None listed
Conditions
Brief summary
This randomised controlled trial (RCT) will assess the effectiveness of an SMS reminder and home-based self-collected samples (home group) to increase the proportion of patients re-tested after a chlamydia infection, compared to an SMS reminder and clinic testing (clinic group). Approximately 600 patients diagnosed with chlamydia across two sexual health clinics will be randomised to the home group or the clinic group. In the home group, patients will receive a ‘collection kit’ containing the collection device, instructions, request form and pre-paid envelope. Three months after the intial diagnosis the clinic will send an SMS reminder to encourage the patient to collect a sample using the collection kit and mail it to the lab or return to the clinic for re-testing if they prefer. Patients randomised to the clinic group will receive an SMS reminder at three months following diagnosis to encourage the patient to return to the clinic for re-testing. At 4 and 5 months after the initial diagnosis, patients will be requested by SMS to complete an online questionnaire to assess the acceptability of home testing, re-testing elsewhere, re-testing barriers and sexual behaviour. Women will also be asked about symptoms of PID. If participants record in the questionnaire that they had a chlamydia test at another clinic since their positive test, or if women report attending another clinic with symptoms of PID, then the researchers will seek their permission for the researchers to contact this clinic to obtain the results of this test/ relevant medical records. The study will require 12 months to complete: 6 months for recruitment and 6 months to allow time for patients to re-test and complete the online questionnaire. The primary outcome is re-testing rate within three months of chlamydia treatment.
Interventions
Three months after the initial diagnosis, the clinic will send an SMS reminder to encourage the patient to collect a sample/s using a collection kit and mail it to the lab with the request slip. The dates will be set by clinic staff at the time of treatment.
The research team will mail a collection kit in an unmarked envelope to the patient 3 months after initial diagnosis. Patients will be instructed in a covering letter to collect their specimen/s and package them according to the instructio
Three months after the initial diagnosis, the clinic will send an SMS reminder to encourage the patient to collect a sample/s using a collection kit and mail it to the lab with the request slip. The dates will be set by clinic staff at the time of treatment. The research team will mail a collection kit in an unmarked envelope to the patient 3 months after initial diagnosis. Patients will be instructed in a covering letter to collect their specimen/s and package them according to the instructions provided and mail them to the laboratory in the supplied pre-paid envelope. The collection kit will contain the collection device, collection instructions, laboratory request form and pre-paid envelope. The collection devices will vary according to the patient’s risk group: heterosexual men will receive a Copan swab for first-pass urine collection; women will receive a swab for lower vaginal self-collection; and men who have sex with men (MSM) will receive two collection devices: (i) a swab for rectal self-collection and (ii) a swab for first-pass urine collection.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 16 years or above; 2. Have a mobile phone; 3. Heterosexual men (reported sexual contact only with a female partner in the last 12 months), men who have sex with men (reported sexual contact with a male partner in the last 12 months, and women; 4. Chlamydia infection as diagnosed by Nucleic Acid Amplification Tests (NAAT); 5. Resides in a jurisdiction serviced by clinic (Victoria for Melbourne Sexual health Centre, or New South Wales for Sydney Sexual Health Centre); and 6. Plans to stay in the jurisdiction serviced by clinic for the next six months.
Exclusion criteria
1. Unwilling or unable to comply with all the requirements of the protocol. 2. Cannot speak English 3. HIV positive 4. Current sex worker (engaged in sex work in the last 12 months)
Outcome results
None listed