Pharmacy-based PrEP Delivery in Kenya
Study Details
Study Description
Brief Summary
Pre- and post-exposure prophylaxis (PrEP and PEP) are highly effective HIV prevention methods when taken as recommended. Although >100 public healthcare facilities across Kenya offer PrEP/PEP, 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/PEP in the public sector and has specifically identified private pharmacies as a target delivery venue. To understand whether and how PrEP and PEP can be delivered in this setting, a four-arm cluster-randomized control trial (cRCT) testing different models of pharmacy-delivered PrEP services will be conducted. In this cRCT, 60 pharmacies spread across Nairobi, Kiambu,
Kisumu, and Homabay Counties will be 1:1:1:1 randomized to:
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Pharmacy PrEP/PEP for a fee; services delivered by pharmacy providers at a 250 KES fee to clients (participants) per visit
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Pharmacy PrEP/PrEP for free; services delivered by pharmacy providers at no fee to clients (250 KES per visit paid to pharmacies by study team)
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Pharmacy PrEP/PEP for free, with HIV testing service (HTS) counselor support; services delivered by pharmacy providers, supported by HTS counselors, at no fee to clients (100 KES fee per visit paid to pharmacies by study team)
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Pharmacy PrEP/PEP referral; pharmacy providers screen clients for HIV risk and refer to public facilities services (100 KES per referral paid to pharmacies by study team) - the "control" arm
Each of the interventions arms (Arms 1-3) will be compared a control arm (Arm 4) at specified time points. Our primary outcomes will be PrEP initiation and continuation within 60 days of initial screening/referral at study pharmacy. Secondary outcomes will include PrEP adherence, PEP initiation, and PEP-to-PrEP transition. Client and provider perceptions of acceptability and feasibility will also be collected. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are two drugs that are highly effective at preventing HIV before and shortly after exposure to HIV, respectively; however, in Kenya, PrEP and PEP are mostly only available in public HIV clinics, a place some people may be uncomfortable or unable to easily access. To understand whether and how PrEP and PEP could be delivered in private pharmacies, a four-arm cRCT in 60 pharmacies spread across Nairobi, Kiambu, Kisumu, and Homabay Counties will be conducted. Groups of 15 pharmacies in each county will be randomized to one of four study arms.
In two study arms, a model in which trained pharmacy providers prescribe and refill PrEP and PEP to eligible clients either for a 250 KES fee paid by the client (Arm 1) or for free, with the study paying the fee on the client's behalf (Arm 2), will be tested. In the third arm, a trained HTS counselor will be stationed at the pharmacy to assist providers with delivery of free PrEP/PEP to eligible clients (Arm 3), with the study paying the pharmacy 100 KES per client served. Providers in these intervention arms (Arms 1-3) will deliver PrEP and PEP services according to criteria on a standardized prescribing checklist (which assesses for HIV risk, screens for medical safety, and confirms HIV-negative status) with oversight by a remote clinician, who will be available for consultation as needed. These intervention arms will each be compared against a control arm (Arm 4) in which pharmacy providers only screen clients for HIV risk and refer them to nearby public healthcare facilities for free PrEP/PEP services. The study will pay pharmacies in the control arm 100 KES per client screened and referred.
Our primary study outcomes are PrEP initiation (i.e., any pills dispensed) and PrEP continuation (i.e., any refills) at a pharmacy or healthcare facility within 60 days of the initial pharmacy-based screening. Secondary outcomes include PrEP initiation and continuation measured at 270 days following pharmacy screen/referral, PrEP adherence (measured via DBS and self-report), PEP initiation (i.e., any dispensing), and PEP-to-PrEP transition. Additionally, the investigators plan on measuring an number of implementation outcomes, including acceptability, feasibility, appropriateness, and costs, among both pharmacy clients and providers using both survey data and in-depth interviews.
Once the the sample size needed to achieve 80% power for assessment of both primary outcome is reached (=9,300 PrEP-eligible clients: 2,325 per arm or ~155 per pharmacy), the the primary analysis will be conducted. Eligible participants, however, will contiune to receive PrEP and PEP services at participating pharmacies until the investigators reach 16 months of implementation at each pharmacy. At this point, the secondary outcomes will be analyzed. The preliminary trial findings will be presented to key Kenyan stakeholders, including members from the Kenya Ministry of Health (MOH), who will then select their preferred model (i.e., arm) to continue implementing for an additional six months. During this period, potential model modifications (e.g., new demand generation strategies) may be tested in the remaining three arms for six months.
The findings from this study may help policymakers and funders understand the demand for PrEP/PEP services (and among what populations) at private pharmacies and what benefit, if any, there is to allowing private pharmacies to deliver full PrEP/PEP services (compared to limiting pharmacies to refer eligible PrEP/PEP clients to public healthcare facilities).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pharmacy PrEP/PEP for a fee Pharmacy providers offer clients PrEP and PEP for a fee of 250 KSH (Kenyan shillings). |
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 "implementor" in this trial)
|
| Experimental: Pharmacy PrEP/PEP for free Pharmacy providers offer clients PrEP and PEP for free. |
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 "implementor" in this trial)
|
| Experimental: Pharmacy PrEP/PEP for free, with HTS counselor support Pharmacy providers offer clients PrEP and PEP for free. HTS counselors will be doing some of the counseling and HIV testing. |
Behavioral: Pharmacy PrEP/PEP for free, with HTS counselor support
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 "implementor" in this trial)
|
| No Intervention: Pharmacy PrEP/PEP referral Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing (optional), and 4) referral to clinic-based PrEP or PEP services 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:* 100 KES per pharmacy PrEP/PEP referral *Pharmacies paid by the research team (i.e., the "implementor" in this trial) |
Outcome Measures
Primary Outcome Measures
- PrEP initiation [60 days]
Proportion 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
- PrEP continuation [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
- PrEP continuation [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)
- PrEP adherence [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.
- PEP initiation [60 days]
Proportion 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).
- PEP-to-PrEP transition [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).
- Behaviors associated with HIV risk [60 and 270 days]
Proportoin 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, 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
- Client acceptability [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).
- Fidelity [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.
- Client willingness to pay [0, 60, 270 days]
Amount eligible pharmacy PrEP clients are willing to pay for each pharmacy PrEP or PEP visit.
- Client quality of care perceptions [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.
- Provider/counselor acceptability [0, 60, 270 days]
Proportion of participants thae 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).
- Provider/counselor feasibility [0, 60, 270 days]
Assessed using the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017, Implement Sci).
- Provider/counselor appropriateness [0, 60, 270 days]
Assessed using the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017, Implement Sci).
- Provider/counselor perceived self-efficacy [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.).
- Provider/counselor adaptations [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).
- Provider/counselor willingness to change [0, 60, 270 days]
Amount pharmacy providers are willing to charge for each pharmacy PrEP or PEP visit under different scenarios.
Eligibility Criteria
Criteria
Inclusion Criteria:
Pharmacies
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Registered with the Pharmacy and Poisons Board (PPB)
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Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
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Must have a private room where HIV testing and PrEP/PEP counseling can occur
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Must be willing to use a study-specific module within a digital platform (Maisha Meds) to record pharmacy PrEP/PEP dispensing
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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
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Owner must agree to allow providers to participate in a monitored WhatsApp group, optional surveys, and optional in-depth interview
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Owner must agree to allow providers to routinely engage with a technical assistant
Pharmacists/HTS counselors
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≥ 18 years old
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Licensed pharmacist, licensed pharmaceutical technologist, or NASCOP-certified HTS counselor
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Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
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Completed training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
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Able and willing to provide informed consent
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Complete study training
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Willing to use a study-specific module within a digital platform (Maisha Meds) to document PrEP/PEP services rendered
Clients
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≥ 16 years old
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Interested in initiating PrEP or PEP
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Meets all criteria for PrEP or PEP initiation on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP safety
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Able and willing to provide informed consent
Exclusion Criteria:
Clients
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Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
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Currently enrolled in any other HIV vaccine or prevention trial
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kenya Medical Research Institute | Kisumu | Kenya | ||
| 2 | Partners in Health & Research Development | Thika | Kenya |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- Kenya Medical Research Institute
- Jhpiego
Investigators
- Study Chair: Rachel Malen, MPH, Fred Hutch Cancer Center
- Study Chair: Kendall Harkey, MPH, Fred Hutch Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1123165
- BMGF INV-033052
- 11136