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. 2024 Jun 19;25(1):394.
doi: 10.1186/s13063-024-08206-6.

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

Harison K Lagat  1 , Jillian Pintye  2 , Elizabeth Harrington  1 , Samantha Houck  1 , Zachary Kwena  3 , Meena Lenn  3 , Felix Mogaka  3 , Vincent Momanyi  3 , Melissa Mugambi  4 , Bernard Nyerere  3 , Josephine Odoyo  3 , Victor Omollo  3 , Katrina F Ortblad  4 , Greshon Rota  3 , Monisha Sharma  1 , Elizabeth A Bukusi  1   3
Affiliations

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

Harison K Lagat et al. Trials. .

Abstract

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.

Keywords: AGYW; HIV prevention; Nurse navigator; Pharmacy-based delivery; PrEP adherence; Pre-exposure prophylaxis.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Distribution of study sites in Kisumu County, Kenya [20]
Fig. 2
Fig. 2
Information-motivation-behavioral skills model for PrEP adherence (adapted from Fisher 2006 and Ferrer et al. 2010). AGYW, adolescent girls and young women; HIV, human immunodeficiency virus; PrEP, pre-exposure prophylaxis
Fig. 3
Fig. 3
PrEP pathway in randomization arms. AGYW, adolescent girls and young women; HIV, human immunodeficiency virus; PrEP, pre-exposure prophylaxis [23]
See this image and copyright information in PMC

References

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