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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,580
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.
Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.
Kenya Medical Research Institute
Kisumu, Kenya
PrEP/PEP initiation
Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period
Time frame: 18 months post implementation
PrEP/PEP continuation
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
Time frame: 18 months post implementation
PrEP initiation
Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period
Time frame: 18 months post implementation
PEP initiation
Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period
Time frame: 18 months post implementation
PrEP/PEP use
Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period
Time frame: 1.5 and 6 months from initiation
PrEP use
Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period
Time frame: 1.5 and 6 months from initiation
PEP use
Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period
Time frame: 1.5 and 6 months from initiation
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PrEP refill
Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP
Time frame: 18 months post implementation
Repeat PEP
Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP
Time frame: 18 months post implementation
PEP-to-PrEP
Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period
Time frame: 18 months post implementation
Engaged with 1+ product
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
Time frame: 18 months post implementation
On-demand PrEP use
Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period
Time frame: 6 months from initiation
PEP-in-Pocket use
Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period
Time frame: 6 months from initiation
Product choice
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).
Time frame: 18 months post implementation
PrEP adherence
Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS
Time frame: 1.5 months from initiation
Reach
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
Time frame: 18 months post implementation
Efficiency
Pharmacy-level; continuous outcome: Avg. duration (per visit \& annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration
Time frame: 18 months post implementation
Fidelity
Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)
Time frame: 1.5 months post initiation
Sustainment
Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months
Time frame: 24 months post implementation
Acceptability
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)
Time frame: 24 months post implementation