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Trial registered on ANZCTR


Registration number
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ACTRN12626001172392p
Ethics application status
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Submitted, not yet approved
Date submitted
Help: Date submitted
22/08/2026
Date registered
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21/09/2026
Date last updated
Help: Date last updated
21/09/2026
Date data sharing statement initially provided
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21/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Integrated point-of-care testing for multiple sexually transmitted infections to enable same-visit treatment among priority populations: a pilot implementation study
Scientific title
Integrated point-of-care testing for multiple sexually transmitted infections and same-visit treatment among priority populations: a pilot implementation study
Additional trial identifiers [1] 318358 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Sexually transmitted infection 343312 0
Condition category
Condition code
Infection 339425 339425 0 0
Sexually transmitted infections
Inflammatory and Immune System 339426 339426 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
1. What is the intervention?
The intervention is an integrated, clinic-based multi-STI point-of-care (POC) testing model. Participants receive rapid finger-prick POC testing for HIV and syphilis and molecular POC testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), with molecular POC testing for Mycoplasma genitalium (MG) performed where clinically indicated.

For HIV and syphilis, capillary blood is obtained by finger-prick and tested using a rapid POC assay. Results are available within approximately 20 minutes.

For CT and NG, specimens are collected according to the anatomical site being tested and may include first-void urine or vaginal, cervical, urethral, rectal or pharyngeal swabs, as clinically indicated. The specimen is prepared in the specified collection medium and a small volume is transferred into a single-use cobas Liat assay tube. The tube is inserted into the cobas Liat analyser, which automatically performs sample preparation, nucleic-acid extraction, amplification using real-time polymerase chain reaction (PCR), and detection of CT and NG genetic targets. Results are available in approximately 20 minutes.

MG POC testing is performed where clinically indicated using an appropriate clinical specimen, such as urine or a genital swab, according to the presenting symptoms and anatomical site being assessed. The specimen is processed using the molecular POC platform, which performs automated nucleic-acid amplification and detection of MG. Results are available during the same clinic visit, in approximately 20 minutes.

Routine laboratory testing is performed in parallel as specified in the study protocol. Participants with a positive CT, NG and/or MG POC result may commence appropriate treatment during the same clinic visit where clinically indicated.

2. Who delivers it and their relevant expertise?

The intervention is delivered by trained clinical staff, principally a registered nurse from Melbourne Sexual Health Centre (MSHC) providing sexual health services at ACCESS Health. The nurse undertakes clinical assessment, specimen collection, POC testing, result delivery, treatment, documentation and follow-up within her scope of practice. The study is supported by investigators with expertise in sexual health, STI clinical management and diagnostic testing, with technical support for the POC platforms provided by Burnet Institute and Roche Diagnostics Australia.

3. How is it delivered?

The intervention is delivered face-to-face and individually during the participant's clinic visit. Following clinical assessment and informed consent, eligible participants undergo specimen collection and POC testing in a designated private clinic area. Results are communicated confidentially during the same visit, with counselling, clinical assessment, treatment or referral provided where indicated.

4. How often and for how long?

The intervention is delivered during a single clinic visit rather than as a series of scheduled sessions. POC testing, result delivery and, where appropriate, treatment are intended to occur during that visit. Participants may subsequently receive routine follow-up, confirmatory testing or additional treatment where clinically required. The protocol does not specify a fixed duration for each individual clinic visit.

5. Where is it delivered?

The intervention is delivered at the ACCESS Health clinic in designated clinical areas that support confidential consultation, specimen collection, testing, result delivery, counselling and treatment. Routine laboratory specimens are transported to MSHC for parallel laboratory testing.

6. Adherence

As this is a single-visit diagnostic and treatment intervention, conventional adherence strategies such as appointment reminders or repeated-session monitoring are not applicable. Completion of the intended testing pathway will be monitored through study and clinical records, including tests offered and completed, POC result delivery, invalid or inconclusive tests, same-visit treatment, referrals and follow-up. Participants may decline any test or research procedure without affecting their usual care.
Intervention code [1] 335144 0
Early detection / Screening
Intervention code [2] 335324 0
Diagnosis / Prognosis
Description of the comparator or control
Routine laboratory-based STI testing will serve as the within-participant comparator to the point-of-care (POC) testing intervention. All participants will continue to undergo routine laboratory testing as part of the existing standard-of-care pathway, and, where the same infection is tested using both methods, each participant’s routine laboratory result will be compared with their corresponding POC result to assess diagnostic agreement. Routine laboratory testing does not involve allocation to a separate study arm; rather, POC and routine testing are performed in parallel within the same participant.

For routine HIV and syphilis testing, venous blood is collected by venepuncture for conventional laboratory serology. For chlamydia and gonorrhoea, matched routine specimens are collected according to clinical indication and anatomical exposure and may include first-pass urine and vaginal, rectal or pharyngeal swabs; an additional urethral swab is collected for Neisseria gonorrhoeae culture where clinically indicated in participants with urethral discharge. Participants undergoing POC Mycoplasma genitalium testing also undergo parallel routine laboratory Mycoplasma genitalium testing.

Specimens for routine laboratory testing are collected during the same index clinic visit at Access Health and transported to Melbourne Sexual Health Centre for processing. POC results are communicated to participants during the clinic visit, whereas routine laboratory results are available subsequently after laboratory processing and are reviewed through the Clinical Patient Management System. Participants who require further clinical review, additional or modified treatment, confirmatory testing or follow-up based on the routine laboratory result are subsequently contacted and managed according to usual Melbourne Sexual Health Centre clinical practice. Therefore, routine laboratory results are not expected to be available during the same visit as the POC results.
Control group
Active

Outcomes
Primary outcome [1] 346639 0
Composite primary outcome: Proportion of participants with at least one positive chlamydia (CT), gonorrhoea (NG) and/or Mycoplasma genitalium (MG) point-of-care (POC) result, for whom treatment is clinically indicated, who commence appropriate treatment during the same clinic visit.
Timepoint [1] 346639 0
Assessed during the index clinic visit after receipt of the POC test result and completion of clinical assessment.
Secondary outcome [1] 466834 0
1. Reach: Proportion of eligible participants who are offered POC testing.
Timepoint [1] 466834 0
Assessed during the index clinic visit at the time testing is offered.
Secondary outcome [2] 467436 0
2. Uptake: Proportion of eligible participants offered POC testing who accept POC testing.
Timepoint [2] 467436 0
Assessed during the index clinic visit when the participant accepts or declines POC testing.
Secondary outcome [3] 467437 0
3. Completion of POC testing: Proportion of participants who accept POC testing who complete the POC tests indicated for them according to the study testing pathway.
Timepoint [3] 467437 0
Assessed during the index clinic visit following completion of POC testing.
Secondary outcome [4] 467438 0
4. Venepuncture-related non-participation: Number and proportion of otherwise potentially eligible participants who do not proceed with the study POC testing pathway because the required venous blood specimen cannot be obtained.
Timepoint [4] 467438 0
Assessed during the index clinic visit following attempted venepuncture.
Secondary outcome [5] 467439 0
5. HIV POC reactivity: Number and proportion of participants undergoing HIV POC testing who have a reactive HIV POC result.
Timepoint [5] 467439 0
Assessed during the index clinic visit following completion of HIV POC testing.
Secondary outcome [6] 467440 0
6. Syphilis POC reactivity: Number and proportion of participants undergoing syphilis POC testing who have a reactive syphilis POC result.
Timepoint [6] 467440 0
Assessed during the index clinic visit following completion of syphilis POC testing.
Secondary outcome [7] 467441 0
7. CT POC positivity: Number and proportion of participants undergoing CT POC testing who have a positive CT POC result.
Timepoint [7] 467441 0
Assessed during the index clinic visit following completion of CT POC testing.
Secondary outcome [8] 467442 0
8. NG POC positivity: Number and proportion of participants undergoing NG POC testing who have a positive NG POC result.
Timepoint [8] 467442 0
Assessed during the index clinic visit following completion of NG POC testing.
Secondary outcome [9] 467443 0
9. MG POC positivity: Number and proportion of participants undergoing clinically indicated MG POC testing who have a positive MG POC result.
Timepoint [9] 467443 0
Assessed during the index clinic visit following completion of MG POC testing.
Secondary outcome [10] 467444 0
10. Same-visit POC result delivery: Proportion of participants completing POC testing who receive their POC result(s) during the same clinic visit.
Timepoint [10] 467444 0
Assessed during the index clinic visit before the participant leaves Access Health.
Secondary outcome [11] 467445 0
11. Subsequent treatment when same-visit treatment is not provided: Among participants for whom treatment is clinically indicated but is not commenced during the index clinic visit, proportion who subsequently commence appropriate treatment.
Timepoint [11] 467445 0
Assessed after the index clinic visit once routine laboratory results and clinically indicated follow-up have been completed.
Secondary outcome [12] 467446 0
12. Time from specimen collection to result delivery: Time from specimen collection to communication of the test result to the participant.
Timepoint [12] 467446 0
Measured from specimen collection until result delivery.
Secondary outcome [13] 467447 0
13. Time from specimen collection to treatment: Among participants for whom treatment is clinically indicated, time from specimen collection to commencement of appropriate treatment.
Timepoint [13] 467447 0
Measured from specimen collection until treatment commencement.
Secondary outcome [14] 467448 0
14. HIV confirmatory testing: Proportion of participants with a reactive HIV POC result who complete confirmatory laboratory HIV testing.
Timepoint [14] 467448 0
Assessed following the index clinic visit once confirmatory laboratory testing has been completed.
Secondary outcome [15] 467449 0
15. Referral to HIV care: Among participants with laboratory-confirmed HIV infection, proportion successfully referred to an appropriate HIV care service.
Timepoint [15] 467449 0
Assessed following laboratory confirmation of HIV and completion of the referral process.
Secondary outcome [16] 467450 0
16. CT diagnostic agreement: Agreement between CT POC and routine laboratory test results among participants with paired CT results.
Timepoint [16] 467450 0
Assessed after the corresponding routine laboratory CT result is available and reconciled with the POC result.
Secondary outcome [17] 467453 0
17. NG diagnostic agreement: Agreement between NG POC and routine laboratory test results among participants with paired NG results.
Timepoint [17] 467453 0
Assessed after the corresponding routine laboratory NG result is available and reconciled with the POC result.
Secondary outcome [18] 467456 0
18. MG diagnostic agreement: Agreement between MG POC and routine laboratory test results among participants with paired MG results.
Timepoint [18] 467456 0
Assessed after the corresponding routine laboratory MG result is available and reconciled with the POC result.
Secondary outcome [19] 467457 0
19. HIV diagnostic agreement: Agreement between HIV POC and routine laboratory test results among participants with paired HIV results.
Timepoint [19] 467457 0
Assessed after the corresponding routine laboratory HIV result is available and reconciled with the POC result.
Secondary outcome [20] 467458 0
20. Syphilis diagnostic agreement: Agreement between syphilis POC and routine laboratory test results among participants with paired syphilis results.
Timepoint [20] 467458 0
Assessed after the corresponding routine laboratory syphilis result is available and reconciled with the POC result.
Secondary outcome [21] 467459 0
21. Participant acceptability: Participant-reported acceptability of the integrated POC STI testing service.
Timepoint [21] 467459 0
Assessed once immediately following completion of POC testing, result delivery and treatment or referral where indicated, before the participant leaves Access Health
Secondary outcome [22] 467928 0
22. Participant experience: Participant-reported experience of the integrated POC STI testing service.
Timepoint [22] 467928 0
Assessed once immediately following completion of POC testing, result delivery and treatment or referral where indicated, before the participant leaves Access Health
Secondary outcome [23] 467929 0
23. Provider-reported feasibility: Provider-reported feasibility of implementing the integrated POC STI testing model in routine clinical practice.
Timepoint [23] 467929 0
After staff have gained experience delivering the POC testing model, during or following the implementation period.
Secondary outcome [24] 467930 0
24. Provider-reported acceptability
Timepoint [24] 467930 0
After staff have gained experience delivering the POC testing model, during or following the implementation period.
Secondary outcome [25] 467931 0
25. Barriers to implementation
Timepoint [25] 467931 0
During or following the implementation period, after staff have experience with the model.
Secondary outcome [26] 467932 0
26. Facilitators to implementation
Timepoint [26] 467932 0
During or following the implementation period, after staff have experience with the model.
Secondary outcome [27] 467933 0
27. Perceived sustainability
Timepoint [27] 467933 0
Towards the end of, or following, the implementation period.
Secondary outcome [28] 467934 0
28. Cost per participant tested
Timepoint [28] 467934 0
Calculated at the end of the implementation period using accumulated study resource-use and cost data.
Secondary outcome [29] 467935 0
29. Cost per infection detected
Timepoint [29] 467935 0
Calculated at the end of the implementation period.
Secondary outcome [30] 467936 0
30. Cost per infection treated
Timepoint [30] 467936 0
Calculated at the end of the implementation period.
Secondary outcome [31] 467937 0
31. Incremental costs and outcomes
Timepoint [31] 467937 0
Calculated at the end of the implementation period, once all relevant cost and outcome data are available.

Eligibility
Key inclusion criteria
Participant/ Service users
- Aged 18 years or older.
- Attending the Access Health clinic.
- Willing to consider STI testing.
- Able to provide informed consent.
- Able to provide the required specimens, including successful venepuncture for parallel routine laboratory HIV and syphilis serology.
- Priority populations include people experiencing homelessness, people who inject drugs, people engaged in sex work, and other individuals who experience barriers to accessing conventional sexual health care.

For staff/service providers, the inclusion criteria are: aged 18 years or older; involved in Access Health clinic services, sexual health care, community engagement or implementation; and able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participant/service users
- Unable or unwilling to provide informed consent.
- Unable to provide the venous blood specimen required for parallel routine laboratory HIV and syphilis serology, including unsuccessful venepuncture.

For the staff/service-provider interview group, the exclusion criterion is simply unable or unwilling to provide informed consent.

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot implementation study, the sample size is pragmatic and based on expected attendance at the Access Health clinic, service capacity, test availability and available funding. A target of approximately 120 service-user participants is considered sufficient to estimate key feasibility and implementation proportions and to identify major workflow and implementation issues. The number of participants with positive CT, NG or MG POC results is expected to be substantially smaller than the total sample; therefore, estimates of same-visit treatment and diagnostic performance will be considered descriptive and exploratory and reported with 95% confidence intervals. The study is not powered to detect small between-group differences or to establish definitive clinical effectiveness. Approximately five staff and service providers will also be interviewed, with recruitment aiming to capture relevant diversity in clinical and operational roles and continuing if additional perspectives are required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 46453 0
3182 - St Kilda

Funding & Sponsors
Funding source category [1] 322804 0
Government body
Name [1] 322804 0
Bayside Health
Country [1] 322804 0
Australia
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Australia
Secondary sponsor category [1] 325942 0
None
Name [1] 325942 0
Address [1] 325942 0
Country [1] 325942 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321245 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 321245 0
Ethics committee country [1] 321245 0
Australia
Date submitted for ethics approval [1] 321245 0
24/08/2026
Approval date [1] 321245 0
Ethics approval number [1] 321245 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153130 0
Prof Jason Ong
Address 153130 0
Melbourne Sexual Health Centre, 580 Swanston St, Carlton VIC 3053
Country 153130 0
Australia
Phone 153130 0
+61 3 9341 6241
Fax 153130 0
Email 153130 0
[email protected]
Contact person for public queries
Name 153131 0
Dr. Sally Zhang
Address 153131 0
Melbourne Sexual Health Centre, 580 Swanston St, Carlton VIC 3053
Country 153131 0
Australia
Phone 153131 0
+61 3 9341 6200
Fax 153131 0
Email 153131 0
[email protected]
Contact person for scientific queries
Name 153132 0
Dr. Sally Zhang
Address 153132 0
Melbourne Sexual Health Centre, 580 Swanston St, Carlton VIC 3053
Country 153132 0
Australia
Phone 153132 0
+61 03 9341 6200
Fax 153132 0
Email 153132 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.