Chlamydia Trachomatis InfectionNCT06234943
Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia
A study testing Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results in people with Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, run by Nova Scotia Health Authority at 5 sites in Canada.
Trial summary
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the first and second most commonly reported sexually transmitted infections (STI) in Canada, respectively, and rates are increasing. While CT and NG can cause a variety of non-specific symptoms, an estimated 77% of CT and 45% of NG cases are asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
- What is being tested?
- Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 31 Jul 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Symptomatic
- Age less than 18 years
- Does not understand English
- Does not have a valid Nova Scotia health card
- Is not able to provide informed consent to participate in research
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Brookline Pharmacy
Bedford, Nova Scotia
Moffatt's Pharmacy
Dartmouth, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A6
Boyd's Pharmasave
Halifax, Nova Scotia
SRx Pharmacy
Halifax, Nova Scotia
About this study
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the first and second most commonly reported sexually transmitted infections (STI) in Canada, respectively, and rates are increasing. While CT and NG can cause a variety of non-specific symptoms, an estimated 77% of CT and 45% of NG cases are asymptomatic. Consequently, many individuals remain undiagnosed, or have delayed diagnosis and consequently miss effective and well-tolerated therapies and may transmit the infection(s) to sexual partners. Untreated CT infection may result in serious sequelae. Also, CT and NG infection are associated with increased risk of acquiring HIV and some cancers. Access to STI testing and treatment are two of the core pillars in the Pan-Canadian Sexually Transmitted and Blood Borne Infections (STBBI) Framework for Action. Currently many Canadians lack a primary care physician and many STI specific clinics are centered in urban areas, further challenging access in rural communities. Increasing access to these core pillars is paramount to reduce the health impact of STBBIs in Canada by 2030.
The purpose of this study is to implement and evaluate a novel pilot project including pharmacy-based CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, treatment, and linkage to care) by community pharmacists in Nova Scotia.
- Being tested
- Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results
- Keywords
- pharmacists, self-swab, pharmacy-based testing, pharmacist prescribing
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test resultsOther
Participants will be tested by self-swab sample (pharyngeal, vaginal or rectal) and/or urine sample (urogenital) for Chlamydia trachomatis and Neisseria gonorrhea. Selection of swab(s) or urine-based testing will be determined by the individual's sexual risk factors. Participants who have positive CT and/or NG test results will undergo clinical assessment of the CT and/or NG infection by the pharmacist and a prescription will be issued for treatment as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Participants requesting test(s) and treatment assessment for CT and NG infection | Other | Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) self-swab(s) and urine collection for asymptomatic testing by a pharmacist. Selection of swab(s) or urine-based testing will be determined by the individual's sexual risk factors. Participants who have positive CT and/or NG test results will undergo clinical assessment of the CT and/or NG infection by the pharmacist and prescription(s) will be issued for treatment as appropriate. Receives: Other: Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who accessed CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, and treatment) by community pharmacists in Nova Scotia.
Measured: Determined at the end of the implementation period (approximately 6 months).
Participant satisfaction with a pharmacy-based CT and NG management program via electronic questionnaires underpinned by the Theoretical Framework of Acceptability.
Measured: Determined at the end of the implementation period (approximately 6 months).
Participant satisfaction with a pharmacy-based CT and NG management program via optional interviews.
Measured: Determined at the end of the implementation period (approximately 6 months).
Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire.
Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire (e.g., race, sexuality, gender identity, disability status, past/current injection drug use, geographical location, socioeconomic status, employment status, sexually transmitted infection risk factors).
Measured: Determined at the end of the implementation period (approximately 6 months).
Number and proportion of CT and NG tests, respectively, that have positive results.
Measured: Determined at the end of the implementation period (approximately 6 months).
Number and proportion of participants assessed and treated by a pharmacist.
Measured: Determined at the end of the implementation period (approximately 6 months)
Number and proportion of participants referred to a physician or clinic for care.
Measured: Determined at the end of the implementation period (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start31 Jul 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia Trachomatis InfectionStudies 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Tasha Ramsey, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234943
- Sponsor's protocol ID
- 60370
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia
- ClinicalTrials.gov ID
- NCT06234943
- Acronym / sponsor ID
- 60370
- Keywords
- pharmacists, self-swab, pharmacy-based testing, pharmacist prescribing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- 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.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the first and second most commonly reported sexually transmitted infections (STI) in Canada, respectively, and rates are increasing. While CT and NG can cause a variety of non-specific symptoms, an estimated 77% of CT and 45% of NG cases are asymptomatic. Consequently, many individuals remain undiagnosed, or have delayed diagnosis and consequently miss effective and well-tolerated therapies and may transmit the infection(s) to sexual partners. Untreated CT infection may result in serious sequelae. Also, CT and NG infection are associated with increased risk of acquiring HIV and some cancers. Access to STI testing and treatment are two of the core pillars in the Pan-Canadian Sexually Transmitted and Blood Borne Infections (STBBI) Framework for Action. Currently many Canadians lack a primary care physician and many STI specific clinics are centered in urban areas, further challenging access in rural communities. Increasing access to these core pillars is paramount to reduce the health impact of STBBIs in Canada by 2030.
The purpose of this study is to implement and evaluate a novel pilot project including pharmacy-based CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, treatment, and linkage to care) by community pharmacists in Nova Scotia.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants requesting test(s) and treatment assessment for CT and NG infection | Other | Other: Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test resultsChlamydia trachomatis (CT) and Neisseria gonorrhea (NG) self-swab(s) and urine collection for asymptomatic testing by a pharmacist. Selection of swab(s) or urine-based testing will be determined by the individual's sexual risk factors. Participants who have positive CT and/or NG test results will undergo clinical assessment of the CT and/or NG infection by the pharmacist and prescription(s) will be issued for treatment as appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Symptomatic
- Age less than 18 years
- Does not understand English
- Does not have a valid Nova Scotia health card
- Is not able to provide informed consent to participate in research
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 |
|---|---|---|
| Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test resultsParticipants will be tested by self-swab sample (pharyngeal, vaginal or rectal) and/or urine sample (urogenital) for Chlamydia trachomatis and Neisseria gonorrhea. Selection of swab(s) or urine-based testing will be determined by the individual's sexual risk factors. Participants who have positive CT and/or NG test results will undergo clinical assessment of the CT and/or NG infection by the pharmacist and a prescription will be issued for treatment as appropriate. | Other | Participants requesting test(s) and treatment assessment for CT and NG infection |
Primary outcome
Number of patients who accessed CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, and treatment) by community pharmacists in Nova Scotia.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Participant satisfaction with a pharmacy-based CT and NG management program via electronic questionnaires underpinned by the Theoretical Framework of Acceptability.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Participant satisfaction with a pharmacy-based CT and NG management program via optional interviews.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire (e.g., race, sexuality, gender identity, disability status, past/current injection drug use, geographical location, socioeconomic status, employment status, sexually transmitted infection risk factors).
Number and proportion of CT and NG tests, respectively, that have positive results.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Number and proportion of participants assessed and treated by a pharmacist.
Time frame: Determined at the end of the implementation period (approximately 6 months)
Number and proportion of participants referred to a physician or clinic for care.
Time frame: Determined at the end of the implementation period (approximately 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results in people with Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, run by Nova Scotia Health Authority at 5 sites in Canada.
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 0 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients who accessed CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, and treatment) by community pharmacists in Nova Scotia. (time frame: Determined at the end of the implementation period (approximately 6 months).). The study lists 7 primary outcomes in all. 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 20 Jan 2025.