HIV PreventionEfficiencyNCT04424524
Streamlining the Efficiency of PrEP Implementation
A study testing Direct-to-pharmacy oral PrEP refill visits in people with HIV Prevention and HIV Preexposure Prophylaxis, run by University of Washington at 1 site in Kenya.
Trial summary
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention, HIV Preexposure Prophylaxis, Implementation
- What is being tested?
- Direct-to-pharmacy oral PrEP refill visits
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 1 siteKenya
- Study dates
- 1 May 2020to 30 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For HIV-negative participants:
- Of legal age (≥18 years)
- Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
- HIV uninfected based on negative HIV tests, per Kenya national guidelines
- Currently or previously accessed PrEP at participating HIV clinic
- For Key delivery informants:
- Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
- Works at any of the clinics implementing PrEP delivery. Key informants may include HIV testing service nurses, counselors, clinicians, social workers, or clinic managers.
Who cannot join
- Not meeting any of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.
Read the detailed description
A prospective, pilot implementation evaluation of patient-centered differentiated care service. The core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in PrEP delivery is in part at the system level, above and beyond the individual client encounter. For this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design.
The specific aims are:
Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP continuation, and 3) adherence.
Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated PrEP delivery model.
Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated PrEP care.
- Conditions
- HIV Prevention, HIV Preexposure Prophylaxis, Implementation
- Being tested
- Direct-to-pharmacy oral PrEP refill visits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-to-pharmacy oral PrEP refill visitsOther
Programmatic direct-to-pharmacy oral PrEP refill visits supported with client HIV self-testing
| Study group | Role | What they receive |
|---|---|---|
| Direct-to-pharmacy oral PrEP refill visits | Other | Intervention Receives: Other: Direct-to-pharmacy oral PrEP refill visits |
| Usual care | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient wait time
Total waiting time at the clinic and contact time with providers measured by time and motion studies
Measured: up to 6 months
PrEP continuation
Measured by return to clinic for PrEP refill
Measured: up to 6 months
PrEP adherence
Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
Measured: up to 6 months
Acceptability of direct-to-pharmacy PrEP care pathway
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Measured: up to 6 months
Acceptability of user HIV self-testing for PrEP care pathway
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Measured: up to 6 months
Feasibility of direct-to-pharmacy PrEP care pathway
Assessed by the Feasibility of Intervention Psychometric Measure (FIM)
Measured: up to 6 months
Secondary outcomes (6)
Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Evaluated through in-depth and key informants qualitative interviews
Measured: up to 6 months
Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Evaluated through in-depth and key informants qualitative interviews
Measured: up to 6 months
Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Extent to which core components of the direct-to-pharmacy PrEP care pathway are implemented as intended will be evaluated through checklists and surveys with clinic managers
Measured: up to 6 months
Safety of HIV self-testing
Accuracy of HIV self-testing measured by frequency false negative and positive tests.
Measured: up to 6 moths
Reasons for PrEP discontinuation
Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use
Measured: up to 6 months
Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Measured through micro-activity costing and time and motion studies
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 May 2020
- Primary completion30 Jun 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kenneth K Mugwanya, University of Washington
- Investigators
- Kenneth Mugwanya, MBChB, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424524
- Sponsor's protocol ID
- STUDY00007949
- Other IDs
- R00MH118134
- Acronym
- Efficiency
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2020
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from Streamlining Efficiency of PrEP Implementation Study will be available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
Publications
Zewdie KB, Ngure K, Mwangi M, Mwangi D, Maina S, Etyang L, Maina G, Ogello V, Owidi E, Mugo NR, Baeten JM, Mugwanya KK. Effect of differentiated direct-to-pharmacy PrEP refill visits supported with client HIV self-testing on clinic visit time and early PrEP continuation. J Int AIDS Soc. 2024 Mar;27(3):e26222. doi: 10.1002/jia2.26222.
PubMed 38446643Wairimu N, Ngure K, Ogello V, Owidi E, Mwangi P, Etyang L, Waituika W, Mwangi M, Githuku DM, Maina S, Irungu E, Mugo N, Mugwanya KK. Low HIV-risk aligned discontinuation among HIV pre-exposure prophylaxis users within public HIV clinics in Kenya: A mixed method study. PLOS Glob Public Health. 2025 Apr 28;5(4):e0004493. doi: 10.1371/journal.pgph.0004493. eCollection 2025.
PubMed 40294082
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya
- ClinicalTrials.gov ID
- NCT04424524
- Acronym / sponsor ID
- Efficiency / STUDY00007949
- Conditions
- HIV Prevention, HIV Preexposure Prophylaxis, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Jun 2020 (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.
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.
Detailed description
A prospective, pilot implementation evaluation of patient-centered differentiated care service. The core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in PrEP delivery is in part at the system level, above and beyond the individual client encounter. For this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design.
The specific aims are:
Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP continuation, and 3) adherence.
Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated PrEP delivery model.
Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated PrEP care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct-to-pharmacy oral PrEP refill visits | Other | Other: Direct-to-pharmacy oral PrEP refill visitsIntervention |
| Usual care | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Of legal age (≥18 years)
- Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
- HIV uninfected based on negative HIV tests, per Kenya national guidelines
- Currently or previously accessed PrEP at participating HIV clinic
- Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
Key exclusion criteria (1 listed)
- Not meeting any of the inclusion criteria listed above.
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 |
|---|---|---|
| Direct-to-pharmacy oral PrEP refill visitsProgrammatic direct-to-pharmacy oral PrEP refill visits supported with client HIV self-testing | Other | Direct-to-pharmacy oral PrEP refill visits |
Primary outcome
Patient wait time
Time frame: up to 6 months
Total waiting time at the clinic and contact time with providers measured by time and motion studies
PrEP continuation
Time frame: up to 6 months
Measured by return to clinic for PrEP refill
PrEP adherence
Time frame: up to 6 months
Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
Acceptability of direct-to-pharmacy PrEP care pathway
Time frame: up to 6 months
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Acceptability of user HIV self-testing for PrEP care pathway
Time frame: up to 6 months
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Feasibility of direct-to-pharmacy PrEP care pathway
Time frame: up to 6 months
Assessed by the Feasibility of Intervention Psychometric Measure (FIM)
6 secondary outcomes
Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time frame: up to 6 months
Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time frame: up to 6 months
Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time frame: up to 6 months
Safety of HIV self-testing
Time frame: up to 6 moths
Reasons for PrEP discontinuation
Time frame: up to 6 months
Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time frame: up to 6 months
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 13 Aug 2024.
- Results publication: PubMed 38446643Zewdie KB, Ngure K, Mwangi M, Mwangi D, Maina S, Etyang L, Maina G, Ogello V, Owidi E, Mugo NR, Baeten JM, Mugwanya KK. Effect of differentiated direct-to-pharmacy PrEP refill visits supported with client HIV self-testing on clinic visit time and early PrEP continuation. J Int AIDS Soc. 2024 Mar;27(3):e26222. doi: 10.1002/jia2.26222.
- Derived from this study: PubMed 40294082Wairimu N, Ngure K, Ogello V, Owidi E, Mwangi P, Etyang L, Waituika W, Mwangi M, Githuku DM, Maina S, Irungu E, Mugo N, Mugwanya KK. Low HIV-risk aligned discontinuation among HIV pre-exposure prophylaxis users within public HIV clinics in Kenya: A mixed method study. PLOS Glob Public Health. 2025 Apr 28;5(4):e0004493. doi: 10.1371/journal.pgph.0004493. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data from Streamlining Efficiency of PrEP Implementation Study will be available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
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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.
Kenneth Mugwanya, MBChB, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct-to-pharmacy oral PrEP refill visits in people with HIV Prevention and HIV Preexposure Prophylaxis, 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 8 inclusion and 1 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 13 Aug 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?
Patient wait time (time frame: up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424524, which also lists 2 linked publications.
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 13 Aug 2024.