Master Thesis in Public Health

A case-control study to investigate risk factors for syphilis among MSM presenting for STI testing in Stockholm, Sweden

Lara Payne

Supervisor: Prof. Johan Giesecke

Ume International School of Public Health, Epidemiology and Public Health Sciences, dept of Public Health and clinical Medicine, Ume University, 2007

Table of contents
ACKNOWLEDGEMENTS ..................................................................................... 3 ABBREVIATIONS ................................................................................................. 5 1. ABSTRACT ....................................................................................................... 6 2. GENERAL BACKGROUND .............................................................................. 7 3. OBJECTIVE AND HYPOTHESES OF STUDY ............................................... 10 4. METHODS ...................................................................................................... 11 4.1 Ethical considerations ............................................................................ 11 4.2 Study design .......................................................................................... 11 4.3 Study population .................................................................................... 11 4.4 Sample size calculation ......................................................................... 15 4.5 Data required ......................................................................................... 15 4.6 Data processing ..................................................................................... 17 4.7 Data validation, recoding and analyses ................................................. 17 4.8 Pilot study .............................................................................................. 18 5. STUDY PLANNING ........................................................................................ 19 6. RESULTS ....................................................................................................... 20 6.1 Study population .................................................................................... 20 6.2 Sexual partners in last 12 months .......................................................... 23 6.3 Partnerships in Sweden and when abroad ............................................ 27 6.4 Use of drugs and alcohol ....................................................................... 30 6.5 Reported behaviour on most recent sexual encounter .......................... 30 6.6 Multivariate logistic regression model .................................................... 31 7. DISCUSSION.................................................................................................. 32 7.1 Study findings ........................................................................................ 33 7.2 Possible limitations and bias in this study .............................................. 37 7.3 Final conclusions on findings ................................................................. 39 8. REFERENCES ............................................................................................... 40 9. APPENDICES ................................................................................................. 43 Appendix 1: Result tables and figures numbers of partners ..................... 43 Appendix 2: Result tables and figures sexual behaviour .......................... 45 Appendix 3: Clinic information sheet............................................................ 49 Appendix 4: Questionnaire used for cases and controls .............................. 50 Appendix 5: Information sheet for study participants ................................... 66

ACKNOWLEDGEMENTS

This project would not have been possible without the contribution both directly and indirectly of many people.

Firstly, I would like to thank all the anonymous men who completed questionnaires and contributed to this research study.

I would like to thank my supervisor Professor Johan Giesecke for his encouragement in developing this research project in the first instance, for learned discussions in epidemiology, for his continued support and above all for keeping project aims in focus!

My gratitude goes to colleagues at Venhlsan clinic, Sdersjukhus, Stockholm, Sweden: Professor Eric Sandstrm for his encouragement, Dr. Anders Karlsson and Dr. Gran Bratt, Nurse Lena Persson and Nurse Stefan Ekroth for their endless advice and friendly support in implementing the study.

My sincere thanks go to my colleague Torsten Berglund (SMI) for his valuable scientific advice in this project, his endless time and support at all stages, for listening and encouraging, and not least for good friendship and a warm welcome to Sweden.

Analyses of the results would not have been finally completed without the assistance and dexterity of Sharon Khlmann-Berenzon, statistician at SMI. Thank you for your excellence in R software and meticulous approach to keep this large dataset in check! But above all thank you for the many, long, yet very enjoyable hours of statistical analyses together.

I would also like to acknowledge and thank Dr. John Imrie (London) for his scientific encouragement and sharing the questionnaire and experiences of the Brighton Syphilis study.

Data on syphilis trends in Sweden were provided by Torsten Berglund and Inga Velicko from the national surveillance database at SMI, and my thanks are given for their assistance.

Thank you to colleagues at SMI, especially Yvonne Andersson, for support and encouragement.

This study was partly financed by a grant from The Swedish National Institute for Public Health.

ABBREVIATIONS

ART CI IDU HIV MSM MSW OR mOR SMI STI UAI

Anti-Retroviral Therapy Confidence Interval Injecting Drug Use Human Immunodeficiency Virus Men having Sex with Men Men having Sex with Women Odds Ratio Matched Odds ratio Swedish Institute for Infectious Disease Control Sexually Transmitted Infections Unprotected Anal Intercourse

1. ABSTRACT In the 5 years between 1999 and 2004, the annual number of reported cases of syphilis increased sharply in Sweden. With reported outbreaks of syphilis within European cities around the same time, and increasing travel abroad, the question remained were the behavioural risk factors among MSM acquiring syphilis in Sweden. A prospective case-control study was carried out at Venhlsan clinic, Stockholm, between 1st October 2004 and 31st August 2005, to investigate possible risk factors for Syphilis among Men having Sex with Men (MSM) presenting for STI testing in Stockholm, Sweden. A decrease in the

number of cases of syphilis resulted in a total of 24 cases and 82 controls being included in the study, being short of the optimum power and sample size but providing an indication of possible risk factors among MSM. Results of the study suggest the following factors as being more likely to be associated with being a case than a control: previously having an STI infection in the last 5 years (particularly syphilis or chlamydia infection), having more than 10 anonymous partners in the last year, and being under the influence of drugs under sexual intercourse with a casual or anonymous partner. These tentative results agree with findings by Imrie et al from a case-control study of syphilis cases in

Brighton, UK, which found a significant association of syphilis with previous STI infection history and recent recreational drug use, and borderline significance with 10 or more casual/anonymous partners.

2. GENERAL BACKGROUND

Syphilis is a sexually transmitted bacterial infection that can be easily prevented through appropriate use of protective measures such as condoms. If infection is acquired and untreated, it can develop from ulcers and sores to a tertiary stage clinical presentation that may include neurological symptoms [1]. Effective treatment with antibiotics is available, thus prompt diagnosis is important.

In the late 1990s an increase in reported syphilis cases was observed across Europe [2], including numerous focalized outbreaks amongst Men who have Sex with Men (MSM) in several European cities. Manchester and Brighton [3], Oslo [4] and Rotterdam [5] experienced outbreaks in 1999, Paris and Berlin and Dublin [6] in 2000 and London in 2001[7]. Annual reported cases of syphilis among MSM in the Scandinavian countries of Denmark [8], Norway and Sweden [9] also increased.

The annual number of reported cases of syphilis in Sweden also increased sharply in the 5 years between 1999 to 2004 (Figure 1). Trends observed in some European cities were also observed in Sweden, with a large increase of cases particularly among MSM (Figure2); from 8 cases in 1999, to 42 cases in 2000 and doubling to 97 cases in 2003. Of the 258 MSM cases in Sweden reported in 2000-03, 70% were reported from Stockholm County. Of the cases reported in 2003, the vast majority of MSM individuals were reported as acquiring infection within Sweden. However, 25% were reported acquiring infection abroad. 7

With reported outbreaks of syphilis across Europe, and increasing travel abroad, the question remained whether syphilis was becoming endemic again among the population of Sweden, and whether directly or indirectly resulting from acquisition abroad. Figure 1: Number of Syphilis cases reported in Sweden (1960-2003)

Figure 2: Infection route of syphilis cases in Sweden (1990-2003)

200 180 160 140 120 100 80 60 40 20 0

19 90 19 91 19 92 19 93 19 94 19 95 19 96 19 97 19 98 19 99 20 00 20 01 20 02 20 03

Men MSM

Men MSW

Women

Syphilis is deemed a marker of risky sexual behaviour and the increase of reported cases in Sweden was of concern. Studies show that infection with syphilis facilitates transmission of HIV in unprotected sex [10]. Therefore if ongoing syphilis transmission amongst MSM and outbreaks were occurring, individuals with undiagnosed syphilis engaging in unprotected sex would be likely furthermore at increased risk of acquiring or transmitting HIV infection.

There are few published case-control studies on syphilis in MSM in Europe in the last 5 years: all from the United Kingdom. A study carried out in Manchester [11] implicated unprotected oral sex as a likely risk factor for syphilis and possibly HIV infection. Preliminary findings from a syphilis case-control study by Imrie et al [12], following a large syphilis outbreak in Brighton, identified no significant association between being a syphilis case and having unprotected oral sex, but found number of oral sex partners and receptive anal sex as risk factors.

This study sought to identify possible behavioural and demographic risk factors for acquiring syphilis, among MSM seeking testing for Sexually Transmitted Infections (STI) in Stockholm, to assist with targeting of prevention measures and public health messages.

3. OBJECTIVE AND HYPOTHESES OF STUDY

Principal objective: To understand possible factors associated with recently acquired syphilis infection, in MSM presenting for STI testing in Stockholm

Hypotheses examples 1. That MSM presenting at a clinic in Stockholm for STI testing and testing recently positive for syphilis, are more likely to have engaged in unprotected oral sex in the 12 months prior to diagnosis than those testing negative for syphilis.

2. That MSM presenting at a clinic in Stockholm for STI testing and testing recently positive for syphilis, have a greater median age than those testing negative for syphilis.

3. That MSM presenting at a clinic in Stockholm for STI testing and testing recently positive for syphilis, are more likely to have had greater than 10 partners in the 12 months prior to diagnosis than those testing negative for syphilis.

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4. METHODS

4.1 Ethical considerations Ethical approval for this study was given by Stockholm Region Ethical Committee (Regionala Etikprvningsnmnden i Stockholm, Diarienummer 04-569/3). All patients were made aware that participation in the study was voluntary, anonymous and confidential, and that non-participation did not affect the healthcare received in any way. An information sheet was provided to respondents concerning the purpose of the study (Appendix 5), how information would be processed, stored and used. A contact at the clinic and at SMI was also provided for any questions that could arise about the study.

4.2 Study design A prospective case-control study was implemented.

4.3 Study population 3.3.1 Population Stockholm city has the largest community of MSM in Sweden. The study population consisted of MSM attending a gay and bisexual mens health clinic, Venhlsan, located in a main hospital of central Stockholm. This clinic was selected for the study as the centre has reported an average of 68% (123/180) of all MSM syphilis notifications from Stockholm, between 2000-2003. Thus the findings of the study were considered to be fairly representative of the MSM population in Stockholm seeking STI testing.

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3.3.2 Definition of cases and controls Eligibility for the study A gay or bisexual man aged 15 years old, having a test result for syphilis within the last 60 days, presenting at Venhlsan clinic in Stockholm, between the dates of 1st October 2004- 31st August 2005.

A case was defined as: A gay or bisexual man having a positive laboratory serology result for primary, secondary or early latent syphilis.

A control was defined as: A gay or bisexual man having a negative laboratory serology result for syphilis.

4.3.4 Mechanism of recruitment Individuals presenting for syphilis testing at the clinic were considered part of the population to be sampled.

4.3.5 Selection of cases All gay or bisexual men on their return visit to clinic for syphilis test results, within the study period of 1st October 2004 - 31st August 2005, found to be positive for primary, secondary or early latent syphilis.

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4.3.6 Selection of controls A gay or bisexual man presenting for a negative syphilis test result at the clinic within two weeks after the matching case. Controls were matched to cases according to known HIV status before testing. By recruitment mechanism, controls will also be matched to cases according to time of year.

Reasons for matching on time and HIV status: Time: - to ensure that controls arise from the same population as cases with an equal chance of experiencing similar temporal exposure factors such as annual organized events, or behaviour due to seasonality.

HIV status: - HIV positive individuals are likely to mix with other HIV positive individuals (ie. sero-concordant). Swedish Communicable Disease law states that an individual with a diagnosed communicable disease infection has a duty to minimise the risk for spread of infection to any sexual contact [13], and specifically for HIV infected individuals, HIV positive individuals should not have unprotected sex [14]. Thus HIV positive individuals may respond to questions in a different way then individuals with HIV status not known or negative.

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4.3.7 Sampling frame Venhlsan has an evening clinic for HIV and STI testing and advice, and a day clinic for HIV-positive patient care. On a weekly basis, two nurses at the clinic identified syphilis cases to be recruited using the list of laboratory results returned to the clinic. Controls were then selected as the four consecutive eligible syphilis negative patients presenting in clinic after the case. Controls could be recruited in the following evening clinic if there were not enough eligible controls presenting after the case recruited in an evening clinic. Eligible controls however needed to have returned to the clinic for their test result within 2 weeks to be matched by time.

Figure 3: Diagram illustrating patient recruitment pathway for case-control study on syphilis among MSM attending an STI clinic in Stockholm.

Data collection
Patients
Return to clinic for syphilis result

Ask whether want to participate in study ?

All meeting eligibility criteria are asked

Patient completes questionnaire at clinic and hands over in sealed envelope at clinic

+
All - cases

1:4 controls

Clinic completes test result sheet

+
Tally sheet monitor Result sheet

SMI
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4.4 Sample size calculation Sample size was calculated for an unmatched case-control study with 95% confidence interval, 80% power, a ratio of 1:4 cases and controls and an expected frequency of exposure in control group of 25%, to be able to detect a 3.0 Odds ratio. The 25% exposure in control group was based on results of a sexual behaviour study undertaken in Venhlsan between 2001-2002 that showed 75% of study participants (n=203) reported unprotected oral genital sex with a casual partner in the last month [15]. The sample size required 156 controls and 39 cases. The observed number of syphilis cases among MSM at Venhlsan in 2003 was 55, thus it was necessary to recruit at least 70% of anticipated annual cases. The approximate number of patient visits to the clinic in a year was 1500. 4.5 Data required Paper questionnaires in Swedish or English were given by the doctor to cases and controls being recruited, after the consultation of their test result. The anonymous questionnaires were self-completed in a private room in the clinic and once completed, asked to be handed in a sealed envelope to reception at the clinic. Questions consisted principally of multiple choice closed-question tick boxes (Appendix 4). A one-page test results sheet was completed by the nurse for every patient (case or control) asked to participate in the study (Appendix 3). The sheet recorded basic information such as age, HIV/STI laboratory results, syphilis disease stage, ART and CD4 count if HIV positive.

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For the purposes of the research, definitions for sexual partnerships were given in the questionnaire as: regular, casual or anonymous.

These definitions were:

- a REGULAR partner is defined as a man who you have or had an ongoing sexual relationship with. You know a lot about these men other than the sex you had with them. This may include steady partners (husbands or boyfriends etc.), or other partners such as lovers or fuck-buddies.

- a CASUAL partner is defined as a man who you dont know much about, other than their name and you may have had sex with them, on maybe one or two occasions. This may include one-night stands.

- an ANONYMOUS partner is defined as a man who you dont know anything about apart from the sex you had with them, and you dont have their name or number. This includes men you may have had sex with in a dark room or cruising ground.

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4.6 Data processing Questionnaires were collated monthly to the study co-ordinator. Data entry was undertaken by the study co-ordinator. Questionnaires did not contain any personal identifiable information. Data was entered using Epidata (Denmark).

4.7 Data validation, recoding and analyses 4.7.1 Data validation Validation of data occurred on entry through a check program on Epidata, and checks undertaken for consistency, validity and logic before analysis. Twelve randomly-selected questionnaires (10%) were also data-entry checked in the raw dataset as a quality control measure. A total of 26 mistakes among 12 questionnaires with 368 variables each was measured and this error level of 0,5% was deemed acceptable. As questionnaires were anonymous, no follow-up on information provided was possible and thus responses to questions were accepted, unless contradictory to other responses in questionnaire, in which case the latter question was excluded and the questionnaire assessed overall as being still valid if less than 2 contradictory statements were made.

4.7.2 Data Recoding Data responses on condom usage were used to define two exposure categories: unprotected and protected sex. Protected sex was defined as those reporting always using a condom for that sex technique, and unprotected as never, sometimes or often using condoms.

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4.7.3 Data analyses These were undertaken in Epi-Info for windows (Version 3.3.2) and R statistics software. As the required sample size was not reached, unmatched odds ratios were calculated in Epi-Info, taking Fisher Exact test results for significance values. However as an unmatched analysis biases towards the null hypothesis, conditional logistic regression providing matched analyses for odds ratios (mOR) were then undertaken in R for all borderline significant ORs, taken as P<0.10. Multiple logistic conditional regression analyses were undertaken using R. Mann Whitney U test was used for testing differences in age distribution. Differences in behaviour reported with different partner types (i.e. irrespective of syphilis status) were tested using a McNemar test (chi-square test of paired proportions P1-P2) [16]. A test result was deemed significant when the confidence interval did not include zero.

4.8 Pilot study The questionnaire was reviewed by a few clinic staff and some volunteer patients. Questionnaires and data collection methods were then revised in consultation with the clinic.

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5. STUDY PLANNING

Planning/ organisation of study Formalisation of questionnaire Application to ethics committee Pilot study undertaken Data collection begins Total weeks: 6 weeks

April 2004 June 2004 July 2004 September 2004 1st October 2005

3 weeks 2 weeks 1 week

Data cleaning Preliminary analysis Preliminary report of findings to clinic Final analyses Final report Total weeks: 14 weeks

October-November 2005 Dec. 2005-Jan. 2006 February 2006 February - March 2007 April-May 2007

3 weeks 2 weeks 2 weeks 3 weeks 4 weeks

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6. RESULTS 6.1 Study population 6.1.1 Recruitment into study Between September 2004 and October 2005, 24 of 25 eligible cases and 93 of 100 controls chose to participate in the study, resulting in a 94% response rate. Nine controls were then subsequently lost to the study: four due to the nonparticipation of the matching case and five were excluded as they did not meet the criteria of having reported a sexual contact in the last 12 months. Thus a total of 24 cases and 82 controls were included in the analysis.

6.1.2 Demography of study population

AGE The age distribution of cases and controls did not differ significantly (Mann Whitney U test p=0.131). Age distribution differed between HIV positive and negative individuals (Mann Whitney U test p<0.001) but was not significantly different among cases and controls by HIV status (Figure 4). Figure 4: Age group distribution by HIV status of cases and control enrolled in syphilis case-control study Figure 4a: HIV positive individuals enrolled in study
cases controls
25

Figure 4b: HIV negative individuals enrolled in study

cases controls

25 20 15 10 5 0 15-24 25-34 35-44 45-54 55-64

20

15

10

0 15-24 25-34 35-44 45-54 55-64

Median age: Cases: 45 years, Controls: 50 years Matched OR=0.92, p=0.231

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Median age: Cases: 38 years, Controls: 34 years Matched OR=1.05, p=0.047

SOCIAL DEMOGRAPHICS AND SEXUALITY The demographics of the population included in the study are shown in Table 1. Over 99% of both cases and controls were resident in Stockholm, Sweden. All cases reported being homosexual and among both cases and controls over 80% were open about their sexuality.

Table 1: Age, Social demography and Sexuality of study population Cases 38.5 n/N % 14/24 58 18/24 75 24/24 100 22/22 100 Controls 36.0 n/N % 42/89 40 59/89 66 87/89 98 85/86 99

Median age (years) Demographics Education - University level Employed Residency in Sweden Residency in Stockholm

Sexuality: Homosexual Bisexual Transsexual Not reported Sexuality openness: Very open Sometimes open Sometimes closed Very closed Don't know

n/N 24/24

% 100

N/N 76/89 10/89 2/89 1/89 N/N 40/89 35/89 9/89 4/89 1/89

% 85 11 2 1 % 45 39 10 4 1

n/N 10/24 12/24 1/24 0/24 1/24

% 42 50 4 0 4

6.1.3 Sexual health of study population Table 2 lists the reported reason for visit to clinic and eventual testing for syphilis. Most individuals presented for testing due to reasons of symptoms or recent unprotected sex.

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Table 2: Reason for visit to clinic and testing for syphilis:

Own/ partners' symptoms Change of relationship Unprotected sex/routine testing Contact tracing Read about syphilis Other /not reported

Cases (N= 24) n % 12 50 0 0 9 38 1 4 1 4 1 4

Controls (N=84) n % 17 20 10 12 41 49 9 11 0 0 7 8

60% of cases and 48% of controls also reported taking a test for an STI prior to their latest to the clinic, under the last 12 months (non significant difference). In the last 5 years, significantly more cases (59%) versus controls (30%) (mOR 3.74, p=0.008), had been diagnosed with an STI (Figure 5). Figure 5: Percentage of cases and controls with an STI in the last 5 years prior to this visit to the clinic

Syphilis Hepatitis C Hepatitis B Hepatitis A Gonorrhea Chlamydia 0 20

mOR 7.75 p=0.0076

Controls Cases

mOR 3.02 p=0.051

40 60 80 100 %

Syphilis cases were more likely to have been previously diagnosed with syphilis or Chlamydia infection in the last 5 years prior to this visit, than controls.

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6.2 Sexual partners in last 12 months

6.2.1 Gender of partner Of 107 men responding, 9 (8%) reported having male and female partners in the last 12 months. None reported having female partners only in the last 12 months and thus no respondents were excluded by this criterion.

6.2.2 Relationship and number of partners and sexual practices

Cases and controls were as likely to have different partner relationships in the last 12 months (Table 3).

Table 3: Types of relationship in last 12 months Partner type Regular Casual Anonymous Cases Controls 16/20 20/24 19/24 70/84 72/80 50/82 mOR 1.52 1.58 0.44 p-value 0.542 0.502 0.102

Over 80% of both cases and controls reported having a regular partner in the last year. Casual partners were reported for 83% of cases and 90% of controls, whereas 79% and 61% of cases and controls respectively reported having an anonymous partner.

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Only half of HIV positive men had regular partners compared to HIV negative men (76/88) (data not shown in table). Seventy-two of 84 HIV negative individuals and 7 of 20 HIV positive individuals, reported having both a regular and a casual or anonymous partner in the last 12 months.

Numbers of partners Reported total number of male partners (for N=75 respondents) in the last 12 months ranged from 1-101 with a median of 10 and a mean of 16 partners (Appendix 1 Figure 1). The number of partners reported by cases and controls significantly differed only for anonymous partners (See Appendix 1 Figures 2-4), where cases were 3.77 times more likely to have had more than 10 partners in the last 12 months (OR=3.77, p =0.041).

6.2.3 Sexual practices in different relationships

No significant differences were observed between cases and controls in the sexual practices reported for regular partners (See Appendix 2a, Table 1). However, in the matched analyses cases were borderline significantly more likely to have given unprotected anal sex with casual partners in the last 12 months (mOR=2.97, p=0.08), and more likely to have fisted their partners (mOR=3.63, p=0.08). No differences in behaviour were significantly different in the matched analyses for anonymous partners. However response rates to these set of

questions dropped in comparison to casual and regular partners. Response rates

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on questions regarding sexual techniques varied from 75-92% for questions about regular partners, to 69-88% for casual and 54-66% for anonymous.

Of those having sex with a casual partner in the last 12 months (92), most (66%) had met their partner through the Internet and had sex with them at home (88%, 83/92) (see Appendix 2 Appendix Table 3b and 3c). Anonymous partners (N=69) were contacted more through video places (38) and Internet (29) followed by bars (26) and saunas (25), with sex occurring most in video places (38), at home (31) and in saunas (26).

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6.2.4 Differences in behaviour with casual and anonymous partners

In order to test whether there were differences in behaviour reported with causal and anonymous partners regardless of syphilis status, and thus whether a distinction between casual or anonymous partners was made, difference tests were undertaken for sexual techniques reported.

A total of 59 people responded to all questions on sexual technique with casual and anonymous partners. Table 4 shows the responses for oral sex and anal sex, where 0=No and 1=Yes. Thus in Table 4a, 5 individuals reported giving oral sex to casual partners but not with anonymous partners, and in Table 4c, 7 people reported receiving anal sex with casual but not anonymous partners.

Table 4: Differences in sexual behaviour reported with a casual or an anonymous partner

Table 4a: Oral sex give

Anon Casual 0 1 0 2 1 1 5 48

Table 4b: Oral sex receive

Casual 0 1 Anon 0 1 2 0 4 50

P1- P2 = -0.07 CI= -0.15 to +0.01

P1- P2 = -0.07 CI= -0.14 to 0.004

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Table 4c: Anal sex receive

A non 0 1 17 0 7 27

Table 4d: Anal sex give

A non 0 1 8 1 10 33

Cas ual 0 1

Cas ual 0 1

P1-P2 = -0.14 CI= -0.23 to 0.04

P1-P2= -0.17 CI= -0.29 to 0.06

Differences in behaviour were thus borderline significant for receiving oral sex, but not giving oral sex, but significantly different between partner types for anal sex practices. No differences were observed for all other sexual practices, unprotected sex, number of oral or anal partners reported (Wilcoxon rank sum test). As anal sex with casual partners had appeared as a borderline significant value in the matched OR analyses (shown in 5.2.3), it was considered best to continue to differentiate casual and anonymous partnership types for all OR analyses. Furthermore, as a check, analyses were undertaken on aggregated data for responses on anonymous and casual partners. No significant differences of behaviour or risk factors between syphilis cases and controls were identified in this dataset (Data not shown here).

6.3 Partnerships in Sweden and when abroad Meeting partners in Sweden 23/24 cases and 69/81 controls reported meeting a casual or anonymous partner in Sweden in the last 12 months (OR=4.0, p=0.15). Appendix table 4 (in Appendix 2b) shows the response regarding places where men reported meeting 27

a casual/anonymous partner in Sweden in the last 12months. Bars, video places and discos were the most frequently reported meeting places. However differences in meeting places for cases and controls were insignificant in matched analyses. Stockholm was named as the location for 95% (42/44) of those meeting in bars, and 97% (33/34) of video places.

57% of cases (13/23) and 72% (60/83) of controls reported meeting a male partner in Sweden through the Internet in the last 12 months (Matched OR=0.477, p=0.16). Cases were much less likely than controls to have had sex with these partners: 69% (9/13) of cases and 95% (56/59) of controls (mOR=0.11, p=0.0298).

Meeting partners abroad Cases and controls were equally likely to have travelled abroad in the last 12 months (83% (19/23) of cases versus 73% (60/82) of controls). Cases were not more significantly likely than controls to meet a casual/anonymous partner abroad (74% (14/19) cases vs. 59% (34/58) controls; OR=1,97, p=0.184. Meeting at bars, saunas and discos were the most common venue (see Appendix 2b Appendix table 5). No places were significantly different on matched analyses. Countries where saunas were visited included: Denmark (10), Spain (7), Germany (6), France (4), Thailand (3) and Norway (3), and other countries (Switzerland, Ireland, England, Estonia, Hungary, Austria, Canada, USA, South Africa, Australia, Brazil, Japan).

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Contrary to the reported behaviour in Sweden, few cases or controls travelling abroad used the Internet to meet partners abroad (2/19 cases and 7/60 controls FE p=0.63). However, of those meeting partner abroad through the Internet (9), nearly all (8) reported also having sex with these partners. These 8 men reported having a regular, casual and an anonymous partner in the last 12months.

6.3.1 Differences in behaviour when abroad and when in Sweden

Testing for differences in meeting places preferences when in Sweden or abroad revealed that MSM were more likely to meet a casual/anonymous partner in a sauna abroad than in Sweden. On the contrary, MSM were more likely to meet casual/anonymous partners at a video place or a park in Sweden. Particularly high numbers of MSM met partners through the Internet in Sweden (Table 5 d), but only 8 met both partners in Sweden and abroad through the Internet.

Table 5: Differences in meeting places for casual/anonymous partners when in Sweden or abroad.

Table 5a: Sauna

SE Abroad 0 1 0 7 20 1 1 1

Table 5b: Video place

SE Abroad 0 1 0 6 1 1 13 9

P1-P2 = 0.65 CI= 0.45 to 0.85

P1-P2= -0.41 CI= -0.61 to 0.21

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Table 5c: Park (N=30)

SE Abroad 0 1 0 17 0 1 5 6

Table 5d: Internet (N=78)

SE Abroad 0 1 0 25 1 1 44 8

P1-P2= -0.17 CI= -0.32 to -0.034

P1-P2= -0.55 CI= -0.66 to 0.43

6.4 Use of drugs and alcohol Cases (15/24, 63%) were twice as likely than controls (33/84, 39%) to have used drugs when having sex with a casual or anonymous partner (mOR 2.38, p=0.057). However cases and controls were equally likely to have been under the influence of alcohol (55% 12/22 cases and 59% 49/83 controls). Any significant differences in type of drugs used between cases and controls could not be calculated due to too little response for each drug type. However, the descriptive data indicate that the most widely-used drugs were poppers (38/52) and viagra (13/51), though viagra was often used simultaneously with other drugs. Between 5-8 respondents reported using amphetamines, cannabis, cocaine or ecstasy. No other drugs were reported.

6.5 Reported behaviour on most recent sexual encounter

Exactly one third of cases reported having sex on the most recent occasion with either a regular, casual or anonymous partner, whereas two-thirds of controls reported having sex last with a regular partner. No significant differences

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between sexual techniques at last sex was reported for cases and controls, except receptive anal intercourse (OR=2.70, p=0.066) and receptive fisting (OR=undefined, 3/15 cases and 0/55 controls, p<0.001). Most men reported having sex at their or their partners home (n=77/103), followed by video places (9/103).

6.6 Multivariate logistic regression model

The following variables were used in a stepwise model of factors contributing to the likelihood of being a case: age, previous STI positive, total number partners>10, total number of anonymous partners >10, drug use. Several variables were not included in the model due to missing data preventing convergence of the model. confounding factor. Age was included in the model as a potential

The best-fit model that resulted was: = Age + PrevSTI<5yrs + anon partners 10+ The model was based on 87 questionnaire replies. Fit to model p=0.00523 Age Previous STI in last 5 years Anonymous partners 10+ OR 1.04 4.82 4.53 95% CI 0.969-1.11 1.196-19.45 1.03-19.77 p-value 0.300 0.027 0.045

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7. DISCUSSION

This study sought to investigate the risk factors associated with being a syphilis case among MSM attending an STI clinic in Stockholm, Sweden. Results of the study suggest the following factors as being more likely to be associated with being a case than a control: previously having an STI infection in the last 5 years (particularly syphilis or chlamydia infection), having more than 10 anonymous partners in the last year, and being under the influence of drugs under sexual intercourse with a casual or anonymous partner. These tentative results agree with findings by Imrie et al [17] from a case-control study of syphilis cases in Brighton, UK, which found a significant association of syphilis with previous STI infection history and recent recreational drug use, and borderline significance with 10 or more casual/anonymous partners.

The results from the study in Stockholm should be interpreted with caution as the study lacked statistical power to be able to disentangle the effect of variables other than these above and control for possible confounders other than age. Despite good recruitment levels into the study, the number of syphilis cases in the wider MSM population of Stockholm decreased during 2004-06 (see Appendix 2c Appendix Figure 5). Too few syphilis cases presented at the clinic under the study period, thus the target sample size could not be reached.

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Considering this limitation, there are nonetheless some interesting results in this study, including descriptive results of the MSM population attending the clinic and differences in behaviour with different partner types.

7.1 Study findings

Homogenous population but median age differs by HIV status The study population recruited appeared to be fairly homogenous; being homosexual men living in Stockholm, with a majority being open about their sexuality. Though age overall did not appear significantly different between

cases and controls, when stratified by HIV status there was an age difference between HIV negative and positive individuals. Age was considered a confounder and not a direct risk factor for acquiring syphilis.

History of previous STI infections Cases were more likely to have been diagnosed with an STI in the last 5 years than controls, similar to findings in the studies of Bellis et al and Imrie et al [11,16].

All types of relationship in the last 12 months The majority of both cases and controls reported having a regular, casual and anonymous partner in the last 12 months, indicating several types of relationship and partner change. Numbers of partners reported differed according to partner

33

type. But this differentiated significantly between cases and controls only on the number of anonymous partners reported, where cases were more likely to have had more than 10 partners in the last 12 months. Relatively high numbers of partners is a cause for concern for its contribution to increasing STI incidences among MSM and has been identified as a cause in other European countries such as Germany [18].

All MSM have oral sex with different partners Between 88-100% of both cases and controls had oral sex with all types of partners, usually unprotected, indicating a high use of this sexual technique and consequent risk for STIs such as syphilis, Chlamydia, and possibly HIV or hepatitis B. The high frequency of oral sex practice among cases and controls implied that no association with syphilis infection could be tested. The high level of reported oral sex practice is similar to findings by Imrie et al [16], who identified an association between syphilis and higher numbers of oral sex partners, but not oral sex itself. However, a strong association of syphilis with oral sex and number of oral sex partners was identified by Bellis et al [11].

Syphilis cases more likely to have risky non-oral sex with casual partners Results suggest that cases were both more likely to engage in giving unprotected anal sex with casual partners and to fist their partners, than controls. This trend was also apparent in the reporting of last sexual encounter where receptive anal intercourse and receptive fisting with casual/anonymous partners were borderline

34

significantly different between cases and controls. These results are similar to Imrie et al [16] who identified a higher odds ratio for receptive anal intercourse with casual/anonymous partners among syphilis cases. No behaviours appeared as risk factors for anonymous partners but this may be due to wide confidence intervals and too smaller numbers for analysis.

Differences in behaviour reported between casual and anonymous partners also indicated that although anal sex occurred with both casual and anonymous partners, significantly more men were likely to have anal sex with casual partners but not with anonymous partners than vice versa. Analyses of behavioural differences with partner types are not reported in the literature and thus cannot be compared.

Many MSM find partners through the Internet in Sweden Sixty-nine percent of MSM in this study reported meeting a partner in Sweden through the Internet and over 80% of these reported having sex with these partners, indicating the Internet as being widely used to meet partners. No difference was observed between cases and controls in Internet use, but cases were much less likely to have had sex with a partner met through the Internet than controls.

In comparison few MSM reported meeting partners abroad through using the Internet. However of those meeting partners abroad this way nearly all also had

35

met a partner in Sweden through the Internet and had sex with partners from abroad and in Sweden. Some studies have linked syphilis outbreaks to meeting partners through the Internet [19-20]. However as a high rate of Internet use is reported in this study, it would indicate that any risk for syphilis in Sweden would be indirectly linked to online-meeting.

Travelling abroad common but meeting places differ to being in Sweden Over three-quarters of MSM in the study population reported travelling abroad in the last 12 months. However there were no significant differences between cases and controls on travel behaviour and likely meeting venues abroad.

Of note, is that MSM in the study population in general met casual/anonymous partners more frequently in video places in Sweden and in saunas when abroad, but bars were also reported as often the location for meeting MSM both in Sweden and abroad. Gay sauna clubs were banned in Sweden between 1987 and April 2004 [21], thus have not generally been accessible, and this may explain the difference in reported use of saunas abroad noted here.

Relatively high use of recreational drugs Over 40% of MSM reported using recreational drugs when having sex with a casual or anonymous partner and syphilis cases were borderline significantly more likely to have used drugs. In particular poppers were the most frequently

36

reported drugs used by the study population, corresponding to findings by Bellis et al in the population of MSM with syphilis in Manchester, UK [11].

7.2 Possible limitations and bias in this study Possible limitations that may affect the results of this study and should be considered here include: selection bias, information bias, systematic error and the role of chance.

Selection bias may have been introduced on selecting controls, through day of recruitment and thus differences in individuals and their lifestyles. However to minimise this effect the selection criteria for controls was consecutively presenting eligible patients. A further selection bias possibility was that the partner of the case was recruited as a control, if the partner attended the clinic within the same evening.

Information bias could have been possible in two different ways. The Swedish Communicable Disease Act requires that an individual with a diagnosed current STI/HIV infection protect their sexual partners from potentially acquiring infection. Thus, bias in the information on condom use may have been introduced in apprehension of this. This is unlikely to have occurred however as study participants were made fully-aware that questionnaires would be self-completed, anonymous and not accessible by the clinic staff.

37

Systematic error could have been introduced if a study participant misunderstood the definition of different partner types. The clear definitions given in the questionnaire aimed to minimise this error.

The findings of the study may also be an underestimate as the control population are men presenting for testing rather than the MSM community in general. However, this larger population sample frame was deemed unfeasible to access for this study and the population of STI clinic attendees chosen as the best option.

Finally, due to the numerous questions and consequent possible variables of interest in this study, significant results may have occurred by random chance. This limitation was handled by having a clear analysis plan for the results where less than 20 key variables were listed as of interest in the questionnaire.

If this study was to be repeated I would consider shortening the questionnaire as the response rate to individual questions decreased as the questionnaire progressed, indicating response fatigue. This likely also introduced information bias. However I believe that it was important to differentiate in the questionnaire between types of partner (regular, casual and anonymous) partners in Sweden, and also investigate the different behaviour of MSM when in Sweden and when abroad.

38

7.3 Final conclusions on findings This study was unable to tease out the exact contributions of possible risk factors for acquiring syphilis among MSM attending an STI clinic in Stockholm. Descriptive data of the study population nonetheless provides some indications of the behaviours and demography of the MSM populations and is in accordance with findings of several published studies in recent years.

Of consideration in this study is that due to the population size in Sweden, MSM social networks may be more inter-connected than in other European cities. The descriptive data shows that MSM in Stockholm are more likely to meet other men in Sweden and in Stockholm. With higher connectivity it is possible that the risk for syphilis changes temporally and spatially. Thus the risk of syphilis in such a population could be micro-foci according to place and time and not in general behaviour, and thus be harder to identify in such a study. A much larger study sample size would be required, or more cases presenting in a shorter period of time in a rapid outbreak in the population. Other studies have shown that at-risk groups can be variable and change in terms of potential risk behaviour [22]. Furthermore variation in behaviour reported could be too subtle to distinguish risks and as measured in a generalised question of 12 months behaviour.

This study had provided experience in reaching the MSM population under epidemic disease investigations and assisted in identifying current sexual behaviour among MSM attending an STI clinic. Such findings can assist in

39

targeting prevention activities, optimising sexual health, educating on the risks for syphilis infection and other STIs, and decrease the potential for HIV infection to spread in the population.

8. REFERENCES

1. Goh BT. Syphilis in adults. Sexually Transmitted Infections. 2005 : 81 (448452) 2. Fenton K, Lowndes C. Recent trends in the epidemiology of sexually transmitted infections in the European Union. Sexually Transmitted Infections Aug 2004 : 80(4) :255-63 3. Eurosurveillance weekly Rates of syphilis in England are rising. 2002. http://www.eurosurveillance.org/ew/2002/020725.asp 4. Blystad H, Nilsen , Aavitsland P. An outbreak of syphilis in Oslo. International Journal of STD and AIDS. 2002. 13: 370-372 5. Outbreak of syphilis in Rotterdam, The Netherlands. Eurosurveillance Weekly 2002. 6 (13) http://www.eurosurveillance.org/ew/2002/020328.asp accessed 27th may 2004 6. Cronin M, Domegan L, Thornton L, Fitzgerald M, Hopkins S, OLorcain P, Creamer E, OFlanagan D. The epidemiology of infectious syphilis in the Republic of Ireland. Eurosurveillance Monthly. Dec 2004 : 9 (12) 7. Righarts A, Simms I, Wallace L, Solomou A, Fenton K. Syphilis surveillance and epidemiology in the United Kingdom. Eurosurveillance Monthly. 2004. 9 (12)

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8. Axelson N, Mazick A, Andersen P. Syphilis 2003 Denmark . Epi-News 2003 http://www.ssi.dk/sw10793.asp accessed 27th may 2004. 9. Blystad H, Berglund T, Blaxhult A. Utbrott av syfilis in Sverige och Norge bland mn som har sex med mn. Epi-aktuellt. 2004. 2 (22)

http://www.smittskyddsinstitutet.se/upload/EPI-Aktuellt/EA-0322.pdf 10. Flemming DT, Wasserheit JN From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection Sexually Transmitted Infections. 1999. 75(1): 3-17 11. Bellis M A, Cook P, Clark P, Syed Q, Hoskins A. Re-emerging syphilis in gay men: a case-control study of behavioural risk factors and HIV status Journal of Epidemiology and Community Health. 2002. 56: 235-236. 12. Imrie J, Lambert NL, Philips A, Mercer C, Copas A, Watson R, Perry N, Dean G, Fisher M. Demographic, sexual partnerships and sexual behaviours associated with recent syphilis diagnosis among men who have sex with men (MSM) on Englands South coast. Poster presentation at spring meeting of British Association for Sexual Health and HIV (BASHH), Bath 19-21st May 2004. 13. Smittskyddslag (2004:168) http://www.notisum.se/rnp/sls/lag/20040168.htm 14. RFSL website. Absolutely positive. Fakta om Smittskyddslagen

http://www.rfsl.se/?p=1363

15. Berglund T. Table 2 in Thesis for doctoral degree: Recent trends in the epidemiology of gonorrhoea in Sweden. 2006. 16. Altman DG. Practical statistics for medical research. 1991. Chapman and Hall 41

17. Imrie J, Lambert N, Mercer CH, Copas A, Philips A, Dean G, Watson R, Fisher M. Refocusing health promotion for syphilis prevention: results of a casecontrol study of men who have sex with men on Englands South coast. Sexually Transmitted Infections. 2006. 82: 80-83 18. Marcus U, Bremer V, Hamouda O, Kramer M, Freiwald M, Jessen H, Rausch M, Reinhardt B, Rothaar A, Schmidt A, Zimmer Y. Understanding recent increases in the incidence of sexually transmitted infections in men having sex with men : changes in risk behavior from risk avoidance to risk reduction Sexually Transmitted Diseases. 2006. 33 (1) 11-17 19. Kent C, Wolf W, Nieri G, Wong W, Klausner J. Internet use and early syphilis infection among men who have sex with men, San Francisco, California 19992003. MMWR Weekly. Dec 19 2003. 52 (50) 1229-232. 20. Klausner J, Wolf W, Fisher-Ponce L, Zolt I, Katz M. Tracing a syphilis epidemic through cyperspace Journal of the American Medical Association. 2000. 284:485-487 21. Lag om upphvande av lagen (1987:375) om frbud mot s.k.bastuklubbar och andra liknadde verksamhete. 7 April 2004. Svensk Frfattningssamling

2004:177. http://62.95.69.3/SFSDOC/04/040177.PDF 22. Wheater C P, Cook PA, Clark P, Syed Q, Bellis M. Re-emerging syphilis: a detrended correspondence analysis of the behaviour of HIV positive and negative gay men BMC Public Health. 2003: 3:34

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9. APPENDICES Appendix 1: Result tables and figures numbers of partners

Appendix 1a: Reported total numbers of partners in last 12 months Appendix Figure 1: Total number of Male partners
60 50 Frequency 40 30 20 10 0 0-4 5-9 Number of partners 10+ Cases Controls N=75 Range of numbers=1-101 Median=10 Mean=16

Appendix Figure 2: Total number of Male Regular partners

60 50
Frequency

Cases Controls

N=98 Range of numbers=0-10 Median=2 Mean=2.4

40 30 20 10 0
0-1 2-4 5-9 10+ Number of partners

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Appendix Figure 3: Total number of Male Casual partners

60 50 40 30 20 10 0 0-1 2-4 Cases Controls

N=91 Range of numbers=0-45 Median=3 Mean=7.1

Frequency

5-9

10+

Number of partners

Appendix Figure 4: Total number of Male Anonymous partners

60 50 Frequency 40 30 20 10 0 0-1 2-4 5-9 10+ Number of partners OR=3.77 (1.057 - 13.43) p=0.041 Cases Controls

N=90 Range of numbers=0-100 Median=2 Mean=7.0

Ref.

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Appendix 2: Result tables and figures sexual behaviour

Appendix 2a: Reported sexual behaviour with different partners in last 12 months Appendix Table 1: Reported sexual behaviour with regular partners cases controls n/N % n/N % OR Oral sex give 16/16 100 66/68 97 N/A Oral sex receive 15/16 94 65/67 97 0.46 Anal sex receive 12/16 75 40/62 65 1.65 Anal sex give 13/15 87 55/66 83 1.30

pvalue FE 0.65 0.48 0.32 0.55 0.17 0.57 0.35 0.58 0.19 0.13 0.31

Group sex Masturbate Rimming receive Rimming give Fingersex Fisting receive Fisting give

9/15 13/16 10/15 9/16 10/15 3/13 4/14

60 81 67 56 67 23 29

23/55 53/64 46/61 32/58 47/58 4/53 10/54

42 83 75 55 81 8 19

2.10 0.90 0.66 1.05 0.47 3.68 1.76

Appendix Table 2: Reported sexual behaviour with casual partners

cases % n/N 19/19 100 18/19 95 18/19 95 17/18 94 15/18 10/15 15/18 11/15 10/18 16/18 11/18 10/19 11/17 3/15 5/15 83 67 83 73 56 89 61 53 65 20 33 controls n/N % 60/68 88 52/57 91 67/68 99 59/64 92 39/63 15/37 50/66 21/50 27/58 47/62 33/57 25/55 47/60 3/52 6/53 62 41 76 42 47 76 58 46 78 6 11 unmatched OR pvalue FE N/A 0.13 1.73 0.53 0.27 0.39 1.44 0.60 3.08 2.93 1.60 3.72 1.43 2.55 1.14 1.33 0.51 4.08 3.92 0.07 0.08 0.37 0.03 0.35 0.20 0.52 0.39 0.20 0.12 0.06 # ## ###

Oral sex give Unprotected oral sex give Oral sex receive Unprotected oral sex receive Anal sex receive Unprotected anal sex receive Anal sex give Unprotected anal sex give Group sex Masturbate Rimming receive Rimming give Fingersex Fisting receive Fisting give

####

# matched OR=2.82 95%CI (0.74-10.8) p=0.11 ## matched OR=2.30 95%CI (0.60-8.84) p=0.22 ### matched OR=2.97 95%CI (0.84-10.6) p=0.08

45 #### matched OR=3.63 95%CI (0.83-15.8) p=0.08

Appendix Table 3: Reported sexual behaviour with anonymous partners

cases % n/N 15/17 88 21/22 96 15/17 88 20/21 95 11/16 11/18 12/16 11/17 8/15 14/18 9/16 7/16 9/15 0/14 3/14 69 61 75 65 53 78 56 44 60 0 21 controls n/N % 42/48 88 57/62 92 44/48 92 64/69 93 22/44 16/40 29/46 23/55 22/41 38/46 24/43 15/39 27/42 1/36 6/38 50 40 63 42 54 83 56 39 64 3 16 unmatched OR pvalue FE 1.07 0.65 1.84 0.50 0.68 0.50 1.56 0.57 2.20 2.36 1.76 2.55 0.99 0.74 1.02 1.24 0.83 N/A 1.45 0.16 0.11 0.29 0.08 0.61 0.45 0.61 0.47 0.50 0.72 0.46

Oral sex give Unprotected oral sex give Oral sex receive Unprotected oral sex receive Anal sex receive Unprotected anal sex receive Anal sex give Unprotected anal sex give Group sex Masturbate Rimming receive Rimming give Fingersex Fisting receive Fisting give
#

matched OR=2.35 95%CI (0.61-9.1) p=0.20

Appendix Table 3b and 3c: Meeting and sex locations with casual and anonymous partners
Table 3b: N=92 N=69 Meeting location Casual Anonymous Through friends 24 N/A Bar 51 26 Video place 27 38 Park 10 10 Bath house 6 6 Telephone chat line 5 4 Leather club 8 8 Work place 1 1 Other 3 3 Through internet 61 29 Restaurant 6 4 Sauna 14 25 Toilet 1 1 Gym 6 8 Through newspaper 0 0 Pride festival 9 5 Private Club 5 4 Abroad 23 20 NB. More than one category possible Table 3c: Sex location Home Bar Video place Park Bath house Hotel Other At friends place Restaurant Sauna Toilet Gym Private club Leather club N=92 Casual 83 17 23 14 1 16 1 13 3 14 3 4 2 5 N=69 Anonymous 31 17 38 13 6 11 3 N/A 3 26 4 7 3 8

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Appendix 2b: Partners within Sweden in last 12 months Appendix Table 4: Reported meeting casual or anonymous partner in Sweden
cases n/N % 4/12 33 14/16 88 0/11 0 4/14 29 2/14 14 4/12 33 1/12 8 5/14 36 7/12 58 5/13 39 1/12 8 2/12 17 13/16 81 0 0 controls n/N % 19/48 40 37/50 74 2/37 5 6/39 15 6/38 16 12/41 29 6/40 15 15/40 38 21/42 50 10/39 26 2/38 5 2/37 5 29/43 67 0 0 unmatched OR pvalue FE 0.76 0.48 2.46 0.22 0.00 N/A 2.20 0.24 0.89 0.63 1.21 0.52 0.52 0.48 0.93 0.59 1.40 0.43 1.81 0.29 1.64 0.57 3.50 0.25 2.09 0.24 N/A N/A

Party Bar Toilet Gym Bath place Leather club Private club Park Disco Pride Restaurant Sauna Video Work

Appendix Table 5: Reported meeting casual or anonymous partner abroad

cases Party Bar Toilet Gym Bath place Leather club Private club Park Disco Pride Restaurant Sauna Video Work n/N 2/10 8/11 0/10 0/10 0/10 3/10 0/10 2/10 6/11 0/10 0/10 9/13 2/10 0/10 % 20 73 0 0 0 30 0 20 55 0 0 69 20 0 controls n/N % 5/22 22 20/28 71 3/20 15 2/20 10 3/21 14 5/20 25 0/19 0 5/22 23 5/19 26 0/19 0 1/19 5 21/27 68 8/21 38 0/19 0 unmatched OR pvalue FE 0.85 0.62 1.01 0.63 N/A 0.28 N/A 0.44 N/A 0.30 1.29 0.55 N/A N/A 0.85 0.62 3.36 0.12 # N/A N/A N/A 0.65 0.64 0.41 0.41 0.28 N/A N/A

*N varies according to item due to non-response # matched OR=0.93 95%CI (0.15 5.80) p=0.938

47

Appendix 2c: Reported syphilis cases among MSM in Stockholm Appendix Figure 5: Number of cases of syphilis infected through sex between men, reported in Stockholm county, Sweden 1998-2006

80 70 60 50 40 30 20 10 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 Year of report

Data source: Swedish Institute for Infectious Disease Control, statutory notifications database

Number of cases

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Appendix 3: Clinic information sheet

Study number:__________

Syphilis Case Control Study

Clinical data

------------------------------------------------------------------------------------------------------Date of recruitment : _ _ /_ _/ _ _ Birth year: _ _ _ _ ------------------------------------------------------------------------------------------------------Laboratory results

Negative Syphilis HIV Gonorrhea Chlamydia Other: _________ [ ] [ ] [ ] [ ] [ ]

Positive [ ] [ ] [ ] [ ] [ ]

Date result _ _/_ _/_ _ _ _/_ _/_ _ _ _/_ _/_ _ _ _/_ _/_ _ _ _/_ _/_ _

not tested [ ] [ ] [ ] [ ] [ ]

If syphilis positive Stage of infection: [ ] Primary [ ] Early latent (<2yrs)

[ ] Secondary [ ] Tertiary [ ] Late latent (>2yrs) [ ] Other

If HIV positive: Previously known HIV positive patient to clinic: [ ] Yes [ ] No Patient on ART in last 12 months? [ ] No [ ] Yes [ ] Not known Most recent CD4 count: ________ Most recent viral load count: ________ Date: _ _ /_ _/ _ _ Date: _ _ /_ _/ _ _

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Appendix 4: Questionnaire used for cases and controls

Study number: ___________ Consent: Yes [ ] No [ ]

Questionnaire for a case-control study on Syphilis in men

Instructions: The questionnaire should takes around 20-25 minutes to complete. The questions are divided into several sections. Please note that some questions may appear to be repeated throughout the questionnaire but they are asked with reference to different situations or partners. Please write in the space provided or place a cross next to the relevant answer for you. On completion of the questionnaire, please seal it in the envelope provided and return the questionnaire to reception. The receptionist will give you a Trisslott (lottery scratch card) as a thank-you for completing this questionnaire. Remember : this is an anonymous questionnaire. The individual responses you provide will not be seen by the clinic staff. Only the project leaders at SMI who will handle the completed questionnaires will see the individual answers and they do not know your identity.

If you have any questions or queries about the study, you are welcome to contact the project co-ordinator Lara Payne at SMI, Tel: 08- 457 2378. If after completing the questionnaire you have any concerns or would like to speak to someone at the clinic, you are welcome to contact Stefan Ekroth (counsellor) or Lena Persson (nurse) at Venhlsan Tel: 08- 616 25 00.

THANK YOU FOR COMPLETING THIS QUESTIONNAIRE!

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Study Number: ___________

Some basic questions about you Q1. How old are you? _ _ years Q2. What is the highest educational qualification that you have? [ ] I have no educational qualifications [ ] School to age 16 [ ] School to age 19 [ ] Degree or higher [ ] Other please specify ________________________ Q3. Are you currently? [ ] Unemployed [ ] Employed / Self-employed [ ] Student [ ] On sick leave [ ] Medically retired [ ] Retired [ ] Other please specify ________________________ Q4. Have you lived mainly in Sweden in the last 12 months? [ ] Yes [ ] No If no: Please name the main other country you have been resident in? :_________________________ Q5. In which county within Sweden have you mainly lived in the last 12 months? Example: Stockholm county _______________________

Q6. How do you describe your sexual orientation? : [ ] Homosexual [ ] Bisexual [ ] Transsexual [ ] Heterosexual [ ] Dont know [ ] None of the above please state: ______________________ Q7. If you consider yourself homosexual or bisexual, how open are you about your sexual identity with others in everyday life: (e.g. family, friends, work colleagues) [ ] Completely open [ ] Open to most people [ ] Open to some people [ ] Not open [ ] Dont know

51

Some questions about your sexual health Q8. What was the main reason that led you to be tested for syphilis (and possibly other sexually transmitted infections) at your most recent visit to Venhlsan? Select only one answer [ ] Symptoms [ ] Partner has/had symptoms [ ] New sexual relationship [ ] Ended a sexual relationship [ ] Unsafe sex (anal, oral or vaginal) with a partner [ ] Routine health check up [ ] Requested to be tested following contact tracing [ ] Response to information/campaign on syphilis [ ] Other :_____________________________ Questions 9 to 12 relate to your sexual health before this most recent visit and testing at the clinic. Q9. Before this visit to the clinic, have you in the last 12 months had a test for any of the following sexually transmitted infections: Chlamydia, Gonorrhea, Hepatitis A,B, C , or Syphilis? [ ] No [ ] Dont know [ ] Yes Q10. Before this visit to the clinic, have you in the last 5 years been diagnosed positive with any of the following sexually transmitted infections, and in which year? Chlamydia Gonorrhoea Hepatitis A Hepatitis B Hepatitis C Syphilis Other STI (not HIV): No [ ] [ ] [ ] [ ] [ ] [ ] [ ] Dont know [ ] [ ] [ ] [ ] [ ] [ ] [ ] Yes [ ] [ ] [ ] [ ] [ ] [ ] [ ] Year positive test ____ ____ ____ ____ ____ ____ ____

Please specify:_______________ Q11. Have you ever had a test for HIV? [ ] No [ ] Dont know [ ] Yes

Go to Q.13 Go to Q.13 If yes, year of most recent HIV test: _ _ _ _

Q12. If you have been tested for HIV (Q.11) , what was the most recent test result? [ ] Negative [ ] Dont know [ ] Dont wish to say [ ] Positive If positive, in what year were you diagnosed? Year: _ _ _ _ 52

Some questions about your sexual lifestyle A sexual contact is defined as having physical interaction with another man or womans genital area and may include masturbation, oral sex, anal or vaginal intercourse, rimming or fisting. Q13. In the last 12 months have you had sexual contacts with: [ ] Men only [ ] Men and women [ ] Women only [ ] I have had no sexual contacts Q14. In the last 12 months, how many men or women did you have sexual contacts with? (please write 0 in the relevant space if none) Number of men : ______ Number of women : ______

The next 3 sections (Questions 15-43) are about your male: A) Regular partners B) Casual partners C) Anonymous partners
Please read and answer each section, following jumps to question numbers where relevant. If you have had sexual contacts with women in the last 12 months please now go to Q.44.

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Some questions about regular partners The following 5 questions are about REGULAR partners. For the purpose of this questionnaire a regular partner is defined as a man who you have or had an ongoing sexual relationship with. You know a lot about these men other than the sex you had with them. This may include steady partners (husbands or boyfriends etc.), or other partners such as lovers or fuck-buddies. Q15. In the last 12 months how many regular partner(s) did you have sexual contact with? a) Number of regular partners: _________ [ ] Dont know (Go to Q.19) [ ] None - I had no regular partner(s) If none, how long ago did you have a regular partner? [ ] Between 1 to 5 years ago [ ] More than 5 years ago Go to Q.19 [ ] Never had a regular partner [ ] Dont remember b) How many of your regular partners were: Steady partners : ____

Lovers/Fuck-buddies: ____

Q16. In the last 12 months, while in a relationship with your regular partner(s) did you have sex with another man? [ [ [ [ ] ] ] ] Yes, but with another regular partner(s) only Yes, with another regular partner(s) and another sexual contact(s) Yes, but only with another sexual contact(s), not a regular partner(s) No, I had no other sexual contacts

Q17. In the last 12 months, how often did you have sexual contact with your regular partner(s)? [ [ [ [ [ ] ] ] ] ] Every day 2-3 times per week Once a week 2-3 times a month Once a month [ [ [ [ [ ] ] ] ] ] 6-10 times in the year 3-5 times in the year Once or twice Not once Dont know

54

Q18. In the last 12 months, please indicate below for each type of sex technique: - If you had this type of sex with your regular partner(s) and - If yes for oral or anal sex, how often you used condoms? Condom use: No Yes Type of sex: Always Often Sometimes Never [ ] [ ] Oral sex: sucking [ ] [ ] [ ] [ ] [ ] [ ] Oral sex: being sucked [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: receptive [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: insertive [ ] [ ] [ ] [ ] [ ] [ ] Group sex: sex with more than one man [ ] [ ] Mutual masturbation [ ] [ ] Being rimmed [ ] [ ] Rimming [ ] [ ] Finger sex (finger in anus) [ ] [ ] Being fisted [ ] [ ] Fisting [ ] [ ] Other: ____________

Q19. Do you ask a new regular partner their HIV status before any sexual contact? [ ] Never [ ] Sometimes [ ] Often [ ] Always

Some questions about casual partners (excluding anonymous) Questions 20 to 27 are about CASUAL partners. Note that ANONYMOUS partners are excluded in the answers to this section. For the purpose of this questionnaire a CASUAL partner is defined as a man who you dont know much about, other than their name and you may have had sex with them, on maybe one or two occasions. This may include one-night stands.

Q20. Do you ask a new casual partner their HIV status before any sexual contact? [ ] Never [ ] Sometimes [ ] Often [ ] Always

Q21. In the last 12 months, with how many casual partner(s) did you have sexual contact with? (Please write 0 if none and go to Q.28) Number of casual partners : ______________ [ ] Dont know Q22. In the last 12 months, how often did you have sexual contact with your casual partner(s)? [ ] Every day [ ] 6-10 times in the year [ ] 2-3 times per week [ ] 3-5 times in the year [ ] Once a week [ ] Once or twice [ ] 2-3 times a month [ ] Not once [ ] Once a month [ ] Dont know

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Q23. In the last 12 months, please indicate below for each type of sex technique: - If you had this type of sex with your casual partner(s) and - If yes for oral or anal sex, how often you used condoms? Condom use: No Yes Type of sex: Always Often Sometimes Never [ ] [ ] Oral sex: sucking [ ] [ ] [ ] [ ] [ ] [ ] Oral sex: being sucked [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: receptive [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: insertive [ ] [ ] [ ] [ ] [ ] [ ] Group sex: sex with more than one man [ ] [ ] Mutual masturbation [ ] [ ] Being rimmed [ ] [ ] Rimming [ ] [ ] Finger sex (finger in anus) [ ] [ ] Being fisted [ ] [ ] Fisting [ ] [ ] Other: ____________

Q24. In the last 12 months, how many casual partners did you have oral sex (sucking or being sucked) with? (Please write 0 if you didnt have oral sex) Number of partners : ________ [ ] Dont know

Q25. In the last 12 months, how many casual partners did you have anal sex (receptive or insertive) with? (Please write 0 if you didnt have anal sex) Number of partners : ________ [ ] Dont know

Q26. In the last 12 months, where did you meet or make contact with your casual partners? Select as many as apply and then please number up to the 3 most often (start with 1=most often, 2= next most often, etc.)
[ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] ] __ __ __ __ __ __ __ __ __ Through friends Bar /pub/club Gay videoclub Park/outside venue/ cruising ground Swimming pool / Spa Telephone chat line or call line Work / college Leather mens club Other (please state)_________ [ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] ] __ __ __ __ __ __ __ __ __ Internet (chat or contact site) Restaurant/ caf Gay sauna Public toilets cottage Gym Personal column newspaper Gayfestival, e.g. Pride Private members club On travels abroad

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Q27. In the last 12 months where did you have sex with casual partners? Tick as many as apply [ ] Your/his home/ place [ ] Friends home [ ] Bar /pub/ danceclub (dark room, toilets etc.) [ ] Restaurant/ caf (toilets etc.) [ ] Gay videoclub [ ] Gay sauna [ ] Park/outside venue/ cruising ground [ ] Public toilet/ cottage [ ] Swimming pool / Spa [ ] Gym [ ] Hotel /hostel room [ ] Private members club [ ] Other (please state)________ [ ] Leather mens club

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Some questions about anonymous partners Questions 28 to 34 are about ANONYMOUS partners. For the purpose of this questionnaire an anonymous partner is defined as a man who you dont know anything about apart from the sex you had with them, and you dont have their name or number. This includes men you may have had sex with in a dark room or cruising ground. Q28. In the last 12 months, with how many anonymous partner(s) did you have sexual contact with? (Please write 0 if none and go to Q35) [ ] Number of anonymous partners : ______________ [ ] Dont know

Q29. In the last 12 months, how often did you have sexual contact with an anonymous partner(s)? [ [ [ [ [ ] ] ] ] ] Every day 2-3 times per week Once a week 2-3 times a month Once a month [ [ [ [ [ ] ] ] ] ] 6-10 times in the year 3-5 times in the year Once or twice Not once Dont know

Q30. In the last 12 months, please indicate below for each type of sex technique: - If you had this type of sex with your anonymous partner(s) and - If yes for oral or anal sex, how often you used condoms? Condom use: No Yes Type of sex: Always Often Sometimes Never [ ] [ ] Oral sex: sucking [ ] [ ] [ ] [ ] [ ] [ ] Oral sex: being sucked [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: receptive [ ] [ ] [ ] [ ] [ ] [ ] Anal sex: insertive [ ] [ ] [ ] [ ] [ ] [ ] Group sex: sex with more than one man [ ] [ ] Mutual masturbation [ ] [ ] Being rimmed [ ] [ ] Rimming [ ] [ ] Finger sex (finger in anus) [ ] [ ] Being fisted [ ] [ ] Fisting [ ] [ ] Other: ____________

Q31. In the last 12 months, how many anonymous partners did you have oral sex (sucking or being sucked) with? (Please write 0 if you didnt have oral sex)
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Number of partners : ________

[ ] Dont know

Q32. In the last 12 months, how many anonymous partners did you have anal sex (receptive or insertive) with? (Please write 0 if you didnt have anal sex) Number of partners : ________ [ ] Dont know

Q33. In the last 12 months, where did you meet or make contact with your anonymous partners? Select as many as apply and then please number up to the 3 most often often (start with 1=most often, 2= next most often, etc.)
[ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] ] __ __ __ __ __ __ __ __ __ Bar /pub/club Gay videoclub Park/outside venue/ cruising ground Swimming pool / Spa Telephone chat line or call line Work / college Leather mens club On travels abroad Other (please state):______ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] __ __ __ __ __ __ __ __ Restaurant/ caf Gay sauna Public toilet cottage Gym Personal column newspaper Gayfestival, e.g. Pride Private members club Internet (chat or contact site)

Q34. In the last 12 months where did you have sex with anonymous partners? Tick as many as apply [ [ [ [ [ [ ] ] ] ] ] ] Bar /pub/ danceclub (dark room, toilets etc.) [ Gay videoclub [ Park/outside venue/ cruising ground [ Swimming pool / Spa [ Leather mens club [ Hotel /hostel room [ ] ] ] ] ] ] Restaurant/ caf (toilets etc.) Gay sauna Public toilet/ cottage Gym Private members club Your/his home/ place

[ ] Other (please state)________

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Some questions about your sexual contacts in Sweden Questions about your possible sexual contacts abroad are included in the next section. The following questions relate to contacts you had with men in Sweden. Q35. In the last 12 months, did you meet a casual/anonymous partner in any of the following places and in which city/town? If you didnt meet a casual/anonymous partner in the last 12 months. Go to Q.36 Place Private party Gay bar/pub Cottage (public toilets) Gym Swimming pool/Spa Leather mens club Private members club Park/ cruising ground Public disco or dance club Gayfestival e.g. gaypride Restaurant/ caf Gay sauna Videoclub Work/ study place Other (please state): No [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Yes [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] City/town(s) in Sweden _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________

_____________

Q36. In the last 12 months, have you used the internet to meet other men in Sweden (they may live in Sweden or be visiting from abroad)? [ ] No [ ] Dont know [ ] Yes If yes, please name the internet sites you used (e.g.QX qruiser, RFSL chat): ____________________________________________

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Q37. In the last 12 months, have you met a man through the internet who you then had sex with in Sweden? [ ] No [ ] Dont know [ ] Yes If yes, how many men did you have sex with ? : __________ If yes, where did you meet to have sex? ( mark a cross in all that apply) [ ] Your/his home/ place [ ] Hotel /hostel room [ ] Bar /pub/ danceclub (dark room, toilets etc.) [ ] Restaurant/ caf (toilets etc.) [ ] Gay videoclub [ ] Gay sauna [ ] Park/outside venue/ cruising ground [ ] Public toilet/ cottage [ ] Swimming pool / Spa [ ] Gym [ ] Leather mens club [ ] Private members club [ ] Other (please state)________ Some questions about travel and sexual contacts abroad Q38. Have you travelled outside Sweden for any length of time in the last 12 months? [ ] No Go to Q.42 [ ] Yes If yes, how many trips outside Sweden did you make? _____ Q39. In the last 12 months, did you meet a casual/anonymous partner abroad in any of the following places and in which country and city/town(s)? If you didnt meet a casual/anonymous partner in the last 12 months, go to Q.40 Place Private party Gay bar/pub Cottage (public toilets) Gym Swimming pool/Spa Leather mens club Private members club Park/ cruising ground Public disco or dance club Gayfestival e.g. gaypride Restaurant/ caf Gay sauna No [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Yes [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Country City/town(s) _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ _________ __________ 61

Videoclub Work/ study place Other (please state):

[ ] [ ]

[ ] [ ]

_________ __________ _________ __________ _________ __________

_____________

Q40. In the last 12 months, have you used the internet to meet other men abroad (they may live in Sweden or be visiting from abroad)? [ ] No [ ] Dont know [ ] Yes If yes, please name the internet sites you used: ____________________________________________ Q41. In the last 12 months, have you met a man through the internet who you then had sex with abroad? [ ] No [ ] Dont know [ ] Yes If yes, how many men did you have sex with ? : __________ And please name the countries where you met to have sex? :

__________________________________________________
Some questions about drugs and alcohol

Q42. Have you in the last 12 months used any of the following drugs when you had sex with a casual/ anonymous male partner? [ ] I did not use any drugs [ ] Dont know [ ] Yes, I used the following drugs: No Amphetamines [ ] Anobolic steroids [ ] Cannabis [ ] Cocaine [ ] Crack [ ] GHB [ ] Ecstasy [ ] Heroin [ ] LSD [ ] Poppers [ ] Viagra (or similar) [ ] Other :________ [ ]

Yes [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

Dont know [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

Decline to answer [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

Q43. Have you in the last 12 months had sex with a casual or anonymous male partner while you considered yourself drunk (as determined then or now)? [ ] No [ ] Yes [ ] Dont know 62

Some questions about the last time you had sex Q44. The last time you had sex, did you have sex with: [ ] a man [ ] a woman Q45. Which partner was it with? [ ] a regular partner . [ ] a casual partner [ ] an anonymous partner [ ] dont remember Q46. How long have they been a sexual partner? [ ] anonymous partner [ ] one night stand [ ] < 1 week [ ] 1-3 weeks [ ] 1-3 months [ ] 3-6 months [ ] 7-12 months [ ] >1 year [ ] dont remember Q47. In which city and country did you (first) meet? [ ] Sweden City: _________________ [ ] Abroad Country and city:___________ Q48. If you last had sex with a casual or anonymous partner, where/how did you (first) meet? If it was a regular partner, please go to Q.50 [ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] ] Through friends Bar /pub /club Gay videoclub Park/ cruising ground Swimming pool / Spa Telephone chat line or call line Work / college Leather mens club Other (please state)_________ [ [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ] ] Internet (chat or contact site) Restaurant/ caf Gay sauna Public toilet cottage Gym Personal column newspaper Gay festival e.g. Pride Private members club On travels abroad

Q49. What approximate time of day did you meet your casual/anonymous partner the last time you had sex? Time _ _ : _ _ e.g. 19:30

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Q50. What kind of sex did you have? Please indicate below for each type of sex technique: - If you had this type of sex with your partner(s) and - If yes for oral or anal sex, how often you used condoms? Condom use: No Yes Type of sex: Yes No Dont remember [ ] [ ] Oral sex: sucking [ ] [ ] [ ] [ ] [ ] Oral sex: being sucked [ ] [ ] [ ] [ ] [ ] Anal sex: receptive [ ] [ ] [ ] [ ] [ ] Anal sex: insertive [ ] [ ] [ ] [ ] [ ] Group sex: sex with more than one man [ ] [ ] Mutual masturbation [ ] [ ] Being rimmed [ ] [ ] Rimming [ ] [ ] Finger Sex [ ] [ ] Being fisted [ ] [ ] Fisting [ ] [ ] Other: ____________ Q51. Where did you have sex? [ ] Your/his home/ place [ [ ] Bar /pub/ danceclub (dark room, toilets etc.) [ [ ] Gay videoclub [ [ ] Park/outside venue/ cruising ground [ [ ] Swimming pool / Spa [ [ ] Other (please state)________

] ] ] ] ]

Hotel /hostel room Restaurant/ caf (toilets etc.) Gay sauna Public toilet/ cottage Gym

Q52.What did you think was the HIV status of your partner? [ ] I assumed he was HIV negative [ ] I assumed he was HIV positive [ ] He told me he was HIV negative [ ] I knew he was HIV negative [ ] He told me he was HIV positive [ ] I knew he was HIV positive [ ] I did not think about his HIV status

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Some general questions Q53. Where do you usually seek information on health issues related to sex? Select as many as apply [ ] Doctor / health clinic [ ] Gay/ GBT organizations (e.g. RFSL) [ ] Friends [ ] Other organization : ________________ [ ] Gay magazines [ ] Internet [ ] Partner [ ] Other: ________________________ Q54. Are there any comments or points you would like to share with us? ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ _______________________________________________________________

Thank you for completing this questionnaire ! Please seal the questionnaire in the envelope provided. Please hand in the closed envelope to the receptionist at Venhlsan. You will be given a Trisslott (lottery card) as a thank-you. If this questionnaire has raised any queries or concerns, you are welcome to contact:
Stefan Ekroth or Lena Persson, Venhlsan tel 08-616 25 00, or Lara Payne , SMI Tel : 08-457 23 78

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Appendix 5: Information sheet for study participants

Patient Information: Study on syphilis in men who have sex with men
Background Syphilis was a rare infection in the 1990s in Sweden. Among men who have sex with men (MSM) only a few cases were reported annually. Since 2000, the situation has changed. In 2003, over 100 cases of syphilis were reported in MSM in Sweden. The majority of infections were acquired in Stockholm, but some were acquired abroad in other European cities. Aims of the study This study focuses on sexual behaviour and factors that may contribute to the transmission of syphilis amongst MSM. The study comprises of a questionnaire through which 54 questions are asked equally to both MSM who are infected with syphilis and those testing negative. The aim of the study is to compare the responses to these questions to identify possible differences and assess possible risk factors for acquiring syphilis. The results will provide better sexual health information for MSM and allow targeting of prevention activities to prevent syphilis spreading further in the population. The study is being done through Venhlsan working with the epidemiology department at the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet, SMI). Your participation and time As someone who has recently tested for syphilis (positive or negative), we are asking you whether you would be willing to consent to participate in this study and give 20-25 minutes of your time to answer the questionnaire. If there is anything you do not wish to answer then that question can be skipped. It is important though that you complete all sections of the questionnaire as fully as possible. Some of the questions and language used may appear sensitive or shocking, and we hope that you do not take offence for their use in this context. Remember that participation in the study is completely voluntary. If you do not wish to participate this will not affect your present or future care at the clinic in anyway. If you do wish to take part in the study, please complete the questionnaire after your appointment and return it sealed in the envelope provided to reception. Even if you only complete some of the questions, it is important that you return the questionnaire in the sealed envelope to reception. To thank you for your participation, a Trisslott (lottery scratch card) will be given to you at reception on return of the questionnaire. Data handling Answers to the questionnaire will not be read by any staff at Venhlsan, only by the project leader at SMI who will analyse the data collectively from all questionnaires and produce a scientific report. Clinical data from your most recent visit to Venhlsan will also be included in the analysis. Confidentiality Remember that participation in this study does not involve providing a name or a personnummer, and you are guaranteed full anonymity for your answers. For administrative and analysis purposes every questionnaire has a study number, but no link will be made to your identity after completion of the questionnaire. Further information If you have any concerns or queries following completion of the questionnaire, you are welcome to contact Stefan Ekroth or Lena Persson, tel: 08-616 25 00, or anyone else signed below. Lara Payne Project leader, Epi/SMI tel 08-457 23 78 Anders Karlsson Doctor Venhlsan tel 08-616 25 00 Gran Bratt Doctor Venhlsan tel 08-616 25 00 Eric Sandstrm Professor, Consultant Venhlsan

tel 08-616 25 71

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