An interventional study of 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 Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, sponsored by Nova Scotia Health Authority. Active, not recruiting at 5 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Screening
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
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.
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
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.
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.
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).
Time frame: Determined at the end of the implementation period (approximately 6 months).
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)
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Nova Scotia Health Authority