NCT05377138Completed
Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study
Evaluate and Optimize a Virtual Care Model for PrEP Delivery: Pilot Study
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 2357 (actual)
- First submitted
- 19 Apr 2022
- Start date
- 24 Oct 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Washington
- Diseases
- HIV
- NCT number
- NCT05377138
What you commit to
- Study type: Interventional
- Participants enrolled: 2357
- From 24 Oct 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jomo Kenyatta University of Agriculture and Technology Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.