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Completed

NCT Number: NCT05377138

Evaluate and Optimize an Online 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jomo Kenyatta University of Agriculture and Technology

Nairobi, Kenya

About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online PEP/PrEP delivery

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. PrEP pill coverage

    Time frame: 1 year

    % of PrEP pill coverage among days at HIV risk among clients that initiated PrEP

  5. Self-reported PrEP use/adherence

    Time frame: 1 year

    Self-reported PrEP use/adherence

  6. Transition from PEP to PrEP

    Time frame: 1 year

    % of clients that initiated PrEP among those what received PEP via MYDAWA

  7. 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?

  8. Acceptability of online PrEP

    Time frame: 1 year

    To what extent is online PrEP judged as suitable, satisfying, or attractive to clients?

  9. Cost associated with online PEP delivery

    Time frame: 1 year

    Cost to deliver PEP to each PEP client

  10. Cost associated with online PrEP delivery

    Time frame: 1 year

    Cost per client month on PrEP

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ePrEP Kenya

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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