Journal Article

PrEPared to choose: the protocol for an implementation study of the delivery of cabotegravir long-acting injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within a real world PrEP choice context in cape town

Macdonald, P., Pike, C., Lebelo, K., Rousseau, E., Mapukata, P., Little, F., Joseph-Davey, D., Bekker, L. G.

2025

Overview

Background Increasing choice among HIV pre-exposure prophylaxis (PrEP) products bears potential to increase uptake, persistence, and coverage amongst those at risk of HIV acquisition. Few studies have evaluated PrEP persistence during real-world delivery of multiple PrEP products from community-based sites to adolescents and young people. Methods The PrEPared to Choose (PtC) study delivers PrEP choice across oral, injectable, and vaginal ring options to adolescents and young people (15–29 years) and their potential male partners in Cape Town, South Africa. This phase 3B clinical trial utilizes a type 2 hybrid implementation design with co-primary clinical and implementation aims that include an analysis of PrEP persistence (defined as sustained use of PrEP product as intended with < 7 vs. < 28 day gap in dosing as scheduled) over the short term (7 months) and long term (18 months), and the identification of implementation strategies that best support PrEP adoption and persistence. PtC is delivered from a mobile clinic and a public health primary care clinic, staffed by trained nurses, HIV counsellors, and peer-navigators. PrEP selection is guided by a co-created PrEP choice counselling intervention, with allowance for product switching at subsequent visits, but no reimbursement for PrEP uptake or return. Discussion PrEPared to Choose will provide an early report of real-world PrEP choice delivery, including all three currently available and approved modalities. The protocol is designed to simulate a real-world environment that provides insight into likely PrEP persistence patterns and practical challenges to PrEP choice implementation in a high HIV burden setting (South Africa) and within high HIV incidence populations (adolescents and young people). The results will be used to inform PrEP choice delivery in South Africa and build a framework into which future, emerging PrEP modalities can be incorporated. Trial approvals and registration This is a phase 3B clinical trial registered with the South African Health Products Regulatory Authority (20230904). Ethical approval was granted by the Human Research Ethics Committee (Faculty of Health Sciences, University of Cape Town, 567/2023). It is registered with the South African National Clinical Trial Registry (DOH-27-012024-5189, 26 January 2024) and ClinicalTrials.gov (NCT06807736, retrospectively registered on 4 February 2025).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adolescents / Adolescents and young people / Adult / Anti-HIV Agents - administration & dosage / Antiretroviral drugs / Biostatistics / Clinical research / Clinical trials / Clinical Trials, Phase III as Topic / College faculty / Delayed-Action Preparations / Diketopiperazines / Disease prevention / Dosage / Environmental Health / Epidemiology / Ethics / Female / Health sciences / Health services / HIV / HIV (Viruses) / HIV infection / HIV Infections - prevention & control / HIV prevention / Human immunodeficiency virus / Humans / Implementation / Injectable PrEP / Injections / Male / Medicine / Medicine & Public Health / Nurses / Pre-Exposure Prophylaxis - methods / PrEP choice / Prevention / Prevention programs / Preventive medicine / Primary care / Primary nursing / Prophylaxis / Public Health / Pyridones / Registration / Regulatory agencies / Research ethics / Sexually transmitted diseases / South Africa / Study Protocol / Teenagers / Towns / Uptake / Vaccine / Womens health / Young Adult / Young adults / Youth