HivNCT05467306
Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
A study testing Nurse-Navigator Enhanced PrEP Support in people with Hiv, run by University of Washington at 1 site in Kenya.
Trial summary
The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Nurse-Navigator Enhanced PrEP Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteKenya
- Study dates
- 17 May 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female gender
- Seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age between ≥14 and <25 years old
- Willingness to receive PrEP screening per national guidelines including HIV testing
- Not currently taking PrEP
- Able and willing to provide informed consent for participation
Who cannot join
- Male gender
- Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age <14 and >24 years old
- Not willing to receive PrEP screening per national guidelines including HIV testing
- Currently taking PrEP
- Not able and/or willing to provide informed consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.
Read the detailed description
In Aim 1, the investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.
Pharmacy selection for cluster RCT (Aim 1): The investigators conducted a landscape analysis of all pharmacies in Kisumu, Kenya as part of the team's ongoing pharmacy-based PrEP delivery studies. In this analysis, the investigators gathered information on the types of customers who attend pharmacies, the types of services offered (e.g., HIV testing) and products purchased (e.g., contraceptive methods) at pharmacies, and availability of a separate private consultation room. The investigators will select 20 pharmacies based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms).
Randomization (Aim 1): All the pharmacies will receive standard pharmacy-based PrEP delivery and be randomized to either receive (n=10 pharmacies) or not receive (n=10 pharmacies) a nurse-navigator to assist with PrEP delivery. To ensure balance between randomization arms in terms of key site characteristics, sites will be categorized on AGYW volume (i.e., monthly number of purchases made by AGYW clients) and distribution frequency of contraceptive methods purchased (based on pharmacy log data) and restricted randomization will be used for site (cluster) allocation to intervention and control arms. Specifically, all possible randomizations that evenly distribute sites on these specified factors (AGYW client volume and distribution of contraceptive methods) into 2 study arms will be generated, and one combination will be selected using a random number generator. Randomization and allocation will be performed by a biostatistician from the UW CFAR Biometrics Core, who has no knowledge of sites other than the variables included in the restricted randomization process, and the Study Statistician, who received an MPH in Biostatistics from UW, will supervise the randomization process. Once assigned, the randomization allocation will be unblinded. Since the randomization will occur at the pharmacy level, it is impossible to blind study team members or participants to the randomization assignments. However, procedures to minimize the influence of the unblinded nature of this study on outcomes will be implemented. Ongoing data monitoring will not include information about study endpoints disaggregated by site or study arm. Only the study statistician will review data on study endpoints by study arm or facility.
- Conditions
- Hiv
- Being tested
- Nurse-Navigator Enhanced PrEP Support
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Navigator Enhanced PrEP SupportBehavioural
Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Navigator Enhanced PrEP Support | Experimental | Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits. Receives: Behavioral: Nurse-Navigator Enhanced PrEP Support |
| Standard PrEP services | No intervention | Standard PrEP services |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation
Binary endpoint (Yes/No) based on self-reported use of daily oral PrEP pills or the DPV-VR at 1-month follow-up after acceptance at enrollment. Self-reported PrEP use will be considered initiation. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance, the participant will be considered non-initiated
Measured: At enrollment
PrEP persistence
Binary endpoint (Yes/No) based on self-reported persistent use of daily oral PrEP pills or the DPV-VR at 10-month follow-up after initiation at 1-month follow-up. Self-reported PrEP use will be considered persistence. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance or discontinued PrEP before 10 months, the participant will be considered non-persistent
Measured: at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start17 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jillian Pintye, University of Washington
- Investigators
- Jillian Pintye, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467306
- Sponsor's protocol ID
- STUDY00013956
- Other IDs
- R01HD108041
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2022
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lagat HK, Pintye J, Harrington E, Houck S, Kwena Z, Lenn M, Mogaka F, Momanyi V, Mugambi M, Nyerere B, Odoyo J, Omollo V, Ortblad KF, Rota G, Sharma M, Bukusi EA. Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial. Trials. 2024 Jun 19;25(1):394. doi: 10.1186/s13063-024-08206-6.
PubMed 38890744
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
- ClinicalTrials.gov ID
- NCT05467306
- Acronym / sponsor ID
- STUDY00013956
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 May 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Jul 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.
The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.
Detailed description
In Aim 1, the investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.
Pharmacy selection for cluster RCT (Aim 1): The investigators conducted a landscape analysis of all pharmacies in Kisumu, Kenya as part of the team's ongoing pharmacy-based PrEP delivery studies. In this analysis, the investigators gathered information on the types of customers who attend pharmacies, the types of services offered (e.g., HIV testing) and products purchased (e.g., contraceptive methods) at pharmacies, and availability of a separate private consultation room. The investigators will select 20 pharmacies based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms).
Randomization (Aim 1): All the pharmacies will receive standard pharmacy-based PrEP delivery and be randomized to either receive (n=10 pharmacies) or not receive (n=10 pharmacies) a nurse-navigator to assist with PrEP delivery. To ensure balance between randomization arms in terms of key site characteristics, sites will be categorized on AGYW volume (i.e., monthly number of purchases made by AGYW clients) and distribution frequency of contraceptive methods purchased (based on pharmacy log data) and restricted randomization will be used for site (cluster) allocation to intervention and control arms. Specifically, all possible randomizations that evenly distribute sites on these specified factors (AGYW client volume and distribution of contraceptive methods) into 2 study arms will be generated, and one combination will be selected using a random number generator. Randomization and allocation will be performed by a biostatistician from the UW CFAR Biometrics Core, who has no knowledge of sites other than the variables included in the restricted randomization process, and the Study Statistician, who received an MPH in Biostatistics from UW, will supervise the randomization process. Once assigned, the randomization allocation will be unblinded. Since the randomization will occur at the pharmacy level, it is impossible to blind study team members or participants to the randomization assignments. However, procedures to minimize the influence of the unblinded nature of this study on outcomes will be implemented. Ongoing data monitoring will not include information about study endpoints disaggregated by site or study arm. Only the study statistician will review data on study endpoints by study arm or facility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Navigator Enhanced PrEP Support | Experimental | Behavioral: Nurse-Navigator Enhanced PrEP SupportPharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits. |
| Standard PrEP services | No intervention | –Standard PrEP services |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female gender
- Seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age between ≥14 and <25 years old
- Willingness to receive PrEP screening per national guidelines including HIV testing
- Not currently taking PrEP
Key exclusion criteria (6 listed)
- Male gender
- Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age <14 and >24 years old
- Not willing to receive PrEP screening per national guidelines including HIV testing
- Currently taking PrEP
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 |
|---|---|---|
| Nurse-Navigator Enhanced PrEP SupportPharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits. | Behavioural | Nurse-Navigator Enhanced PrEP Support |
Primary outcome
PrEP initiation
Time frame: At enrollment
Binary endpoint (Yes/No) based on self-reported use of daily oral PrEP pills or the DPV-VR at 1-month follow-up after acceptance at enrollment. Self-reported PrEP use will be considered initiation. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance, the participant will be considered non-initiated
PrEP persistence
Time frame: at 10 months
Binary endpoint (Yes/No) based on self-reported persistent use of daily oral PrEP pills or the DPV-VR at 10-month follow-up after initiation at 1-month follow-up. Self-reported PrEP use will be considered persistence. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance or discontinued PrEP before 10 months, the participant will be considered non-persistent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 38890744Lagat HK, Pintye J, Harrington E, Houck S, Kwena Z, Lenn M, Mogaka F, Momanyi V, Mugambi M, Nyerere B, Odoyo J, Omollo V, Ortblad KF, Rota G, Sharma M, Bukusi EA. Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial. Trials. 2024 Jun 19;25(1):394. doi: 10.1186/s13063-024-08206-6.
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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.
Jillian Pintye, 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 Nurse-Navigator Enhanced PrEP Support in people with Hiv, 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: At enrollment). The study lists 2 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 NCT05467306, which also lists 1 linked publication.
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 May 2026.