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Background <p>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.</p> Methods <p>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 &lt; 7 vs. &lt; 28&#xa0;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.</p> Discussion <p>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.</p> Trial approvals and registration <p>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).</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月24日

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

摘要

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).