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Pharmacy-based PrEP Delivery in Kenya

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ClinicalTrials.gov Identifier: NCT05842122
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : April 26, 2024
Sponsor:
Collaborators:
Kenya Medical Research Institute
Jhpiego
Information provided by (Responsible Party):
Katrina Ortblad, Fred Hutchinson Cancer Center

Study Description
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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 PrEP/PEP service delivery models on PrEP/PEP initiation and continuation outcomes, compared to pharmacy referral to clinic-based PrEP/PEP services (i.e., 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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: Pharmacy PrEP/PEP for a fee Behavioral: Pharmacy PrEP/PEP for free Behavioral: HTS counselor supported pharmacy PrEP/PEP for free Behavioral: Pharmacy referral to clinic-based PrEP/PEP Not Applicable

Detailed Description:
Participating study pharmacies will be 1:1:1:1 randomized to either: 1) pharmacy PrEP/PEP services for a fee (clients pay 250 KES/visit; study team compensates pharmacies 0 KES/visit); pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 250 KES/visit); 3) HTS counselor-supported pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit); or 4) pharmacy referral to existing clinic-based PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit). The primary cRCT outcomes are PrEP initiation and continuation, assessed 60 days following clients first pharmacy PrEP/PEP visit/referral. We will implement the trial for up to 16 months, or longer, depending on achievement of our primary study objectives.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the cluster-randomized control trial, the intervention will be introduced in a parallel fashion (i.e., all pharmacies assigned a given intervention will receive the intervention at the start of the trial).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
Actual Study Start Date : June 20, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pharmacy PrEP/PEP for a fee
Pharmacy providers offer clients PrEP and PEP services for a fee of 250 Kenyan Shillings (KES) per visit (study team compensates pharmacy providers 0 KES per visit).
 Behavioral: Pharmacy PrEP/PEP for a fee
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 250 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 0 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)
Active Comparator: Pharmacy PrEP/PEP for free
Pharmacy providers offer clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 250 KES per visit).
 Behavioral: Pharmacy PrEP/PEP for free
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 0 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 250 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)
Active Comparator: HTS counselor supported pharmacy PrEP/PEP for free
HIV testing service (HTS) counselors support pharmacy providers in offering clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 100 KES per visit).
 Behavioral: HTS counselor supported pharmacy PrEP/PEP for free
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery with support from a HTS counselor (to assist with screening and HIV testing)
  • Cost to client: 0 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 100 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)
Active Comparator: Pharmacy referral to clinic-based PrEP/PEP
Pharmacy providers offer clients referral to PrEP and PEP services at nearby public clinics for a fee of 0 KES per referral (study team compensates pharmacy providers 100 KES per referral).
 Behavioral: Pharmacy referral to clinic-based PrEP/PEP
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) referral to clinic-based PrEP/PEP services
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 0 KES per pharmacy PrEP/PEP referral
  • Payment to pharmacy:* 100 KES per pharmacy PrEP/PEP referral *Pharmacies paid by the research team (i.e., the "implementer" in this trial)


Outcome Measures
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Primary Outcome Measures :
  1. PrEP initiation [ Time Frame: 60 days ]
    Number of participants that initiated (i.e., were dispensed) PrEP at the pharmacy/clinic within 60 days of initial pharmacy-based screening, among those screened and found eligible for pharmacy-delivered PrEP services

  2. PrEP continuation [ Time Frame: 60 days ]
    Proportion of participants that returned to the pharmacy/clinic and refilled PrEP within 60 days of initial pharmacy-based screening, among those who initiated PrEP at the pharmacy or clinic


Secondary Outcome Measures :
  1. PrEP continuation [ Time Frame: 270 days ]

    Proportion of participants that returned to the pharmacy/clinic and refilled PrEP within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage), among those who initiated PrEP at the pharmacy or clinic.

    • Proportion of participants that refilled PrEP at least twice at a pharmacy/clinic within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage), among those who initiated PrEP at the pharmacy or clinic
    • Proportion of particpants that refilled PrEP at a pharmacy/clinic >15 days after their expected refill date, among those who initiated PrEP at the pharmacy or clinic (i.e., stopping and restarting)

  2. PrEP adherence [ Time Frame: 60 days ]
    Proportion of participants with drug concentrations indicating adherence, among those participants randomly selected for DBS at 60 days post PrEP initiation; proportion of participants with self-reported behaviors indicative of good adherence (using the Wilson et al scale), among those who initiated PrEP at the pharmacy or clinic.

  3. PEP initiation [ Time Frame: 60 days ]
    Number of participants that initiated (i.e., were dispensed) PEP at the pharmacy or clinic within 3 days, among those screened and found eligible for PEP (measured at 60 days following initial pharmacy screening).

  4. PEP-to-PrEP transition [ Time Frame: 60 days ]
    Proportion of participants that initiated PrEP at the pharmacy or clinic within one month, among those that successfully completed PEP (tested HIV-negative between 28 and 45 days after initiating PEP) and were found eligible for PrEP (per criteria on the prescribing checklist).

  5. Behaviors associated with HIV risk [ Time Frame: 60 and 270 days ]
    Proportion of participants reporting any as well as specific self-reported behaviors associated with HIV risk according to Kenya's 8-item Risk Assessment Screening Tool, including sex with a partner of unknown HIV status or engagement in transactional sex. Also, number of reported sexual partners in the past three months, proportion of participants reporting multiple sexual partners in the past three months, and any condomless sex in the past month. All measures assessed will be assessed among those screened and found eligible for pharmacy-delivered PrEP services.


Other Outcome Measures:
  1. Client acceptability [ Time Frame: 0, 60, 270 days ]
    Proportion of participants that agree to statements that measure different domains of the Theoretical Framework of Acceptability (Sekhon et al., 2017, BMC Health Serv Res), which consists of seven component constructs (e.g., affective attitude, burden, perceived effectiveness).

  2. Fidelity [ Time Frame: 0, 60, 270 days ]
    Proportion of participants that received different core components of the intervention (e.g., counseling on HIV risk, medical history, HIV testing, drug dispensing), as specified in the protocol.

  3. Client willingness to pay [ Time Frame: 0, 60, 270 days ]
    Amount eligible pharmacy PrEP clients are willing to pay for each pharmacy PrEP or PEP visit.

  4. Client quality of care perceptions [ Time Frame: 0, 60, 270 days ]
    Assessed using a modified perceived service quality scale (pSQ-SF6) (Carter et al., 2022, Res Social Adm Pharm), with higher score indicating higher perceived service quality.

  5. Provider/counselor acceptability [ Time Frame: 0, 60, 270 days ]
    Proportion of participants that agree with statements assessing different domains of the Theoretical Framework of Acceptability (Sekhon et al., 2017, BMC Health Serv Res), which consists of seven component constructs (e.g., affective attitude, burden, perceived effectiveness).

  6. Provider/counselor feasibility [ Time Frame: 0, 60, 270 days ]
    Assessed using the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017, Implement Sci).

  7. Provider/counselor appropriateness [ Time Frame: 0, 60, 270 days ]
    Assessed using the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017, Implement Sci).

  8. Provider/counselor perceived self-efficacy [ Time Frame: 0, 60, 270 days ]
    Proportion of participants that agree with statements that assess providers' level of confidence delivering different core components of the pharmacy PrEP intervention (e.g., counseling, HIV testing, referral, etc.).

  9. Provider/counselor adaptations [ Time Frame: for the full 18 months of the cRCT ]
    Assessed using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) (Miller et al., 2021, Implement Sci).

  10. Provider/counselor willingness to change [ Time Frame: 0, 60, 270 days ]
    Amount pharmacy providers are willing to charge for each pharmacy PrEP or PEP visit under different scenarios.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Pharmacies

  • Registered with the Pharmacy and Poisons Board (PPB)
  • Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
  • Must have a private room where HIV testing and PrEP/PEP counseling can occur
  • Must be willing to use a study-specific module within a digital platform (Maisha Meds) to record pharmacy PrEP/PEP dispensing
  • Owner must agree to allow a trained research assistant to come to the pharmacy on select days to collect data from a random subset of participants
  • Owner must agree to allow providers to participate in a monitored WhatsApp group, optional surveys, and optional in-depth interview
  • Owner must agree to allow providers to routinely engage with a technical assistant

Pharmacists/HTS counselors

  • ≥ 18 years old
  • Licensed pharmacist, licensed pharmaceutical technologist, or NASCOP-certified HTS counselor
  • Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
  • Completed training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
  • Able and willing to provide informed consent
  • Complete study training
  • Willing to use a study-specific module within a digital platform (Maisha Meds) to document PrEP/PEP services rendered

Clients

  • ≥ 16 years old
  • Interested in being screened for PrEP or PEP
  • Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP safety
  • Able and willing to provide informed consent

Exclusion Criteria:

Clients

  • Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
  • Currently enrolled in any other HIV vaccine or prevention trial
  • Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05842122


Contacts
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Contact: Katrina F Ortblad, ScD 2066677267 kortblad@fredhutch.org

Locations
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Kenya
Kenya Medical Research Institute Recruiting
Kisumu, Kenya
Contact: Elizabeth Bukusi, PhD       ebukusi@rctp.or.ke   
Partners in Health & Research Development Recruiting
Thika, Kenya
Contact: Kenneth Ngure, PhD       kngure@pipsthika.org   
Sponsors and Collaborators
Fred Hutchinson Cancer Center
Kenya Medical Research Institute
Jhpiego
Investigators
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Study Chair: Rachel Malen, MPH Fred Hutch Cancer Center
Study Chair: Kendall Harkey, MPH Fred Hutch Cancer Center
More Information
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Responsible Party: Katrina Ortblad, Assistant Professor, Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT05842122    
Other Study ID Numbers: RG1123165
BMGF INV-033052 ( Other Grant/Funding Number: Bill & Melinda Gates Foundation )
11136 ( Other Identifier: Fred Hutchinson Cancer Center IRB )
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified data may be available upon request at the discretion of the study PI (Ortblad).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katrina Ortblad, Fred Hutchinson Cancer Center:
Kenya
HIV pre-exposure prophylaxis (PrEP) delivery
PEP
Pharmacy