7(e)-3.8(as)-3.9(ures for stay)-7.8(ing health)]TJ 19.8033 0 TD .001 Tc .0004 Tw [(y)-7.2( \(re)7.7(maining negative/avoidin)3.7(g)-1.7( )5.5(re-infection and )]TJ -19.8033 -1.1475 TD .0012 Tc .0002 Tw [(transm)8.5(ission of STI/HIV to others\) )]TJ /TT2 1 Tf -1.6393 -1.1585 TD .0003 Tc 0 Tw (- )Tj /TT4 1 Tf 1.6393 0 TD .001 Tc .0004 Tw [(Referrals for additional co)3.7(unseling and )5.5(support)5.6( )]TJ -3.2787 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0008 Tc .0006 Tw [(Counselors will describe the window period and t)5.4(h)-1.9(e i)5.4(m)8.1(porta)]TJ 24.1967 0 TD .0006 Tc .0008 Tw [(nce of repeated testi)-5.7(ng as well as )-5.4(following t)5.2(h)-2.1(e risk )]TJ -24.1967 -1.1475 TD .0009 Tc .0005 Tw [(reduction pla)7.6(n)-1.8( for in)3.6(divid)3.6(u)3.6(a)2.1(ls who test negative for HIV/)]TJ 22.8634 0 TD [(STIs. 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Th)]TJ 15.2678 0 TD .0009 Tc .0005 Tw [(e i)-5.4(m)8.2(portance of seeking treatment and com)8.2(p)-1.8(leting treat)-5.4(m)8.2(ent will also )]TJ -15.2678 -1.153 TD .001 Tc .0004 Tw [(be em)8.3(phasized to ensure that those who t)5.6(est positive have)]TJ 23.1148 0 TD [( the oppor)6.1(tunit)5.6(y)-7.2( t)5.6(o)-1.7( test )5.5(negative in the next round.)5.1( )]TJ /TT12 1 Tf -23.1148 -1.1585 TD 0 Tc 0 Tw ( )Tj 0 -1.153 TD ( )Tj 0 -1.1475 TD .0008 Tc .0006 Tw (Distribution of cash payment)Tj /TT10 1 Tf 11.9945 0 TD .0014 Tc 0 Tw ( )Tj /TT4 1 Tf -11.9945 -1.1475 TD .0007 Tc .0007 Tw [(Following )5.5(post-counseling, those participants in the tr)5.8(eat)]TJ 22.7869 0 TD .0008 Tw [(ment group who tested )5.5(negative for all conditional )5.5(STIs )]TJ -22.7869 -1.153 TD .0004 Tc .001 Tw [(will receive t)-5.9(h)-2.3(eir conditional-cash pay)-7.8(m)2.3(ent in envelope )]TJ 22.5027 0 TD .0006 Tc .0008 Tw [(from)7.9( a )-5.4(study)-7.6( staff person \(who is not )5.5(their counselor\). )]TJ -22.5027 -1.153 TD .0008 Tc .0006 Tw [(The Tsh 2,500 \(about )5.5($2\) i)5.4(n)-1.9(convenience fee will be given to)]TJ 24.235 0 TD [( the )5.5(participant in the)7.5( same envelope. Participants )]TJ -24.235 -1.153 TD .0009 Tc .0005 Tw [(who test posit)5.5(ive for one or)6( m)8.2(o)-1.8(r)-4.9(e)2.1( STIs will not recei)]TJ 20.9781 0 TD .0006 Tc .0008 Tw [(ve a conditional)5.2( cash pay)-7.6(m)7.9(en)-7.6(t for that round. The )]TJ -20.9781 -1.1475 TD .0007 Tw (participant will still receive the Tsh )Tj 14.4699 0 TD .0008 Tw (2,500 inconvenience fee in an enve)Tj 14.1257 0 TD .0003 Tc .0011 Tw [(lope from)7.6( )-5.4(a study)-7.9( staff person. )5.5( )]TJ /TT8 1 Tf -28.5956 -1.1585 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 0 -1.1475 TD .0011 Tc .0003 Tw [(CCT cash pay)-7.1(m)8.4(ents will onl)5.7(y)-7.1( be distri)5.7(buted duri)5.7(ng R)6.9(ounds )]TJ 24.0656 0 TD .0009 Tc .0005 Tw [(2, 3, and 4 \()6(o)-1.8(r study m)8.2(onth 4, 8, )5.5(and 12\). T)5.2(h)-1.8(ese cash )]TJ -24.0656 -1.153 TD .0008 Tc .0006 Tw [(pay)-7.4(m)8.1(ents will serve to reward safe sexual behavior th)]TJ 21.5355 0 TD .0007 Tc (at occurred in the interval)Tj 10.2951 0 TD .0002 Tc .0012 Tw ( since the last test. )Tj -31.8306 -1.153 TD 0 Tc 0 Tw ( )Tj /TT12 1 Tf 0 -1.1585 TD .0014 Tw [(Lottery prizes)-4.3( )]TJ /TT4 1 Tf 0 -1.1421 TD .0012 Tc .0111 Tw [(Control grou)3.9(p participants who report to the stud)3.9(y)-7( station )]TJ 23.4098 0 TD [(and com)8.5(p)-1.5(lete their interview at ro)-7(unds 2, 3, an)3.9(d 4 will )]TJ -23.4098 -1.153 TD .0006 Tc .0226 Tw [(be eligible for a prize drawing, determ)7.9(ined by)-7.6( l)5.2(o)-2.1(ttery. )]TJ 22.2022 0 TD .0013 Tc .0219 Tw [(Treatm)8.6(e)2.5(nt group )5.4(participants w)]TJ 12.6667 0 TD .0007 Tc .0225 Tw [(ill also be eligible )5.4(as long )]TJ -34.8689 -1.153 TD .0003 Tc .1213 Tw [(as they)-7.9( )5.5(have tested negative for all rewarded STIs that )]TJ 23.1749 0 TD [(round. )5.5(All participants reporting )5.5(for the interview at)-5.9( )]TJ -23.1749 -1.153 TD .0008 Tc .006 Tw [(round )5.4(5 will be eligible for a lottery)-7.4( as well, regardless of)]TJ 23.1093 0 TD .0007 Tc [( their ST)-5.9(I status. The )-5.5(prizes will be Tsh100,000, )5.4(given )]TJ -23.1093 -1.153 TD .0012 Tc .0002 Tw [(to one m)8.5(a)2.4(n and one woman in each vill)5.8(age in each round )]TJ 23.0984 0 TD .0005 Tc .0009 Tw [(\(about 1 i)5.1(n)-2.2( 150 chance of winning during each round\). )]TJ /TT8 1 Tf -23.0984 -1.153 TD 0 Tc 0 Tw ( )Tj /TT12 1 Tf T* .0004 Tc .001 Tw [(Treatment of)-5.4( STIs )]TJ /TT4 1 Tf 0 -1.1475 TD .0007 Tc .0007 Tw [(All study)-7.5( part)5.3(icipants testing positive for)5.8( )5.5(any)-7.5( )5.5(STI w)]TJ 20.8087 0 TD .0008 Tw [(ill )5.5(be offered free treatment and counseling for the )]TJ -20.8087 -1.153 TD [(condition. T)4.9(h)-2.1(e treat)-5.7(m)7.9(e)1.8(nt )-5.4(will be ad)-7.6(m)7.9(i)-.3(nistered by)-7.6( t)5.2(h)-2.1(e h)]TJ 22.0383 0 TD [(ealth staff at the nearest health facility)-7.6(, )5.5(and will be )]TJ -22.0383 -1.153 TD .001 Tc .0004 Tw [(equivalent to )5.5(the national standard of)]TJ 14.8907 0 TD [( care syndrom)8.3(ic )-5.4(m)8.3(a)2.2(nagemen)-7.2(t).1( of STIs. Treatm)8.3(e)2.2(nt kits are provided fr)6.1(ee of )]TJ -14.8907 -1.153 TD .0005 Tc .0009 Tw [(charge to health facilities, but the study)-7.7( )5.5(team)7.8( will pro)-7.7(v)-2.2(ide )]TJ 23.3443 0 TD (extras to ensure that there )Tj 10.541 0 TD [(are suffi)-5.8(cient kits in-stock )]TJ -33.8852 -1.1475 TD .0004 Tc .001 Tw [(to treat the study)-7.8( )5.5(population. )]TJ 0 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0008 Tc .0006 Tw [(Participants who test posit)5.4(ive for an STI)5.9( during the st)5.4(ud)]TJ 22.388 0 TD [(y)-7.4( will be )5.5(pr)5.9(ovided with )5.5(2 vouchers \(one for participant )]TJ -22.388 -1.153 TD .0009 Tc .0005 Tw [(and one for t)5.5(h)3.6(em)8.2( to give to )5.5(a sexual partner\) for free treatme)]TJ 24.2514 0 TD .0007 Tc .0007 Tw (nt at the local health clinic, to be used within one )Tj -24.2514 -1.153 TD .0012 Tc .0002 Tw [(m)8.5(onth. 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At )]TJ 21.9235 0 TD .0004 Tc .001 Tw [(the second visit 2-3 weeks later they)-7.8( wil)5(l)-.5( receive their)-5.4( )]TJ -21.9235 -1.153 TD .0008 Tc .0006 Tw [(test results, post-test counseling, and fre)7.5(e treatment vouchers. )]TJ /F1 1 Tf -1.6393 -1.2186 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0007 Tc .0007 Tw [(The pre and post-test counseling will be i)5.3(d)-2(entical to )]TJ 21.0055 0 TD [(that described above \(the gr)5.8(oup counseling sessions in )]TJ -21.0055 -1.153 TD .0008 Tw [(the village will have finished by)-7.6( round )5.5(4, so Contro)]TJ 20.6503 0 TD .001 Tc .0004 Tw [(l-)6.1(R4 participants will not be )5.5(involved in a)7.7(n)3.7(y)-7.2( group )]TJ -20.6503 -1.153 TD [(counseling\). )5.5( )]TJ /F1 1 Tf -1.6393 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0008 Tc .0006 Tw [(The blood and urine specimen collectio)-7.4(n procedur)]TJ 20.1475 0 TD .0005 Tc .0009 Tw [(es will be identi)5.1(cal to those described above. )]TJ /F1 1 Tf -21.7869 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0007 Tc .0007 Tw [(The STIs tested for will be identical to t)]TJ 15.9727 0 TD (hose listed above at r)Tj 8.459 0 TD .0019 Tc -.006 Tw [(ound 4 )-5.5(\(includi)6.5(ng HIV\). )]TJ /F1 1 Tf -26.071 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0007 Tc .0007 Tw [(The laboratory testing proc)7.4(edures will be identical to those described above. )]TJ /F1 1 Tf -1.6393 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0004 Tc .001 Tw [(The inconvenience fees an)-7.8(d inclusion in the lotter)5.5(y)-7.8( wi)]TJ 21.6995 0 TD .0009 Tc .0005 Tw [(ll be identical to those described above f)6(o)-1.8(r control )]TJ -21.6995 -1.153 TD [(group enr)6(o)-1.8(llees.)-5.9( )]TJ /F1 1 Tf -1.6393 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0006 Tc .0008 Tw [(Free STI treat)-5.7(ment vouchers will be identical to that described above. )]TJ /F1 1 Tf -1.6393 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .001 Tc .0004 Tw [(The round 4 s)7.6(u)-1.7(rve)7.7(y)-7.2( questionnaire for the)7.7( Control-R4 e)7.7(n)]TJ 22.3661 0 TD .0006 Tc .0008 Tw (rollees will be identical to )Tj 10.6557 0 TD .0004 Tc .001 Tw (that used for the main )Tj -33.0219 -1.153 TD .0007 Tc .0007 Tw [(study)-7.5( enrolle)7.4(es at round 4 )5.5(\(except that sections U a)]TJ 20.4426 0 TD [(nd W will be omitted for the Control-R4 e)7.4(n)-2(rollees, as )]TJ -20.4426 -1.1475 TD .0008 Tc [(indicated b)3.5(y)-7.4( t)5.4(h)-1.9(e questionna)7.5(ire skip patterns\). )]TJ /F1 1 Tf -1.6393 -1.224 TD 0 Tc 0 Tw ()Tj /TT2 1 Tf .459 0 TD ( )Tj /TT4 1 Tf 1.1803 0 TD .0007 Tc .0007 Tw [(Control-R4 e)7.4(n)-2(rollees will not be invited to particip)]TJ 20.3388 0 TD .0008 Tw [(ate in any)-7.6( supple)7.3(m)2.5(ental studies \(such as qualitative sub-)]TJ -20.3388 -1.153 TD -.0014 Tc 0 Tw [(study)-9.6(\))-1.7(. )]TJ -1.6393 -1.153 TD 0 Tc ( )Tj T* ( )Tj /TT10 1 Tf 0 -1.1585 TD .0004 Tc .001 Tw [(Desc)-3.8(ription of locations for interventi)-5.9(on/study activities )]TJ /TT4 1 Tf 0 -1.1421 TD 0 Tc 0 Tw ( )Tj /TT8 1 Tf 0 -1.1585 TD .0006 Tc .0008 Tw [(Enrollment, STI testing, basic counseling, and survey)-3.6(s )]TJ /TT4 1 Tf 0 -1.1475 TD .0005 Tc .0009 Tw [(Study)-7.7( stations)-5.3( will be te)7.2(m)7.8(porary)-7.7( structures set up )]TJ 20.6995 0 TD (in each village that will serve as the location where )Tj -20.6995 -1.153 TD .0006 Tc .0008 Tw [(intervention/s)7.2(t)-.3(udy)-7.6( activitie)7.3(s take place, i)-5.7(n)-2.1(cluding enrollm)]TJ 23.0874 0 TD .0007 Tw [(ent, speci)-5.6(men collectio)-7.5(n, test result and cash pa)7.4(y)-7.5(m)2.6(ent )]TJ -23.0874 -1.153 TD .0008 Tc [(distribution, s)7.4(u)-1.9(rve)7.5(y)-7.4( adm)8.1(i)-.1(nistration, etc. Dedicated areas )]TJ 22.612 0 TD .0007 Tc [(will be set )-5.4(up within )5.5(the )5.5(stations that allow for priva)7.4(c)1.9(y)-7.5( )]TJ -22.612 -1.153 TD [(during specimen collectio)-7.5(n, results distribution and c)7.4(ounse)]TJ 23.5683 0 TD .0008 Tw [(ling, and surve)7.3(y)-7.6( administration. These stations )-5.4(will be )]TJ -23.5683 -1.1475 TD .0008 Tc .0006 Tw [(convenientl)5.4(y)-7.4( )5.5(located within each village and will be open)]TJ 23.0929 0 TD .0012 Tc .0002 Tw [( hours t)5.8(h)-1.5(at are respectf)-4.6(ul of school)5.8(, )5.5(em)8.5(ploy)-7(m)8.5(e)2.4(nt, and )]TJ -23.0929 -1.153 TD .0007 Tc .0007 Tw [(other commit)-5.6(m)2.6(ents. Ho)-7.5(me visits will onl)5.3(y occur when partic)]TJ 24.3443 0 TD .0008 Tc [(ipants fail to appear at the study)-7.4( st)5.4(ation duri)5.4(ng t)5.4(h)-1.9(eir )]TJ -24.3443 -1.153 TD .0011 Tc .0003 Tw [(designated week \(perm)8.4(i).2(ssi)-5.2(on to f)6.2(o)-1.6(llow-)6.2(up in t)5.7(h)-1.6(e hom)8.4(e w)]TJ 22.8087 0 TD .0009 Tc .0005 Tw [(ill be obtained from)8.2( participants at the outset of the )]TJ -22.8087 -1.153 TD .0005 Tc .0009 Tw [(study)-7.7(\)).2(. All of)5.6( these strategi)-5.8(es are in place to m)7.8(i)-.4(ni)-5.8(m)7.8(i)-5.8(ze)]TJ 21.6448 0 TD .0007 Tc .0007 Tw [( pulling parti)5.3(c)1.9(ipants away)-7.5( from)8( productive pursuits as well )]TJ -21.6448 -1.153 TD [(as )-5.4(maintain their privacy. )5.5(Note the study stations will m)]TJ 22.4208 0 TD .0009 Tc .0005 Tw (ove with the field teams fro)Tj 11.0601 0 TD .0008 Tc .0006 Tw [(m)8.1( village-to-village and will )]TJ -33.4809 -1.1475 TD .0006 Tc .0008 Tw [(onl)5.2(y)-7.6( )5.5(be set up in each site for 2 weeks per round \(one )]TJ 21.6667 0 TD .0008 Tc .0006 Tw [(week for speci)-5.5(m)8.1(en collecti)-5.5(on and )5.5(one week for results )]TJ -21.6667 -1.153 TD .0012 Tc -.0053 Tw [(distributio)3.9(n\). )]TJ /TT2 1 Tf 10.02 0 0 10.02 57.6 135.9001 Tm 0 Tc 0 Tw ( )Tj /TT8 1 Tf 10.98 0 0 10.98 57.6 123.48 Tm .0011 Tc .0003 Tw [(Group couns)7.7(eling sessions )]TJ /TT4 1 Tf 0 -1.1475 TD .0009 Tc .0005 Tw [(The intervent)5.5(i)0(on sessions will be conducted in each co)]TJ 21.8689 0 TD .0003 Tc .0011 Tw [(mmunity)-7.9( )5.5(in )5.5(a private, confidential space \(either a )]TJ -21.8689 -1.1475 TD .0007 Tc .0007 Tw [(co)-7.5(mm)8(unity)-7.5( fa)7.4(cility)-7.5( )5.5(or a pri)5.3(v)-2(ate house, depending )5.5(on )5.5(what is available in a given community)-7.5(\).)4.8( )]TJ 0 -1.153 TD 0 Tc 0 Tw ( )Tj /TT10 1 Tf 0 -1.1585 TD ( )Tj 0 -1.153 TD .0007 Tc .0007 Tw (Study personnel and time )Tj /TT8 1 Tf T* .0003 Tc .0011 Tw (Time )Tj ET endstream endobj 58 0 obj <> endobj 59 0 obj <>/Font<>/ProcSet[/PDF/Text]>> endobj 60 0 obj <>stream /GS1 gs BT /TT2 1 Tf 7.98 0 0 7.98 57.6 748.62 Tm 0 g 0 Tc 0 Tw ( )Tj 0 -89.9774 TD -.0001 Tc .0005 Tw [( )-29045.1(Page 21 )-7.5(of 29)]TJ /TT4 1 Tf 12 0 0 12 342.72 30.6 Tm 14.24 Tc 0 Tw ( )Tj 10.98 0 0 10.98 57.6 736.6801 Tm 0 Tc .0014 Tw [(Please )-5.4(see the)-4.2( time esti)-6.3(m)1.9(at)-6.3(es for each of the study)-8.2( )5.5(procedur)]TJ 23.8634 0 TD [(es listed)-8.2( in the chronology)]TJ 10.5792 0 TD .0001 Tc [( above. Twenty)-8.1(-four of )]TJ -34.4426 -1.153 TD .0008 Tc .0006 Tw [(these hours are spent in the )5.5(group counseling sessions. Still, no)]TJ 25.2678 0 TD .001 Tc .0004 Tw [( m)8.3(o)-1.7(r)-4.8(e)2.2( than 3.5 )5.5(hours of study)-7.2( a)7.7(c)2.2(tivities per m)8.3(onth )]TJ -25.2678 -1.153 TD .0007 Tc .0007 Tw (will ever be required. )Tj /TT8 1 Tf 8.8142 0 TD 0 Tc 0 Tw ( )Tj -8.8142 -1.1585 TD ( )Tj 0 -1.153 TD .0006 Tc (Personnel )Tj /TT4 1 Tf 0 -1.1421 TD .0005 Tc .0009 Tw [(Please )-5.4(see the study)-7.7( pr)5.6(ocedure details above for specific lis)]TJ 23.7268 0 TD .0007 Tc .0007 Tw [(tings of )5.5(personnel to )5.5(be i)]TJ 9.9344 0 TD .0011 Tc .0003 Tw [(nvol)5.7(ved. )5.5(Here, we provide )]TJ -33.6612 -1.153 TD [(m)8.4(o)-1.6(re detail about t)5.7(h)-1.6(e personnel that )]TJ 14.6393 0 TD .0007 Tc .0007 Tw [(is i)5.3(n)-2(teracting with participants. )]TJ -14.6393 -1.153 TD 0 Tc 0 Tw ( )Tj T* .0012 Tc .0002 Tw [(Phlebotom)8.5(ist)-5.1(s)2.4(: We will hire phlebotom)]TJ 15.7486 0 TD .0006 Tc .0008 Tw [(ists who have been certified)-7.6( by)-7.6( na)]TJ 13.6393 0 TD .0005 Tc .0009 Tw [(tional authorities in )5.5(Tanzania to )]TJ ET 57.6 633.72 62.34 .53998 re f BT 10.98 0 0 10.98 57.6 622.8 Tm .0011 Tc .0003 Tw [(conduct the b)3.8(l).2(ood )5.5(draws. )]TJ /TT12 1 Tf 0 -1.153 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 0 -1.1475 TD .0005 Tc .0009 Tw [(Study)-7.7( counselors: We will hire individuals who ar)]TJ 20.3661 0 TD .0006 Tc .0008 Tw [(e certified VCT )-5.4(counselors )]TJ 11.0765 0 TD .0008 Tc .0006 Tw (through Tanzanias National )Tj ET 57.6 595.8 75.48 .53998 re f BT 10.98 0 0 10.98 57.6 584.88 Tm .0003 Tc .0011 Tw [(HIV/AI)-5.5(DS Programme to s)-4(e)1.5(rve as study)-7.9( )5.5(counselors in )5.5(this )]TJ 23.7322 0 TD .0001 Tc .0013 Tw [(study)-8.1(.)-1.3( This certificatio)-8.1(n ensures that study)-8.1( counselors )]TJ -23.7322 -1.153 TD .0007 Tc .0007 Tw [(are knowledgeable about HIV/AIDS cou)-7.5(n)-2(seling and te)7.4(s)]TJ 22.3115 0 TD .0011 Tc .0003 Tw [(ting procedu)3.8(r).8(es in the Tanzanian context. Stud)3.8(y )]TJ -22.3115 -1.153 TD .0008 Tc .0006 Tw [(counselors will receive additional training through t)5.4(h)-1.9(is)7.4( stud)]TJ 23.8361 0 TD .0004 Tc .001 Tw [(y)-7.8( to enable them)7.7( to effectively)-7.8( counsel participants )]TJ -23.8361 -1.153 TD .0009 Tc .0005 Tw [(through the s)7.5(p)-1.8(ecific study)-7.3(-)6(r).6(elated issues. Study c)]TJ 19.6175 0 TD .0008 Tc .0006 Tw [(ouns)7.4(elors will also facilitate group counseling sessions. )]TJ /TT12 1 Tf -19.6175 -1.153 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 0 -1.1475 TD .0007 Tc .0007 Tw (Fieldworkers / Interviewers: We will )Tj 15.0492 0 TD .0008 Tw (hire experienced fieldworkers/interv)Tj 14.5738 0 TD .0004 Tc .001 Tw [(iewers t)-5.9(o)-2.3( assist with questionnaire )]TJ ET 57.6 519.9 121.56 .54004 re f BT 10.98 0 0 10.98 57.6 508.98 Tm .0007 Tc .0007 Tw [(ad)-7.5(m)8(i)-.2(nistration and specimen processing in the field. )5.5( )]TJ /TT12 1 Tf 0 -1.1585 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 0 -1.1475 TD .0014 Tw [(Laboratory)-8.2( staff: The )-5.4(m)7.3(i)-.9(cr)-5.8(obiology)-8.2( laboratory)-8.2( staff at)]TJ 21.5847 0 TD .0002 Tc .0012 Tw [( IHRDC, )-5.4(ma)-4(naged by)-8( Boniphace Jullu, )5.5(has extensive)-4( )]TJ ET 57.6 481.92 71.16 .53998 re f BT 10.98 0 0 10.98 57.6 471.06 Tm .0007 Tc .0007 Tw [(experience in processing bi)5.3(ological sam)8(p)-2(les for large ra)]TJ 22.3279 0 TD .0008 Tc [(ndom)8.1(ized trials. The lab has effective procedures in )]TJ -22.3279 -1.153 TD .0005 Tc .0009 Tw (place to for maintaining participan)Tj 13.8525 0 TD .0003 Tc .0011 Tw [(t confidentiality)-7.9( for )5.5(all speci)-6(mens)-4(.)]TJ /TT2 1 Tf 10.02 0 0 10.02 360.3 458.4 Tm 0 Tc 0 Tw ( )Tj /TT4 1 Tf 10.98 0 0 10.98 57.6 445.74 Tm ( )Tj 0 -1.153 TD .0006 Tc .0008 Tw (Qualitative sub-study )Tj ET 57.6 431.34 94.38 .54001 re f BT 10.98 0 0 10.98 57.6 420.42 Tm .0007 Tw [(Interviews will be conduct)5.3(e)1.9(d in Swahili )5.5(by)-7.5( a Tanzan)]TJ 21.0874 0 TD .0011 Tc .0003 Tw [(ian trained in )5.5(qualitative int)5.7(e)2.3(rviewing techniques. )5.5( )]TJ -21.0874 -1.153 TD 0 Tc 0 Tw ( )Tj 0 -1.1475 TD .0009 Tc .0005 Tw (Conversational diarists )Tj ET 57.6 393.42 101.16 .53998 re f BT 10.98 0 0 10.98 57.6 382.5 Tm .0003 Tc .0011 Tw [(Ten local community)-7.9( residents \(each in a separate )-5.4(st)]TJ 20.9781 0 TD .0008 Tc .0006 Tw [(udy)-7.4( )5.5(village\) will be hired )]TJ 10.3825 0 TD .0007 Tc [(to anony)-7.5(m)8(ously record )]TJ -31.3607 -1.153 TD .0009 Tc .0005 Tw [(conversations overheard in )5.5(the villa)]TJ 14.3005 0 TD .0007 Tc .0007 Tw [(ge regarding t)5.3(h)-2(e study)-7.5(.)-.7( )5.5( The in)]TJ 12.2732 0 TD .0011 Tc .0003 Tw [(te)7.8(rviewers will )-5.4(undergo )5.5(training in )]TJ -26.5738 -1.153 TD [(appropriate techniques for r)6.1(ecording data and ensuring)3.7( )]TJ 22.1749 0 TD [(confidentialit)5.7(y of the ano)3.8(n)3.8(y)-7.1(m)8.4(ous conve)7.8(rsations recorded. )]TJ /TT2 1 Tf 10.02 0 0 10.02 57.6 345.36 Tm 0 Tc 0 Tw ( )Tj /TT4 1 Tf 10.98 0 0 10.98 57.6 333.06 Tm .0014 Tc [(Round )5.5(4 Con)4.1(t).5(rol Group \()8.1(Control-R4\) )]TJ ET 57.6 331.32 174.78 .53998 re f BT 10.98 0 0 10.98 57.6 320.4 Tm .0002 Tc .0012 Tw [(The Control-R4 study)-8( activities will take place at the )-5.4(sa)]TJ 22.2842 0 TD .0005 Tc .0009 Tw [(me study)-7.7( station as for the )-5.4(m)7.8(a)1.7(in enrollees, during the )]TJ -22.2842 -1.153 TD .0006 Tc .0008 Tw [(same weeks, with the sam)7.9(e)-3.6( study)-7.6( pers)]TJ 15.2186 0 TD (onnel. We anticipate that the initial )Tj 14.5792 0 TD .0005 Tc .0009 Tw [(visit wi)5.1(ll take approxi)-5.8(m)7.8(ately)-7.7( 2 hours, )]TJ -29.7978 -1.153 TD .0007 Tc .0007 Tw [(and the second visit to )5.5(pick up resu)]TJ 14.1093 0 TD .0003 Tc .0011 Tw (lts will take less than one hour. )Tj /TT2 1 Tf 10.02 0 0 10.02 57.6 283.2601 Tm 0 Tc 0 Tw ( )Tj 0 -1.1437 TD ( )Tj 0 -1.1497 TD -.0007 Tc -.0017 Tw [(Data Collecti)7.7(on Instruments: )]TJ 1 0 0 rg 1.7964 -1.1437 TD 0 Tc 0 Tw ( )Tj /TT4 1 Tf 10.98 0 0 10.98 57.6 236.4601 Tm 0 g .0014 Tc [(Main stud)4.1(y )]TJ ET 57.6 234.72 49.8 .54001 re f BT /TT2 1 Tf 10.02 0 0 10.02 57.6 224.64 Tm 1 0 0 rg 0 Tc ( )Tj /TT8 1 Tf 10.98 0 0 10.98 57.6 212.28 Tm 0 g .0014 Tw [(Baseline surv)-4.2(ey)]TJ /TT12 1 Tf 6.3115 0 TD .0003 Tc .0011 Tw (: )Tj /TT4 1 Tf .8361 0 TD .0005 Tc .0009 Tw [(During the first visit to )5.5(the study)-7.7( stati)5.1(on at)]TJ 16.9727 0 TD .0004 Tc .001 Tw [( baseline, study)-7.8( couns)7(elors will interview all )]TJ -24.1202 -1.1475 TD .0007 Tc .0007 Tw (participants using a structured baseline questionnaire. Pa)Tj 22.7322 0 TD .0008 Tw (rticipants will be asked a series of questions regarding )Tj -22.7322 -1.153 TD .0012 Tc .0002 Tw [(dem)8.5(ographics, sexual behavior, econom)8.5(ic)]TJ 16.8251 0 TD .0007 Tc .0007 Tw [( activity)-7.5(, )5.5(knowledge and )5.5(beliefs a)]TJ 13.459 0 TD .0005 Tc .0009 Tw [(bout HIV & STIs, )-5.4(etc. during a f)5.6(ace-)]TJ -30.2842 -1.153 TD .0002 Tc .0012 Tw [(to-face interview with a study)-8( counselor. )]TJ /TT10 1 Tf 0 -1.1585 TD 0 Tc 0 Tw ( )Tj /TT8 1 Tf 0 -1.1475 TD .0003 Tc .0011 Tw (Short surveys)Tj /TT12 1 Tf 5.4262 0 TD 0 Tw (: )Tj /TT10 1 Tf .5847 0 TD 0 Tc ( )Tj /TT4 1 Tf .2514 0 TD .0016 Tc -.0002 Tw [(During the )5.5(4-m)8.9(onth and 8-m)8.9(onth intervention )]TJ 18.6503 0 TD .0007 Tc .0007 Tw [(r)5.8(ounds \(Rounds 2-)5.8(3\), study counselors will )]TJ -24.9126 -1.1475 TD .0008 Tc [(interview all participants using a structured short que)7.5(s)]TJ 21.6721 0 TD .0007 Tc (tionnaire. 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