Condition category
Infections and Infestations
Date applied
01/05/2017
Date assigned
09/05/2017
Last edited
14/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chlamydia is a common sexually transmitted infection. The current guidelines recommend testing again after a chlamydia infection, but the best timing is not known. The aim of this study is to find the best time to retest after chlamydia treatment.

Who can participate?
Heterosexual patients of the Amsterdam STI clinic with a chlamydia infection, aged 12 or older

What does the study involve?
After being diagnosed and treated, participants are randomly allocated to be offered a retest either 8, 16 or 26 weeks later. Participants can choose to do this at home and send a self-collected sample by mail, or at the clinic. The number and percentage of participants retested and chlamydia infection rates are assessed up to 35 weeks later.

What are the possible benefits and risks of participating?
The benefit for the participant is that chlamydia re-infections are diagnosed and treated. There are no risks involved in participation.

Where is the study run from?
Public Health Service (GGD) Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
May 2012 to April 2017

Who is funding the study?
Public Health Service (GGD) Amsterdam (Netherlands)

Who is the main contact?
Prof. Henry de Vries

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henry de Vries

ORCID ID

http://orcid.org/0000-0001-9784-547X

Contact details

Public Health Service
Department of Infectious Diseases
Nieuwe Achtergracht 100
Amsterdam
1018WT
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

What is the optimal time to retest patients with a urogenital chlamydia infection? A randomized controlled trial

Acronym

Study hypothesis

The trialists postulated that in heterosexual visitors of the STI clinic with a urogenital chlamydia infection, the proportion being retested would be lower with a later timing of retest, and that the proportion positive would be higher with a later timing of retest. If so, the trialists envisioned an optimum timing to offer a retest, which would provide the highest yield of diagnosed reinfections.

Ethics approval

The study was reviewed by the ethics committee of the Academic Medical Center, University of Amsterdam, Netherlands. The board exempted the study from a full review and written patient consent as it was a modification of current practice and did not apply to the Dutch law ‘Medical Research Involving Human Subjects Act (WMO)’.

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Urogenital Chlamydia trachomatis infection

Intervention

A single-centre randomized controlled trial among urogenital chlamydia nucleic acid amplification test positive heterosexual Amsterdam STI clinic clients. After treatment, patients were randomly assigned for retesting 8, 16 or 26 weeks later. Patients could choose to do this at home (and send a self-collected sample by mail), or at the clinic. Retest uptake and chlamydia positivity at follow-up were calculated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. The number and percentage of participants retested up to 35 weeks after inclusion
2. The proportion of participants who were CT positive, measured by nucleic acid amplification test, up to 35 weeks after inclusion

Secondary outcome measures

1. The number, percentage and chlamydia positivity proportion of participants who:
1.1. Returned more than 1 week before the assigned date
1.2. Returned at assigned date (this was defined as a visit in the period >1 week before, until 6 weeks after the assigned date)
1.3. Returned >6 weeks after the assigned date but no later than 35 weeks (8 months) after inclusion
1.4. Those who did not return within 35 weeks of inclusion

Overall trial start date

01/05/2012

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Heterosexual patients of the Amsterdam STI clinic testing positive for urogenital chlamydia
2. Aged 12 years or older

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

2500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2012

Recruitment end date

01/03/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Public Health Service (GGD) Amsterdam
STI outpatient clinic Department of Infectious Diseases Weesperplein 1
Amsterdam
1018 WT
Netherlands

Sponsor information

Organisation

Public Health Service

Sponsor details

Department of Infectious Diseases
Nieuwe Achtergracht 100
Amsterdam
1018 WT
Netherlands

Sponsor type

Government

Website

ggd.amsterdam.nl

Funders

Funder type

Government

Funder name

Public Health Service (GGD) Amsterdam

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists have presented the preliminary results during two scientific meetings, in 2013 during the international society for STD Research (ISSTDR) meeting in Vienna, Austria, and in 2014 during the International Society for Human Chlamydia Infection (ISHCI) meeting in Monterrey, CA, USA. Currently they are submitting the definite results to a scientific peer reviewed journal.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Henry de Vries.

Intention to publish date

15/05/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: http://journals.lww.com/stdjournal/Abstract/publishahead/What_Is_the_Optimal_Time_to_Retest_Patients_With_a.98398.aspx

Publication citations

Additional files

Editorial Notes

14/11/2017: Publication reference added.