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BMC Infectious Diseases
Published in: BMC Infectious Diseases 1/2014

Open Access 01-12-2014 | Study protocol

Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests

Authors: Kirsty S Smith, Jane S Hocking, Marcus Chen, Christopher K Fairley, Anna McNulty, Phillip Read, Catriona S Bradshaw, Sepehr N Tabrizi, Handan Wand, Marion Saville, William Rawlinson, Suzanne M Garland, Basil Donovan, John M Kaldor, Rebecca Guy

Published in: BMC Infectious Diseases | Issue 1/2014

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Abstract

Background

Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups.

Methods/Design

The REACT (retest after Chlamydia trachomatis) trial involves 600 patients diagnosed with chlamydia: 200 MSM, 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice. Participants will be randomised to the home group (3-month SMS reminder and home-collection) or the clinic group (3-month SMS reminder to return to the clinic). Participants in the home group will be given the choice of attending the clinic if they prefer. The mailed home-collection kit includes a self-collected vaginal swab (women), UriSWAB (Copan) for urine collection (heterosexual men), and UriSWAB plus rectal swab (MSM). The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis, and the secondary outcomes are: the repeat positive test rate; the reinfection rate; the acceptability of home testing with SMS reminders; and the cost effectiveness of home testing. Sexual behaviour data collected via an online survey at 4-5 months, and genotyping of repeat infections, will be used to discriminate reinfections from treatment failures. The trial will be conducted over two years. An intention to treat analysis will be conducted.

Discussion

This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting, repeat infection and reinfection rates in three risk groups. The trial will determine client acceptability and cost effectiveness of this strategy.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12611000968​976.
Appendix
Available only for authorised users
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Metadata
Title
Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests
Authors
Kirsty S Smith
Jane S Hocking
Marcus Chen
Christopher K Fairley
Anna McNulty
Phillip Read
Catriona S Bradshaw
Sepehr N Tabrizi
Handan Wand
Marion Saville
William Rawlinson
Suzanne M Garland
Basil Donovan
John M Kaldor
Rebecca Guy
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Infectious Diseases / Issue 1/2014
Electronic ISSN: 1471-2334
DOI
https://doi.org/10.1186/1471-2334-14-223

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