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NCT05467306Active, not recruiting

Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1900 (estimated)
First submitted
13 Jul 2022
Start date
17 May 2023
Primary completion date
31 Mar 2027
Lead sponsor
University of Washington
Diseases
HIV
NCT number
NCT05467306

What you commit to

  • Study type: Interventional
  • Planned participants: 1900
  • From 17 May 2023 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
  • Currently taking PrEP

Other illness

  • Not willing to receive PrEP screening per national guidelines including HIV testing

Age

  • Age \<14 and \>24 years old

Other

  • Male gender
  • Not able and/or willing to provide informed consent for participation

Who the study is looking for

  • 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

Age in the registry: 15 years to 24 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kenya Medical Research Institute
Coordinator of this site? Confirm its status
KisumuKenyaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.