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Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06234943
Enrollment
100
Registered
2024-01-31
Start date
2024-07-31
Completion date
2025-09-30
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection

Keywords

pharmacists, self-swab, pharmacy-based testing, pharmacist prescribing

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.

Interventions

OTHERChlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection. Clinical assessment and prescribing of treatment for participants with positive test results

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.

Sponsors

Dalhousie University
CollaboratorOTHER
Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.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.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.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.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.Determined at the end of the implementation period (approximately 6 months).
Number and proportion of participants assessed and treated by a pharmacist.Determined at the end of the implementation period (approximately 6 months)
Number and proportion of participants referred to a physician or clinic for care.Determined at the end of the implementation period (approximately 6 months)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026