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Open Access 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

Kirsty S Smith1*, Jane S Hocking2, Marcus Chen23, Christopher K Fairley23, Anna McNulty45, Phillip Read14, Catriona S Bradshaw23, Sepehr N Tabrizi10789, Handan Wand1, Marion Saville6, William Rawlinson11, Suzanne M Garland10789, Basil Donovan14, John M Kaldor1 and Rebecca Guy1

Author Affiliations

1 Kirby Institute, University of New South Wales, Sydney, NSW, Australia

2 Melbourne School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia

3 Melbourne Sexual Health Centre, Carlton, Victoria, Australia

4 Sydney Sexual Health Centre, Sydney, NSW, Australia

5 School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia

6 VCS Pathology, Carlton, Victoria, Australia

7 Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia

8 Department of Microbiology, Royal Children’s Hospital, Parkville, Victoria, Australia

9 Department of Microbiology and Infectious Diseases, Royal Women’s Hospital, Parkville, Victoria, Australia

10 Murdoch Childrens Research Institute, Parkville, Victoria, Australia

11 Virology Division, SEALS Microbiology, Prince of Wales Hospital, Randwick, NSW, Australia

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BMC Infectious Diseases 2014, 14:223  doi:10.1186/1471-2334-14-223

Published: 24 April 2014

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 ACTRN12611000968976.

Keywords:
Chlamydia; Retesting; Positivity; Reinfection; Home-collection