Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05377138 |
| Other study ID # |
STUDY00014987 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2022 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Washington |
| Contact |
Paulami Naik |
| Phone |
206-221-1041 |
| Email |
pnaik47[@]uw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
