Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Chlamydia Trachomatis Infection Clinical Trial

Official title:

Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234943
• Other study ID #: 60370
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Nova Scotia Health Authority
• Contact: Tasha D Ramsey, PharmD
• Phone: 902-473-6829
• Email: Tasha.Ramsey[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Communicable Diseases
• Gonorrhea
• Infections
• Neisseria Gonorrheae Infection

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).	Determined at the end of the implementation period (approximately 6 months).
Primary	Number and proportion of CT and NG tests, respectively, that have positive results.		Determined at the end of the implementation period (approximately 6 months).
Primary	Number and proportion of participants assessed and treated by a pharmacist.		Determined at the end of the implementation period (approximately 6 months)
Primary	Number and proportion of participants referred to a physician or clinic for care.		Determined at the end of the implementation period (approximately 6 months)