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

NCT05377138 | Completed

• 1 other identifier: STUDY00014987
• Study Type: interventional
• Target: 2,357
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Online PrEP; PEP; Online PEP; pharmacies; HIV prevention; Kenya

Outcome Measures

Primary Outcomes (3)

• PrEP initiation

  % of participants that were delivered PrEP among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.

  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.

  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.

  1 year

Secondary Outcomes (10)

• PrEP continuation: any refills

  1 year

• PrEP continuation => 2 refills

  1 year

• PrEP stopping and restarting

  1 year

• PrEP pill coverage

  1 year

• Self-reported PrEP use/adherence

  1 year

Study Arms (1)

MYDAWA clients

EXPERIMENTAL

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

Interventions

Online PEP/PrEP delivery OTHER

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

MYDAWA clients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Jomo Kenyatta University of Agriculture and Technology

Nairobi, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Monisha Sharma, PhD, MSPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Katrina F Ortblad, ScD, MPH

  Fred Hutch Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health

Model Details: MYDAWA clients determined to be eligible for PrEP or PEP following online screening and a remote meeting with a MYDAWA clinical officer will be delivered a blood-based HIV self-test followed by daily oral PrEP or PEP) at home and continued remote HIV prevention (i.e., PrEP) support for a small fee.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 17, 2022
• Study Start: October 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)