ISRCTN15996256已完成未知
STRUM cross-over cluster randomised controlled trial of Accelerated Partner Therapy (APT) to improve partner notification outcomes for heterosexual people with sexually transmitted Chlamydia trachomatis infection
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 3,639
研究概览
简要总结
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32229523 protocol (added 02/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36182235/ (added 03/10/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •INDEX PATIENT INCLUSION CRITERIA
- •1. 16 years or older
- •2. Have tested positive for c. Trachomatis (Chlamydia) during the study period
- •3. Who had at least one sexual partner in the past 6 months (apart from men with non-gonococcal urethritis (NGU) or epididymo-orchitis (men) where the look-back period is 1 month)
- •Patients diagnosed with pelvic inflammatory disease (PID) or cervicitis (women) or non-NGU (men) on the day of first clinic attendance will also be eligible, as these patients will routinely be given treatment for chlamydia before definitive diagnostic test results are available.
- •Please note:
- •Re. PID & cervicitis: Chlamydia is a common cause of PID and cervicitis and it is routine practice to treat women with either condition as presumptive chlamydia” until test results are known.
- •Re. NGU or epididymo-orchitis (men): urethritis (penile discharge and pain of passing urine) is a common presentation of chlamydia in men. Routinely men with urethritis will be microscopy of a urethral specimen performed at the initial clinic visit. If this does not show appearances suggestive of gonorrhoea, the man will be treated for presumptive chlamydia at least until tests are known.
- •SEX PARTNER INCLUSION CRITERIA
- •Sex partners within the past 6 months who are selected by the index patient for APT will be eligible
- •STAFF INCLUSION CRITERIA
- •1. Involvement or role in delivering the LUSTRUM Chlamydia PN trial OR
- •2. Involvement or role in delivering or supporting the delivery of PN services OR
- •3. Involvement or role in the management of patients testing for and/or diagnosed with chlamydia
排除标准
- •INDEX PATIENT EXCLUSION CRITERIA
- •1. Patients aged under 16 years
- •2. Patients co-infected with other Sexually Transmitted Infections (STIs) including HIV, as these patients have Partner Notification (PN) requirements that will not be best met by Accelerated Partner Therapy (APT)
- •3. Men who had sex with one or more men in the past 6 months, as the epidemiology of STIs and HIV in this population is more complex and this form of APT may not be an appropriate intervention to meet all of their health needs
- •4. Any other clinical, social, or other circumstances which emerge during the consultation which mean that APT may not be suitable. This will include those whose diagnosis was the result of sexual assault
- •5. Patients who have paid for or who have been paid for sex in the past 6 months
- •SEX PARTNER EXCLUSION CRITERIA
- •1. Those aged under 16 years
- •2. Men who had sex with a man in the past 6 months
- •3. Those with insufficient English language competence to engage in a telephone consultation safely with adequate understanding.
- •4. Women who are pregnant
- •5. Women with symptoms of pelvic infection
- •6. Men with symptoms of testicular involvement
- •7. Men and women with likely-chlamydia-related extra-genital symptoms
- •8. Those with allergy or contraindications to azithromycin or doxycycline (first-line treatments for chlamydia)
- •9. Those with co-existent infection with T. pallidum and/or HIV as these cases require different investigation and management.
- •10. Any other extenuating circumstances which emerge during the consultation which mean that APT may not be suitable, including those who report sexual assault by the index patient or those reporting inter-partner violence
- •11. Patients who have paid for or who have been paid for sex in the past 6 months
- •These exclusion criteria will be assessed by the Health Adviser/Healthcare Professional during the telephone consultation, guided by the RELAY data collection tool.
研究者
相似试验
已完成
不适用
The effect of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancerChemotherapy-induced nausea and vomitingSigns and SymptomsNausea and vomitingISRCTN13287728Beijing Municipal Administration of Hospitals136
已完成
不适用
Health professional Administered Brief Insomnia Therapy (HABIT) trialMental and Behavioural DisordersDisorders of initiating and maintaining sleep [insomnias]InsomniaISRCTN42499563niversity of Oxford642
已完成
不适用
Is it possible to reduce smoking at Danish vocational high schools?ISRCTN16455577niversity of Southern Denmark1,000
已完成
不适用
PACT: cluster randomised controlled trial of the ‘Your Care Needs You!’ interventioCare transitionsISRCTN17062524Bradford Teaching Hospitals NHS Foundation Trust1,000
已完成
不适用
Standard open radical cystectomy (ORC) versus robotically assisted radical cystectomy (RARC)Malignant neoplasm of bladderCancerBladder cancerISRCTN13680280niversity College London338