Pharmacy-Based Testing and Treatment for Chlamydia and Gonorrhea

Recruiting at 4 trial locations

Overseen By Tasha D Ramsey, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Symptomatic, Age < 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on individual treatment needs

100 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the idea that Pharmacy-Based Testing and Treatment for Chlamydia and Gonorrhea is an effective treatment?

The available research shows that self-obtained vaginal swabs are as effective as samples taken by a doctor for detecting Chlamydia, and they are more effective than urine samples. This suggests that self-swabbing, which is part of pharmacy-based testing, is a reliable method. Additionally, the use of self-administered swabs is preferred by many women, which could lead to increased testing rates. The research also indicates that expedited treatment through pharmacies is feasible, making it a practical option for treating Chlamydia. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment involving self-swabs and urine collection for Chlamydia trachomatis and Neisseria gonorrhea?

Research shows that self-obtained vaginal swabs are as effective as clinician-taken samples for detecting Chlamydia trachomatis, and they are preferred by women. This suggests that self-swabs and urine collection could be effective for testing and treating these infections. ^{1 2 3 4 5}

What safety data exists for pharmacy-based testing and treatment for chlamydia and gonorrhea?

The available research indicates that self-collection of samples for STI testing, including chlamydia and gonorrhea, is generally acceptable and feasible. Studies show that self-collection at pharmacies and at home is well-received, with many participants feeling comfortable with the process. The COVID-19 pandemic has accelerated the demand for at-home self-collection and telemedicine services, highlighting the benefits of increased access, convenience, and privacy. However, challenges remain, such as regulatory approval and ensuring that target populations are effectively reached. Overall, the approach is seen as a promising way to enhance screening and treatment access. ^{6 7 8 9 10}

Is self-collection of samples for chlamydia and gonorrhea testing safe?

Research shows that self-collection of samples, like urine or vaginal swabs, for chlamydia and gonorrhea testing is generally safe and acceptable to participants. These methods have been used in various studies and are considered feasible, with many people feeling comfortable using them. ^{6 7 8 9 10}

Is the self-swab or urine collection treatment for Chlamydia and Gonorrhea promising?

Yes, the self-swab or urine collection treatment is promising because it makes testing more accessible by allowing people to collect samples at home or in pharmacies, which can be more convenient and less intimidating than visiting a clinic. This approach can help reach more people, especially in areas where traditional health services are over-stretched, and it can also be cost-effective in preventing complications from these infections. ^{5 11 12 13 14}

How is the pharmacy-based testing and treatment for Chlamydia and Gonorrhea different from other treatments?

This treatment is unique because it allows individuals to collect their own samples, such as self-swabs or urine, and submit them at a community pharmacy, which can improve access due to longer opening hours and convenient locations. This approach can make testing and treatment more accessible compared to traditional sexual health services, which may be over-stretched. ^{5 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals in Nova Scotia who may have been exposed to sexually transmitted infections, specifically gonorrhea and chlamydia. It's designed to help those without a primary care physician or who live far from urban STI clinics. The study aims to make testing and treatment more accessible.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing and Assessment

Participants undergo self-swab and urine collection for asymptomatic testing by a pharmacist. Positive results lead to clinical assessment and prescription issuance.

6 months

Ongoing visits as needed for testing and assessment

Treatment

Participants with positive test results receive appropriate treatment prescriptions from pharmacists.

Varies based on individual treatment needs

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Chlamydia trachomatis and Neisseria gonorrhea self-swab(s) and/or urine collection

Trial Overview The trial is evaluating a new approach where community pharmacists in Nova Scotia manage the testing (self-swab or urine collection) and treatment of gonorrhea and chlamydia. This includes clinical assessment and prescribing medication if tests come back positive.

Participant Groups

Group I: Participants requesting test(s) and treatment assessment for CT and NG infection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Findings from Research

New Zealand women at high risk for sexually transmitted infections prefer self-taken vaginal swabs for STI testing over clinician-taken samples, indicating a strong preference for self-collection methods.

Self-obtained vaginal swabs have been shown to be equally effective as clinician-taken samples in detecting STIs, particularly Chlamydia trachomatis, suggesting they should be widely available for testing in New Zealand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-obtained vaginal swabs for PCR chlamydia testing: a practical alternative. Rose, SB., Lawton, BA., Bromhead, C., et al.[2009]

In a study of 541 young women, vulval swabs and urine samples were found to be as effective as traditional cervix samples for detecting Chlamydia, with a high sensitivity of 100% for all methods.

The overall prevalence of Chlamydia infection was 4.1%, indicating that self-administered sampling methods like vulval swabs and urine could increase testing rates among young women without compromising accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection of chlamydia trachomatis in urine, vulval and cervical swabs]. Bakken, IJ., Bratt, H., Skjeldestad, FE., et al.[2008]

New self-testing technology for chlamydia and gonorrhea could significantly increase screening rates, which is crucial for early detection and treatment of these infections.

The introduction of self-tests will require new strategies for managing positive results, including patient follow-up and partner treatment, as well as innovative surveillance methods to track infections outside of traditional laboratory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing for the Chlamydia and Gonorrhea Self-Test. Peterman, TA., Kreisel, K., Habel, MA., et al.[2020]

Self-administered vaginal swabs (SAS) for detecting Chlamydia trachomatis were found to be a feasible alternative to urine samples, with a sensitivity of 81.1% and specificity of 98.6% based on a study of 1,382 female Army recruits.

While most participants felt comfortable using both methods, a higher percentage preferred urine collection over SAS, indicating that while SAS is acceptable, urine remains the more favored option for future use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference among female Army recruits for use of self-administrated vaginal swabs or urine to screen for Chlamydia trachomatis genital infections. Hsieh, YH., Howell, MR., Gaydos, JC., et al.[2015]

Using paper treatment vouchers for expedited treatment of patients with uncomplicated Chlamydia trachomatis is a practical approach that can be implemented in community pharmacies.

This method allows for quicker access to treatment, potentially improving patient outcomes and reducing the spread of the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An audit of expedited treatment for uncomplicated Chlamydia trachomatis index cases at the community pharmacy. McClure, KS., Cameron, ST.[2018]

A study involving 777 women showed that 40.3% were willing to self-collect vaginal swabs at a pharmacy for STI screening, indicating a feasible method to increase testing rates.

The prevalence of STIs among participants was 3.9%, and the majority of women (63%) felt comfortable with the self-collection process, suggesting that pharmacy clinics could be effective venues for STI screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of recruiting women to collect a self-administered vaginal swab at a pharmacy clinic for sexually transmissible infection screening. Gaydos, CA., Barnes, M., Holden, J., et al.[2021]

The COVID-19 pandemic has led to a significant reduction in STI testing, highlighting the need for at-home self-testing and specimen self-collection, particularly for STIs like syphilis, gonorrhea, and chlamydia.

Telemedicine has emerged as a solution, allowing patients to receive self-collection kits at home, which they can send to labs for testing, although challenges remain in terms of cost, regulatory approval, and ensuring access for those most in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-Home Specimen Self-Collection and Self-Testing for Sexually Transmitted Infection Screening Demand Accelerated by the COVID-19 Pandemic: a Review of Laboratory Implementation Issues. Kersh, EN., Shukla, M., Raphael, BH., et al.[2022]

A study involving 88 participants assigned female at birth found that 69% preferred at-home self-collection for gonorrhea and chlamydia screening, indicating a strong acceptance of this method to improve access to STI testing.

However, preferences for at-home screening were lower among individuals with lower educational attainment, lack of insurance, or unemployment, highlighting the need to address social determinants of health to effectively increase STI screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-Home Self-Collection of Urine or Vaginal Samples for Gonorrhea and Chlamydia Screening Among Young People Who Were Assigned Female at Birth. Chongsuwat, T., Cody, PJ.[2023]

Molecular diagnostic tests that utilize urine or self-collected swabs can enhance screening for sexually transmitted infections (STIs) like gonorrhea, chlamydia, trichomoniasis, and Mycoplasma genitalium.

These tests are not only faster and more sensitive but also more acceptable to patients, potentially leading to quicker diagnoses and treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STI update: Testing, treatment, and emerging threats. Hlatshwayo, M., Reno, HEL., Yarbrough, ML.[2020]

The study found that self-collected urine samples for chlamydia testing were generally acceptable to at-risk young people, with 413 testing kits requested, but only 195 samples (47.2%) were returned, indicating challenges in sample collection methods.

The positive rate for chlamydia among the returned samples was 3.1%, suggesting that while the outreach and online engagement were effective in raising awareness, the drop-off method for sample collection was not well received by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The C-project: use of self-collection kits to screen for Chlamydia trachomatis in young people in a community-based health promotion project. Martin, L., Freedman, E., Burton, L., et al.[2018]

A pilot study in three community pharmacies in London showed that offering chlamydia testing and treatment is feasible and well-accepted, with 83 tests conducted and a 9.5% positivity rate for Chlamydia trachomatis.

The service particularly improved access for young women, with 16% of clients stating they would not have been tested otherwise, although confidentiality concerns and pharmacist availability were noted as areas for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlamydia testing in community pharmacies: evaluation of a feasibility pilot in south east London. Baraitser, P., Pearce, V., Holmes, J., et al.[2022]

A pilot program in a high-prevalence area for Chlamydia trachomatis (CT) successfully identified a 9% positivity rate among women aged 15-29, with a higher rate of 14% in those aged 15-24, indicating a significant presence of the infection in this demographic.

Despite the program's potential, participation was low at 27%, highlighting the need for improved outreach and collaboration between pharmacies, healthcare providers, and community organizations to enhance case detection and treatment of CT infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of a pharmacy-based screening programme for Chlamydia trachomatis in a high-risk health centre population in Amsterdam using mailed home-collected urine samples. van Bergen, JE., Postma, MJ., Peerbooms, PG., et al.[2022]

A survey of 2887 patients at STI clinics revealed that most participants (58%) preferred to wait for a doctor rather than use self-obtained vaginal swabs or first-catch urine samples for Chlamydia and Gonorrhea screening.

Despite the option for self-collection being available, only 46% of patients preferred to self-collect a sample if the clinic was busy, indicating a need for better education on self-collection practices to increase acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening methods for Chlamydia trachomatis and Neisseria gonorrhoeae infections in sexually transmitted infection clinics: what do patients prefer? Howard, EJ., Xu, F., Taylor, SN., et al.[2015]

The study found that urethral swabs for Chlamydia trachomatis detection using the Pharmacia EIA test had a sensitivity of 100% and specificity of 95%, indicating they are highly reliable for diagnosing the infection.

Urine samples, while positive in 24% of cases where urethral swabs were positive, were not sufficient to replace urethral swabs for accurate laboratory diagnosis of Chlamydia, highlighting the importance of using the more reliable swab method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urine and the laboratory diagnosis of Chlamydia trachomatis in males. Kok, TW., Payne, LE., Bailey, SE., et al.[2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Self-obtained vaginal swabs for PCR chlamydia testing: a practical alternative. [2009]

2. Norway pubmed.ncbi.nlm.nih.gov

[Detection of chlamydia trachomatis in urine, vulval and cervical swabs]. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Preparing for the Chlamydia and Gonorrhea Self-Test. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Preference among female Army recruits for use of self-administrated vaginal swabs or urine to screen for Chlamydia trachomatis genital infections. [2015]

5. England pubmed.ncbi.nlm.nih.gov

An audit of expedited treatment for uncomplicated Chlamydia trachomatis index cases at the community pharmacy. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of recruiting women to collect a self-administered vaginal swab at a pharmacy clinic for sexually transmissible infection screening. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

At-Home Specimen Self-Collection and Self-Testing for Sexually Transmitted Infection Screening Demand Accelerated by the COVID-19 Pandemic: a Review of Laboratory Implementation Issues. [2022]

8. England pubmed.ncbi.nlm.nih.gov

At-Home Self-Collection of Urine or Vaginal Samples for Gonorrhea and Chlamydia Screening Among Young People Who Were Assigned Female at Birth. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

STI update: Testing, treatment, and emerging threats. [2020]

10. Australia pubmed.ncbi.nlm.nih.gov

The C-project: use of self-collection kits to screen for Chlamydia trachomatis in young people in a community-based health promotion project. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Chlamydia testing in community pharmacies: evaluation of a feasibility pilot in south east London. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of a pharmacy-based screening programme for Chlamydia trachomatis in a high-risk health centre population in Amsterdam using mailed home-collected urine samples. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Screening methods for Chlamydia trachomatis and Neisseria gonorrhoeae infections in sexually transmitted infection clinics: what do patients prefer? [2015]

14. England pubmed.ncbi.nlm.nih.gov

Urine and the laboratory diagnosis of Chlamydia trachomatis in males. [2019]