Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

NCT06234943 | Active Not Recruiting

• 1 other identifier: 60370
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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).

• 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)

Study Arms (1)

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

OTHER

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (5)

Brookline Pharmacy

Bedford, Nova Scotia, Canada

Location

Moffatt's Pharmacy

Dartmouth, Nova Scotia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A6, Canada

Location

Boyd's Pharmasave

Halifax, Nova Scotia, Canada

Location

SRx Pharmacy

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Therapeutics and Prophylactics Lead: Emerging and Re-Emerging Infections

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 31, 2024
• Study Start: July 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CA (5)