A trial of self-collection samples to increase chlamydia re-testing following a chlamydia diagnosis amongst clients attending two urban sexual health clinics.

Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: 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. CONDITION: Chlamydia PRIMARY OUTCOME: Chlamydia re‐testing at 1‐4 months after a chlamydia infection. ; Patients will be asked if they have had a repeat test on an online questionnaire at 4‐5 months after initial diagnosis. Data linkage to patient medical records will also be undertaken. SECONDARY OUTCOME: Acceptability. ; Participants will be reminded by SMS at 4 and 5 months to undertake a survey online to assess the acceptability of the self‐collected samples and barriers to and preferences for re‐testing. Chlamydia re‐infection rate at re‐test ‐ discriminated using sexual behaviour data and chlamydia sequencing. ; ; For patients who have a repeat positive test, the baseline and re‐testing specimens for these patients will be transported to the Royal Women's Hospital for genotyping using OmpA typing and Mutliple locus sequence typing (MLST). ; ; Researchers will also send an SMS to the patients at 4 and 5 months to remind them to complete a quantitative survey online. The SMS will contain the name of the website and the participant's code which will be linked to their patient details captured at consent. The survey will investigate whether the patient and his or her partner/s were treated for chlamydia and sexual behaviour since the initial diagnosis. Organism load and serovar distribution of chlamydia infections. In addition to OmpA typing and mutliple locus sequence typing (MLST), organism load and betaglobin testing will be conducted on all baseline and positive retest samples. Samples will be coded with no identifying details. Persistent positivity at re‐rest. ; Chlamydia infection will be diagnosed by Nucleic Acid Amplification Tests (NAAT). PID incidence in women. ; At 4‐5 months the percentage of women diagnosed with PID will be calculated among those re‐tested and those not re‐tested. ; ; Women reporting pelvic or lower abdominal pain of less than 1 month duration on the online questionnaire will be contacted by the research team to explore in more detail the nature and duration of these and other relevant symptoms, in order to determine if the symptoms may indicate PID. ; ; Study nurses at the clinics will be asked to provide evidence of a diagnosis of PID for: ; 1. All women attending who indicate PID related symptoms on the questionnaire; and ; 2. Any other women who consented to the study who presented with PID symptoms or were given a PID diagnosis throughout the study period. ; ; If the woman attended another health care provider, her consent will be sought to request release of relevant medical records and a consent form will be sent to those who agree. ; ; 1. Probable case: ; Survey responses and medical records will be reviewed independently by two sexual health physicians (with review by a third where they disagree) and cases will be classified as probable, possible or not PID according to the following criteria: ; A clinical diagnosis of PID based on modified Hager's criteria‐ pelvic pain plus cervical motion tenderness and/or uterine and/or adnexal tenderness ; OR ; Laparoscopic abnormalities consistent with PID ; 2. Possible case: ; Abdominal/ pelvic pain with features of PID, but no record of cervical motion tenderness or uterine or adnexal tenderness ; 3. Cases will be classified as not PID when any subsequent diagnoses invalidate the diagnosis of PID 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.
Epistemonikos ID: ff79c3840739e2abab3953fefd659545190df5c3
First added on: Aug 22, 2024