Hiv Clinical Trial
Official title:
Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
A cluster-randomized control trial (cRCT) testing different cost-sharing models for the delivery of HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya. The goal is to assess the effect of different pharmacy-based PrEP/PEP service delivery models on PrEP/PEP initiation and continuation outcomes, compared to pharmacy referral to clinic-based PrEP/PEP services (i.e., what is currently allowed in Kenya at the moment without any changes to policies or guidelines). In the cRCT, 60 pharmacies across Central and Western Kenya will be randomized to one of 4 study arms.
Participating study pharmacies will be 1:1:1:1 randomized to either: 1) pharmacy PrEP/PEP services for a fee (clients pay 250 KES/visit; study team compensates pharmacies 0 KES/visit); pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 250 KES/visit); 3) HTS counselor-supported pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit); or 4) pharmacy referral to existing clinic-based PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit). The primary cRCT outcomes are PrEP initiation and continuation, assessed 60 days following clients first pharmacy PrEP/PEP visit/referral. We will implement the trial for up to 16 months, or longer, depending on achievement of our primary study objectives. ;
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