Journal Article

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

Harrington, Elizabeth, Lagat, Harison K., Sharma, Monisha, Bukusi, Elizabeth A., Kwena, Zachary, Houck, Samantha, Momanyi, Vincent, Odoyo, Josephine, Omollo, Victor, Lenn, Meena, Rota, Greshon, Pintye, Jillian, Ortblad, Katrina F., Mugambi, Melissa, Mogaka, Felix, Nyerere, Bernard

2024

Overview

Background In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. Methods The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW ( n  = 1900 total, n  = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. Discussion We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. Trial Registration ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / AGYW / Anti-HIV Agents - administration & dosage / Antiretroviral drugs / Biomedicine / Birth control / Clinical trials / Clinics / Community Pharmacy Services / Condoms / Counseling / Customer services / Disease prevention / Drug stores / Drugstores / Female / Girls / Health Sciences / HIV / HIV (Viruses) / HIV Infections - prevention & control / HIV prevention / Human immunodeficiency virus / Humans / Immune system / Informed consent / Intervention / Kenya / Medical care / Medical tests / Medication Adherence / Medicine / Medicine & Public Health / Multicenter Studies as Topic / Nurse navigator / Nurses / Oral contraceptives / Participation / Pharmacy / Pharmacy-based delivery / Pre-exposure prophylaxis / Pre-Exposure Prophylaxis - methods / PrEP adherence / Prevention / Quality management / Randomized Controlled Trials as Topic / Sexual behavior / Sexually transmitted diseases / Statistics for Life Sciences / Study Protocol / Teenage girls / Teenagers / Time Factors / Treatment Outcome / Womens health / Young Adult / Young women