A randomised trial of rapid point-of-care tests for chlamydia and gonorrhoea infections in remote Aboriginal communities.

Research Program

Project Funding

NHMRC Project Grant

Date Commenced:

05/2011

Project Status

Ongoing

Expected Date of Completion:

12/2014

Currently recruiting

About the Project

Rationale

Rates of sexually transmissible infections (STIs) in remote Aboriginal communities are among the highest in the world. Bacterial STIs are important causes of ill health, can be personally distressing and are associated with stigma. These infections can have serious clinical consequences such as pelvic inflammatory disease (PID), infertility and systemic disease and place a substantial burden on health services. STIs can also increase an individual’s susceptibility to transmitting and acquiring HIV infection.

In order to interrupt disease transmission in populations at higher risk of chlamydia and gonorrhoea, it is essential to make a diagnosis and undertake treatment as early as possible in people who have infection. Without treatment, infection with chlamydia can persist for many months. Timely diagnosis also enables potentially infected sex partners to be identified through partner notification strategies, and treated.

Because of the rarity of symptoms and the inherent delays in the majority of cases that are asymptomatic and therefore depend on a laboratory finding to initiate treatment, currently available diagnostic strategies for chlamydia and gonorrhoea are not ideal in remote settings. A potential solution to this problem is the use of rapid point-of-care tests that can provide an immediate result in field settings, thereby allowing clinical services to offer treatment and begin the process of partner notification at the time when the specimen is taken.

Aims

To measure the effectiveness, cost-effectiveness and acceptability of rapid point-of-care testing for chlamydia and gonorrhoea infections in remote Aboriginal communities.

Design & Method

The study will employ a cross-over randomised trial design. A total of ten health services in Queensland and Western Australia will be recruited to participate in the trial. Each clinic will undertake the clinical management of chlamydia and gonorrhoea under two different modalities for one year each, in a randomly assigned order. In the first year, half of the health services will be randomly assigned to manage these infections under current guidelines, and the other half will supplement standard guidelines with rapid point-of-care testing, such that treatment is offered at the time of diagnosis for those found to be positive by the rapid test. In the second year, the clinics will cross over to the opposite management modality. The study will require four years to complete, including 12 months preparation, two years for the intervention and 12 months for analysis and reporting.

Progress/Update

Consultation, protocol development, and ethical approval is underway

Benefits

Current strategies for diagnosing and treating bacterial STIs have had limited success in decreasing community level prevalence of chlamydia and gonorrhoea. Rapid point-of-care tests are available but not used because there is uncertainty about their overall benefit and clinical acceptability. The results of this definitive, randomised trial will provide crucial information to guide sexual health clinical practice in remote Aboriginal communities. If successful, the trial will provide clear evidence that rapid point-of-care tests are capable of improving the timelines of treatment and decreasing re-infection rates. Mathematical modelling and health economic analyses can then be used to make the case for large scale implementation of this technology

Output

Two to three manuscripts expected

Collaborating Centres

Melbourne Sexual Health Centre

School of Population Health, University of Melbourne

Royal Women’s Hospital, Melbourne

Queensland Children's Medical Research Institute

Other Investigators

Dr David Whiley, Professor Christopher Fairley, A/Prof Sepehr Tabrizi

Project Members