Clinical trial NCT06234943: Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia
Official title: Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Neisseria Gonorrheae Infection
Keywords: pharmacists
self-swab
pharmacy-based testing
pharmacist prescribing
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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. 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.


Eligibility criteria: Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Participant satisfaction with a pharmacy-based CT and NG management program via electronic questionnaires underpinned by the Theoretical Framework of Acceptability.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Participant satisfaction with a pharmacy-based CT and NG management program via optional interviews.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Number and proportion of CT and NG tests, respectively, that have positive results.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Number and proportion of participants assessed and treated by a pharmacist.
timeFrame: Determined at the end of the implementation period (approximately 6 months)
measure: Number and proportion of participants referred to a physician or clinic for care.
timeFrame: Determined at the end of the implementation period (approximately 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: Canada
facility: Brookline Pharmacy
state: Nova Scotia
city: Dartmouth
country: Canada
facility: Moffatt's Pharmacy
state: Nova Scotia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Boyd's Pharmasave
state: Nova Scotia
city: Halifax
country: Canada
facility: SRx Pharmacy
state: Nova Scotia
Study officials:
References: