HIV
Conditions
Keywords
Kenya, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), Pharmacy
Brief summary
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.
Detailed 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.
Interventions
OTHERStandard pharmacy PrEP/PEP delivery
Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.
OTHERTelehealth delivery of pharmacy PrEP/PEP
Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP. SMS support from remote nurses available between pharmacy visits.
Sponsors
Fred Hutchinson Cancer Center
Kenya Medical Research Institute
ClickMedix LLC
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP/PEP initiation | 18 months post implementation | Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period |
| PrEP/PEP continuation | 18 months post implementation | Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation | 18 months post implementation | Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period |
| PEP initiation | 18 months post implementation | Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period |
| PrEP/PEP use | 1.5 and 6 months from initiation | Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period |
| PrEP use | 1.5 and 6 months from initiation | Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period |
| PEP use | 1.5 and 6 months from initiation | Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period |
| PrEP refill | 18 months post implementation | Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP |
| Repeat PEP | 18 months post implementation | Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP |
| PEP-to-PrEP | 18 months post implementation | Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period |
| Engaged with 1+ product | 18 months post implementation | Pharmacy-level; count outcome: # of unique clients that were dispensed more than one HIV prevention product (oral PrEP, injectable PrEP, PEP, etc) over the implementation period |
| On-demand PrEP use | 6 months from initiation | Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period |
| PEP-in-Pocket use | 6 months from initiation | Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period |
| Product choice | 18 months post implementation | Individual-level; binary outcome: % of total PrEP/PEP clients that were dispensed each type of product (e.g., oral PrEP, on- demand PrEP, PEP, DVR, etc). |
| PrEP adherence | 1.5 months from initiation | Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS |
| Reach | 18 months post implementation | Individual-level; binary outcome: % of PrEP/PEP clients in different populations of interest (e.g., men; youth \<25 years); with separate evaluations by product type |
| Efficiency | 18 months post implementation | Pharmacy-level; continuous outcome: Avg. duration (per visit \& annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration |
| Fidelity | 1.5 months post initiation | Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs) |
| Sustainment | 24 months post implementation | Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months |
| Acceptability | 24 months post implementation | Individual-level; cont, binary outcome: # of unique client who find the study components acceptable; % of providers, including remote nurses, indicating acceptability; Also assessed in Aim 2 (described below) |
Countries
Kenya
Contacts
CONTACTKatrina F Ortblad
STUDY_CHAIRKendall V Harkey
Fred Hutch Cancer Center
STUDY_CHAIRRachel C Malen
Fred Hutch Cancer Center
PRINCIPAL_INVESTIGATORKatrina F Ortblad
Fred Hutch Cancer Center
Outcome results
None listed