HIV PreventionPeerPrEPNCT04982250

Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya

A study testing Enhanced peer PrEP referral + HIVST delivery in people with HIV Prevention, run by Fred Hutchinson Cancer Center at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Prevention
What is being tested?: Enhanced peer PrEP referral + HIVST delivery
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteKenya
Study dates: 24 Feb 2022to 27 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 24 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

For peer providers (qualitative data, pilot):
Age ≥16 to 24 years*
Female
Have been on PrEP for a minimum of three months
Good adherence to PrEP (i.e., self-report take PrEP all the time)
Willing to disclose PrEP use to their peers

Show all 29Show fewer

Able to identify up to 4 peers at risk of HIV infection
Willing to participate in training with study counselors on PrEP referral and HIVST use
Willing to refer peers to PrEP and deliver HIVSTs
Able and willing to provide written informed consent
Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer providers (cRCT):
Age ≥16 to 24 years*
Female
Must have refilled or initiated PrEP (i.e., been dispensed PrEP)
Not currently enrolled in an HIV study
Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition
Willing to participate in training with study counselors on PrEP referral and HIVST use
Willing to refer peers to PrEP and deliver HIVSTs
Able and willing to provide written informed consent
Willing to provide contact information for follow-up
Willing to engage in all research activities including completion of questionnaires
Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer clients (pilot, RCT):
Age ≥16 to 24 years*
Female
Referred by peer (i.e., a PrEP users) to initiate PrEP
Able and willing to provide informed consent
NOTE: We will only enroll young women ≥16 to 17 years into the study if they are emancipated minors and thus able to legally provide consent for participation in research. Kenyan law acknowledges women ages 14 to 17 who have become pregnant as emancipated minors. The PHRD site/UW collaboration has successfully enrolled emancipated minors into a number of prior studies, including PrEP clinical trials. In addition, Kenya's national policy guidelines explicitly permit PrEP use in this age group.

Who cannot join

For peer providers (qualitative data, pilot):
Age ≥16 or >24 years
Male
Have not used PrEP for a minimum of three months
Not willing to disclose PrEP use to their peers
Not able to identify up to 4 peers at risk of HIV infection

Show all 24Show fewer

Not willing to participate in training with study counselors on PrEP referral and HIVST use
Not willing to refer peers to PrEP and deliver HIVSTs
Not able and willing to provide written informed consent
For peer providers (cRCT):
Age ≥16 or >24 years
Male
Have not used PrEP
Currently enrolled in an HIV study
Not able to identify up to 4 peers at risk of HIV infection
Illiterate
Not willing to participate in training with study counselors on PrEP referral and HIVST use
Not willing to refer peers to PrEP and deliver HIVSTs
Not able and willing to provide written informed consent
For peer clients (pilot, cRCT):
Age ≥16 or >24 years
Male
Not referred by peer (i.e., a PrEP users) to initiate PrEP
Not able and willing to provide written informed consent

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Partners in Health and Research Development
Thika

Other trials in Kenya

About this study

Official title: Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial

Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: enhanced peer PrEP referral with HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to standard informal word-of-month peer PrEP referral (currently ongoing in Kenya), enhanced peer PrEP referral with HIVST delivery will increase PrEP initiation, continuation, and adherence among peers; have high fidelity; and be low cost.

Read the detailed description

HIV PrEP is highly effective, but uptake remains low among young women in Africa, one of the populations at greatest HIV risk. In Kenya, one of the target groups for HIV incidence reduction is young women (16-24 years), who account for 33% of the total of new HIV infections yet comprise only 10% of the population. Barriers to PrEP initiation for this population are multi-faceted and include institutional (e.g., stigma associated with use) and intra-personal (e.g., lack of PrEP knowledge or self-efficacy) barriers. Thus, innovative PrEP delivery models that can overcome these barriers are needed. The opinion of peers often influences the behaviors and preferences of young women, including those related to health and health care. Most young women who have initiated PrEP in Kenya to date have done so because of informal peer referral, thus peer referral enhanced with training and HIVST delivery has the potential to increase PrEP initiation among members of this population. HIVST is a new technology that has the potential to enhance peer PrEP referral. Much of the emphasis on HIVST to date has been on identifying new individuals living with HIV and facilitating linkage to treatment, but most individuals who self-test will test negative and may be interested in starting prevention services, like PrEP.

We hypothesize that an enhanced peer PrEP referral model with HIVST delivery can increase PrEP initiation among young Kenyan women at HIV risk compared to standard informal peer PrEP referral. We conducted formative qualitative research to inform the design of such a model and propose refining this model in a pilot study with 16 young female PrEP users (i.e., "peer providers" or "index peers") who will be encouraged to referred up to four peer (i.e., "peer clients" or "referred peers"; =64 in total) using the defined implementation strategies (i.e., formalized training on PrEP and HIVST, and HIVST delivery). At one month, we will measure model adoption (e.g., peer referral, PrEP initiation) and feasibility (e.g., peer follow up) using survey data and qualitatively measure model acceptability using focus group discussions (FDGs) with index and referred peers (4-5 FDGs, 3-6 women/FDG).

We will incorporate findings from the pilot into a refined version of the enhanced peer PrEP referral with HIVST delivery model and test this compared to standard peer PrEP referral in hybrid effectiveness-implementation cluster-randomized controlled trial (cRCT). In our cRCT, we will randomize 80 index peers to either: 1) enhanced peer PrEP referral, where they are encouraged to refer 4 peer (i.e., "referred peers") to PrEP using an educational brochure, HIVSTs (2/peer), and a MOH-style referral slip, or 2) standard peer PrEP referral, where they are encouraged to refer 4 peer clients to PrEP using word-of-mouth, as is ongoing in Kenya, and a MOH-style referral slip. All trial outcomes will be measured among referred peers, as reported by index peers, three months later. Effectiveness outcomes will include PrEP initiation [primary], PrEP continuation (any refilling), and recent HIV testing (past 3 months); self-reported PrEP adherence will be assessed among referred peers reached for follow-up. Implementation outcomes will include model acceptability, fidelity, and costs. The results from this cRCT will address one of the greatest challenges to PrEP scale-up today and inform an R01 proposal for a community-randomized trial and budget impact analysis.

Conditions: HIV Prevention
Being tested: Enhanced peer PrEP referral + HIVST delivery
Keywords: Kenya, adolescent girls and young women (AGYW), HIV pre-exposure prophylaxis (PrEP) delivery, HIV self-testing delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced peer PrEP referral + HIVST deliveryBehavioural
After a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards.

Study groups in NCT04982250
Study group	Role	What they receive
"Enhanced peer PrEP referral + HIVST delivery"	Experimental	After a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards. Receives: Behavioral: Enhanced peer PrEP referral + HIVST delivery
"Standard peer PrEP referral"	No intervention	Young female PrEP users will be encouraged to refer 4 peers to PrEP using informal word-of-mouth recruitment strategies and Kenya MOH-style referral cards.

What is being measured

The primary outcome is the main question the study is designed to answer.

cRCT: PrEP Initiation
Number of referred peers that initiated PrEP, among all referred peers, as reported by index peers.
Measured: 3 months
Pilot: PrEP Initiation, as Reported by Index Peers
Number of referred peers that initiated PrEP, among all eligible referred peers, as reported by index peers.
Measured: 1 month
Pilot: PrEP Initiation, as Reported by Referred Peers
Number of referred peers that initiated PrEP, among eligible referred peers who enrolled and completed follow-up, as reported by referred peers.
Measured: 1 month

Secondary outcomes (6)

Pilot: PrEP Referral
Number of referred peers referred to PrEP, among all referred peers, as reported by index peers.
Measured: 1 month
Pilot: HIVST Use
Number of referred peers that used HIVST, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Measured: 1 month
cRCT: Recent HIV Testing
Number of referred peers who tested for HIV (any form, including HIVST) since peer PrEP referral, among all referred peers, as reported by index peers.
Measured: 3 months
cRCT: PrEP Continuation (Referred Peers)
Number of referred peers that returned to a clinic to refill PrEP since referral, among all referred peers, as reported by index peers.
Measured: 3 months
cRCT: PrEP Continuation (Index Peers)
Number of index peers that returned to a clinic to refill PrEP in the past 3 months.
Measured: 3 months
cRCT: PrEP Adherence
A 0-100 point PrEP adherence score derived from the validated three-item Wilson et al Adherence scale with higher scores indicating higher adherence, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202227 Aug 2024

First posted29 Jul 2021
Study start24 Feb 2022
Primary completion5 Jun 2024
Study completion27 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies of the same condition, open and under way.
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
Model description: The pilot study will be a single group model (anticipated N=104), and the RCT will be a parallel model (anticipated N=400).
Masking: None (open label)
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04982250
Sponsor's protocol ID: RG1121770
Other IDs: K99MH121166
Acronym: PeerPrEP
Status last verified: Oct 2025
First submitted: 23 Jul 2021
Last updated: 3 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All data (deidentified) used for primary, secondary, and other outcomes reported in the main manuscript along with a data dictionary.

Publications

Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
PubMed 27098408
Ortblad KF, Wairimu N, Culquichicon C, Njeru I, Malen RC, Reedy AM, Ekwunife O, McGowan M, Mwangi M, Muthoni A, Kiboi D, Njoroge S, Gao F, Baeten JM, Ngure K. Effect of enhanced peer PrEP referral with HIV self-testing delivery among young Kenyan women: A randomized controlled trial of peer networks. PLoS Med. 2026 Mar 30;23(3):e1005023. doi: 10.1371/journal.pmed.1005023. eCollection 2026 Mar.
PubMed 41911315
Wairimu N, Malen RC, Reedy AM, Mogere P, Njeru I, Culquichicon C, McGowan M, Gao F, Baeten JM, Ngure K, Ortblad KF. Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial. Trials. 2023 Nov 4;24(1):705. doi: 10.1186/s13063-023-07734-x.
PubMed 37925450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial
ClinicalTrials.gov ID: NCT04982250
Acronym / sponsor ID: PeerPrEP / RG1121770
Conditions: HIV Prevention
Keywords: Kenya, adolescent girls and young women (AGYW), HIV pre-exposure prophylaxis (PrEP) delivery, HIV self-testing delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 24 Feb 2022 (actual)
Primary completion: 5 Jun 2024 (actual)
Study completion: 27 Aug 2024 (actual)
First posted: 29 Jul 2021 (actual)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The pilot study will be a single group model (anticipated N=104), and the RCT will be a parallel model (anticipated N=400).

Arm	Type	Receives
"Enhanced peer PrEP referral + HIVST delivery"	Experimental	Behavioral: Enhanced peer PrEP referral + HIVST deliveryAfter a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards.
"Standard peer PrEP referral"	No intervention	–Young female PrEP users will be encouraged to refer 4 peers to PrEP using informal word-of-mouth recruitment strategies and Kenya MOH-style referral cards.

Who may qualify

Ages: 16 to 24 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (29 listed)

Age ≥16 to 24 years*
Female
Have been on PrEP for a minimum of three months
Good adherence to PrEP (i.e., self-report take PrEP all the time)
Willing to disclose PrEP use to their peers

Key exclusion criteria (24 listed)

Age ≥16 or >24 years
Male
Have not used PrEP for a minimum of three months
Not willing to disclose PrEP use to their peers
Not able to identify up to 4 peers at risk of HIV infection

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
Enhanced peer PrEP referral + HIVST deliveryAfter a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards.	Behavioural	"Enhanced peer PrEP referral + HIVST delivery"

Primary outcome

cRCT: PrEP Initiation
Time frame: 3 months
Number of referred peers that initiated PrEP, among all referred peers, as reported by index peers.
Pilot: PrEP Initiation, as Reported by Index Peers
Time frame: 1 month
Number of referred peers that initiated PrEP, among all eligible referred peers, as reported by index peers.
Pilot: PrEP Initiation, as Reported by Referred Peers
Time frame: 1 month
Number of referred peers that initiated PrEP, among eligible referred peers who enrolled and completed follow-up, as reported by referred peers.

6 secondary outcomes

Pilot: PrEP Referral
Time frame: 1 month
Pilot: HIVST Use
Time frame: 1 month
cRCT: Recent HIV Testing
Time frame: 3 months
cRCT: PrEP Continuation (Referred Peers)
Time frame: 3 months
cRCT: PrEP Continuation (Index Peers)
Time frame: 3 months
cRCT: PrEP Adherence
Time frame: 3 months

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot: Index Peers (k)	16	16
Pilot: Referred Peers (n)	56	30
cRCT: Enhanced Group; Index Peers (k)	40	40
cRCT: Standard Group; Index Peers (k)	42	42
cRCT: Enhanced Group; Referred Peers (n)	137	55
cRCT: Standard Group; Referred Peers (n)	104	28

Primary outcome: cRCT: PrEP Initiation

Time frame: 3 months. Count of participants. Unit: Participants

Measure	cRCT: Enhanced Group; Referred Peers (n) n = 137	cRCT: Standard Group; Referred Peers (n) n = 104
Value	41	41

cRCT: Enhanced Group; Referred Peers (n) vs cRCT: Standard Group; Referred Peers (n): Risk Difference (RD): -6 (95% CI -26 to 11)

Population analysed: Outcome only applies to cRCT referred peers.

Primary outcome: Pilot: PrEP Initiation, as Reported by Index Peers

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Pilot: Referred Peers (n) n = 55
Value	43

Population analysed: Outcome only applies to pilot referred peers. The denominator (n=55) excludes one referred peer reported as HIV-positive.

Primary outcome: Pilot: PrEP Initiation, as Reported by Referred Peers

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Pilot: Referred Peers (n) n = 26
Value	22

Population analysed: Outcome only applies to pilot referred peers who enrolled and completed follow-up. The denominator (n=26) excludes four referred peers who were already/currently using PrEP at the time of referral.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot: Index Peers (k)	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Pilot: Referred Peers (n)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
cRCT: Enhanced Group; Index Peers (k)	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40
cRCT: Standard Group; Index Peers (k)	0 of 42 (0%)	1 of 42 (2.4%)	0 of 42
cRCT: Enhanced Group; Referred Peers (n)	0 of 55 (0%)	0 of 55 (0%)	0 of 55
cRCT: Standard Group; Referred Peers (n)	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Limitations and caveats (from the sponsor): Limitations included relying on index peers to report outcomes for referred peers in our primary analysis; low enrollment and follow-up among referred peers; relying on self-report for HIV testing and PrEP outcomes; and the relatively short follow-up period for all study participants (one month for pilot and three months for cRCT).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27098408Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
Derived from this study: PubMed 41911315Ortblad KF, Wairimu N, Culquichicon C, Njeru I, Malen RC, Reedy AM, Ekwunife O, McGowan M, Mwangi M, Muthoni A, Kiboi D, Njoroge S, Gao F, Baeten JM, Ngure K. Effect of enhanced peer PrEP referral with HIV self-testing delivery among young Kenyan women: A randomized controlled trial of peer networks. PLoS Med. 2026 Mar 30;23(3):e1005023. doi: 10.1371/journal.pmed.1005023. eCollection 2026 Mar.
Derived from this study: PubMed 37925450Wairimu N, Malen RC, Reedy AM, Mogere P, Njeru I, Culquichicon C, McGowan M, Gao F, Baeten JM, Ngure K, Ortblad KF. Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial. Trials. 2023 Nov 4;24(1):705. doi: 10.1186/s13063-023-07734-x.
Individual participant dataSharing planned: Yes. All data (deidentified) used for primary, secondary, and other outcomes reported in the main manuscript along with a data dictionary.

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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.

Katrina F Ortblad, ScD, MPH principal investigator

Fred Hutchinson 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 Enhanced peer PrEP referral + HIVST delivery in people with HIV Prevention, run by Fred Hutchinson Cancer Center 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 29 inclusion and 24 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 3 Nov 2025. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

cRCT: PrEP Initiation (time frame: 3 months). 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?

On the ClinicalTrials.gov record for NCT04982250, which also lists 3 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 3 Nov 2025.