ChlamydiaNCT01596946
Home-sampling in Partner Notification of Chlamydia
A study testing Contact tracing mode test at clinic and Self-sampling at home - Sent Test Kit in people with Chlamydia, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial summary
Though partner notification is mandatory to perform of Chlamydia trachomatis infected individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chlamydia
- What is being tested?
- Contact tracing mode test at clinic and Self-sampling at home - Sent Test Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sexual Partners to chlamydia infected index patients accepting to participate in the study.
Who cannot join
- Index patients not living in Sweden or not speaking Swedish.
- MSM.
- Sexual partners living in another county or abroad.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.
Though partner notification is mandatory to perform of Chlamydia trachomatis infected individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission. The investigators wanted to determine whether there was any difference in time between home-sampling and clinical testing as a tool of partner notification measured from eliciting of partners to date of testing.
- Conditions
- Chlamydia
- Being tested
- Contact tracing mode test at clinic, Self-sampling at home - Sent Test Kit
- Keywords
- contact tracing, home sampling, cluster randomisation
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact tracing mode test at clinicBehavioural
Self-sampling at home - Sent Test KitBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Contact tracing mode test at clinic | Active comparator | Conventional mode of contact tracing where the partners were asked by either the index patient or demanded by the counsellor to attend a clinic for C. trachomatis testing. The date of testing for chlamydia of the study subject i e a sexual partner to a chlamydia infected index patient was noted. Those partners being C trachomatis positive were referred to the STD-clinic for contact tracing and following the same study arm a the index patient. Receives: Behavioral: Contact tracing mode test at clinic |
| Self-sampling at home | Experimental | The intervention: Self-sampling of sexual partners to infected index patient for chlamydia by urine test or vaginal sampling at home. They sent the kit tube to a microbiological laboratorium for analysis. The test kit was sent by post by the counsellor at the STD-clinic or distributed via the index patient. The partner in this arm was informed about the test result from the STD-clinic and those tested C trachomatis positive were given an appointment for treating and contact tracing as soon as possible. Their partners were not randomised but following the same mode. The days from the counselling conversation with the index patient to the date of testing was measured and compared with partners tested following arm 1 mode. Receives: Behavioral: Self-sampling at home - Sent Test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners, if sexual partners had attended a clinic for testing or had the opportunity of home-sampling.
Measured: 60 days or more were defined as an exclusion criterion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startNov 2006
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Responsible party
- Principal investigator, Lars Falk, Ostergotland County Council, Sweden
- Investigators
- Lars Falk, MD PhD, Principal investigator, Östergötland CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596946
- Sponsor's protocol ID
- Forss8743, LiO 201 261
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01596946
- Acronym / sponsor ID
- Forss8743, LiO 201 261
- Conditions
- Chlamydia
- Keywords
- contact tracing, home sampling, cluster randomisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Study start
- Nov 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Though partner notification is mandatory to perform of Chlamydia trachomatis infected individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission. The investigators wanted to determine whether there was any difference in time between home-sampling and clinical testing as a tool of partner notification measured from eliciting of partners to date of testing.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact tracing mode test at clinic | Active comparator | Behavioral: Contact tracing mode test at clinicConventional mode of contact tracing where the partners were asked by either the index patient or demanded by the counsellor to attend a clinic for C. trachomatis testing. The date of testing for chlamydia of the study subject i e a sexual partner to a chlamydia infected index patient was noted. Those partners being C trachomatis positive were referred to the STD-clinic for contact tracing and following the same study arm a the index patient. |
| Self-sampling at home | Experimental | Behavioral: Self-sampling at home - Sent Test KitThe intervention: Self-sampling of sexual partners to infected index patient for chlamydia by urine test or vaginal sampling at home. They sent the kit tube to a microbiological laboratorium for analysis. The test kit was sent by post by the counsellor at the STD-clinic or distributed via the index patient. The partner in this arm was informed about the test result from the STD-clinic and those tested C trachomatis positive were given an appointment for treating and contact tracing as soon as possible. Their partners were not randomised but following the same mode. The days from the counselling conversation with the index patient to the date of testing was measured and compared with partners tested following arm 1 mode. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Sexual Partners to chlamydia infected index patients accepting to participate in the study.
Key exclusion criteria (3 listed)
- Index patients not living in Sweden or not speaking Swedish.
- MSM.
- Sexual partners living in another county or abroad.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contact tracing mode test at clinic | Behavioural | Contact tracing mode test at clinic |
| Self-sampling at home - Sent Test Kit | Behavioural | Self-sampling at home |
Primary outcome
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners
Time frame: 60 days or more were defined as an exclusion criterion
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners, if sexual partners had attended a clinic for testing or had the opportunity of home-sampling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Falk, MD PhD principal investigator
Östergötland CC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact tracing mode test at clinic and Self-sampling at home - Sent Test Kit in people with Chlamydia, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners (time frame: 60 days or more were defined as an exclusion criterion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.