Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study (ePrEP Kenya)

May 25, 2024 updated by: Monisha Sharma, University of Washington

Evaluate and Optimize a Virtual Care Model for PrEP Delivery: Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Jomo Kenyatta University of Agriculture and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MYDAWA clients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP initiation
Time Frame: 1 year
% of participants that were delivered PrEP among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
1 year
PEP initiation
Time Frame: 1 year
% of participants that were delivered PEP among those screened for HIV risk and determined PEP eligible via the online (MYDAWA) platform.
1 year
PrEP continuation: refills with 45 days of PrEP initiation
Time Frame: 1 year
% 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP continuation: any refills
Time Frame: 1 year
% of participants who refilled PrEP (at least once) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
1 year
PrEP pill coverage
Time Frame: 1 year
% of PrEP pill coverage among days at HIV risk among clients that initiated PrEP
1 year
Self-reported PrEP use/adherence
Time Frame: 1 year
Self-reported PrEP use/adherence
1 year
Transition from PEP to PrEP
Time Frame: 1 year
% of clients that initiated PrEP among those what received PEP via MYDAWA
1 year
Feasibility of implementing online PrEP
Time Frame: 1 year
To what extent can online PrEP be successfully delivered to intended participants in the Kenyan context?
1 year
Acceptability of online PrEP
Time Frame: 1 year
To what extent is online PrEP judged as suitable, satisfying, or attractive to clients?
1 year
Cost associated with online PEP delivery
Time Frame: 1 year
Cost to deliver PEP to each PEP client
1 year
Cost associated with online PrEP delivery
Time Frame: 1 year
Cost per client month on PrEP
1 year
PrEP continuation => 2 refills
Time Frame: 1 year
% of participants who refilled PrEP (at least twice) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
1 year
PrEP stopping and restarting
Time Frame: 1 year
% 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Bill and Melinda Gates Foundation
Fred Hutchinson Cancer Center
Jomo Kenyatta University of Agriculture and Technology
Audere
Partners in Health & Research Development
MYDAWA

Investigators

  • Principal Investigator: Monisha Sharma, PhD, MSPH, University of Washington
  • Principal Investigator: Katrina F Ortblad, ScD, MPH, Fred Hutch Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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