ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1180-2947

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chlamydia

Gonorrhoea

Condition category

Condition code

Public Health

Health service research

Infection

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]

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]

Proportion of practice patients reporting at least one partner is notified.

Timepoint [1]

At follow-up phone contact by HA/nurse (within 1month of STI treatment)

Primary outcome [2]

Proportion of practice patients reporting at least one partner treated

Timepoint [2]

At follow-up phone contact by HA/nurse (within 1month of STI treatment)

Secondary outcome [1]

Proportion of practice patients with whom follow-up contact is made (process outcome)

Timepoint [1]

Within 1month of STI treatment

Secondary outcome [2]

Proportion of practice patients attending for test of reinfection

Timepoint [2]

Within 6 months of STI treatment - assessed via laboratory testing data obtained at the study conclusion.

Secondary outcome [3]

Proportion of practice patients with negative result on re-test (ie absence of reinfection)

Timepoint [3]

Within 6 months of STI treatment - assessed via laboratory testing data obtained at the study conclusion.

Secondary outcome [4]

Proportion of patients reporting all partners treated

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

4/07/2016

Actual

6/07/2016

Date of last participant enrolment

Anticipated

Actual

6/07/2016

Date of last data collection

Anticipated

1/09/2017

Actual

31/07/2017

Sample size

Target

250

Accrual to date

Final

287

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Lottery Health Research Grants Board

Address [1]

The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Istar Limited

Address [2]

8 Braithwaite Street

Karori

Wellington 6012

Country [2]

New Zealand

Funding source category [3]

University

Name [3]

University of Otago Dean's Grant

Address [3]

University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

09/03/2016

Approval date [1]

01/04/2016

Ethics approval number [1]

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

Dr Sally Rose

Address

Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64 4 918 6249

Fax

sally.rose@otago.ac.nz

Contact person for public queries

Name

Sally Rose

Address

Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64 4 918 6249

Fax

sally.rose@otago.ac.nz

Contact person for scientific queries

Name

Sally Rose

Address

Department of Primary Health Care & General Practice
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64 4 918 6249

Fax

sally.rose@otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clinician education, advice and SMS/text reminders improve test of reinfection rates following diagnosis of Chlamydia trachomatis or Neisseria gonorrhoeae: Before and after study in primary care.	2020	https://dx.doi.org/10.1136/bmjsrh-2018-200185

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically