One-Step PrEP

Seattle, USA

The One-Step PrEP program provides access to pre-exposure prophylaxis (PrEP) through a pharmacist-managed PrEP clinic located in a community pharmacy. Use of the model resulted in high PrEP initiation rates.

Program description

This pharmacist-managed HIV PrEP clinic is located in Seattle, Washington, at an independent pharmacy. The One-Step PrEP team consisted of clinical pharmacists who initiated and managed PrEP distribution, as well as ancillary pharmacy staff who assisted with administrative and pharmacy tasks (e.g., processing prescriptions, scheduling appointments).

The program required a collaborative drug therapy agreement (CDTA) to establish a relationship between pharmacists and a medical director (an HIV specialist physician in this case). The CDTA allowed pharmacists to take on certain roles that are normally out of their scope of practice. Pharmacists received training through six self-directed modules that included information on Center for Disease Control and Prevention (CDC) PrEP guidelines, clinical trials, testing and treatment approaches, sexual history taking and risk-reduction counselling. Competency training occurred at regular intervals. Pharmacists also participated in ongoing training through case reviews.

Clients were referred to the program through local community-based agencies and local public health departments. A marketing plan was implemented to assist with recruitment. Once referred, clients received an initial consultation with a pharmacist where their medical and sexual histories were obtained and lab testing occurred as per the CDC guidelines. If clients were HIV negative and qualified for PrEP, they were offered PrEP for 30 days dispensed through the clinic (clients could also choose to have PrEP dispensed through a pharmacy of their choice) and were enrolled in the automatic refill option. Clients also received:

  • counselling from the pharmacist on PrEP side effects and adherence
  • referrals to mental health and substance use programs, as required
  • coordination of insurance, as required
  • 30-minute follow-up appointments with pharmacists in the clinic where all regular testing was performed including HIV and sexually transmitted infection (STI) testing at one month and then every three months (phone call, text message and email reminders were used)
  • treatment for STIs when diagnosed
  • counselling on behavioural risk reduction

Clients were referred to their primary care doctor or the medical director for concerns outside of the pharmacists’ scope of practice under the CDTA. If clients did not have a primary care physician, they were required to obtain one within one year of starting the program.

If clients presented to the PrEP program and had a preliminary HIV positive test they were immediately referred to the medical director.


Between March 2015 and February 2018, 714 clients were evaluated in the pharmacist-managed PrEP clinic and 695 (97%) initiated PrEP. Of those who initiated PrEP:

  • the mean age was approximately 35 years
  • 99% were cisgender male
  • the primary indication for PrEP was high-risk sexual behaviour in men who have sex with men
  • 74% started the medication the same day

Three hundred and seventy-two clients remained active at the pharmacist-managed clinic as of February 2018; 11% of them had started PrEP use at the clinic, briefly discontinued it and then returned. Of the 323 clients who discontinued services and did not return, 34% transferred care and were linked to a primary care provider, 41% were lost to follow-up, 11% relocated and 12% had decreased perceived risk. There were no HIV seroconversions in clients who were engaged in the program. One client tested positive for HIV after having been lost to the program for three months.

STI testing was an important component of the program. Results show that 207 STIs were diagnosed in 135 clients, including 104 cases of chlamydia and 66 cases of gonorrhea. The majority of the chlamydia and gonorrhea cases were detected through rectal screening.

What does this mean for service providers?

The One-Step PrEP program demonstrates a way to increase PrEP access through use of a pharmacist-managed clinic, which could increase access for people who do not access health services in traditional settings or where PrEP access is limited. The scope of practice of pharmacists, including prescribing abilities, would need to be considered in other jurisdictions.

Delivery of this program in the pharmacist-managed clinic required the development of detailed testing procedures, and the pharmacists needed to obtain phlebotomy certification to perform the needed blood draws. The pharmacy also needed to have the ability to send tests to outside labs. Detailed procedures would need to be established in any pharmacy looking to create a similar program.

Related resources

Text Message Reminders – Case Study

Making the Links Program – Case Study


Tung EL, Thomas A, Eichner A et al. Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care. Sexual Health. 2018;15:556-61.