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NCT Number: NCT06234943

Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brookline Pharmacy, Bedford, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Characteristics of clients accessing the pharmacy-based CT and NG management program using an electronic questionnaire.

    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 (e.g., race, sexuality, gender identity, disability status, past/current injection drug use, geographical location, socioeconomic status, employment status, sexually transmitted infection risk factors).

  5. 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).

  6. Number and proportion of participants assessed and treated by a pharmacist.

    Time frame: Determined at the end of the implementation period (approximately 6 months)

  7. 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)

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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