Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study

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.

Conditions

• HIV Infections

Interventions

OTHER

Online PEP/PrEP delivery

Delivery of PEP or PrEP after online consultation and HIVST image upload.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Jomo Kenyatta University of Agriculture and Technology

  collaborator OTHER

• Partners in Health & Research Development

  collaborator UNKNOWN

• MYDAWA

  collaborator UNKNOWN

• Audere

  collaborator UNKNOWN

• University of Washington

  lead OTHER

Principal Investigators

• Monisha Sharma, PhD, MSPH · University of Washington

• Katrina F Ortblad, ScD, MPH · Fred Hutch Cancer Center

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-24

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Kenya

Study Locations