Pharmacy PrEP cRCT

Phase 4

• Conditions: HIV/AIDS

• Registration Number: PACTR202302662168727
• Lead Sponsor: jhpiego

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10800

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PrEP initiation, PrEP continuation

Secondary Outcome Measures

Name	Time	Method
PrEP continuation at 270 days, Any PrEP continuation 1 refills within 270 days, PEP initiation, PEP to PrEP transition at 60 days, PrEP adherence at 60 days, acceptability and appropriateness.