What is the optimal time to retest patients with a urogenital chlamydia infection?

ISRCTN ISRCTN12159453
DOI https://doi.org/10.1186/ISRCTN12159453
Submission date
01/05/2017
Registration date
09/05/2017
Last edited
14/11/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Henry de Vries
Scientific

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

ORCiD logoORCID ID 0000-0001-9784-547X

Study information

Study designSingle-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Participant information sheet No participant information sheet available
Scientific titleWhat is the optimal time to retest patients with a urogenital chlamydia infection? A randomized controlled trial
Study objectivesThe 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(s)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)’.
Health condition(s) or problem(s) studiedUrogenital Chlamydia trachomatis infection
InterventionA 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/05/2012
Completion date01/04/2017

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants2500
Key inclusion criteria1. Heterosexual patients of the Amsterdam STI clinic testing positive for urogenital chlamydia
2. Aged 12 years or older
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/05/2012
Date of final enrolment01/03/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Sponsor information

Public Health Service
Government

Department of Infectious Diseases
Nieuwe Achtergracht 100
Amsterdam
1018 WT
Netherlands

Website ggd.amsterdam.nl
ROR logo "ROR" https://ror.org/042jn4x95

Funders

Funder type

Government

Public Health Service (GGD) Amsterdam

No information available

Results and Publications

Intention to publish date15/05/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Henry de Vries.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2018 Yes No

Editorial Notes

14/11/2017: Publication reference added.