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While the progress towards reaching the UNAIDS 95-95-95 targets in South African adults seems promising, the progress in the paediatric population is lagging far behind; only 79% percent of children living with HIV know their status. Of these, only 47% are on treatment, and a mere 34% of those are virally suppressed. Thus, virological suppression has been attained in only 13% of children living with HIV in South Africa. Multiple factors contribute to the high treatment failure rate, one of them being a lack of paediatric-friendly antiretroviral treatment (ART) formulations. For example, the Lopinavir/ritonavir syrup, which is the current mainstay of ART for young children, has an extremely unpleasant taste, contributing to the poor tolerability and lack of adherence by children using the formulation. Furthermore, the lack of appropriate formulations limits the optimisation of regimens, especially for young children and those who cannot swallow tablets. Switching from syrups to dispersible tablets will improve ease of administration and adherence and result in cost-saving. Despite the approval of simplified paediatric-friendly formulations internationally, including other sub-Saharan African countries, unnecessary delays are experienced in South Africa. Clinician groups and community organisations must speak up and demand that approvals be expedited to ensure the delivery of life-changing and life-saving formulations to our patients as a matter of urgency.

IntroductionMen who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.Methods and analysisThrough extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention’s potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.Ethics and disseminationThis study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.Registration detailsRegistered under the National Institutes of Health’s ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017–0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.