Clinical trial NCT05377138: Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study
Official title: Evaluate and Optimize a Virtual Care Model for PrEP Delivery: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Online PrEP
PEP
Online PEP
pharmacies
HIV prevention
Kenya
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Fred Hutchinson Cancer Center
name: Jomo Kenyatta University of Agriculture and Technology
name: Partners in Health & Research Development
name: MYDAWA
name: Audere
First posted: 2022-05-17
Enrollment: 2357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MYDAWA clients determined to be eligible for PrEP or PEP following online screening and a remote meeting with a MYDAWA clinical officer will be delivered a blood-based HIV self-test followed by daily oral PrEP or PEP) at home and continued remote HIV prevention (i.e., PrEP) support for a small fee.
Primary purpose: OTHER

Brief summary: Daily oral pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition, but uptake in Kenya remains low. Barriers to clinic-based PrEP delivery exist (e.g., long wait times, stigma), thus the delivery of PrEP via online pharmacy platforms has the potential to expand the reach of PrEP access in Kenya. In this pilot study, the investigators will test a new model of PrEP delivery that has never been tried in a sub-Saharan African setting: online pharmacy-delivered PrEP. The investigators will work in collaboration with MYDAWA, an online pharmacy in Kenya, to deliver PrEP on their platform for 18 months. Online PrEP delivery will include a PrEP eligibility assessment, HIV self-test delivery, a remote clinical encounter, PrEP medication delivery, and virtual PrEP support tools. If a participant is identified as eligible for pre-exposure prophylaxis (PEP), then PEP will be prescribed for 29 days and the participant will be asked to make another appointment at the end of this time to reassess for PrEP eligibility. The investigators will measure PrEP uptake and continuation over time and also measure a number of implementation outcomes, including acceptability and costs. The investigators anticipate that online pharmacy PrEP delivery will result in high uptake and continuation (similar to that or greater than public clinics), will be acceptable to clients, and will be low cost.

Detailed description: Online PrEP may help overcome patient- and provider-level barriers to facility-delivered PrEP. At the patient-level, online PrEP may increase privacy and convenience by enabling patients to receive PrEP at a location and time of their choice. Additionally, by expanding options for PrEP delivery, patients can select a model that fits their preferences. The delivery of PrEP directly via couriers may also decrease the time patients spend (and costs associated with) traveling to and waiting at health facilities, and the stigma associated with visiting HIV clinics for PrEP care. At the provider-level, online PrEP may decrease crowding at facilities and increase the time providers can spend with patients seeking treatment services. Additionally, shifting some PrEP delivery responsibilities to lower-paid couriers may be cost saving to the health system. Together, these advantages of online PrEP may increase PrEP continuation among individuals at risk for HIV.

MYDAWA, Kenya's first licensed online pharmacy (https://mydawa.com), is uniquely positioned to support online PrEP delivery by applying technology to deliver essential medicines and health supplies to local communities.

The overall goal of this study is to generate data to support the relevant policy decisions regarding broader adoption of online PrEP delivery in the region. The investigators plan to develop and evaluate the feasibility of a online delivery model to support PrEP initiation and continuation among individuals at risk of HIV acquisition in Kenya. The model will deliver once-daily oral tenofovir/emtricitabine (TDF/FTC). To evaluate the feasibility of this model in Kenya, the investigators propose testing the uptake of a "minimally viable" model, understanding the characteristics of online PrEP clients and the acceptability of the model among these clients, and evaluating the costs associated with the model.

Specific objectives

1. To develop and pilot test a model of online PrEP delivery on PrEP initiation and continuation outcomes among individuals at risk of HIV acquisition in Kenya.
2. To evaluate the acceptability, appropriateness, feasibility, and costs of an online PrEP delivery model in Kenya.

Hypothesis The investigators hypothesize that an online PrEP delivery model will address patient- and provider-level barriers to clinic-delivered PrEP and result in high PrEP initiation and continuation (compared to facility-based models), be acceptable and appropriate and providers and clients, and low-cost.

Eligibility criteria: Inclusion criteria:

* Accessed MYDAWA Services for HIVST or requested PrEP information through MYDAWA
* Are interested in and willing to take PrEP and are willing to pay for the PrEP delivery cost
* Be willing to pay for a blood-based HIVST and delivery cost
* Self-reported HIV negative
* Are able to access the MyDAWA platform using computer or a smartphone for the duration of the study
* Are able to access the internet
* Are able to read and comprehend English
* Are living in or willing to travel to the Nairobi area to receive virtual PrEP services
* Are able and willing to provide informed consent electronically.

Primary outcomes:
measure: PrEP initiation
timeFrame: 1 year
measure: PrEP continuation: refills with 45 days of PrEP initiation
timeFrame: 1 year
measure: PEP initiation
timeFrame: 1 year
Secondary outcomes:
measure: PrEP continuation: any refills
timeFrame: 1 year
measure: PrEP continuation => 2 refills
timeFrame: 1 year
measure: PrEP stopping and restarting
timeFrame: 1 year
measure: PrEP pill coverage
timeFrame: 1 year
measure: Self-reported PrEP use/adherence
timeFrame: 1 year
measure: Transition from PEP to PrEP
timeFrame: 1 year
measure: Feasibility of implementing online PrEP
timeFrame: 1 year
measure: Acceptability of online PrEP
timeFrame: 1 year
measure: Cost associated with online PEP delivery
timeFrame: 1 year
measure: Cost associated with online PrEP delivery
timeFrame: 1 year
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Jomo Kenyatta University of Agriculture and Technology
Study officials:
affiliation: University of Washington
name: Monisha Sharma, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch Cancer Center
name: Katrina F Ortblad, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: