Trial design and enrolment characteristics of LATA (long-acting treatment in adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to

Anena, Diana, Chappell, Elizabeth, Nazzinda, Rashidah et al. (25 more authors) (Accepted: 2025) Trial design and enrolment characteristics of LATA (long-acting treatment in adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to. Contemporary Clinical Trials. 108213. ISSN: 1551-7144 (In Press)

Abstract

Background Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults. Methods LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12-

Metadata

Item Type:	Article
Authors/Creators:	Anena, Diana Chappell, Elizabeth Nazzinda, Rashidah Kiilu, Cecilia Chitsamatanga, Moses Arumugam, Tiyara Green, Alexandra Mutuluuza, Cissy Kityo Bwakura-Dangarembizi, Mutsa Siika, Abraham Archary, Moherndran Jafta, Lungile Namukwaya, Stella Seeley, Janet Akabwai, George Mugerwa, Henry Bevers, Lisanne Burger, David Walker, Simon https://orcid.org/0000-0002-5750-3691 Bamford, Alasdair South, Annabelle Apoto, Naomi Bush, Molly Thomason, Margaret J. Spittle, Ben Ford, Deborah Kekitiinwa, Adeodata R. Pett, Sarah L.
Copyright, Publisher and Additional Information:	This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.
Keywords:	HIV,Adolescents,Cabotegravir and rilpivirine,Antiretroviral therapy,Injectable,Clinical trial
Dates:	Accepted: 31 December 2025
Institution:	The University of York
Academic Units:	The University of York > Faculty of Social Sciences (York) > Centre for Health Economics (York)
Date Deposited:	09 Jan 2026 11:00
Last Modified:	09 Jan 2026 11:00
Published Version:	https://doi.org/10.1016/j.cct.2025.108213
Status:	In Press
Refereed:	Yes
Identification Number:	10.1016/j.cct.2025.108213
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:236320

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