Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842122
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-04-05
Brief Title:
Pharmacy-based PrEP Delivery in Kenya
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Pharmacy Delivery to Expand the Reach of PrEP in Kenya Cluster-randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PrEPPEP service delivery models on PrEPPEP initiation and continuation outcomes compared to pharmacy referral to clinic-based PrEPPEP services ie 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
Detailed Description:
Participating study pharmacies will be 1111 randomized to either 1 pharmacy PrEPPEP services for a fee clients pay 250 KESvisit study team compensates pharmacies 0 KESvisit pharmacy PrEPPEP services for free clients pay 0 KESvisit study team compensates pharmacies 250 KESvisit 3 HTS counselor-supported pharmacy PrEPPEP services for free clients pay 0 KESvisit study team compensates pharmacies 100 KESvisit or 4 pharmacy referral to existing clinic-based PrEPPEP services clients pay 0 KESvisit study team compensates pharmacies 100 KESvisit The primary cRCT outcomes are PrEP initiation and continuation assessed 60 days following clients first pharmacy PrEPPEP visitreferral We will implement the trial for up to 16 months or longer depending on achievement of our primary study objectives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMGF INV-033052 | OTHER_GRANT | None | None |
| 11136 | OTHER | Fred Hutchinson Cancer Center IRB | None |