Clinical Research Directory

The Prevalence of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Patients Suspected of Hemorrhagic Proctosigmoiditis

Background Chlamydia trachomatis and Neisseria gonorrhoeae can cause infectious proctitis, which macroscopically cannot be distinguished from haemorrhagic proctosigmoiditis (HP) caused by inflammatory bowel disease. In Denmark, general practitioners are advised to consider whether patients presenting with proctitis symptoms might have a sexually transmitted infection (STI). However, there is no requirement for STI testing before referring the patient to a specialised department. At specialised departments, it is not standard practice to systematically inquire about sexual risk behaviour or to test for Chlamydia and Gonorrhoea. As a result, there is no data on how many patients diagnosed with HP due to chronic inflammatory bowel disease are also positive for an STI, either as the sole cause or as a contributing factor to their inflammation. Chlamydia and Gonorrhoea are the most common causes of symptomatic, sexually transmitted proctitis and are increasingly prevalent in Denmark. Materials and methods Since diagnosing haemorrhagic proctosigmoiditis requires an endoscopy (sigmoidoscopy or colonoscopy), all newly diagnosed patients will undergo such an examination. Moreover, an endoscopy is often performed in individuals with refractory proctosigmoiditis. If inflammation is observed up to 35 cm from the anal opening, an additional swab will be taken during the procedure to test for Chlamydia and Gonorrhoea using standard PCR techniques. If the swab is not taken during the endoscopy, it will be collected during a follow-up outpatient visit. The tests will be analysed immediately at the Department of Microbiology, Aarhus University Hospital. Over 24 months, the investigators will examine all patients diagnosed with proctosigmoiditis at the Department of Liver, Digestive, and Gastrointestinal Diseases at Aarhus University Hospital (AUH), Viborg/Silkeborg Regional Hospital, Horsens Regional Hospital, Gødstrup Regional Hospital and Randers Regional Hospital. This includes patients with inflammation extending from the anal opening to 35 cm proximally, as well as those with treatment-refractory proctosigmoiditis. All patient data will be prospectively collected through Region Midt EPJ, Denmark's electronic medical record system, and registered in a REDCap database. The tested patients will undergo standard follow-up at their respective departments. Supple-mentary, patients who test positive for Chlamydia or Gonorrhoea will be offered treatment at the Venereology Outpatient Clinic, Aarhus University Hospital. If they are only on 5-ASA treatment and it is found reasonable to pause their treatment, their IBD treatment will be paused during treatment for STI. The studied patients will form a prospective cohort, and their disease progression, including the extent of haemorrhagic proctitis and current medication, will be recorded. Endpoints Primary endpoint: \- Prevalence of Chlamydia and Gonorrhoea in our cohort of individuals with suspected haemorrhagic proctitis. Secondary endpoints: * Prevalence of Chlamydia and Gonorrhoea across gender * Prevalence of Chlamydia and Gonorrhoea across age groups * Prevalence of Chlamydia and Gonorrhoea depending on time for diagnosis * Frequency of clinical remission of proctitis after treatment with STI-related antibiotics * Differences in the frequency of clinical remission between those with a negative or positive STI test at inclusion

Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents (IYG)

The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. The study has been approved by the Provincial Research Ethics Committee of Granada under code 202499906944441. The sole intention of the investigators is to ensure that participants receive correct and sufficient information to assess and decide whether or not to give consent for the child's participation in this study. The information sheet should be read carefully, and any questions may be addressed to the investigators. The objective of the study is to culturally adapt the program It's Your Game: Keep it Real (IYG), which aims to prevent risky sexual and affective behaviors in adolescents. The IYG program consists of 12 lessons, each lasting 45 minutes. These lessons aim to help the child identify personal norms and boundaries regarding sexuality, recognize situations that might challenge these boundaries, and develop refusal skills to maintain them. The program also covers topics such as the characteristics of healthy and unhealthy relationships, friendships, anatomy and reproduction, the social, emotional, and physical consequences of sexual activity, the consequences of teenage pregnancy and STIs, condom and contraceptive use, and communication skills. This adaptation will involve the child completing all 12 lessons (two lessons per week over a period of six weeks) that make up the IYG program, as well as filling out a series of questionnaires. These questionnaires will allow the investigators to assess the usability of the program in Spain (including ease of use, comprehension, acceptability, as well as aspects most liked and suggestions for improvement). Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way. In all cases, the CONFIDENTIALITY of the data collected will be maintained in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD) 3/2018, of December 5. Regarding the study results, these may be shared with the scientific community through presentations, conferences, and/or publications. The investigators express appreciation in advance for cooperation in this study.

Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision

The goal of this interventional study is to provide more access to STI testing for patients who seek abortion care through telemedicine, particularly for those whose access to STI testing is otherwise limited. The main questions it aims to answer are: What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision? How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care? What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population? What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service? Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested. Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.