Chlamydia trachomatis infection Infections and Infestations Chlamydial infection, unspecified
Conditions
Interventions
This study has three components:
1. Cross-over cluster randomised controlled trial of Accelerated Partner Therapy (APT)
2. Cost-effectiveness sub-studies (within-trial economic evaluation and model-ba
Sponsors
Central and North West London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary biological outcome (the proportion of index patients positive for chlamydia 12-16 weeks after diagnosis) is a proxy for re-infection. This will be ascertained from the results of the follow-up chlamydia test at 12-16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The key secondary outcome is the proportion of sex partners treated two weeks after the initial diagnosis. This will be ascertained by index patient reports at the 2-week follow-up phone call with the research health adviser 2. Patient acceptability, measured using process evaluation telephone interviews within 8 weeks of APT consultation 3. Number of partners treated per index patient, measured by telephone call with research health adviser at 2-week follow-up 3. Time to achieve partner treatment, measured by telephone call with research health adviser at 2-week follow-up 4. Number of partners notified per index patient, measured by telephone call with research health adviser at 2-week follow-up 5. STI and HIV testing in sex partners, measured by return of postal self-samples from test kits in APT pack 6. Sex partner positivity for STIs and HIV, measured by return of postal self-samples from test kits in APT pack 7. Adverse events, measured using local activity logs in each clinic 8. Costs associated with the intervention, measured by economic evaluation studies based on costings of trial | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed