88-456 WNITE - CITY CLERK
PINK - FINANCE G I TY O SA I NT PAU L Council /y� �//�� � .
CANARV - DEPARTMENT FIIe NO• �V —• �
BLUE -MAVOR
�
Counc l� esolution
ia
Presented By
Referred To Committee: Date
Out of Committee By Date
RESOLVED, that the proper City Off cials are hereby authorized and directed to
execute a contract with the State f Minnesota, Minnesota Department of Health;
WHERESY, the City shall provide un er the tenons of this contract through the
Saint Paul Division of Public Heal h, a program to evaluate the risk of himan
immuno-deficiency virus (HIV) thro gh screening and counseling procedures among
patients attending public sexually transmitted disease clinics;
WHEREBY, the above services will e sure that individuals will understand the
meaning of the test result, counse ing will be individualized according to
behavioral needs, risk reduction w' 11 be emphasized, and referrals will be made
for medical evaluation and psychos cial support.
COUNCILMEN
Yeas D].mOnd Nays Requested by Department of:
Goswitz � In Fav r Communit Services
Long �
Rettman Agains BY
Scheibel
Sonnen
WilsOri APR — 5 � Form A rov by C' y At rney
Adopted by Council: Date
�
Certified Pas Co ncil Se ry BY `
BY �o .
A►ppr by iNavor: Da APR = �900 Approv by Mayor for Su i Cotlncil
By
PUBIISNED � �� :�: 1 v 1 $�
Ca��tY_�r�ces DEP14 MfMT N.� Os7�i3V
�a�hla�rn ffiahslaAd _ ,_ CONT T �a����
244-7702 PNONE
March a. 29t8 DATE �i e� ', Q
ASSIGN Nt�'BER EOR ROUTING ORDER C1i All ocations for..S� nature :
.,,� Department Qirector 3 Director of Management/Mayor�
Finance and Management Services Direct r � � City Gle�k �� I�� ��
8udget Director �` City cauncii ' - ��-
�City Attorney �. _
� HAT WILL BE ACHIEYED BY TAKING ACTION �1 E ATTACHED MATERIALS? (Purpose/
Rationale) :
Resolution to allow city signa�nres on an agreement be�tween the City of Saint Paul,
through ita Division of Puhlic Iieslth and the Minneaota Department of Health. Uader the
te�s of the contract, the Division of Pu lic Aealth will provide a program to eva luate the
risk of himman immunodeficiency virus (HIV among patients attegding public aexually
traaemitted disease clinics through scree ing and connseli edures. F
Rl�� RECEiVED
OST BENEFIT BUDGETARY AND PERSONNEL IMPAC S ANTICIPATE�pR�.8 j98g MAR 1 O 19$$
Mp`fpa"g���C�" ��V�vk�
Fundi� will _be. received from the Minnesot Department of Hea,lth for the grant period :
Februa�q 1,- 1988 - September 30, 1988. Th total amount of the contract is $14,400. No
persoanel impacts are anticipated. �
�Il�kNCING 50URCE AND BUDGET ACTIVITY NUMBER ARGED OR CREDITED: (Mayor's signa-
ture not re-
Total Amaunt of"Transaction: 514,400. quired if under �
� �10,OOq� �
Fur��ng Sourc�: Minnesota Department of Health �+ounc�l Research Center
Activity Number: 33242 • �AR 2$ �988
ATTACHMENTS List and Number All Attacfunents :
1. A�r+eee�eat, original and four copiea
2. R�esolution '. .
RECEIV�D .
Mp� 15 1988
DEPARTMENT REVIEW , CITY ATTORNEY REVIEW /
Yes No Council Resolution Required? � Resolution Required? (/Yes No
Yes No Insurance Required? Insurance Sufficient? Yes No ��
Yes No Insurance Attached:
(SEE •REVERSE SIDE FO INSTRUCTIONS) �
Revised 12/84
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;� ` >t ,:':. CONT'RA�CTUAL� s�r�a ern�lo�ree) SERVICES � � �- .u=,,: .- �
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Trn.No. FY Account-l.0.--•, Depi./D'w.-- _ Soq .'MA,'_. gutfix . .Object Vendor Typs �c��►p�;
,. �. . , 1 , .
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Purehas�Terms Auet No. C.CD. 1 C.CD. 2 C.CD. 3 Co� •4' Cost CadrS
st� , Numbw EntM�d By
Typ�of Tn�tion � A 40 � A 41 � � .� •
_ st� _ �:�u.wi er , Ent�tW By ,
� A 44 � A 48 � A 46
NOTICE TO CONTRACTOR: You are required by Min�eso a Statutes, 1981 Supplement, Sectior; 27p,g8 to provide your sociaF security
number or Minnesota tax identification number if you do usiness with the State of Minnesota. This �nformatiort may be usecl in the
enforcement of federal and state tax laws. Supplying these numbers could result in action to require you .o file state tax returm artd
pay delinquent state tax liabilities. This contract will not be approved unless these numben are provided. These nu^�rxwillbeavsit�
to federal and state tax authorities and state personnel invol eci in the payment of state obligations.
THIS CONTRACT, which shall be interpreted pursuant to he taws of the State of Minnesota, between the State of,Minn�rta;actie�q
through its De .artment of Heal tfi
(hereinafter STATE) and the Ci t of St. Paul a ti n throu h i ts Heal th De artment
address 555 Cedar Street St, Paul PAinnesota 55101 -
Soc.Sec.or MN Tax I.D.No. tax exem t Federa# Employer I.D.No. (if applicable) N/A - �
(hereinafterCONTRACTOR),witnesseth that: -
WHEREAS,the STATE,pursuant to Minnesota Statutes 1 05 b '
isempoweredto rovide f r the or anization f services for the revention and control of disease
and the limitation f disabilities result n therefrom � ,ana
WHEREAS, ursuant to M.S. 144.0742 the C mmissioner of Health is em owered to ent r� in con-
tractual a reements with an ublic or r vate entit for the rovision of statutoril re;a�t
WHEREAS,CONTRACTOR represents that it is duly qualifi and willing to perform ihe services set forth herein,/ scri bed health
NOW,THEREFORE,it is agreed: / 521^V1CeS.
l. CONTRACTOR'S DUTfES (Attach additional page if n essary). CONTRACTOR,who is not a state employee, shatL•
Perform the duties descri�ed. in Exhib ts A and D, attached hereto and made a part hereof.
��.
fil .,CpNDITlONS OF PAYM�NT. Ali services provided by ,ONT�AGTOR pursuan;�t+a�#�s:c�»t�t:shalk;t��''�pe�ermMdrs�-t�u a�at•�
�-isfaction,qfithe S'fATE,aa c�termined in the sale discreti '.`�f it�'asitt4orrzed age+�►t,aru# in�a+�rd v�th atl a�,���1��s'_y,
and locai laws, ordir+ances. �ul�•�ci �e�l�tions. CONT ACTOR,sha�t cbi recsiue��r�� for wc�r'k �au�d#�+�r t1+s�ST��F+to qs;:,-.��
. . , ,.. , . .
unsatisfactory,or performed ii+vrotation o#federal,state o local iaw,prdinance,ruie or regulaiion. '' �
- __ .. - February 1 -- -' .. .
1V. TERM OF CONTRACT. This coni�act shalfbe effective o - - - , 1:9� ' �-
.if►�tf�+s snt�_
d te a,s it is exe��ted as to encumbra�ce by the Commis ioner of Finance, whichever oCCU�s laCe�,9r�1d!�`�r�Fts,MoM.e�t un�i .
�e�LEtT15er , lg 8$ , or unti all obliqations set forth ir� this co�sl�cs�Ti��+k��s�ft���i#iida��
_ , . _ ,_---_ _ _ __ __� �__ . .. . �__._ -_ _ . _ _ _ -----
._. __
_ .__ _<_. .__._.,. _ �
whichever occurs fi rst. . .. _ . y�,��:� ,.. �.:,.- .
V. CANCELLATION, This contract may be cancelled by th STATE or CONTRACTOR at any iZt'rre,rr��+ �►+' w'i�dt�taure, e�pna
thirty (30) days' written notice to the other party. In the event of such a cancellation CC)N`f�#AC.�'t� �l Me � �y
_ _ � _ __ : _ __:_-,,._.._ -
payment, determined on a pro rata basis,#ar.work or serv ces sati3factorily performed.
Vl. STATE'5 AUTHORIZED: AGENT. The STATE'S i aui ized°a�ent,for�the� purposes,.of administu�tion: 4►�' i4�es �r�t'' is`
. ..- . . . , , . .�
Such agent shall have final authority for acceptance of NTRACTOR'S services and if such serv��,;,; �fe scCl�(i�tad as s�tisf'�d'y,
shell so certify on each invoice.submitted pursiiant to Cla se I1, paragraph B. - � �- - �-'
V I I. ASSIGNMENT. CONTRACTOR shaU neither assign nor transfer any rights or obligations under this�oi'r#�ct w'sthout the priar' -
. , _
vircitten consent of the STATE. . ` . . - - .: -_. _
Vllt. AMENDMENTS. Any amendmenu to this contract shall e in writing, and shall be executed by t�e satne �arGia��wt►ts�executad
the arig+nal contract,or the+r suocessors in office. `
. . ,. -
IX. IIABILITY. CONTRACTOA agrees to indemnify and sa e and hold the STATE, its agents end emp��o.y�lia�rr�lb�i�rd�h ari+�r a�d
�II c{aims or causes of action arising from the.perform ce of this contract by CONTRACTOR �or E."�t�F�'t'i`�'�ef'
emp(oyees. This clause shall not be construed_to bar a y legal remedies CONTRACTO�R may have ����ilk'�E'S�rs to
. fulfill its obligations pur3uant�to this con'tract _..___ _ :� :'_ : '. -_ . = • . . __� : -�. � -- _
_._.. _. . _
X. STATE: AtJDITS. �'he books,�records, documenta,�and Ccourrting praeedures and practices of iiie CE]f47r'�tAl�� �elsvant�- ,�:
_ .
this contract shall be subject:to examination bX the contr ing department and.the legislative auditor. __ _ . . ____=�_: :-. .
�CI. :OWNERSHIP OF DOCUMENTS. Any reports;:studies, p otagraphs,._negatives, or othe�documents prepared` ���►tTt�yR�"TC�'�"
in the performance of its obligations under thfs contract hall be the exclusive property of the STATE•a�d`al1'suCl4 e�atetiqals st�aN
be remitted to the STATE by CONTRACTOR upon com letian,-termination or cancellation of this contracC.�E�!`��ACTC'IR sh�a#1'- -
nof use, willingly. aHaw or cause to have such materials. sed for any �Rurpose other. than.performance crf.�4�C'�R10.t;TOR'S�i-
. . _ . , , . . . -.. .
. - � - '. . - _
__. . _ ,_ ,
gations under this contract witfiout the prior writien.con t:-of tfie $TATE `: . .. •. , . . ;. ..: . . - . •
. • : . , . •.. . . ._ . : �.
Xll. AFFIRMATIVE-ACTION_:_'(When applicabte) �CON�'RAC OR�certifies �that_it�has received a cerEificate�of cat�ipliance froni tfts
: Commissioner of Human Rights pursuant to.Minnewta St utes;1981�Supptement,_Seciion.363.073. � - - '
Xtll. IIUORKERS' COMPENS�ITION: In accordance wiih the �p ovisions-of Minnesota Statutes, 198f Supptement;�ectibn 17S.t87, ttie` ".'
STATE affirms that CONTRACTOR has provided accep able evidence of compliance with the_ workers' campensation insurans�
coverage requirement of Minnesota Statutes, 1981.Supple ent, Section 176.181, Subdivision 2. � �
XIV. ANTITRUST. CONTRACTOR hereby assigns to the Sta e of Minnesota any and all claims for overcharges as�to goocis arxt/ax -
services provided in.connection with this contract resulti g.#rom.antitrust violations<which arise under_the ant�'trust laws•o# the.
� . . . _.. , _ . , _. - .,• • .. , . : __ . ,., :_: . . . .
United States and ihe antitrust laws of the State of Minne ta. �
XV. OTH OVISIONS. (At h addi 'onal page if necessar ): . . -
�DirECtar of Community Service '
�
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iN WITNESS WMEREOF,the parties have caused this contract t be duly executed inter�ding to be bound thereby. _
� : �� ��
,
R ill Clinic
St. Paul Di ision of Public Health
Exhibit A
Cont actor's Duties
The CONTRACTOR who is not a ST E employee, shall, for a period beginnirtg
February 1, 1988, and ending Sept ber 30, 1988, conduct a program designed to
' evaluate the risk of fiuman i unodeficiency virus (HIV) among patients
� attending public sexually trans itted disease clinics including, but not
iimited to, the following: -
A. Select and enroll potentia participants by a predetermined samplinq
scheme as described in th protocol (Exhibit D - "An Approach ta
Determine Human Inmunodefi iency Yirus and Viral Hepatitis, Type g
Seroprevalence Among Sexuall Transmitted Disease Clients in Minnesota"}.
B. Interview and inform enroll d patients who have agreed to participate
using a information sheet a d a standardized questionnaire provided by
. the STATE (Exhibit D - "Minn sota Department of Health/Red Door/Room 111
Clinic Seroprevalence Study nformation Sheet" and "Red Door/Room lll/MOH
Seroprevalence Study")
C. Draw blood from participat ng patients and submit the specimens to
laboratori�es approved by t e STATE for HIV antibody testing; viral
hepatitis, type B testing (H sAg and anti-HBs); and syphilis testing.
D. For participants desiring to know their test results, counsel each person
about the HIV antibody test nd include:
1. assessment of the perso 's emotional response to the test resu�ts;
and
2. information about the me ning of the test result for the person; and
3. risk reduction and dise se prevention recortanendations specific to
the person's risk of exp sure to HIV; and
4. referrals for medical ev uation and psychosocial support; and
. 5. counseling about notif ing and referring tfi eir sexual and/or
needlesharing partners r the purpose of HIV risk reduction and
disease prevention counse ing and antibody testing.
E. Record laboratory results ont the completed questionnaires.
F. Present completed questionna res and Non-Participant Information Sheets
to STATE on a monthly basis.
1
� ���-�s�
� Exhibit B
CONSIDERATI AND TERMS OF PAYMENT
A. For services performed in th s contract, CONTRACTOR shall :
1. Receive the rate of re mbursement of twenty•five dollars (S25.00j
for each person who i enrolled in the study and completes tfie
. questionnaire.
2. Receive reimbursement r the actual cost of HIV and hepatitis B
serologic tests, not to exceed rates as shown in a) and b) below,
for each person who is nrolled in the study and who completes the
questionnaire. CONTRAC OR shall not exceed these amounts withoat
the prior written conse t of the STATE'S authorized agent for this
contract.
a) Four dollars (�4. ) per HIV antibody screening test (EIA)
performed.
b) Ten doliars (E10. O) per confirmatory test (Western blot)
performed.
c) Three dollars (S3 00) per HBsAg test performed and three
dollars (53.00) per anti-HBs test performed.
d) The total reimbu sement by the STATE for screening and .
confirmatory tests hall not exceed four thousand four hundred
(�4400.00) withou the written consent of the STATE'S
authorized agent fo this contract.
B. CONTRACTOR shall present invoices for services performed monthly, no
later than the twenty- ifth calendar day following the month of
invoice, reflecting only those services performed during the month
of the invoice.
C. Invoices for services pe formed shall be presented on forms provided
by the STATE (Exhibit ) according to the line item budget as
2
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' fallows:
1. COUNSELING SERVICE �10,00Q
400 persons courtse ed @ 525.00/person
2. TESTING SERYICES S 4,400
400 screening test @ 54.00/test 51600.00
40 Confirmatory te ts @ �10.00/test E 400.00
400 HBsAg and anti NBs tests @ E3.00/test �2400.00
TOTAL �14,400
D. No more than 10� of the funds identified in line item amounts shown
in C. (above) may be ransferred to other line items or used for
any other purpose wit out the prior written permission of the
STATE'S authorized agen for this contract.
3
, . �"�...,S,E,Ss
� Exhibit C
` COUNSELIN6 AND TEST SITE INVOICE
FOR I�Fi/RED �OR/ OOMI 111 SEROPREVALENCE STUDY
CONTRACTOR Name:
Address:
• Service Period:
CONTRACTOR'S Agent Signature:
Counseling Services
(#) persons couns led @ �_ /person
Testing
(#) HIV Screening tes s performed @ �_/test
(#) HIV Confirmatory ests performed @ S__/test
(#) HBsAg and anti-HB tests performed @ E_Jtest
TOTAL -�
4
' ���SP
` An Approach to Det ine Human. Immunodeficiency
Virus and Viral Hepa itis, Type B Seroprevalence amonq
Sexually Transmitt Disease Clients in Minnesota
I. INTROOUC7ION
� The epidemiology of t e acquired immunodeficiency syndrome (AIQS)
� and human inanunodeficiency irus (HIV) infection in Minnesota has been
largely determined by surveillance of AIDS cases. Since 1982, AIDS cases -
have been reported accordin to the criteria set forth by the Centers for
Disease Control (CDC) surveillance definition for AIDS. The surveillance
definition is narrow an specific and does not include oti�er
manifestations of HIV inf ction. In addition, because of the long
incubation period for AIDS, data on current trends for AIDS cases only
provide information regardi g HIV trartsmission in Minnesota for the
period three to five years o.
7he availability of an IV antibody test allows for determination of
NIV infection regardless of symptoms and its use can aid in determining
the prevalence of HIV infection and assessing infection trends. To date,
most HIV antibody -testing in Minnesota has involved persons who are
self-selected volunteers; t us, the results may not be representative of
the true rates of infection For example, HIV antibody seroprevalence
data are available from the ffve public health counseling and test sites
(CTS's) in the State. Cli nts at the CTS's represent persons who have
motivated themselves to vis t the clinic. Such persons are also likeiy
to be more motivated tow rd making behavioral changes; therefare,
aggregate data drawn from this group are likely to contain a self-
selection bias and may unde stimate the true prevalence of HIV infection
in the State. Such selecti n bias was demonstrated recently in a study
of prevalence of antibody t viral hepatitis, type 6 (HBV) among clients
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at the CTS's. In N vember 1986, 34.5x (156/452) of the
homosexual/bisexuai me� wh attended the Red Door CTS were fourtd ta be
anti-HBs positive; whereas a study of homosexual/bisexual men visiting
the Red Door Clinic in 197 -80 for sexually transmitted diseases (STD'sj
found 587G (280/482) to be either anti-HBs or HBsAg positive. These
� results suggest that CTS lients reflect a different population thaa
patients visiting an STD cl nic. _
This protocol outlines a methodology for determining HIV and HBV
prevalence and risk factors among clients attending two STD clinics in
Minnesota. Participants w 11 be drawn from clients who come to the
clinic for symptomatic STD' and, therefore, should represent a sample
with relatively minimal sel -selection bias. The purpose of this effort
is to determine the prevalen e of HIV and HBV in this population and to
assess possible risk fact rs for acquiring infection. Homosexual,
bisexua) , and heterosexual p tients will be studied.
II. STATEMENT OF OBJECTIVES:
A. To evaluate patients a tending two STD clinics in Minnesota (Red
Door Clinic, Room 111 C inicj. A pilot study will be conducted ta
estimate HIV and HBV p evalence for these patients and to assess
risk factors for acquiring HIV and HBV infections.
B. To correlate HIV and HB prevalence of the study patients.
C. To use data obtained i the pilot study to determine appropriate
HIV/HSV screening proce ures for patients visiting the STD clinics
in Minnesota and to evelop recommendations for Minnesota STD
clinics regarding NIV co nseling and testing of clinic patients.
D. Similar data will period'cally be obtained from the two STD clinics
to monitor trends in HI and possibly H6V prevalence in STD clinic
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patients.
III. BACKGROUI� AND RATIONALE
A. Prevalence of HIY Infec iort
To date, the ma�o risk group for acquiring HIV infection in
Minnesota has been hom sexual/bisexual men. Approximately 90x of
all AIDS cases in the State have occurred in homosexual/bisexua'E
men. HIV antibody serop evalence data for homosexual/bisexual men in
Minnesota are incomplet . The data that are available likeiy do not
accurately reflect the t-risk population. Two sources of data have
been used to det rmirte HIY seroprevalence rates far
homosexual/bisexual men These include men who visit the CTS's and
men who participated in a voluntary HIV antibody seroprevalence
study. Men for the latter study were identified thraugh
participation in one o three gay social organizations or because
they were clients at on of two gay bars during the period of study.
Twenty-twa (13�) of 180 men who participated in the fall of 1985
were HIV antibody positi e. Participants in these and other similar
studies represent a bi sed sample since these participants had
actively identified the selves as being homosexual and• voluntarily
participated in the stud . The HIV antibody seroprevalence rate for
homosexual/bisexual men who have attended the CTS's is I59�, but
again, such persons rep esent a self-selected group. In sampling
homosexual/bisexual men ho attend STD clinics for symptoms, self-
selectiun bias will be 1 mited. However, this group may represent a
population at increas d risk due to higher sexual activity.
Therefore, NIV antibody eroprevalence data from this source need ta
be placed into perspecti e with other sources of data.
3
' C�`A���
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HIV is knorm to transmitted heterosexually from men to wart�n
and from women to n� (1-b). Data on HIY transmission in the
heterosexual population in Minnesota are limited. Some information
is available from th CTS's and some is available from special
, studies, such as the i vestigation of "swinger's clubs" in the St.
Paul area (7). Such d ta indicate a low level of infection (<2X)
among Minnesota heteros xuals with no otfier known risk factors.
Monitoring and int rviewing HIV-antibody positive blood dcrtors
for risk factors is ne method to determine HIV spread among
unsuspecting heterosex als. Over 450,000 units of blood from
Minnesota do�ors have b en tested to date; of these, 15 donors have
been found to be HIV-an ibody positive. Population-based estimates
from these data sugges the following infection rates for blood
donors: 0.01� of ma e donors and 0.00091: of female danors.
Fourteen of these 15 ar males; 13 admitted to male-to-male sex as
a risk factor, and no r sk factor was identified for the rematning
male donor (although cu ture of that persons's blood yielded HIY) .
The female donor had se ual contact with a bisexual male and a male
intravenous drug abuser From this evidence, the risk of second
generation heterosexual transmission in Minnesota appears to be
small .
All military induct es are mandatorily tested for HIV antibody.
In Minnesota, eight mal recruits out of 15,735 (0.057X) males and
one female recruit out of 2,135 (0.046X) females tested through
March 1987 were found o be HIV-antibody positive. Risk factor
information on these rec uits is unavailable at this time.
In August 1987, the U.S. Centers for Disease Control issued a
4
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, report entitled "Publi Health Service Guideline for Counselinq and
Antibody Testing to revent HIV Infection and AIOS." These
recon�endations includ the statement that, "All persons seeking
treatment for a sexua ly transmitted disease, in all health-care
settings. . . should be routinely counseled and tested for NIV
antibody." The actual implementation of these guidelines has not
yet taken place in most health-care settings, including STD clinics.
Through this study, t e MON can obtain baseline data about kIV
antibody seroprevalenc a�d risk factors to aid Minnesota STD
clinics in assessing t e recort�nendations and developing appropriate
screening programs for IV.
B. Viral Hepatitis, Type 6
Homosexual men ha e also been documented to be at increased
risk for HBV infection {8-10) . HBV prevalence data for homosexual
men in Minnesota were ollected in 1978-79 on clients attending
the Red Door Clinic; th HBV prevalence for this group was shown to
be approximately 58°�, s specified earlier. Although transmission
of HBV has been docume ted to occur between heterosexuals (1I-12),
only one study has demo strated an increased risk of HBV amonq male
heterosexuals, w�th th risk increasing with increasing levels of
heterosexual activity ( 3) .
C. Relationship between H8 and HIV
A recently publish d study examined HIV antibody prevalence in
New York City (14j . HIV antibody was found in 10 of 295
heterosexual males ( .4�) who denied intravenous drug use.
Seropositivity was ass iated with serologic evidence of past HBV
infection and syphilis nfection (65/295 [22.09'a] anti-HBs reactive;
20/295 [6.8�) RPR react ve) . Seropositivity was not associated with
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any self-reported s xual activity, including contact with
prostitutes. .
HBV seroprevalen e for homosexual/bisexual men atteRdiRg
Minnesota CTS's in Nov ber 1986 was found to be approximately 359G
• and was not signif cantly associated with HIY antibady
seropositivity. Other orrelations between HBY and HIV prevalence
in Minnesota have not b en made.
IV. METHOOS •
A. Participating Clinics
_Two Mi�nesota STD linics, representing areas with 88� of the
STD morbidity in the St te, will be enrolled in this study. These
clinics also serve as t e MOH-sponsored HIV Counseling and �estTrtq
Sites (CTS's). The si es are: Hennepin County Cortanunity Health
Department Red Door C1 nic, and the St. Paul Divisiort of Public
Health Room 111 Clinic. The medical directors of the two clinics,
Or. Keith Henry and D . Margaret Simpson, will be project co-
investigators, along wit MOH staff.
B. Overview af the Study
STD clinic patient who are seeking examination or .treatment
for symptoms compatible ith STD's other than HIV infection will be
asked to participate in this study. After permission is granted,
patients will be inter iewed for demographic and sexual history
information by the nurse/clinician using a standardized
questionnaire. A blood specimen will be drawn for testing for NIY
antibody, HBV infection HBsAg and anti-HBs), and syphilis (USR) (if
syphilis testing has not been done within the last 30 days}.
Patients will be i formed that they should make appointments
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with the CTS portion o the clinic to be counseled about their test
results. Names and her required information for those that test
NIV-antibody positive ill be reported to MDH, as is currently done,
to comply with MOH di ease reparting rules. Counseling and other
� services will not be enied to persons who seek CTS services and
refuse to give their n nres.
C. Patient Inclusion Crit ria
All patients, ma e and female, aged 18 and above, seeking
examination or treat t for symptoms compatible with an STD are
eiiqible for enrollmen into this study. This includes patients who
are presenting with a ew disease episode who have not visited the
clinic in the last 90 ays. Patients returning for examination or
treatment of genital w rts will be excluded. History of previous
HIV-antibody testing is not a reason for exclusion, although
participants should be enrolled in the study only once. Persons
presenting to the clini solely for HIV-antibody testing will not be
included in the study.
D. Sampling Procedures
Ideally, all patie ts attending the Red Door Clinic or Room 111
and meeting the patien criteria would be asked to participate.
Because of the labor i tensive nature of the study and for other
practical reasons, it's not possible to enroll all patients and a
sampling scheme is need d. Approximately 70 patients are seen each
day at the Red Door Cli ic and 40 patients each day at the Room Ili
Clinic. The study need to enroll five patients per day (25/week)
from the Red Ooor Clini and four patients per day (20/week) from
the Room 111 Clinic. T elve hundred patients will be enrolled over
7
, ��-�"�
, a seven-month period (6 O from Red Door and 400 froom Room IlI). A
sampling procedure f r both clinics that• doesn't alloN for
specialized seiection r bias by the nurse/clinicians needs to be
implemented.
The sampling pro edure for the Red Door Clinic has bee�
developed after modifyi g current patient check-in procedures. Two
patient sign-in clipboa ds will be used. One clipboard wi11 be used
to sign in persons req esting HIV-antibody testing and the atFrer
clipboard will be use to sign in routine STD patients. Upon
opening the clinic day, the 2nd, 4th, 7th, 9th, and llth routine STD
patients seen that day (total of 5 daily) will be seiected to be
enrolled in the study f om their listing on the sign-in sheet. The
,
sign-in clerk will indi ate to the nurse/clinician which patients
are to be enrolled.
The sampling proc dure for the Room 111 Clinic has been
developed by Dr. Henry a d Room 111 staff. At Room lll, a separate
listing of STD client is maintained at the time the patient
registers. Upon opening the clinic, the lst, 5th, 9th and 13th STD
clients seen .on each da (total of 4 daily) will have th�ir chart
marked by the secretary to be enrolled in the study protocol and
have the appropriate blo d samples obtained and survey administered.
E. Enrollment Procedures �
After examination r treatment for symptoms compatible with
STD's, the nurse/clinici n will discuss the study with the patient.
An information sheet abo t the study will be provided by the MOH far
the nurse/clinician to u e (Appendix I). The patient wiil be told
that the purpose of the tudy is to exami�e blood specimens for HIV
antibody from sexually a tive persons and to correlate HIV antibody
8
����
s
status and HBV ser logy with information obtained from a
questio�naire (Appendi II). The patient will then be given a
consent form to read. If the patient has participated in the study
before, then he/she wil not be enrolled again.
• At Room 111, al four nurses will receive instructions
regarding the protocol during an inservice conducted by Dr, Henry -
(who will administer 2- surveys himself) . At Red Door Clinic, ali
nurses/cliniciarts will be informed about the protocol and wi11 be
trained to administer he questionnaire. All staff are trained fn
NIV antibody pre- and p st-test counseling.
After consent is o tained, the nurse/clinician will answer any
questions about the stu y, provide pretest counseling, and will then
complete the standarize questionnaire by interviewing the patiertt.
Consent for the study 'll be indicated on the questionnaire. The
interviews should take pproximately 20-25 minutes.
Two tubes (approx mately 15 ml) of clotted blood (red top
. tubes) will be drawn a d labeled by name and with caded numbers
which will also be used o code the questionnaire.
Patients will be i ormed that they should make appointments to
learn of their results. Post-test HIV antibody counseling wf11 be
offered at tfiat time, ' imilar to what norma]ly occurs in the CTS
portion of the clinics. Results for the hepatitis B and syphilis
tests will also be dis w sed at that time.
Persons without app rent risk factors for HIV infection (i .e.,
male-to-male sex, intrav nous drug abuse) will be re-interviewed by
the nurse/clinicians and possibly by MDH staff to ascertain a risk
factor.
9 ,
����
` F. Laboratory Testing
The blood specimen from Room 111 patients will be sent to the
American Red Cross Bloo Services, St. Paul Region Laboratory. Red
Door Clinic blood spe imens will be sent to the Memorial Blaod -
Center of Minneapolis. Testing for HIY antibody and HBV (anti-H8
and HBsAg) will be per ormed on all specimens. Both Room I11 and
Red Door Clinic speci ns for syphilis (USR) will be sent to ht�N
Public Health Laborator es. �
G. Non-Participants
Persons who refuse to have blood drawn for.HIV antibody .testing
will . still be interv'ewed by the nurse/clinician using the
standardized questio naire. If the patient refuses to be
interviewed using the standardized questionnaire, a brief form,
attached to the back o the questionnaire will be used to obtatn
basic demographic and isk factor information (Appendix III). The
purpose of obtaining th s information is to allow comparison between
participants and non-p rticipants so that selection bias can be
evaluated.
At Room 111, reco s pertaininq to the other STD cl ients seen
,
during the study period wi11 be tabulated (by St. Paul Divfsion of
Public Health data man gement personnel) in order to contrast the
study population to the general STD population. Those data witl be
shared with the MDH ha f-way through the study period and at the �
conclusion of the stu y. At the Red Door Clinic, demographfc
comparisons between stu y participants and other STD patients will
also be made. �
Richard Danila w 11 review the enrollment procedures and
results for each clini . If non-participant rates are too high as
io
, �����
.
�udged by him and the o-investigators, corrective measures will be
implemented and evaluat d.
H. Recordinq of Results
The questionnaire will be retained by the clinic vrttil the
• laboratory results ar completed. Designated clinic personnel
(preferably no more th two persons at each site) will record the
laboratory results ont the questionnaire when the results are
returned to the clinic. Completed questionnaires will be delivered
to the MDH by courier or cading and keypunching. Copies of test
results will also be s nt to the MOH for verification and quajity
control purposes.
I. Time of Study and Numbe of Patients to be Enrolled
This study will b conducted for approximately six months at
the Red Door Clinic and Room 111 Clinic.
, One thousand pati ts will be enrolled in the study over the
six-month period. Six hundred patients (5/day X 5 days/week X 24
weeks) from the Re� oor Clinic and four hundred (4/day X 5
days/week X 20 weeksj f om the Room 111 Clinic will be enrolled.
J. Reimbursement
Both clinics will be reimbursed at a rate of 325 per
participant interviewed and all laboratory tests will be paid for as
specified in contracts etween the MDH and each of. the two clinics.
K. Project Participan s
Richard Danila wil serve as a primary project investigator.
Drs. Margaret Simpson nd Keith Henry will serve as project co-
investigators. They will determine the sampling scheme, be
responsible for staff raining and management, and coordinate and
11
. �f/�'�
� oversee the day•to-day activities of the pro�ect. Kris MacOonaTd
and Michael Osterhol will assist with pro�ect development,
analysis, and report p eparation. Results may be surtanarized for
publication. Richard anila will serve as primary author. Qther
co-investigators and s dy assistants and representatives from the
blood banks wili be inc uded as co-authors. -
IV. ANALYSIS AND RESULTS
All questionnaires will be reviewed by Richard Dan91a, AIDS
Epidemiology Unit, to review for missing data and coding or data errors.
Clinic personnel will be con acted by telephone or in person to ciairfy
questions or correct errors. Site visits will be made by Richard Danila,
at the beginninq of the stud , and every two to three months during the
study period.
The completed and revie d questionnaires will be coded by MOH staff
and sent to the Center for H 1th Statistics for keypunching.
Risk factors for acquis ion of HIV and HBV seropositivity will be
tested by measures of assoc ation, such as the odds ratio, with the
appropriate tests of signifi ance also being conducted. Univariate and
multivariate analyses will be used, as appropriate.
Monthly and cumulative ummary results for Red Ooor artd Room 11I
will be reported directly ack to each clinic on a monthly basis.
Summary results for the en ire study will also be reported to both
clinics.
The results of the study w'rll also be circulated to other State STD
clinics. Recommendations for ail Minnesota STD clinics will be bas�d on
the results.
12
, C/-� �
, Referencas
1. Piot P, Quinn TC, Taelman H, et al . Acquired immu�odefitiency syndrome in
a heterasexual population in Zaire. Lancet 1984;2:65-b9.
2. Redfield RR, Markham PD, Sa ahuddin SZ, et al , frequent transmission of
HTLV-III among spouses of p tients with AIDS-related complex and AIDS.
JAMA 1985;253:1571-1573.
• 3. Kreiss JK, Kitchen LW, Princ H, et al . Antibody to human T-lymphotropfc
virus type III in wives of hemophiliacs. Ann Intern Med 1985;102:623- _
626.
4. Luzi G, Ensoli B, Turbessi , et al . Transmission of HTLV-III infQttion
by heterosexual contact. La cet 1985;2:1081.
5. Calabrese LH, Gopalakrishna KV. Transmission of HTLV-III infection from
man to woman to man. N Engl J Med 1986;314:981.
6. Fischl MA, Dickinson GM, S ott GB, et al . Evaluation of heterosexual
partners, children, and hou ehold contacts of adults with AIDS. JRMA
1987;257:640-644.
7. CDC. Positive HTLV-III/LAV Antibody Results for-Sexually Active Female
Members of Social/Sexual Clu s - Minnesota. MMWR 198b;35:697-99.
8. Szmuness W, Much MI, Prince , et al . On the role of sexual behavior in
the spread of hepatitis 6 in ection. Ann Intern Med 1975;83:489-495.
9. Dietzman DE, Harnisch JP, ay CG, et al . Hepatitis B surface antiqert
(HBsAg) and antibody of HBs : Prevalence in homosexual and heterosexual
men. JAMA 1977;238:2625-262 .
10. Schreeder MT, Thompson SE, adler SC, et al . Hepatitis B in homosexual
men: Prevalence of infecti n and factors related to transmission. 3
Infect Dis 1982;146:7-15.
� 11. Wright RA. Hepatitis B and the HBsAg carrier. An outbreak related to
sexual contact. JAd�Uel 1975;2 2:717-721. .
12. Koff RS, Slavin MM, Conne ly LJD, et al . Contagiousness of acute
hepatitis B: Secondary attack rates in household contacts.
Gastroenterology 1977;72:297 300.
13. Alter MJ, Ahtone J, Weisfus I, et al . Hepatitis B Virus Transmissian
Between Heterosexuals. JAMA 1987;256:1307-10.
14. Rabkin CS, Thomas PA, Jaffe HW, et al . Prevalence of Antibody to HTl.Y-
III/LAV in a Population Atte ding a Sexually Transmitted Diseases Clinic.
Sex Trans Ois 1987;14:48-51.
13
` /�I,.,.�/„�✓r'
u-'
,
MINNESOTA DEPARTMENT OF H LTH/REO DOOR CLINIC/ROOMI 111 CLINIC
SEROPREYALENCE STUDY INFOt�lATIO�t SHEET
CODE ER _ _ _ _ _ _
The Minnesota Department of Health MDH), the Hennepin County Health Department
Red Door Clinic, and the St. Paul Division of Public Health Room 11I CTinic
are conducting a study of AIDS vi us infection among patients being seen at
sexually transmitted disease clini s. We hope to learn what the level of
infection is and to determine what f ctors correlate witt� an AIDS virus infection.
You are being asked to participate b cause we are asking a sample of ail sexually
transmitted disease clinic patients seen at this clinic. To obtain an accurate
assessment it is extremely import nt that all persons who are selected to
participate actually enroll in the s udy.
If you decide to participate, yo will be interviewed regarding your past
behaviors that may have put you at isk for being infected with the AIDS virus. -
After the interview is completed, a nurse/clinician will draw a biood sample
from your arm. Two tubes of bloo , about 4 tablespoons, will be drawn. The
risk of complications from blood dr wing are extremely small . In the rare event
of subsequent complications, you will be responsible for your own medical care
and costs. The interview and b]ood rawing will take about 20-30 minutes.
Your blood sample will be tested f r evidence of infection to the AIDS virus,
hepatitis B virus, and syphilis ( f you haven't been tested for syphitis in
the last 30 days). You can make n appointment to return in about two weeks
to find out what your test result are. Your results are identified � code
numbers so be sur.e to bring this for with �ou w�ien ,�u return.
Your decision whether or not to pa ticipate in this study will not affect your.
future relations with this clinic r the MDH. Once you decide to particfpate •
you may withdraw at anytime.
If you have any questions about this study, please ask now, or call this ciinic
(Red Door - 347-3300, Room 111 - 292 7752, or the MDH - 623-5414).
You can keep this copy for your own ecords.
���„� r). ��.. ; ,�.
Richard N. Danila Ke'th Henry Margaret Simpson
Minnesota Department of Health Ro m 111 Clinic Red Door Clinic
Project Investigator Pr ject Co-Investigator Project Co-Investigator
Interviewer