An interventional study of Online PEP/PrEP delivery in HIV Infections, sponsored by University of Washington. Completed at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University of Washington · Not applicable, Interventional, and Other
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.
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
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 2,357 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Inclusion criteria:
MYDAWA clients determined to be eligible for PrEP or PEP can order them online and have them delivered a small fee. This is not currently the standard of care in Kenya. Those who are not in the study can only receive PrEP or PEP at healthcare facilities in Kenya.
Other: Online PEP/PrEP delivery
Delivery of PEP or PrEP after online consultation and HIVST image upload.
PrEP initiation
% of participants that were delivered PrEP among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PrEP continuation: refills with 45 days of PrEP initiation
% of participants who refilled PrEP within 45 days of first PrEP delivery among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PEP initiation
% of participants that were delivered PEP among those screened for HIV risk and determined PEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PrEP continuation: any refills
% of participants who refilled PrEP (at least once) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PrEP continuation => 2 refills
% of participants who refilled PrEP (at least twice) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PrEP stopping and restarting
% of participants who refilled PrEP (at least once) with a gap of at least 14 days between when their pills would runt out and the next delivery of pills, among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Time frame: 1 year
PrEP pill coverage
% of PrEP pill coverage among days at HIV risk among clients that initiated PrEP
Time frame: 1 year
Self-reported PrEP use/adherence
Self-reported PrEP use/adherence
Time frame: 1 year
Transition from PEP to PrEP
% of clients that initiated PrEP among those what received PEP via MYDAWA
Time frame: 1 year
Feasibility of implementing online PrEP
To what extent can online PrEP be successfully delivered to intended participants in the Kenyan context?
Time frame: 1 year
Acceptability of online PrEP
To what extent is online PrEP judged as suitable, satisfying, or attractive to clients?
Time frame: 1 year
Cost associated with online PEP delivery
Cost to deliver PEP to each PEP client
Time frame: 1 year
Cost associated with online PrEP delivery
Cost per client month on PrEP
Time frame: 1 year
Plan to share: No
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