Pharmacy-Based Testing and Treatment for Chlamydia and Gonorrhea

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to simplify testing and treatment for chlamydia and gonorrhea, two common sexually transmitted infections (STIs) in Canada. The study explores pharmacy-based testing, where individuals can collect their own samples, such as swabs or urine, with guidance from a pharmacist. Those who test positive will receive an assessment and, if necessary, a prescription for treatment from the pharmacist. This trial targets individuals in Nova Scotia who are asymptomatic, possess a valid health card, and can communicate in English. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions in the community.

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 prior data suggests that this pharmacy-based testing and treatment method is safe?

Research has shown that collecting personal samples, such as urine or swabs, for chlamydia and gonorrhea testing is generally safe and well-accepted. Studies indicate that these self-collection methods not only work but also enhance the process of checking for sexually transmitted infections (STIs). The process is typically easy and harmless. Additionally, using self-collected samples in pharmacies has proven to be a promising way to increase access to STI testing, especially for those who might not visit a clinic. Research has not identified any major safety concerns with this method, making it a reliable option for testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new approach to testing and treating chlamydia and gonorrhea because it makes testing more accessible. Unlike the standard practice where testing requires a visit to a doctor's office or clinic, this method allows individuals to get tested by a pharmacist using self-swabs or urine samples at a pharmacy. This not only makes it easier for people to get tested, especially those who are asymptomatic, but also speeds up the process of getting prescriptions if treatment is needed. Ultimately, this could lead to earlier detection and treatment of infections, reducing their spread and improving public health outcomes.

What evidence suggests that this pharmacy-based testing and treatment is effective for Chlamydia and Gonorrhea?

This trial will evaluate the effectiveness of self-swab and urine collection methods for testing Chlamydia and Gonorrhea in a pharmacy setting. Studies have shown that people can collect their own samples to test for these infections as effectively as healthcare professionals. Research indicates that self-swabs or urine samples can accurately detect these infections, making them reliable testing methods. For instance, women using self-collected vaginal swabs can detect Chlamydia as accurately as when a doctor collects the sample. Many women prefer these self-collection methods, which might encourage more people to get tested. Overall, offering self-collection options can make testing more accessible and help catch these infections early. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1544319125006521

Implementation of community pharmacy-based testing and ... Of the participants tested, 17% had positive test results; 14% had chlamydia and 3% gonorrhea infections. All participants with positive test ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06234943

Pharmacy-based Testing and Treatment for Gonorrhea ... 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 [ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11404247/

At-home specimen self-collection as an additional testing ... Offering self-collection of specimens at home or in other non-clinical settings could be used as an additional strategy to increase sexually transmitted ...

4. withpower.com withpower.com/trial/phase-gonorrhea-2024-4c109

Pharmacy-Based Testing and Treatment for Chlamydia ... Research shows that self-obtained vaginal swabs are as effective as clinician-taken samples for detecting Chlamydia trachomatis, and they are preferred by women ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3097250/

Home versus clinic-based specimen collection for Chlamydia ... Home-based screening with self-collected urine or vaginal specimens is a highly feasible and acceptable method, and shows promise in improving STI screening ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1544319125006521/pdf?md5=1e4c1913094fedd4a2bdf347d48d3f85&pid=1-s2.0-S1544319125006521-main.pdf

Journal Pre-proof Pharmacists offered chlamydia and gonorrhea testing using patient self-collected swabs and first- catch urine. Specimens were tested at the Central Zone ...

7. japha.org japha.org/article/S1544-3191(23)00352-7/fulltext

Pharmacy-based sexually transmitted infection service ... Research on pharmacy-based STI services includes predominately small-scale, cross-sectional studies, and focuses on chlamydia screening.