The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000837426
Ethics application status
Approved
Date submitted
21/06/2016
Date registered
27/06/2016
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to facilitate partner notification and rescreening for sexually transmitted infections (STIs) in primary care.
Scientific title
Pilot Study: Facilitating partner notification and rescreening for STIs diagnosed in primary care
Secondary ID [1] 289504 0
None
Universal Trial Number (UTN)
U1111-1180-2947
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia 299206 0
Gonorrhoea 299207 0
Condition category
Condition code
Public Health 299214 299214 0 0
Health service research
Infection 299255 299255 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This health service delivery intervention is offered to all patients diagnosed with Chlamydia/Gonorrhoea at the practice. Practices rather than patients are the study participants. We are trialling 2 models:

Model 1. Health advisor assisted partner notification - partner notification discussed in clinic as per usual care (varies from clinician to clinician, visit duration variable 10-20minutes). Patient is then referred to specialist sexual health advisor (HA) for phone follow-up at 1week post-treatment. 1-week call by HA: to check on treatment compliance and partner notification (with further advice and assistance provided as needed) - approx duration of call 10minutes.

Model 2. Training for practice team members to facilitate partner notification processes in the practice. Two team members attend 2.5hr partner notification training session provided by specialist sexual health advisor, sexual health clinician and research team members.

Partner notification is delivered by the practice nurse who received PN training where possible or by the clinician at the treatment consultation as per usual care (varies from clinician to clinician, visit duration 10-20minutes). Follow-up phone call 1-week post-treatment by practice nurse who received PN training to check on treatment compliance and partner notification (with further advice and assistance provided as needed) - approx duration of call 10minutes

The partner notification training workshop will be run as a small-group session led by a sexual health advisor and clinical nurse specialist from the local sexual health service. Content will be drawn from local and international best practice guidelines (eg NZ Sexual Health Society, Australasian ASHM, British BASHH guidelines and US CDC and public health approaches to notifiable diseases which include gonorrhoea and chlamydia). The workshop will cover rationale for notifying partners and returning for test of reinfection, how to initiate discussion about partner notification, patient and provider-led approaches, risk reduction advice, phone follow-up to check progress and offer further assistance, with role-play used to simulate patient-provider discussion.

Both models:
Clinician asked to offer newly developed partner notification information sheet for patients and partners.
Reminder text message sent at 2-2.5mths post treatment to recall patients for a 3mth test of reinfection.
Intervention code [1] 295095 0
Other interventions
Comparator / control treatment
Baseline data were collected via clinical notes review at participating practices to assess current practice related to partner notification. Data collected for 40 patients per practice who were diagnosed with chlamydia/gonorrhoea in past 2yrs. Data collection took place Nov2015-March 2016
Control group
Historical

Outcomes
Primary outcome [1] 298692 0
Proportion of practice patients reporting at least one partner is notified.
Timepoint [1] 298692 0
At follow-up phone contact by HA/nurse (within 1month of STI treatment)
Primary outcome [2] 298693 0
Proportion of practice patients reporting at least one partner treated
Timepoint [2] 298693 0
At follow-up phone contact by HA/nurse (within 1month of STI treatment)
Secondary outcome [1] 324976 0
Proportion of practice patients with whom follow-up contact is made (process outcome)
Timepoint [1] 324976 0
Within 1month of STI treatment
Secondary outcome [2] 324977 0
Proportion of practice patients attending for test of reinfection
Timepoint [2] 324977 0
Within 6 months of STI treatment - assessed via laboratory testing data obtained at the study conclusion.
Secondary outcome [3] 324978 0
Proportion of practice patients with negative result on re-test (ie absence of reinfection)
Timepoint [3] 324978 0
Within 6 months of STI treatment - assessed via laboratory testing data obtained at the study conclusion.
Secondary outcome [4] 325029 0
Proportion of patients reporting all partners treated
Timepoint [4] 325029 0
At follow-up phone contact by HA/nurse (within 1month of STI treatment)

Eligibility
Key inclusion criteria
Primary care practices diagnosing at least 50 cases of chlamydia or gonorrhoea annually.
Not currently undertaking partner notification for all STI cases.

Practices rather than their patients are the participants in this pilot study.
All patients diagnosed with chlamydia or gonorrhoea at participating practices during the study period will be included in data collection.

Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to trial new approaches to partner notification.
Practices rather than their patients are the participants in this study so there are no relevant exclusion criteria for patients.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Between group comparison on primary and secondary outcome measures. As this is a pilot study we will be reviewing the processes as well as potential for differences in clinical outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7976 0
New Zealand
State/province [1] 7976 0
Wellington

Funding & Sponsors
Funding source category [1] 293877 0
Government body
Name [1] 293877 0
Lottery Health Research Grants Board
Address [1] 293877 0
The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011
Country [1] 293877 0
New Zealand
Funding source category [2] 296561 0
Charities/Societies/Foundations
Name [2] 296561 0
Istar Limited
Address [2] 296561 0
8 Braithwaite Street

Karori

Wellington 6012
Country [2] 296561 0
New Zealand
Funding source category [3] 296626 0
University
Name [3] 296626 0
University of Otago Dean's Grant
Address [3] 296626 0
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country [3] 296626 0
New Zealand
Primary sponsor type
Individual
Name
Dr Sally Rose
Address
Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country
New Zealand
Secondary sponsor category [1] 292706 0
None
Name [1] 292706 0
Address [1] 292706 0
Country [1] 292706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295295 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 295295 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 295295 0
New Zealand
Date submitted for ethics approval [1] 295295 0
09/03/2016
Approval date [1] 295295 0
01/04/2016
Ethics approval number [1] 295295 0
16/CEN/38

Summary
Brief summary
Background: A significant gap exists between recommended and actual management of patients diagnosed with sexually transmitted infections (STIs) in primary care. Guidelines recommend that partner notification and testing for reinfection 3months post-treatment should be routinely undertaken for patients diagnosed with STIs. These processes are important to interrupt STI transmission, reduce reinfection and the health consequences of untreated infection, but for a range of reasons do not always occur.
Study aim: This pilot intervention study will trial new strategies designed to improve partner notification outcomes including reinfection rates for patients at participating practices.
Design: Primary care practices will trial one of two models of health service delivery. Model 1: Three practices will work with a specialist sexual health advisor to ensure patients receive information about, and follow-up on partner notification. Model 2: Three practices will provide patients with information about, and follow-up on partner notification once key team members have received partner notification training from the specialist sexual health advisor. Both groups will be asked to offer new partner notification information sheets for patients and their partners and will trial the use of a text message reminder to recall patients for a 3month test of reinfection.
Measures: Between group comparison of the proportions of patients who report having notified at least one partner/sexual contact; and proportions of patients who report at least one partner/sexual contact has been treated. Proportions of patients in both groups returning for a 3-month test of reinfection will be compared with baseline data collected prior to the intervention.
Comment: This pilot study is not powered to detect significant differences in clinical outcomes. We are testing new health service delivery processes that if acceptable to providers, and suggestive of improved patient outcomes could be integrated into routine patient care, and/or tested further in an adequately powered intervention study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66806 0
Dr Sally Rose
Address 66806 0
Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 66806 0
New Zealand
Phone 66806 0
+64 4 918 6249
Fax 66806 0
Email 66806 0
sally.rose@otago.ac.nz
Contact person for public queries
Name 66807 0
Dr Sally Rose
Address 66807 0
Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 66807 0
New Zealand
Phone 66807 0
+64 4 918 6249
Fax 66807 0
Email 66807 0
sally.rose@otago.ac.nz
Contact person for scientific queries
Name 66808 0
Dr Sally Rose
Address 66808 0
Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 66808 0
New Zealand
Phone 66808 0
+64 4 918 6249
Fax 66808 0
Email 66808 0
sally.rose@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary