Pharmacy delivery to expand the reach of PrEP in Kenya: cluster-randomized control trial

jhpiego0 sites10,800 target enrollmentFebruary 9, 2023

ConditionsHIV/AIDS

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Client eligibility criteria:
•(1\) age \=16 years;
•(2\) determined to be at risk of HIV acquisition (according to the RAST); and
•(3\) determined to be eligible for PrEP or PEP (according to the Prescribing Checklist).
•Provider eligibility criteria: :
•(1\) age 18 years or above;
•(2\) licensed pharmaceutical technologist, licensed pharmacist, or NASCOP\-certified HTS counselor;
•(3\) currently employed at a pharmacy selected for study participation or—in the case of HTS counselors—hired by the study to be stationed at a study pharmacy; and
•(4\) able and willing to provide informed consent

•Client exclusion criteria:
•(1\) are unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study\-related information, as needed;
•(2\) are currently enrolled in any other HIV vaccine or prevention clinical trial; and/or
•(3\) have a condition that, in the opinion of the Principle Investigator or designee, would preclude provision of informed consent or make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
•Provider exclusion criteria:
•(1\) are unwilling to complete the required training;
•(2\) unwilling to deliver PrEP/PEP in accordance with the study protocol (e.g., using the Prescribing Checklist; making and documenting referrals as necessary); and
•(3\) have a condition that, in the opinion of the Principle Investigator or designee, would preclude provision of informed consent or make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.