Pharmacy-based PrEP Delivery in Kenya

Hiv Clinical Trial

Official title:

Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842122
• Other study ID #: RG1123165
• Secondary ID: BMGF INV-0330521
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Katrina F Ortblad, ScD
• Phone: 2066677267
• Email: kortblad[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11520
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu
Kenya	Partners in Health & Research Development	Thika

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	Jhpiego, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client acceptability	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).	0, 60, 270 days
Other	Fidelity	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.	0, 60, 270 days
Other	Client willingness to pay	Amount eligible pharmacy PrEP clients are willing to pay for each pharmacy PrEP or PEP visit.	0, 60, 270 days
Other	Client quality of care perceptions	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.	0, 60, 270 days
Other	Provider/counselor acceptability	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).	0, 60, 270 days
Other	Provider/counselor feasibility	Assessed using the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017, Implement Sci).	0, 60, 270 days
Other	Provider/counselor appropriateness	Assessed using the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017, Implement Sci).	0, 60, 270 days
Other	Provider/counselor perceived self-efficacy	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.).	0, 60, 270 days
Other	Provider/counselor adaptations	Assessed using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) (Miller et al., 2021, Implement Sci).	for the full 18 months of the cRCT
Other	Provider/counselor willingness to change	Amount pharmacy providers are willing to charge for each pharmacy PrEP or PEP visit under different scenarios.	0, 60, 270 days
Primary	PrEP initiation	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	60 days
Primary	PrEP continuation	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	60 days
Secondary	PrEP continuation	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)	270 days
Secondary	PrEP adherence	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.	60 days
Secondary	PEP initiation	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).	60 days
Secondary	PEP-to-PrEP transition	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).	60 days
Secondary	Behaviors associated with HIV risk	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.	60 and 270 days