Improving PrEP access for young women in Kenya through pharmacies
Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
NA · University of Washington · NCT05467306
This study is testing if using nurse-navigators in pharmacies can help young women in Kenya start and stick with a daily HIV prevention pill called PrEP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | Female |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT05467306 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the initiation, persistence, and adherence to pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kisumu, Kenya, by utilizing nurse-navigators within a pharmacy-based delivery model. A total of 20 retail pharmacies will be randomized into two groups, with 1900 AGYW participants enrolled after purchasing contraceptives. Participants will be offered either daily oral PrEP or the DPV-VR and will be followed for 10 months to assess the effectiveness of the intervention. The study will measure and compare PrEP outcomes at the pharmacy level between the two groups, along with secondary outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 14 to 24 who are seeking contraception from participating pharmacies.
Not a fit: Patients who are male, not seeking contraception, or currently taking PrEP will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve PrEP uptake and adherence among young women, thereby reducing HIV transmission rates.
How similar studies have performed: Previous studies have shown promising results in enhancing PrEP access and adherence through pharmacy-based models, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Kisumu
- Kenya Medical Research Institute — Kisumu, Kenya (RECRUITING)
Study contacts
- Principal investigator: Jillian Pintye, PhD — University of Washington
- Study coordinator: Meena Lenn
- Email: mlenn@uw.edu
- Phone: 206 221-7322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiv