HIV InfectionsePrEP KenyaNCT05377138
Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study
A study testing Online PEP/PrEP delivery in people with HIV Infections, run by University of Washington at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Online PEP/PrEP delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,357 participants
- Where
- 1 siteKenya
- Study dates
- 24 Oct 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- HIV Infections
- Being tested
- Online PEP/PrEP delivery
- Keywords
- Online PrEP, PEP, Online PEP, pharmacies, HIV prevention, Kenya
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online PEP/PrEP deliveryOther
Delivery of PEP or PrEP after online consultation and HIVST image upload.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online PEP/PrEP delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation
% of participants that were delivered PrEP among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (10)
PrEP continuation: any refills
% of participants who refilled PrEP (at least once) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Measured: 1 year
PrEP continuation => 2 refills
% of participants who refilled PrEP (at least twice) among those screened for HIV risk and determined PrEP eligible via the online (MYDAWA) platform.
Measured: 1 year
PrEP stopping and restarting
% 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.
Measured: 1 year
PrEP pill coverage
% of PrEP pill coverage among days at HIV risk among clients that initiated PrEP
Measured: 1 year
Self-reported PrEP use/adherence
Self-reported PrEP use/adherence
Measured: 1 year
Transition from PEP to PrEP
% of clients that initiated PrEP among those what received PEP via MYDAWA
Measured: 1 year
Feasibility of implementing online PrEP
To what extent can online PrEP be successfully delivered to intended participants in the Kenyan context?
Measured: 1 year
Acceptability of online PrEP
To what extent is online PrEP judged as suitable, satisfying, or attractive to clients?
Measured: 1 year
Cost associated with online PEP delivery
Cost to deliver PEP to each PEP client
Measured: 1 year
Cost associated with online PrEP delivery
Cost per client month on PrEP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start24 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Fred Hutchinson Cancer Center, Jomo Kenyatta University of Agriculture and Technology, Partners in Health & Research Development, MYDAWA, Audere
- Responsible party
- Principal investigator, Monisha Sharma, University of Washington
- Investigators
- Monisha Sharma, PhD, MSPH, Principal investigator, University of WashingtonKatrina F Ortblad, ScD, MPH, Principal investigator, Fred Hutch Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377138
- Sponsor's protocol ID
- STUDY00014987
- Acronym
- ePrEP Kenya
- Status last verified
- May 2024
- First submitted
- 19 Apr 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate and Optimize a Virtual Care Model for PrEP Delivery: Pilot Study
- ClinicalTrials.gov ID
- NCT05377138
- Acronym / sponsor ID
- ePrEP Kenya / STUDY00014987
- Conditions
- HIV Infections
- Keywords
- Online PrEP, PEP, Online PEP, pharmacies, HIV prevention, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,357 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Fred Hutchinson Cancer Center, Jomo Kenyatta University of Agriculture and Technology, Partners in Health & Research Development, MYDAWA, Audere
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MYDAWA clients | Experimental | Other: Online PEP/PrEP deliveryMYDAWA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online PEP/PrEP deliveryDelivery of PEP or PrEP after online consultation and HIVST image upload. | Other | MYDAWA clients |
Primary outcome
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.
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.
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.
10 secondary outcomes
PrEP continuation: any refills
Time frame: 1 year
PrEP continuation => 2 refills
Time frame: 1 year
PrEP stopping and restarting
Time frame: 1 year
PrEP pill coverage
Time frame: 1 year
Self-reported PrEP use/adherence
Time frame: 1 year
Transition from PEP to PrEP
Time frame: 1 year
Feasibility of implementing online PrEP
Time frame: 1 year
Acceptability of online PrEP
Time frame: 1 year
Cost associated with online PEP delivery
Time frame: 1 year
Cost associated with online PrEP delivery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monisha Sharma, PhD, MSPH principal investigator
University of Washington
Katrina F Ortblad, ScD, MPH principal investigator
Fred Hutch Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online PEP/PrEP delivery in people with HIV Infections, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.