TelePharm PrEP/PEP

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment in 3 months

Conditions: HIV

Treatments: Other: Telehealth delivery of pharmacy PrEP/PEP; Other: Standard pharmacy PrEP/PEP delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07561658

R01MH140465 (U.S. NIH Grant/Contract)

RG1125680

Details and patient eligibility

About

In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers. The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.

Full description

Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support. The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.

Enrollment: 1,580 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Pharmacies

• Registered with the Pharmacy and Poisons Board (PPB)
• Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
• Must have a private room where HIV testing and PrEP/PEP counseling can occur
• >3 km from other study pharmacies
• Willing to participate in research activities, including 2-day training for pharmacy providers
• Willing to share pharmacy records with us
• Sells HIVST kits that are WHO certified.

Pharmacists/remote nurses

• ≥ 18 years old
• Licensed pharmacist, pharmaceutical technologist, or nurse
• Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
• Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
• Able and willing to provide informed consent

Clients

• ≥ 15 years old
• Interested in being screened for PrEP or PEP
• Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP/PEP safety
• Able and willing to provide informed consent

Exclusion criteria

Clients

• Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
• Currently enrolled in any other HIV vaccine or prevention trial
• Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,580 participants in 2 patient groups

Telehealth support

Experimental group

Description:

Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).

Treatment:

Other: Telehealth delivery of pharmacy PrEP/PEP

Standard delivery

Active Comparator group

Description:

Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).

Treatment:

Other: Standard pharmacy PrEP/PEP delivery