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Pharmacy PrEP cRCT

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202302662168727
Enrollment
10800
Registered
2023-02-10
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Sponsors

jhpiego
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
PrEP initiation, PrEP continuation

Secondary

MeasureTime frame
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.

Countries

Kenya

Contacts

Public ContactElizabeth Bukusi

Co principal investigator

ebukusi@kemri.go.ke+254733617503

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026