Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302662168727 Date of Approval: 10/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pharmacy PrEP cRCT
Official scientific title Pharmacy delivery to expand the reach of PrEP in Kenya: cluster-randomized control trial
Brief summary describing the background and objectives of the trial Pre- and post-exposure prophylaxis (PrEP and PEP) are highly effective HIV prevention methods when taken as recommended. Although over 100 public health facilities across Kenya offer PrEP, initiation at these clinics remains suboptimal due to challenges such as long wait times and stigma. In response, the Kenya Ministry of Health (MOH) is seeking to leverage the private sector to reach individuals who are unable or unwilling to access PrEP in the public sector and has specifically identified private pharmacies as a target PrEP delivery venue. To understand whether and how PrEP and PEP can be delivered in this setting, we will conduct a 16-month, 4-arm cluster randomized control trial. We will randomize 60 pharmacies spread across Nairobi, Kiambu, Kisumu, and Homabay Counties to one of four delivery models. In three models, a trained pharmacy provider (Arms 1 and 2) or an HIV Testing Services counselor (Arm 3) will prescribe and refill PrEP/PEP to eligible clients using a standardized checklist and consultation with a remote clinician, as needed. In Arm 1, clients will pay 250 KES to receive PrEP/PEP; in Arms 2 and 3, the study will pay this fee on the client’s behalf. Each of these arms will be compared a control arm (Arm 4) in which pharmacy providers screen interested clients for HIV risk and refer them for free to traditional clinic-based PrEP/PEP services. Our primary outcomes will be PrEP initiation and continuation (i.e., any refilling) at 60 days following enrollment. Secondary outcomes will include PrEP adherence and PEP-to-PrEP transition. We will also collect client and provider perceptions of acceptability and feasibility. The Kenya MOH will select one model for the study to maintain for an additional six months and identify model modifications (e.g., demand creation strategies) to concurrently implement in the remaining three arms. This study may help elucidate the potential value-add, if any, of expanding PrEP/PEP delivery to private pharmacies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/04/2023
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 10800
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arm 1 22 months Pharmacy provider-delivered PrEP/PEP for a fee 2700
Experimental Group Arm 2 22 months Pharmacy provider-delivered PrEP/PEP for free 2700
Experimental Group Arm 3 22 months HTS counselor-assisted PrEP/PEP delivery for free 2700
Control Group Arm 4 22 months Pharmacy provider free referral to clinic-based PrEP/PEP services, representing what pharmacy providers are currently allowed to do in Kenya and thus akin to the SOC for free 2700 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/01/2023 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Way Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PrEP initiation, PrEP continuation 60
Secondary Outcome 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. 270
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute Research Care and Training Programme Ondiek Kisumu 40100 Kenya
Kenya Medical Research Institute Partners in Health Research and Development OAU Road Thika Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor jhpiego 14 riverside Nairobi 00800 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University of Washington 908 Jefferson Seattle United States of America
Fred Hutchinson Cancer Center 1100 Fairview Seattle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Katrina Ortblad kortblad@fredhutch.org +12062651856 1100 Fairview
City Postal code Country Position/Affiliation
Seattle United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Elizabeth Bukusi ebukusi@kemri.go.ke +254733617503 Mbagathi way
City Postal code Country Position/Affiliation
Nairobi Kenya Co principal investigator
Role Name Email Phone Street address
Scientific Enquiries Katrina Ortblad kortblad@fredhutch.org +12066677267 1100 Fairview
City Postal code Country Position/Affiliation
Seattle United States of America Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data thatunderlie the results reported in thisarticle, after deidentification (text,tables, figures, and appendices) willbe available.The Clinical study reportwill be available for researchers whoprovide a methodologically soundproposal immediately after studypublication.This data shall only beused to achieve aims in the approvedprotocols Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 5 years Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information