Participation, retention, and associated factors of women in a prospective multicenter study on Chlamydia trachomatis infections (FemCure).

Prospective studies are key study designs when attempting to unravel health mechanisms that are widely applicable. Understanding the internal validity of a prospective study is essential to judge a study's quality. Moreover, insights in possible sampling bias and the external validity of a prospective study are useful to judge the applicability of a study's findings. We evaluated participation, retention, and associated factors of women in a multicenter prospective cohort (FemCure) to understand the study's validity.Chlamydia trachomatis (CT) infected adult women, negative for HIV, syphilis, and Neisseria gonorrhoeae were eligible to be preselected and included at three sexually transmitted infection (STI) clinics in the Netherlands (2016-2017). The planned follow-up for participants was 3 months, with two weekly rectal and vaginal CT self-sampling and online questionnaires administered at home and at the clinic. We calculated the proportions of preselected, included, and retained (completed follow-up) women. Associations with non-preselection, noninclusion, and non-retention (called attrition) were assessed (logistic and Cox regression).Among the 4,916 women, 1,763 (35.9%) were preselected, of whom 560 (31.8%) were included. The study population had diverse baseline characteristics: study site, migration background, high education, and no STI history were associated with non-preselection and noninclusion. Retention was 76.3% (n = 427). Attrition was 10.71/100 person/month (95% confidence interval 9.97, 12.69) and was associated with young age and low education. In an outpatient clinical setting, it proved feasible to include and retain women in an intensive prospective cohort. External validity was limited as the study population was not representative (sampling bias), but this did not affect the internal validity. Selective attrition, however (potential selection bias), should be accounted for when interpreting the study results.

Treatment Effectiveness of Azithromycin and Doxycycline in Uncomplicated Rectal and Vaginal Chlamydia trachomatis Infections in Women: A Multicenter Observational Study (FemCure).

BACKGROUND: Rectal infections with Chlamydia trachomatis (CT) are prevalent in women visiting a sexually transmitted infection outpatient clinic, but it remains unclear what the most effective treatment is. We assessed the effectiveness of doxycycline and azithromycin for the treatment of rectal and vaginal chlamydia in women. METHODS: This study is part of a prospective multicenter cohort study (FemCure). Treatment consisted of doxycycline (100 mg twice daily for 7 days) in rectal CT-positive women, and of azithromycin (1 g single dose) in vaginally positive women who were rectally untested or rectally negative. Participants self-collected rectal and vaginal samples at enrollment (treatment time-point) and during 4 weeks of follow-up. The endpoint was microbiological cure by a negative nucleic acid amplification test at 4 weeks. Differences between cure proportions and 95% confidence intervals (CIs) were calculated. RESULTS: We analyzed 416 patients, of whom 319 had both rectal and vaginal chlamydia at enrollment, 22 had rectal chlamydia only, and 75 had vaginal chlamydia only. In 341 rectal infections, microbiological cure in azithromycin-treated women was 78.5% (95% CI, 72.6%-83.7%; n = 164/209) and 95.5% (95% CI, 91.0%-98.2%; n = 126/132) in doxycycline-treated women (difference, 17.0% [95% CI, 9.6%-24.7%]; P < .001). In 394 vaginal infections, cure was 93.5% (95% CI, 90.1%-96.1%; n = 246/263) in azithromycin-treated women and 95.4% (95% CI, 90.9%-98.2%; n = 125/131) in doxycycline-treated women (difference, 1.9% [95% CI, -3.6% to 6.7%]; P = .504). CONCLUSIONS: The effectiveness of doxycycline is high and exceeds that of azithromycin for the treatment of rectal CT infections in women. CLINICAL TRIALS REGISTRATION: NCT02694497.

Incidence of repeat testing and diagnoses of Chlamydia trachomatis and Neisseria gonorrhoea in swingers, homosexual and heterosexual men and women at two large Dutch STI clinics, 2006-2013.

OBJECTIVE: Swingers, that is, heterosexuals who as a couple have sex with others, including group sex and bisexual behaviour, are an older-aged risk group for STIs. Here, we report on their repeat testing (reattendance) and STI yield compared with other heterosexuals and men who have sex with men (MSM, homosexual men) at two Dutch STI clinics. METHODS: Swingers are routinely (since 2006, South Limburg, registration-completeness: 99%) or partially (since 2010, Amsterdam, registration-completeness: 20%) included in the clinic patient registries. Data (retrospective cohort) are analysed to assess incidence (per 100 person-years (PY)) of reattendance and STI (Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG)) and associated factors calculating HRs. RESULTS: In South Limburg 7714 and in Amsterdam 2070 swinger consultations were identified. Since 2010, swingers' incidence of reattendance was 48-57/100 PY. Incidence was lower in MSM (30-39/100 PY, HR 0.56; 95% CI 0.51 to 0.61, South Limburg; HR 0.88; 95% CI 0.80 to 0.96, Amsterdam), heterosexual men (8-14/100 PY, HR 0.16; 95% CI 0.15 to 0.17, South Limburg; HR 0.33; 95% CI 0.30 to 0.36, Amsterdam) and women (13-20/100 PY, HR 0.56; 95% CI 0.51 to 0.61, South Limburg; HR 0.46; 95% CI 0.42 to 0.51, Amsterdam). Swingers' STI incidence at reattendance was 11-12/100 PY. Incidence was similar in heterosexual men (14-15/100 PY; HR 1.19; 95% CI 0.90 to 1.57, South Limburg; HR 1.20; 95% CI 0.91 to 1.59, Amsterdam) and women (12-14/100 PY; HR 1.14; 95% CI 0.88 to 1.49, South Limburg; HR 0.98; 95% CI 0.74 to 1.29, Amsterdam) and higher in MSM (18-22/100 PY; HR 1.59; 95% CI 1.19 to 2.12, South Limburg; HR 1.80; 95% CI 1.36 to 2.37, Amsterdam). Risk factors for STI incidence were partner-notified (contact-tracing), symptoms and previous STI. Swingers' positivity at any clinic attendance was 3-4% for NG (ie, higher than other heterosexuals) and 6-8% for CT (ie, lower than heterosexuals overall but higher than older heterosexuals). CONCLUSIONS: Systematic identification reveals that swingers are part of the normal STI clinic populations. They frequently repeat test yet are likely under-recognised in clinics which not routinely ask about swinging. Given swingers' notable STI rates, usage of services is warranted, although use may be restricted, that is, to those with an STI risk factor (as did Dutch clinics). As swingers have dense sexual networks, enhancing contact-tracing may have high impact.

Design of the FemCure study: prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care.

BACKGROUND: In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control. METHODS: A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed. DISCUSSION: The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02694497 .

Challenging Health in All Policies, an action research study in Dutch municipalities.

The Dutch government encourages municipalities to develop 'Health in All Policies' (HiAP). The development of such a policy requires inter-sectoral collaboration, however municipalities show little initiative in this regard. Operating in an advisory role, the regional Public Health Service (PHS) has supported municipalities in South-Limburg in setting up inter-sectoral collaboration. A coaching program for municipal stakeholders was developed and implemented to improve HiAP, using obesity as an example. To determine the effectiveness of this coaching program, civil servants, managers and municipal councilors were invited to fill in an Internet questionnaire prior to and at the completion of the program. By means of a log-book all activities were registered in coached municipalities and in-depth interviews were held with municipal managers. Outcomes were scored depending on the stage of HiAP proposals. Six of the nine coached municipalities showed concrete outcomes in terms of HiAP proposals. The results show that more support and involvement at each system level stimulates the development of HiAP. The program contributed positively to the implementation of HiAP interventions targeting obesity. The pretest results for coached municipalities were better compared to non-coached municipalities. However, after 30 months of coaching this positive starting position faded away. We recommend that the municipal management become more involved in the development of HiAP and advise the PHS to increasingly demonstrate their expertise. Here lies a challenge for municipalities and their regional PHS.

The reach of a computer-tailored nutrition education program in the Dutch heart health community intervention "Hartslag Limburg".

OBJECTIVE: To study the reach of an efficacious, computer-tailored nutrition education tool in a field setting. DESIGN: Data from self-administered questionnaires were used. SETTING: The computer-tailored nutrition education tool (CTT) was adopted by a regional public health service organization and implemented in a regional heart-health community project. PARTICIPANTS: The 1293 inhabitants of the region that requested the computer nutrition education tool during a 25-month implementation period. MAIN OUTCOME MEASURES: Demographic characteristics; intake of fat, fruit, and vegetables; and psychosocial behavioral determinants. ANALYSIS: Descriptive statistics. RESULTS: The CTT reached almost 1% of the targeted population. Most participants were female (82%), and almost half were low educated. Many participants had diets higher in fat and lower in fruits and vegetables than recommended, were unaware of their unfavorable diets, and had low self-efficacy and intentions towards change. CONCLUSIONS AND IMPLICATIONS: Only a small, but possibly important, part of the target population was reached. Additional ways to reach more people should be explored.

Evaluation of a Dutch public-private partnership to promote healthier diet.

PURPOSE: Public-private partnerships may help to promote healthy diets. We assessed customers' exposure to and the acceptability of a Dutch public-private healthy diet campaign in butcher's shops and investigated the effects on the purchase of lean meat and the use of liquid cooking margarine and potential behavioral determinants. METHODS: The pretest-posttest control group design included 486 customers (242 experimental and 244 control) of butcher shops representing 64% of the original sample. Campaign exposure, acceptability, and behavioral effects were measured by a questionnaire. RESULTS: Seventy-one percent of the customers noticed the campaign. Scores on the acceptability were positive to very positive. Regression analysis revealed that customers in the experimental condition evaluated the campaign better (B = .415; p < .05) and felt more encouraged to buy lean meat (B = .252; p < .05) than customers in the control condition. No effects on behavior were found. DISCUSSION: Study design limitations included possible campaign exposure of control group participants. The study shows the feasibility and acceptability of a joint health-promoting activity through a public-private partnership, but there were no effects on behavior.

Costs of the 'Hartslag Limburg' community heart health intervention.

BACKGROUND: Little is known about the costs of community programmes to prevent cardiovascular diseases. The present study calculated the economic costs of all interventions within a Dutch community programme called Hartslag Limburg, in such a way as to facilitate generalisation to other countries. It also calculated the difference between the economic costs and the costs incurred by the coordinating institution. METHODS: Hartslag Limburg was a large-scale community programme that consisted of many interventions to prevent cardiovascular diseases. The target population consisted of all inhabitants of the region (n = 180.000). Special attention was paid to reach persons with a low socio-economic status. Costs were calculated using the guidelines for economic evaluation in health care. An overview of the material and staffing input involved was drawn up for every single intervention, and volume components were attached to each intervention component. These data were gathered during to the implementation of the intervention. Finally, the input was valued, using Dutch price levels for 2004. RESULTS: The economic costs of the interventions that were implemented within the five-year community programme (n = 180,000) were calculated to be about euro900,000. euro555,000 was spent on interventions to change people's exercise patterns, euro250,000 on improving nutrition, euro50,000 on smoking cessation, and euro45,000 on lifestyle in general. The coordinating agency contributed about 10% to the costs of the interventions. Other institutions that were part of the programme's network and external subsidy providers contributed the other 90% of the costs. CONCLUSION: The current study calculated the costs of a community programme in a detailed and systematic way, allowing the costs to be easily adapted to other countries and regions. The study further showed that the difference between economic costs and the costs incurred by the coordinating agency can be very large. Cost sharing was facilitated by the unique approach used in the Hartslag Limburg programme.

The Dutch Heart Health Community Intervention 'Hartslag Limburg': effects on smoking behaviour.

BACKGROUND AND METHODS: A pretest-posttest control group design with two posttests was used to evaluate the effects of a regional Dutch Heart Health Community Intervention on smoking behaviour and its determinants. At baseline, a cohort research population of 1,200 smokers was recruited in the intervention region and in a control region. Data was gathered by means of short structured telephone interviews. RESULTS: No significant differences were found between the intervention region and the control region on smoking behaviour and its determinants. CONCLUSION: It is concluded that the regional intervention was unable to exceed secular trends in smoking cessation.

The Dutch Heart Health Community Intervention 'Hartslag Limburg': design and results of a process study.

In 1998, a regional cardiovascular diseases prevention program was started in The Netherlands. This paper presents the design and results of a process study on the community intervention. The main purpose of the study was to gain insight into the reasons why expected effects were or were not achieved. Data was collected using multiple data sources and/or methods to measure indicators of intervention implementation. The results indicate that the community analysis and the subsequent organization of nine local Health Committees had been satisfactory. However, some factors that might influence the actual functioning of the Health Committees could be improved. Furthermore, the expert training for the members of these Committees had not yet been carried out as planned and there were doubts about the added value of collaboration with experts thus far. Environmental strategies were felt to need more attention and ensuring long-term continuation requires continuous effort. Most of the 293 intervention activities had focused on nutrition, while smoking cessation activities had been given lowest priority. It is concluded that the process evaluation has provided information about successful and less successful elements of the community intervention.

The Dutch Heart Health community intervention 'Hartslag Limburg': results of an effect study at individual level.

'Hartslag Limburg' (Dutch for Heartbeat Limburg), a regional cardiovascular diseases (CVD) prevention program, integrates a community strategy and a high-risk strategy to reduce CVD risk behaviors. The present paper focuses on the effects of the community intervention on fat intake and physical activity. The project was based on community organization principles and health education theories and methods. In order to implement the intervention, nine local Health Committees were set up, each organizing activities that facilitate and encourage people to adopt a healthier lifestyle. A pre-test-post-test control group design with two post-tests was used to evaluate the intervention. At baseline, representative random cohort research samples were selected in the Maastricht region and in a control region. Data on fat intake and physical activity, and on the psychosocial determinants of these behaviors, were gathered by means of mail surveys. The present study indicates that the intervention had a significant effect on fat reduction, especially among respondents aged