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Trial registered on ANZCTR


Registration number
ACTRN12611000968976
Ethics application status
Approved
Date submitted
24/08/2011
Date registered
9/09/2011
Date last updated
8/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of self-collection samples to increase chlamydia re-testing following a chlamydia diagnosis amongst clients attending two urban sexual health clinics.
Scientific title
Randomised controlled trial (RCT) of self-collection samples to increase chlamydia re-testing following a chlamydia diagnosis amongst clients attending two urban sexual health clinics.
Secondary ID [1] 262862 0
None
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia 270580 0
Condition category
Condition code
Infection 270746 270746 0 0
Sexually transmitted infections
Public Health 270907 270907 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 269209 0
Early detection / Screening
Intervention code [2] 269347 0
Diagnosis / Prognosis
Comparator / control treatment
Three months after the initial diagnosis, the clinic will send an SMS reminder to encourage the patient to return to the clinic for re-testing. This is standard of care at the two participating clinics. The dates will be set by clinic staff at the time of treatment.
Control group
Active

Outcomes
Primary outcome [1] 279444 0
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.
Timepoint [1] 279444 0
1-4 months after the initial diagnosis.
Secondary outcome [1] 287656 0
Persistent positivity at re-rest.
Chlamydia infection will be diagnosed by Nucleic Acid Amplification Tests (NAAT).
Timepoint [1] 287656 0
At time of re-test.
Secondary outcome [2] 287657 0
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.
Timepoint [2] 287657 0
At 4 to 5 months following initial diagnosis.
Secondary outcome [3] 287658 0
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.
Timepoint [3] 287658 0
At 4 to 5 months following initial diagnosis.
Secondary outcome [4] 287659 0
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.

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:
1. Probable case:
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
Timepoint [4] 287659 0
At 4 to 5 months following initial diagnosis.
Secondary outcome [5] 316761 0
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.
Timepoint [5] 316761 0
Following ITT analysis, using all samples collected between baseline and 5 months following initial diagnosis.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. All positive chlamydia results will be reviewed by the follow-up nurses at each of the clinics.
2. Among potentially eligible participants, the nurse will call the patient and let them know of the chlamydia diagnosis and for those not already treated, recommend they come to the clinic for treatment. During the call the nurse will give a brief overview of the trial and ask their permission to pass on their contact details to a member of the research team.
3. If the patient agrees, a member of the research team, will then contact the patient to go over the trial requirements and undertake a verbal consent process.
4. Once they have consent, the member of the research team will select an opaque randomisation envelope and inform the patient which group they are in— the home or clinic group and:
a. Obtain detailed contact information and confirm mobile phone number
b. Inform the clinic if the patient consented or not, and if randomised to the home or clinic group. This information will be recorded in the clinic database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomised to the intervention or control strategies using a minimisation approach. This will maximise the balance across risk groups (MSM, heterosexual men and women). Patients will be randomised at the Kirby Institute. Randomisation codes will be performed by the statistician at the Kirby Institute and will be conducted using sealed opaque envelopes containing computer generated randomisation numbers in blocks, stratified for risk group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 4468 0
3053
Recruitment postcode(s) [2] 9948 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 269676 0
Government body
Name [1] 269676 0
National Health and Medical Research Council
Address [1] 269676 0
GPO Box 1421
Canberra ACT 2601
Country [1] 269676 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Kirby Institute,
Wallace Wurth Building,
UNSW Australia
High Street, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 268771 0
None
Name [1] 268771 0
Address [1] 268771 0
Country [1] 268771 0
Other collaborator category [1] 252205 0
Other Collaborative groups
Name [1] 252205 0
Sydney Sexual Health Centre
Address [1] 252205 0
Sydney Hospital
PO Box 1614, Macquarie Street
Sydney 2001, NSW
Country [1] 252205 0
Australia
Other collaborator category [2] 252206 0
Other Collaborative groups
Name [2] 252206 0
Melbourne Sexual Health Centre
Address [2] 252206 0
580 Swanston St
Carlton 3053, Victoria
Country [2] 252206 0
Australia
Other collaborator category [3] 252207 0
Other Collaborative groups
Name [3] 252207 0
VCS Pathology
Address [3] 252207 0
265 Faraday St
Carlton 3053, Victoria
Country [3] 252207 0
Australia
Other collaborator category [4] 252208 0
Hospital
Name [4] 252208 0
The Royal Women's Hospital
Address [4] 252208 0
The Royal Women’s Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Locked Bag 300, Parkville, Victoria 3052
Country [4] 252208 0
Australia
Other collaborator category [5] 252209 0
Hospital
Name [5] 252209 0
Prince of Wales Hospital
Address [5] 252209 0
Serology and Virology Division, (SAViD) SEALS Microbiology, Prince of Wales Hospital,
Level 3, Clinical Sciences Building, High Street, Randwick NSW 2031,
Country [5] 252209 0
Australia
Other collaborator category [6] 252225 0
University
Name [6] 252225 0
University of Melbourne
Address [6] 252225 0
Melbourne School of Population and Global Health, 207 Bouverie Street,The University of Melbourne, Parkville 3010 VIC Australia
Country [6] 252225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271628 0
South Eastern Sydney & Illawarra Area Health Services Ethics Unit
Ethics committee address [1] 271628 0
Room G71, East Wing
Edmund Blacket Bldg
Prince of Wales Hospital
Cnr High and Avoca Streets
Randwick NSW 2031
Ethics committee country [1] 271628 0
Australia
Date submitted for ethics approval [1] 271628 0
Approval date [1] 271628 0
07/06/2011
Ethics approval number [1] 271628 0
1/10/0223
Ethics committee name [2] 271629 0
The Alfred Ethics Committee
Ethics committee address [2] 271629 0
Ground Floor, Linay Pavilion
The Alfred Hospital,
55 Commercial Road,
Melbourne, Victoria 3004
Ethics committee country [2] 271629 0
Australia
Date submitted for ethics approval [2] 271629 0
Approval date [2] 271629 0
02/06/2011
Ethics approval number [2] 271629 0
1/10/0407
Ethics committee name [3] 271630 0
University of NSW Ethics Committee
Ethics committee address [3] 271630 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [3] 271630 0
Australia
Date submitted for ethics approval [3] 271630 0
Approval date [3] 271630 0
15/06/2011
Ethics approval number [3] 271630 0
11243

Summary
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.
Trial website
www.reactstudy.net
Trial related presentations / publications
1. Smith KS, Hocking JS, Chen M, Fairley CK, McNulty A, Read P, Bradshaw CS, Tabrizi SN, Wand H, Saville M, Rawlinson W, Garland SM, Donovan B, Kaldor JM, Guy R. Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests. BMC Infect Dis. 2014;14:223.

2. Smith KS, Hocking JS, Chen M, Fairley CK, McNulty A, Read P, Bradshaw CS, Tabrizi SN, Wand H, Saville M, Rawlinson W, Garland SM, Donovan B, Kaldor JM, Guy RJ. Dual Intervention to Increase Chlamydia Retesting. Am J Prev Med. 2015;49(1):1–11.

3. Smith KS, Kaldor JM, Hocking JS, Jamil MS, McNulty A, Read P, Bradshaw CS, Chen M, Fairley CK, Wand H, Worthington K, Blake S, Knight V, Rawlinson W, Saville M, Tabrizi SN, Garland SM, Donovan B, Guy RJ. The acceptability and cost of a home-based chlamydia retesting strategy: findings from the REACT randomised controlled trial. BMC Public Health. 2016 Jan 28;16(1):83.

4. Smith KS, Guy R, Danielewski J, Tabrizi SN, Fairley CK, McNulty A, Rawlinson W, Saville M, Garland SM, Donovan B, Kaldor JM, Hocking JS. Biological and behavioural factors associated with positive chlamydia retests. This is a non-final version of an article published in final form in Sexually Transmitted Diseases. Sexually Transmitted Diseases. 2017; 44(7):417-422
Public notes

Contacts
Principal investigator
Name 33035 0
Prof Rebecca Guy
Address 33035 0
Kirby Institute,
Wallace Wurth Building,
UNSW Australia
High Street, Kensington NSW 2052
Country 33035 0
Australia
Phone 33035 0
+61 2 9385 0978
Fax 33035 0
Email 33035 0
rguy@kirby.unsw.edu.au
Contact person for public queries
Name 16282 0
Prof Rebecca Guy
Address 16282 0
Kirby Institute,
Wallace Wurth Building,
UNSW Australia
High Street, Kensington NSW 2052
Country 16282 0
Australia
Phone 16282 0
+61 2 9385 0900
Fax 16282 0
Email 16282 0
rguy@kirby.unsw.edu.au
Contact person for scientific queries
Name 7210 0
Prof Rebecca Guy
Address 7210 0
Kirby Institute,
Wallace Wurth Building,
UNSW Australia
High Street, Kensington NSW 2052
Country 7210 0
Australia
Phone 7210 0
+61 2 9385 0900
Fax 7210 0
Email 7210 0
rguy@kirby.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary