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Authors
Pike, C.
Rousseau, E.
Macdonald, P.
Mapukata, P.
Lebelo, K.
Joseph-Davey, D.
Little, F.
Bekker, L. G.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct06807736 at ClinicalTrials.govDocuments that mention this clinical trial
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
https://doi.org/10.1186/s12889-025-24370-z
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Funding
Funding for this research was provided by:
Bill and Melinda Gates Foundation (INV-033649, INV-033649, INV-033649, INV-033649, INV-033649, INV-033649, INV-033649, INV-033649)
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Article History
Received: 10 February 2025
Accepted: 8 August 2025
First Online: 24 September 2025
Declarations
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: ViiV Healthcare donated the injectable study product (Cabotegravir long-acting). The authors have no further competing interests to declare.
: Ethical approval for the study was granted by the Human Research Ethics Committee of the University of Cape Town, Faculty of Health Sciences (HREC 567/2023). Participation in the project is voluntary. Participants are asked to provide digital informed consent for data collection, and parental waiver of consent to participate has been approved for adolescents aged 15–17 years. PrEPared to Choose is registered as a phase 3B clinical trial with the South African Health products Regulatory Authority (Ref: 20230904). The study is registered with the South African National Clinical Trial Registry (DOH-27-012024-5189, registered on 26 January 2024) and and ClinicalTrials.gov (NCT06807736, retrospectively registered on 4 February 2025). It is conducted with support and approval from the City of Cape Town (ref: 10968). This protocol paper correlates with version 2.1, November 2024 of the protocol.
: Not applicable.
