Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Nova Scotia Health Authority (NSHA)

Status: Not yet enrolling

Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06234943

60370

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Participants requesting test(s) and treatment assessment for CT and NG infection

Other group

Description:

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.

Treatment:

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