Study protocol

Community-based trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial

Pippa Oakeshott¹ , Sally Kerry¹ , Helen Atherton² , Adamma Aghaizu¹ , Sima Hay³ , David Taylor-Robinson⁴ , Ian Simms⁵ and Phillip Hay⁶

¹  Division of Community Health Sciences, St George's, University of London, London, SW17 0RE, UK

²  Department of Primary Care and Social Medicine, Imperial College, London, W2 1NY, UK

³  Department of Health and Social Care Research, Kings College London, London, SE1 8WA, UK

⁴  Department of Genitourinary Medicine and Communicable Diseases, Imperial College School of Medicine, St Mary's, London, W2 1NY, UK

⁵  Health Protection Agency, Centre for Infections, London, NW9 5EQ, UK

⁶  Department of Genitourinary Medicine, St George's Hospital, London, SW17 0RE, UK

author email corresponding author email

Trials 2008, 9:73doi:10.1186/1745-6215-9-73

Published:	10 December 2008

Abstract

Background

Pelvic inflammatory disease (PID) is common and can lead to tubal factor infertility, ectopic pregnancy or chronic pelvic pain. Despite major UK government investment in the National Chlamydia Screening Programme, evidence of benefit remains controversial. The main aim of this trial was to investigate whether screening and treatment of chlamydial infection reduced the incidence of PID over 12 months. Secondary aims were to conduct exploratory studies of the role of bacterial vaginosis (BV) in the development of PID and of the natural history of chlamydial infection.

Design

Randomised controlled trial with follow up after 12 months.

Setting non-healthcare

Common rooms and lecture theatres at 20 universities and further education colleges in Greater London.

Participants

2500 sexually active female students were asked to complete a questionnaire on sexual health and provide self-administered vaginal swabs and smears.

Intervention

Vaginal swabs from intervention women were tested for chlamydia by polymerase chain reaction (PCR) and those infected referred for treatment. Vaginal swabs from control women were stored and analysed after a year. Vaginal smears were Gram stained and analysed for BV.

Main outcome measure

Incidence of clinical PID over 12 months in intervention and control groups. Possible cases of PID will be identified from questionnaires and record searches. Confirmation of the diagnosis will be done by detailed review of medical records by three independent researchers blind to whether the woman is in intervention or control group.

Trial registration

Clinical Trials NCT 00115388